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COMPLICATIONS
Potential complications (e.g. infection) that may be associated with the use of the
SENOMARK® are the same as those associated with the use of other biopsy marking
devices.
SENOMARK Biopsy Site Marker
®
For use with 9 Gauge ATEC™
HOW SUPPLIED
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ENGLISH
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Instructions For Use
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of
a physician.
Plunger (A)
Handle (B)
DESCRIPTION
The SenoRx Inc. SENOMARK® Biopsy Site Marker consists of a disposable
applicator containing:
3
resorbable polyglycolic acid (PGA) pads. The center pad
contains a titanium wireform.
1
polyethylene glycol (PEG) plug at the proximal end.
Secondary Alignment
Indicator (C)
ATEC™ Stop
with Alignment
Indicator (D)
Adaptor (E)
(slide back for 9 cm cannula
or remove for 12 cm cannula)
The wireform is intended for long-term radiographic marking of the biopsy site.
The pads are visible via ultrasound for approximately 3 weeks and are essentially
resorbed in approximately 12 weeks.
7KHV\ULQJHOLNHDSSOLFDWRU¿WVZLWKLQWKHJDXJHATEC™ to access the biopsy
cavity.1 Pads are deployed from the applicator through the biopsy device and into
the biopsy cavity.
Tip Protector (G)
INTENDED USE
The SENOMARK® is intended to radiographically and sonographically mark breast
tissue during a percutaneous breast biopsy procedure.
Pellet Deployment
Aperture (F)
CONTRAINDICATIONS
This device is not intended for use except as indicated.
WARNINGS
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1.
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2.
Inspect the package to ensure that the package integrity has not been
compromised. The product is sterile unless the seal is broken.
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package and check for damage. REMOVE TIP PROTECTOR (G).
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4.
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9.
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PRECAUTIONS
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procedures.
Figure 1
Make certain that the collection of biopsy specimens has been completed.
Ensure that the sample notch has been cleared of all tissue.
Remove Adaptor (E) if using ATEC™FP/RUFP
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3ODFHWKHSENOMARK® applicator into the ATEC™ biopsy device cannula and
advance until the ATEC™VWRS'RUWKH$GDSWRU(LVVHDWHGLQWKHFDQQXOD
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device cannula.
Immediately deploy the SENOMARK® pads by advancing the plunger (A) while
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applicator with the sample notch. The pads will be fully dispensed when the
plunger contacts the handle.
Rotate the biopsy device cannula 180 degrees to position the sample notch
away from the dispensed pads.
10. Remove the SENOMARK® applicator from the biopsy device cannula. Avoid the
use of force. (See Caution below.)
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instructions.
package is damaged.
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Caution:,IDQ\UHVLVWDQFHLVHQFRXQWHUHGZKLOHUHPRYLQJWKHDSSOLFDWRUOHDYH
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‡ 0DLQWDLQFRUUHFWDOLJQPHQWRIWKHLQGLFDWRUV&'LQ)LJXUHZLWKWKHVDPSOH the SENOMARK applicator within the probe and remove the entire probe/applicator
assembly. Failure to do so may result in breakage of the applicator tip.
notch when dispensing pads.
Assembled in Thailand.
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© 2012 by C. R. Bard Inc. All rights reserved.
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The SENOMARK® is compatible with the 9 Gauge 9cm and 12cm ATEC™%LRSV\'HYLFH
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COMPLICATIONS
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Piston (A)
DESCRIPTION
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applicateur à usage unique contenant les éléments suivants :
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Poignée (B)
Indicateur d’ alignement
secondaire (C)
Butee ATEC™
avec indicateur
d’alignement (D)
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sont essentiellement résorbés en 12 semaines environ.
Adaptateur (E)
(glisser pour une canule
de 9 cm ou retirer pour
une canule de 12 cm)
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ATEC™ calibre 9 pour accéder
à la cavité de biopsie.1/HVFXORWVVRQWGpSOR\pVGHSXLVO¶DSSOLFDWHXUGDQVODFDYLWp
de biopsie en passant par le dispositif de biopsie.
APPLICATION
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Cache de l’embout (G)
Obturateur de
déploiement
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AVERTISSEMENTS
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soit installé dans la canule.
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endommagé.
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tampons sont entièrement distribués lorsque le piston entre en contact avec
la poignée.
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aux instructions du fabricant.
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Assemblé en Thaïlande.
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© 2012 by C. R. Bard Inc. Tous droits réservés.
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anderer Biopsiemarkierungsprodukte einhergehen.
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Sekundäre Ausrichtungsanzeige (C)
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Adapter (E)
(bei 9 cm-Kanule
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Kraftaufwand vermeiden (siehe untenstehende Vorsichtshinweise).
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$SSOLNDWRURUGQXQJVJHPl‰HQWVRUJHQ
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SENOMARK®-Applikator in der Sonde belassen und die gesamte Sonden-/Applikator(LQKHLWHQWIHUQHQ$QGHUQIDOOVNDQQHV]XP%UXFKGHU$SSOLNDWRUVSLW]HNRPPHQ
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Zusammengebaut in Thailand.
‡ 9HU|IIHQWOLFKWH6WXGLHQPLW/(GHOVWDKO%LRSVLHPDUNHUQYHUJOHLFKEDUHU
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© 2012 by C. R. Bard Inc. Alle Rechte vorbehalten.
1
'DVSENOMARK®-Produkt ist mit dem 9-cm- und 12-cm-ATEC™%LRSVLHJHUlW*DXJHNRPSDWLEHO
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COMPLICAZIONI
3RVVLELOLFRPSOLFD]LRQLDGHVHPSLRLQIH]LRQLFKHSRVVRQRHVVHUHFRQQHVVHDOO
XVR
del SENOMARK®VRQRDQDORJKHDOOHFRPSOLFD]LRQLOHJDWHDOO
XVRGLDOWULGLVSRVLWLYLGL
marcatura per biopsia.
SENOMARK 0DUFDWRUHGLVLWRGLELRSVLD
®
SHUO
XVRFRQATEC™GDJDXJH
CONDIZIONI DI STERILITÀ
ITALIANO
Il SENOMARK® viene fornito sterile ed è esclusivamente monouso.
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DESCRIZIONE
Stantuffo (A)
Il marcatore di sito di biopsia SENOMARK® SenoRx Inc. comprende un applicatore
monouso che contiene:
3
tamponi riassorbibili di acido poliglicolico (PGA). Il tam
SRQHFHQWUDOHFRQWLHQHXQDIRUPDGL¿ORLQWLWDQLR
WDSSRLQJOLFROSROLHWLOHQH3(*DOO
HVWUHPLWjSURVVLPDOH
Impugnatura (B)
Indicatore di allineamento
secondario (C)
Arresto ATEC™
con indicatore
dell’allineamento (D)
/DIRUPDGL¿ORqSUHYLVWDSHUO
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praticamente riassorbiti in circa 12 settimane.
Addattatore (E)
(far scorrere all’indietro per la
cannula da 9 cm o rimuovere per
la cannula da 12 cm)
/
DSSOLFDWRUHVLPLOHDXQDVLULQJDYLHQHLQVHULWRDOO
LQWHUQRGLXQGLVSRVLWLYR
ATEC™GDJDXJHSHUO
DFFHVVRDOODFDYLWjGLELRSVLD1 I tamponi sono distribuiti
GDOO
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Protettore punta (G)
USO PREVISTO
Apertura per erogazione
delle pastiglie (F)
Il SENOMARK®qSUHYLVWRSHUPDUFDUHUDGLRJUD¿FDPHQWHHVRQRJUD¿FDPHQWHLO
tessuto mammario durante un intervento di biopsia mammaria percutanea.
CONTROINDICAZIONI
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XVRLQGLFDWR
Figura 1
AVVERTENZE
‡ ,SD]LHQWLFRQQRWDLSHUVHQVLELOLWjDLPDWHULDOLHOHQFDWLQHOODGHVFUL]LRQH
SRVVRQRVRIIULUHGLXQDUHD]LRQHDOOHUJLFDDWDOHLPSLDQWR
‡ LOGLVSRVLWLYRSENOMARK®QRQqUDFFRPDQGDWRSHUO
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1.
Assicurarsi che la raccolta dei campioni di biopsia sia stata comple tata.
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3527(7725('(//$3817$*
‡ 4XHVWRGLVSRVLWLYRqLQGLFDWRHVFOXVLYDPHQWHSHUXVRVLQJROR,OULXWLOL]]R
GLTXHVWRGLVSRVLWLYRPHGLFDOHFRPSRUWDLOULVFKLRGLFRQWDPLQD]LRQH
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RLPSRVVLELOLGDSXOLUHXQDYROWDFKHÀXLGLRWHVVXWLRUJDQLFLFKH
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FRPSOLFDQ]HGLWLSRLQIHWWLYR
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ULVWHULOL]]D]LRQHDFDXVDGLXQDSRWHQ]LDOHFRQWDPLQD]LRQHSLURJHQD
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SUHVHQWHGLVSRVLWLYRPHGLFDOHDXPHQWDQRODSUREDELOLWjGLXQVXRFDWWLYR
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PRECAUZIONI
‡ questo dispositivo deve essere usato esclusivamente da medici competenti
negli interventi di biopsia percutanea.
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FP/RFP3HWLWH3HULO'LVSRVLWLYRSHUELRSVLDATEC™
FP/RFP3HWLWHIDUVFRUUHUHO¶$GDWWDWRUH(
YHUVRO¶LPSXJQDWXUD¿QRDTXDQGRQRQVLLQQHVWDFRQO¶DUUHVWR'VXOO¶DOEHUR
GHOO¶DSSOLFDWRUH
6HJXHQGROHLVWUX]LRQLGLATEC™ULPXRYHUHLOPHFFDQLVPRGLJXLGDGDOOD
FDQQXODGHOGLVSRVLWLYRSHUELRSVLDODVFLDQGRODFDQQXODQHOOD
&ROORFDUHO¶DSSOLFDWRUHSENOMARK® nella cannula del dispositivo per biopsia
ATEC™HIDUHDYDQ]DUH¿QRDTXDQGRO¶DUUHVWRATEC™'RO¶DGDWWDWRUH(
non si sistema nella cannula.
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cannula del dispositivo per biopsia.
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saranno completamente distribuiti quando lo stantuffo entra in contatto con
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tacca del campione lontano dai tamponi distribuiti.
(VWUDUUHO¶DSSOLFDWRUHSENOMARK® dalla cannula del dispositivo per biopsia.
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‡ non usare questo prodotto se la barriera sterile è stata aperta o se la
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‡ questo prodotto è fornito sterile ed è esclusivamente monouso. NON
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Assemblato in Tailandia.
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VLVWHPD05,DXQDSRWHQ]DGLFDPSRGL7
© 2012 by C. R. Bard Inc. Tutti i diritti riservati.
‡ PDQWHQHUHJOLLQGLFDWRUL&H'QHOOD)LJXUDFRUUHWWDPHQWHDOOLQHDWLFRQOD
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COMPLICACIONES
/DVFRPSOLFDFLRQHVSRWHQFLDOHVSHMLQIHFFLyQTXHSXHGHQDVRFLDUVHDOXVR
del SENOMARK® son las mismas que se asocian al uso de otros dispositivos de
marcación en biopsias.
PRESENTACIÓN
El SENOMARK®VHVXPLQLVWUDHVWHULOL]DGR\HVWiFRQFHELGRSDUDXQVRORXVR
SENOMARK 0DUFDGRUGHVLWLRVSDUDELRSVLDV
®
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INSTRUCCIONES DE USO
Émbolo (A)
DESCRIPCIÓN
Mango (B)
El marcador de sitios para biopsias SENOMARK de SenoRx Inc. consta de un
aplicador desechable que contiene:
®
3
almohadillas de ácido poliglicólico (PGA) reabsorbibles.
/DDOPRKDGLOODFHQWUDOFRQWLHQHXQDHVWUXFWXUDGHDODPEUHGHWLWDQLR
1
tapón de polietilenglicol (PEG) en el extremo proximal.
/DHVWUXFWXUDGHDODPEUHHVWiGLVHxDGDSDUDXWLOL]DUVHFRPRPDUFDGRUUDGLRJUi¿FR
GHOVLWLRGHODELRSVLDDODUJRSOD]R/DVDOPRKDGLOODVVRQYLVLEOHVSRUHFRJUDItD
GXUDQWHVHPDQDVDSUR[LPDGDPHQWH\VHUHDEVRUEHQFDVLWRWDOPHQWHHQXQDV
12 semanas.
(ODSOLFDGRUFRQIRUPDGHMHULQJDVHDFRSODHQHOATEC™ de calibre 9 para acceder
a la cavidad de biopsia.1/DVDOPRKDGLOODVVHH[SXOVDQGHODSOLFDGRUDWUDYpVGHO
dispositivo de biopsia al interior de la cavidad de biopsia.
USO PREVISTO
El SENOMARK®HVWiGLVHxDGRSDUDPDUFDUUDGLRJUi¿FD\HFRJUi¿FDPHQWHHOWHMLGR
mamario durante un procedimiento de biopsia mamaria percutánea.
CONTRAINDICACIONES
Este dispositivo no tiene otro uso que el indicado.
ADVERTENCIAS
‡ /RVSDFLHQWHVFRQKLSHUVHQVLELOLGDGFRQRFLGDDORVPDWHULDOHV
HQXPHUDGRVHQODGHVFULSFLyQGHOGLVSRVLWLYRSXHGHQSUHVHQWDUUHDFFLyQ
DOpUJLFDDHVWHLPSODQWH
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PDPDULDV
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FRQWDPLQDFLyQHQWUHSDFLHQWHV\DTXHORVGLVSRVLWLYRVPpGLFRV
HVSHFLDOPHQWHDTXpOORVFRQO~PHQHVSHTXHxRV\ODUJRVXQLRQHV\R
KHQGLGXUDVHQWUHFRPSRQHQWHVVRQGLItFLOHVRLPSRVLEOHVGHOLPSLDUXQD
YH]TXHORVOtTXLGRVFRUSRUDOHVRWHMLGRVFRQSRWHQFLDOGHFRQWDPLQDFLyQ
SLUyJHQDRPLFURELDQDKDQHQWUDGRHQFRQWDFWRFRQHOGLVSRVLWLYR
PpGLFRGXUDQWHXQSHULRGRGHWLHPSRLQGHWHUPLQDGR(OPDWHULDO
ELROyJLFRUHVLGXDOSXHGHIRPHQWDUODFRQWDPLQDFLyQGHOGLVSRVLWLYR
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LQIHFFLRVDV
‡ 1RUHHVWHULOL]DU'HVSXpVGHODUHHVWHULOL]DFLyQQRVHJDUDQWL]DOD
HVWHULOLGDGGHOSURGXFWRGHELGRDOQLYHOLQGHWHUPLQDGRGHSRVLEOH
FRQWDPLQDFLyQPLFURELDQDRSLUyJHQDTXHSRGUtDFDXVDUFRPSOLFDFLRQHV
LQIHFFLRVDV/DOLPSLH]DHOUHSURFHVDPLHQWR\RODUHHVWHULOL]DFLyQGH
HVWHGLVSRVLWLYRPpGLFRDXPHQWDQODSUREDELOLGDGGHIXQFLRQDPLHQWR
LQFRUUHFWRGHOGLVSRVLWLYRGHELGRDSRVLEOHVHIHFWRVDGYHUVRVVREUHORV
FRPSRQHQWHVLQÀXHQFLDGRVSRUFDPELRVWpUPLFRV\RPHFiQLFRV
PRECAUCIONES
‡ (OGLVSRVLWLYRGHEHVHUXWLOL]DGRH[FOXVLYDPHQWHSRUPpGLFRVFRQODIRUPDFLyQ
adecuada en procedimientos de biopsia percutáneos.
‡ 1RXWLOLFHHVWHSURGXFWRVLODSURWHFFLyQHVWpULOVHKDDELHUWRSUHYLDPHQWHRVL
HOSDTXHWHSUHVHQWDGDxRV
‡ (VWHSURGXFWRVHVXPLQLVWUDHQFRQGLFLRQHVGHHVWHULOLGDG\HVWiGLVHxDGR
para un solo uso. 125((67(5,/,=$5
‡ 1RGREOHHOWXERÀH[LEOH
‡ $OLQHHFRUUHFWDPHQWHORVLQGLFDGRUHV&\'HQOD¿JXUDFRQODPXHVFDSDUD
muestras cuando dispense las almohadillas.
‡ Asegúrese de que se liberan todas las almohadillas.
‡ $OPDFHQHDXQDWHPSHUDWXUDLQIHULRUHVDž&
‡ /RVHVWXGLRVSXEOLFDGRVFRQPDUFDGRUHVGHELRSVLDGHDFHURLQR[LGDEOH
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VLJQL¿FDWLYRGHORVPDUFDGRUHVFXDQGRORVHQVD\RVVHUHDOL]DQHQXQVLVWHPD
GH50FRQXQDLQWHQVLGDGGHFDPSRGH7
5
Indicador de alineación
secundario (C)
Tope del ATEC™
con indicador de
alineación(D)
Adaptador (E)
(deslizar hacia atrás para cánula
de 9 cm o extraer para cánula
de 12 cm)
Protector de la punta (G)
Abertura de colocación de
esferas(F)
Figura 1
1.
Asegúrese de que la recogida de espécimenes de biopsia haya concluido.
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2.
Revise el paquete para comprobar su integridad. El producto permanecerá
estéril si el paquete no está abierto o roto.
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&RORTXHHODSOLFDGRUSENOMARK® en la cánula del dispositivo de biopsia
ATEC™ y avance hasta que el tope del ATEC™'RHODGDSWDGRU(HVWpQ
ELHQVXMHWRVDODFiQXOD
$OLQHHORVLQGLFDGRUHV&\'GHOSENOMARK® con la muesca para muestras
de la cánula del dispositivo de biopsia.
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pPEROR$PLHQWUDVHMHUFHSUHVLyQKDFLDGHODQWHVREUHHOPDQJR%\FRUULMD
ODDOLQHDFLyQGHODSOLFDGRUFRQODPXHVFDGHODPXHVWUD/DVDOPRKDGLOODVVH
liberarán en su totalidad cuando el émbolo entre en contacto con el mango.
*LUHODFiQXODGHOGLVSRVLWLYRGHELRSVLDJUDGRVSDUDDOHMDUODPXHVFD
para muestras de las almohadillas dispensadas.
10. Extraiga el aplicador SENOMARK® de la cánula del dispositivo de biopsia. Evite
XWLOL]DUODIXHU]D9HDOD3UHFDXFLyQDFRQWLQXDFLyQ
11.
Cierre la muesca para muestras y retire el dispositivo de biopsia siguiendo
las instrucciones del fabricante.
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&RQ¿UPHODSRVLFLyQ¿QDOGHOPDUFDGRUPHGLDQWHWpFQLFDVGHDGTXLVLFLyQGH
imágenes.
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SENOMARK® HQODVRQGD\UHWLUHHOFRQMXQWRFRPSOHWRGHVRQGD\DSOLFDGRU6LQR
DFW~DDVtODSXQWDGHODSOLFDGRUSRGUtDURPSHUVH
Ensamblado en Tailandia.
© 2012 by C. R. Bard Inc. Todos los derechos reservados.
SENOMARK® es compatible con los dispositivos de biopsia ATEC™GHFDOLEUHGH\FP
IDEULFDGRVSRU6XURV6XUJLFDO6\VWHPV,QF)UDQNOLQ,1
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COMPLICATIES
0RJHOLMNHFRPSOLFDWLHV]RDOVLQIHFWLHGLHJHSDDUGNXQQHQJDDQPHWKHWJHEUXLN
van de SENOMARK®]LMQGH]HOIGHDOVGHFRPSOLFDWLHVGLHNXQQHQRSWUHGHQELMKHW
gebruik van andere biopsiemarkeringshulpmiddelen.
SENOMARK®ELRSVLHSODDWVPDUNHULQJVKXOSPLGGHO
9RRUJHEUXLNPHWATEC™YDQJDXJH
LEVERING
'HSENOMARK® wordt steriel geleverd en is uitsluitend bedoeld voor eenmalig
gebruik.
NEDERLANDS
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BESCHRIJVING
+HW6HQR5[,QFSENOMARK® biopsieplaatsmarkeringshulpmiddel bestaat uit een
wegwerpapplicator met:
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bevat een titanium draadvorm.
1
plug van polyethyleenglycol (PEG) aan het proximale uiteinde.
Plunjer (A)
Handvat (B)
'HGUDDGYRUPLVEHGRHOGYRRUODQJGXULJHU|QWJHQPDUNHULQJYDQGHELRSVLHSODDWV
'HSDGV]LMQJHGXUHQGHRQJHYHHUZHNHQ]LFKWEDDUPHWHFKRJUD¿HHQZRUGHQ
binnen ongeveer 12 weken grotendeels geresorbeerd.
Secundaire
uitlijnindicator (C)
ATEC™ stopper
met uitlijnindicator (D)
'HRSHHQLQMHFWLHVSXLWOLMNHQGHDSSOLFDWRUZRUGWLQJHEUDFKWLQGHATEC™
YDQJDXJHYRRUKHWYHUNULMJHQYDQWRHJDQJWRWGHELRSVLHKROWH1 Via het
biopsiehulpmiddel worden de pads door de applicator in de biopsieholte
afgegeven.
Adapter (E)
(terugschuiven voor canule
van 9 cm of verwijderen
voor canule van 12 cm)
BEOOGD GEBRUIK
'HSENOMARK®LVEHGRHOGYRRUU|QWJHQRORJLVFKHQHFKRJUD¿VFKPDUNHUHQYDQ
ERUVWZHHIVHOWLMGHQVHHQSHUFXWDQHELRSVLHSURFHGXUHYDQGHERUVW
Tipbescherming (G)
Afgifteopening
voor korrels (F)
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WAARSCHUWINGEN
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GLH]LMQYHUPHOGLQGHEHVFKULMYLQJYDQKHWKXOSPLGGHONDQ]LFKHHQ
DOOHUJLVFKHUHDFWLHRSGLWLPSODQWDDWYRRUGRHQ
Afbeelding 1
‡ 'HSENOMARK®ZRUGWQLHWDDQEHYROHQYRRUJHEUXLNELMSDWLsQWHQPHW
ERUVWLPSODQWDWHQ
1.
Zorg ervoor dat de afname van biopsiemonsters is voltooid. Controleer of de
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‡ 1LHWJHEUXLNHQELMDDQZH]LJKHLGYDQLQIHFWLH
‡ 9HUPLMGKHWJHEUXLNYDQRYHUPDWLJHNUDFKWWLMGHQVKHWYHUZLMGHUHQYDQGH DSSOLFDWRURPEUHNHQYDQGHDSSOLFDWRUWLSWHYRRUNRPHQ
‡ 'LWKXOSPLGGHOLVRQWZRUSHQYRRUJHEUXLNELMppQSDWLsQW+HUJHEUXLN
YDQGLWPHGLVFKHKXOSPLGGHOEUHQJWKHWULVLFRPHW]LFKPHH
YDQNUXLVFRQWDPLQDWLHWXVVHQSDWLsQWHQRPGDWPHGLVFKHKXOSPLGGHOHQ±
PHWQDPHKXOSPLGGHOHQPHWODQJHVPDOOHOXPLQDJHZULFKWHQHQRI
VSOHWHQWXVVHQGHRQGHUGHOHQ±PRHLOLMNRIRQPRJHOLMNWHUHLQLJHQ]LMQ
DOVOLFKDDPVYORHLVWRIIHQRIZHHIVHOPHWPRJHOLMNS\URJHQHRIPLFURELsOH FRQWDPLQDWLHHHQPDDOJHGXUHQGHRQEHSDDOGHWLMGLQFRQWDFW]LMQ
JHNRPHQPHWKHWPHGLVFKHKXOSPLGGHO5HVWHQELRORJLVFKPDWHULDDO
NXQQHQGHYHURQWUHLQLJLQJYDQKHWKXOSPLGGHOPHWS\URJHQHQRIPLFUR
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RSWUHGHQ
‡ 1LHWRSQLHXZVWHULOLVHUHQ1DKHUVWHULOLVDWLHNDQGHVWHULOLWHLWYDQKHW
SURGXFWQLHWZRUGHQJHJDUDQGHHUGRPGDWHHQRQEHSDDOGHPDWHYDQ
PRJHOLMNS\URJHQHRIPLFURELsOHYHURQWUHLQLJLQJDDQZH]LJNDQ]LMQGLH
WRWLQIHFWLHX]HFRPSOLFDWLHVNDQOHLGHQ'RRUKHWEHWUHIIHQGHPHGLVFKH
KXOSPLGGHOWHUHLQLJHQRSQLHXZJHUHHGWHPDNHQYRRUJHEUXLNHQRI
RSQLHXZWHVWHULOLVHUHQQHHPWGHNDQVWRHGDWKHWKXOSPLGGHOVOHFKW
IXQFWLRQHHUWZHJHQVKHWPRJHOLMNQHJDWLHYHHIIHFWRSGHRQGHUGHOHQGLH
ZRUGHQEHwQYORHGGRRUWKHUPLVFKHHQRIPHFKDQLVFKHYHUDQGHULQJHQ
1HHPPHWEHKXOSYDQHHQVWDQGDDUGDVHSWLVFKHWHFKQLHNKHWSENOMARK®
hulpmiddel uit de verpakking en controleer het op beschadiging.
9(5:,-'(5'(7,3%(6&+(50,1**
9HUZLMGHUDGDSWHU(DOVXKHWATEC™FP/RIFP
3HWLWHELRSVLHKXOSPLGGHOJHEUXLNW6FKXLIELMKHWATEC™FP/RI
0909-12 (9 cm Petite) biopsiehulpmiddel de adapter (E) in de richting van het
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9HUZLMGHUDDQGHKDQGYDQGHLQVWUXFWLHVELMGHATEC™KHWDDQGULMI
PHFKDQLVPHYDQGHFDQXOHYDQKHWELRSVLHKXOSPLGGHOWHUZLMOXGHFDQXOHLQ
GHERUVWODDW]LWWHQ
3ODDWVGHSENOMARK® applicator in de canule van het ATEC™ biopsieKXOSPLGGHOHQYRHUGH]HRSWRWGHATEC™VWRSSHU'RIGHDGDSWHU(LQGH
canule is ingebracht.
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het biopsiehulpmiddel.
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GXZHQWHUZLMOXYRRUZDDUWVHGUXNEOLMIWXLWRHIHQHQRSKHWDSSOLFDWRUKDQGYDW%
HQFRUULJHHUGHXLWOLMQLQJYDQGHDSSOLFDWRUPHWGHLQNHSLQJ$OOHSDGVZRUGHQ
DIJHJHYHQZDQQHHUGHSOXQMHUWHJHQKHWKDQGYDWNRPW
'UDDLGHFDQXOHYDQKHWELRSVLHKXOSPLGGHOJUDGHQRPGHLQNHSLQJXLWGH
buurt van de afgegeven pads te plaatsen.
VOORZORGSMAATREGELEN
‡ +HWKXOSPLGGHOPDJXLWVOXLWHQGZRUGHQJHEUXLNWGRRUDUWVHQPHWHHQRSOHLGLQJ 9HUZLMGHUGHSENOMARK® applicator uit de canule van het biopsie-hulpmiddel.
in percutane biopsieprocedures.
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‡ Gebruik dit product niet als de steriele barrière eerder geopend is of als de
verpakking beschadigd is.
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van de fabrikant.
‡ 'LWSURGXFWZRUGWVWHULHOJHOHYHUGHQLVXLWVOXLWHQGEHGRHOGYRRUHHQPDOLJ
gebruik. 1,(7231,(8:67(5,/,6(5(1
:HUSGHDSSOLFDWRURSGHMXLVWHZLM]HZHJ
%HYHVWLJGHGH¿QLWLHYHSRVLWLHYDQGHPDUNHULQJDDQGHKDQGYDQ
beeldvorming.
‡ Zorg dat er geen knikken in de slang komen.
Let op:$OVXWLMGHQVKHWYHUZLMGHUHQYDQGHDSSOLFDWRUZHHUVWDQGRQGHUYLQGWODDW
u de SENOMARK®DSSOLFDWRULQGHVRQGH]LWWHQHQYHUZLMGHUWXGHVRQGHDSSOLFDWRU
YROOHGLJ$OVXGLWQLHWGRHWkan de applicatortip breken.
‡ =RUJELMKHWDIJHYHQYDQGHSDGVGDWGHLQGLFDWRUHQ&HQ'LQDIEHHOGLQJ
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‡ Controleer of alle pads worden afgegeven.
Geassembleerd in Thailand.
‡ %HZDUHQELMWHPSHUDWXUHQRQGHUž&
© 2012 by C. R. Bard Inc. Alle rechten voorbehouden.
‡ *HSXEOLFHHUGHVWXGLHVPHW/URHVWYULMVWDOHQELRSVLHPDUNHULQJHQYDQ
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1
'HSENOMARK® is compatibel met het ATEC™ biopsiehulpmiddel van 9 gauge en een lengte van
FPHQFPGDWZRUGWYHUYDDUGLJGGRRU6XURV6XUJLFDO6\VWHPV,QF)UDQNOLQ,QGLDQD96
6
&203/,&$d®(6
$VSRWHQFLDLVFRPSOLFDo}HVSRUH[HPSORLQIHFomRTXHSRGHPHVWDUDVVRFLDGDV
jXWLOL]DomRGRSENOMARK®VmRLJXDLVjVDVVRFLDGDVjXWLOL]DomRGHRXWURV
dispositivos de marcação de biopsia.
SM®
0DUFDGRUGR/RFDOGH%LRSVLDSENOMARK®
3DUDXWLOL]DomRFRPXPATEC™GHFDOLEUH
APRESENTAÇÃO
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PORTUGUÊS
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Êmbolo (A)
DESCRIÇÃO
20DUFDGRUGR/RFDOGH%LRSVLDSENOMARK® da SenoRx Inc. consiste num
aplicador descartável que contém:
Pega (B)
F RPSUHVVDVUHDEVRUYtYHLVGHiFLGRSROLJOLFyOLFR3*$$FRPSUHVVD
central contém um marcador metálico em titânio.
1
tampão em polietilenoglicol (PEG) na extremidade proximal.
Indicador de Alinhamento
Secundário (C)
Batente ATEC™ com
Indicador de
Alinhamento (D)
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da biopsia. $VFRPSUHVVDVVmRYLVtYHLVSRUXOWUDVRQVGXUDQWHDSUR[LPDGDPHQWH
3 semanas e são essencialmente reabsorvidas no espaço de aproximadamente
12 semanas.
Adaptador (E) (deslocar
para trás para uma cânula
de 9 cm ou retirar para
uma cânula de 12 cm)
O aplicador do tipo seringa encaixa no ATEC™ de calibre 9 para aceder à cavidade
de biopsia.1$VFRPSUHVVDVVmRLQWURGX]LGDVSHORDSOLFDGRUDWUDYpVGRGLVSRVLWLYR
de biopsia e dentro da cavidade de biopsia.
Protector da Ponta (G)
UTILIZAÇÃO PREVISTA
O SENOMARK®GHVWLQDVHDPDUFDUGHIRUPDUDGLRJUi¿FDHVRQRJUi¿FDRWHFLGRGD
mama durante um procedimento de biopsia percutânea da mama.
Abertura de Aplicação de
Grânulos (F)
&2175$,1',&$d®(6
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Figura 1
ADVERTÊNCIAS
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DHVWHLPSODQWH
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PDPiULRV
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‡ (VWHGLVSRVLWLYRIRLFRQFHELGRDSHQDVSDUDXWLOL]DomR~QLFD
$UHXWLOL]DomRGHVWHGLVSRVLWLYRPpGLFRDSUHVHQWDRULVFRGHFULDU
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1.
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tecido.
2.
Inspeccione a embalagem para garantir que a integridade da embalagem
não foi comprometida. O produto encontra-se estéril a menos que o selo
tenha sido violado.
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HPEDODJHPHYHUL¿TXHVHDSUHVHQWDGDQRV5(7,5(23527(&725'$
3217$*
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FP/RXFP3HWLWH1RFDVRGR'LVSRVLWLYRGH
Biopsia ATEC™FP/RXFP3HWLWHIDoDGHVOL]DUR
$GDSWDGRU(QDGLUHFomRGDSHJDDWpTXHHVWHHQJDWHQREDWHQWH'QD
haste do aplicador.
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&RORTXHRDSOLFDGRUSENOMARK® na cânula do dispositivo de biopsia ATEC™
e faça-o avançar até que o batente ATEC™'RXR$GDSWDGRU(¿TXH
assente na cânula.
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8.
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35(&$8d®(6
‡ 2GLVSRVLWLYRGHYHDSHQDVVHUXWLOL]DGRSRUPpGLFRVFRPIRUPDomRHP
procedimentos de biopsia percutânea.
10.
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1­25((67(5,/,=$5
12.
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câmara de extracção de amostra ao distribuir compressas.
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amostra na cânula do dispositivo de biopsia.
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rPEROR$HQTXDQWRPDQWpPDSUHVVmRSDUDDIUHQWHQDSHJD%HR
alinhamento correcto do aplicador com a câmara de extracção de amostra.
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contacto com a pega.
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Retire o aplicador SENOMARK® da cânula do dispositivo de biopsia. Evite
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acordo com as instruções do fabricante.
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desta forma pode resultar na quebra da ponta do aplicador.
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Montado na Tailândia.
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de tamanho comparável não apresentaram deslocamento do marcador e
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sistema de IRM com uma força GHFDPSRGH7
© 2012 by C. R. Bard Inc. Todos os direitos reservados.
O SENOMARK®pFRPSDWtYHOFRPR'LVSRVLWLYRGH%LRSVLDATEC™ GHFDOLEUHGHHFP
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1
7
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ȅİijĮȡȝȠȖȑĮȢȠȠʌȠȓȠȢȑȤİȚIJȘȝȠȡijȒıȪȡȚȖȖĮȢİijĮȡȝȩȗİȚȝȑıĮıIJȘıȣıțİȣȒ
ATEC™ IJȦȞJDXJHȖȚĮʌȡȩıȕĮıȘıIJȘȞțȠȚȜȩIJȘIJĮȕȚȠȥȓĮȢ1ȉĮİʌȚșȑȝĮIJĮ
İțʌIJȪııȠȞIJĮȚĮʌȩIJȠȞİijĮȡȝȠȖȑĮįȚĮȝȑıȠȣIJȘȢıȣıțİȣȒȢȕȚȠȥȓĮȢțĮȚİȞIJȩȢIJȘȢ
țȠȚȜȩIJȘIJĮȢȕȚȠȥȓĮȢ
12 cm
ȋȇǾȈǾīǿǹȉǾȃȅȆȅǿǹȆȇȅȅȇǿǽǼȉǹǿ
(Z)
ȅȚȤȞȘșȑIJȘȢSENOMARK®ʌȡȠȠȡȓȗİIJĮȚȖȚĮIJȘȞĮțIJȚȞȠȖȡĮijȚțȒțĮȚȣʌİȡȘȤȠȖȡĮijȚțȒ
ȚȤȞȘșȑIJȘıȘȚıIJȠȪIJȠȣȝĮıIJȠȪțĮIJȐIJȘįȚȐȡțİȚĮİʌȑȝȕĮıȘȢįȚĮįİȡȝȚțȒȢȕȚȠȥȓĮȢIJȠȣ
ȝĮıIJȠȪ
(ΣΤ)
ǹȃȉǼȃǻǼǿȄǼǿȈ
ǾıȣıțİȣȒĮȣIJȒʌȡȠȠȡȓȗİIJĮȚĮʌȠțȜİȚıIJȚțȐțĮȚȝȩȞȠȖȚĮIJȘȞİȞįİȚțȞȣȩȝİȞȘȤȡȒıȘ
ȆȇȅǼǿǻȅȆȅǿǾȈǼǿȈ
Eικόνα 1
‡ ȅȚĮıșİȞİȓȢȝİȖȞȦıIJȒȣʌİȡİȣĮȚıșȘıȓĮıIJĮȣȜȚțȐʌȠȣĮȞĮijȑȡȠȞIJĮȚıIJȘȞ
ʌİȡȚȖȡĮijȒIJȘȢıȣıțİȣȒȢİȞįȑȤİIJĮȚȞĮİȝijĮȞȓıȠȣȞĮȜȜİȡȖȚțȒĮȞIJȓįȡĮıȘ
ıİĮȣIJȩIJȠİȝijȪIJİȣȝĮ
‡ ȅȚȤȞȘșȑIJȘȢSENOMARK®įİȞıȣȞȚıIJȐIJĮȚȖȚĮȤȡȒıȘıİĮıșİȞİȓȢȝİ
İȝijȣIJİȪȝĮIJĮȝĮıIJȠȪ
‡ ȂȘȤȡȘıȚȝȠʌȠȚİȓIJİʌĮȡȠȣıȓĮȜȠȓȝȦȟȘȢ
‡ ǹʌȠijȪȖİIJİIJȘȞİijĮȡȝȠȖȒȣʌİȡȕȠȜȚțȒȢįȪȞĮȝȘȢțĮIJȐIJȘȞĮijĮȓȡİıȘIJȠȣ
İijĮȡȝȠȖȑĮȖȚĮIJȘȞĮʌȠIJȡȠʌȒșȡĮȪıȘȢIJȠȣȐțȡȠȣIJȠȣİijĮȡȝȠȖȑĮ
‡ ǾıȣıțİȣȒĮȣIJȒȑȤİȚıȤİįȚĮıIJİȓȖȚĮȝȓĮȝȩȞȠȤȡȒıȘǾİʌĮȞȐȤȡȘıȘĮȣIJȒȢ
IJȘȢȚĮIJȡȚțȒȢıȣıțİȣȒȢİȞȑȤİȚIJȠȞțȓȞįȣȞȠįȚĮıIJĮȣȡȠȪȝİȞȘȢȝȩȜȣȞıȘȢ
IJȦȞĮıșİȞȫȞțĮșȫȢȠȚȚĮIJȡȚțȑȢıȣıțİȣȑȢ±ȚįȚĮȓIJİȡĮĮȣIJȑȢȝİȝĮțȡȚȠȪȢ
țĮȚȝȚțȡȠȪȢĮȣȜȠȪȢĮȡșȡȫıİȚȢȒțĮȚıȤȚıȝȑȢȝİIJĮȟȪIJȦȞȝİȡȫȞ±İȓȞĮȚ
įȪıțȠȜȠȒĮįȪȞĮIJȠȞĮțĮșĮȡȚıIJȠȪȞȝȩȜȚȢIJĮıȦȝĮIJȚțȐȣȖȡȐȒȠȚȚıIJȠȓ
ȝİʌȚșĮȞȒʌȣȡİIJȠȖȩȞȠȒȝȚțȡȠȕȚĮțȒȝȩȜȣȞıȘȑȜșȠȣȞıİİʌĮijȒȝİIJȘȞ
ȚĮIJȡȚțȒıȣıțİȣȒȖȚĮĮʌȡȠıįȚȩȡȚıIJȘȤȡȠȞȚțȒʌİȡȓȠįȠȉĮțĮIJȐȜȠȚʌĮ
ȕȚȠȜȠȖȚțȠȪȣȜȚțȠȪİȓȞĮȚįȣȞĮIJȩȞĮİȣȞȠȒıȠȣȞIJȘȝȩȜȣȞıȘIJȘȢıȣıțİȣȒȢ
ȝİʌȣȡİIJȠȖȩȞĮȒȝȚțȡȠȠȡȖĮȞȚıȝȠȪȢȘȠʌȠȓĮİȞįȑȤİIJĮȚȞĮȠįȘȖȒıİȚıİ
ȜȠȚȝȫįİȚȢİʌȚʌȜȠțȑȢ
‡ ȃĮȝȘȞİʌĮȞĮʌȠıIJİȚȡȫȞİIJĮȚȂİIJȐĮʌȩİʌĮȞĮʌȠıIJİȓȡȦıȘįİȞ
įȚĮıijĮȜȓȗİIJĮȚȘıIJİȚȡȩIJȘIJĮIJȠȣʌȡȠȧȩȞIJȠȢȜȩȖȦʌȚșĮȞȒȢʌȣȡİIJȠȖȩȞȠȣ
ȒȝȚțȡȠȕȚĮțȒȢȝȩȜȣȞıȘȢĮʌȡȠıįȚȠȡȓıIJȠȣȕĮșȝȠȪȘȠʌȠȓĮİȞįȑȤİIJĮȚȞĮ
ȠįȘȖȒıİȚıİȜȠȚȝȫįİȚȢİʌȚʌȜȠțȑȢȅțĮșĮȡȚıȝȩȢȘİʌĮȞİʌİȟİȡȖĮıȓĮȒ
țĮȚȘİʌĮȞĮʌȠıIJİȓȡȦıȘIJȘȢʌĮȡȠȪıĮȢȚĮIJȡȚțȒȢıȣıțİȣȒȢĮȣȟȐȞİȚIJȘȞ
ʌȚșĮȞȩIJȘIJĮįȣıȜİȚIJȠȣȡȖȓĮȢIJȘȢȜȩȖȦʌȚșĮȞȫȞĮȞİʌȚșȪȝȘIJȦȞĮȞIJȚįȡȐıİȦȞ
ıIJĮȝȑȡȘʌȠȣİʌȘȡİȐȗȠȞIJĮȚĮʌȩșİȡȝȚțȑȢ
ȒțĮȚȝȘȤĮȞȚțȑȢĮȜȜĮȖȑȢ
ȆȇȅĭȊȁǹȄǼǿȈ
‡ ǾıȣıțİȣȒșĮʌȡȑʌİȚȞĮȤȡȘıȚȝȠʌȠȚİȓIJĮȚȝȩȞȠȞĮʌȩȚĮIJȡȠȪȢİțʌĮȚįİȣȝȑȞȠȣȢıİ
İʌİȝȕȐıİȚȢįȚĮįİȡȝȚțȒȢȕȚȠȥȓĮȢ
‡ ȂȘȤȡȘıȚȝȠʌȠȚİȓIJİIJȠʌȡȠȧȩȞĮȣIJȩİȐȞȠıIJİȓȡȠȢijȡĮȖȝȩȢȑȤİȚʌȡȠȘȖȠȣȝȑȞȦȢ
ĮȞȠȚȤIJİȓȒȘıȣıțİȣĮıȓĮȑȤİȚȣʌȠıIJİȓȗȘȝȚȐ
‡ ȉȠʌȡȠȧȩȞĮȣIJȩʌĮȡȑȤİIJĮȚıIJİȓȡȠțĮȚʌȡȠȠȡȓȗİIJĮȚȖȚĮȝȓĮȝȩȞȠȤȡȒıȘȂǾȃ
ǼȆǹȃǹȆȅȈȉǼǿȇȍȃǼȉǼ
‡ ȂȘıIJȡİȕȜȫȞİIJİIJȠȞİȪțĮȝʌIJȠıȦȜȒȞĮ
‡ ȀĮIJȐIJȘȞIJȠʌȠșȑIJȘıȘIJȦȞİʌȚșİȝȐIJȦȞįȚĮIJȘȡȒıIJİIJȘȞȠȡșȒİȣșȣȖȡȐȝȝȚıȘIJȦȞ
ȚȤȞȘșİIJȫȞīțĮȚǻıIJȘȞİȚțȩȞĮȝİIJȘȞİȖțȠʌȒįİȚȖȝĮIJȠȜȘȥȓĮȢ
‡ ǻȚĮıijĮȜȓıIJİȩIJȚȑȤȠȣȞIJȠʌȠșİIJȘșİȓȩȜĮIJĮİʌȚșȑȝĮIJĮ
‡ ĭȣȜȐııİIJİıİșİȡȝȠțȡĮıȓĮȤĮȝȘȜȩIJİȡȘĮʌȩƒ&
‡ ȈİȝİȜȑIJİȢʌȠȣȑȤȠȣȞįȘȝȠıȚİȣșİȓȝİȚȤȞȘșȑIJİȢȕȚȠȥȓĮȢĮʌȩĮȞȠȟİȓįȦIJȠȤȐȜȣȕĮ
/ʌĮȡȩȝȠȚȠȣȝİȖȑșȠȣȢįİȞȑȤİȚțĮIJĮįİȚȤșİȓțȓȞȘıȘIJȦȞȚȤȞȘșİIJȫȞİȞȫ
țĮIJĮįİȓȤșȘțİĮıȒȝĮȞIJȘĮȪȟȘıȘIJȘȢșİȡȝȠțȡĮıȓĮȢIJȦȞȚȤȞȘșİIJȫȞțĮIJȐIJȘįȠțȚȝȒ
ıİıȪıIJȘȝĮĮʌİȚțȩȞȚıȘȢȝĮȖȞȘIJȚțȠȪıȣȞIJȠȞȚıȝȠȪ05,ȝİȑȞIJĮıȘʌİįȓȠȣȉ
8
ǺİȕĮȚȦșİȓIJİȩIJȚȑȤİȚȠȜȠțȜȘȡȦșİȓȘıȣȜȜȠȖȒIJȦȞįİȚȖȝȐIJȦȞȕȚȠȥȓĮȢ
ǻȚĮıijĮȜȓıIJİȩIJȚįİȞȣʌȐȡȤİȚȚıIJȩȢıIJȘȞİȖțȠʌȒįİȚȖȝĮIJȠȜȘȥȓĮȢ
ǼʌȚșİȦȡȒıIJİIJȘıȣıțİȣĮıȓĮȫıIJİȞĮįȚĮıijĮȜȓıİIJİȩIJȚįİȞȑȤİȚʌĮȡĮȕȚĮıIJİȓȘ
ĮțİȡĮȚȩIJȘIJȐIJȘȢȉȠʌȡȠȧȩȞİȓȞĮȚıIJİȓȡȠİțIJȩȢİȐȞȑȤİȚıʌȐıİȚȘıijȡȐȖȚıȘ
ȋȡȘıȚȝȠʌȠȚȫȞIJĮȢIJȣʌȚțȒȐıȘʌIJȘIJİȤȞȚțȒĮijĮȚȡȑıIJİIJȘıȣıțİȣȒ
SENOMARK®ĮʌȩIJȘıȣıțİȣĮıȓĮțĮȚİȜȑȖȟIJİȖȚĮIJȣȤȩȞȗȘȝȚȐǹĭǹǿȇǼȈȉǼȉȅ
ȆȇȅȈȉǹȉǼȊȉǿȀȅȉȅȊǹȀȇȅȊǽ
ǹijĮȚȡȑıIJİIJȠȞʌȡȠıĮȡȝȠȖȑĮ(İȐȞȤȡȘıȚȝȠʌȠȚİȓIJİıȣıțİȣȒȕȚȠȥȓĮȢATEC™
FPȝİȖȐȜȠȣȝİȖȑșȠȣȢȒFPȝȚțȡȠȪȝİȖȑșȠȣȢīȚĮ
IJȘıȣıțİȣȒȕȚȠȥȓĮȢATEC™FPȝİȖȐȜȠȣȝİȖȑșȠȣȢȒ
FPȝȚțȡȠȪȝİȖȑșȠȣȢıȪȡİIJİIJȠȞʌȡȠıĮȡȝȠȖȑĮ(ʌȡȠȢIJȘȞțĮIJİȪșȣȞıȘIJȘȢ
ȜĮȕȒȢȑȦȢȩIJȠȣİȝʌȜĮțİȓȝİIJȠĮȞĮıȤİIJȚțȩǻıIJȠȞȐȟȠȞĮIJȠȣİijĮȡȝȠȖȑĮ
ǹțȠȜȠȣșȫȞIJĮȢIJȚȢȠįȘȖȓİȢATEC™ĮijĮȚȡȑıIJİIJȠȞȝȘȤĮȞȚıȝȩȠįȘȖȠȪĮʌȩIJȘȞ
țȐȞȠȣȜĮIJȘȢıȣıțİȣȒȢȕȚȠȥȓĮȢĮijȒȞȠȞIJĮȢIJȘȞțȐȞȠȣȜĮȝȑıĮıIJȠȞȝĮıIJȩ
ȉȠʌȠșİIJȒıIJİIJȠȞİijĮȡȝȠȖȑĮSENOMARK®İȞIJȩȢIJȘȢțȐȞȠȣȜĮȢIJȘȢıȣıțİȣȒȢ
ȕȚȠȥȓĮȢATEC™țĮȚʌȡȠȦșȒıIJİȑȦȢȩIJȠȣIJȠĮȞĮıȤİIJȚțȩATEC™ǻȒȠ
ʌȡȠıĮȡȝȠȖȑĮȢǼİijĮȡȝȩıİȚıIJȘȞțȐȞȠȣȜĮ
ǼȣșȣȖȡĮȝȝȓıIJİIJȠȣȢȚȤȞȘșȑIJİȢSENOMARK®īțĮȚǻȝİIJȘȞİȖțȠʌȒ
įİȚȖȝĮIJȠȜȘȥȓĮȢıIJȘȞțȐȞȠȣȜĮIJȘȢıȣıțİȣȒȢȕȚȠȥȓĮȢ
ǼțʌIJȪȟIJİĮȝȑıȦȢIJĮİʌȚșȑȝĮIJĮSENOMARK®ʌȡȠȦșȫȞIJĮȢIJȠȑȝȕȠȜȠǹİȞȫ
įȚĮIJȘȡİȓIJİIJȘȞʌȡȠȢIJĮİȝʌȡȩȢʌȓİıȘıIJȘȜĮȕȒǺțĮȚIJȘȞȠȡșȒİȣșȣȖȡȐȝȝȚıȘ
IJȠȣİijĮȡȝȠȖȑĮȝİIJȘȞİȖțȠʌȒįİȚȖȝĮIJȠȜȘȥȓĮȢȉĮİʌȚșȑȝĮIJĮșĮȑȤȠȣȞ
IJȠʌȠșİIJȘșİȓʌȜȒȡȦȢȩIJĮȞIJȠȑȝȕȠȜȠȑȡșİȚıİİʌĮijȒȝİIJȘȜĮȕȒ
ȆİȡȚıIJȡȑȥIJİIJȘȞțȐȞȠȣȜĮIJȘȢıȣıțİȣȒȢȕȚȠȥȓĮȢțĮIJȐȝȠȓȡİȢȫıIJİȞĮ
IJȠʌȠșİIJȒıİIJİIJȘȞİȖțȠʌȒįİȚȖȝĮIJȠȜȘȥȓĮȢȝĮțȡȚȐĮʌȩIJĮİʌȚșȑȝĮIJĮʌȠȣȑȤȠȣȞ
IJȠʌȠșİIJȘșİȓ
ǹijĮȚȡȑıIJİIJȠȞİijĮȡȝȠȖȑĮSENOMARK®ĮʌȩIJȘȞțȐȞȠȣȜĮIJȘȢıȣıțİȣȒȢȕȚȠȥȓĮȢ
ǹʌȠijȪȖİIJİIJȘȞİijĮȡȝȠȖȒįȪȞĮȝȘȢǻİȓIJİIJȘȞʌȡȠıȠȤȒʌĮȡĮțȐIJȦ
ȀȜİȓıIJİIJȘȞİȖțȠʌȒįİȚȖȝĮIJȠȜȘȥȓĮȢțĮȚĮijĮȚȡȑıIJİIJȘıȣıțİȣȒȕȚȠȥȓĮȢ
ıȪȝijȦȞĮȝİIJȚȢȠįȘȖȓİȢIJȠȣțĮIJĮıțİȣĮıIJȒ
ǹʌȠȡȡȓȥIJİțĮIJȐȜȜȘȜĮIJȠȞİijĮȡȝȠȖȑĮ
ǼʌȚȕİȕĮȚȫıIJİȝİĮʌİȚțȩȞȚıȘIJȘȞIJİȜȚțȒșȑıȘIJȠȣȚȤȞȘșȑIJȘ
ȆȡȠıȠȤȒǼȐȞĮȚıșĮȞșİȓIJİĮȞIJȓıIJĮıȘțĮIJȐIJȘȞĮijĮȓȡİıȘIJȠȣİijĮȡȝȠȖȑĮĮijȒıIJİ
IJȠȞİijĮȡȝȠȖȑĮSENOMARK®ıIJȠİıȦIJİȡȚțȩIJȠȣțĮșİIJȒȡĮțĮȚĮijĮȚȡȑıIJİȠȜȩțȜȘȡȘ
IJȘįȚȐIJĮȟȘțĮșİIJȒȡĮİijĮȡȝȠȖȑĮȈİĮȞIJȓșİIJȘʌİȡȓʌIJȦıȘİȞįȑȤİIJĮȚȞĮʌȡȠțȜȘșİȓ
șȡĮȪıȘIJȠȣȐțȡȠȣIJȠȣİijĮȡȝȠȖȑĮ
ȈȣȞĮȡȝȠȜȠȖȒșȘțİıIJȘȞȉĮȧȜȐȞįȘ
‹E\&5%DUG,QFȂİIJȘȞİʌȚijȪȜĮȟȘʌĮȞIJȩȢįȚțĮȚȫȝĮIJȠȢ
ȅȚȤȞȘșȑIJȘȢSENOMARK®İȓȞĮȚıȣȝȕĮIJȩȢȝİIJȘıȣıțİȣȒȕȚȠȥȓĮȢATEC™įȚĮȝȑIJȡȠȣ*DXJH
ȝȒțȠȣȢFPțĮȚFPʌȠȣțĮIJĮıțİȣȐȗİȚȘ6XURV6XUJLFDO6\VWHPV,QF)UDQNOLQ,1
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Vie SENOMARK®W\\Q\WYlOLWW|PlVWLW\|QWlPlOOlPlQWll$VDPDOODNXQ
SDLQDWNDKYDD%HWHHQSlLQMDNRUMDDYLHQWLODLWWHHQNRKGLVWXVQl\WHORYHQ
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‡ /DLWHWWDVDDNl\WWllDLQRDVWDDQSHUNXWDDQLVLLQELRSVLDWRLPHQSLWHLVLLQNRXOXWHWWX 6LMRLWDQl\WHORYLSRLVSlLQYLHG\LVWlW\\Q\LVWlNLHUWlPlOOlELRSVLDODLWWHHQ
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10.
Poista
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.DWVRPXLVWXWXVWDMlOMHPSlQl
vahingoittunut.
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67(5,/2,'$88'(67$$1
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‡ Joustavaa letkua ei saa taittaa.
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‡ 3LGlLOPDLVLPHW&MD'NXYDVVDRLNHLQNRKGLVWHWWXLQDQl\WHORYHQNDQVVD
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‡ 9DUPLVWDHWWlNDLNNLW\\Q\WRQYLHW\
Muistutus:-RVYLHQWLODLWHWWDSRLVWHWWDHVVDWXQWXXYlKlLVLQWlNLQYDVWXVWD
MlWlSENOMARK®YLHQWLODLWHNRHWWLPHHQMDSRLVWDNRHWLQMDYLHQWLODLWH\KWHQl
NRNRQDLVXXWHQD0XXWHQYLHQWLODLWWHHQNlUNLYRLYDKLQJRLWWXD
‡ 6lLO\WlDOOHƒ&QOlPS|WLODVVD
Koottu Thaimaassa.
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1
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11
SM®
KOMPLIKASJONER
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av SENOMARK® er de samme som ved bruk av andre biopsimarkører.
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™
LEVERINGSFORM
NORSK
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Stempel (A)
BESKRIVELSE
Håndtak (B)
SenoRx Inc. SENOMARK® biopsistedsmarkør består av en engangsapplikator med:
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tråd av titan.
1
PEG-plugg i den proksimale enden.
Tråden er beregnet på langsiktig røntgenmarkering av biopsistedet. Markørene
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tolv uker.
Sekundær innrettingsindikator (C)
ATEC™-stopp
med innrettingsindikator (D)
Adapter (E)
(skyves tilbake for kanyler
på 9 cm eller fjernes for
kanyler på 12 cm
'HQVSU¡\WHOLJQHQGHDSSOLNDWRUHQInUSODVVLATEC™-ustyret (9 gauge) for å trenge
inn i biopsihulrommet.10DUN¡UHQHI¡UHVIUDDSSOLNDWRUHQJMHQQRPELRSVLXWVW\UHWLQQ
i biopsihulrommet.
TILTENKT BRUK
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perkutan brystbiopsi.
Spissbeskyttelse (G)
KONTRAINDIKASJONER
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Åpning for utplassering
av markør (F)
ADVARSLER
‡ 3DVLHQWHUPHGNMHQWRYHUI¡OVRPKHWRYHUIRUPDWHULDOHQHRSSI¡UW
LEHVNULYHOVHQDYXWVW\UHWNDQKDHQDOOHUJLVNUHDNVMRQSnGHWWH
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Figur 1
‡ SENOMARK®DQEHIDOHVLNNHWLOSDVLHQWHUPHGEU\VWLPSODQWDW
‡ 8WVW\UHWVNDOLNNHEUXNHVYHGLQIHNVMRQ
1.
Påse at biopsiprøvene er tatt. Påse at prøvekammeret er helt tømt for vev.
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forseglingen er brutt.
‡ $QRUGQLQJHQHUXWIRUPHWEDUHWLOHQJDQJVEUXN'HUVRPGHQQH
PHGLVLQVNHDQRUGQLQJHQEUXNHVRPLJMHQLQQHE UHUGHWHQULVLNR
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3.
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kanylen.
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Plasser umiddelbart ut SENOMARK® -markørene ved å trykke ned stempelet
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av applikatoren med prøvekammeret. Alle markørene er plassert ut når
stempelet kommer i kontakt med håndtaket.
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utplasserte markørene.
)MHUQSENOMARK® -applikatoren fra biopsiutstyrets kanyle. Ikke bruk makt. (Se
advarslene nedenfor.)
11.
Steng prøvekammeret og ta ut biopsiutstyret i henhold til produsentens
bruksanvisning.
12. Kasser applikatoren på forskriftsmessig måte.
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LNNHJM¡UHVNDQDSSOLNDWRUHQVVSLVVNQHNNH
‡ 3XEOLVHUWHVWXGLHUPHGWLOQ UPHWOLNHVWRUHELRSVLPDUN¡UHUDYUXVWIULWWVWnO
Montert i Thailand.
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© 2012 by C. R. Bard Inc. Med enerett.
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tytanu
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Pomocniczy wskaźnik
ustawienia (C)
Ogranicznik
ATEC™ ze
wskaźnikiem
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Adapter (E)
(odsunąć do tyłu w przypadku
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1LH]DVWRVRZDQLHVLĊGRWHMLQVWUXNFMLPRĪHVSRZRGRZDü]áDPDQLHNRĔFyZNL
aplikatora.
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Marker SENOMARK®MHVWNRPSDW\ELOQ\]VRQGDPLELRSV\MQ\PLATEC™ 9 G 9 cm i 12 cm
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A SENOMARK®HV]N|]WVWHULOHQV]iOOtWMXNpVNL]iUyODJHJ\V]HULKDV]QiODWUDV]ROJiO
+$6=1È/$7,Ò7087$7ÏOiVGD]iEUiW
SMTSU9G
+DV]QiODWL~WPXWDWy
Dugattyú (A)
LEÍRÁS
A SenoRx Inc. SENOMARK®ELRSV]LiVKHO\PHJMHO|OĘMHHJ\V]HUKDV]QiODWRV
DSSOLNiWRUEyOiOODPHO\DN|YHWNH]ĘNHWWDUWDOPD]]D
IHOV]tYyGySROLJOLNROVDY3*6SiUQD$N|]pSVĘSiUQDWLWiQEyO
NpV]OWIRUPi]RWWGUyWRWWDUWDOPD]
1
polietilén-glikol (PEG) dugó a proximális végénél.
Fogantyú (B)
$IRUPi]RWWGUyWDELRSV]LiVKHO\WDUWyVUDGLROyJLDLPHJMHO|OpVpUHV]ROJiO$SiUQiN
N|UOEHOOKpWLJOiWKDWyNXOWUDKDQJJDOpVOpQ\HJpEHQN|UOEHOOKpWDODWW
IHOV]tYyGQDN
Második
illesztésjelző (C)
ATEC™ ütköző
illesztésjelzővel (D)
Adapter (E)
(9 mm-es kanül esetén
csúsztassa vissza, illetve
12 cm-es kanül esetén
távolítsa el)
$IHFVNHQGĘV]HUĦDSSOLNiWRUD*VATEC™HV]N|]EHLOOHV]NHGLNDELRSV]LiV
UHJEHW|UWpQĘEHKDWROiVWHOĘVHJtWHQGĘ1$SiUQiNDELRSV]LiVHV]N|]|QNHUHV]WO
YiOQDNOHD]DSSOLNiWRUUyOpVNHUOQHNDELRSV]LiVUHJEH
Hegyvédő (G)
AJÁNLOTT FELHASZNÁLÁS
A SENOMARK®HV]N|]SHUNXWiQHPOĘELRSV]LiVHOMiUiVVRUiQD]HPOĘV]|YHW
U|QWJHQQHOpVXOWUDKDQJJDOOiWKDWyPHJMHO|OpVpUHV]ROJiO
Pelletbehehelyező
nyílás (F)
ELLENJAVALLATOK
$]HV]N|]NL]iUyODJDPHJDGRWWPyGRQKDV]QiOKDWy
),*<(/0(=7(7e6(.
1. ábra
‡ $]RNQiODEHWHJHNQpODNLNpU]pNHQ\HND]HV]N|]OHtUiVEDQIHOVRUROW
DQ\DJRNUDDOOHUJLiVUHDNFLyOpSKHWIHOD]LPSODQWiWXPPDOV]HPEHQ
*\Ę]ĘGM|QPHJDUUyOKRJ\DELRSV]LiVPLQWiNJ\ĦMWpVHEHIHMH]ĘG|WW
(OOHQĘUL]]HKRJ\DPLQWDYpWHOLKRURQ\UyOOHWLV]WtWRWWPLQGHQV]|YHWPDUDGYiQ\W
‡ $SENOMARK® HV]N|]DONDOPD]iVDQHPDMiQORWWHPOĘLPSODQWiWXPPDO
UHQGHONH]ĘEHWHJQpO
9L]VJiOMDPHJDFVRPDJROiVWpVHOOHQĘUL]]HKRJ\QHPVpUOWHPHJ
DFVRPDJROiVpSVpJH$WHUPpNVWHULODPHQQ\LEHDVWHULOYpGĘ]iUQHPVpUOW
meg.
6]DEYiQ\RVDV]HSWLNXVWHFKQLNDDONDOPD]iViYDOYHJ\HNLDFVRPDJROiVEyOD
SENOMARK®HV]N|]WpVHOOHQĘUL]]HQHPVpUOWH9(*<(/($+(*<9e'ė7
(G).
+DATEC™FPHV/YDJ\FPHVNLFVL3HWLWH
ELRSV]LiVHV]N|]WKDV]QiOWiYROtWVDHOD]DGDSWHUW(ATEC™ 0909-20
FPHV/YDJ\FPHVNLFVL3HWLWHELRSV]LiVHV]N|]HVHWpQ
FV~V]WDVVDD]DGDSWHUW(DIRJDQW\~LUiQ\iEDDPtJEHDNDGD]DSSOLNiWRU
WHQJHO\pQOpYʁWN|]ĘEH'
$]ATEC™~WPXWDWiVDLV]HULQWWiYROtWVDHODELRSV]LiVHV]N|]NDQOMpEĘOD
FpO]yV]HUNH]HWHWpVN|]EHQKDJ\MDDNDQOWD]HPOĘEHQ
+HO\H]]HDSENOMARK®DSSOLNiWRUWD]ATEC™ELRSV]LiVHV]N|]NDQOMpEH
pVYH]HVVHEHD]ATEC™WN|]ĘMpLJ'YDJ\DPtJD]DGDSWHU(
EHOHLOOHV]NHGLNDNDQOEH
‡ 1HKDV]QiOMDD]HV]N|]WKDIHUWĘ]pViOOIHQQ
‡ 9LJ\i]DW(OWiYROtWiVDVRUiQQHJ\DNRUROMRQW~O]RWWHUĘWD]DSSOLNiWRUUD
QHKRJ\OHW|UM|QDKHJ\H
‡ $]HV]N|]NL]iUyODJHJ\V]HUKDV]QiODWRV-HOHQRUYRVLHV]N|]
~MUDIHOKDV]QiOiVDIHUWĘ]pViWYLWHOpQHNNRFNi]DWiYDOMiUDEHWHJHNN|]|WW
PLYHOD]RUYRVLHV]N|]|N±NO|Q|VHQDKRVV]~pVNLVPpUHWĦOXPHQQHO
FVDWODNR]yNNDOpVYDJ\D]DONDWUpV]HNN|]|WWLUpVHNNHOUHQGHONH]ĘN±
PHJWLV]WtWiVDQHKp]YDJ\OHKHWHWOHQPLXWiQDSRWHQFLiOLVDQSLURJpQ
YDJ\PLNURELiOLVV]HQQ\H]ĘGpVVHOUHQGHONH]ĘWHVWQHGYHNYDJ\V]|YHWHN
PHJKDWiUR]KDWDWODQLGHLJpULQWNH]pVEHNHUOWHND]RUYRVLHV]N|]]HO
$ELROyJLDLDQ\DJPDUDGYiQ\HOĘVHJtWKHWLD]HV]N|]V]HQQ\H]ĘGpVpW
SLURJpQHNNHOYDJ\PLNURRUJDQL]PXVRNNDODPLIHUWĘ]pVHV
V]|YĘGPpQ\HNKH]YH]HWKHW
‡ 1HVWHULOL]iOMD~MUDÒMUDVWHULOL]iOiVXWiQDWHUPpNVWHULOLWiVDQHPJDUDQWiOW
DPHJKDWiUR]KDWDWODQIRN~OHKHWVpJHVSLURJpQYDJ\PLNURELiOLV
V]HQQ\H]ĘGpVPLDWWDPLIHUWĘ]pVHVV]|YĘGPpQ\HNKH]YH]HWKHW-HOHQ
RUYRVLHV]N|]WLV]WtWiVD~MUDIHOGROJR]iVDpVYDJ\~MUDVWHULOL]iOiVD
Q|YHOLDQQDNYDOyV]tQĦVpJpWKRJ\D]HV]N|]QHPPĦN|GLNPHJIHOHOĘHQ D]RO\DQDONDWUpV]HNHWpUĘOHKHWVpJHVQHPNtYiQDWRVKDWiVRNPLDWW
DPHO\HNHWDWHUPLNXVpVYDJ\PHFKDQLNXVYiOWR]iVRNEHIRO\iVROQDN
Ï9,17e=.('e6(.
‡ $]HV]N|]WNL]iUyODJDSHUNXWiQELRSV]LiVHOMiUiVRNEDQMiUWDVRUYRV
KDV]QiOKDWMD
‡ 1HKDV]QiOMDDWHUPpNHWKDNRUiEEDQPHJQ\LWRWWiNDVWHULOOH]iUiVWYDJ\VpUOW
a csomagolás.
‡ (]WDWHUPpNHWVWHULOHQV]iOOtWMXNpVNL]iUyODJHJ\V]HULKDV]QiODWUDV]ROJiONE
67(5,/,=È/-$Ò-5$
‡ 9LJ\i]]RQKRJ\QHW|UM|QPHJDKDMOpNRQ\FVĘ
‡ $SiUQiNEHDGDJROiVDNRUWDUWVDPHJDMHO]ĘND]iEUiQD&pV'pVD
PLQWDYpWHOLKRURQ\SRQWRVLOOHV]WpVpW
‡ (OOHQĘUL]]HKRJ\EHDGDJROWDD]|VV]HVSiUQiW
‡ $]HV]N|]Wž&DODWWLKĘPpUVpNOHWHQWiUROMD
‡ $]|VV]HKDVRQOtWKDWyPpUHWĦ/UR]VGDPHQWHVDFpOEyONpV]OWELRSV]LiV
MHO|OĘNNHOYpJ]HWWSXEOLNiOWYL]VJiODWRNNLPXWDWWiNKRJ\7PiJQHVHV
PH]ĘYHOUHQGHONH]Ę05UHQGV]HUEHQYpJ]HWWWHV]WHOpVVRUiQDMHO|OĘQHP
PR]GXOWHOpVMHOHQWpNWHOHQYROWDIHOPHOHJHGpVH
,JD]tWVDDSENOMARK®MHO]ĘLW&pV'DELRSV]LiVHV]N|]NDQOMpEHQOpYĘ
PLQWDYpWHOLKRURQ\KR]
$GXJDWW\~$HOĘUHWROiViYDOpVN|]EHQDIRJDQW\~UD%J\DNRUROWHOĘUH
LUiQ\XOyQ\RPiVIHQQWDUWiViYDOD]RQQDOYiODVV]DOHDSENOMARK®SiUQiNDW
pVNRUULJiOMDD]DSSOLNiWRUpVDPLQWDYpWHOLKRURQ\LOOHV]WpVpW$PLNRUD
GXJDWW\~pULQWNH]LNDIRJDQW\~YDODSiUQiNWHOMHVHQEHDGDJROyGWDN
)RUJDVVDHOIRNNDODELRSV]LiVHV]N|]NDQOMpWKRJ\HOWiYROtWVD
a mintavételi hornyot a beadagolt párnáktól.
7iYROtWVDHODELRSV]LiVHV]N|]NDQOMpEĘODSENOMARK® applikátort. A
PĦYHOHWVRUiQNHUOMHD]HUĘDONDOPD]iViW/iVGD]DOiEEL¿J\HOPH]WHWpVW
$J\iUWy~WPXWDWiVDLV]HULQW]iUMDDPLQWDYpWHOLKRUQ\RWpVWiYROtWVDHOD
ELRSV]LiVHV]N|]W
$PHJIHOHOĘPyGRQiUWDOPDWODQtWVDD]DSSOLNiWRUW
.pSDONRWiVVDOHOOHQĘUL]]HDMHO|OĘYpJOHJHVKHO\]HWpW
)LJ\HOHP+DD]DSSOLNiWRUHOWiYROtWiVDVRUiQEiUPLO\HQHOOHQiOOiVWWDSDV]WDO
KDJ\MDDV]RQGiEDQDSENOMARK®DSSOLNiWRUWpVHJ\WWWiYROtWVDHODWHOMHVV]RQGD
DSSOLNiWRUHJ\VpJHW(OOHQNH]ĘHVHWEHQHOW|UKHWD]DSSOLNiWRUKHJ\H
gVV]HV]HUHOYH7KDLI|OG|Q
‹E\&5%DUG,QF0LQGHQMRJIHQQWDUWYD
A SENOMARK®D6XURV6XUJLFDO6\VWHPV,QF)UDQNOLQ,1iOWDOJ\iUWRWW*VFPHVpVFPHV
ATEC™ELRSV]LiVHV]N|]]HONRPSDWLELOLV
1
14
SM®
KOMPLIKACE
=QDþNRYDþPtVWDELRSVLHSENOMARK
®
3URSRXåLWtVATEC™ 9 Gauge
ý(6.<
SMTSU9G
1iYRGNSRXåLWt
3RWHQFLiOQtNRPSOLNDFHQDSĜLQIHNFHNWHUpPRKRXVRXYLVHWVSRXåLWtP
]QDþNRYDþHSENOMARK®MVRXVWHMQpMDNRW\NWHUpVRXYLVtVSRXåLWtPMLQêFK
ELRSWLFNêFK]QDþNRYDFtFK]DĜt]HQt
-$.-(35267ě('(.'2'È9È1
SENOMARK®MHGRGiYiQVWHULOQtDMHXUþHQSRX]HNMHGQRUi]RYpPXSRXåLWt
1È92'.328ä,7Ë9L]REUi]HN
POPIS
Píst (A)
=QDþNRYDþPtVWDELRSVLH6HQR5[,QFSENOMARK®VHVNOiGi]MHGQRUi]RYpKR
DSOLNiWRUXREVDKXMtFtKR
Y VWĜHEDWHOQpSROãWiĜN\VN\VHOLQRXSRO\JO\NRORYRX3*$6WĜHGQt
SROãWiĜHNREVDKXMHWLWDQRYêGUiW
S
RO\HW\OHQJO\NRORYRX3(*]iWNXQDSUR[LPiOQtPNRQFL
Rukojeť (B)
'UiWMHXUþHQNGORXKRGREpPXUWJR]QDþHQtPtVWDELRSVLH3ROãWiĜN\MVRXYLGLWHOQp
XOWUD]YXNHPSRGREXSĜLEOLåQČWêGQĤDYVWĜHEDMtVH]KUXEDSRWêGQHFK
Vedlejší
indikátor
vyrovnání (C)
™
Zarážka ATEC
s indikátorem
vyrovnání (D)
$SOLNiWRUSRGREQêVWĜtNDþFHVHYHMGHGR]DĜt]HQtATEC™*DXJHSĜLSĜtVWXSXGR
dutiny po biopsii.13ROãWiĜN\VHXPLVĢXMtDSOLNiWRUHPSRPRFtELRSWLFNpKR]DĜt]HQtD
do dutiny po biopsii.
Adaptér (E) (pro 9cm
kanylu posuňte zpět nebo
pro 12cm kanylu sejměte)
=$0éâ/(1e328ä,7Ë
SENOMARK®MHXUþHQNUWJDXOWUD]YXNRYpPXR]QDþHQtSUVQtWNiQČSĜLSHUNXWiQQt
ELRSVLL]SUVX
Chránič hrotu (G)
KONTRAINDIKACE
7DWR]DĜt]HQtQHQtXUþHQRNMLQpPXQHåXYHGHQpPXSRXåLWt
Otvor pro umístění
pelety (F)
VAROVÁNÍ
‡ 8SDFLHQWĤVH]QiPRXK\SHUVHQ]LWLYLWRXQDPDWHULiO\XYHGHQpYSRSLVX
YêURENXPĤåHWHQWRLPSODQWiWY\YRODWDOHUJLFNRXUHDNFL
‡ SENOMARK® VHQHGRSRUXþXMHSRXåtYDWXSDFLHQWHNVSUVQtPLLPSODQWiW\
‡ 1HSRXåtYHMWHMHOLSĜtWRPQDLQIHNFH
‡ 3ĜLY\MtPiQtDSOLNiWRUXQHSRXåtYHMWHQDGPČUQRXVtOXDE\QHGRãORN
RGORPHQtKURWXDSOLNiWRUX
‡ 7HQWRSURVWĜHGHNMHXUþHQSRX]HNMHGQRUi]RYpPXSRXåLWt
3ĜLRSDNRYDQpPSRXåLWtWRKRWRSURVWĜHGNXKUR]tQHEH]SHþtSĜHQRVX
LQIHNFHPH]LSDFLHQW\SURWRåH]GUDYRWQLFNpSURVWĜHGN\]HMPpQD
SURVWĜHGN\VGORXKRXD~]NRXGXWLQRXVSRMLQHERVSiUDPLPH]LGtO\MH
YHOPLVORåLWpþL]FHODQHPRåQpGRNRQDOHY\þLVWLWRGWČOHVQêFKWHNXWLQ
QHERWNiQtRGQLFKåKUR]tS\URJHQQtQHERPLNURELiOQtNRQWDPLQDFH
=E\WN\ELRORJLFNpKRPDWHULiOXPRKRX]SĤVRELWNRQWDPLQDFLSURVWĜHGNX
S\URJHQQtPLOiWNDPLQHERPLNURRUJDQLVP\NWHUpPRKRXEêWSĜtþLQRX
LQIHNþQtFKNRPSOLNDFt
‡ 1HSURYiGČMWHUHVWHULOL]DFL$QLSRUHVWHULOL]DFLQHO]H]DUXþLWVWHULOLWX
SURVWĜHGNXSURWRåHPĤåHEêWYQHXUþLWHOQpPtĜH]DVDåHQS\URJHQQt
QHERPLNURELiOQtNRQWDPLQDFtNWHUiPĤåH]SĤVRELWLQIHNþQtNRPSOLNDFH
ýLãWČQtRãHWĜHQtDQHERUHVWHULOL]DFHWRKRWR]GUDYRWQLFNpKRSURVWĜHGNX
]Y\ãXMHSUDYGČSRGREQRVWMHKR]iYDG\YGĤVOHGNXSĜtSDGQêFK
QHSĜt]QLYêFKYOLYĤWHSHOQêFKDQHERPHFKDQLFNêFK]PČQQDMHKR
VRXþiVWL
Obrázek 1
=DMLVWČWHDE\E\OGRNRQþHQRGEČUELRSWLFNêFKY]RUNĤ=DMLVWČWHDE\E\O]iĜH]
SURY]RUHNRþLãWČQRGYHãNHUpWNiQČ
3URKOpGQČWHEDOHQtDE\MVWHVHXMLVWLOLåHFHOLVWYRVWREDOXQHQtQDUXãHQD
3URGXNWMHVWHULOQtSRNXGQHQtWČVQČQt]ORPHQp
6WDQGDUGQtDVHSWLFNRXWHFKQLNRXY\MPČWH]DĜt]HQtSENOMARK®]REDOX
D]NRQWUROXMWH]GDQHQtSRãNR]HQ6(-0ċ7(&+5È1,ý+5278*
3RNXGSRXåtYiWHELRSWLFNp]DĜt]HQtATEC™FP/QHER
FP3HWLWHY\MPČWHDGDSWpU(8ELRSWLFNpKR]DĜt]HQtATEC™ 0909-20
FP/þLFP3HWLWHSRVXĖWHDGDSWpU(YHVPČUXUXNRMHWLDå
]DSDGQHGR]DUiåN\'QDGĜtNXDSOLNiWRUX
3RGOHSRN\QĤATEC™Y\MPČWHRYOiGDFtPHFKDQLVPXV]NDQ\O\ELRSWLFNpKR
]DĜt]HQtDSRQHFKHMWHNDQ\OXYSUVX
=DYHćWHDSOLNiWRUSENOMARK®GRNDQ\O\ELRSWLFNpKR]DĜt]HQtATEC™
DSRVXQXMWHDåMH]DUiåNDATEC™'QHERDGDSWpU(XVD]HQYNDQ\OH
9\URYQHMWHLQGLNiWRU\SENOMARK®&D'VH]iĜH]HPSURY]RUHNQDNDQ\OH
ELRSWLFNpKR]DĜt]HQt
2NDPåLWČXPtVWČWHSROãWiĜN\SENOMARK®SRVXQXWtPStVWX$DSĜLWRP
]DFKRYHMWHGRSĜHGQêWODNQDUXNRMHĢ%DRSUDYWHY\URYQiQtDSOLNiWRUXVH
]iĜH]HPSURY]RUHN3ROãWiĜN\EXGRX~SOQČ]DYHGHQ\NG\åVHStVWGRWNQH
UXNRMHWL
2WRþWHNDQ\ORXELRSWLFNpKR]DĜt]HQtRVWXSĖĤDåMH]iĜH]SURY]RUHN
Y]GiOHQRG]DYHGHQêFKSROãWiĜNĤ
%(=3(ý12671Ë23$7ě(1Ë
‡ =DĜt]HQtVPtEêWSRXåtYiQRSRX]HOpNDĜLãNROHQêPLYSHUNXWiQQtFKELRSWLFNêFK
postupech.
‡ 7HQWRSURGXNWQHSRXåtYHMWHSRNXGE\ODVWHULOQtEDULpUDGĜtYHRWHYĜHQDQHER
SRNXGMHREDOSRãNR]HQ
‡ 7HQWRSURGXNWMHGRGiYiQVWHULOQtDMHXUþHQSRX]HNMHGQRUi]RYpPXSRXåLWt
1(3529È'ċ-7(5(67(5,/,=$&,
9\MPČWHDSOLNiWRUSENOMARK®]NDQ\O\ELRSWLFNpKR]DĜt]HQt1HSRXåtYHMWH
VtOX9L]XSR]RUQČQtQtåH
‡ 1H]DX]OXMWHRKHEQRXKDGLþNX
8]DYĜHWH]iĜH]SURY]RUHNDY\MPČWHELRSWLFNp]DĜt]HQtSRGOH
SRN\QĤYêUREFH
‡ 3ĜL]DYiGČQtSROãWiĜNĤ]DFKRYiYHMWHVSUiYQpY\URYQiQtLQGLNiWRUĤ&D'QD
REUi]NXVH]iĜH]HPSURY]RUHN
$SOLNiWRUĜiGQČ]OLNYLGXMWH
‡ =DMLVWČWHDE\E\O\]DYHGHQ\YãHFKQ\SROãWiĜN\
=REUD]HQtPSRWYUćWHNRQHþQRXSRORKX]QDþN\
8SR]RUQČQt3RNXGMHSĜLY\MtPiQtDSOLNiWRUX]MLãWČQMDNêNROLRGSRUSRQHFKHMWH
aplikátor SENOMARK®YVRQGČDY\WiKQČWHFHORXVHVWDYXVRQG\VDSOLNiWRUHP
‡ =YHĜHMQČQpVWXGLHVELRSWLFNêPL]QDþNRYDþL]QHUH]RYpRFHOL/VURYQDWHOQp 3RNXGWDNQHXþLQtWHPĤåHGRMtWNRGORPHQtKURWXDSOLNiWRUX
YHOLNRVWLQHSURNi]DO\SĜLWHVWRYiQtYV\VWpPX05,SĜLVtOHSROH7PLJUDFL
6PRQWRYiQRY7KDMVNX
]QDþNRYDþĤDGRãORSRX]HNMHMLFKQHYê]QDPQpPXRKĜHYX
‹E\&5%DUG,QF9HãNHUiSUiYDY\KUD]HQD
‡ 8FKRYiYHMWHSĜLWHSORWČQLåãtQHåž&
SENOMARK®MHNRPSDWLELOQtVELRSWLFNêP]DĜt]HQtPATEC™*DXJHRGpOFHFPþLFP
Y\UiEČQêPVSROHþQRVWt6XURV6XUJLFDO6\VWHPV,QF)UDQNOLQ,1
1
15
.203/ø.$6<21/$5
SM®
SENOMARK®NXOODQÕPÕ\ODLOLúNLOHQGLULOHELOHFHNSRWDQVL\HONRPSOLNDV\RQODU
|UQH÷LQHQIHNVL\RQGL÷HUEL\RSVLLúDUHWOHPHFLKD]ODUÕQÕQNXOODQÕPÕ\ODLOLúNLOL
NRPSOLNDV\RQODUODD\QÕGÕU
SENOMARK®%L\RSVL%|OJHøúDUHWOH\LFLVL
9 G ATEC™LOHNXOODQÕPLoLQGLU
7('$5ø.ù(./ø
7h5.d(
SENOMARK®VWHULORODUDNVD÷ODQPDNWDGÕUYHVDGHFHELUNH]NXOODQÕOPDVÕ
DPDoODQPÕúWÕU
SMTSU9G
.8//$10$7$/ø0$7,ùHNLO
HJ|]DWÕQÕ]
.XOODQÕP7DOLPDWODUÕ
AÇIKLAMA
Piston (A)
SenoRx Inc. SENOMARK®%L\RSVL%|OJHøúDUHWOH\LFLVLDúD÷ÕGDNLOHULLoHUHQWHN
NXOODQÕPOÕNELUX\JXOD\ÕFÕGDQROXúXU
3
tekrar emilebilen poliglikolik asit (PGA) pedleri. Orta ped titanyum tel
formu içerir.
S
URNVLPDOXoWDEXOXQDQSROLHWLOHQJOLNRO3(*WÕSD
Tutma Kolu (B)
7HOIRUPXQDPDFÕEL\RSVLE|OJHVLQLQX]XQVUHOLUDG\RJUD¿NLúDUHWOHQPHVLGLU3HGOHU
XOWUDVRQ\DUGÕPÕ\OD\DNODúÕNKDIWDJ|UOHELOLUYH\DNODúÕNKDIWDLoLQGHE\N
|OoGHWHNUDUHPLOLU
Hizalama
Göstergeli ATEC™
Durma Noktas‫( ו‬D)
İkincil Hizalama
Göstergesi (C)
Adaptör (E)
(9 cm kanül kadar geri
kayd‫ו‬r‫ו‬n veya 12 cm
kanül kadar ç‫ו‬kar‫ו‬n)
ùÕUÕQJD\DEHQ]H\HQX\JXOD\ÕFÕEL\RSVLERúOX÷XQDHULúPHN]HUH*|OoVQGHNL
ATEC™LoLQH\HUOHúLU13HGOHUX\JXOD\ÕFÕGDQEL\RSVLFLKD]ÕYDVÕWDVÕ\ODYHEL\RSVL
ERúOX÷XQXQLoLQH\HUOHúWLULOLU
KULLANIM AMACI
SENOMARK®SHUNWDQPHPHEL\RSVLSURVHGUHVQDVÕQGDPHPHGRNXVXQX
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16
SM®
SENOMARK 切片部位標記
®
搭配 9 號 ATEC
繁體中文
併發症
使用 SENOMARK® 的相關潛在併發症 (例如感染)，與使用其他切片標記裝置的
相同。
供應方式
SENOMARK® 屬於無菌產品，僅供一次性使用。
使用說明 (請參閱圖
SMTSU9G
使用說明
Plunger
(A)
柱塞$
說明
SENOMARK 切片部位標記有拋棄式塗藥器，其中包含：
手柄%
Handle (B)
®
3片
可吸收聚乙醇酸 (PGA) 墊。中墊包含鈦鋼絲型件。
1個
近端聚乙二醇 (PEG) 栓。
鋼絲型件用於長期的切片部位放射性標記。過了 3 週左右用超音波仍看得見墊
子，不過在 12 週左右則已大致吸收。
Secondary Alignment
次要對齊指標&
™
有對齊指標'
Stop
ATEC
的 ATEC
止檔
with
Alignment
Indicator (D)
注射器型塗藥器可搭配 9 號 ATEC ，進入切片腔內。1 墊子是透過切片裝置從塗
藥器植入切片腔。
Indicator (C)
接頭( (E)
Adaptor
(若為FP套管請向後推，若為
(slide
back for 9 cm cannula
FP套管請取出
or
remove for 12 cm cannula)
預定用途
SENOMARK® 可以 X 光和超音波的方式，在經皮切片程序標記乳房組織。
使用禁忌
這項裝置不適用於指示以外的用途。
Tip Protector (G)
尖端保護套*
警告
‡ 已知對裝置說明列出物質過敏的病患，可能對此植體有過敏反應。
Pellet Deployment
Aperture (F)
‡ SENOMARK® 不建議用於有乳房植體的病患。
彈丸劑植入孔)
‡ 出現感染時，請勿使用。
‡ 取出塗藥器時避免過度施力，以免塗藥器尖端破裂。
‡ 本裝置僅供一次性使用。重複使用本醫療裝置有病患交叉污染的風險，因為一
旦有潛在熱原或微生物污染之體液或組織與醫療裝置接觸的時間不確定，醫療
裝置 (尤其是部件之間有長型小內腔、接縫和 或裂縫者便很難或無法清理。
生物材料殘留物可能助長熱原或微生物污染裝置，進而導致感染性的併發症。
‡ 請勿重複消毒。重複消毒過後，無法保證本產品的無菌狀態，因為潛在熱原或
微生物污染的程度不確定，可能導致感染性的併發症。清潔、再製和 或重複
消毒目前的醫療裝置，會提高裝置故障的可能性，因為部件受熱和 或機械變
更影響，可能出現不良影響。
圖
1 1
Figure
1.
確定切片標本已採集完成。確定樣本切口完全沒有組織。
2.
請檢查包裝確保其完好無損。產品開封前為無菌。
3.
使用標準無菌技術，從包裝取出 SENOMARK® 裝置，然後檢查是否受損。
取下尖端保護套 (G)。
4.
如果使用的是 ATEC 0912-20 (12 cm 大號) 或 0912-12
(12 cm 特小號) 切片裝置，請取出接頭 (E)。若為 ATEC 0909-20
(9 cm 大號) 或 0909-12 (9 cm 特小號) 切片裝置，朝手柄方向推動接頭
(E)，直到它與塗藥器軸的止檔'接合。
‡ 請勿扭結軟管。
遵照ATEC 說明，從切片裝置套管取出驅動機構，同時將套管留在乳房。
‡ 墊子投藥時，讓指標 (圖 1 內的 C 與'與樣本切口正確對齊。
將 SENOMARK® 塗藥器放入 ATEC 切片裝置套管，然後推進，直到 ATEC
止檔'或接頭 (E) 固定在套管內。
注意事項
‡ 只有受過經皮切片程序訓練的醫師，才能使用這項裝置。
‡ 如果無菌屏障已開封或如果包裝已破損，請勿使用此產品。
‡ 這屬於無菌產品，僅供一次性使用。請勿重複消毒。
‡ 確定所有墊子都已投藥。
‡ 保存在ž&以下的溫度。
將SENOMARK® 指標 (C 與'對齊切片裝置套管的樣本切口。
‡ 針對大小相當之/不銹鋼切片標記所發表的研究顯示，在7磁場強度
的 MRI 系統測試時，標記完全沒有位移，而且標記溫度僅微幅上升。
8.
推進柱塞 (A)，繼續將塗藥器手柄 (B) 向前施壓，同時將塗藥器正確對齊
樣本切口，即可馬上植入 SENOMARK® 墊。 柱塞碰到手柄時，墊子便投藥
完全。
9.
將切片裝置套管旋轉 180 度，讓樣本切口離開已投藥的墊子。
10. 從切片裝置套管取出 SENOMARK® 塗藥器。避免施力。(請參閱下方警示。)
11.
根據製造商的說明，關上樣本切口並取出切片裝置。
12. 妥善棄置塗藥器。
13. 以造影確認最終的標記位置。
警示： 如果取出塗藥器時受阻，將 SENOMARK® 塗藥器留在探針內，並且取出整
個探針 塗藥器組件。否則可能導致塗藥器尖端破裂。
組裝地：泰國。
© 2012 by C. R. Bard Inc. 保留所有權利。
1
SENOMARK® 與6XURV6XUJLFDO6\VWHPV,QF)UDQNOLQ,1製造的 9 號 9 cm 和 12 cm ATEC 切片
裝置相容。
17
SM®
SENOMARK® 생검
부위 마커
‫׀‬؄!ࣼओ
SENOMARK® 는 멸균 상태로 제공되며 일회용으로만 사용해야 합니다.
হଵ!௼ೇ)‫ ࡪ׽‬1 ౠ஼*
9֜୴௼!ATEC™ ૫ঢ়!হଵ
૿૚
(A)
(B)
SMTSU9G
হଵ௼ೇঢ়
ৣࢥ
SenoRx Inc. SENOMARK® 생검 부위 마커는 다음을 포함하는 일회용 도구로 구성
되어 있습니다.
3
분해성 PGA(폴리 글리코 산) 패드 중앙 패드 티타늄
와이어 폼을 포함합니다.
1
말단부에 있는 PEG(폴리에틸렌 글리콜) 플러그
(C)
ATEC™
(D)
(E) (9cm
12cm
와이어 폼은 생검 부위에 장시간 지속되는 방사선 표시를 하기
위한 것입니다. 패드는 약 3주 동안 초음파를 통해 볼 수 있으며
약 12주 이내에 다시 흡수됩니다.
(G)
주사기 형태의 애플리케이터는 생검 공동에 들어가도록 9게이지 ATEC™에 잘
들어 맞습니다.1 패드는 생검 장치를 통해 애플리케이터에서 생검 공동으로 배
치됩니다.
ଵ‫ݓ‬
(F)
SENOMARK® 는 경피 유방 생검 시술 중에 유방 조직에 방사선 및 초음파 유도 방
식으로 표시하는 데 사용됩니다.
‫؃‬؈!হฑ
이 장치는 지시한 방식 이외의 방식으로 사용하면 안 됩니다.
1
ֵ֮
‡ ஍ು ৣࢥ૫!ਦࠩ‫!ݦ‬ஏ࠻૫!ׂࣤ৪ୣ!ब୴‫ࣆ୼ূ!୴!܂ஂ็!܂‬૫!ષࠉ௼! 1.
ࣳ୨ୣ!֮ยฌ!ਦ‫୾!ݓ‬੎܏‫ܙ‬/
생검 검체의 수집을 완료했는지 확인합니다. 샘플 노치에서
모든 조직을 제거해야 합니다.
‡ SENOMARK ‫!׀୶!܂‬ୗࣼ!ূ୼ࣆୣ!ੑਪซ!็ஂ૫֜‫!܂‬হଵฉࢡ!઴!‫܏ݩ‬
‫ܙ‬/
2.
포장이 손상되지 않았는지 잘 검사합니다. 봉인된 부분이
그대로 유지되면 제품은 멸균 상태입니다.
3.
표준 무균 기법을 사용하여 포장에서 SENOMARK® 장치를 꺼내고 손상된 부
분이 없는지 확인합니다. 팁 보호 장치(G)를
분리합니다.
4.
ATEC™ FP/또는 0912-12(12cm Petite) 생검 장치를
사용할 경우 어댑터(E)를 분리합니다. ATEC™ FP/
또는 0909-12(9cm Petite) 생검 장치의 경우 애플리케이터
샤프트의 조정 장치'에 잘 고정될 때까지 핸들 방향으로
어댑터(E)를 밀어줍니다.
ATEC™ 지침에 따라 생검 장치 캐뉼라에서 드라이버 기구를
제거하고 캐뉼라는 가슴 부위에 그대로 둡니다.
SENOMARK® 애플리케이터를 ATEC™ 생검 장치 캐뉼라에 놓고
ATEC™ 조정 장치' 또는 어댑터(E)가 캐뉼라에 고정될 때까지 당겨줍니
다.
SENOMARK® 지시계&'를 생검 장치 캐뉼라의 샘플 노치와
맞춥니다.
8.
핸들(B)에 압력을 가하면서 플런저(A)를 밀어 SENOMARK® 패드를
즉시 배치한 다음 샘플 노치에 맞춰 애플리케이터를 정렬합니다. 플런저가 핸
들에 닿으면 패드가 완전히 배치된 것입니다.
‡ 이전에 멸균 장벽이 개봉되었거나 포장이 손상된 경우에는
제품을 사용하지 마십시오.
9.
생검 장치 캐뉼라를 180도 회전하여 배치된 패드에서 샘플
노치가 멀리 떨어지도록 합니다.
‡ 이 제품은 멸균 상태로 제공되며 일회용으로만 사용해야
합니다. ஏࢢ‫׻‬ฉ௼!࡮੘ੑଊ/
10. 생검 장치 캐뉼라에서 SENOMARK® 애플리케이터를 분리합니다.
힘을 가하지 않도록 주의합니다. (아래의 주의를 참조하십시오.)
‡ 유연한 튜브가 꼬이지 않도록 주의하십시오.
11.
‡ 패드를 배치할 때 샘플 노치와 지시계가 정확히 정렬되게
하십시오(그림 1의 &'.
12. 애플리케이터를 적절히 폐기합니다.
‡ 모든 패드를 잘 배치하십시오.
13. 영상을 통해 최종 마커 위치를 확인합니다.
®
‡ հૺ!ू୏૫‫!܂‬হଵฉࢡ!઴!‫ܙ܏ݩ‬/
‡ ૂ෽ࡦ೩୴ോ!ඝ୯!චਅୣ!࡯؈!୏ฒ!ׂ‫ݓ‬ซ!ຓୣ!թฒঢ়!!
ૂ෽ࡦ೩୴ോ࡞!ॄࡦฉࢡ!઴!‫ܙ܏ݩ‬/
‡ ୴!஍ು‫୷!܂‬๐ଵୠࠨࡰ!হଵฒો!ฏ܏‫ܙ‬/!ࣵ૷৪!߃‫࣢!܂‬৏ࣆࠨ!୶ซ!ଊ
ૺ୴!୾ୣ!ਦ!୾‫!܂‬౾ૃ୴‫!ڌ‬஼௽ୣ!ๆ୶ฌ!ਦ!૤‫!܂‬؈ի!‫ݝ‬઴!୯࠻!؈؈
ଗ!ந಍‫֮!ݧ‬ଶ-!‫מ‬৪෪!হ୴୯!ඐে!ूॄୣ!৬౶ฉ؈!૚ࠠ֍‫ॆ!ڌ‬թ‫܉‬ฌ!
ਦ!୾ୠࣝࠨ!୴!୯࠻!؈‫!࡞מ‬ஏহଵฉࢡ!็ஂ!ի!‫י‬౛!ଊૺ୴!ࣵ৏ฉ֜!‫ݩ‬
܏‫ܙ‬/!৏ࣆชண!ࣆఀ୴!୾ୣ!֮ଶ!ࣵ૷৪!ࣆఀ୴‫࣢!ڌ‬৏ࣆࠨ!஍ುթ!ଊૺ‫ݥ‬
૚!հૺ৪!ฏन௻ୣ!ୗࣵฌ!ਦ୾੎܏‫ܙ‬/
‡ ஏࢢ‫׻‬ฉ௼!࡮੘ੑଊ/!ஏࢢ‫׻‬ซ!๜૫‫!܂‬հૺ৪!ฏन௻ୣ!ୗࣵฌ!
ਦ!୾‫૷ࣵ!܂‬৪!߃‫࣢!܂‬৏ࣆ!ଊૺ୯!ப‫!࡞ݓ‬ๆ୶ฌ!ਦ!૤ୠࣝࠨ!!
஬෪୴!ࢢ‫!׻‬৅ീ୶௼!ब஍ฌ!ਦ!૤੎܏‫ܙ‬/!୯࠻!؈؈࡞!৬౶ฉֵ-!ஏ౵
ࡦฉֵ-!ஏࢢ‫׻‬ฉࢡ!૷!࣭0߃‫!܂‬୯ชண!णๅࠨ!୶ฒ!૿ผୣ!!
ࣴ‫מ!܂‬৪෪૫!‫ܫ‬ซ!ूபண!๗ׂ!‫ࣄޣ‬૫!஍ುթ!ֵ஍‫!ڑ‬թ‫܉‬৪୴ۖલః
܏‫ܙ‬/
௜୯!হฑ
‡ 경피 생검 시술을 훈련 받은 의사만이 이 장치를 사용해야
합니다.
제조업체 지시에 따라 샘플 노치를 닫고 생검 장치를
분리합니다.
‡ ž&이하 온도에 보관하십시오.
௜୯;!애플리케이터를 분리할 때 저항이 느껴질 경우 SENOMARK®
‡ / 크기의 스테인리스 스틸 생검 마커를 7 자장 강도의 MRI 시스템에서 애플리케이터를 탐침 내에 두고 전체 탐침/애플리케이터 조립품을
테스트할 경우 마커가 움직이지 않으며 약간 발열된 것으로 나타났습니다.
분리합니다. 이렇게 하지 않으면 애플리케이터 팁이 깨질 수 있습니다.
ฏन௻
태국에서 조립.
SENOMARK® 의 사용과 관련이 있을 수 있는 잠재적인 합병증(예: 감염)은 기타 생
검 표시 장치의 사용과 관련이 있을 수 있는 합병증과
유사합니다.
© 2012 by C. R. Bard Inc. 판권 소유.
1
SENOMARK®는 6XURV6XUJLFDO6\VWHPV,QF)UDQNOLQ,1에서 제조한 9게이지 9cm 및 12cm
ATEC™ 생검 장치와 호환됩니다.
18
ɈɋɅɈɀɇȿɇɂə
ȼɨɡɦɨɠɧɵɟɨɫɥɨɠɧɟɧɢɹɧɚɩɪɢɦɟɪɢɧɮɟɤɰɢɹɫɜɹɡɚɧɧɵɟɫɢɫɩɨɥɶɡɨɜɚɧɢɟɦ
SENOMARK®ɬɟɠɟɱɬɨɢɩɪɢɢɫɩɨɥɶɡɨɜɚɧɢɢɞɪɭɝɢɯɭɫɬɪɨɣɫɬɜɦɚɪɤɢɪɨɜɤɢɞɥɹ
ɛɢɨɩɫɢɢ
SM®
ɆɚɪɤɟɪɦɟɫɬɚɛɢɨɩɫɢɢSENOMARK®
ȾɥɹɢɫɩɨɥɶɡɨɜɚɧɢɹɫATEC™ɤɚɥɢɛɪɚ
ɎɈɊɆȺɉɈɋɌȺȼɄɂ
SENOMARK®ɩɨɫɬɚɜɥɹɟɬɫɹɫɬɟɪɢɥɶɧɵɦɢɩɪɟɞɧɚɡɧɚɱɟɧɬɨɥɶɤɨɞɥɹɨɞɧɨɪɚɡɨɜɨɝɨ
ɢɫɩɨɥɶɡɨɜɚɧɢɹ
ɊɍɋɋɄɂɃ
ɍɄȺɁȺɇɂəɉɈɉɊɂɆȿɇȿɇɂɘɫɦɪɢɫ
SMTSU9G
ɂɧɫɬɪɭɤɰɢɢɩɨɩɪɢɦɟɧɟɧɢɸ
ɉɨɪɲɟɧɶ$
Plunger (A)
ɈɉɂɋȺɇɂȿ
Ɇɚɪɤɟɪɦɟɫɬɚɛɢɨɩɫɢɢ6HQR5[,QFSENOMARK ɜɤɥɸɱɚɸɳɢɣɨɞɧɨɪɚɡɨɜɵɣ
ɚɩɩɥɢɤɚɬɨɪɫɨɞɟɪɠɢɬ
Ɋɭɱɤɚ%
Handle (B)
®
ɪɚɫɫɚɫɵɜɚɟɦɵɟɤɚɩɫɭɥɵɢɡɩɨɥɢɝɥɢɤɨɥɢɟɜɨɣɤɢɫɥɨɬɵɉȽɄ
ȼɫɪɟɞɧɟɣɤɚɩɫɭɥɟɡɚɤɥɸɱɟɧɚɬɢɬɚɧɨɜɚɹɩɪɨɜɨɥɨɱɧɚɹɮɨɪɦɚ
ɜɫɬɚɜɤɭɢɡɩɨɥɢɷɬɢɥɟɧɝɥɢɤɨɥɹɉɗȽɜɩɪɨɤɫɢɦɚɥɶɧɨɦɩɨɥɨɠɟɧɢɢ
Ɉɝɪɚɧɢɱɢɬɟɥɶ
ɉɪɨɜɨɥɨɱɧɚɹɮɨɪɦɚɩɪɟɞɧɚɡɧɚɱɟɧɚɞɥɹɞɨɥɝɨɫɪɨɱɧɨɣɜɢɞɢɦɨɣɩɪɢ
ɪɟɧɬɝɟɧɨɝɪɚɮɢɢɦɚɪɤɢɪɨɜɤɢɦɟɫɬɚɛɢɨɩɫɢɢɄɚɩɫɭɥɵɜɢɞɢɦɵɩɪɢɭɥɶɬɪɚɡɜɭɤɨɜɨɦ
ɢɫɫɥɟɞɨɜɚɧɢɢɜɬɟɱɟɧɢɟɩɪɢɛɥɧɟɞɟɥɶɢɪɚɫɫɚɫɵɜɚɸɬɫɹɤɚɤɩɪɚɜɢɥɨɜɬɟɱɟɧɢɟ
ɩɪɢɛɥɧɟɞɟɥɶ
Ⱦɨɩɨɥɧɢɬɟɥɶɧɵɣɭɤɚɡɚɬɟɥɶ
Secondary Alignment
ɩɨɥɨɠɟɧɢɹ&
Indicator (C)
™
Stop
ATEC
ɫɭɤɚɡɚɬɟɥɟɦ
with
Alignment
ɩɨɥɨɠɟɧɢɹ
Indicator
(D)
ATEC™'
ɉɟɪɟɯɨɞɧɢɤ(
Adaptor
(E)
ɞɥɹɤɚɧɸɥɢɫɦ²ɫɞɜɢɧɶɬɟ
(slide
back for 9 cm cannula
ɧɚɡɚɞɞɥɹɤɚɧɸɥɢɫɦ²
or remove for 12 cm cannula)
ɒɩɪɢɰɟɩɨɞɨɛɧɵɣɚɩɩɥɢɤɚɬɨɪɭɫɬɚɧɚɜɥɢɜɚɟɬɫɹɜɧɭɬɪɶATEC™1ɤɚɥɢɛɪɚ
ɢɢɫɩɨɥɶɡɭɟɬɫɹɞɥɹɩɪɨɧɢɤɧɨɜɟɧɢɹɤɦɟɫɬɭɛɢɨɩɫɢɢ
ɫɧɢɦɢɬɟ
ɉɊɂɆȿɇȿɇɂȿɉɈɇȺɁɇȺɑȿɇɂɘ
SENOMARK®ɩɪɟɞɧɚɡɧɚɱɟɧɞɥɹɜɢɞɢɦɨɣɩɪɢɪɟɧɬɝɟɧɨɝɪɚɮɢɢɢɍɁɂɦɚɪɤɢɪɨɜɤɢɭɱɚɫɬɤɚ
ɬɤɚɧɢɦɨɥɨɱɧɨɣɠɟɥɟɡɵɩɪɢɩɪɨɜɟɞɟɧɢɢɱɪɟɫɤɨɠɧɨɣɛɢɨɩɫɢɢɦɨɥɨɱɧɨɣɠɟɥɟɡɵ
Ɂɚɳɢɬɧɵɣɤɨɥɩɚɱɨɤɞɥɹ
Tip Protector (G)
ɧɚɤɨɧɟɱɧɢɤɚ*
ɉɊɈɌɂȼɈɉɈɄȺɁȺɇɂə
ɍɫɬɪɨɣɫɬɜɨɧɟɩɪɟɞɧɚɡɧɚɱɟɧɨɞɥɹɢɫɩɨɥɶɡɨɜɚɧɢɹɜɰɟɥɹɯɩɨɦɢɦɨɭɤɚɡɚɧɧɵɯ
Ɉɬɜɟɪɫɬɢɟɞɥɹ
Pellet Deployment
ɜɵɜɨɞɚɝɪɚɧɭɥ)
Aperture (F)
ɉɊȿȾɍɉɊȿɀȾȿɇɂə
‡ ɍɩɚɰɢɟɧɬɨɜɫɩɨɞɬɜɟɪɠɞɟɧɧɨɣɚɥɥɟɪɝɢɟɣɧɚɦɚɬɟɪɢɚɥɵɩɟɪɟɱɢɫɥɟɧɧɵɟ
ɜɨɩɢɫɚɧɢɢɭɫɬɪɨɣɫɬɜɚɦɨɠɟɬɜɨɡɧɢɤɧɭɬɶɚɥɥɟɪɝɢɱɟɫɤɚɹɪɟɚɤɰɢɹɧɚɷɬɨɬ
ɢɦɩɥɚɧɬɚɬ
‡ SENOMARK®ɧɟɪɟɤɨɦɟɧɞɭɟɬɫɹɞɥɹɢɫɩɨɥɶɡɨɜɚɧɢɹɭɩɚɰɢɟɧɬɨɜɫɝɪɭɞɧɵɦɢ
ɢɦɩɥɚɧɬɚɬɚɦɢ
Ɋɢɫ
Figure 1
ɍɛɟɞɢɬɟɫɶɱɬɨɡɚɛɨɪɨɛɪɚɡɰɨɜɞɥɹɛɢɨɩɫɢɢɡɚɜɟɪɲɟɧɍɛɟɞɢɬɟɫɶ
ɱɬɨɜɵɟɦɤɚɞɥɹɡɚɛɨɪɚɩɨɥɧɨɫɬɶɸɨɱɢɳɟɧɚɨɬɨɛɪɚɡɰɨɜɬɤɚɧɢ
ɉɪɨɜɟɪɶɬɟɭɩɚɤɨɜɤɭɭɛɟɞɢɜɲɢɫɶɜɬɨɦɱɬɨɟɟɰɟɥɨɫɬɧɨɫɬɶɧɟɧɚɪɭɲɟɧɚ
ɂɡɞɟɥɢɟɫɬɟɪɢɥɶɧɨɟɫɥɢɝɚɪɚɧɬɢɣɧɚɹɩɟɱɚɬɶɧɟɩɨɜɪɟɠɞɟɧɚ
‡ ɍɫɬɪɨɣɫɬɜɨɩɪɟɞɧɚɡɧɚɱɟɧɨɬɨɥɶɤɨɞɥɹɨɞɧɨɤɪɚɬɧɨɝɨɩɪɢɦɟɧɟɧɢɹ
ɉɨɜɬɨɪɧɨɟɢɫɩɨɥɶɡɨɜɚɧɢɟɷɬɨɝɨɦɟɞɢɰɢɧɫɤɨɝɨɭɫɬɪɨɣɫɬɜɚɫɨɩɪɹɠɟɧɨ
ɫɪɢɫɤɨɦɩɟɪɟɤɪɟɫɬɧɨɝɨɡɚɪɚɠɟɧɢɹɩɚɰɢɟɧɬɨɜɩɨɫɤɨɥɶɤɭɦɟɞɢɰɢɧɫɤɢɟ
ɭɫɬɪɨɣɫɬɜɚ²ɜɱɚɫɬɧɨɫɬɢɬɟɤɨɬɨɪɵɟɢɦɟɸɬɞɥɢɧɧɵɣɢɭɡɤɢɣɩɪɨɫɜɟɬ
ɬɨɱɤɢɫɨɟɞɢɧɟɧɢɹɢɢɥɢɡɚɡɨɪɵɦɟɠɞɭɤɨɦɩɨɧɟɧɬɚɦɢ²ɬɪɭɞɧɨɢɥɢ
ɧɟɜɨɡɦɨɠɧɨɨɱɢɫɬɢɬɶɩɨɫɥɟɤɨɧɬɚɤɬɚɛɢɨɥɨɝɢɱɟɫɤɢɯɠɢɞɤɨɫɬɟɣɢɥɢɬɤɚɧɟɣ
ɩɨɬɟɧɰɢɚɥɶɧɨɫɨɞɟɪɠɚɳɢɯɩɢɪɨɝɟɧɧɵɟɜɟɳɟɫɬɜɚɢɥɢɦɢɤɪɨɨɪɝɚɧɢɡɦɵ
ɫɦɟɞɢɰɢɧɫɤɢɦɭɫɬɪɨɣɫɬɜɨɦɜɬɟɱɟɧɢɟɧɟɨɩɪɟɞɟɥɟɧɧɨɝɨɩɟɪɢɨɞɚɜɪɟɦɟɧɢ
Ɉɫɬɚɬɤɢɛɢɨɥɨɝɢɱɟɫɤɨɝɨɦɚɬɟɪɢɚɥɚɦɨɝɭɬɫɩɨɫɨɛɫɬɜɨɜɚɬɶɡɚɝɪɹɡɧɟɧɢɸ
ɭɫɬɪɨɣɫɬɜɚɩɢɪɨɝɟɧɧɵɦɢɜɟɳɟɫɬɜɚɦɢɢɥɢɦɢɤɪɨɨɪɝɚɧɢɡɦɚɦɢɤɨɬɨɪɵɟ
ɦɨɝɭɬɩɪɢɜɟɫɬɢɤɢɧɮɟɤɰɢɨɧɧɵɦɨɫɥɨɠɧɟɧɢɹɦ
‡ ɉɨɜɬɨɪɧɚɹɫɬɟɪɢɥɢɡɚɰɢɹɡɚɩɪɟɳɟɧɚɉɨɫɥɟɩɨɜɬɨɪɧɨɣɫɬɟɪɢɥɢɡɚɰɢɢ
ɉɪɢɦɟɧɹɹɫɬɚɧɞɚɪɬɧɭɸɚɫɟɩɬɢɱɟɫɤɭɸɦɟɬɨɞɢɤɭɢɡɜɥɟɤɢɬɟɭɫɬɪɨɣɫɬɜɨ
SENOMARK®ɢɡɭɩɚɤɨɜɤɢɢɩɪɨɜɟɪɶɬɟɧɚɩɪɟɞɦɟɬɩɨɜɪɟɠɞɟɧɢɣɋɇɂɆɂɌȿ
ɁȺɓɂɌɇɕɃɄɈɅɉȺɑɈɄȾɅəɇȺɄɈɇȿɑɇɂɄȺ*
‡ Ɂɚɩɪɟɳɚɟɬɫɹɢɫɩɨɥɶɡɨɜɚɬɶɜɭɫɥɨɜɢɹɯɧɚɥɢɱɢɹɢɧɮɟɤɰɢɢ
‡ ɉɪɢɥɨɠɟɧɢɟɱɪɟɡɦɟɪɧɨɝɨɭɫɢɥɢɹɩɪɢɢɡɜɥɟɱɟɧɢɢɚɩɩɥɢɤɚɬɨɪɚɦɨɠɟɬ
ɩɪɢɜɟɫɬɢɤɩɨɜɪɟɠɞɟɧɢɸɧɚɤɨɧɟɱɧɢɤɚɚɩɩɥɢɤɚɬɨɪɚ
ɧɟɥɶɡɹɝɚɪɚɧɬɢɪɨɜɚɬɶɫɬɟɪɢɥɶɧɨɫɬɶɢɡɞɟɥɢɹɢɡɡɚɧɟɜɨɡɦɨɠɧɨɫɬɢ
ɨɩɪɟɞɟɥɢɬɶɫɬɟɩɟɧɶɡɚɝɪɹɡɧɟɧɢɹɩɢɪɨɝɟɧɧɵɦɢɜɟɳɟɫɬɜɚɦɢɢɥɢ
ɦɢɤɪɨɨɪɝɚɧɢɡɦɚɦɢɤɨɬɨɪɵɟɦɨɝɭɬɩɪɢɜɟɫɬɢɤɢɧɮɟɤɰɢɨɧɧɵɦ
ɨɫɥɨɠɧɟɧɢɹɦɈɱɢɫɬɤɚɩɨɜɬɨɪɧɵɟɨɛɪɚɛɨɬɤɚɢɢɥɢɫɬɟɪɢɥɢɡɚɰɢɹɞɚɧɧɨɝɨ
ɦɟɞɢɰɢɧɫɤɨɝɨɭɫɬɪɨɣɫɬɜɚɩɨɜɵɲɚɸɬɜɟɪɨɹɬɧɨɫɬɶɟɝɨɧɟɢɫɩɪɚɜɧɨɫɬɢɢɡɡɚ
ɨɬɪɢɰɚɬɟɥɶɧɵɯɩɨɫɥɟɞɫɬɜɢɣɜɵɡɜɚɧɧɵɯɬɟɪɦɢɱɟɫɤɨɣɨɛɪɚɛɨɬɤɨɣɢɢɥɢ
ɦɟɯɚɧɢɱɟɫɤɢɦɢɢɡɦɟɧɟɧɢɹɦɢɟɝɨɤɨɦɩɨɧɟɧɬɨɜ
ȿɫɥɢɢɫɩɨɥɶɡɭɟɬɫɹɭɫɬɪɨɣɫɬɜɨɞɥɹɛɢɨɩɫɢɢATEC™/ɫɦɢɥɢ
3HWLWHɫɦɬɨɭɞɚɥɢɬɟɩɟɪɟɯɨɞɧɢɤ(Ⱦɥɹɭɫɬɪɨɣɫɬɜɚɞɥɹ
ɛɢɨɩɫɢɢATEC™/ɫɦɢɥɢ3HWLWHɫɦɩɪɨɞɜɢɝɚɣɬɟ
ɩɟɪɟɯɨɞɧɢɤ(ɜɧɚɩɪɚɜɥɟɧɢɢɪɭɱɤɢɩɨɤɚɨɧɧɟɤɨɫɧɟɬɫɹɨɝɪɚɧɢɱɢɬɟɥɹ'
ɧɚɫɬɟɪɠɧɟɚɩɩɥɢɤɚɬɨɪɚ
ɋɥɟɞɭɹɢɧɫɬɪɭɤɰɢɹɦɭɫɬɪɨɣɫɬɜɚATEC™ɢɡɜɥɟɤɢɬɟɦɟɯɚɧɢɡɦɞɪɚɣɜɟɪɚ
ɢɡɤɚɧɸɥɢɭɫɬɪɨɣɫɬɜɚɞɥɹɛɢɨɩɫɢɢɨɫɬɚɜɢɜɤɚɧɸɥɸɜɦɨɥɨɱɧɨɣɠɟɥɟɡɟ
ɍɫɬɚɧɨɜɢɬɟɚɩɩɥɢɤɚɬɨɪSENOMARK®ɜɤɚɧɸɥɸɭɫɬɪɨɣɫɬɜɚɞɥɹɛɢɨɩɫɢɢATEC™
ɢɩɪɨɞɜɢɝɚɣɬɟɩɨɤɚɨɝɪɚɧɢɱɢɬɟɥɶATEC™'ɢɥɢɩɟɪɟɯɨɞɧɢɤ(ɧɟɭɩɪɭɬɫɹ
ɜɤɚɧɸɥɸ
ɋɨɜɦɟɫɬɢɬɟɭɤɚɡɚɬɟɥɢSENOMARK®&ɢ'ɫɜɵɟɦɤɨɣɞɥɹɡɚɛɨɪɚɜɤɚɧɸɥɟ
ɭɫɬɪɨɣɫɬɜɚɞɥɹɛɢɨɩɫɢɢ
ɆȿɊɕɉɊȿȾɈɋɌɈɊɈɀɇɈɋɌɂ
‡ Ⱦɚɧɧɨɟɭɫɬɪɨɣɫɬɜɨɞɨɥɠɧɨɢɫɩɨɥɶɡɨɜɚɬɶɫɹɬɨɥɶɤɨɜɪɚɱɚɦɢɨɛɭɱɟɧɧɵɦɢ
ɩɪɨɜɟɞɟɧɢɸɱɪɟɫɤɨɠɧɨɣɛɢɨɩɫɢɢ
ɉɪɨɞɜɢɝɚɹɩɨɪɲɟɧɶ$ɧɟɡɚɦɟɞɥɢɬɟɥɶɧɨɜɜɟɞɢɬɟɤɚɩɫɭɥɵSENOMARK®
ɜɬɨɠɟɜɪɟɦɹɧɚɞɚɜɥɢɜɚɹɪɭɱɤɭ%ɢɫɥɟɞɹɡɚɩɪɚɜɢɥɶɧɵɦɫɨɜɦɟɳɟɧɢɟɦ
ɚɩɩɥɢɤɚɬɨɪɚɫɜɵɟɦɤɨɣɞɥɹɡɚɛɨɪɚɄɨɝɞɚɩɨɪɲɟɧɶɤɨɫɧɟɬɫɹɪɭɱɤɢɤɚɩɫɭɥɵ
ɛɭɞɭɬɩɨɥɧɨɫɬɶɸɜɜɟɞɟɧɵ
ɉɨɜɟɪɧɢɬɟɤɚɧɸɥɸɭɫɬɪɨɣɫɬɜɚɞɥɹɛɢɨɩɫɢɢɧɚƒɱɬɨɛɵɜɵɟɦɤɚɞɥɹ
ɡɚɛɨɪɚɧɚɯɨɞɢɥɚɫɶɧɚɧɟɤɨɬɨɪɨɦɪɚɫɫɬɨɹɧɢɢɨɬɜɜɨɞɢɦɵɯɤɚɩɫɭɥ
‡ Ɂɚɩɪɟɳɚɟɬɫɹɩɪɢɦɟɧɹɬɶɢɡɞɟɥɢɟɟɫɥɢɫɬɟɪɢɥɶɧɵɣɛɚɪɶɟɪɛɵɥ
ɩɪɟɞɜɚɪɢɬɟɥɶɧɨɜɫɤɪɵɬɢɥɢɭɩɚɤɨɜɤɚɩɨɜɪɟɠɞɟɧɚ
ɂɡɜɥɟɤɢɬɟɚɩɩɥɢɤɚɬɨɪSENOMARK®ɢɡɤɚɧɸɥɢɭɫɬɪɨɣɫɬɜɚɞɥɹɛɢɨɩɫɢɢ
ɇɟɩɪɢɥɚɝɚɣɬɟɱɪɟɡɦɟɪɧɭɸɫɢɥɭɫɦɩɪɟɞɭɩɪɟɠɞɟɧɢɟɧɢɠɟ
‡ ɂɡɞɟɥɢɟɩɨɫɬɚɜɥɹɟɬɫɹɫɬɟɪɢɥɶɧɵɦɢɩɪɟɞɧɚɡɧɚɱɟɧɨɬɨɥɶɤɨɞɥɹɨɞɧɨɪɚɡɨɜɨɝɨ
ɢɫɩɨɥɶɡɨɜɚɧɢɹɉɈȼɌɈɊɇȺəɋɌȿɊɂɅɂɁȺɐɂəɁȺɉɊȿɓȿɇȺ
Ɂɚɤɪɨɣɬɟɜɵɟɦɤɭɞɥɹɡɚɛɨɪɚɢɢɡɜɥɟɤɢɬɟɭɫɬɪɨɣɫɬɜɨɞɥɹɛɢɨɩɫɢɢɫɨɛɥɸɞɚɹ
ɢɧɫɬɪɭɤɰɢɢɩɪɨɢɡɜɨɞɢɬɟɥɹ
‡ Ɂɚɩɪɟɳɚɟɬɫɹɩɟɪɟɤɪɭɱɢɜɚɬɶɝɢɛɤɭɸɥɢɧɢɸ
ɍɬɢɥɢɡɢɪɭɣɬɟɚɩɩɥɢɤɚɬɨɪɧɚɞɥɟɠɚɳɢɦɨɛɪɚɡɨɦ
‡ ɉɪɢɜɜɟɞɟɧɢɢɤɚɩɫɭɥɭɛɟɞɢɬɟɫɶɜɩɪɚɜɢɥɶɧɨɦɫɨɜɦɟɳɟɧɢɢɭɤɚɡɚɬɟɥɟɣ
&ɢ'ɧɚɪɢɫɫɜɵɟɦɤɨɣɞɥɹɡɚɛɨɪɚ
ɉɪɨɜɟɪɶɬɟɨɤɨɧɱɚɬɟɥɶɧɨɟɩɨɥɨɠɟɧɢɟɦɚɪɤɟɪɚɫɩɨɦɨɳɶɸɜɢɡɭɚɥɢɡɚɰɢɢ
‡ ɍɛɟɞɢɬɟɫɶɱɬɨɜɜɟɞɟɧɵɜɫɟɤɚɩɫɭɥɵ
‡ ɋɥɟɞɭɟɬɯɪɚɧɢɬɶɩɪɢɬɟɦɩɟɪɚɬɭɪɟɧɢɠɟž&
‡ Ɉɩɭɛɥɢɤɨɜɚɧɧɵɟɢɫɫɥɟɞɨɜɚɧɢɹɫɨɪɚɡɦɟɪɧɵɯɦɚɪɤɟɪɨɜɦɟɫɬɚɛɢɨɩɫɢɢ
ɢɡɧɟɪɠɚɜɟɸɳɟɣɫɬɚɥɢɦɚɪɤɢ/ɭɤɚɡɵɜɚɸɬɧɚɨɬɫɭɬɫɬɜɢɟɞɜɢɠɟɧɢɹ
ɦɚɪɤɟɪɚɢɟɝɨɧɟɡɧɚɱɢɬɟɥɶɧɨɟɧɚɝɪɟɜɚɧɢɟɩɪɢɬɟɫɬɢɪɨɜɚɧɢɢɜɫɢɫɬɟɦɟɆɊɌ
ɫɧɚɩɪɹɠɟɧɧɨɫɬɶɸɩɨɥɹ7
ɉɪɟɞɭɩɪɟɠɞɟɧɢɟȿɫɥɢɜɦɨɦɟɧɬɢɡɜɥɟɱɟɧɢɹɚɩɩɥɢɤɚɬɨɪɚɨɳɭɳɚɟɬɫɹ
ɫɨɩɪɨɬɢɜɥɟɧɢɟɨɫɬɚɜɶɬɟɚɩɩɥɢɤɚɬɨɪSENOMARK®ɜɡɨɧɞɟɢɢɡɜɥɟɤɢɬɟɛɥɨɤ
ɡɨɧɞɚɚɩɩɥɢɤɚɬɨɪɚɜɫɛɨɪɟɇɟɫɨɛɥɸɞɟɧɢɟɷɬɨɝɨɬɪɟɛɨɜɚɧɢɹɦɨɠɟɬɩɪɢɜɟɫɬɢɤ
ɩɨɜɪɟɠɞɟɧɢɸɧɚɤɨɧɟɱɧɢɤɚɚɩɩɥɢɤɚɬɨɪɚ
ɋɨɛɪɚɧɨɜɌɚɢɥɚɧɞɟ
‹Ʉɨɦɩɚɧɢɹ&5%DUG,QFȼɫɟɩɪɚɜɚɡɚɳɢɳɟɧɵ
1
SENOMARK®ɫɨɜɦɟɫɬɢɦɫɭɫɬɪɨɣɫɬɜɨɦɞɥɹɛɢɨɩɫɢɢATEC™ɤɚɥɢɛɪɚɪɚɡɦɟɪɨɦɫɦɢɫɦ
ɩɪɨɢɡɜɨɞɫɬɜɚ6XURV6XUJLFDO6\VWHPV,QFɎɪɚɧɤɥɢɧɂɧɞɢɚɧɚ
19
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Tilgate Forest Business Park
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3.5HY 11/11