Download ENGLISH - Bard Biopsy Systems

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Transcript 
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Multi-Lumen Balloon Applicator For Brachytherapy
ENGLISH
B01245, B01256, B11245 & B11256
INSTRUCTIONS FOR USE
Caution: Federal (USA) law restricts this device to sale by or on the order of a
physician.
DESCRIPTION
The CONTURA® MLB Applicator consists of a multi-lumen catheter attached to an
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PRECAUTIONS
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stylet is positioned in the central treatment lumen, and treatment lumens #1-4
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procedure to prevent potential abrasion or puncture of the CONTURA® balloon.
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The CONTURA® MLB accessories provided for introduction and deployment include:
and whenever possible position tissue between the potential balloon surface
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and the tails.
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‡ 6WRUHWKHCONTURA®$SSOLFDWRUDWURRPWHPSHUDWXUHž&PD[LPXP
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‡ &DUHPXVWEHWDNHQZKHQKDQGOLQJDQGPDQLSXODWLQJWKHCONTURA® balloon to
Afterloader compatibility:
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with the Applicator prior to treatment.
‡
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consistent for each treatment fraction.
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INDICATIONS FOR USE
The CONTURA® MLB Applicator is intended to provide brachytherapy when the
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CONTRAINDICATIONS
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VXUURXQGLQJWKHFDYLW\WKDWPD\FDXVHWKHCONTURA® balloon to be
asymmetrical.
COMPLICATIONS
Complications that may be associated with the use of the CONTURA® MLB
Applicator are the same as those associated with the use of similar devices.
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rash, asymptomatic fat necrosis, breast infection, breast blister and lymphedema.
WARNINGS
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HOW SUPPLIED
The CONTURA® MLB Applicator and accessories are provided sterile and are
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DIRECTIONS FOR USE
3/$&(0(175HIHUWR)LJXUHV
Stiffening Stylet (J)
Central Treatment Lumen #5 (K)
Treatment Lumen #1 Stripe (I)
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Inflation Port
Luer Cap (C)
Applicator (A)
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Treatment Lumen
Cap and Fillers (L)
Treatment Lumen #5
Treatment Lumen #1
Contrast Media Tray (D)
Scalpel (E)
Treatment Lumen #4
Treatment Lumen #2
Drainage
Catheter (H)
10 ml Syringe
Split Sheath (G)
30 ml Syringe (B)
Inflation Port (M) (Blue)
Trocar (F)
Treatment Lumen #3
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Vacuum Port (N) (White)
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1.
Use ultrasound to identify the lumpectomy cavity.
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vertically, completely withdraw the saline from balloon.
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provided.
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consistent for each treatment fraction.
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treatment dwell positions and dwell times for optimized radiation delivery of a
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visualization.
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Determine the desired point on the breast surface for the insertion of the
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Trocar.
Treatment Lumen number ‘5’ corresponds to the central lumen. Remove the
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red caps and use commercially available connectors to attach the treatment
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lumens to the afterloader.
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Note::KHQXVLQJWKH*DPPD0HGSOXV™ afterloader, the treatment lumens of
4.
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Sheath.
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incision.
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5.
After each treatment replace the red caps and secure catheter shaft.
REMOVAL
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a red Treatment Lumen Cap (L).
Remove the CONTURA®0/%$SSOLFDWRUE\¿UVWDWWDFKLQJDV\ULQJHWRWKHEOXH
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Note: ,IGLI¿FXOW\LVHQFRXQWHUHGGHÀDWLQJEDOORRQZLWKV\ULQJH
Model
Desired balloon diameter
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B01245
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PO
B11245
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PO
B01256
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51 ml
B11256
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2.
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patient’s chart.
2
Rotate and withdraw (unscrew) the Applicator from the cavity.
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Applicateur De Ballonnet Multi-Lumière Pour La Curiethérapie
FRANÇAIS
B01245, B01256, B11245 et B11256
MODE D’EMPLOI
DESCRIPTION
L’applicateur de ballonnet multi-lumière (MLB) CONTURA® est composé d’un cathéter
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Les accessoires CONTURA® MLB fournis pour l’introduction et le déploiement incluent :
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Varian
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Nucletron
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INDICATIONS
L’applicateur CONTURA®0/%HVWFRQoXSRXUSHUPHWWUHODFXULHWKpUDSLHORUVTXHOH
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CONTRE-INDICATIONS
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ballonnet CONTURA®.
AVERTISSEMENTS
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Gaine fendue (G)
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7.
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catetere all’incisione della pelle.
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riempimento del palloncino
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linea di riferimento del lume di trattamento no,OXQJRORVWHORGHOFDWHWHUH,OOXPH
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afterloader.
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Diametro desiderato del palloncino
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B01245, B01256, B11245 Y B11256
INSTRUCCIONES DE USO
DESCRIPCIÓN
El aplicador de BML CONTURA® consiste en un catéter multiluminal conectado a un
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FLQFRFDQDOHVGHWUDWDPLHQWRXQFDQDOFHQWUDOXELFDGRDORODUJRGHOHMHORQJLWXGLQDO
del aplicador y cuatro canales curvos simétricamente dispuestos alrededor del canal
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canales de tratamiento 1 a 4 se obturan con capuchones. También se suministran
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para aplicar el vacío intracavitario.
Los accesorios BML CONTURA®TXHVHSURSRUFLRQDQSDUDODLQWURGXFFLyQ\HO
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¿JXUD
PRECAUCIONES
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radioterapia.
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Varian
Nucletron
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aplicador CONTURA®FRPRPRGDOLGDGDOWHUQDWLYDDODLUUDGLDFLyQPDPDULDWRWDOHQ
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ni marcadores de metal para evitar la abrasión o perforación accidental del balón
CONTURA®. También se recomienda colocar con cuidado los nudos y las colas de
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INDICACIONES DE USO
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El aplicador de BML CONTURA®HVWiLQGLFDGRSDUDUHDOL]DUODEUDTXLWHUDSLDFXDQGRHO
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de una tumorectomía por cáncer de mama.
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CONTRAINDICACIONES
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insertar la punta del trocar.
‡
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‡
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en el balón CONTURA®.
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aplicador antes de administrar el tratamiento.
‡
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se debe llevar a cabo antes de cada fracción de radiación terapéutica con el
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tratamiento. La orientación debe mantenerse constante en cada fracción de
radiación.
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ADVERTENCIAS
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‡
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9XHOYDDFRORFDUORVFDSXFKRQHVHQORVFRQHFWRUHV/XHU\HQORVFDQDOHVGH
radiación después de su uso.
COMPLICACIONES
Las posibles complicaciones asociadas con el uso del aplicador de BML
CONTURA®VRQODVPLVPDVTXHSXHGHQVXUJLUDOXWLOL]DUGLVSRVLWLYRVVLPLODUHV\
HQWUHRWUDVVRQHULWHPDIXJDVDQLYHOGHOVLWLRGHOFDWpWHUPDVWDOJLDHTXLPRVLV
¿EURVLVPDPDULDWHODQJLHFWDVLDVLQGXUDFLyQPDPDULDVHURPDPDPDULRHGHPD
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SDUHVWHVLDVGRORUD[LODUIDWLJDSUXULWRUHWUDFFLyQPDPDULDQiXVHDVLUULWDFLyQ
FXWiQHDGHVFDPDFLyQK~PHGDKHPDWRPDHUXSFLyQFXWiQHDQHFURVLVJUDVD
asintomática, infección mamaria, formación de ampollas mamarias y linfedema.
PRESENTACIÓN
El aplicador de BLM CONTURA® y sus accesorios se suministran en condiciones
estériles y están destinados a emplearse en un solo paciente.
9
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MODO DE EMPLEO
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VHSXHGHQDVSLUDUFRQXQDMHULQJDGHPOFRQHFWDGDDOSXHUWRGHYDFtREODQFR1
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,16(5&,Ï1±9HDODV¿JXUDV\
Estilete rígido (J)
Canal de tratamiento central n.º 5 (K)
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la incisión cutánea.
Marca lineal del canal de tratamiento n.º 1 (I)
&RORTXHHOFDWpWHUHQODSRVLFLyQPiVUHFWDSRVLEOH\DOLQHHODPDUFDFRQODLQFLVLyQ
cutánea.
Capuchón de
conector Luer
del puerto de
inflado (C)
Aplicador (A)
$SOLTXHXQDSyVLWRTXLU~UJLFRHQHOVLWLRGHVDOLGDFRQHOFDWpWHUFRORFDGRHQODSRVLFLyQ
más recta posible.
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a la historia clínica de la paciente.
$'0,1,675$&,Ï1'(5$',$&,Ï1±9HDODV¿JXUDV\
)LJXUD$3/,&$'25CONTURA®
Canal de tratamiento n.º 5
Capuchón del canal de
tratamiento y material de relleno (L)
Canal de tratamiento n.º 1
Bandeja para medio de contraste (D)
Canal de tratamiento n.º 4
Bisturí (E)
Canal de tratamiento n.º 2
Catéter de
drenaje (H)
Puerto de inflado
(M) (Azul)
Vaina dividida (G)
Jeringa de 10 ml
Jeringa de 30 ml (B)
Trocar (F)
Canal de tratamiento n.º 3
Puerto de vacío (N) (Blanco)
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)LJXUD$&&(625,26
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Abra el envase estéril del aplicador de BML CONTURA®\UHWLUHHODSOLFDGRU$\XQDMHULQJDGH
PO%5HWLUHHOFDSXFKyQGHOFRQHFWRU/XHUGHOSXHUWRGHLQÀDGR&HLQ\HFWHPO%
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salina del balón.
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2.
Nota: Una concentración más elevada de medio de contraste puede reducir la visibilidad del
marcador luminal.
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5HWLUHHOFDWpWHUGHGUHQDMH
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cutánea.
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‡
de conectarlas al aplicador.
1.
Modelo
Diámetro deseado del balón
9ROXPHQDSUR[LPDGRGHOOHQDGR
del balón
PO
B11245
FPGHGLiPHWUR[FPGHODUJR
PO
B01256
FPGHGLiPHWUR[FPGHODUJR
51 ml
B11256
FPGHGLiPHWUR[FPGHODUJR
PO
/RVFDQDOHVGHWUDWDPLHQWRVHGHVLJQDQFRQORVQ~PHURV³´³´³´³´\³´\VH
FRORFDQHQODSRVLFLyQLQGLFDGDHQOD¿JXUD(OQ~PHURµ³´FRUUHVSRQGHDOFDQDOPiV
SUy[LPR\SDUDOHORDODPDUFDOLQHDOGHOFDQDOGHWUDWDPLHQWRQž,DORODUJRGHOHMH
GHOFDWpWHU(OQ~PHUR³´FRUUHVSRQGHDOFDQDOFHQWUDO5HWLUHORVFDSXFKRQHVURMRV\
utilice los conectores comerciales para acoplar los canales de tratamiento al dispositivo
GHFDUJDGLIHULGD
Nota: &XDQGRVHXWLOL]DHOGLVSRVLWLYRGHFDUJDGLIHULGD*DPPD0HGSOXV™, los canales
GHWUDWDPLHQWRGHODSOLFDGRUVHGHEHQUHFRUWDUKDVWDODORQJLWXGDGHFXDGDPHGLDQWHHO
el calibrador de cuchilla *DPPD0HGSOXV™.
5HWLUHHOHVWLOHWHUtJLGR-GHOFDQDOGHWUDWDPLHQWRFHQWUDO.&RORTXHXQFDSXFKyQGHFDQDOGH
WUDWDPLHQWRURMR/
FPGHGLiPHWUR[FPGHODUJR
6HGHEHXWLOL]DUOD7&FRPELQDGDFRQXQVRIWZDUHGHSODQL¿FDFLyQWHUDSpXWLFDFRPHUFLDO
para determinar los canales de tratamiento adecuados, las posiciones de tratamiento
y los tiempos de permanencia para la administración óptima de la dosis de radiación
prescrita en el volumen de tratamiento previsto.
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la orientación del aplicador CONTURA®9HUL¿TXHODRULHQWDFLyQFRUUHFWDGHODSOLFDGRU
la posición del balón, el volumen del balón, el espacio entre el balón y la piel, y la
DGDSWDFLyQDODFDYLGDGPHGLDQWHJXtDHFRJUi¿FDDQWHVGHODDGPLQLVWUDFLyQGHFDGD
IUDFFLyQGHUDGLDFLyQ&RUULMDVHJ~QVHDQHFHVDULR
'HWHUPLQHHOSXQWRGHODVXSHU¿FLHPDPDULDHQHOTXHVHGHVHDLQVHUWDUHODSOLFDGRU,Q\HFWHHO
DQHVWpVLFRORFDODGHFXDGRHQODSLHO\HQHOWUD\HFWRKDVWDODFDYLGDGGHODWXPRUHFWRPtD(IHFW~H
XQDLQFLVLyQFXWiQHDFRQHOELVWXUtGHWDPDxRVX¿FLHQWHSDUDSRGHULQVHUWDUSRUFRPSOHWRODSXQWD
GHOWURFDU)6LVHFRQVLGHUDQHFHVDULRODLQFLVLyQFXWiQHDVHSXHGHGLODWDU+DJDDYDQ]DUHO
WURFDUFRQODYDLQDGLYLGLGD*HLQVpUWHORHQODFDYLGDG5HWLUHHOWURFDU
B01245
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se produzcan curvas bruscas ni acodamientos cuando se lo conecta al dispositivo de
FDUJDGLIHULGD+'5/DPHGLFLyQGHODORQJLWXGGHWUDWDPLHQWRVHGHEHOOHYDUDFDER
antes de cada fracción de radiación terapéutica con el dispositivo orientado en la misma
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constante en cada fracción de radiación.
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del catéter.
(;75$&&,Ï1
Retire el aplicador de BML CONTURA®FRQHFWDQGRXQDMHULQJDDOSXHUWRGHLQÀDGRD]XO\
GHVLQÀDQGRHOEDOyQ
Nota:6LVXUJHQGL¿FXOWDGHVSDUDGHVLQÀDUHOEDOyQFRQODMHULQJD
9
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6
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la mezcla de medio de contraste y solución salida presente en el interior del balón
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6
LQRD~QQRSXHGHGHVLQÀDUVHHOEDOyQLQVHUWHXQDMHULQJDFRQXQDDJXMD
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+DJDJLUDUHODSOLFDGRU\UHWtUHORGHVHQUyVTXHORGHODFDYLGDG
10
‡
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‡
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‡
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PHFKDQLVFKHYHUDQGHULQJHQ]LMQEHwQYORHG
Multi-Lumen Ballonapplicator Voor Brachytherapie
NEDERLANDS
B01245, B01256, B11245 en B11256
*(%58,.6$$1:,-=,1*
BESCHRIJVING
De CONTURA®0/%DSSOLFDWRUEHVWDDWXLWHHQPXOWLOXPHQNDWKHWHUGLHEHYHVWLJGLVDDQ
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RSYRHUHQYDQGHELMGHEHVWUDOLQJVEHKDQGHOLQJJHEUXLNWHSODDWVLQJVGUDDG (U]LMQYLMI
EHKDQGHOOXPLQDppQFHQWUDDOOXPHQODQJVGHOHQJWHDVYDQGHDSSOLFDWRUHQYLHUJHNURPGH
lumina met een symmetrische offset van het centrale lumen. Er is een afneembaar
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NDQZRUGHQXLWJHRHIHQG
9225=25*60$$75(*(/(1
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‡
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en labels (afb. 2).
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Varian
Nucletron
‡
‡
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*DPPD0HGSOXV™ Series
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INDICATIES
De CONTURA MLB applicator dient voor het uitvoeren van brachytherapie wanneer de arts
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®
CONTRA-INDICATIES
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weefsel rondom de holte) waardoor de CONTURA® ballon asymmetrisch zal worden.
COMPLICATIES
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De CONTURA®0/%DSSOLFDWRUHQDFFHVVRLUHV]LMQELMOHYHULQJVWHULHOHQGLHQHQXLWVOXLWHQG
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Dividida (G)
Seringa de 10 ml
Seringa de 30 ml (B)
Lúmen de Tratamento Nº. 3 Orifício de Vácuo (N) (Branco)
Trocarte (F)
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Tabuleiro (D) fornecido.
pretendido.
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calibrador de corte de comprimento *DPPD0HGSOXV™.
6. Fazer avançar o Aplicador através da Bainha Dividida para dentro da cavidade. Retirar
a Bainha.
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cateter.
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Modelo
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B01245
FP'Lk[FPFRPS
B11245
FP'Lk[FPFRPS
PO
B01256
FP'Lk[FPFRPS
51 ml
B11256
FP'Lk[FPFRPS
PO
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VHULQJD
2. Rodar e retirar (desenroscar) o Aplicador da cavidade.
14
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ǼijĮȡȝȠȖİĮȢȂʌĮȜȠȞȚȠȣȆȠȜȜĮʌȜȦȞǹȣȜȦȞīȚĮ
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ĮijĮȓȡİıȘȢIJȠȣİijĮȡȝȠȖȑĮĮʌȩIJȠȞĮıșİȞȒıȣȞȚıIJȐIJĮȚȘȤİȚȡȠȣȡȖȚțȒ
ĮijĮȓȡİıȒIJȠȣ
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ȈȣȞȚıIJȫȞIJĮȚıȣȖțİȞIJȡȫıİȚȢıțȚĮȖȡĮijȚțȠȪȝȑıȠȣȝȚțȡȩIJİȡİȢĮʌȩȫıIJİ
ȞĮĮʌȠijİȪȖİIJĮȚȘİȟĮıșȑȞȘıȘIJȘȢįȩıȘȢ
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īȚĮĮıșİȞİȓȢʌȠȣİȓȞĮȚĮȜȜİȡȖȚțȠȓıİʌĮȡȐȖȠȞIJİȢȝİȕȐıȘIJȠȚȫįȚȠ
ıȣȞȚıIJȫȞIJĮȚȝȘȚȠȞIJȚțȐıțȚĮȖȡĮijȚțȐȝȑıĮ
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ǾıȣıțİȣȒĮȣIJȒȑȤİȚıȤİįȚĮıIJİȓȖȚĮȝȓĮȝȩȞȠȤȡȒıȘǾİʌĮȞĮȤȡȘıȚȝȠʌȠȓȘıȘ
ĮȣIJȒȢIJȘȢȚĮIJȡȚțȒȢıȣıțİȣȒȢİȞȑȤİȚIJȠȞțȓȞįȣȞȠįȚĮıIJĮȣȡȠȪȝİȞȘȢȝȩȜȣȞıȘȢ
ȝİIJĮȟȪIJȦȞĮıșİȞȫȞįȚȩIJȚȠȚȚĮIJȡȚțȑȢıȣıțİȣȑȢİȚįȚțȩIJİȡĮİțİȓȞİȢ
ȝİȝĮțȡȚȠȪȢțĮȚıIJİȞȠȪȢĮȣȜȠȪȢıȣȞįȑıİȚȢțĮȚȒıȤȚıȝȑȢȝİIJĮȟȪIJȦȞ
İȟĮȡIJȘȝȐIJȦȞİȓȞĮȚįȪıțȠȜȠȒĮįȪȞĮIJȠȞȞĮțĮșĮȡȚıIJȠȪȞĮʌȩIJȘıIJȚȖȝȒʌȠȣ
ıȦȝĮIJȚțȐȣȖȡȐȒȚıIJȠȓȝİʌȚșĮȞȒʌȣȡİIJȠȖȩȞȠȒȝȚțȡȠȕȚĮțȒİʌȚȝȩȜȣȞıȘ
ȑȤȠȣȞȑȡșİȚıİİʌĮijȒȝİIJȘȞȚĮIJȡȚțȒıȣıțİȣȒȖȚĮĮʌȡȠıįȚȩȡȚıIJȘȤȡȠȞȚțȒ
įȚȐȡțİȚĮȉĮțĮIJȐȜȠȚʌĮIJȦȞȕȚȠȜȠȖȚțȫȞȣȜȚțȫȞİȓȞĮȚįȣȞĮIJȩȞȞĮʌȡȠȐȖȠȣȞ
IJȘȞİʌȚȝȩȜȣȞıȘIJȘȢıȣıțİȣȒȢȝİʌȣȡİIJȠȖȩȞĮȒȝȚțȡȠȠȡȖĮȞȚıȝȠȪȢȠȚȠʌȠȓȠȚ
İȞįȑȤİIJĮȚȞĮʌȡȠțĮȜȑıȠȣȞȜȠȚȝȫįİȚȢİʌȚʌȜȠțȑȢ
‡
ȂȘȞİʌĮȞĮʌȠıIJİȚȡȫȞİIJİȂİIJȐIJȘȞİʌĮȞĮʌȠıIJİȓȡȦıȘȘıIJİȚȡȩIJȘIJĮIJȠȣ
ʌȡȠȧȩȞIJȠȢįİȞİȓȞĮȚİȖȖȣȘȝȑȞȘȜȩȖȦIJȘȢʌĮȡȠȣıȓĮȢĮʌȡȠıįȚȩȡȚıIJȠȣȕĮșȝȠȪ
ʌȚșĮȞȒȢʌȣȡİIJȠȖȩȞȠȣȒȝȚțȡȠȕȚĮțȒȢİʌȚȝȩȜȣȞıȘȢȘȠʌȠȓĮİȞįȑȤİIJĮȚȞĮ
ʌȡȠțĮȜȑıİȚȜȠȚȝȫįİȚȢİʌȚʌȜȠțȑȢȅțĮșĮȡȚıȝȩȢȘİʌĮȞİʌİȟİȡȖĮıȓĮțĮȚȒȘ
İʌĮȞĮʌȠıIJİȓȡȦıȘIJȘȢʌĮȡȠȪıĮȢȚĮIJȡȚțȒȢıȣıțİȣȒȢĮȣȟȐȞİȚIJȘȞʌȚșĮȞȩIJȘIJĮ
İıijĮȜȝȑȞȘȢȜİȚIJȠȣȡȖȓĮȢIJȘȢȜȩȖȦʌȚșĮȞȫȞĮȞİʌȚșȪȝȘIJȦȞİȞİȡȖİȚȫȞʌȠȣ
ȝʌȠȡİȓȞĮʌȡȠțĮȜȑıȠȣȞıIJĮİȟĮȡIJȒȝĮIJĮȠȚșİȡȝȚțȑȢțĮȚȒȠȚȝȘȤĮȞȚțȑȢ
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İȚțȩȞĮȅȚĮȣȜȠȓʌĮȡȑȤȠȞIJĮȚȖȚĮIJȘıȪȞįİıȘİȝʌȠȡȚțȐįȚĮșȑıȚȝȠȣĮʌȠȝĮțȡȣıȝȑȞȠȣ
İȟȠʌȜȚıȝȠȪĮȣIJȩȝĮIJȘȢȝİIJĮijȩȡIJȦıȘȢDIWHUORDGHUȣȥȘȜȠȪȡȣșȝȠȪįȩıȘȢ+'5ȖȚĮ
IJȘįȚȑȜİȣıȘIJȠȣıȪȡȝĮIJȠȢȤȠȡȒȖȘıȘȢIJȘȢĮțIJȚȞȠșİȡĮʌİȓĮȢȆĮȡȑȤȠȞIJĮȚʌȑȞIJİĮȣȜȠȓ
șİȡĮʌİȓĮȢDzȞĮȢțİȞIJȡȚțȩȢĮȣȜȩȢʌȠȣȕȡȓıțİIJĮȚțĮIJȐȝȒțȠȢIJȠȣȝĮțȡȠȪȐȟȠȞĮIJȠȣ
İijĮȡȝȠȖȑĮțĮȚIJȑııİȡȚȢțȣȡIJȠȓĮȣȜȠȓʌȠȣİȓȞĮȚıȣȝȝİIJȡȚțȐȝİIJĮIJȠʌȚıȝȑȞȠȚĮʌȩIJȠȞ
țİȞIJȡȚțȩĮȣȜȩDzȞĮȢĮijĮȚȡȠȪȝİȞȠȢİȞȚıȤȣIJȚțȩȢıIJȣȜİȩȢİȓȞĮȚIJȠʌȠșİIJȘȝȑȞȠȢıIJȠȞ
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ȆĮȡȑȤȠȞIJĮȚİʌȓıȘȢįȪȠİȖȖȪȢșȪȡİȢȝİıȣȞįȑıȝȠȣȢIJȪʌȠȣ/XHUȖȚĮIJȘįȚȩȖțȦıȘ
ıȪȝʌIJȣȟȘIJȠȣȝʌĮȜȠȞȚȠȪțĮșȫȢțĮȚȖȚĮIJȘȞİijĮȡȝȠȖȒțİȞȠȪİȞIJȩȢIJȘȢțȠȚȜȩIJȘIJĮȢ
ȉĮȕȠȘșȘIJȚțȐİȟĮȡIJȒȝĮIJĮIJȠȣCONTURA®0/%ʌȠȣʌĮȡȑȤȠȞIJĮȚȖȚĮIJȘȞİȚıĮȖȦȖȒțĮȚIJȘȞ
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ıȪȡȚȖȖİȢįȚȩȖțȦıȘȢIJȦȞPOțĮȚȝȚĮıȪȡȚȖȖĮįȚȩȖțȦıȘȢIJȦȞPOȑȞĮȞȣıIJȑȡȚȃȠ
ȆȇȅĭȊȁǹȄǼǿȈ
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ȠȖțİțIJȠȝȒȖȚĮțĮȡțȓȞȠIJȠȣȝĮıIJȠȪ
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‡ ȅİijĮȡȝȠȖȑĮȢįİȞʌȡȠȠȡȓȗİIJĮȚȖȚĮȤȡȒıȘıİțȠȚȜȩIJȘIJİȢʌȠȣİȓȞĮȚʌȠȜȪȝȚțȡȑȢ
ʌȠȜȪȝİȖȐȜİȢțĮȚȒȑȤȠȣȞıȤȒȝĮIJĮıIJĮȠʌȠȓĮįİȞİȓȞĮȚįȣȞĮIJȩȞȞĮİijĮȡȝȩıİȚIJȠ
įȚȠȖțȦȝȑȞȠȝʌĮȜȩȞȚ
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ǹʌȠșȘțİȪıIJİIJȠȞİijĮȡȝȠȖȑĮCONTURA®ıİșİȡȝȠțȡĮıȓĮįȦȝĮIJȓȠȣȝȑȖȚıIJȘž&
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ȆȡȑʌİȚȞĮİȓıIJİʌȡȠıİțIJȚțȠȓțĮIJȐIJȘȤȡȒıȘțĮȚIJȠȞȤİȚȡȚıȝȩIJȠȣȝʌĮȜȠȞȚȠȪ
CONTURA®ȫıIJİȞĮĮʌȠIJȡĮʌİȓIJȣȤȩȞʌȡȩțȜȘıȘȗȘȝȚȐȢțĮȚȝȩȜȣȞıȘIJȘȢİʌȚijȐȞİȚĮȢ
IJȠȣȝʌĮȜȠȞȚȠȪĮʌȩȟȑȞĮȣȜȚțȐ
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ĬĮʌȡȑʌİȚȞĮȤȡȘıȚȝȠʌȠȚȘșİȓȑȞĮȞȣıIJȑȡȚȖȚĮIJȘįȚȐȞȠȚȟȘIJȠȝȒȢıIJȠįȑȡȝĮʌȡȚȞĮʌȩ
IJȘȞİȚıĮȖȦȖȒIJȠȣȐțȡȠȣIJȠȣIJȡȠțȐȡ
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ȂȘȞİȖȤȪİIJİȣȖȡȐıIJȘșȪȡĮİijĮȡȝȠȖȒȢțİȞȠȪ
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ȂİIJȐIJȘȤȡȒıȘİʌĮȞĮIJȠʌȠșİIJȒıIJİIJĮʌȫȝĮIJĮ/XHUțĮșȫȢțĮȚIJĮʌȫȝĮIJĮĮȣȜȫȞ
ĮțIJȚȞȠȕȩȜȘıȘȢ
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ȂȩȞȠȞțȜȚȞȚțȩʌȡȠıȦʌȚțȩʌȠȣȑȤİȚİțʌĮȚįİȣșİȓıİȜİȚIJȠȣȡȖȓĮİȟȠʌȜȚıȝȠȪ
ĮȣIJȩȝĮIJȘȢȝİIJĮijȩȡIJȦıȘȢDIWHUORDGHUȣȥȘȜȠȪȡȣșȝȠȪįȩıȘȢ+'5șĮʌȡȑʌİȚȞĮ
ȤȠȡȘȖİȓĮțIJȚȞȠȕȠȜȓĮȤȡȘıȚȝȠʌȠȚȫȞIJĮȢIJȠȞİijĮȡȝȠȖȑĮ
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ȅİijĮȡȝȠȖȑĮȢįİȞʌȡȠȠȡȓȗİIJĮȚȖȚĮȤȡȒıȘıİĮıșİȞİȓȢȝİĮıȣȞȒșȘĮȞĮIJȠȝȓĮ
ʌİȡȚȜĮȝȕĮȞȠȝȑȞȘȢIJȘȢįȠȝȒȢIJȦȞʌȜİȣȡȫȞȝİȝİȖȐȜȘțȪȡIJȦıȘțĮȚȒȝİĮȞȚıȠȝİȡȒ
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ʌȠıȩIJȘIJĮIJȠȣȚıIJȠȪʌȠȣʌİȡȚȕȐȜȜİȚIJȘȞțȠȚȜȩIJȘIJĮȖİȖȠȞȩȢʌȠȣİȞįȑȤİIJĮȚȞĮ
ʌȡȠțĮȜȑıİȚĮıȣȝȝİIJȡȓĮIJȠȣȝʌĮȜȠȞȚȠȪCONTURA®.
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ȆȇȅǼǿǻȅȆȅǿǾȈǼǿȈ
‡ ȆȡȠıȑȟIJİțĮIJȐIJȘȞIJȠʌȠșȑIJȘıȘIJȠȣȐțȡȠȣIJȠȣIJȡȠțȐȡțȠȞIJȐıIJȠșȦȡĮțȚțȩ
IJȠȓȤȦȝĮȒıIJȠȩȡȚȠIJȠȣįȑȡȝĮIJȠȢȫıIJİȞĮĮʌȠijİȣȤșİȓĮțȠȪıȚĮȕȜȐȕȘIJȠȣ
ȚıIJȠȪ
‡
ȂȘȞʌȜȘȡȫȞİIJİIJȠȞİijĮȡȝȠȖȑĮȝİʌİȡȚııȩIJİȡĮĮʌȩPO%%
ȒPO%%ȣȖȡȠȪįȚȩIJȚȘȣʌİȡʌȜȒȡȦıȘİȞįȑȤİIJĮȚȞĮ
ʌȡȠțĮȜȑıİȚįȚȐȡȡȘȟȘIJȠȣȝʌĮȜȠȞȚȠȪțĮȚȒĮıIJȠȤȓĮIJȘȢıȣıțİȣȒȢ
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ȅİijĮȡȝȠȖȑĮȢʌȡȑʌİȚȞĮįȠțȚȝȐȗİIJĮȚİțIJȦȞʌȡȠIJȑȡȦȞʌȡȚȞĮʌȩIJȘȞ
İȝijȪIJİȣıȘȂȘȤȡȘıȚȝȠʌȠȚİȓIJİIJȠȝʌĮȜȩȞȚİȐȞįİȞİȓȞĮȚțĮIJȐʌȡȠıȑȖȖȚıȘ
ıȣȝȝİIJȡȚțȩțĮȚȒİȐȞİȞIJȠʌȚıIJİȓȠʌȠȚĮįȒʌȠIJİįȚĮijȣȖȒ
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ǾțȠȚȜȩIJȘIJĮIJȠȣȝĮıIJȠȪʌȡȑʌİȚȞĮĮʌİȚțȠȞȓȗİIJĮȚʌȡȚȞĮʌȩIJȘȞİȝijȪIJİȣıȘ
ȫıIJİȞĮįȚĮıijĮȜȓȗİIJĮȚȩIJȚȠİijĮȡȝȠȖȑĮȢșĮİijĮȡȝȩıİȚıȦıIJȐȂȘ
ȤȡȘıȚȝȠʌȠȚİȓIJİİȐȞȘțȠȚȜȩIJȘIJĮİȓȞĮȚʌȠȜȪȝȚțȡȒȂȘȤȡȘıȚȝȠʌȠȚİȓIJİİȐȞȘ
ĮʌȩıIJĮıȘIJȘȢİʌȚijȐȞİȚĮȢIJȠȣȝʌĮȜȠȞȚȠȪĮʌȩIJȘȞİʌȚijȐȞİȚĮIJȠȣįȑȡȝĮIJȠȢ
İȓȞĮȚȝȚțȡȩIJİȡȘĮʌȩPPİțIJȩȢțĮȚĮȞȘȝȑȖȚıIJȘįȩıȘıIJȠįȑȡȝĮİȓȞĮȚ”
IJȘȢıȣȞIJĮȖȠȖȡĮijȘȝȑȞȘȢįȩıȘȢȋȡȘıȚȝȠʌȠȚȒıIJİĮȣȜȩȒĮȣȜȠȪȢȝİ
țĮIJȐȜȜȘȜȘȝİIJĮIJȩʌȚıȘȫıIJİȞĮİȜĮȤȚıIJȠʌȠȚȘșİȓȘȑțșİıȘIJȠȣįȑȡȝĮIJȠȢ
‡
īȚĮȞĮįȚĮıijĮȜȓıİIJİıȦıIJȒțĮIJĮȞȠȝȒIJȘȢįȩıȘȢIJȘȢșİȡĮʌİȓĮȢȠ
İijĮȡȝȠȖȑĮȢʌȡȑʌİȚȞĮĮʌİȚțȠȞȓȗİIJĮȚʌȡȚȞĮʌȩIJȘȞʌĮȡȠȤȒțȐșİIJȝȒȝĮIJȠȢIJȘȢ
ȀĮIJȐIJȘȞȠȖțİțIJȠȝȒįİȞșĮʌȡȑʌİȚȞĮȤȡȘıȚȝȠʌȠȚȠȪȞIJĮȚĮȖȖİȚĮțȐȝİIJĮȜȜȚțȐțȜȚʌȒ
țȜȚʌįİȚțIJȠįȩIJȘıȘȢȫıIJİȞĮĮʌȠijİȣȤșİȓʌȚșĮȞȒIJȡȚȕȒȒįȚȐȡȡȘȟȘIJȠȣȝʌĮȜȠȞȚȠȪ
CONTURA®ĬĮʌȡȑʌİȚİʌȓıȘȢȞĮİijĮȡȝȩȗİIJĮȚʌȡȠıȠȤȒȫıIJİȠȚțȩȝʌȠȚIJȦȞ
ȡĮȝȝȐIJȦȞțĮȚIJĮȐțȡĮIJȠȣȢȞĮțĮIJİȣșȪȞȠȞIJĮȚİțIJȩȢIJȘȢțȠȚȜȩIJȘIJĮȢțĮȚȩʌȠȣİȓȞĮȚ
įȣȞĮIJȩȞȞĮʌĮȡİȝȕȐȜȜİIJĮȚȚıIJȩȢĮȞȐȝİıĮıIJȘȞʌȚșĮȞȒİʌȚijȐȞİȚĮIJȠȣȝʌĮȜȠȞȚȠȪțĮȚ
ıIJĮȐțȡĮIJȦȞȡĮȝȝȐIJȦȞ
‡
ȆȡȚȞĮʌȩIJȘșİȡĮʌİȓĮİʌȚȕİȕĮȚȫıIJİȩIJȚįȚĮIJȓșİȞIJĮȚȠȚțĮIJȐȜȜȘȜȠȚıȪȞįİıȝȠȚIJȠȣ
İȟȠʌȜȚıȝȠȪĮȣIJȩȝĮIJȘȢȝİIJĮijȩȡIJȦıȘȢțĮȚȩIJȚȜİȚIJȠȣȡȖȠȪȞȝİIJȠȞİijĮȡȝȠȖȑĮ
ȈȘȝĮȞIJȚțȩȠİijĮȡȝȠȖȑĮȢʌȡȑʌİȚȞĮʌĮȡĮȝȑȞİȚȩıȠIJȠįȣȞĮIJȩȞʌȚȠİȣșİȚĮıȝȑȞȠȢ
țĮȚȤȦȡȓȢȝİȖȐȜİȢțȣȡIJȫıİȚȢțĮȚıIJȡİȕȜȫıİȚȢțĮIJȐIJȘıȪȞįİıȘıİİȟȠʌȜȚıȝȩ
ĮȣIJȩȝĮIJȘȢȝİIJĮijȩȡIJȦıȘȢȣȥȘȜȠȪȡȣșȝȠȪįȩıȘȢȅȚȝİIJȡȒıİȚȢIJȠȣȝȒțȠȣȢ
șİȡĮʌİȓĮȢșĮʌȡȑʌİȚȞĮȜĮȝȕȐȞȠȞIJĮȚʌȡȚȞĮʌȩțȐșİIJȝȒȝĮșİȡĮʌİȓĮȢȝİIJȘ
ıȣıțİȣȒıIJȠȞȓįȚȠʌȡȠıĮȞĮIJȠȜȚıȝȩȩʌȦȢıIJȘșİȡĮʌİȓĮȅʌȡȠıĮȞĮIJȠȜȚıȝȩȢșĮ
ʌȡȑʌİȚȞĮʌĮȡĮȝȑȞİȚıIJĮșİȡȩȢȖȚĮțȐșİIJȝȒȝĮșİȡĮʌİȓĮȢ
ȆȡȚȞĮʌȩIJȘȤȡȒıȘİʌȚșİȦȡȒıIJİIJȘıȣıțİȣĮıȓĮǹʌȠȡȡȓȥIJİİȐȞȘıijȡĮȖȓįĮȑȤİȚ
ʌĮȡĮȕȚĮıIJİȓȒİȐȞȘıȣıțİȣĮıȓĮȑȤİȚȣʌȠıIJİȓȗȘȝȚȐ
ǼȆǿȆȁȅȀǼȈ
ȅȚİʌȚʌȜȠțȑȢʌȠȣİȞįȑȤİIJĮȚȞĮıȤİIJȓȗȠȞIJĮȚȝİIJȘȤȡȒıȘIJȠȣİijĮȡȝȠȖȑĮCONTURA®
0/%İȓȞĮȚȠȚȓįȚİȢȝİĮȣIJȑȢʌȠȣıȤİIJȓȗȠȞIJĮȚȝİIJȘȤȡȒıȘʌĮȡȩȝȠȚȦȞıȣıțİȣȫȞǹȣIJȑȢ
İȞįȑȤİIJĮȚȞĮʌİȡȚȜĮȝȕȐȞȠȣȞİȡȪșȘȝĮİțȡȠȒĮʌȩIJȠıȘȝİȓȠțĮșİIJȘȡȚĮıȝȠȪʌȩȞȠȢ
ıIJȠȝĮıIJȩİțȤȪȝȦıȘȓȞȦıȘIJȠȣȝĮıIJȠȪIJȘȜĮȖȖİȚİțIJĮıȓĮıțȜȒȡȣȞıȘIJȠȣȝĮıIJȠȪ
ıȑȡȦȝĮIJȠȣȝĮıIJȠȪȠȓįȘȝĮIJȠȣȝĮıIJȠȪȟȘȡȐĮʌȠȜȑʌȚıȘȟȘȡȠįİȡȝȓĮĮʌȠȤȡȦȝĮIJȚıȝȩ
IJȠȣįȑȡȝĮIJȠȢʌĮȡĮȚıșȘıȓĮʌȩȞȠıIJȘȝĮıȤȐȜȘțȩʌȦıȘțȞȘıȝȩİȚıȠȜțȒIJȠȣȝĮıIJȠȪ
ȞĮȣIJȓĮİȡİșȚıȝȩIJȠȣįȑȡȝĮIJȠȢȣȖȡȒĮʌȠȜȑʌȚıȘĮȚȝȐIJȦȝĮİȟȐȞșȘȝĮĮıȣȝʌIJȦȝĮIJȚțȒ
ȜȚʌȫįȘȞȑțȡȦıȘȜȠȓȝȦȟȘIJȠȣȝĮıIJȠȪijȣıĮȜȓįĮıIJȠȝĮıIJȩțĮȚȜİȝijȠȓįȘȝĮ
15
ǼʌĮȞĮIJȠʌȠșİIJȒıIJİIJȠʌȫȝĮ/XHUıIJȘșȪȡĮįȚȩȖțȦıȘȢǿī
ȋȡȘıȚȝȠʌȠȚȒıIJİȣʌİȡȘȤȠȖȡȐijȘȝĮȖȚĮȞĮİʌȚȕİȕĮȚȫıİIJİIJȘȞțĮIJȐȜȜȘȜȘIJȠʌȠșȑIJȘıȘ
IJȠȞȩȖțȠțĮȚIJȘȞʌȡȠıĮȡȝȠȖȒıIJȘȞțȠȚȜȩIJȘIJĮȉȣȤȩȞȣȖȡȐțĮȚĮȑȡĮȢȖȪȡȦĮʌȩIJȠ
ȝʌĮȜȩȞȚIJȠȣİijĮȡȝȠȖȑĮȝʌȠȡȠȪȞȞĮĮȞĮȡȡȠijȘșȠȪȞȝİȝȚĮıȪȡȚȖȖĮIJȦȞPOʌȠȣ
ıȣȞįȑİIJĮȚıIJȘȞȜİȣțȒșȪȡĮİijĮȡȝȠȖȒȢțİȞȠȪǿǻȅȩȖțȠȢIJȠȣȝʌĮȜȠȞȚȠȪȝʌȠȡİȓȞĮ
ȡȣșȝȚıIJİȓȝȑıȦIJȘȢȝʌȜİșȪȡĮȢįȚȩȖțȦıȘȢǿīǼʌĮȞĮIJȠʌȠșİIJȒıIJİIJĮʌȫȝĮIJĮ/XHU
ȝȩȜȚȢIJİȜİȚȫıİIJİ
ǼʌȚȕİȕĮȚȫıIJİȩIJȚȘȡȓȖĮIJȠȣĮȣȜȠȪșİȡĮʌİȓĮȢĮȡİȓȞĮȚİȣșȣȖȡĮȝȝȚıȝȑȞȘȝİIJȘȞIJȠȝȒ
IJȠȣįȑȡȝĮIJȠȢ
ȉȠʌȠșİIJȒıIJİIJȠȞțĮșİIJȒȡĮȝİIJȑIJȠȚȠIJȡȩʌȠȫıIJİȞĮİȜĮȤȚıIJȠʌȠȚİȓIJĮȚȘțȪȡIJȦıȒIJȠȣțĮȚ
ȞĮİȣșȣȖȡĮȝȝȓȗİIJĮȚȠįİȓțIJȘȢȝİIJȘȞIJȠȝȒIJȠȣįȑȡȝĮIJȠȢ
ǼijĮȡȝȩıIJİȝȚĮȤİȚȡȠȣȡȖȚțȒİʌȓįİıȘıIJȠıȘȝİȓȠİȟȩįȠȣȝİIJȠȞțĮșİIJȒȡĮIJȠʌȠșİIJȘȝȑȞȠ
ȝİIJȑIJȠȚȠIJȡȩʌȠȫıIJİȞĮİȜĮȤȚıIJȠʌȠȚİȓIJĮȚȘțȪȡIJȦıȒIJȠȣ
ȀĮIJĮȖȡȐȥIJİIJȠȞIJİȜȚțȩȩȖțȠʌȜȒȡȦıȘȢIJȠȣȝʌĮȜȠȞȚȠȪıIJȚȢİIJȚțȑIJİȢʌȠȣʌĮȡȑȤȠȞIJĮȚțĮȚ
İʌȚțȠȜȜȒıIJİıIJȠįȚȐȖȡĮȝȝĮIJȠȣĮıșİȞȒ
ȋȅȇǾīǾȈǾǹȀȉǿȃȅǺȅȁǿǹȈǹȞĮIJȡȑȟIJİıIJȚȢİȚțȩȞİȢțĮȚ
ȉȇȅȆȅȈǻǿǹĬǼȈǾȈ
ȅİijĮȡȝȠȖȑĮȢCONTURA®0/%țĮȚIJĮȕȠȘșȘIJȚțȐİȟĮȡIJȒȝĮIJĮʌĮȡȑȤȠȞIJĮȚıIJİȓȡĮțĮȚ
ʌȡȠȠȡȓȗȠȞIJĮȚȖȚĮȤȡȒıȘıİȑȞĮȞȝȩȞȠȞĮıșİȞȒ
ȅǻǾīǿǼȈȋȇǾȈǾȈ
ȉȅȆȅĬǼȉǾȈǾǹȞĮIJȡȑȟIJİıIJȚȢİȚțȩȞİȢțĮȚ
5
1
ǼȚțȩȞĮǼĭǹȇȂȅīǼǹȈCONTURA®
(IB)
4
2
(E)
(H)
ІГ
10 ml
(Z)
3
30 ml (B)
(∑T)
ǼȚțȩȞĮǺȅǾĬǾȉǿȀǹǼȄǹȇȉǾȂǹȉǹ
ȋȡȘıȚȝȠʌȠȚȒıIJİȣʌİȡȒȤȠȣȢȖȚĮIJȘȞĮȞĮȖȞȫȡȚıȘIJȘȢțȠȚȜȩIJȘIJĮȢIJȘȢȠȖțİțIJȠȝȒȢ
ǹȞȠȓȟIJİIJȘıIJİȓȡĮıȣıțİȣĮıȓĮIJȠȣİijĮȡȝȠȖȑĮCONTURA®0/%țĮȚĮijĮȚȡȑıIJİIJȠȞ
İijĮȡȝȠȖȑĮ$țĮȚȝȚĮıȪȡȚȖȖĮIJȦȞPO%ǹijĮȚȡȑıIJİIJȠʌȫȝĮ/XHUIJȘȢșȪȡĮȢ
įȚȩȖțȦıȘȢīțĮȚİȖȤȪıIJİPO%%ȒPO%%ıIJİȓȡȠȣ
ijȣıȚȠȜȠȖȚțȠȪȠȡȠȪȝȑıĮıIJȠȞİijĮȡȝȠȖȑĮțĮȚİȜȑȖȟIJİȖȚĮIJȣȤȩȞįȚĮijȣȖȒțĮȚĮıȣȝȝİIJȡȓĮ
ǹʌȠȡȡȓȥIJİIJȠȞİijĮȡȝȠȖȑĮİȐȞİȓȞĮȚİȜĮIJIJȦȝĮIJȚțȩȢȀȡĮIJȫȞIJĮȢIJȠȞİijĮȡȝȠȖȑĮĮʌȩ
IJȠȣȢıȣȞįȑıȝȠȣȢȝİIJȠȝʌĮȜȩȞȚȞĮțȡȑȝİIJĮȚțĮIJĮțȩȡȣijĮĮijĮȚȡȑıIJİİȞIJİȜȫȢIJȠȞ
ijȣıȚȠȜȠȖȚțȩȠȡȩĮʌȩIJȠȝʌĮȜȩȞȚ
ȆȡȠİIJȠȚȝȐıIJİȑȞĮįȚȐȜȣȝĮijȣıȚȠȜȠȖȚțȠȪȠȡȠȪıțȚĮȖȡĮijȚțȠȪȝȑıȠȣȝȑȖȚıIJȘȢ
ıȣȖțȑȞIJȡȦıȘȢıIJȠȞįȓıțȠǻʌȠȣʌĮȡȑȤİIJĮȚ
ȈȘȝİȓȦıȘȅȚȣȥȘȜȩIJİȡİȢıȣȖțİȞIJȡȫıİȚȢıțȚĮȖȡĮijȚțȠȪȝȑıȠȣİȞįȑȤİIJĮȚȞĮ
ʌİȡȚȠȡȓıȠȣȞIJȘȞĮʌİȚțȩȞȚıȘIJȦȞįİȚțIJȫȞIJȦȞĮȣȜȫȞ
ȆȡȠıįȚȠȡȓıIJİIJȠİʌȚșȣȝȘIJȩıȘȝİȓȠıIJȘȞİʌȚijȐȞİȚĮIJȠȣȝĮıIJȠȪȖȚĮIJȘȞİȚıĮȖȦȖȒ
IJȠȣİijĮȡȝȠȖȑĮǼȖȤȪıIJİțĮIJȐȜȜȘȜȠĮȞĮȚıșȘIJȚțȩıIJȠįȑȡȝĮțĮȚțĮIJȐIJȘȞȠįȩȑȦȢ
IJȘȞțȠȚȜȩIJȘIJĮIJȘȢȠȖțİțIJȠȝȒȢȀȐȞIJİȝȚĮIJȠȝȒıIJȠįȑȡȝĮȝİIJȠȞȣıIJȑȡȚıIJȠıȘȝİȓȠ
İȚıĮȖȦȖȒȢȝİȝȒțȠȢİʌĮȡțȑȢȫıIJİȞĮİȚıȐȖİIJĮȚʌȜȒȡȦȢIJȠȐțȡȠIJȠȣIJȡȠțȐȡȈȉ
ǻȚİȣȡȪȞİIJİIJȘȞIJȠȝȒIJȠȣįȑȡȝĮIJȠȢİȐȞIJȠİʌȚșȣȝİȓIJİȆȡȠȦșȒıIJİIJȠIJȡȠțȐȡȝİIJȠ
įȚĮȚȡȠȪȝİȞȠșȘțȐȡȚǽİȞIJȩȢIJȘȢțȠȚȜȩIJȘIJĮȢǹijĮȚȡȑıIJİIJȠIJȡȠțȐȡ
ȈȣȞįȑıIJİȝȚĮıȪȡȚȖȖĮIJȦȞPOıIJȠȞțĮșİIJȒȡĮʌĮȡȠȤȑIJİȣıȘȢǾțĮȚʌĮȡȠȤİIJİȪıIJİ
IJȣȤȩȞȣȖȡȐĮʌȩIJȘȞțȠȚȜȩIJȘIJĮİȚıȐȖȠȞIJĮȢIJȠȞțĮșİIJȒȡĮʌĮȡȠȤȑIJİȣıȘȢįȚĮȝȑıȠȣIJȠȣ
įȚĮȚȡȠȪȝİȞȠȣșȘțĮȡȚȠȪțĮȚĮȞĮȡȡȠijȫȞIJĮȢǹijĮȚȡȑıIJİIJȠȞțĮșİIJȒȡĮʌĮȡȠȤȑIJİȣıȘȢ
ǼȚıȐȖİIJİIJȠȞİijĮȡȝȠȖȑĮįȚĮȝȑıȠȣIJȠȣįȚĮȚȡȠȪȝİȞȠȣșȘțĮȡȚȠȪİȞIJȩȢIJȘȢțȠȚȜȩIJȘIJĮȢ
ǹijĮȚȡȑıIJİIJȠșȘțȐȡȚ
ǼȣșȣȖȡĮȝȝȓıIJİIJȘȡȓȖĮIJȠȣĮȣȜȠȪșİȡĮʌİȓĮȢĮȡĬıIJȠȞȐȟȠȞĮIJȠȣțĮșİIJȒȡĮȝİIJȘȞ
IJȠȝȒIJȠȣįȑȡȝĮIJȠȢ
ǹijĮȚȡȑıIJİIJȠȞİȞȚıȤȣIJȚțȩıIJȣȜİȩǿĮʌȩIJȠȞțİȞIJȡȚțȩĮȣȜȩșİȡĮʌİȓĮȢǿǹȈȣȞįȑıIJİ
ȑȞĮțȩțțȚȞȠʌȫȝĮĮȣȜȠȪșİȡĮʌİȓĮȢǿǺ
ȋȡȘıȚȝȠʌȠȚȫȞIJĮȢIJȚȢıȪȡȚȖȖİȢʌȠȣʌĮȡȑȤȠȞIJĮȚĮijĮȚȡȑıIJİȩȜȠȞIJȠȞĮȑȡĮĮʌȩIJȠȞ
İijĮȡȝȠȖȑĮțĮȚįȚȠȖțȫıIJİIJȠȝʌĮȜȩȞȚIJȠȣİijĮȡȝȠȖȑĮȝİIJȠįȚȐȜȣȝĮIJȠȣıțȚĮȖȡĮijȚțȠȪ
ȝȑıȠȣȑȦȢȩIJȠȣİʌȚIJİȣȤșİȓȠİʌȚșȣȝȘIJȩȢȩȖțȠȢʌȜȒȡȦıȘȢǹijĮȚȡȑıIJİȩȜȠȞIJȠȞĮȑȡĮ
ĮʌȩIJȚȢıȪȡȚȖȖİȢʌȜȒȡȦıȘȢʌȡȚȞIJȚȢıȣȞįȑıİIJİıIJȠȞİijĮȡȝȠȖȑĮ
ȂȠȞIJȑȜȠ
ǼʌȚșȣȝȘIJȒįȚȐȝİIJȡȠȢIJȠȣȝʌĮȜȠȞȚȠȪ
B01245
FPįȚȐȝİIJȡȠȢ[FPȝȒțȠȢ
PO
B11245
FPįȚȐȝİIJȡȠȢ[FPȝȒțȠȢ
PO
B01256
FPįȚȐȝİIJȡȠȢ[FPȝȒțȠȢ
51 ml
B11256
FPįȚȐȝİIJȡȠȢ[FPȝȒțȠȢ
PO
‡
ȀĮIJȐʌȡȠıȑȖȖȚıȘȩȖțȠȢ
ʌȜȒȡȦıȘȢIJȠȣȝʌĮȜȠȞȚȠȪ
16
І∆
ǼȚțȩȞĮȆȇȅȈǹȃǹȉȅȁǿȈȂȅȈǹȊȁȅȊĬǼȇǹȆǼǿǹȈ
ȈȘȝĮȞIJȚțȩȠİijĮȡȝȠȖȑĮȢʌȡȑʌİȚȞĮʌĮȡĮȝȑȞİȚȩıȠIJȠįȣȞĮIJȩȞʌȚȠİȣșİȚĮıȝȑȞȠȢțĮȚ
ȤȦȡȓȢȝİȖȐȜİȢțȣȡIJȫıİȚȢțĮȚıIJȡİȕȜȫıİȚȢțĮIJȐIJȘıȪȞįİıȘıİİȟȠʌȜȚıȝȩĮȣIJȩȝĮIJȘȢ
ȝİIJĮijȩȡIJȦıȘȢȣȥȘȜȠȪȡȣșȝȠȪįȩıȘȢȅȚȝİIJȡȒıİȚȢIJȠȣȝȒțȠȣȢșİȡĮʌİȓĮȢșĮ
ʌȡȑʌİȚȞĮȜĮȝȕȐȞȠȞIJĮȚʌȡȚȞĮʌȩțȐșİIJȝȒȝĮșİȡĮʌİȓĮȢȝİIJȘıȣıțİȣȒıIJȠȞȓįȚȠ
ʌȡȠıĮȞĮIJȠȜȚıȝȩȩʌȦȢıIJȘșİȡĮʌİȓĮȅʌȡȠıĮȞĮIJȠȜȚıȝȩȢșĮʌȡȑʌİȚȞĮʌĮȡĮȝȑȞİȚ
ıIJĮșİȡȩȢȖȚĮțȐșİIJȝȒȝĮșİȡĮʌİȓĮȢ
ǾĮȟȠȞȚțȒIJȠȝȠȖȡĮijȓĮșĮʌȡȑʌİȚȞĮȤȡȘıȚȝȠʌȠȚİȓIJĮȚıİıȣȞįȣĮıȝȩȝİİȝʌȠȡȚțȐ
įȚĮșȑıȚȝȠȜȠȖȚıȝȚțȩıȤİįȚĮıȝȠȪșİȡĮʌİȓĮȢȫıIJİȞĮʌȡȠıįȚȠȡȚıIJȠȪȞȠȚțĮIJȐȜȜȘȜȠȚ
ĮȣȜȠȓșİȡĮʌİȓĮȢȠȚșȑıİȚȢʌĮȡĮȝȠȞȒȢIJȘȢșİȡĮʌİȓĮȢțĮȚȠȤȡȩȞȠȢʌĮȡĮȝȠȞȒȢȖȚĮ
ȕİȜIJȚıIJȠʌȠȓȘıȘIJȘȢȤȠȡȒȖȘıȘȢĮțIJȚȞȠȕȠȜȓĮȢȝȚĮȢıȣȞIJĮȖȠȖȡĮijȘȝȑȞȘȢįȩıȘȢıIJȠȞ
ıIJȠȤİȣȩȝİȞȠȩȖțȠșİȡĮʌİȓĮȢ
ȋȡȘıȚȝȠʌȠȚȫȞIJĮȢIJȘȞȡȓȖĮIJȠȣĮȣȜȠȪșİȡĮʌİȓĮȢĮȡȦȢıȘȝİȓȠĮȞĮijȠȡȐȢ
ıȘȝİȚȫıIJİIJȠȞʌȡȠıĮȞĮIJȠȜȚıȝȩIJȠȣİijĮȡȝȠȖȑĮCONTURA®ǼʌȚȕİȕĮȚȫıIJİIJȠȞȠȡșȩ
ʌȡȠıĮȞĮIJȠȜȚıȝȩIJȠȣİijĮȡȝȠȖȑĮIJȘșȑıȘIJȠȣȝʌĮȜȠȞȚȠȪIJȠȞȩȖțȠIJȠȣȝʌĮȜȠȞȚȠȪ
IJȘȞĮʌȩıIJĮıȘĮʌȩIJȠįȑȡȝĮțĮȚIJȘȞʌȡȠıĮȡȝȠȖȒȝİȤȡȒıȘĮʌİȚțȩȞȚıȘȢʌȡȚȞĮʌȩIJȘ
ȤȠȡȒȖȘıȘțȐșİțȜȐıȝĮIJȠȢĮțIJȚȞȠȕȠȜȓĮȢȀȐȞIJİȡȣșȝȓıİȚȢİȐȞİȓȞĮȚĮʌĮȡĮȓIJȘIJȠ
ȅȚĮȣȜȠȓșİȡĮʌİȓĮȢİȓȞĮȚĮȡȚșȝȘȝȑȞȠȚȦȢțĮȚțĮȚİȓȞĮȚIJȠʌȠșİIJȘȝȑȞȠȚ
ȩʌȦȢijĮȓȞİIJĮȚıIJȘȞİȚțȩȞĮȅĮȣȜȩȢȝİIJȠȞĮȡȚșȝȩĮȞIJȚıIJȠȚȤİȓıIJȠȞĮȣȜȩȝİ
ȝİIJĮIJȩʌȚıȘʌȜȘıȚȑıIJİȡĮțĮȚʌĮȡȐȜȜȘȜĮȝİIJȘȡȓȖĮIJȠȣĮȣȜȠȪșİȡĮʌİȓĮȢĮȡĬțĮIJȐ
ȝȒțȠȢIJȠȣȐȟȠȞĮIJȠȣțĮșİIJȒȡĮȅĮȣȜȩȢșİȡĮʌİȓĮȢȝİIJȠȞĮȡȚșȝȩĮȞIJȚıIJȠȚȤİȓıIJȠȞ
țİȞIJȡȚțȩĮȣȜȩǹijĮȚȡȑıIJİIJĮțȩțțȚȞĮʌȫȝĮIJĮțĮȚȤȡȘıȚȝȠʌȠȚȒıIJİİȝʌȠȡȚțȐįȚĮșȑıȚȝȠȣȢ
ıȣȞįȑıȝȠȣȢȖȚĮIJȘıȪȞįİıȘIJȦȞĮȣȜȫȞșİȡĮʌİȓĮȢȝİIJȠȞİȟȠʌȜȚıȝȩĮȣIJȩȝĮIJȘȢ
ȝİIJĮijȩȡIJȦıȘȢ
ȈȘȝİȓȦıȘǼȐȞȤȡȘıȚȝȠʌȠȚİȓIJİIJȠȞİȟȠʌȜȚıȝȩĮȣIJȩȝĮIJȘȢȝİIJĮijȩȡIJȦıȘȢ
*DPPD0HGSOXV™ȠȚĮȣȜȠȓșİȡĮʌİȓĮȢIJȠȣİijĮȡȝȠȖȑĮʌȡȑʌİȚʌȡȫIJĮȞĮĮʌȠțȠʌȠȪȞ
ıIJȠțĮIJȐȜȜȘȜȠȝȒțȠȢȤȡȘıȚȝȠʌȠȚȫȞIJĮȢIJȠȞțĮIJȐȜȜȘȜȠȝİIJȡȘIJȒțȠʌȒȢȝȒțȠȣȢ
*DPPD0HGSOXV™.
ȂİIJȐĮʌȩțȐșİșİȡĮʌİȓĮİʌĮȞĮIJȠʌȠșİIJȒıIJİIJĮțȩțțȚȞĮʌȫȝĮIJĮțĮȚıIJİȡİȫıIJİIJȠȞ
ȐȟȠȞĮIJȠȣțĮșİIJȒȡĮ
ǹĭǹǿȇǼȈǾ
ǹijĮȚȡȑıIJİIJȠȞİijĮȡȝȠȖȑĮCONTURA®0/%ıȣȞįȑȠȞIJĮȢĮȡȤȚțȐȝȚĮıȪȡȚȖȖĮıIJȘȝʌȜİ
șȪȡĮįȚȩȖțȦıȘȢțĮȚıȣȝʌIJȪııȠȞIJĮȢIJȠȝʌĮȜȩȞȚ
ȈȘȝİȓȦıȘȈİʌİȡȓʌIJȦıȘʌȠȣıȣȞĮȞIJȒıİIJİįȣıțȠȜȓİȢțĮIJȐIJȘıȪȝʌIJȣȟȘIJȠȣ
ȝʌĮȜȠȞȚȠȪȝİIJȘıȪȡȚȖȖĮ
ǼʌĮȞĮıȣȞįȑıIJİIJȘıȪȡȚȖȖĮțĮȚʌİȡȚıIJȡȑȥIJİıIJĮșİȡȐįİȟȚȩıIJȡȠijĮȫıIJİȞĮIJȘȞ
İȞİȡȖȠʌȠȚȒıİIJİʌȜȒȡȦȢIJȘȕĮȜȕȓįĮǼȐȞțĮȚʌȐȜȚIJȠȝʌĮȜȩȞȚįİȞıȣȝʌIJȪııİIJĮȚ
IJȩIJİ
ȀȩȥIJİIJȘıȦȜȒȞȦıȘIJȘȢȝʌȜİșȪȡĮȢįȚȩȖțȦıȘȢȉȠʌİȡȚİȤȩȝİȞȠijȣıȚȠȜȠȖȚțȠȪ
ȠȡȠȪıțȚĮȖȡĮijȚțȠȪĮʌȩIJȠȝʌĮȜȩȞȚșĮĮȡȤȓıİȚȞĮįȚĮȡȡȑİȚĮʌȩIJȠȐțȡȠIJȘȢ
țȠȝȝȑȞȘȢıȦȜȒȞȦıȘȢ
ǼȐȞIJȠȝʌĮȜȩȞȚțĮȚʌȐȜȚįİȞȝʌȠȡİȓȞĮıȣȝʌIJȣȤșİȓİȚıȐȖİIJİȝȚĮıȪȡȚȖȖĮȝİȕİȜȩȞĮ
ĮʌİȣșİȓĮȢıIJȠȝʌĮȜȩȞȚȈȣȝʌIJȪȟIJİIJȠȝʌĮȜȩȞȚĮijĮȚȡȫȞIJĮȢIJȠʌİȡȚİȤȩȝİȞȠȝİIJȘ
ıȪȡȚȖȖĮ
ȆİȡȚıIJȡȑȥIJİțĮȚĮijĮȚȡȑıIJİȟİȕȚįȫıIJİIJȠȞİijĮȡȝȠȖȑĮĮʌȩIJȘȞțȠȚȜȩIJȘIJĮ
NURSVY VNHUHOOHUY YPHGSRWHQWLHOS\URJHQHOOHUPLNURELHONRQWDPLQHULQJ
KDUKDIWNRQWDNWPHGGHQPHGLFLQVNHDQRUGQLQJLXEHVWHPPHOLJWLG%LRORJLVNH
UHVWPDWHULDOHUNDQIUHPPHNRQWDPLQHULQJDIDQRUGQLQJHQPHGS\URJHQHUHOOHU
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0XOWLOXPHQEDOORQDSSOLNDWRU7LO%UDN\WHUDSL
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B01245, B01256, B11245 & B11256
0nLNNHUHVWHULOLVHUHV(IWHUUHVWHULOLVHULQJNDQSURGXNWHWVVWHULOLWHWLNNHJDUDQWHUHV
SJDHQXEHVWHPPHOLJJUDGDISRWHQWLHOS\URJHQHOOHUPLNURELHONRQWDPLQHULQJ
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Oppblåsingsport (M) (blå)
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Trzpień usztywniający (J)
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Oznaczenie prześwitu leczniczego nr (I)
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Prześwit leczniczy nr 5
Prześwit leczniczy nr 1
Kuweta na środki kontrastowe (D)
Skalpel (E)
Prześwit leczniczy nr 4
Prześwit leczniczy nr 2
Cewnik do
drenażu (H)
Strzykawka 10 ml
Port do napełniania (M)
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Strzykawka 30 ml (B)
Trokar (F)
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30 ml-es fecskendő (B)
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Skapel (E)
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katetr (H)
Plnicí port (M) (modrý)
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Sheath (G)
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Trokar (F)
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/pþHEQpOXPHQ\MVRXRþtVORYiQ\DDXPtVWČQ\MDN]Qi]RUĖXMHREU
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na lumenu.
3R]QiPND3RNXGSRXåLMHWHDIWHUORDGHU*DPPD0HGSOXV™, bude nutné
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PČĜLFtKR]DĜt]HQt*DPPD0HGSOXV™.
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YNĤåL
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Model
3RåDGRYDQêSUĤPČUEDOyQNX
3ĜLEOLåQêSOQLFt
REMHPEDOyQNX
B01245
SUĤPČUFP[GpONDFP
PO
B11245
SUĤPČUFP[GpONDFP
PO
B01256
SUĤPČUFP[GpONDFP
51 ml
B11256
SUĤPČUFP[GpONDFP
PO
3RNDåGpPR]DĜRYDFtP]iNURNXYUDĢWHQDPtVWRþHUYHQpX]iYČU\
D]DMLVWČWHGĜtNNDWHWUX
‡
9<-087Ë
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3R]QiPND3RNXGMHY\SUD]GĖRYiQtEDOyQNXVWĜtNDþNRXREWtåQp
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3RNXGEDOyQHNQDGiOHQHO]HY\SUi]GQLW]DStFKQČWHSĜtPRGREDOyQNX
VWĜtNDþNXVMHKORX9\SUi]GQČWHEDOyQHNRGViYiQtPREVDKXVWĜtNDþNRX
5RWXMWHDSOLNiWRUDY\WDKXMWHMHM]GXWLQ\ÄY\ãURXEXMWH³
9UDĢWHX]iYČU/XHUQDSOQLFtSRUW0
3RPRFtXOWUD]YXNXSRWYUćWHVSUiYQpXPtVWČQtDVKRGXVREMHPHPDWYDUHP
GXWLQ\.DSDOLQXDY]GXFKRENORSXMtFtEDOyQHNO]HRGViWPOVWĜtNDþNRX
SĜLSRMHQRXNEtOpPXYDNXRYpPXSRUWX12EMHPEDOyQNXO]HXSUDYLWVNU]
PRGUêSOQLFtSRUW03RGRNRQþHQtYUDĢWHQDPtVWRX]iYČU\/XHU
2YČĜWHåHSUXKOpþHEQpKROXPHQXþMH]DURYQiQVLQFL]tYNĤåL
8PtVWČWHNDWHWUWDNDE\VHFRQHMPpQČRKêEDOD]QDþNDE\OD]DURYQiQDVLQ
FL]tYNĤåL
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RPH]XMtFtMHKRRKêEiQt
=D]QDPHQHMWHREMHPQDSOQČQtEDOyQNXQDGRGDQpãWtWN\DSĜLOHSWHMHGR
záznamu pacienta.
‡
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WHPL]OHQPHVLWHNUDULúOHPHNRQPDVÕYHYH\DWHNUDUVWHULOL]DV\RQXWHUPDOYH
YH\DPHNDQLNGH÷LúLNOLNOHUGHQHWNLOHQHQELOHúHQOHU]HULQGHNLRODVÕDGYHUVHWNLOHU
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TANIM
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Merkezi Tedavi Lumeni no 5 (K)
Tedavi Lümeni No 1 Şeridi (I)
Şişrme Portu
Luer Kapagi (C)
Aplikatör (A)
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Tedavi Lümeni Kapaği
ve Doldurucular (L)
Kontrast Madde Tepsisi (D)
Bistüri (E)
Drenaj
Kateteri (H)
Yarιk Kιlιf (G)
10 ml Şιrιnga
30 ml Şιrιnga (B)
Trokar (F)
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Model
øVWHQHQEDORQoDSÕ
B01245
FPdDS[FPX]XQOXN
PO
B11245
FPdDS[FPX]XQOXN
PO
B01256
FPdDS[FPX]XQOXN
51 ml
B11256
FPdDS[FPX]XQOXN
PO
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Tedavi Lümeni No 5
Tedavi Lümeni No 4
Tedavi Lümeni No 1
Tedavi Lümeni No 2
Şişirme Portu (M) (Mavi)
Tedavi Lümeni No 3
Vakum Portu (N) (Beyaz)
ùHNLO7('$9ø/h0(1ø25<$17$6<218
gQHPOL$SOLNDW|U+'5DUGÕO\NOH\LFL\HED÷OÕROGX÷XQGDPPNQROGX÷XQFDG]ROPDOÕ
YHNHVNLQH÷LOPHOHUYH\DENOPHOHUEXOXQPDPDOÕGÕU7HGDYLX]XQOX÷X|OoPOHULKHU
WHGDYLIUDNVL\RQX|QFHVLQGHFLKD]WHGDYLLOHD\QÕ\|QOHQGLUPHGHRODFDNúHNLOGHHOGH
HGLOPHOLGLU<|QOHQGLUPHKHUWHGDYLIUDNVL\RQXLoLQWXWDUOÕNDOPDOÕGÕU
+HGHÀHQHQWHGDYLKDFPLQH|QHULOHQGR]XQRSWLPL]HHGLOPLúUDG\DV\RQLOHWLPLLoLQX\JXQ
WHGDYLOPHQOHULWHGDYLNDOPDSR]LV\RQODUÕYHNDOPDVUHOHULQLEHOLUOHPHN]HUHWLFDUL
RODUDNVD÷ODQDQWHGDYLSODQODPD\D]ÕOÕPÕ\ODELUOLNWH%7J|UQWOHPHNXOODQÕOPDOÕGÕU
‡
ஏਂ‫ݔ‬ฉ௼!࡮੘ੑଊ!ஏਂ‫!ݔ‬๜૫‫܂‬-!հૺ!ฏन௻ୣ!ಌ߻ฌ!ਦ!୾‫!܂‬உஏண!ࣵ૷
ୂ!߃‫࣢!܂‬৏ࣆ!ଊૺୠࠨ!୶ฒ!஬෪!ࣁ‫׻‬৪ୣ!ब஍ฌ!ਦ!૤੎܏‫ܙ‬/!!य!୯࠻!؈؈
࡞!৬౶-!ஏ౵ࡦ!࣭0߃‫!܂‬ஏਂ‫ݔ‬ฌ!֮ଶ-!ू෪୴!૷!࣭0߃‫!܂‬؈ְண!ण‫ݝ‬ୠࠨ!୴
৅!๗ׂ࡞!୷ୠೱ!஍॥թ!ଊஃ‫ݝ‬ฌ!թ‫܉‬৪୴!ۖલః܏‫ܙ‬/
௜୯
‫׿‬நು࠻ଵ!ࢎ඘!ࡁ࢘!෭ৡ!ૂ෽ࡦ೩୴ോ
ซ‫ן‬૚
B01245, B01256, B11245 & B11256
ৣࢥঢ়!
‡
본 애플리케이터는 카테터 임플란트, 방사선 치료 계획 및 실행 분야의 훈련을 받은 의
사만 사용할 수 있습니다.
‡
유방종괴절제술 동안 CONTURA® 풍선이 긁히거나 터지지 않도록 금속혈관 및 마킹 클
립을 사용하지 마십시오. 봉합 매듭VXWXUHNQRWV과 꼬리(tails)를 공동에서 멀리 두도
록 하고, 가능하면 언제나 조직을 잠재 풍선 표면과 꼬리 중간에 두십시오.
‡
CONTURA® 애플리케이터는 실내 온도(최대 25ºC)에서 보관하십시오.
‡
CONTURA® 풍선 표면이 손상되거나 이물질로 표면이 오염되지 않도록 풍선을 조심해
서 다루십시오.
‡
트로카 팁을 삽입하기에 앞서 스캘플을 사용하여 피부를 절개하십시오.
‡
액을 진공 포트에 주입하지 마십시오.
‡
사용 후에는 루어 캡과 방사 루멘 캡을 교체하십시오.
‡
HDR 후부하기 조작 훈련을 받은 임상전문인력만이 애플리케이터를 사용하여 방사선
을 전달 할 수 있습니다.
‡
치료에 앞서 적절한 후부하 커넥터를 사용할 수 있는지, 그리고 이 커넥터가 애플리케
이터와 작동하는지를 확인하십시오.
‡
중요: HDR 후부하기 연결 시 애플리케이터는 최대한 곧은 상태를 유지해야 하며 날카
롭게 구부러진 부분이나 뒤틀린 곳이 없어야 합니다. 각 시술 전 시술하려는 방향으로
장치를 둔 상태에서 시술 길이를 측정해야 합니다. 각 시술 마다 방향은 일정하게 유지
되어야 합니다.
‡
사용 전 패키지를 검사하십시오. 봉인씰에 손을 댄 흔적이 있거나 포장이 손상된 경우
는 제품을 바로 폐기하십시오.
ৣࢥ
CONTURA® MLB 애플리케이터는 팽창가능한 구형 풍선에 부착된 멀티 루멘 카테터로 구
성되어 있습니다(그림 1). 루멘은 상용 +'5+LJK'RVH5DWH 원격 후부하 장비에 부착하
여 방사선 치료용 전달 외이어의 통로로 사용할 수 있습니다. 5개의 치료 루멘이 제공되
고 하나의 중앙 루멘은 애플리케이터의 긴 축을 따라 위치하며 4개의 곡선 루멘은 중앙
루멘으로부터 대칭적으로 위치합니다. 탈부착가능한 강직 스타일렛VWLIIHQLQJVW\OHW은 중
앙 치료 루멘 안에 있으며 1-4번 치료 루멘에는 루멘 캡이 있습니다. 두 개의 근위 포트
에는 풍선 팽창/수축 및 공동 내(intracavitary) 진공 애플리케이션을 위한 루어(Luer) 타입
의 커넥터가 있습니다.
CONTURA® MLB 액세서리는 다음을 포함합니다: 스플릿 쉬스(split sheath)가 있는 트로카,
배수 카테터, 3개의 FPO 인플레이션 주사기, 1개의 10ml 인플레이션 주사기, 11호 스캘
플, 조영제 트레이, 방사 루멘 캡 및 라벨(그림 2).
๜ूฉ؈!฻็৪:
Varian
Nucletron
‡
‡
‡
‡
‡ PLFUR6HOHFWURQ™9
‡ PLFUR6HOHFWURQ™'LJLWDO
‡ )OH[LWURQ™
9DUL6RXUFH,'™
9DUL6RXUFH™ 200 Series
*DPPD0HGSOXV™ Series
9DUL6RXUFH™ iX Series
ฏन௻
CONTURA® MLB 애플리케이터 사용과 관련된 합병증은 유사한 장치 사용과 관련된 합병증
과 같습니다. 합병증은 다음을 포함할 수 있습니다: 홍반, 카테터 부위 배농, 흉부 통증, 반
상출혈 , 유방섬유증, 모세혈관확장증, 유방경화, 유방장액종, 유방부종, 건성 표피탈락, 건
조한 피부, 피부 착색, 감각이상, 액와통증, 피로, 소양증, 유방 수축, 메스꺼움, 피부 자극, 습
성 표피탈락, 혈종, 발진, 무증상 지방괴사, 유방 감염, 유방 물집 및 림프수종.
ֵ֮;!ୗࣼ઻!ು࠻!ੑ!ୗࣼ!த౾!୴ࠓ୴‫ގ‬૫୴৷LUULGLDWLRQ୯!‫ܫ‬౾!ਦ‫ܜ‬ୠࠨঢ়୯!
CONTURA®!ૂ෽ࡦ೩୴ോ୯!઴ப৪!࣭!๗ׂ‫!܂‬ப࡫‫ݥ‬௼!શા੎܏‫ܙ‬/
제품 제공 상태
ଵ‫ݓ‬
CONTURA® MLB 애플리케이터와 액서서리는 무균 상태로 제공되며 일회용입니다.
CONTURA® MLB 애플리케이터는 의사가 유방암 치료로서의 유방종괴절제술 후 공동 내 হଵओ
(intracavitary) 방사선을 수술 마진에 전달하기로 선택할 경우 근접치료를 할 수 있도록
ࣾು!.!‫ ࡪ׽‬1ׂ 2࡞!ౠ஼ฉ੘ੑଊ
설계되었습니다.
강직 스타일렛(J)
‫؃‬؈
‡
애플리케이터는 너무 작거나 큰 공동 및/또는 팽창된 풍선을 수용할 수 없는 형태의 공
동에는 사용할 수 없습니다.
‡
심하게 구부러진 갈비뼈 및/또는 공동을 감싸고 있는 조직의 양이 동일하지 않은 등의
흔치 않은 해부학적 구조를 가진 환자에게는 이 애플리케이터를 사용할 수 없습니다.
CONTURA® 풍선이 비대칭으로 될 수 있습니다.
중앙 치료 루멘 #5(K)
치료 루멘 #1 스트라이프(I)
팽창 포트
루어 캡(C)
ֵ֮
‡
୯‫ݓ‬ฉ௼!શୢ!஼௽!ਅ৅ୣ!ଃࣼฉ؈!୏ฒ!ඊࠨೋ!ඝୣ!๼ूढ୴‫!ڌ‬กू!࡮௾!թ
ؔ୴!୏ುੑറ!‫ޣ‬૫‫!܂‬උຏ!஼੗ฒ!௜੘ੑଊ/
‡
ૂ෽ࡦ೩୴ോ‫ ܂‬PO%% ߃‫܂‬PO%%թ!‫!܂ڳ‬ଵૃ
ୣ!‫ڸ‬௼!࡮੘ੑଊ/!෭ৡ!චਅ!࣭0߃‫!܂‬஍ು!ֵ஍୴!ࣵ৏ฌ!ਦ!୾੎܏‫ܙ‬/
‡
ૂ෽ࡦ೩୴ോ‫ރࣳ!܂‬ੑ!୴੒!த!ൕੈඊ࡞!֍ಆો!ฏ܏‫ܙ‬/!!!෭ৡ୴!‫ܫ‬ೊ୴!લ܏֍
‫ڌ‬0લ܏ֵ!ে‫୾!୴ॄू!܂‬ୠࢡ!হଵฉ௼!࡮੘ੑଊ/
‡
ૂ෽ࡦ೩୴ോթ!‫!֜ࡺ!ل‬ฉ‫ރࣳ!ࠩݓ‬ੑ!୴੒!த૫!ୗࣼ!‫ݝ׀‬EUHDVWFDYLW\ୣ!ಖ
૿ฒો! ฏ܏‫ܙ‬/‫ !ࣁڬ !୴ݝ׀‬ஃୠࢡ! হଵฉ௼! ࡮੘ੑଊ/! ಘֵ! กूࠈ୴! ౵ࣼࠈ୯
୴ฉթ!લܑ!֮ଶ!෭ৡ!ෟࢡ૫ঢ়!กू!ෟࢡؔ௼୯!֍ࡦթ 5mm ࣢ࡰ୴ࢡ!হ
ଵฉ௼!࡮੘ੑଊ/!!!!กू!‫ۍ‬ತୣ!ಘਂๅฉ؈!୏ฒ!ண஥ซ!ଊ෻৲!ࡁ࢘)‫*އ‬ୣ!হ
ଵฉ੘ੑଊ/
애플리케이터(A)
‫!ࡪ׽‬CONTURA® ૂ෽ࡦ೩୴ോ
치료 루멘 캡 및 필러(L)
조영제 트레이(D)
스캘플(E)
‡
ண஥ซ!ು࠻ࠈୣ!த‫ܞ‬ฌ!ਦ!୾‫ࠩݓ‬-!ժ!ࣼহৡୣ!த‫ܞ‬ฉ؈!த!ࣳ‫ރ‬ੑ!ૂ෽ࡦ೩୴
ോ࡞!ಖ૿ฉ૳!ண஥ซ!୏ು-!෭ৡࠈ-!กू!ի֥!࣭!ਨ୨‫!࡞ݓ‬ๆ୶ฒો!ฏ܏‫ܙ‬/
‡
็ஂ૫֜ঢ়!ૂ෽ࡦ೩୴ോ࡞!ॾ!‫ݓׂ!ޣ‬ซ!஢ฑ୴!‫ؼ܀‬௼ࢡ!ਦਪண୶!ࣼओୠࠨ!஬
֍ฌ!֕ୣ!‫׭‬஍ฏ܏‫ܙ‬/
‡
൳૳ૃ୴!ຉ৞‫֕!܂ݥ‬ୣ!ଃࣼฉ؈!୏ฒ!஼૿஬!‫!܂ݓە‬21&!࣢ࡰ୷!֕ୣ!‫׭‬஍ฏ܏
‫ܙ‬/
10ml 주사기
‡
୴ଊ‫!ސ‬؈ࣳ୯!ૌ஬૫!ષࠓ࡛؈!ࣳ୨ୣ!ब୴‫ஂ็!܂‬૫֜‫!܂‬॥୴ଌ৪!஼૿஬࡞!‫׭‬
஍ฏ܏‫ܙ‬/!
30ml 주사기(B)
‡
୴!஍ು‫୷!܂‬๐ଵୠࠨ!ৣְ‫ݥ‬૦੎܏‫ܙ‬/!य!୯࠻!؈؈࡞!ஏহଵฉࢡ!
배액 카테터(H)
스플릿 쉬스(G)
트로카(F)
‫ૃ ࡪ׽‬৬ঢ়ࡦ
็ஂի! ‫י‬౛! ଊૺ୴! ࣵ৏ฌ! ਦ! ୾੎܏‫ܙ‬/! උຏ! ू෪! হ୴૫! ،ֵ! ஃୢ! ࡁ࣢‫ڌ‬
OXPLQD ஼୶ඊ!࣭0߃‫!܂‬ඐ୴!୾‫!܂‬؈؈‫܂‬-!உஏண!ࣵ૷ୂ!߃‫࣢!܂‬৏ࣆ!ଊૺ୴!‫!ݦ‬
౾ૃ୴‫୶!ڌ‬౾஼௽ׂ!ந಍นୣ!֮ଶ!‫!୴ځؠ‬৬౶ฉ؈թ!૚ࠠ֍‫ॆ!ڌ‬թ‫܉‬ฏ܏‫ܙ‬/!৏ 1. 초음파를 사용하여 유방종괴절제술 동공을 확인하십시오.
ࣆชண!஄૳ࣆୢ!հૺ!ฏन௻ୣ!ಌ߻ฌ!ਦ!୾‫࣢!܂‬৏ࣆ!ୗ؈ୂ!߃‫ୂ૷ࣵ!܂‬ୠࠨ!୶
ฒ!஍ು࡞!ଊૺੑറ!ਦ!୾੎܏‫ܙ‬/
2. CONTURA® MLB 애플리케이터 무균 포장을 풀고 애플리케이터(A)와 PO 주사기(B) 1 치료 루멘 #1 스트라이프를 참조하여 CONTURA® 애플리케이터의 위치를 파악하십시
개를 빼내십시오. 인플레이션 포트 루어 캡(C)를 벗기고 PO (B01245, B11245) 또는
오. 각 방사선 전달에 앞서 영상 촬영을 이용하여 올바른 애플리케이터 위치, 풍선 위
PO%%의 무균 식염수액을 애플리케이터로 주입한 후 새는 곳이 없
치, 풍선 볼륨, 피부 간격 및 순응도를 확인하십시오. 필요한 경우 조절하십시오.
는지, 대칭을 이루는지를 확인하십시오. 결함이 있는 애플리케이터는 버리십시오. 커넥 4. 치료 루멘에는 의 번호가 매겨져 있으며 위치는 그림 3에 나와 있습니
터 쪽으로 애플리케이터를 잡고(이 때 풍선은 세로로 달려 있도록 함) 풍선 쪽으로부터
다. '1'번 루멘은 카테터 샤프트의 치료 루멘 #1 스트라이프(I)에 가장 가깝고 병행하
식염수액을 뒤로 빼내십시오.
는 오프셋 루멘에 해당합니다. 치료 루멘 '5'번은 중앙 루멘에 해당합니다. 적색 캡을
제공된 트레이(D)에서 최대 의 조영제/무균 식염수액을 프렙하십시오.
벗기고 상용 커넥터를 사용하여 치료 루멘을 후부하기에 부착하십시오.
ౠֵ; 고농도의 조영제는 루멘 마커 육안 관찰을 방해할 수 있습니다.
ౠֵ; *DPPD0HGSOXV™ 후부하기 사용시 애플리케이터의 치료 루멘은 적절한
*DPPD0HGSOXV™ 길이 절단 게이지를 사용하여 길이를 먼저
4. 애플리케어티 삽입을 위해 유방 표면의 원하는 지점을 확인하십시오. 적절한 마취제
를 피부와 유방종괴절제술 동공 경로에 주입하십시오. 트로카(F)팁을 완전히 삽입하
잘라주어야 합니다.
기 위해 삽입지점에 스캘플로 충분한 길이만큼 피부 절개를 하십시오. 필요한 경우 피 5. 치료 후에는 적색 캡을 교체하고 카테터 샤프트를 단단히 고정하십시오.
부 절개 부위를 확장하십시오. 트로카를 6SOLW6KHDWK*와 함께 동공 안으로 밀어넣으 ‡ ๐ਦ
십시오. 트로카를 빼십시오.
1. 주사기를 청색 팽창 포트에 부착하고 풍선의 바람을 빼서 CONTURA® MLB 애플리케이
5. PO 주사기를 배액 카테터(H)에 부착하고, 배액 카테터는 스플릿 쉬스를 통해 삽입한
터를 회수하십시오.
후 석션을 실시하여 동공 내에 남아 있는 액을 모두 빼내십시오. 배액 카테터를 빼십
ౠֵ;!주사기로 풍선의 바람을 뺄 때 문제가 생긴다면:
시오.
1) 주사기를 다시 부착하고 시계방향으로 단단히 회전하여 밸브를 완전히 활성화하십
6. 애플리케이터는 스플릿 쉬스를 통해 공동 안으로 삽입하십시오. 쉬스를 빼십시오.
시오. 그래도 풍선이 수축하지 않는다면
7. 카테터 샤프트 위의 치료 루멘 #1 스트라이프,가 절개된 피부와 일직선으로 위치하게
2) 청색 팽창 포트 튜빙을 자르십시오. 이제 자른 튜빙의 끝 쪽에서 풍선의 내용물(식
하십시오.
염수액/조영제)이 흘러 나옵니다.
강직 스타일렛-을 중앙 치료 루멘.에서 빼십시오. 적색 치료 루멘 캡(L)을 부착하
풍선이 여전히 수축되지 않으면 주사기와 바늘을 직접 풍선에 삽입하십시오. 주사
십시오.
기를 사용하여 내용물을 빼내어 풍선을 수축시키십시오.
9. 제공된 주사기를 사용하여 애플리케이터의 공기를 제거하고, 조영제로 애플리케이터
2. 애플리케이터를 돌려서(나사를 품) 공동으로부터 회수하십시오.
풍선을 원하는만큼 팽창시키십시오. 애플리케이터에 부착하기 충전시 사용한 주사기
안의 공기를 완전히 빼내십시오.
모델
원하는 풍선 직경
대략적인 풍선
충전량
B01245
직경 4cm x 길이 4.4cm
PO
B11245
직경 5cm x 길이 4.4cm
PO
B01256
직경 4.5cm x 길이 5.4cm
51 ml
B11256
직경 6cm x 길이 5.4cm
PO
10. 루어 캡을 팽창 포트(M)에 두십시오.
11. 초음파를 이용하여 위치, 볼륨, 공동 순응(cavity conformance)이 적절한지 확인하십시
오. 애플리케이터 풍선을 둘러싼 액과 공기는 백색 진공 포트(N)에 부착된 30ml 주사기
로 빨아들일 수 있습니다. 풍선 볼륨은 청색 팽창 포트(M)를 통해 조절할 수 있습니다.
완료되면 루어 캡을 교체하십시오.
12. 치료 루멘 #1 스트라이프가 절개된 피부와 정렬을 이루는지 확인하십시오.
카테터 구부러짐을 최소화하고 마커와 절개된 피부가 일직선을 이루도록 카테터의 위
치를 잡으십시오.
14. 구부러짐을 최소화하도록 카테터가 위치한 출구 부위에 수술적 드레싱을 하십시오.
15. 제공된 라벨에 최종 풍선 충전량을 기록하고 환자 차트에 부착하십시오.
ࣼহৡ!த‫!ܞ‬.!‫!ࡪ׽‬2ׂ!4ୣ!ౠ஼ฉ੘ੑଊ
치료 루멘 #5
치료 루멘 #1
치료 루멘 #4
치료 루멘 #2
팽창 포트(M) (청색)
치료 루멘 #3 진공 포트(N) (백색)
‫!!ࡪ׽‬ು࠻!ࡁ࢘!ࣼผ!
1. 중요: HDR 후부하기 연결 시 애플리케이터는 최대한 곧은 상태를 유지해야 하며 날카
롭게 구부러진 부분이나 뒤틀린 곳이 없어야 합니다. 각 시술 전 시술하려는 방향으로
장치를 둔 상태에서 시술 길이를 측정해야 합니다. 각 시술 마다 방향은 일정하게 유지
되어야 합니다.
2. CT 촬영은 상용 치료 계획 소프트웨어와 함께 사용하며 타깃 치료량에 최적화된 처방
방사선량을 전달할 수 있는 적절한 치료 루멘, 치료 유지 위치 및 유지 시간을 결정해
야 합니다.
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Bard, Contura 는 &5%DUG,QF 또는 계열회사의 상표 그리고/또는 등록상표입니다
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&RS\ULJKW‹&5%DUG,QF$OOH5HFKWHYRUEHKDOWHQ*HGUXFNWLQ86$
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ȆȞİȣȝĮIJȚțȐǻȚțĮȚȫȝĮIJĮ‹&5%DUG,QFȂİIJȘȞİʌȚijȪȜĮȟȘʌĮȞIJȩȢįȚțĮȚȫȝĮIJȠȢǼțIJȣʌȫșȘțİıIJȚȢǾȆǹ
&RS\ULJKW‹&5%DUG,QF$OOHUHWWLJKHGHUIRUEHKROGHV7U\NWL86$
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저작권 ‹&5%DUG,QF 판권 소유. 미국에서 인쇄.
Manufacturer:
6HQR5[,QF
:HVWUG6WUHHW
7HPSH$=
USA
7(/ )$; www.bardbiopsy.com
$XWKRUL]HG5HSUHVHQWDWLYHLQ
the European Community
Bard Limited
Forest House
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