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SM UC MRI
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SENOMARK ULTRACORTM MRI 14 Gauge Tissue Marker And
Introducer Kit
ENGLISH
INSTRUCTIONS FOR USE
SMUCMRI14GT (Titanium Marker)
SMUCMRI14GSS (Stainless Steel Marker)
UCMRINTLOC (Introducer Kit – packaged separately)
14 Gauge Tissue Marker and Introducer Kit
Caution: Federal (U.S.A.) law restricts these devices to sale by
or on the order of a physician.
DESCRIPTION
The SenoRx Inc. SENOMARK ULTRACORTM MRI Tissue Marker
consists of a disposable 14 gauge beveled needle Applicator
containing:
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embedded in the middle pad;
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tissue site. The pads are visible via ultrasound for approximately
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marks and a locking plunger. The pads are deployed from the
beveled needle tip into the tissue site.
The ULTRACOR® MRI Introducer Kit consists of:
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The titanium Trocar and plastic Sheath are used to access the
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Localization System.
INTENDED USE
The SENOMARK ULTRACORTM MRI is intended to radiographically and
sonographically mark breast tissue prior to or during a breast biopsy
procedure.
CONTRAINDICATIONS
This device is not intended for use except as indicated.
WARNINGS
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COMPLICATIONS
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the use of the SENOMARK ULTRACORTM MRI and ULTRACOR® MRI
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tissue marking devices.
HOW SUPPLIED
The SENOMARK ULTRACORTM MRI and ULTRACOR® MRI Introducer Kit
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DIRECTIONS FOR USE (Refer to Figure 1)
ULTRACOR® MRI Introducer Kit
1. Inspect the packaging to insure that package integrity has not
been compromised. The product is sterile unless the seal is
broken.
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(J) and Obturator (M).
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nick.
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Trocar and Sheath assembly and position the stop (L) on the
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ULTRACOR® MRI Introducer Kit
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markers and ULTRACOR®05,ORJR)WRFRQ¿UPGHSWKDQG
orient needle bevel.
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ENCOR® MRI Introducer Kit
Note: refer to ENCOR®05,,QWURGXFHU.LW(&05,17/2&LQVWUXFWLRQV
for use and description of components.
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applicator.
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PRECAUTIONS
CANNULA
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percutaneous breast biopsy procedures.
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opened or if the package is damaged.
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only. DO NOT RESTERILIZE.
of applicator.
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gauze beneath the guide block to temporarily hold pressure
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during imaging.
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Sheath.
target site.
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8. Hold compression as described by standard medical guidelines.
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Note that the ULTRACOR®05,ORJR)LVDOLJQHGZLWKWKHQHHGOH
bevel.
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Obturator.
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target site.
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compression to the needle track to minimize bleeding. Hold
compression until bleeding has ceased.
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Figure 1.
SENOMARK ULTRACOR™ MRI Tissue Marker and Introducer Kit
SENOMARK ULTRACORTM MRI Applicator
Unlocked (H)
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Assembled in Thailand.
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SENOMARK ULTRACOR™ MRI et ULTRACOR® MRI sont similaires à celles
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MODE D’EMPLOI
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DESCRIPTION
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du site tissulaire. Les tampons sont visibles par ultrasons pendant
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environ.
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suivants :
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PRÉSENTATION
Les kits d’introducteur SENOMARK ULTRACOR™ MRI et ULTRACOR®
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INSTRUCTIONS D’UTILISATION (se référer à la Figure 1)
Kit d’introducteur ULTRACOR® MRI
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APPLICATION
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CONTRE-INDICATIONS
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AVERTISSEMENTS
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l’applicateur tout en maintenant l’applicateur en position. Retirer
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&RORFDFLyQGHODSOLFDGRUSENOMARK ULTRACOR™ MRI usando
el juego de introductor ULTRACOR® MRI
(VWDELOLFHODIXQGDDODYH]TXHUHWLUDHOWURFDUREWXUDGRU
HLQWURGX]FDHODSOLFDGRU%HQODIXQGD8WLOLFHODVPDUFDV
de profundidad y el logo ULTRACOR®05,)SDUDFRQ¿UPDU
ODSURIXQGLGDG\RULHQWHHOELVHOGHODDJXMD
&RORFDFLyQGHODSOLFDGRUSENOMARK ULTRACOR™ MRI usando
el juego de introductor ENCOR® MRI
Nota:FRQVXOWHODVLQVWUXFFLRQHVGHOMXHJRGHLQWURGXFWRU
(&05,17/2&ENCOR® 05,SDUDHOXVR\ODGHVFULSFLyQ
de los componentes.
5HWLUHHOREWXUDGRUVRQGDGHODFiQXOD
&RORTXHHODGDSWDGRUVREUHODDJXMDGHODSOLFDGRUFRPR
VHPXHVWUDHQOD¿JXUDLQIHULRU&ROyTXHOR¿UPHPHQWHFRQWUD
el mango del aplicador.
PRECAUCIONES
%25'(6(*81'2
%25'(35,0(52
‡ $OPDFHQDUDWHPSHUDWXUDVLQIHULRUHVDž&
‡ (VWRVGLVSRVLWLYRVVyORGHEHQVHUXWLOL]DGRVSRUPpGLFRVTXH
WHQJDQIRUPDFLyQHQSURFHGLPLHQWRVGHELRSVLDGHPDPD
SHUFXWiQHD
AGUJA
$'$37$'25
‡ 1RXVHHVWRVSURGXFWRVVLODEDUUHUDHVWpULOKDVLGRSUHYLDPHQWH
,QWURGX]FDHODSOLFDGRUHQODFiQXODKDVWDTXHODSDUWHIURQWDO
DELHUWDRVLHOSDTXHWHHVWiGDxDGR
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‡ (VWRVSURGXFWRVVHVXPLQLVWUDQHVWpULOHV\HVWiQSUHYLVWRVSDUD
CÁNULA
$'$37$'25
$3/,&$'25
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‡ 1RORXVHVLODDJXMDHVWiGREODGDRODSXQWDHVWiGDxDGD
‡ 9HUL¿TXHTXHODIXQGDQRVHPXHYDFXDQGRUHWLUHHOWURFDU
obturador.
‡ 9HUL¿TXHTXHODIXQGDQRVHPXHYDFXDQGRFRORTXHHODSOLFDGRU 'HVEORTXHHHOpPERORJLUiQGRORKDFLDODGHUHFKDž
dentro de la funda.
,PSOHPHQWHHOPDUFDGRUKDFLHQGRDYDQ]DUHOpPERORKDVWDTXH
haga contacto con el tubo del aplicador.
‡ $VHJ~UHVHGHTXHVHGLVSHQVHQWRGDVODVDOPRKDGLOODV
5HWLUHHODSOLFDGRU\ODFiQXODVLPXOWiQHDPHQWH\FRORTXH
JDVDHVWpULOEDMRHOEORTXHJXtDSDUDPDQWHQHUWHPSRUDOPHQWH
ODSUHVLyQGXUDQWHODDGTXLVLFLyQGHLPiJHQHV
9XHOYDDDGTXLULULPiJHQHVGHODPDPDSDUDYHUL¿FDU
ODFRORFDFLyQGHODSLH]DGHFDEOHHQHOVLWLRREMHWLYR
0DQWHQJDODFRPSUHVLyQFRPRVHGHVFULEDHQODVGLUHFWULFHV
PpGLFDVHVWiQGDUHV
,PSOHPHQWDFLyQGHEROLWDGHVGHHODSOLFDGRU
SENOMARK ULTRACOR™ MRI
&RQ¿UPHTXHHOORJRULTRACOR®05,)HVWpDOLQHDGRFRQHOELVHOGH
ODDJXMD
/LEHUHHOEORTXHRGHVHJXULGDGGHOpPEROR*JLUiQGROR$
KDFLDODGHUHFKDžKDVWDTXHHOVtPERORGHEORTXHRHVWp
verticalmente alineado (H) con el logo.
,PSOHPHQWHLQPHGLDWDPHQWHWRGRHOFRQWHQLGRGHODSOLFDGRU
KDFLHQGRDYDQ]DUHOpPERORKDVWDTXHKDJDFRQWDFWRFRQHO
WXERGHODSOLFDGRUDODYH]TXHPDQWLHQHHODSOLFDGRUHVWDEOH
HQVXSRVLFLyQ5HWLUHHODSOLFDGRUGHODIXQGD\VXVWLWX\DFRQ
un trocar u obturador.
9XHOYDDDGTXLULULPiJHQHVGHODPDPDSDUDYHUL¿FDUOD
FRORFDFLyQGHODSLH]DGHFDEOHHQHOVLWLRREMHWLYR
5HWLUHODIXQGD\HOWURFDUREWXUDGRUPDQWHQLHQGRODFRPSUHVLyQ
HQODWUD\HFWRULDGHODDJXMDSDUDPLQLPL]DUHOVDQJUDGR0DQWHQJD
ODFRPSUHVLyQKDVWDTXHFHVHHOVDQJUDGR
'HVHFKHHODSOLFDGRUODIXQGDHOREWXUDGRUHOEORTXHJXtDGH
DJXMD\HOWURFDUDGHFXDGDPHQWH
Figura 1.
SENOMARK ULTRACOR™ MRI Marcador
de tejido y juego de introductor
Aplicador SENOMARK ULTRACOR™ MRI
'HVEORTXHDGR+
%ORTXHDGR*
Émbolo (A)
$SOLFDGRU%
$JXMD&
Logo ULTRACOR® 05,)
Adaptador (I)
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$OPRKDGLOODVPDUFDGRU'
Juego de introductor ULTRACOR® MRI
Trocar de titanio y funda de
SOiVWLFR1
3URWHFWRUGHSXQWD.
Ret (L)
%ORTXHGHJXtD
GHDJXMD-
Obturador (M)
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1,QYLYR&RUSRUDWLRQ:DXNHVKD:,
SM UC MRI
TM
‡
‡
SENOMARK ULTRACOR 05,ZHHIVHOPDUNHULQJYDQJDXJH
en inbrengset
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NEDERLANDS
GEBRUIKSAANWIJZING
COMPLICATIES
0RJHOLMNHFRPSOLFDWLHV]RDOVLQIHFWLHGLHJHSDDUGNXQQHQJDDQ
met het gebruik van de SENOMARK ULTRACORTM MRI en ULTRACOR®
05,LQEUHQJVHW]LMQYHUJHOLMNEDDUPHWGHFRPSOLFDWLHVGLHNXQQHQ
RSWUHGHQELMKHWJHEUXLNYDQDQGHUHZHHIVHOPDUNHULQJVKXOSPLGGHOHQ
SMUCMRI14GT (titanium markering)
608&05,*66URHVWYULMVWDOHQPDUNHULQJ
8&05,17/2&LQEUHQJVHW±DI]RQGHUOLMNYHUSDNW
:HHIVHOPDUNHULQJYDQJDXJHHQLQEUHQJVHW
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14 gauge die de volgende onderdelen bevat:
‡ UHVRUEHHUEDUHSDGVYDQSRO\JO\FRO]XXU3*$,QGHPLGGHOVWH
pad is een draadvorm ingebed;
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'HGUDDGYRUPLVEHGRHOGYRRUODQJGXULJHU|QWJHQPDUNHULQJYDQGH
ZHHIVHOSODDWV'HSDGV]LMQJHGXUHQGHRQJHYHHUZHNHQ]LFKWEDDU
PHWHFKRJUD¿HHQZRUGHQELQQHQRQJHYHHUZHNHQJURWHQGHHOV
geresorbeerd.
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GLHSWHPDUNHULQJHQYDQFPHQHHQYHUJUHQGHOEDUHSOXQMHU9LDGHWLS
YDQGHVFKXLQJHVOHSHQQDDOGZRUGHQGHSDGVLQGHZHHIVHOSODDWV
afgegeven.
'HULTRACOR® MRI inbrengset bestaat uit:
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‡ HHQNXQVWVWRIREWXUDWRU
‡ HHQQDDOGYRHUGHUEORN
'HWLWDQLXPWURFDUHQNXQVWVWRIKXOVZRUGHQJHEUXLNWYRRUKHW
YHUNULMJHQYDQWRHJDQJWRWGHZHHIVHOSODDWV+HWQDDOGYRHUGHUEORNLV
compatibel met het Invivo1 lokalisatiesysteem met raster.
BEOOGD GEBRUIK
'HSENOMARK ULTRACORTM05,LVEHGRHOGYRRUU|QWJHQRORJLVFKHQ
HFKRJUD¿VFKPDUNHUHQYDQERUVWZHHIVHOYRRUDIJDDQGDDQRIWLMGHQV
een borstbiopsie.
CONTRA-INDICATIES
'LWKXOSPLGGHOLVXLWVOXLWHQGEHGRHOGYRRUKHWDDQJHJHYHQJHEUXLN
WAARSCHUWINGEN
‡ %LMSDWLsQWHQPHWHHQEHNHQGHRYHUJHYRHOLJKHLGYRRU
GHPDWHULDOHQGLH]LMQYHUPHOGLQGHEHVFKULMYLQJYDQ
KHWKXOSPLGGHONDQ]LFKHHQDOOHUJLVFKHUHDFWLHRSGLW
LPSODQWDDWYRRUGRHQ
‡ 'HSENOMARK ULTRACORTM MRI wordt niet aanbevolen voor
JHEUXLNELMSDWLsQWHQPHWERUVWLPSODQWDWHQ
‡ 1LHWJHEUXLNHQELMDDQZH]LJKHLGYDQLQIHFWLH
VOORZORGSMAATREGELEN
‡ %HZDUHQELMWHPSHUDWXUHQRQGHUž&
‡ 'H]HKXOSPLGGHOHQPRJHQXLWVOXLWHQGZRUGHQJHEUXLNWGRRU
artsen met een opleiding in percutane biopsieprocedures
van de borst.
‡ *HEUXLNGH]HSURGXFWHQQLHWDOVGHVWHULHOHEDUULqUHHHUGHU
geopend is of als de verpakking beschadigd is.
‡ 'H]HSURGXFWHQZRUGHQVWHULHOJHOHYHUGHQ]LMQXLWVOXLWHQG
bedoeld voor eenmalig gebruik. NIET OPNIEUW
STERILISEREN.
‡ 1LHWJHEUXLNHQDOVGHQDDOGYHUERJHQHQRIGHWLSEHVFKDGLJGLV
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REWXUDWRUZRUGWYHUZLMGHUG
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LQGHKXOVZRUGWJHSODDWVW
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ELRSVLHPDUNHULQJHQYDQYHUJHOLMNEDUHJURRWWHKHEEHQ
DDQJHWRRQGGDWELMWHVWHQLQHHQ05,V\VWHHPPHWHHQ
YHOGVWHUNWHYDQ7JHHQEHZHJLQJHQJHHQDDQPHUNHOLMNH
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LEVERING
'HSENOMARK ULTRACORTM MRI en ULTRACOR®05,LQEUHQJVHWZRUGHQ
VWHULHOJHOHYHUGHQ]LMQXLWVOXLWHQGEHGRHOGYRRUHHQPDOLJJHEUXLN
AANWIJZINGEN VOOR GEBRUIK (zie afbeelding 1)
ULTRACOR® MRI inbrengset
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2SHQGHYHUSDNNLQJHQQHHPGHWLWDQLXPWURFDUHQKXOV1
het naaldvoerderblok (J) en de obturator (M) eruit met behulp
van een standaard aseptische techniek.
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apparatuur. Maak een incisie in de huid.
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van de trocar met de huls en plaats de stopper (L) op de huls.
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het doelgebied. Ten behoeve van beeldvorming kan de trocar
ZRUGHQYHUYDQJHQGRRUGHREWXUDWRU
9LVXDOLVHHUGHERUVWRSQLHXZRPGHSODDWVLQJYDQGHWURFDUWLS
LQKHWGRHOJHELHGWHFRQWUROHUHQ:LM]LJGHSRVLWLH]RQRGLJ
Plaatsing van de SENOMARK ULTRACORTM05,DSSOLFDWRUPHW
behulp van de ULTRACOR® MRI inbrengset
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DSSOLFDWRU%LQGHKXOVLQEUHQJW*HEUXLNGHGLHSWHPDUNHULQJHQ
en het ULTRACOR®05,ORJR)RPGHGLHSWHWHEHYHVWLJHQHQGH
afschuining van de naald te richten.
Plaatsing van de SENOMARK ULTRACORTM 05,DSSOLFDWRUPHW
behulp van de ENCOR® MRI inbrengset
2SPHUNLQJ5DDGSOHHJGHJHEUXLNVDDQZLM]LQJYDQGHENCOR® MRI
LQEUHQJVHW(&05,17/2&HQGHEHVFKULMYLQJYDQGHRQGHUGHOHQ
9HUZLMGHUGHREWXUDWRUVRQGHXLWGHFDQXOH
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JHWRRQGRSRQGHUVWDDQGHDIEHHOGLQJ3ODDWVGH]HVWHYLJWHJHQ
het handvat van de applicator.
((567(5$1'
1$$/'
7:(('(5$1'
$'$37(5
%UHQJGHDSSOLFDWRULQGHFDQXOHLQWRWKHWYRRUVWHJHGHHOWHGH
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&$18/(
$'$37(5
$33/,&$725
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*HHIGHPDUNHULQJDIGRRUGHSOXQMHUQDDUYRUHQWHGXZHQWRW
deze de cilinder van de applicator raakt.
9HUZLMGHUGHDSSOLFDWRUHQFDQXOHWHJHOLMNHUWLMGHQOHJHHQVWHULHO
JDDVMHRQGHUKHWQDDOGYRHUGHUEORNRPKLHUWLMGHOLMNGUXNRSWH
KRXGHQWLMGHQVEHHOGYRUPLQJ
11
9LVXDOLVHHUGHERUVWRSQLHXZRPGHSODDWVLQJYDQGHGUDDGYRUP
in het doelgebied te controleren.
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VWDQGDDUGULFKWOLMQHQ
Afbeelding 1.
SENOMARK ULTRACORTM MRI ZHHIVHOPDUNHULQJHQLQEUHQJVHW
SENOMARK ULTRACORTM MRI applicator
Afgifte van korrels door de SENOMARK ULTRACORTM MRI
applicator
Het ULTRACOR®05,ORJR)PRHW]LMQXLWJHOLMQGPHWGHDIVFKXLQLQJYDQ
de naald.
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GRRUGHSOXQMHU$JUDGHQUHFKWVRPWHGUDDLHQWRWKHW
YHUJUHQGHOLQJVV\PERROYHUWLFDDOLVXLWJHOLMQG+PHWKHWORJR
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SOXQMHUQDDUYRUHQWHGXZHQWRWGH]HWHJHQGHFLOLQGHUYDQGH
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9HUZLMGHUGHDSSOLFDWRUXLWGHKXOVHQYHUYDQJGH]HGRRUGH
trocar of obturator.
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in het doelgebied te controleren.
4. Handhaaf compressie op de naaldroute om de bloeding tot een
PLQLPXPWHEHSHUNHQHQYHUZLMGHUGHKXOVHQWURFDUREWXUDWRU
%OLMIFRPSUHVVLHXLWRHIHQHQWRWGHEORHGLQJLVJHVWRSW
'HDSSOLFDWRUKXOVREWXUDWRUWURFDUHQKHWQDDOGYRHUGHUEORN
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9HUJUHQGHOG*
Ontgrendeld (H)
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ULTRACOR®05,ORJR)
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ULTRACOR® MRI inbrengset
Titanium trocar
en kunststof huls (N)
Stopper (L)
Tipbescherming (K)
Naaldvoerderblok (J)
Obturator (M)
Geassembleerd in Thailand.
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1,QYLYR&RUSRUDWLRQ:DXNHVKD:LVFRQVLQ96
SM UC MRI
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‡
Kit de Introdutor e Marcador de Tecido de Calibre 14
SENOMARK ULTRACORTM MRI
PORTUGUÊS
INSTRUÇÕES DE UTILIZAÇÃO
SMUCMRI14GT (Marcador em Titânio)
608&05,*660DUFDGRUHP$oR,QR[LGiYHO
UCMRINTLOC (Kit de Introdutor – embalado em separado)
Kit de Introdutor e Marcador de Tecido de Calibre 14
DESCRIÇÃO
O Marcador de Tecido SENOMARK ULTRACORTM MRI da SenoRx Inc.
FRQVLVWHQXP$SOLFDGRUGHVFDUWiYHOFRPDJXOKDHPELVHO
GHFDOLEUHTXHFRQWpP
‡ FRPSUHVVDVUHDEVRUYtYHLVGHiFLGRSROLJOLFyOLFR3*$FRP
XPPDUFDGRUPHWiOLFRLQWHJUDGRQDFRPSUHVVDGRPHLR
‡ WDPSmRHPSROLHWLOHQRJOLFRO3(*QDH[WUHPLGDGHGLVWDO
2PDUFDGRUPHWiOLFRGHVWLQDVHjPDUFDomRUDGLRJUi¿FDDORQJR
SUD]RGRORFDOGRWHFLGR$VFRPSUHVVDVVmRYLVtYHLVSRUXOWUD
VRQVGXUDQWHDSUR[LPDGDPHQWHVHPDQDVHVmRHVVHQFLDOPHQWH
UHDEVRUYLGDVQRHVSDoRGHDSUR[LPDGDPHQWHVHPDQDV
2$SOLFDGRUWHPXPDDJXOKDHPELVHOGHFPFDOLEUHFRP
PDUFDVGHSURIXQGLGDGHGHFPHXPrPERORGHEORTXHLR$V
FRPSUHVVDVVmRDSOLFDGDVGDSRQWDGDDJXOKDHPELVHOSDUDRORFDO
do tecido.
O Kit de Introdutor ULTRACOR®05,pFRPSRVWRSRU
‡ XP7URFDUWHHPWLWkQLRFRPXPD%DLQKDGHSOiVWLFR
‡ XP2EWXUDGRUSOiVWLFR
‡ XP%ORFR*XLDGD$JXOKD
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R6LVWHPDGH/RFDOL]DomRGH*UHOKD,QYLYR1.
UTILIZAÇÃO PREVISTA
O SENOMARK ULTRACORTM05,GHVWLQDVHDPDUFDUGHIRUPD
UDGLRJUi¿FDHVRQRJUi¿FDRWHFLGRGDPDPDDQWHVRXGXUDQWHXP
SURFHGLPHQWRGHELRSVLDPDPiULD
CONTRA-INDICAÇÕES
(VWHGLVSRVLWLYRQmRVHGHVWLQDDVHUXWLOL]DGRGHRXWUDIRUPDDQmRVHU
a indicada.
ADVERTÊNCIAS
‡ 2VGRHQWHVFRPXPDKLSHUVHQVLELOLGDGHFRQKHFLGDDRV
PDWHULDLVOLVWDGRVQDGHVFULomRGRGLVSRVLWLYRSRGHP
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‡ 1mRVHUHFRPHQGDDXWLOL]DomRGRSENOMARK ULTRACORTM
05,HPGRHQWHVFRPLPSODQWHVPDPiULRV
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(VWXGRVSXEOLFDGRVFRPPDUFDGRUHVGHELRSVLDHPDoR
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GHVORFDPHQWRGRPDUFDGRUHUHYHODUDPXPDTXHFLPHQWR
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COMPLICAÇÕES
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SENOMARK ULTRACORTM MRI e ULTRACOR®05,VmRVHPHOKDQWHV
jVDVVRFLDGDVjXWLOL]DomRGHRXWURVGLVSRVLWLYRVGHPDUFDomR
de tecido.
MODO DE FORNECIMENTO
O Kit de Introdutor SENOMARK ULTRACORTM MRI e ULTRACOR®05,VmR
IRUQHFLGRVHVWpUHLVHGHVWLQDPVHDSHQDVDXPD~QLFDXWLOL]DomR
INSTRUÇÕES DE UTILIZAÇÃO (Consulte a Figura 1)
Kit de Introdutor ULTRACOR® MRI
,QVSHFFLRQHDHPEDODJHPSDUDJDUDQWLUTXHDLQWHJULGDGHGD
HPEDODJHPQmRIRLFRPSURPHWLGD2SURGXWRHQFRQWUDVHHVWpULO
DPHQRVTXHRVHORWHQKDVLGRYLRODGR
8WLOL]DQGRXPDWpFQLFDDVVpSWLFDSDGUmRDEUDDHPEDODJHP
HUHWLUHR7URFDUWHHP7LWkQLRHD%DLQKD1%ORFR*XLDGD
Agulha (J) e Obturador (M).
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8WLOL]HR%ORFR*XLDGD$JXOKDFRPD*UHOKDGH'LVSRVLWLYRVGH
,50(IHFWXHXPDLQFLVmRQDSHOH
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FRQMXQWRGH7URFDUWHH%DLQKDHSRVLFLRQHREDWHQWH/QD
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LQWURGX]DRFRQMXQWRGH7URFDUWHH%DLQKDQDPDPDRULHQWDQGR
a ponta do Trocarte para o local alvo. O Trocarte pode ser
substituído pelo Obturador para procedimentos de imagiologia.
9ROWHDREWHUXPDQRYDLPDJHPGDPDPDSDUDYHUL¿FDU
DFRORFDomRGDSRQWDGR7URFDUWHQRORFDODOYR0RGL¿TXH
DSRVLomRVHQHFHVViULR
&RORFDomRGR$SOLFDGRUSENOMARK ULTRACORTM MRI utilizando
o Kit de Introdutor ULTRACOR® MRI
(VWDELOL]HD%DLQKDHQTXDQWRUHWLUDR7URFDUWH2EWXUDGRU
HLQWURGX]R$SOLFDGRU%QD%DLQKD8WLOL]HRVPDUFDGRUHV
GHSURIXQGLGDGHHRORJyWLSR)ULTRACOR®05,SDUDFRQ¿UPDU
a profundidade e orientar a ponta em bisel da agulha.
&RORFDomRGR$SOLFDGRUSENOMARK ULTRACORTM MRI utilizando
o Kit de Introdutor ENCOR® MRI
Nota:FRQVXOWHDVLQVWUXo}HVGHXWLOL]DomRHDGHVFULomRGRV
componentes do Kit de Introdutor ENCOR®05,(&05,17/2&
5HWLUHRR2EWXUDGRU6RQGDGDFkQXOD
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do aplicador.
PRECAUÇÕES
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‡ $UPD]HQHDWHPSHUDWXUDVLQIHULRUHVDƒ&
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percutânea.
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608&05,*66ǿȤȞȘșȑIJȘȢĮʌȩĮȞȠȟİȓįȦIJȠĮIJıȐȜȚ
8&05,17/2&ȀȚIJİȚıĮȖȦȖȑĮıȣıțİȣȐȗİIJĮȚȟİȤȦȡȚıIJȐ
ǿȤȞȘșȑIJȘȢȚıIJȠȪțĮȚțȚIJİȚıĮȖȦȖȑĮIJȦȞ*DXJH
ȆǼȇǿīȇǹĭǾ
ȅȚȤȞȘșȑIJȘȢȚıIJȠȪSENOMARK ULTRACORTM05,IJȘȢ6HQR5[,QF
ĮʌȠIJİȜİȓIJĮȚĮʌȩȑȞĮȞĮȞĮȜȫıȚȝȠİijĮȡȝȠȖȑĮȝİȜȠȟȠIJȠȝȘȝȑȞȘ
ȕİȜȩȞĮIJȦȞJDXJHȠȠʌȠȓȠȢʌİȡȚȑȤİȚ
‡ ĮʌȠȡȡȠijȒıȚȝĮİʌȚșȑȝĮIJĮĮʌȩʌȠȜȣȖȜȣțȠȜȚțȩȠȟȪ3*$
İțIJȦȞȠʌȠȓȠIJȠȝİıĮȓȠİʌȓșİȝĮijȑȡİȚİȞıȦȝĮIJȦȝȑȞȠȑȞĮ
ȝȠȡijȠʌȠȚȘȝȑȞȠıȪȡȝĮ
‡ ȕȪıȝĮĮʌȩʌȠȜȣİșȣȜİȞȠȖȜȣțȩȜȘ3(*ıIJȠʌİȡȚijİȡȚțȩȐțȡȠ
ȉȠȝȠȡijȠʌȠȚȘȝȑȞȠıȪȡȝĮʌȡȠȠȡȓȗİIJĮȚȖȚĮIJȘȝĮțȡȠȤȡȩȞȚĮ
ĮțIJȚȞȠȖȡĮijȚțȒȚȤȞȘșȑIJȘıȘIJȠȣıȘȝİȓȠȣIJȠȣȚıIJȠȪȉĮİʌȚșȑȝĮIJĮİȓȞĮȚ
ȠȡĮIJȐȝȑıȦȣʌİȡȒȤȦȞȖȚĮʌİȡȓʌȠȣİȕįȠȝȐįİȢțĮȚȠȣıȚĮıIJȚțȐ
ĮʌȠȡȡȠijȠȪȞIJĮȚıİİȕįȠȝȐįİȢʌİȡȓʌȠȣ
ȅİijĮȡȝȠȖȑĮȢijȑȡİȚȜȠȟȠIJȠȝȘȝȑȞȘȕİȜȩȞĮIJȦȞFP*ȝİ
ıȘȝȐįȚĮȕȐșȠȣȢĮȞȐFPțĮșȫȢțĮȚȑȞĮȑȝȕȠȜȠĮıijȐȜȚıȘȢȉĮ
İʌȚșȑȝĮIJĮİțʌIJȪııȠȞIJĮȚĮʌȩIJȠȐțȡȠIJȘȢȜȠȟȠIJȠȝȘȝȑȞȘȢȕİȜȩȞĮȢıIJȠ
ıȘȝİȓȠIJȠȣȚıIJȠȪ
ȉȠțȚIJİȚıĮȖȦȖȑĮULTRACOR®05,ĮʌȠIJİȜİȓIJĮȚĮʌȩ
‡ ȑȞĮIJȡȠțȐȡĮʌȩIJȚIJȐȞȚȠȝİʌȜĮıIJȚțȩșȘțȐȡȚ
‡ ȑȞĮʌȜĮıIJȚțȩİʌȚʌȦȝĮIJȚțȩ
‡ ȑȞĮȝʌȜȠțȠįȘȖȠȪȕİȜȩȞĮȢ
ȉȠIJȡȠțȐȡĮʌȩIJȚIJȐȞȚȠțĮȚIJȠʌȜĮıIJȚțȩșȘțȐȡȚȤȡȘıȚȝȠʌȠȚȠȪȞIJĮȚȖȚĮ
IJȘȞʌȡȩıȕĮıȘıIJȠıȘȝİȓȠIJȠȣȚıIJȠȪȉȠȝʌȜȠțȠįȘȖȠȪȕİȜȩȞĮȢİȓȞĮȚ
ıȣȝȕĮIJȩȝİIJȠıȪıIJȘȝĮʌȡȠıįȚȠȡȚıȝȠȪșȑıȘȢȝȑıȦʌȜȑȖȝĮIJȠȢ
Invivo1.
ȋȇǾȈǾīǿǹȉǾȃȅȆȅǿǹȆȇȅȅȇǿǽǼȉǹǿ
ȅȚȤȞȘșȑIJȘȢSENOMARK ULTRACORTM05,ʌȡȠȠȡȓȗİIJĮȚȖȚĮIJȘȞ
ĮțIJȚȞȠȖȡĮijȚțȒțĮȚȣʌİȡȘȤȠȖȡĮijȚțȒȚȤȞȘșȑIJȘıȘȚıIJȠȪIJȠȣȝĮıIJȠȪ
ʌȡȚȞȒțĮIJȐIJȘįȚȐȡțİȚĮİʌȑȝȕĮıȘȢȕȚȠȥȓĮȢȝĮıIJȠȪ
ǹȃȉǼȃǻǼǿȄǼǿȈ
ǾıȣıțİȣȒĮȣIJȒʌȡȠȠȡȓȗİIJĮȚĮʌȠțȜİȚıIJȚțȐțĮȚȝȩȞȠȖȚĮIJȘȞ
İȞįİȚțȞȣȩȝİȞȘȤȡȒıȘ
ȆȇȅǼǿǻȅȆȅǿǾȈǼǿȈ
‡ ȅȚĮıșİȞİȓȢȝİȖȞȦıIJȒȣʌİȡİȣĮȚıșȘıȓĮıIJĮȣȜȚțȐʌȠȣ
ĮȞĮijȑȡȠȞIJĮȚıIJȘȞʌİȡȚȖȡĮijȒIJȘȢıȣıțİȣȒȢİȞįȑȤİIJĮȚȞĮ
İȝijĮȞȓıȠȣȞĮȜȜİȡȖȚțȒĮȞIJȓįȡĮıȘıİĮȣIJȩIJȠİȝijȪIJİȣȝĮ
‡ ȅȚȤȞȘșȑIJȘȢSENOMARK ULTRACORTM05,įİȞıȣȞȚıIJȐIJĮȚȖȚĮ
ȤȡȒıȘıİĮıșİȞİȓȢȝİİȝijȣIJİȪȝĮIJĮȝĮıIJȠȪ
‡ ȂȘȤȡȘıȚȝȠʌȠȚİȓIJİʌĮȡȠȣıȓĮȜȠȓȝȦȟȘȢ
ǼʌȚȕİȕĮȚȫıIJİȩIJȚIJȠșȘțȐȡȚįİȞȝİIJĮțȚȞİȓIJĮȚțĮIJȐIJȘȞ
IJȠʌȠșȑIJȘıȘIJȠȣİijĮȡȝȠȖȑĮȝȑıĮıIJȠșȘțȐȡȚ
ǻȚĮıijĮȜȓıIJİȩIJȚȑȤȠȣȞȤȠȡȘȖȘșİȓȩȜĮIJĮİʌȚșȑȝĮIJĮ
ȈİȝİȜȑIJİȢʌȠȣȑȤȠȣȞįȘȝȠıȚİȣșİȓȝİȚȤȞȘșȑIJİȢȕȚȠȥȓĮȢĮʌȩ
ĮȞȠȟİȓįȦIJȠĮIJıȐȜȚ/ʌĮȡȩȝȠȚȠȣȝİȖȑșȠȣȢįİȞȑȤİȚ
țĮIJĮįİȚȤșİȓțȓȞȘıȘIJȦȞȚȤȞȘșİIJȫȞİȞȫțĮIJĮįİȓȤșȘțİĮıȒȝĮȞIJȘ
ĮȪȟȘıȘIJȘȢșİȡȝȠțȡĮıȓĮȢIJȦȞȚȤȞȘșİIJȫȞțĮIJȐIJȘįȠțȚȝȒıİ
ıȪıIJȘȝĮĮʌİȚțȩȞȚıȘȢȝĮȖȞȘIJȚțȠȪıȣȞIJȠȞȚıȝȠȪ05,ȝİȑȞIJĮıȘ
ʌİįȓȠȣȉ
ǼȆǿȆȁȅȀǼȈ
ȅȚįȣȞȘIJȚțȑȢİʌȚʌȜȠțȑȢʌȤȜȠȓȝȦȟȘȠȚȠʌȠȓİȢİȞįȑȤİIJĮȚȞĮ
ıȤİIJȓȗȠȞIJĮȚȝİIJȘȤȡȒıȘIJȠȣȚȤȞȘșȑIJȘSENOMARK ULTRACORTM MRI
țĮȚIJȠȣțȚIJİȚıĮȖȦȖȑĮULTRACOR®05,İȓȞĮȚʌĮȡȩȝȠȚİȢȝİĮȣIJȑȢʌȠȣ
ıȤİIJȓȗȠȞIJĮȚȝİIJȘȤȡȒıȘȐȜȜȦȞıȣıțİȣȫȞȚȤȞȘșȑIJȘıȘȢȚıIJȠȪ
ȉȇȅȆȅȈǻǿǹĬǼȈǾȈ
ȅȚȤȞȘșȑIJȘȢSENOMARK ULTRACORTM05,țĮȚIJȠțȚIJİȚıĮȖȦȖȑĮ
ULTRACOR®05,ʌĮȡȑȤȠȞIJĮȚıIJİȓȡĮțĮȚʌȡȠȠȡȓȗȠȞIJĮȚȖȚĮȝȓĮȝȩȞȠȤȡȒıȘ
ȅǻǾīǿǼȈȋȇǾȈǾȈǹȞĮIJȡȑȟIJİıIJȘȞİȚțȩȞĮ
ȀȚIJİȚıĮȖȦȖȑĮULTRACOR® MRI
ǼʌȚșİȦȡȒıIJİIJȘıȣıțİȣĮıȓĮȫıIJİȞĮįȚĮıijĮȜȓıİIJİȩIJȚįİȞȑȤİȚ
ʌĮȡĮȕȚĮıIJİȓȘĮțİȡĮȚȩIJȘIJȐIJȘȢȉȠʌȡȠȧȩȞİȓȞĮȚıIJİȓȡȠİțIJȩȢİȐȞ
ȑȤİȚıʌȐıİȚȘıijȡȐȖȚıȘ
ȋȡȘıȚȝȠʌȠȚȫȞIJĮȢIJȣʌȚțȒȐıȘʌIJȘIJİȤȞȚțȒĮȞȠȓȟIJİIJȘıȣıțİȣĮıȓĮ
țĮȚĮijĮȚȡȑıIJİIJȠIJȡȠțȐȡĮʌȩIJȚIJȐȞȚȠțĮȚIJȠșȘțȐȡȚ1IJȠȝʌȜȠț
ȠįȘȖȠȪȕİȜȩȞĮȢǿțĮȚIJȠİʌȚʌȦȝĮIJȚțȩǿī
ǹȞĮȖȞȦȡȓıIJİIJȘıIJȠȤİȣȩȝİȞȘĮȜȜȠȓȦıȘȒıȘȝİȓȠıIJȠȞȝĮıIJȩ
ȋȡȘıȚȝȠʌȠȚȒıIJİIJȠȝʌȜȠțȠįȘȖȠȪȕİȜȩȞĮȢȝİIJȠʌȜȑȖȝĮIJȦȞ
ıȣıțİȣȫȞȂ5,ȀȐȞIJİȝȚĮIJȠȝȒįȚĮȞȣȖȝȠȪıIJȠįȑȡȝĮ
ǹijĮȚȡȑıIJİIJȠʌȡȠıIJĮIJİȣIJȚțȩȐțȡȠȣǿǹțĮȚĮijĮȚȡȑıIJİIJȠȞ
ʌȡȠıĮȡȝȠȖȑĮĬĮʌȩIJȘįȚȐIJĮȟȘIJȡȠțȐȡțĮȚșȘțĮȡȚȠȪțĮȚ
IJȠʌȠșİIJȒıIJİIJȠĮȞĮıȤİIJȚțȩǿǺıIJȠșȘțȐȡȚȋȡȘıȚȝȠʌȠȚȫȞIJĮȢ
IJĮıȘȝȐįȚĮȕȐșȠȣȢĮȞȐFPİȚıȐȖİIJİIJȘįȚȐIJĮȟȘIJȡȠțȐȡțĮȚ
șȘțĮȡȚȠȪıIJȠȞȝĮıIJȩțĮIJİȣșȪȞȠȞIJĮȢIJȠȐțȡȠIJȠȣIJȡȠțȐȡıIJȠ
ıIJȠȤİȣȩȝİȞȠıȘȝİȓȠȉȠIJȡȠțȐȡȝʌȠȡİȓȞĮĮȞIJȚțĮIJĮıIJĮșİȓȝİIJȠ
İʌȚʌȦȝĮIJȚțȩȖȚĮĮʌİȚțȩȞȚıȘ
ǼțIJİȜȑıIJİİʌĮȞĮȜȘʌIJȚțȒĮʌİȚțȩȞȚıȘIJȠȣȝĮıIJȠȪȖȚĮIJȘȞ
İʌȚȕİȕĮȓȦıȘIJȘȢIJȠʌȠșȑIJȘıȘȢIJȠȣȐțȡȠȣIJȠȣIJȡȠțȐȡıIJȠ
ıIJȠȤİȣȩȝİȞȠıȘȝİȓȠǼȐȞİȓȞĮȚĮʌĮȡĮȓIJȘIJȠIJȡȠʌȠʌȠȚȒıIJİIJȘșȑıȘ
ȉȠʌȠșȑIJȘıȘIJȠȣİijĮȡȝȠȖȑĮSENOMARK ULTRACORTM MRI
ȤȡȘıȚȝȠʌȠȚȫȞIJĮȢIJȠțȚIJİȚıĮȖȦȖȑĮULTRACOR® MRI
ȈIJĮșİȡȠʌȠȚȒıIJİIJȠșȘțȐȡȚİȞȫĮijĮȚȡİȓIJİIJȠIJȡȠțȐȡİʌȚʌȦȝĮIJȚțȩ
țĮȚİȚıȐȖİIJİIJȠȞİijĮȡȝȠȖȑĮǺıIJȠșȘțȐȡȚȋȡȘıȚȝȠʌȠȚȒıIJİ
IJȠȣȢįİȓțIJİȢȕȐșȠȣȢțĮȚIJȠȜȠȖȩIJȣʌȠULTRACOR®05,ȈȉȖȚĮȞĮ
İʌȚȕİȕĮȚȫıİIJİIJȠȕȐșȠȢțĮȚȞĮʌȡȠıĮȞĮIJȠȜȓıİIJİIJȘȜȠȟȩIJȝȘıȘ
IJȘȢȕİȜȩȞĮȢ
ȉȠʌȠșȑIJȘıȘIJȠȣİijĮȡȝȠȖȑĮSENOMARK ULTRACORTM MRI
ȤȡȘıȚȝȠʌȠȚȫȞIJĮȢIJȠțȚIJİȚıĮȖȦȖȑĮENCOR® MRI
ȈȘȝİȓȦıȘĮȞĮIJȡȑȟIJİıIJȚȢȠįȘȖȓİȢȤȡȒıȘȢțĮȚıIJȘȞʌİȡȚȖȡĮijȒIJȦȞ
İȟĮȡIJȘȝȐIJȦȞIJȠȣțȚIJİȚıĮȖȦȖȑĮENCOR®05,(&05,17/2&
ǹijĮȚȡȑıIJİIJȠİʌȚʌȦȝĮIJȚțȩțĮșİIJȒȡĮĮʌȩIJȘȞțȐȞȠȣȜĮ
ȉȠʌȠșİIJȒıIJİIJȠȞʌȡȠıĮȡȝȠȖȑĮıIJȘȕİȜȩȞĮIJȠȣİijĮȡȝȠȖȑĮ
ȩʌȦȢijĮȓȞİIJĮȚıIJȘȞʌĮȡĮțȐIJȦİȚțȩȞĮȆȚȑıIJİIJȠȞıijȚțIJȐıIJȘ
ȜĮȕȒIJȠȣİijĮȡȝȠȖȑĮ
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SENOMARK ULTRACORTM MRI 14 號組織標記和導引器套組
供應方式
SENOMARK ULTRACORTM MRI 和 ULTRACOR® MRI 導引器套組屬於無
菌產品，僅供一次性使用。
繁體中文
使用說明 (請參閱圖 1)
ULTRACOR® MRI 導引器套組
1. 請檢查包裝確保其完好無損。產品開封前為無菌。
SMUCMRI14GT (鈦標記)
使用標準無菌技術打開包裝，取出鈦套管和導引鞘 (N)、
SMUCMRI14GSS (不銹鋼標記)
針導檔塊 (J) 以及填塞器 (M)。
UCMRINTLOC (導引器套組 – 另外包裝)
在乳房找到目標病灶或部位。
14 號組織標記和導引器套組
4. 使用針導檔塊搭配 MRI 裝置分格。 劃開皮膚。
說明
取下尖端保護套 (K) 並從套管和導引鞘組件取出接頭 (I)，然後將
SenoRx Inc. SENOMARK ULTRACORTM MRI 組織標記有拋棄式 14 號斜
止檔 (L) 放在導引鞘。使用FP深度標記，將套管和導引鞘組
面針頭塗藥器，其中包含：
件插入乳房，同時將套管尖端朝向目標部位。若要造影，可以用
填塞器取代套管。
‡ 片可吸收聚乙醇酸3*$墊，中墊內嵌鋼絲型件；
重新進行乳房造影，確認套管尖端放置於目標部位。視需要
‡ 遠端有聚乙二醇3(*栓。
修改位置。
鋼絲型件用於長期的組織部位放射性標記。過了週左右用超音波仍
使用 ULTRACOR® MRI 導引器套組放置 SENOMARK ULTRACORTM MRI
看得見墊子，不過在週左右則已大致吸收。
塗藥器
塗藥器採用斜面FP 14G 針，搭配FP深度標記和鎖定柱
1. 取出套管 填塞器以及將塗藥器%插入導引鞘時，穩住
塞。墊子是從斜面針頭置植入組織部位。
導引鞘。使用深度標記和 ULTRACOR® MRI 標誌)，確認深
ULTRACOR® MRI 導引器套組包含：
度及調整針頭斜面的方向。
‡ 含塑膠導引鞘的鈦套管；
使用 ENCOR® MRI 導引器套組放置 SENOMARK ULTRACORTM MRI 塗藥器
‡ 塑膠填塞器；
註： 請參閱 ENCOR® MRI 導引器套組(&05,17/2&使用說明和部
‡ 針導檔塊。
件說明。
1
鈦套管和塑膠導引鞘用於進入組織部位。針導檔塊與 Invivo 分格定
1. 從套管取出填塞器 探針。
位系統相容。
將接頭放在塗藥器的針，如下圖所示。將它緊緊靠著塗藥器手柄。
預定用途
第二緣
第一緣
TM
在乳房切片程序前或過程中，SENOMARK ULTRACOR MRI 可以
;光和超音波的方式標記乳房組織。
使用說明
使用禁忌
這項裝置不適用於指示以外的用途。
警告
‡
‡
已知對裝置說明列出物質過敏的病患，可能對此植體有過
敏反應。
SENOMARK ULTRACORTM MRI 不建議用於有乳房植體的病患。
‡
出現感染時，請勿使用。
注意事項
• 保存在ž&以下的溫度。
• 只有受過經皮乳房切片程序訓練的醫師，才能使用這些裝置。
• 如果無菌屏障已開封或如果包裝已破損，請勿使用這些產品。
• 這些屬於無菌產品，僅供一次性使用。請勿重複消毒。
• 如果針彎曲且 或針頭受損，請勿使用。
• 取下套管 填塞器時，確認導引鞘並未移位。
• 在導引鞘內放置塗藥器時，確認導引鞘並未移位。
• 確定所有墊子都已投藥。
• 針對大小相當之/不銹鋼切片標記所發表的研究顯示，
在7磁場強度的 MRI 系統測試時，標記完全沒有位移，
而且標記溫度僅微幅上升。
併發症
使用 SENOMARK ULTRACORTM MRI 和 ULTRACOR® MRI 導引器套組的
相關潛在併發症 (例如感染)，與使用其他組織標記裝置的相似。
針
接頭
將塗藥器插入套管，直到前面部分進入套管密封，並且在第一
緣停住。
套管
接頭
塗藥器
4. 以順時針方向旋轉ƒ，解除鎖定柱塞。
推進柱塞，直到接觸塗藥器身管為止來植入標記。
同時取出塗藥器和套管，然後將無菌紗布放在針導檔塊下方，
在造影時暫時保持壓力。
重新進行乳房造影，確認鋼絲型件放置於目標部位。
8. 根據標準醫療準則所述，繼續施壓。
從 SENOMARK ULTRACORTM MRI 塗藥器植入彈丸劑
請注意，ULTRACOR® MRI 標誌)必須對齊針頭斜面。
1. 以順時針方向旋轉柱塞$度，直到鎖的符號垂直對齊 (H)
標誌，即可鬆開柱塞安全鎖 (G)。
推進柱塞，直到接觸塗藥器身管為止，同時讓塗藥器保持穩定，
即可馬上植入塗藥器的所有裝物。從導引鞘取出塗藥器，換上套
管或填塞器。
重新進行乳房造影，確認鋼絲型件放置於目標部位。
4. 取出導引鞘和套管 填塞器，同時繼續對針道施壓，盡量減
少出血。繼續施壓，直到出血停止為止。
妥善棄置塗藥器、導引鞘、填塞器、針導檔塊和套管。
圖 1.
SENOMARK ULTRACORTM MRI 組織標記和導引器套組
SENOMARK ULTRACORTM MRI 塗藥器
解除鎖定 (H)
已鎖定 (G)
柱塞 (A)
塗藥器%)
針 (C)
ULTRACOR® MRI 標誌)
接頭 (I)
尖端保護套(
標記墊'
ULTRACOr® MRI 導引器套組
鈦套管和塑膠導引鞘 (N)
止檔 (L)
尖端保護套 (K)
針導檔塊 (J)
填塞器 (M)
組裝地：泰國。
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ฏन௻
SENOMARK ULTRACOR™ MRI 14 ֜୴௼!஼௽!࡮೟!࣭!ୗ‫!ׄݓ‬മඊ SENOMARK ULTRACOR™ MRI 및 ULTRACOR® MRI 유도관 키트의
사용과 관련한 잠재적인 합병증(예: 감염)은 다른 일반적인 조직 표시
장치 사용 시 나타날 수 있는 합병증과 유사합니다.
한국어
হଵ!௼ೇ
SMUCMRI14GT(티타늄 마커)
SMUCMRI14GSS(스테인리스 스틸 마커)
UCMRINTLOC(유도관 키트 – 별매)
14 게이지 조직 마커 및 유도관 키트
‫׀‬؄!ࣼओ
SENOMARK ULTRACOR™ MRI 및 ULTRACOR® MRI 유도관 키트는 멸균
상태로 제공되며 일회용으로만 사용해야 합니다.
হଵ!௼ೇ)‫!ࡪ׽‬2!ౠ஼*
ULTRACOR® MRI ୗ‫!ׄݓ‬മඊ
1. 포장이 손상되지 않았는지 잘 검사합니다. 봉인된 부분이 그대로
ৣࢥ
유지되면 제품은 멸균 상태입니다.
SenoRx Inc. SENOMARK ULTRACOR™ MRI 조직 마커는 다음을
표준 무균 기법을 사용하여 포장을 열고 티타늄 투관침과
포함하는 일회용 14 게이지 사면 바늘로 구성되어 있습니다.
시스(N), 바늘 가이드 블록(J), 밀폐 장치(M)를 꺼냅니다.
‡
분해성 3*$(폴리 글리코 산) 패드개(중앙 패드에 와이어
유방에서 대상 병변 또는 부위를 찾습니다.
폼 내장)
4. 바늘 가이드 블록을 MRI 장치 그리드와 함께 사용합니다. 피부를
‡
말단부에 있는 3(*(폴리에틸렌 글리콜) 플러그
절개합니다.
와이어 폼은 조직 부위에 장시간 지속되는 방사선 표시를 하기 위한
팁 보호 장치(K)와 어댑터(I)를 투관침 및 시스 조립품에서
것입니다. 패드는 약주 동안 초음파를 통해 볼 수 있으며 약주
분리하고 시스에서 조정 장치(L)의 위치를 잡습니다. FP
이내에 다시 흡수됩니다.
단위의 깊이 눈금을 확인하고 투관침 팁이 대상 부위를 향하도록
애플리케이터에는 FP 단위의 깊이 눈금과 잠금 플런저 및 사면이
하면서 투관침 및 시스 조립품을 유방에 삽입합니다. 영상
있는FP/14G 바늘이 사용됩니다. 패드는 사면 바늘 끝에서 조직
촬영용으로 사용할 경우 투관침을 밀폐 장치로 교체할 수
부위로 전개됩니다.
있습니다.
®
ULTRACOR MRI 유도관 키트 구성품:
유방 영상을 다시 보면서 투관침 팁이 대상 부위에 정확하게
‡
플라스틱 시스가 있는 티타늄 투관침
위치했는지 확인합니다. 필요한 경우 위치를 조정합니다.
‡
플라스틱 밀폐 장치
ULTRACOR® MRI ୗ‫!ׄݓ‬മඊ࡞!হଵซ!SENOMARK ULTRACOR™
MRIૂ෽ࡦ೩୴ോ!ࣾು
‡
바늘 가이드 블록
1. 시스를 잘 고정한 상태에서 투관침/밀폐 장치를 분리하고
티타늄 투관침과 플라스틱 시스는 조직 부위에 접근하는 데
애플리케이터(%)를 시스에 삽입합니다. 깊이 눈금과
사용됩니다. 바늘 가이드 블록은 Invivo1 그리드 위치 추정 시스템에
ULTRACOR® MRI 로고())를 이용하여 깊이를 확인하고 바늘
사용할 수 있습니다.
사면의 방향을 잡습니다.
ଵ‫ݓ‬
NCOR® MRI!ୗ‫!ׄݓ‬മඊ࡞!হଵซ!SENOMARK ULTRACOR™ MRI
E
SENOMARK ULTRACOR™ MRI 는 경피 유방 생검 시술 전 또는 시술
ૂ෽ࡦ೩୴ോ!ࣾು
중에 유방 조직에 방사선 및 초음파 유도 방식으로 표시하는 데
ౠֵ; 구성품에 대한 설명과 사용 방법은 ENCOR® MRI 유도관 키트
사용됩니다.
(&05,17/2& 지침을 참조하십시오.
‫؃‬؈!হฑ
1. 캐뉼라에서 밀폐 장치/탐침을 분리합니다.
이 장치는 지시한 방식 이외의 방식으로 사용하면 안 됩니다.
아래 그림과 같이 어댑터를 애플리케이터의 바늘에 끼웁니다.
애플리케이터의 핸들 쪽에 단단히 끼워야 합니다.
ֵ֮
두 번째 에지
첫 번째 에지
‡ ஍ು!ৣࢥ૫!ਦࠩ‫!ݦ‬ஏ࠻૫!ׂࣤ৪ୣ!ब୴‫!܂ஂ็!܂‬
୴!ূ୼ࣆ૫!ષࠉ௼!ࣳ୨ୣ!֮ยฌ!ਦ‫୾!ݓ‬੎܏‫ܙ‬/
‡ SENOMARK ULTRACOR™ MRI‫!׀୶!܂‬ୗࣼ!ূ୼ࣆୣ!ੑਪซ!
็ஂ૫֜‫!܂‬হଵฉࢡ!઴!‫ܙ܏ݩ‬/
바늘
어댑터
‡ հૺ!ू୏૫‫!܂‬হଵฉࢡ!઴!‫ܙ܏ݩ‬/
앞부분이 캐뉼라의 봉인 부분에 들어갈 때까지 애플리케이터를
캐뉼라에 삽입하고 첫 번째 에지 위치에서 멈춥니다.
௜୯!হฑ
캐뉼라
어댑터
애플리케이터
‡
ž& 이하 온도에 보관하십시오.
‡
경피 유방 생검 시술을 훈련 받은 의사만이 이 장치를 사용해야
합니다.
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이전에 멸균 장벽이 개봉되었거나 포장이 손상된 경우에는 제품을 4. 플런저를 시계 방향으로° 돌려 풉니다.
사용하지 마십시오.
애플리케이터의 배럴에 닿을 때까지 플런저를 밀어 마커를
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이 제품은 멸균 상태로 제공되며 일회용으로만 사용해야 합니다.
배치합니다.
재멸균 처리하지 마십시오.
애플리케이터와 캐뉼라를 동시에 분리한 후 무균 거즈를 가이드
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바늘이 구부러지거나 팁이 손상된 경우 사용하지 마십시오.
블록 아래에 대고 영상을 촬영하는 동안 누릅니다.
‡
투관침/밀폐 장치를 분리할 때 시스가 움직이지 않도록
유방 영상을 다시 보면서 와이어 폼이 대상 부위에 정확하게
주의하십시오.
위치했는지 확인합니다.
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애플리케이터를 시스에 넣을 때 시스가 움직이지 않도록
8. 표준 의료 지침에 따라 절개부를 누릅니다.
주의하십시오.
SENOMARK ULTRACOR™ MRI ૂ෽ࡦ೩୴ോ૫ঢ়!ස࡬!தջ
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모든 패드를 잘 배치하십시오.
ULTRACOR® MRI 로고)G*를 바늘 사면과 맞추어야 합니다.
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/ 크기의 스테인리스 스틸 생검 마커를 7 자장 강도의
1. 잠금 기호가 로고와 세로로 맞춰질 때까지(H) 플런저(A)를 시계
MRI 시스템에서 테스트할 경우 마커가 움직이지 않으며 약간
방향으로도 돌려 플런저 안전 잠금 장치(G)를 풉니다.
발열된 것으로 나타났습니다.
애플리케이터의 배럴에 닿을 때까지 플런저를 밀어
애플리케이터의 모든 내용물을 배치합니다. 이때 애플리케이터가
움직이지 않도록 잘 고정합니다. 시스에서 애플리케이터를
분리하고 투관침 또는 밀폐 장치로 교체합니다.
4.
유방 영상을 다시 보면서 와이어 폼이 대상 부위에 정확하게
위치했는지 확인합니다.
출혈이 최소화되도록 바늘을 삽입한 부위를 누르면서 시스와
투관침/밀폐 장치를 분리합니다. 출혈이 멈출 때까지 계속
누릅니다.
애플리케이터, 시스, 밀폐 장치, 바늘 가이드 블록, 투관침을
적절하게 폐기합니다.
‫!ࡪ׽‬1.
SENOMARK ULTRACOR™ MRI ஼௽!࡮೟!࣭!ୗ‫!ׄݓ‬മඊ
SENOMARK ULTRACOR™ MRI!ૂ෽ࡦ೩୴ോ
잠금 해제 상태(H)
잠긴 상태(G)
플런저(A)
애플리케이터%
ULTRACOR® MRI 로고)
바늘(C)
어댑터(I)
팁 보호 장치(()
마커 패드'
ULTRACOR MRIୗ‫!ׄݓ‬മඊ
®
티타늄 투관침
및 플라스틱 시스(N)
조정 장치(L)
팁 보호 장치(K)
바늘 가이드 블
록(J)
밀폐 장치(M)
태국에서 조립.
‹E\&5%DUG,QF 판권 소유.
1,QYLYR&RUSRUDWLRQ:DXNHVKD:,1
워키쇼
Invivo Corporation, 위스콘신주
SM UC MRI
TM
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ȻɢɨɥɨɝɢɱɟɫɤɢɣɦɚɪɤɟɪɤɚɥɢɛɪɚSENOMARK ULTRACORTM MRI
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ɢɤɨɦɩɥɟɤɬɢɧɬɪɨɞɶɸɫɟɪɚ
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ɊɍɋɋɄɂɃ
ɂɇɋɌɊɍɄɐɂɂɉɈɉɊɂɆȿɇȿɇɂɘ
608&05,*7ɬɢɬɚɧɨɜɵɣɦɚɪɤɟɪ
608&05,*66ɦɚɪɤɟɪɢɡɧɟɪɠɚɜɟɸɳɟɣɫɬɚɥɢ
8
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ɭɩɚɤɨɜɚɧɨɬɞɟɥɶɧɨ
Ȼ
ɢɨɥɨɝɢɱɟɫɤɢɣɦɚɪɤɟɪɤɚɥɢɛɪɚɢɤɨɦɩɥɟɤɬ
ɢɧɬɪɨɞɶɸɫɟɪɚ
ɉɪɢɭɫɬɚɧɨɜɤɟɚɩɩɥɢɤɚɬɨɪɚɜɧɭɬɪɢɨɛɨɥɨɱɤɢɬɚɤɠɟɭɛɟɞɢɬɟɫɶ
ɱɬɨɨɛɨɥɨɱɤɚɧɟɫɞɜɢɧɭɥɚɫɶ
ɍɛɟɞɢɬɟɫɶɱɬɨɜɜɟɞɟɧɵɜɫɟɤɚɩɫɭɥɵ
Ɉɩɭɛɥɢɤɨɜɚɧɧɵɟɢɫɫɥɟɞɨɜɚɧɢɹɫɨɪɚɡɦɟɪɧɵɯɦɚɪɤɟɪɨɜ
ɦɟɫɬɚɛɢɨɩɫɢɢɢɡɧɟɪɠɚɜɟɸɳɟɣɫɬɚɥɢɦɚɪɤɢ/
ɭɤɚɡɵɜɚɸɬɧɚɨɬɫɭɬɫɬɜɢɟɞɜɢɠɟɧɢɹɦɚɪɤɟɪɚɢɟɝɨ
ɧɟɡɧɚɱɢɬɟɥɶɧɨɟɧɚɝɪɟɜɚɧɢɟɩɪɢɬɟɫɬɢɪɨɜɚɧɢɢ
ɜɫɢɫɬɟɦɟɆɊɌɫɧɚɩɪɹɠɟɧɧɨɫɬɶɸɩɨɥɹ7
ɈɋɅɈɀɇȿɇɂə
ȼɨɡɦɨɠɧɵɟɨɫɥɨɠɧɟɧɢɹɧɚɩɪɢɦɟɪɢɧɮɟɤɰɢɹɫɜɹɡɚɧɧɵɟ
ɫɢɫɩɨɥɶɡɨɜɚɧɢɟɦSENOMARK ULTRACORTM05,ɢɤɨɦɩɥɟɤɬɚ
ɢɧɬɪɨɞɶɸɫɟɪɚULTRACOR®05,ɬɟɠɟɱɬɨɢɩɪɢɢɫɩɨɥɶɡɨɜɚɧɢɢ
ɞɪɭɝɢɯɭɫɬɪɨɣɫɬɜɛɢɨɦɚɪɤɢɪɨɜɤɢ
ɈɉɂɋȺɇɂȿ
Ȼɢɨɥɨɝɢɱɟɫɤɢɣɦɚɪɤɟɪ6HQR5[,QFSENOMARK ULTRACORTM05,
ɜɤɥɸɱɚɸɳɢɣɨɞɧɨɪɚɡɨɜɵɣɚɩɩɥɢɤɚɬɨɪɫɢɝɥɨɣɫɨɫɤɨɲɟɧɧɵɦ
ɤɪɚɟɦɤɚɥɢɛɪɚɫɨɞɟɪɠɢɬ
‡ ɪɚɫɫɚɫɵɜɚɟɦɵɟɤɚɩɫɭɥɵɢɡɩɨɥɢɝɥɢɤɨɥɢɟɜɨɣɤɢɫɥɨɬɵɉȽɄ
ɫɡɚɤɥɸɱɟɧɧɨɣɜɫɪɟɞɧɟɣɤɚɩɫɭɥɟɩɪɨɜɨɥɨɱɧɨɣɮɨɪɦɨɣ
‡ ɜɫɬɚɜɤɭɢɡɩɨɥɢɷɬɢɥɟɧɝɥɢɤɨɥɹɉɗȽɜɞɢɫɬɚɥɶɧɨɦɩɨɥɨɠɟɧɢɢ
ɉɪɨɜɨɥɨɱɧɚɹɮɨɪɦɚɩɪɟɞɧɚɡɧɚɱɟɧɚɞɥɹɞɨɥɝɨɫɪɨɱɧɨɣɜɢɞɢɦɨɣ
ɩɪɢɪɟɧɬɝɟɧɨɝɪɚɮɢɢɦɚɪɤɢɪɨɜɤɢɦɟɫɬɚɛɢɨɩɫɢɢɄɚɩɫɭɥɵɜɢɞɢɦɵ
ɩɪɢɭɥɶɬɪɚɡɜɭɤɨɜɨɦɢɫɫɥɟɞɨɜɚɧɢɢɜɬɟɱɟɧɢɟɩɪɢɛɥɧɟɞɟɥɶ
ɢɪɚɫɫɚɫɵɜɚɸɬɫɹɤɚɤɩɪɚɜɢɥɨɜɬɟɱɟɧɢɟɩɪɢɛɥɧɟɞɟɥɶ
Ⱥɩɩɥɢɤɚɬɨɪɢɦɟɟɬɢɝɥɭɫɨɫɤɨɲɟɧɧɵɦɤɪɚɟɦɞɥɢɧɨɣɫɦ*
ɫɫɦɞɟɥɟɧɢɹɦɢɢɛɥɨɤɢɪɭɟɦɵɦɩɨɪɲɧɟɦɋɨɫɤɨɲɟɧɧɨɝɨ
ɧɚɤɨɧɟɱɧɢɤɚɢɝɥɵɤɚɩɫɭɥɵɜɜɨɞɹɬɫɹɜɦɟɫɬɨɛɢɨɩɫɢɢ
ɄɨɦɩɥɟɤɬɢɧɬɪɨɞɶɸɫɟɪɚULTRACOR®05,ɜɤɥɸɱɚɟɬ
‡ ɬɢɬɚɧɨɜɵɣɬɪɨɚɤɚɪɫɩɥɚɫɬɢɤɨɜɨɣɨɛɨɥɨɱɤɨɣ
‡ ɩɥɚɫɬɢɤɨɜɵɣɨɛɬɭɪɚɬɨɪ
‡ ɛɥɨɤɧɚɩɪɚɜɥɹɸɳɟɣɞɥɹɢɝɥ
Ɍɢɬɚɧɨɜɵɣɬɪɨɚɤɚɪɫɩɥɚɫɬɢɤɨɜɨɣɨɛɨɥɨɱɤɨɣɢɫɩɨɥɶɡɭɟɬɫɹɞɥɹ
ɩɪɨɧɢɤɧɨɜɟɧɢɹɤɦɟɫɬɭɛɢɨɩɫɢɢȻɥɨɤɧɚɩɪɚɜɥɹɸɳɟɣɞɥɹɢɝɥ
ɫɨɜɦɟɫɬɢɦɫɫɟɬɤɨɣɫɢɫɬɟɦɵɥɨɤɚɥɢɡɚɰɢɢ,QYLYR1.
ɎɈɊɆȺɉɈɋɌȺȼɄɂ
SENOMARK ULTRACORTM05,ɢɤɨɦɩɥɟɤɬɢɧɬɪɨɞɶɸɫɟɪɚ
ULTRACOR®05,ɩɨɫɬɚɜɥɹɸɬɫɹɫɬɟɪɢɥɶɧɵɦɢɢɩɪɟɞɧɚɡɧɚɱɟɧɵ
ɬɨɥɶɤɨɞɥɹɨɞɧɨɪɚɡɨɜɨɝɨɢɫɩɨɥɶɡɨɜɚɧɢɹ
ɍɄȺɁȺɇɂəɉɈɉɊɂɆȿɇȿɇɂɘɫɦɪɢɫ
ɄɈɆɉɅȿɄɌɂɇɌɊɈȾɖɘɋȿɊȺ8/75$&25® MRI
ɉɪɨɜɟɪɶɬɟɭɩɚɤɨɜɤɭɭɛɟɞɢɜɲɢɫɶɜɬɨɦɱɬɨɟɟɰɟɥɨɫɬɧɨɫɬɶ
ɧɟɧɚɪɭɲɟɧɚɂɡɞɟɥɢɟɫɬɟɪɢɥɶɧɨɟɫɥɢɝɚɪɚɧɬɢɣɧɚɹɩɟɱɚɬɶ
ɧɟɩɨɜɪɟɠɞɟɧɚ
ɉɪɢɦɟɧɹɹɫɬɚɧɞɚɪɬɧɭɸɚɫɟɩɬɢɱɟɫɤɭɸɦɟɬɨɞɢɤɭɨɬɤɪɨɣɬɟ
ɭɩɚɤɨɜɤɭɢɢɡɜɥɟɤɢɬɟɬɢɬɚɧɨɜɵɣɬɪɨɚɤɚɪɫɨɛɨɥɨɱɤɨɣ1
ɛɥɨɤɧɚɩɪɚɜɥɹɸɳɟɣɞɥɹɢɝɥ-ɢɨɛɬɭɪɚɬɨɪ0
Ɉɩɪɟɞɟɥɢɬɟɩɨɪɚɠɟɧɧɵɣɭɱɚɫɬɨɤɢɥɢɡɨɧɭɢɧɬɟɪɟɫɚ
ɜɦɨɥɨɱɧɨɣɠɟɥɟɡɟ
ɂɫɩɨɥɶɡɭɣɬɟɛɥɨɤɧɚɩɪɚɜɥɹɸɳɟɣɞɥɹɢɝɥɫɫɟɬɤɨɣɞɥɹ
ɭɫɬɪɨɣɫɬɜɆɊɌɉɪɨɢɡɜɟɞɢɬɟɤɨɠɧɵɣɧɚɞɪɟɡ
ɋɧɢɦɢɬɟɡɚɳɢɬɧɵɣɤɨɥɩɚɱɨɤɞɥɹɧɚɤɨɧɟɱɧɢɤɚ.
ɢɩɟɪɟɯɨɞɧɢɤ,ɫɛɥɨɤɚɬɪɨɚɤɚɪɚɫɨɛɨɥɨɱɤɨɣɢɭɫɬɚɧɨɜɢɬɟ
ɨɝɪɚɧɢɱɢɬɟɥɶ/ɜɧɭɠɧɨɟɩɨɥɨɠɟɧɢɟɧɚɨɛɨɥɨɱɤɟ
ɉɨɥɶɡɭɹɫɶɫɦɞɟɥɟɧɢɹɦɢɜɜɟɞɢɬɟɛɥɨɤɬɪɨɚɤɚɪɚ
ɫɨɛɨɥɨɱɤɨɣɜɦɨɥɨɱɧɭɸɠɟɥɟɡɭɧɚɩɪɚɜɥɹɹɧɚɤɨɧɟɱɧɢɤ
ɬɪɨɚɤɚɪɚɜɡɨɧɭɢɧɬɟɪɟɫɚȼɰɟɥɹɯɜɢɡɭɚɥɢɡɚɰɢɢɬɪɨɚɤɚɪ
ɉɊɂɆȿɇȿɇɂȿɉɈɇȺɁɇȺɑȿɇɂɘ
ɦɨɠɧɨɡɚɦɟɧɢɬɶɧɚɨɛɬɭɪɚɬɨɪ
SENOMARK ULTRACORTM05,ɩɪɟɞɧɚɡɧɚɱɟɧɞɥɹɜɢɞɢɦɨɣɩɪɢ
ɋɩɨɦɨɳɶɸɩɨɜɬɨɪɧɨɣɜɢɡɭɚɥɢɡɚɰɢɢɦɨɥɨɱɧɨɣɠɟɥɟɡɵ
ɪɟɧɬɝɟɧɨɝɪɚɮɢɢɢɍɁɂɦɚɪɤɢɪɨɜɤɢɭɱɚɫɬɤɚɬɤɚɧɢɦɨɥɨɱɧɨɣ
ɩɪɨɜɟɪɶɬɟɪɚɫɩɨɥɨɠɟɧɢɟɧɚɤɨɧɟɱɧɢɤɚɬɪɨɚɤɚɪɚɜɡɨɧɟ
ɠɟɥɟɡɵɞɨɢɥɢɜɨɜɪɟɦɹɩɪɨɜɟɞɟɧɢɹɛɢɨɩɫɢɢ
ɢɧɬɟɪɟɫɚɉɪɢɧɟɨɛɯɨɞɢɦɨɫɬɢɢɡɦɟɧɢɬɟɩɨɥɨɠɟɧɢɟ
ɊɚɡɦɟɳɟɧɢɟɚɩɩɥɢɤɚɬɨɪɚSENOMARK ULTRACORTM MRI
ɉɊɈɌɂȼɈɉɈɄȺɁȺɇɂə
ɫɩɨɦɨɳɶɸɤɨɦɩɥɟɤɬɚɢɧɬɪɨɞɶɸɫɟɪɚULTRACOR® MRI
ɍɫɬɪɨɣɫɬɜɨɧɟɩɪɟɞɧɚɡɧɚɱɟɧɨɞɥɹɢɫɩɨɥɶɡɨɜɚɧɢɹɜɰɟɥɹɯ
ɍɞɟɪɠɢɜɚɣɬɟɨɛɨɥɨɱɤɭɩɪɢɢɡɜɥɟɱɟɧɢɢɬɪɨɚɤɚɪɚɨɛɬɭɪɚɬɨɪɚ
ɩɨɦɢɦɨɭɤɚɡɚɧɧɵɯ
ɢɜɜɟɞɟɧɢɢɚɩɩɥɢɤɚɬɨɪɚ%ɜɨɛɨɥɨɱɤɭɉɨɥɶɡɭɹɫɶ
ɞɟɥɟɧɢɹɦɢɢɥɨɝɨɬɢɩɨɦULTRACOR®05,)ɭɛɟɞɢɬɟɫɶ
ɉɊȿȾɍɉɊȿɀȾȿɇɂə
ɱɬɨɧɭɠɧɚɹɝɥɭɛɢɧɚɞɨɫɬɢɝɧɭɬɚɢɡɚɞɚɣɬɟɧɚɩɪɚɜɥɟɧɢɟ
‡ ɍɩɚɰɢɟɧɬɨɜɫɩɨɞɬɜɟɪɠɞɟɧɧɨɣɚɥɥɟɪɝɢɟɣɧɚɦɚɬɟɪɢɚɥɵ
ɫɤɨɫɚɢɝɥɵ
ɩɟɪɟɱɢɫɥɟɧɧɵɟɜɨɩɢɫɚɧɢɢɭɫɬɪɨɣɫɬɜɚɦɨɠɟɬ
ɊɚɡɦɟɳɟɧɢɟɚɩɩɥɢɤɚɬɨɪɚSENOMARK ULTRACORTM MRI
ɜɨɡɧɢɤɧɭɬɶɚɥɥɟɪɝɢɱɟɫɤɚɹɪɟɚɤɰɢɹɧɚɷɬɨɬɢɦɩɥɚɧɬɚɬ.
ɫɩɨɦɨɳɶɸɤɨɦɩɥɟɤɬɚɢɧɬɪɨɞɶɸɫɟɪɚENCOR® MRI
‡ SENOMARK ULTRACORTM05,ɧɟɪɟɤɨɦɟɧɞɭɟɬɫɹɞɥɹ
ɢɫɩɨɥɶɡɨɜɚɧɢɹɭɩɚɰɢɟɧɬɨɜɫɝɪɭɞɧɵɦɢɢɦɩɥɚɧɬɚɬɚɦɢ ɉɪɢɦɟɱɚɧɢɟ ɋɦɢɧɫɬɪɭɤɰɢɢɩɨɩɪɢɦɟɧɟɧɢɸɢɨɩɢɫɚɧɢɟ
®
‡ Ɂɚɩɪɟɳɚɟɬɫɹɢɫɩɨɥɶɡɨɜɚɬɶɜɭɫɥɨɜɢɹɯɧɚɥɢɱɢɹɢɧɮɟɤɰɢɢ ɤɨɦɩɨɧɟɧɬɨɜɤɨɦɩɥɟɤɬɚɢɧɬɪɨɞɶɸɫɟɪɚ (NCOR MRI
(&05,17/2&
ɆȿɊɕɉɊȿȾɈɋɌɈɊɈɀɇɈɋɌɂ
ɂɡɜɥɟɤɢɬɟɨɛɬɭɪɚɬɨɪɡɨɧɞɢɡɤɚɧɸɥɢ
‡ ɋɥɟɞɭɟɬɯɪɚɧɢɬɶɩɪɢɬɟɦɩɟɪɚɬɭɪɟɧɢɠɟž&
ɍɫɬɚɧɨɜɢɬɟɩɟɪɟɯɨɞɧɢɤɧɚɢɝɥɭɚɩɩɥɢɤɚɬɨɪɚɤɚɤɩɨɤɚɡɚɧɨɧɚ
ɪɢɫɭɧɤɟɧɢɠɟɍɫɬɚɧɨɜɢɬɟɟɝɨɜɩɥɨɬɧɭɸɤɪɭɱɤɟɚɩɩɥɢɤɚɬɨɪɚ
‡ Ⱦɚɧɧɵɟɭɫɬɪɨɣɫɬɜɚɞɨɥɠɧɵɢɫɩɨɥɶɡɨɜɚɬɶɫɹɬɨɥɶɤɨɜɪɚɱɚɦɢ
ȼɌɈɊɈɃȼɕɋɌɍɉ
ɨɛɭɱɟɧɧɵɦɢɩɪɨɜɟɞɟɧɢɸɱɪɟɫɤɨɠɧɨɣɛɢɨɩɫɢɢɦɨɥɨɱɧɨɣɠɟɥɟɡɵ
ɉȿɊȼɕɃȼɕɋɌɍɉ
‡ Ɂɚɩɪɟɳɚɟɬɫɹɩɪɢɦɟɧɹɬɶɢɡɞɟɥɢɹɟɫɥɢɫɬɟɪɢɥɶɧɵɣɛɚɪɶɟɪ
ɛɵɥɩɪɟɞɜɚɪɢɬɟɥɶɧɨɜɫɤɪɵɬɢɥɢɭɩɚɤɨɜɤɚɩɨɜɪɟɠɞɟɧɚ
‡ ɂɡɞɟɥɢɹɩɨɫɬɚɜɥɹɸɬɫɹɫɬɟɪɢɥɶɧɵɦɢɢɩɪɟɞɧɚɡɧɚɱɟɧɵ
ɉȿɊȿɏɈȾɇɂɄ
ɂȽɅȺ
ɬɨɥɶɤɨɞɥɹɨɞɧɨɪɚɡɨɜɨɝɨɢɫɩɨɥɶɡɨɜɚɧɢɹɉɈȼɌɈɊɇȺə
ɋɌȿɊɂɅɂɁȺɐɂəɁȺɉɊȿɓȿɇȺ
‡ Ɂɚɩɪɟɳɚɟɬɫɹɢɫɩɨɥɶɡɨɜɚɬɶɟɫɥɢɢɝɥɚɢɡɨɝɧɭɬɚɢɢɥɢ
ɧɚɤɨɧɟɱɧɢɤɩɨɜɪɟɠɞɟɧ
‡ ɉɪɢɢɡɜɥɟɱɟɧɢɢɬɪɨɚɤɚɪɚɨɛɬɭɪɚɬɨɪɚɭɛɟɞɢɬɟɫɶɱɬɨɨɛɨɥɨɱɤɚ
ɧɟɫɞɜɢɧɭɥɚɫɶ
ȼɫɬɚɜɥɹɣɬɟɚɩɩɥɢɤɚɬɨɪɜɤɚɧɸɥɸɩɨɤɚɟɝɨɩɟɪɟɞɧɹɹɱɚɫɬɶ
ɧɟɜɨɣɞɟɬɜɡɚɬɜɨɪɤɚɧɸɥɢɢɧɟɨɫɬɚɧɨɜɢɬɫɹɭɩɟɪɜɨɝɨ
ɜɵɫɬɭɩɚ
ɄȺɇɘɅə
ɉȿɊȿɏɈȾɇɂɄ
Ɋɢɫ
ȻɢɨɥɨɝɢɱɟɫɤɢɣɦɚɪɤɟɪSENOMARK ULTRACOR™ MRI
ɢɤɨɦɩɥɟɤɬɢɧɬɪɨɞɶɸɫɟɪɚ
ȺɉɉɅɂɄȺɌɈɊ
ȺɩɩɥɢɤɚɬɨɪSENOMARK ULTRACORTM MRI
Ɋɚɡɛɥɨɤɢɪɭɣɬɟɩɨɪɲɟɧɶɩɨɜɟɪɧɭɜɟɝɨɩɨɱɚɫɨɜɨɣ
ɫɬɪɟɥɤɟɧɚƒ
ȼɜɟɞɢɬɟɦɚɪɤɟɪɩɪɨɞɜɢɝɚɹɩɨɪɲɟɧɶɩɨɤɚɨɧɧɟɤɨɫɧɟɬɫɹ
ɤɨɪɩɭɫɚɚɩɩɥɢɤɚɬɨɪɚ
ɂɡɜɥɟɤɢɬɟɜɦɟɫɬɟɚɩɩɥɢɤɚɬɨɪɢɤɚɧɸɥɸɢɧɚɥɨɠɢɬɟ
ɫɬɟɪɢɥɶɧɭɸɦɚɪɥɟɜɭɸɫɚɥɮɟɬɤɭɩɨɞɛɥɨɤɨɦɧɚɩɪɚɜɥɹɸɳɟɣ
ɞɥɹɢɝɥɱɬɨɛɵɡɚɠɚɬɶɷɬɨɦɟɫɬɨɧɚɜɪɟɦɹɜɢɡɭɚɥɢɡɚɰɢɢ
ɋɩɨɦɨɳɶɸɩɨɜɬɨɪɧɨɣɜɢɡɭɚɥɢɡɚɰɢɢɦɨɥɨɱɧɨɣɠɟɥɟɡɵ
ɩɪɨɜɟɪɶɬɟɪɚɫɩɨɥɨɠɟɧɢɟɩɪɨɜɨɥɨɱɧɨɣɮɨɪɦɵɜɡɨɧɟɢɧɬɟɪɟɫɚ
Ɂɚɠɢɦɚɣɬɟɦɟɫɬɨɩɪɨɤɨɥɚɫɨɛɥɸɞɚɹɫɬɚɧɞɚɪɬɧɵɟ
ɦɟɞɢɰɢɧɫɤɢɟɪɟɤɨɦɟɧɞɚɰɢɢ
Ɋɚɡɛɥɨɤɢɪɨɜɚɧ+
Ȼɥɨɤɢɪɨɜɚɧ*
ɉɨɪɲɟɧɶ$
ȼɜɟɞɟɧɢɟɝɪɚɧɭɥɢɡɚɩɩɥɢɤɚɬɨɪɚSENOMARK ULTRACORTM MRI
ɉɨɦɧɢɬɟɱɬɨɥɨɝɨɬɢɩULTRACOR®05,)ɜɵɪɨɜɧɟɧɨɬɧɨɫɢɬɟɥɶɧɨ
ɫɤɨɫɚɢɝɥɵ
Ɋɚɡɛɥɨɤɢɪɭɣɬɟɩɪɟɞɨɯɪɚɧɢɬɟɥɶɧɵɣɮɢɤɫɚɬɨɪɩɨɪɲɧɹ*
ɩɨɜɟɪɧɭɜɩɨɪɲɟɧɶ$ɩɨɱɚɫɨɜɨɣɫɬɪɟɥɤɟɧɚƒɱɬɨɛɵ
ɫɢɦɜɨɥɡɚɦɤɚɨɤɚɡɚɥɫɹɧɚɨɞɧɨɣɥɢɧɢɢ+ɫɥɨɝɨɬɢɩɨɦ
ɇɟɡɚɦɟɞɥɢɬɟɥɶɧɨɜɜɟɞɢɬɟɜɫɟɫɨɞɟɪɠɢɦɨɟɚɩɩɥɢɤɚɬɨɪɚ
ɩɪɨɞɜɢɝɚɹɩɨɪɲɟɧɶɩɨɤɚɨɧɧɟɤɨɫɧɟɬɫɹɤɨɪɩɭɫɚɚɩɩɥɢɤɚɬɨɪɚ
ɩɪɢɷɬɨɦɭɞɟɪɠɢɜɚɹɚɩɩɥɢɤɚɬɨɪɂɡɜɥɟɤɢɬɟɚɩɩɥɢɤɚɬɨɪ
ɢɡɨɛɨɥɨɱɤɢɢɡɚɦɟɧɢɬɟɟɝɨɬɪɨɚɤɚɪɨɦɢɥɢɨɛɬɭɪɚɬɨɪɨɦ
ɋɩɨɦɨɳɶɸɩɨɜɬɨɪɧɨɣɜɢɡɭɚɥɢɡɚɰɢɢɦɨɥɨɱɧɨɣɠɟɥɟɡɵ
ɩɪɨɜɟɪɶɬɟɪɚɫɩɨɥɨɠɟɧɢɟɩɪɨɜɨɥɨɱɧɨɣɮɨɪɦɵɜɡɨɧɟɢɧɬɟɪɟɫɚ
ɂɡɜɥɟɤɢɬɟɨɛɨɥɨɱɤɭɢɬɪɨɚɤɚɪɨɛɬɭɪɚɬɨɪɡɚɠɢɦɚɹɦɟɫɬɨ
ɨɬɜɜɨɞɚɢɝɥɵɞɥɹɭɦɟɧɶɲɟɧɢɹɤɪɨɜɨɬɟɱɟɧɢɹɁɚɠɢɦɚɣɬɟ
ɷɬɨɦɟɫɬɨɞɨɨɫɬɚɧɨɜɤɢɤɪɨɜɨɬɟɱɟɧɢɹ
ɍɬɢɥɢɡɢɪɭɣɬɟɚɩɩɥɢɤɚɬɨɪɨɛɨɥɨɱɤɭɨɛɬɭɪɚɬɨɪɛɥɨɤ
ɧɚɩɪɚɜɥɹɸɳɟɣɞɥɹɢɝɥɢɬɪɨɚɤɚɪɧɚɞɥɟɠɚɳɢɦɨɛɪɚɡɨɦ
Ⱥɩɩɥɢɤɚɬɨɪ%
ɂɝɥɚ&
Ʌɨɝɨɬɢɩ
ULTRACOR®05,)
Ɂɚɳɢɬɧɵɣɤɨɥɩɚɱɨɤ
ɞɥɹɧɚɤɨɧɟɱɧɢɤɚ(
ɉɟɪɟɯɨɞɧɢɤ,
Ʉɚɩɫɭɥɵɦɚɪɤɟɪɚ'
ɄɨɦɩɥɟɤɬɢɧɬɪɨɞɶɸɫɟɪɚULTRACOr® MRI
Ɍɢɬɚɧɨɜɵɣɬɪɨɚɤɚɪ
ɫɩɥɚɫɬɢɤɨɜɨɣɨɛɨɥɨɱɤɨɣ1
Ɂɚɳɢɬɧɵɣɤɨɥɩɚɱɨɤɞɥɹ
ɧɚɤɨɧɟɱɧɢɤɚ.
Ɉɝɪɚɧɢɱɢɬɟɥɶ/
Ȼɥɨɤɧɚɩɪɚɜɥɹɸɳɟɣ
ɞɥɹɢɝɥ-
Ɉɛɬɭɪɚɬɨɪ0
ɋɨɛɪɚɧɨɜɌɚɢɥɚɧɞɟ
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KHQGLGXUDVHQWUHFRPSRQHQWHVVRQGLItFLOHVRLPSRVLEOHVGHOLPSLDUXQDYH]TXHORVOtTXLGRVFRUSRUDOHVRWHMLGRVFRQSRWHQFLDOGH
FRQWDPLQDFLyQSLUyJHQDRPLFURELDQDKDQHQWUDGRHQFRQWDFWRFRQHOGLVSRVLWLYRPpGLFRGXUDQWHXQSHULRGRGHWLHPSRLQGHWHUPLQDGR
(OPDWHULDOELROyJLFRUHVLGXDOSXHGHIRPHQWDUODFRQWDPLQDFLyQGHOGLVSRVLWLYRFRQSLUyJHQRVRPLFURRUJDQLVPRVTXHSXHGHQFDXVDU
complicaciones infecciosas.
1RUHHVWHULOL]DU'HVSXpVGHODUHHVWHULOL]DFLyQQRVHJDUDQWL]DODHVWHULOLGDGGHOSURGXFWRGHELGRDOQLYHOLQGHWHUPLQDGRGHSRVLEOHFRQWDPLQDFLyQ
PLFURELDQDRSLUyJHQDTXHSRGUtDFDXVDUFRPSOLFDFLRQHVLQIHFFLRVDV/DOLPSLH]DHOUHSURFHVDPLHQWR\RODUHHVWHULOL]DFLyQGHHVWH
GLVSRVLWLYRPpGLFRDXPHQWDQODSUREDELOLGDGGHIXQFLRQDPLHQWRLQFRUUHFWRGHOGLVSRVLWLYRGHELGRDSRVLEOHVHIHFWRVDGYHUVRVVREUHORV
FRPSRQHQWHVLQÀXHQFLDGRVSRUFDPELRVWpUPLFRV\RPHFiQLFRV
NEDERLANDS
'LWKXOSPLGGHOLVRQWZRUSHQYRRUJHEUXLNELMppQSDWLsQW+HUJHEUXLNYDQGLWPHGLVFKHKXOSPLGGHOEUHQJWKHWULVLFRPHW]LFKPHHYDQ
NUXLVFRQWDPLQDWLHWXVVHQSDWLsQWHQRPGDWPHGLVFKHKXOSPLGGHOHQ±PHWQDPHKXOSPLGGHOHQPHWODQJHVPDOOHOXPLQDJHZULFKWHQHQRI
VSOHWHQWXVVHQGHRQGHUGHOHQ±PRHLOLMNRIRQPRJHOLMNWHUHLQLJHQ]LMQDOVOLFKDDPVYORHLVWRIIHQRIZHHIVHOPHWPRJHOLMNS\URJHQHRIPLFURELsOH
FRQWDPLQDWLHHHQPDDOJHGXUHQGHRQEHSDDOGHWLMGLQFRQWDFW]LMQJHNRPHQPHWKHWPHGLVFKHKXOSPLGGHO5HVWHQELRORJLVFKPDWHULDDO
NXQQHQGHYHURQWUHLQLJLQJYDQKHWKXOSPLGGHOPHWS\URJHQHQRIPLFURRUJDQLVPHQEHYRUGHUHQZDDUGRRULQIHFWLHX]HFRPSOLFDWLHVNXQQHQ
optreden.
1LHWRSQLHXZVWHULOLVHUHQ1DKHUVWHULOLVDWLHNDQGHVWHULOLWHLWYDQKHWSURGXFWQLHWZRUGHQJHJDUDQGHHUGRPGDWHHQRQEHSDDOGHPDWHYDQ
PRJHOLMNS\URJHQHRIPLFURELsOHYHURQWUHLQLJLQJDDQZH]LJNDQ]LMQGLHWRWLQIHFWLHX]HFRPSOLFDWLHVNDQOHLGHQ'RRUKHWEHWUHIIHQGH
PHGLVFKHKXOSPLGGHOWHUHLQLJHQRSQLHXZJHUHHGWHPDNHQYRRUJHEUXLNHQRIRSQLHXZWHVWHULOLVHUHQQHHPWGHNDQVWRHGDWKHWKXOSPLGGHO
VOHFKWIXQFWLRQHHUWZHJHQVKHWPRJHOLMNQHJDWLHYHHIIHFWRSGHRQGHUGHOHQGLHZRUGHQEHwQYORHGGRRUWKHUPLVFKHHQRIPHFKDQLVFKH
veranderingen.
PORTUGUÊS
(VWHGLVSRVLWLYRIRLFRQFHELGRDSHQDVSDUDXWLOL]DomR~QLFD$UHXWLOL]DomRGHVWHGLVSRVLWLYRPpGLFRDSUHVHQWDRULVFRGHFULDUFRQWDPLQDomR
FUX]DGDSDUDRGRHQWHXPDYH]TXHDOLPSH]DGRVGLVSRVLWLYRVPpGLFRVSULQFLSDOPHQWHRVTXHSRVVXHPO~PHQHVSHTXHQRVH
ORQJRVXQL}HVHRXSHTXHQDVDEHUWXUDVHQWUHRVFRPSRQHQWHVpGLItFLORXLPSRVVtYHOVHRVÀXLGRVFRUSRUDLVRXWHFLGRVFRPSRWHQFLDO
FRQWDPLQDomRSLURJpQLFDRXPLFURELDQDWLYHUHPHVWDGRHPFRQWDFWRFRPRGLVSRVLWLYRPpGLFRSRUXPSHUtRGRGHWHPSRLQGHWHUPLQDGR
2UHVtGXRGHPDWHULDOELROyJLFRSRGHSURPRYHUDFRQWDPLQ DomRGRGLVSRVLWLYRSRUPLFURUJDQLVPRVRXSLUyJHQRVTXHSRGHPUHVXOWDUHP
complicações infecciosas.
1mRUHHVWHULOL]DU$SyVUHHVWHULOL]DomRQmRVHJDUDQWHDHVWHULOLGDGHGRSURGXWRSRUTXHRSRWHQFLDOGHFRQWDPLQDomRPLFURELDQDRX
SLURJpQLFDpLQGHWHUPLQDGRRTXHSRGHUHVXOWDUHPFRPSOLFDo}HVLQIHFFLRVDV$OLPSH]DUHSURFHVVDPHQWRHRXUHHVWHULOL]DomRGR
SUHVHQWHGLVSRVLWLYRPpGLFRDXPHQWDDSUREDELOLGDGHGHPDXIXQFLRQDPHQWRGRGLVSRVLWLYRGHYLGRDSRWHQFLDLVHIHLWRVDGYHUVRVQRV
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ĮȞIJȚįȡȐıİȦȞıIJĮȝȑȡȘʌȠȣİʌȘȡİȐȗȠȞIJĮȚĮʌȩșİȡȝȚțȑȢȒțĮȚȝȘȤĮȞȚțȑȢĮȜȜĮȖȑȢ
DANSK
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at rengøre når først legemsvæsker eller mikrobiel kontaminering har været i kontakt med anordningen i et vist tidsrum. Rester af biologisk
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0nLNNHJHQVWHULOLVHUHV(IWHUJHQVWHULOLVHULQJJDUDQWHUHVVWHULOLWHWHQDISURGXNWHWLNNHIRUGLJUDGHQDIPXOLJS\URJHQHOOHULQ¿FHUHQGH
PLNURELHONRQWDPLQHULQJLNNHODGHUVLJIDVWVOn5HQJ¡ULQJJHQEHKDQGOLQJRJHOOHUVWHULOLVHULQJDIDQRUGQLQJHQ¡JHUULVLNRHQIRUDW
anordningen ikke vil fungere korrekt som følge af forandringer af komponenterne fremkaldt af varme eller mekaniske påvirkninger.
SVENSKA
'HQQDSURGXNWlUHQGDVWDYVHGGI|UHQJnQJVEUXNcWHUDQYlQGQLQJDYGHQQDPHGLFLQWHNQLVNDSURGXNWPHGI|UULVNI|UNRUVNRQWDPLQDWLRQ
DYSDWLHQWHUGnPHGLFLQWHNQLVNDSURGXNWHU±VlUVNLOWGHPHGOnQJDRFKVPnOXPHQOHGHURFKHOOHUVSULQJRUPHOODQNRPSRQHQWHU±lUVYnUD
HOOHURP|MOLJDDWWUHQJ|UDQlUNURSSVYlWVNRUHOOHUYlYQDGPHGSRWHQWLHOOS\URJHQHOOHUPLNURELHOONRQWDPLQHULQJKDUYDULWLNRQWDNWPHGGHQ
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mikroorganismer vilket kan leda till infektionsrelaterade komplikationer.
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ELYHUNQLQJDUSnNRPSRQHQWHUVRPSnYHUNDVDYWHUPLVNDRFKHOOHUPHNDQLVNDI|UlQGULQJDU
SUOMI
/DLWHRQNHUWDNl\WW|LQHQ/DLWWHHQXXGHOOHHQNl\WW|DLKHXWWDDSRWLODLGHQULVWLNRQWDPLQDDWLRULVNLQNRVNDOllNLQWlODLWWHLWD±HWHQNLQODLWWHLWD
MRLVVDRQSLWNLlWDLO\K\LWlOXXPHQHLWDOLLWRNVLDMDWDLXXUWHLWDRVLHQYlOLOOl±RQYDLNHDWDLPDKGRWRQSXKGLVWDDVHQMlONHHQNXQQHRYDWROOHHW
SLWNllQNRVNHWXNVLVVDUXXPLLQQHVWHLGHQWDLNXGRVWHQNDQVVDMRLVVDRQPDKGROOLVWDS\URJHHQLVWDWDLPLNURELNRQWDPLQDDWLRWD/DLWWHHVHHQ
MllQ\WELRORJLQHQPDWHULDDOLYRLHGLVWllVHQS\URJHHQLWDLPLNURELNRQWDPLQDDWLRWDPLNlYRLDLKHXWWDDLQIHNWLRRQOLLWW\YLlNRPSOLNDDWLRLWD
(LVDDVWHULORLGDXXGHVWDDQ7XRWWHHQVWHULLOL\WWlXXGHOOHHQVWHULORLQQLQMlONHHQHLYRLGDWDDWDNRVNDVHQPDKGROOLQHQS\URJHHQLWDL
PLNURELNRQWDPLQDDWLRQPllUlMRNDYRLDLKHXWWDDLQIHNWLRRQOLLWW\YLlNRPSOLNDDWLRLWDHLROHPllULWHWWlYLVVl.l\W|VVlROHYDQOllNLQWlODLWWHHQ
SXKGLVWXVXXGHOOHHQNlVLWWHO\MDWDLVWHULORLQWLOLVllYlWODLWWHHQYLUKHHOOLVHQWRLPLQQDQPDKGROOLVXXWWDPLNlMRKWXXVHQOlPS|MDWDL
mekaanisille muutoksille herkkiin osiin kohdistuvista haittavaikutuksista.
NORSK
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har hatt kontakt med den medisinske anordningen i en ubestemt tidsperiode. Rester av biologisk materiale kan fremme kontamineringen av
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medisinske anordning øker sannsynligheten for at anordningen vil svikte på grunn av potensielle ugunstige virkninger på komponenter som
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POLSKI
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繁體中文
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。
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제품은 일회 사용을 원칙으로 한다. 특히 부품 사이에 크고 작은 루멘(lumen), 이음새, 균열이 있는 의료 장치들은 발열성 혹은 세균성
오염 가능성이 있는 체액이나 조직이 장치와 확인할 수 없는 기간 동안 일단 접촉하고 나면, 깨끗하게 하기가 어렵거나 불가능하기 때문에
이 장치를 재사용할 경우 환자간 오염의 위험성이 증가한다. 생체 물질의 잔여물로 인해 이 제품이 감염성 합병증을 일으킬 수 있는
발열물질이나 미생물에 오염될 가능성이 높아진다.
재멸균하지 않는다. 감염성 합병증을 일으킬 수 있는 확인할 수 없는 발열성, 세균성 오염의 가능성이 있기 때문에 제품의 멸균 상태를
보장할 수 없다. 본 제품의 소독, 재처리, 재멸균으로 인한 온도 및 기계적인 변화에 영향을 받는 부품들의
부작용 때문에 장치가 제대로 작동하지 않을 확률이 높아진다.
ɊɍɋɋɄɂɃ
ɍɫɬɪɨɣɫɬɜɨɩɪɟɞɧɚɡɧɚɱɟɧɨɬɨɥɶɤɨɞɥɹɨɞɧɨɤɪɚɬɧɨɝɨɩɪɢɦɟɧɟɧɢɹɉɨɜɬɨɪɧɨɟɢɫɩɨɥɶɡɨɜɚɧɢɟɷɬɨɝɨɦɟɞɢɰɢɧɫɤɨɝɨɭɫɬɪɨɣɫɬɜɚ
ɫɨɩɪɹɠɟɧɨɫɪɢɫɤɨɦɩɟɪɟɤɪɟɫɬɧɨɝɨɡɚɪɚɠɟɧɢɹɩɚɰɢɟɧɬɨɜɩɨɫɤɨɥɶɤɭɦɟɞɢɰɢɧɫɤɢɟɭɫɬɪɨɣɫɬɜɚ²ɜɱɚɫɬɧɨɫɬɢɬɟɤɨɬɨɪɵɟɢɦɟɸɬ
ɞɥɢɧɧɵɣɢɭɡɤɢɣɩɪɨɫɜɟɬɬɨɱɤɢɫɨɟɞɢɧɟɧɢɹɢɢɥɢɡɚɡɨɪɵɦɟɠɞɭɤɨɦɩɨɧɟɧɬɚɦɢ²ɬɪɭɞɧɨɢɥɢɧɟɜɨɡɦɨɠɧɨɨɱɢɫɬɢɬɶɩɨɫɥɟɤɨɧɬɚɤɬɚ
ɛɢɨɥɨɝɢɱɟɫɤɢɯɠɢɞɤɨɫɬɟɣɢɥɢɬɤɚɧɟɣɩɨɬɟɧɰɢɚɥɶɧɨɫɨɞɟɪɠɚɳɢɯɩɢɪɨɝɟɧɧɵɟɜɟɳɟɫɬɜɚɢɥɢɦɢɤɪɨɨɪɝɚɧɢɡɦɵɫɦɟɞɢɰɢɧɫɤɢɦ
ɭɫɬɪɨɣɫɬɜɨɦɜɬɟɱɟɧɢɟɧɟɨɩɪɟɞɟɥɟɧɧɨɝɨɩɟɪɢɨɞɚɜɪɟɦɟɧɢɈɫɬɚɬɤɢɛɢɨɥɨɝɢɱɟɫɤɨɝɨɦɚɬɟɪɢɚɥɚɦɨɝɭɬɫɩɨɫɨɛɫɬɜɨɜɚɬɶɡɚɝɪɹɡɧɟɧɢɸ
ɭɫɬɪɨɣɫɬɜɚɩɢɪɨɝɟɧɧɵɦɢɜɟɳɟɫɬɜɚɦɢɢɥɢɦɢɤɪɨɨɪɝɚɧɢɡɦɚɦɢɤɨɬɨɪɵɟɦɨɝɭɬɩɪɢɜɟɫɬɢɤɢɧɮɟɤɰɢɨɧɧɵɦɨɫɥɨɠɧɟɧɢɹɦ
ɉɨɜɬɨɪɧɚɹɫɬɟɪɢɥɢɡɚɰɢɹɡɚɩɪɟɳɟɧɚɉɨɫɥɟɩɨɜɬɨɪɧɨɣɫɬɟɪɢɥɢɡɚɰɢɢɧɟɥɶɡɹɝɚɪɚɧɬɢɪɨɜɚɬɶɫɬɟɪɢɥɶɧɨɫɬɶɢɡɞɟɥɢɹɢɡɡɚ
ɧɟɜɨɡɦɨɠɧɨɫɬɢɨɩɪɟɞɟɥɢɬɶɫɬɟɩɟɧɶɡɚɝɪɹɡɧɟɧɢɹɩɢɪɨɝɟɧɧɵɦɢɜɟɳɟɫɬɜɚɦɢɢɥɢɦɢɤɪɨɨɪɝɚɧɢɡɦɚɦɢɤɨɬɨɪɵɟɦɨɝɭɬɩɪɢɜɟɫɬɢ
ɤɢɧɮɟɤɰɢɨɧɧɵɦɨɫɥɨɠɧɟɧɢɹɦɈɱɢɫɬɤɚɩɨɜɬɨɪɧɵɟɨɛɪɚɛɨɬɤɚɢɢɥɢɫɬɟɪɢɥɢɡɚɰɢɹɞɚɧɧɨɝɨɦɟɞɢɰɢɧɫɤɨɝɨɭɫɬɪɨɣɫɬɜɚɩɨɜɵɲɚɸɬ
ɜɟɪɨɹɬɧɨɫɬɶɟɝɨɧɟɢɫɩɪɚɜɧɨɫɬɢɢɡɡɚɨɬɪɢɰɚɬɟɥɶɧɵɯɩɨɫɥɟɞɫɬɜɢɣɜɵɡɜɚɧɧɵɯɬɟɪɦɢɱɟɫɤɨɣɨɛɪɚɛɨɬɤɨɣɢɢɥɢɦɟɯɚɧɢɱɟɫɤɢɦɢ
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Manufacturer:
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