5296A Ed 2013-01_IFU DG EVO_Layout 1

FRONT 1
BLACK
4/13
FR
®
195621
EN
DE
®
IT
ES
SUTURE CHIRURGICALE SHARPSHOOTER
Polyester, tressée, verte, 91,4 cm (36”)
2-0 U.S.P. 3 métrique
Double aiguille de 33 cm (13”)
de long x 0,7 mm (0,026”) de diam.
SHARPSHOOTER NAHTMATERIAL
SUTURA CHIRURGICA SHARPSHOOTER
SUTURA QUIRÚRGICA SHARPSHOOTER
SUTURA CIRÚRGICA SHARPSHOOTER®
3RO\HVWHUJUQJHÁRFKWHQFPµ
USP 2-0 (3 metrisch)
Doppelt armierte Nadeln, 33 cm (13”) lang x
0,7 mm (0,026”) Durchmesser
Filo in poliestere intrecciato verde 91,4 cm (36”)
cal. U.S.P. 2-0, sist. metrico 3,0
Aghi a doppia punta da 33 cm (13”)
di lunghezza x 0,7 mm (0,026”) di diametro
Poliéster trenzado verde de 91,4 cm (36”)
2-0 U.S.P., 3,0 métrico
Agujas de brazo doble de 33 cm (13”)
Long. x 0,7 mm (0,026”) diám.
Trançada verde, em poliéster, 91,4 cm (36”)
2-0 U.S.P., 3,0 sistema métrico
Agulhas duplas para sutura 33 cm (13”)
comprimento x 0,7 mm (0,026”) diâm.
Important information for the operating surgeon
Informations importantes à l’attention du chirurgien
Wichtige Informationen für den behandelnden Chirurgen
Informazioni importanti per il chirurgo
Información importante para el cirujano
Informações importantes para o cirurgião
DESCRIPTION
DESCRIPTION
BESCHREIBUNG
DESCRIZIONE
DESCRIPCIÓN
DESCRIÇÃO
SharpShooter® Surgical Suture is a nonabsorbable, sterile, surgical
suture composed of braided Poly(ethylene terephthalate)(PET) and
DI¿[HGWRGRXEOHDUPHGQHHGOHVVWUDLJKWWURFDUSRLQWFP´ORQJ
E\PP´LQGLDPHWHU7KHVXWXUHLVSUHSDUHGIURP¿EHUVRI
high molecular weight, long-chain, linear polyesters having recurrent
DURPDWLFULQJVDVDQLQWHJUDOFRPSRQHQW7KHVXWXUHLVFP´
863PHWULFEUDLGHGDQGSURYLGHGZLWKDVLOLFRQHFRDWLQJDQG
dyed (green). The pigment for the green dyed suture is D&C Green
No. 6. The product meets all the requirements established by the
United States Pharmacopeia (U.S.P.) for Nonabsorbable Surgical
Suture.
/DVXWXUH6KDUS6KRRWHU® est une suture chirurgicale non résorbable, stérile,
WUHVVpHFRPSRVpHGHSRO\pWK\OqQHWpUpSKWDODWH3(7¿[pHjXQHGRXEOH
DLJXLOOHGURLWHjSRLQWGHWURFDUWGHFP´GHORQJHWPP´
GHGLDPqWUH(OOHHVWIDEULTXpHjEDVHGH¿EUHVGHSRO\HVWHUVOLQpDLUHVj
PDVVHPROpFXODLUHpOHYpHHWjORQJXHFKDvQHTXLSRVVqGHQWGHVQR\DX[
DURPDWLTXHVSpULRGLTXHV(OOHPHVXUHFP´863PpWULTXH
(OOHHVWWUHVVpHHWIRXUQLHHQGXLWHGHVLOLFRQHHWWHLQWpHHQYHUW/HSLJPHQW
XWLOLVpSRXUODWHLQWHYHUWHHVW©'&*UHHQ1ƒª/HSURGXLWHVWFRQIRUPH
jWRXWHVOHVH[LJHQFHVpWDEOLHVSDUODSKDUPDFRSpHGHVeWDWV8QLV8QLWHG
States Pharmacopeia, U.S.P.) pour la catégorie des sutures chirurgicales non
absorbables.
SharpShooter® Nahtmaterial ist ein nicht resorbierbares, steriles Nahtmaterial
DXVJHÀRFKWHQHP3RO\HWK\OHQWHUHSKWKDODW3(7GDVDQGRSSHOWDUPLHUWHQ
JHUDGHQ1DGHOQPLW7URNDUVSLW]HEHIHVWLJWLVWGLHFP”) lang sind und
einen Durchmesser von 0,7 mm (0,026”) haben. Das Nahtmaterial besteht aus
linearen, langkettigen Polyesterfasern mit hohem Molekulargewicht, die als wesentliche Komponente wiederkehrende aromatische Ringstrukturen enthalten.
'DV1DKWPDWHULDOLVWFP”ODQJ863PHWULVFKJHÀRFKWHQPLW
6LOLNRQEHVFKLFKWHWXQGJUQJHIlUEW)UGLHJUQH)lUEXQJGHV1DKWPDWHULDOVZLUGGHU)DUEVWRIIÄ'&*UHHQ1U³YHUZHQGHW'DV3URGXNWHUIOOWDOOH
$QIRUGHUXQJHQGHU8QLWHG6WDWHV3KDUPDFRSHLD863IUQLFKWUHVRUELHUEDUH
Nahtmaterialien.
/DVXWXUDFKLUXUJLFD6KDUS6KRRWHU® è una sutura chirurgica sterile non
DVVRUELELOHGLSROLHWLOHQWHUHIWDODWR3(7LQWUHFFLDWRHGq¿VVDWDDGDJKLD
GRSSLDSXQWDGLULWWLFRQSXQWDWUHTXDUWLGLFP´GLOXQJKH]]DHPP
´GLGLDPHWUR/DVXWXUDqUHDOL]]DWDXVDQGR¿EUHGLSROLHVWHULOLQHDUL
a catena lunga ad alto peso molecolare che comprendono anelli aromatici
ULFRUUHQWLFRPHFRPSRQHQWHLQWHJUDWR/DVXWXUDqOXQJDFP´
FDO863VLVWPHWULFRKDXQDVWUXWWXUDDWUHFFLDHGqGRWDWDGL
ULYHVWLPHQWRGLVLOLFRQH/DVXWXUDqWLQWDLQYHUGHFRQLOSLJPHQWR'&*UHHQ
1,OSURGRWWRqFRQIRUPHDWXWWLLUHTXLVLWLLPSRVWLGDOODIDUPDFRSHDGHJOL
Stati Uniti (U.S.P.) per le suture chirurgiche non assorbibili.
/DVXWXUDTXLU~UJLFD6KDUS6KRRWHU®HVXQDVXWXUDTXLU~UJLFDQRDEVRUELEOH
estéril compuesta por tereftalato de polietileno (PET) trenzado y unido a agujas
GHEUD]RGREOHUHFWDVGHSXQWDWURFDUGHFP´GHODUJRSRUPP
´GHGLiPHWUR/DVXWXUDHVWiIDEULFDGDDSDUWLUGH¿EUDVGHSROLpVWHUHV
lineales de alto peso molecular y cadena larga, con anillos aromáticos
UHFXUUHQWHVFRPRFRPSRQHQWHLQWHJUDO/DVXWXUDHVWUHQ]DGD\PLGHFP
´863PpWULFR\VHVXPLQLVWUDFRQXQUHYHVWLPLHQWRVLOLFRQDGR\
teñido (verde). El pigmento de la sutura teñida de verde es D&C Green n.º 6. El
SURGXFWRVDWLVIDFHWRGRVORVUHTXLVLWRVHVWDEOHFLGRVSRUOD)DUPDFRSHLDGHORV
(VWDGRV8QLGRV8QLWHG6WDWHV3KDUPDFRSHLD863SDUDVXWXUDVTXLU~UJLFDV
no absorbibles.
SharpShooter®pXPDVXWXUDFLU~UJLFDQmRDEVRUYtYHOHVWHULOL]DGDFRPSRVWD
SRUSROLHWLOHQRWHUHIWDODWR3(7WUDQoDGRH¿[DGDHPDJXOKDVGXSODVSDUD
VXWXUDUHFWDVGHSRQWDWURFDUWHFRPFP´GHFRPSULPHQWRHPP
´GHGLkPHWUR$VXWXUDpIHLWDGH¿EUDVGHSROLpVWHUHVOLQHDUHVGH
alto peso molecular e cadeias longas, com anéis aromáticos recorrentes
FRPRXPFRPSRQHQWHLQWHJUDO$VXWXUDWHPFP´863
QRVLVWHPDPpWULFRpWUDQoDGDWHPXPUHYHVWLPHQWRGHVLOLFRQHHpWLQJLGD
YHUGH2SLJPHQWRGDVXWXUDWLQJLGDGHYHUGHpR'&*UHHQ1R2
SURGXWRFXPSUHFRPWRGRVRVUHTXLVLWRVHVWDEHOHFLGRVSHOD)DUPDFRSHLD
$PHULFDQD863SDUDVXWXUDVFLU~UJLFDVQmRDEVRUYtYHLV
INDICATIONS
/DVXWXUHHQ3(7HVWLQGLTXpHSRXUOHUDSSURFKHPHQWHWRXODOLJDWXUHGHV
tissus mous.
INDIKATIONEN
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:HLFKJHZHEHXQGRGHU/LJDWXULQGL]LHUW
SharpShooter Nahtmaterial ist zur Verwendung mit dem SharpShooter Nahtsystem bei der Behandlung von Meniskusverletzungen im Knie vorgesehen.
INDICATIONS FOR USE
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and/or ligation.
The SharpShooter Surgical Sutures are designed to be used with the
SharpShooter Tissue Repair System for use in the repair of injuries to
the meniscus of the Knee.
CONTRAINDICATIONS
None known.
WARNINGS
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Contents sterile unless package has been opened or
damaged.
2. Users should be familiar with surgical procedures and techniques
involving nonabsorbable sutures before employing PET suture for
wound closures, as the risk of wound dehiscence may vary with the
site of the application and the suture material used.
$FFHSWDEOHVXUJLFDOSUDFWLFHPXVWEHIROORZHGZLWKUHVSHFWWR
drainage and closure of infected or contaminated wounds.
PRECAUTIONS
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WRDYRLGGDPDJHIURPKDQGOLQJ$YRLGFUXVKLQJRUFULPSLQJGDPDJH
due to application of surgical instruments such as suture passers,
forceps, or needle holders.
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DFFHSWDEOHVXUJLFDOWHFKQLTXHRIÀDWVTXDUHWLHVZLWKDGGLWLRQDO
WKURZVDVZDUUDQWHGE\VXUJLFDOFLUFXPVWDQFHDQGWKHH[SHULHQFHRI
the surgeon.
8VHUVVKRXOGH[HUFLVHFDXWLRQZKHQKDQGOLQJVXUJLFDOQHHGOHVWR
avoid inadvertent needle sticks. Discard used needles in “sharps”
container.
Sharpshooter Surgical Suture is Single Use Only.
Do Not Reuse. Do Not Resterilize.
ADVERSE REACTIONS
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tissues which is followed by gradual encapsulation of the suture by
¿EURXVFRQQHFWLYHWLVVXH3RO\HVWHU6XWXUHLVQRWDEVRUEHGQRULVDQ\
VLJQL¿FDQWFKDQJHLQWHQVLOHVWUHQJWKUHWHQWLRQNQRZQWRRFFXUin vivo.
$GYHUVHHIIHFWVDVVRFLDWHGZLWKWKHXVHRIWKLVGHYLFHLQFOXGHZRXQG
dehiscence, calculi formation in urinary and biliary tracts when
prolonged contact with salt solutions such as urine and bile occurs,
LQIHFWHGZRXQGVPLQLPDODFXWHLQÀDPPDWRU\WLVVXHUHDFWLRQDQGSDLQ
edema, and erythema at the wound site.
LIMITED WARRANTY, LIMITATION OF LIABILITY AND DISCLAIMER
OF OTHER WARRANTIES
This product is warranted to be free from defects in material and
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ZKHQVKLSSHG,Y\6SRUWV0HGLFLQH¶V62/(UHVSRQVLELOLW\VKDOOEHWKH
replacement of the product.
7KHPDQXIDFWXUHUWKHLPSRUWHUDQGWKHVXSSOLHUVRI,Y\6SRUWV
Medicine products are not liable for complications or other effects
that might occur for reasons such as incorrect indications or surgical
technique, unsuitable choice of material or handling thereof,
unsuitable use or handling of the instruments, asepsis and so on. The
operating surgeon is responsible for any such complications or other
consequences.
RE-ORDERING:
SharpShooter®+DQGOH5HIHUHQFH1XPEHU
SharpShooter®6XUJLFDO6XWXUH5HIHUHQFH1XPEHU
SharpShooter®&DQQXODV5HIHUHQFH1XPEHUV
$QWHULRU
5LJKW/HIW
/HVVXWXUHVFKLUXUJLFDOHV6KDUS6KRRWHUVRQWFRQoXHVSRXUrWUHXWLOLVpHV
avec le système de réparation tissulaire SharpShooter dans le cadre de la
réparation des lésions méniscales du genou.
CONTRE-INDICATIONS
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AVERTISSEMENTS
1HSDVUHVWpULOLVHU-HWHUOHVVXWXUHVRXYHUWHVHWQRQ
XWLOLVpHV&RQWHQXVWpULOHVDXIVLO¶HPEDOODJHDpWpRXYHUW
ou endommagé.
/HVXWLOLVDWHXUVGRLYHQWFRQQDvWUHOHVSURFpGXUHVFKLUXUJLFDOHVHWOHV
WHFKQLTXHVUHODWLYHVDX[VXWXUHVQRQDEVRUEDEOHVDYDQWG¶XWLOLVHUOHV
sutures en PET pour la fermeture des plaies. En effet, le risque de
GpKLVFHQFHGHVSODLHVSHXWYDULHUHQIRQFWLRQGXVLWHG¶DSSOLFDWLRQHWGHV
instruments utilisés pour la suture.
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FHTXLDWUDLWDXGUDLQDJHHWjODIHUPHWXUHGHVSODLHVLQIHFWpHVRX
contaminées.
PRÉCAUTIONS
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YHLOOHUjpYLWHUWRXWGRPPDJHSRVVLEOHeYLWHUG¶pFUDVHURXGHSLQFHUOHV
VXWXUHVORUVGHO¶XWLOLVDWLRQG¶LQVWUXPHQWVFKLUXUJLFDX[FRPPHOHVIRUFHSV
ou les porte-aiguilles.
&RPPHDYHFWRXWLQVWUXPHQWGHVXWXUHODVROLGLWpGXQRXDJHH[LJH
le respect des techniques chirurgicales appropriées concernant les
Q°XGVSODWVHWO¶XWLOLVDWLRQGHSRLQWVVXSSOpPHQWDLUHVHQIRQFWLRQGHV
FLUFRQVWDQFHVFKLUXUJLFDOHVHWGHO¶H[SpULHQFHGXFKLUXUJLHQ
)DLUHSUHXYHGHSUXGHQFHORUVGXPDQLHPHQWGHVDLJXLOOHVFKLUXUJLFDOHV
D¿QG¶pYLWHUOHVSLT€UHVDFFLGHQWHOOHV-HWHUOHVDLJXLOOHVXVDJpHVGDQVXQ
FROOHFWHXUG¶REMHWVSRLQWXV
La suture chirurgicale Sharpshooter est réservée à un
usage unique. Ne pas réutiliser. Ne pas restériliser.
RÉACTIONS INDÉSIRABLES
/DVXWXUHHQSRO\HVWHUSURYRTXHXQHUpDFWLRQLQÀDPPDWRLUHOpJqUHGDQVOHV
WLVVXVVXLYLHG¶XQHHQFDSVXODWLRQSURJUHVVLYHSDUOHWLVVXFRQMRQFWLI¿EUHX[
(OOHQ¶HVWSDVDEVRUEpHHWDXFXQFKDQJHPHQWVLJQL¿FDWLIGHVDUpVLVWDQFHj
ODWUDFWLRQQ¶DSXrWUHREVHUYpin vivo.
/HVUpDFWLRQVLQGpVLUDEOHVDVVRFLpHVjO¶XWLOLVDWLRQGHFHGLVSRVLWLILQFOXHQW
déhiscence de la plaie, formation de calculs dans les voies urinaires ou
biliaires en cas de contact prolongé avec des solutions salines telles que
O¶XULQHRXODELOHLQIHFWLRQGHODSODLHUpDFWLRQLQÀDPPDWRLUHWLVVXODLUHOpJqUH
ainsi que douleur, œdème et érythème sur le site de la plaie.
LIMITATION DE GARANTIE, LIMITE DE RESPONSABILITÉ
ET EXCLUSION DE TOUTE AUTRE GARANTIE
&HSURGXLWHVWJDUDQWLVDQVGpIDXWGHIDEULFDWLRQHWGHPDLQG¶RHXYUH'DQV
O¶pYHQWXDOLWpROHSURGXLWVHUDLWFRQVLGpUpFRPPHGpIHFWXHX[DXPRPHQWGH
ODOLYUDLVRQ,Y\6SRUWV0HGLFLQHHVW81,48(0(17WHQXHGHOHUHPSODFHU
/HIDEULFDQWO¶LPSRUWDWHXUHWOHVIRXUQLVVHXUVGHVSURGXLWV,Y\6SRUWV
0HGLFLQHQHGRLYHQWSDVrWUHWHQXVUHVSRQVDEOHVGHWRXWHFRPSOLFDWLRQ
RXWRXWHDXWUHFRQVpTXHQFHVXVFHSWLEOHG¶DYRLUOLHXVXLWHjXQHXWLOLVDWLRQ
LQDSSURSULpHRXXQHWHFKQLTXHFKLUXUJLFDOHLQFRUUHFWHXQFKRL[G¶LQVWUXPHQW
inadapté ou une manipulation inappropriée du produit, une utilisation ou une
PDQLSXODWLRQLQDGDSWpHVGHVLQVWUXPHQWVXQHDVHSVLHHWF/HFKLUXUJLHQHVW
responsable de toutes les complications ou autres conséquences.
RÉAPPROVISIONNEMENT :
Poignée SharpShooter®UpIpUHQFH
Suture chirurgicale SharpShooter®UpIpUHQFH
Canules SharpShooter®UpIpUHQFHV
$QWpULHXUH
GURLWHJDXFKH
“Use by date. . .
(Year, Month)”
EN
“Consult operating instructions”
FR
®
®
PT
Polyester, Green Braided 91.4 cm (36”)
2-0 U.S.P. 3.0 Metric
Double-Armed Needles 33 cm (13”)
Long x 0.7 mm (0.026”) Dia.
SHARPSHOOTER SURGICAL SUTURE
®
KONTRAINDIKATIONEN
Keine bekannt.
WARNHINWEISE
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1DKWPDWHULDOHQWVRUJHQ'HU,QKDOWLVWQXUEHLXQEHVFKlGLJWHU
XQGXQJH|IIQHWHU9HUSDFNXQJVWHULO
$QZHQGHUPVVHQPLWGHQFKLUXUJLVFKHQ9HUIDKUHQXQG7HFKQLNHQEHLGHU
Verwendung von nicht resorbierbarem Nahtmaterial vertraut sein, bevor das
PET-Nahtmaterial zum Verschluss von Wunden verwendet wird, da das Risiko
HLQHU:XQGGHKLV]HQ]YRQGHU$QZHQGXQJVVWHOOHXQGGHPYHUZHQGHWHQ
Nahtmaterial abhängt.
%HLGHU'UDLQDJHXQGEHLP9HUVFKOXVVLQ¿]LHUWHURGHUYHUXQUHLQLJWHU:XQGHQ
PXVVJHPl‰DQHUNDQQWHUFKLUXUJLVFKHU3UD[LVYRUJHJDQJHQZHUGHQ
VORSICHTSMASSNAHMEN
1DKWPDWHULDOVWHWVXPVLFKWLJKDQGKDEHQGDPLWHVQLFKWEHVFKlGLJWZLUG
%HLGHU9HUZHQGXQJYRQFKLUXUJLVFKHQ)KUXQJVLQVWUXPHQWHQ=DQJHQRGHU
1DGHOKDOWHUQGDUDXIDFKWHQGDVVGDV1DKWPDWHULDOQLFKWGXUFK4XHWVFKHQ
RGHU)DOWHQEHVFKlGLJWZLUG
2. Wie bei allen Nahtmaterialien muss zur ausreichenden Knotensicherheit die
DQHUNDQQWH2SHUDWLRQVWHFKQLNPLWÀDFKHQ.UHX]NQRWHQDQJHZHQGHWZHUGHQ
wobei je nach Gegebenheiten und Ermessen des Chirurgen zusätzliche
Schlingen verwendet werden.
%HLGHU+DQGKDEXQJFKLUXUJLVFKHU1DGHOQYRUVLFKWLJYRUJHKHQXPYHUVHhentliche Stichverletzungen zu vermeiden. Gebrauchte Nadeln in einem
Kanülenentsorgungsbehälter entsorgen.
SharpShooter Nahtmaterial ist nur zum einmaligen
Gebrauch bestimmt. Nicht wiederverwenden.
Nicht erneut sterilisieren.
EINGESCHRÄNKTE GARANTIE, HAFTUNGSBESCHRÄNKUNG UND
AUSSCHLUSS SONSTIGER GEWÄHRLEISTUNGEN
Es wird gewährleistet, dass dieses Produkt frei von Material- und VerarbeiWXQJVIHKOHUQLVW)DOOVIHVWJHVWHOOWZLUGGDVVGDV3URGXNWEHUHLWVEHLP9HUVDQG
IHKOHUKDIWZDULVW,Y\6SRUWV0HGLFLQH$//(,1,*IUGHQ(UVDW]GHV3URGXNWV
verantwortlich.
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Medicine übernehmen keine Haftung bei Komplikationen oder anderweitigen
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$VHSVLVHWFDXIWUHWHQ'HUEHKDQGHOQGH&KLUXUJWUlJWGLH9HUDQWZRUWXQJIU
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NACHBESTELLUNG:
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SharpShooter®.DQOHQ%HVWHOOQXPPHUQ
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“Keep dry”
“Do not use if package
is damaged”
INDICACIONES DE USO
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de tejido blando.
INDICAÇÕES DE UTILIZAÇÃO
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OLJDomRGRVWHFLGRVPROHV
/HVXWXUHFKLUXUJLFKH6KDUS6KRRWHUVRQRFRQFHSLWHSHUO¶XVRDVVLHPHDO
sistema di riparazione tessutale SharpShooter per la riparazione di lesioni al
menisco del ginocchio.
/DVVXWXUDVTXLU~UJLFDV6KDUS6KRRWHUHVWiQGLVHxDGDVSDUDXWLOL]DUVHFRQHO
VLVWHPDGHUHSDUDFLyQGHWHMLGRV6KDUS6KRRWHUSDUDUHSDUDUOHVLRQHVHQORV
meniscos de la rodilla.
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FRPR6LVWHPDGHUHSDUDomRGHWHFLGRV6KDUS6KRRWHUSDUDDUHSDUDomRGH
lesões no menisco do joelho.
CONTROINDICAZIONI
Nessuna nota.
CONTRAINDICACIONES
No se conoce ninguna.
CONTRA-INDICAÇÕES
Nenhuma conhecida.
AVVERTENZE
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sia stata aperta o danneggiata.
ADVERTENCIAS
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El contenido se suministra estéril, a menos que el envase se
haya abierto o dañado.
AVISOS
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2FRQWH~GRGDHPEDODJHPHVWiHVWHULOL]DGRDPHQRVTXH
DHPEDODJHPWHQKDVLGRDEHUWDRXHVWHMDGDQL¿FDGD
2. Gli operatori devono avere dimestichezza con le procedure e le tecniche
FKLUXUJLFKHFKHSUHYHGRQRO¶XVRGLVXWXUHQRQDVVRUELELOLSULPDGLXWLOL]]DUH
la sutura in PET per la chiusura di ferite, in quanto il rischio di deiscenza
della ferita può variare a seconda del sito di applicazione e del materiale
della sutura utilizzata.
/RVXVXDULRVGHEHQHVWDUIDPLOLDUL]DGRVFRQODVWpFQLFDV\ORVSURFHGLPLHQWRV
TXLU~UJLFRVTXHLQYROXFUDQHOXVRGHVXWXUDVQRDEVRUELEOHVDQWHVGHHPSHODU
la sutura PET para cerrar heridas, ya que el riesgo de dehiscencia de las
KHULGDVSXHGHYDULDUVHJ~QHOOXJDUGHDSOLFDFLyQ\HOPDWHULDOGHVXWXUD
utilizado.
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DVWpFQLFDVFLU~UJLFDVXWLOL]DGRVFRPVXWXUDVQmRDEVRUYtYHLVDQWHVGH
XWLOL]DUHPDVXWXUDHP3(7SDUDIHFKDUIHULGDVSRLVRULVFRGHGHLVFrQFLD
SRGHYDULDUFRQVRDQWHRORFDOGDDSOLFDomRHRPDWHULDOGDVXWXUDXWLOL]DGD
ÊQHFHVVDULRDGRWWDUHSURFHGXUHFKLUXUJLFKHFRQVROLGDWHSHUTXDQWR
riguarda il drenaggio e la chiusura di ferite infette e contaminate.
'HEHHPSOHDUVHXQDSUiFWLFDTXLU~UJLFDDGHFXDGDSDUDHOGUHQDMH\HOFLHUUH
de heridas infectadas o contaminadas.
PRECAUZIONI
0DQLSRODUHTXHVWRRTXDOVLDVLDOWURPDWHULDOHGHOODVXWXUDFRQFDXWHOD
per evitare possibili danni. Evitare di schiacciare o piegare la sutura con
strumenti chirurgici quali passa-sutura, pinze o porta-aghi.
PRECAUCIONES
$OPDQLSXODUHVWHRFXDOTXLHURWURPDWHULDOGHVXWXUDVHGHEHWHQHU
SUHFDXFLyQSDUDHYLWDUGDxRVGHULYDGRVGHODPDQLSXODFLyQ(YLWHORVGDxRV
SRUDSODVWDPLHQWRRFRUWHGHELGRDODDSOLFDFLyQGHLQVWUXPHQWRVTXLU~UJLFRV
FRPRSDVDGRUHVGHVXWXUDIyUFHSVRSRUWDDJXMDV
PRECAUÇÕES
$RPDQXVHDUHVWHRXTXDOTXHURXWURPDWHULDOGHVXWXUDGHYHWHUFXLGDGR
SDUDHYLWDUGDQL¿FiOR(YLWHGDQRVSRUHVPDJDPHQWRRXDSHUWRGHYLGRj
XWLOL]DomRGHLQVWUXPHQWRVFLU~UJLFRVFRPRSDVVDGRUHVGHVXWXUDVSLQoDV
ou porta-agulhas.
$OLJXDOTXHFRQFXDOTXLHUPDWHULDOGHVXWXUDSDUDORJUDUXQQXGRVHJXURVH
GHEHHPSOHDUODWpFQLFDTXLU~UJLFDDFHSWDEOHGHDWDGXUDVFXDGUDGDV\SODQDV
FRQSDVDGDVDGLFLRQDOHVVHJ~QORLQGLTXHQODVFLUFXQVWDQFLDVTXLU~UJLFDV\OD
H[SHULHQFLDGHOFLUXMDQR
7DOFRPRTXDOTXHURXWURPDWHULDOGHVXWXUDSDUDTXHRVQyV¿TXHP
GHYLGDPHQWHVHJXURVpSUHFLVRXWLOL]DUDWpFQLFDFLU~UJLFDDGHTXDGDGH
ODoRVSODQRVHTXDGUDGRVFRPYROWDVDGLFLRQDLVFRQIRUPHDFLUFXQVWkQFLD
FLU~UJLFDHDH[SHULrQFLDGRFLUXUJLmR
/RVXVXDULRVGHEHQWHQHUFXLGDGRDOPDQLSXODUDJXMDVTXLU~UJLFDVSDUDHYLWDU
el punzado accidental. Desecha las agujas usadas en envases para objetos
¿ORVRV
2VXWLOL]DGRUHVGHYHPWHUFXLGDGRDRPDQXVHDUDJXOKDVFLU~UJLFDVSDUD
QmRVHSLFDUHPDFLGHQWDOPHQWH(OLPLQHDVDJXOKDVXVDGDVHPUHFLSLHQWHV
SUySULRVSDUDREMHFWRVD¿DGRV
La sutura quirúrgica Sharpshooter está diseñada
exclusivamente para un solo uso. No reutilizar.
No reesterilizar.
A Sutura cirúrgica Sharpshooter destina-se apenas a
uma única utilização. Não reutilize. Não reesterilize.
2. Come con qualsiasi altro materiale di sutura, per ottenere una sicurezza
del nodo adeguata utilizzare la tecnica chirurgica accettata di legature
quadrate piane e passaggi aggiuntivi, qualora indicati in base alle
FLUFRVWDQ]HHDOO¶HVSHULHQ]DGHOFKLUXUJR
3UHVWDUHSDUWLFRODUHDWWHQ]LRQHGXUDQWHODPDQLSROD]LRQHGLDJKLFKLUXUJLFL
per prevenire punture accidentali. Gettare gli aghi usati in recipienti
riservati a strumenti acuminati.
La sutura chirurgica SharpShooter è esclusivamente
monouso. Non riutilizzare. Non risterilizzare.
UNERWÜNSCHTE EREIGNISSE
Polyester-Nahtmaterial verursacht eine minimale akute Entzündungsreaktion im
*HZHEHJHIROJWYRQHLQHUDOOPlKOLFKHQ9HUNDSVHOXQJGHU1DKWGXUFK¿EU|VHV
Bindegewebe. Polyester-Nahtmaterial wird nicht resorbiert. Es sind auch keine
VLJQL¿NDQWHQbQGHUXQJHQEHLP(UKDOWGHU5HL‰IHVWLJNHLWin vivo bekannt.
8QHUZQVFKWH(UHLJQLVVHLQ=XVDPPHQKDQJPLWGHU9HUZHQGXQJGLHVHV
3URGXNWVVLQGXD:XQGGHKLV]HQ].RQNUHPHQWELOGXQJLQGHU*DOOHXQGLQGHQ
+DUQZHJHQEHLOlQJHUHP.RQWDNWPLW6DO]O|VXQJHQ]%8ULQXQG*DOOHQVlXUH
:XQGLQIHNWLRQHQPLQLPDOHDNXWH(QW]QGXQJVUHDNWLRQLP*HZHEH6FKPHU]HQ
Ödeme und Erytheme an der Wundstelle.
“Caution”
INDICAZIONI PER L’USO
/DVXWXUDLQ3(7qLQGLFDWDSHUO¶XVRQHOO¶DYYLFLQDPHQWRHROHJDWXUDJHQHUDOL
di tessuto molle.
EFFETTI INDESIDERATI
/HVXWXUHLQSROLHVWHUHLQGXFRQRXQDOLHYLVVLPDUHD]LRQHLQ¿DPPDWRULDDFXWD
nei tessuti, seguita dal graduale incapsulamento della sutura nel tessuto
FRQQHWWLYR¿EURVR/DVXWXUDGLSROLHVWHUHQRQYLHQHDVVRUELWDHin vivo non
qVWDWDRVVHUYDWDDOFXQDPRGL¿FDVLJQL¿FDWLYDGHOOHSURSULHWjGLUHVLVWHQ]D
alla trazione.
REACÇÕES ADVERSAS
$VVXWXUDVHPSROLpVWHUSURYRFDPXPDUHDFomRLQÀDPDWyULDDJXGDPtQLPD
QRVWHFLGRVTXHpVHJXLGDSHODHQFDSVXODomRJUDGXDOGDVXWXUDSRUWHFLGR
FRQMXQWLYR¿EURVR$6XWXUDHPSROLpVWHUQmRpDEVRUYLGDQHPVHFRQKHFHP
DOWHUDo}HVVLJQL¿FDWLYDVGDUHVLVWrQFLDjWHQVmRin vivo.
*OLHIIHWWLLQGHVLGHUDWLDVVRFLDWLDOO¶XVRGHOSUHVHQWHGLVSRVLWLYRFRPSUHQGRQR
deiscenza della ferita, formazione di calcoli negli apparati urinario e biliare
qualora vi sia un contatto prolungato con soluzioni saline quali urina e bile,
LQIH]LRQLDOODIHULWDOLHYLVVLPDUHD]LRQHLQ¿DPPDWRULDDFXWDGHOWHVVXWR
nonché dolore, edema ed eritema in corrispondenza del sito della ferita.
/RVHIHFWRVDGYHUVRVDVRFLDGRVFRQHOXVRGHHVWHGLVSRVLWLYRLQFOX\HQ
GHKLVFHQFLDGHODKHULGDIRUPDFLyQGHFiOFXORVHQORVWUDFWRVXULQDULR\ELOLDU
cuando se produce el contacto prolongado con soluciones salinas tales como la
RULQD\ODELOLVKHULGDVLQIHFWDGDVUHDFFLyQLQÀDPDWRULDDJXGDPtQLPDGHOWHMLGR
y dolor, edema y eritema en el lugar de la herida.
2VHIHLWRVDGYHUVRVDVVRFLDGRVjXWLOL]DomRGHVWHGLVSRVLWLYRLQFOXHP
GHLVFrQFLDGDIHULGDIRUPDomRGHFiOFXORVQRVWUDFWRVXULQiULRHELOLDUHP
FDVRGHFRQWDFWRSURORQJDGRFRPVROXo}HVVDOLQDVFRPRDXULQDHDEtOLV
LQIHFomRGDIHULGDUHDFomRLQÀDPDWyULDDJXGDPtQLPDGRVWHFLGRVGRU
edema e eritema no local da ferida.
GARANZIA LIMITATA, LIMITAZIONE DELLE RESPONSABILITÀ E
DISCONOSCIMENTO DI ALTRE GARANZIE
4XHVWRSURGRWWRqJDUDQWLWRSULYRGLGLIHWWLGHLPDWHULDOLHGLODYRUD]LRQH
4XDORUDYHQJDVWDELOLWRFKHLOSURGRWWRHUDGLIHWWRVRDOPRPHQWRGHOOD
VSHGL]LRQHO¶81,&$UHVSRQVDELOLWjGL,Y\6SRUWV0HGLFLQHqODVRVWLWX]LRQH
del prodotto.
,OSURGXWWRUHO¶LPSRUWDWRUHHLIRUQLWRULGHLSURGRWWL,Y\6SRUWV0HGLFLQH
QRQVLDVVXPHUDQQRDOFXQDUHVSRQVDELOLWjSHUFRPSOLFD]LRQLRDOWULHIIHWWL
che possono presentarsi per cause quali indicazioni o tecnica chirurgica
non corrette, scelta del materiale o manipolazione non idonee, uso o
manipolazione degli strumenti non adeguata, asepsi e così via. Eventuali
FRPSOLFD]LRQLGLTXHVWRWLSRRDOWUHFRQVHJXHQ]HVRQRGLUHVSRQVDELOLWjGHO
FKLUXUJRFKHHVHJXHO¶LQWHUYHQWR
GARANTÍA LIMITADA, LIMITACIÓN DE RESPONSABILIDAD Y EXCLUSIÓN
DE OTRAS GARANTÍAS
*DUDQWL]DPRVTXHHVWHSURGXFWRQRWLHQHGHIHFWRVGHPDWHULDOQLGHIDEULFDFLyQ
En caso de que se determine que el producto estaba defectuoso cuando se
HQYLyODÒ1,&$UHVSRQVDELOLGDGGH,Y\6SRUWV0HGLFLQHVHUiUHHPSOD]DUHO
producto.
(OIDEULFDQWHHOLPSRUWDGRU\ORVSURYHHGRUHVGHSURGXFWRV,Y\6SRUWV0HGLFLQH
no se hacen responsables de complicaciones u otros efectos que se puedan
PDQLIHVWDUGHELGRDLQGLFDFLRQHVRWpFQLFDVTXLU~UJLFDVLQFRUUHFWDVHOHFFLyQ
LQFRUUHFWDGHOPDWHULDORODPDQLSXODFLyQGHOPLVPRXVRLQDSURSLDGRGHORV
instrumentos, asepsia, etc. El cirujano es el responsable de cualquiera de estas
complicaciones u otras consecuencias.
GARANTIA LIMITADA, LIMITAÇÃO DE RESPONSABILIDADE E RECUSA
DE OUTRAS GARANTIAS
(VWHSURGXWRWHPXPDJDUDQWLDFRQWUDGHIHLWRVGHPDWHULDOHPmRGHREUD
Caso se determine que o produto apresentava algum defeito aquando do
HQYLRDÒ1,&$UHVSRQVDELOLGDGHGD,Y\6SRUWV0HGLFLQHVHUiDVXEVWLWXLomR
do produto.
2IDEULFDQWHRLPSRUWDGRUHRVIRUQHFHGRUHVGRVSURGXWRVGD,Y\6SRUWV
0HGLFLQHQmRVmRUHVSRQViYHLVSRUFRPSOLFDo}HVRXRXWURVHIHLWRVTXH
SRVVDPRFRUUHUSRUUD]}HVFRPRLQGLFDo}HVRXWpFQLFDFLU~UJLFDLQFRUUHFWDV
escolha inadequada de material ou manuseamento indevido do mesmo,
XWLOL]DomRRXPDQXVHDPHQWRQmRDGHTXDGRGRVLQVWUXPHQWRVDVVHSVLD
HQWUHRXWURV2FLUXUJLmRpUHVSRQViYHOSRUWDLVFRPSOLFDo}HVRXRXWUDV
FRQVHTXrQFLDV
RIORDINO:
,PSXJQDWXUD6KDUS6KRRWHU®FRGLFH
Sutura chirurgica SharpShooter®FRGLFH
Cannule SharpShooter®FRGLFL
$QWHULRUH
GHVWUDVLQLVWUD
“Do not re-use”
“Do not resterilize”
“Sterilized using irradiation”
PEDIDOS:
Mango SharpShooter®Q~PHURGHUHIHUHQFLD
6XWXUDTXLU~UJLFD6KDUS6KRRWHU®Q~PHURGHUHIHUHQFLD
Cánulas SharpShooter®Q~PHURGHUHIHUHQFLD
$QWHULRU
GHUHFKDL]TXLHUGD
ENCOMENDAR:
Pega SharpShooter®UHIHUrQFLD
6XWXUDFLU~UJLFD6KDUS6KRRWHU®UHIHUrQFLD
Cânulas SharpShooter®UHIHUrQFLDV
$QWHULRU
GLUHLWDHVTXHUGD
Authorized EC representative:
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Rx Only
IT
Manufacturer:
Ivy Sports Medicine
545 Penobscot Drive
Redwood City, CA 94063
USA
ES
5296-Ed.-A 01/2013
PT
SUTURE CHIRURGICALE SHARPSHOOTER
Polyester, tressée, verte, 91,4 cm (36”)
2-0 U.S.P. 3 métrique
Double aiguille de 33 cm (13”)
de long x 0,7 mm (0,026”) de diam.
SHARPSHOOTER NAHTMATERIAL
SUTURA CHIRURGICA SHARPSHOOTER
SUTURA QUIRÚRGICA SHARPSHOOTER
SUTURA CIRÚRGICA SHARPSHOOTER®
3RO\HVWHUJUQJHÁRFKWHQFPµ
USP 2-0 (3 metrisch)
Doppelt armierte Nadeln, 33 cm (13”) lang x
0,7 mm (0,026”) Durchmesser
Filo in poliestere intrecciato verde 91,4 cm (36”)
cal. U.S.P. 2-0, sist. metrico 3,0
Aghi a doppia punta da 33 cm (13”)
di lunghezza x 0,7 mm (0,026”) di diametro
Poliéster trenzado verde de 91,4 cm (36”)
2-0 U.S.P., 3,0 métrico
Agujas de brazo doble de 33 cm (13”)
Long. x 0,7 mm (0,026”) diám.
Trançada verde, em poliéster, 91,4 cm (36”)
2-0 U.S.P., 3,0 sistema métrico
Agulhas duplas para sutura 33 cm (13”)
comprimento x 0,7 mm (0,026”) diâm.
Important information for the operating surgeon
Informations importantes à l’attention du chirurgien
Wichtige Informationen für den behandelnden Chirurgen
Informazioni importanti per il chirurgo
Información importante para el cirujano
Informações importantes para o cirurgião
DESCRIPTION
DESCRIPTION
BESCHREIBUNG
DESCRIZIONE
DESCRIPCIÓN
DESCRIÇÃO
SharpShooter® Surgical Suture is a nonabsorbable, sterile, surgical
suture composed of braided Poly(ethylene terephthalate)(PET) and
DI¿[HGWRGRXEOHDUPHGQHHGOHVVWUDLJKWWURFDUSRLQWFP´ORQJ
E\PP´LQGLDPHWHU7KHVXWXUHLVSUHSDUHGIURP¿EHUVRI
high molecular weight, long-chain, linear polyesters having recurrent
DURPDWLFULQJVDVDQLQWHJUDOFRPSRQHQW7KHVXWXUHLVFP´
863PHWULFEUDLGHGDQGSURYLGHGZLWKDVLOLFRQHFRDWLQJDQG
dyed (green). The pigment for the green dyed suture is D&C Green
No. 6. The product meets all the requirements established by the
United States Pharmacopeia (U.S.P.) for Nonabsorbable Surgical
Suture.
/DVXWXUH6KDUS6KRRWHU® est une suture chirurgicale non résorbable, stérile,
WUHVVpHFRPSRVpHGHSRO\pWK\OqQHWpUpSKWDODWH3(7¿[pHjXQHGRXEOH
DLJXLOOHGURLWHjSRLQWGHWURFDUWGHFP´GHORQJHWPP´
GHGLDPqWUH(OOHHVWIDEULTXpHjEDVHGH¿EUHVGHSRO\HVWHUVOLQpDLUHVj
PDVVHPROpFXODLUHpOHYpHHWjORQJXHFKDvQHTXLSRVVqGHQWGHVQR\DX[
DURPDWLTXHVSpULRGLTXHV(OOHPHVXUHFP´863PpWULTXH
(OOHHVWWUHVVpHHWIRXUQLHHQGXLWHGHVLOLFRQHHWWHLQWpHHQYHUW/HSLJPHQW
XWLOLVpSRXUODWHLQWHYHUWHHVW©'&*UHHQ1ƒª/HSURGXLWHVWFRQIRUPH
jWRXWHVOHVH[LJHQFHVpWDEOLHVSDUODSKDUPDFRSpHGHVeWDWV8QLV8QLWHG
States Pharmacopeia, U.S.P.) pour la catégorie des sutures chirurgicales non
absorbables.
SharpShooter® Nahtmaterial ist ein nicht resorbierbares, steriles Nahtmaterial
DXVJHÀRFKWHQHP3RO\HWK\OHQWHUHSKWKDODW3(7GDVDQGRSSHOWDUPLHUWHQ
JHUDGHQ1DGHOQPLW7URNDUVSLW]HEHIHVWLJWLVWGLHFP”) lang sind und
einen Durchmesser von 0,7 mm (0,026”) haben. Das Nahtmaterial besteht aus
linearen, langkettigen Polyesterfasern mit hohem Molekulargewicht, die als wesentliche Komponente wiederkehrende aromatische Ringstrukturen enthalten.
'DV1DKWPDWHULDOLVWFP”ODQJ863PHWULVFKJHÀRFKWHQPLW
6LOLNRQEHVFKLFKWHWXQGJUQJHIlUEW)UGLHJUQH)lUEXQJGHV1DKWPDWHULDOVZLUGGHU)DUEVWRIIÄ'&*UHHQ1U³YHUZHQGHW'DV3URGXNWHUIOOWDOOH
$QIRUGHUXQJHQGHU8QLWHG6WDWHV3KDUPDFRSHLD863IUQLFKWUHVRUELHUEDUH
Nahtmaterialien.
/DVXWXUDFKLUXUJLFD6KDUS6KRRWHU® è una sutura chirurgica sterile non
DVVRUELELOHGLSROLHWLOHQWHUHIWDODWR3(7LQWUHFFLDWRHGq¿VVDWDDGDJKLD
GRSSLDSXQWDGLULWWLFRQSXQWDWUHTXDUWLGLFP´GLOXQJKH]]DHPP
´GLGLDPHWUR/DVXWXUDqUHDOL]]DWDXVDQGR¿EUHGLSROLHVWHULOLQHDUL
a catena lunga ad alto peso molecolare che comprendono anelli aromatici
ULFRUUHQWLFRPHFRPSRQHQWHLQWHJUDWR/DVXWXUDqOXQJDFP´
FDO863VLVWPHWULFRKDXQDVWUXWWXUDDWUHFFLDHGqGRWDWDGL
ULYHVWLPHQWRGLVLOLFRQH/DVXWXUDqWLQWDLQYHUGHFRQLOSLJPHQWR'&*UHHQ
1,OSURGRWWRqFRQIRUPHDWXWWLLUHTXLVLWLLPSRVWLGDOODIDUPDFRSHDGHJOL
Stati Uniti (U.S.P.) per le suture chirurgiche non assorbibili.
/DVXWXUDTXLU~UJLFD6KDUS6KRRWHU®HVXQDVXWXUDTXLU~UJLFDQRDEVRUELEOH
estéril compuesta por tereftalato de polietileno (PET) trenzado y unido a agujas
GHEUD]RGREOHUHFWDVGHSXQWDWURFDUGHFP´GHODUJRSRUPP
´GHGLiPHWUR/DVXWXUDHVWiIDEULFDGDDSDUWLUGH¿EUDVGHSROLpVWHUHV
lineales de alto peso molecular y cadena larga, con anillos aromáticos
UHFXUUHQWHVFRPRFRPSRQHQWHLQWHJUDO/DVXWXUDHVWUHQ]DGD\PLGHFP
´863PpWULFR\VHVXPLQLVWUDFRQXQUHYHVWLPLHQWRVLOLFRQDGR\
teñido (verde). El pigmento de la sutura teñida de verde es D&C Green n.º 6. El
SURGXFWRVDWLVIDFHWRGRVORVUHTXLVLWRVHVWDEOHFLGRVSRUOD)DUPDFRSHLDGHORV
(VWDGRV8QLGRV8QLWHG6WDWHV3KDUPDFRSHLD863SDUDVXWXUDVTXLU~UJLFDV
no absorbibles.
SharpShooter®pXPDVXWXUDFLU~UJLFDQmRDEVRUYtYHOHVWHULOL]DGDFRPSRVWD
SRUSROLHWLOHQRWHUHIWDODWR3(7WUDQoDGRH¿[DGDHPDJXOKDVGXSODVSDUD
VXWXUDUHFWDVGHSRQWDWURFDUWHFRPFP´GHFRPSULPHQWRHPP
´GHGLkPHWUR$VXWXUDpIHLWDGH¿EUDVGHSROLpVWHUHVOLQHDUHVGH
alto peso molecular e cadeias longas, com anéis aromáticos recorrentes
FRPRXPFRPSRQHQWHLQWHJUDO$VXWXUDWHPFP´863
QRVLVWHPDPpWULFRpWUDQoDGDWHPXPUHYHVWLPHQWRGHVLOLFRQHHpWLQJLGD
YHUGH2SLJPHQWRGDVXWXUDWLQJLGDGHYHUGHpR'&*UHHQ1R2
SURGXWRFXPSUHFRPWRGRVRVUHTXLVLWRVHVWDEHOHFLGRVSHOD)DUPDFRSHLD
$PHULFDQD863SDUDVXWXUDVFLU~UJLFDVQmRDEVRUYtYHLV
INDICATIONS
/DVXWXUHHQ3(7HVWLQGLTXpHSRXUOHUDSSURFKHPHQWHWRXODOLJDWXUHGHV
tissus mous.
INDIKATIONEN
3(71DKWPDWHULDOLVW]XUDOOJHPHLQHQ9HUZHQGXQJIUGLH$GDSWLRQYRQ
:HLFKJHZHEHXQGRGHU/LJDWXULQGL]LHUW
SharpShooter Nahtmaterial ist zur Verwendung mit dem SharpShooter Nahtsystem bei der Behandlung von Meniskusverletzungen im Knie vorgesehen.
INDICATIONS FOR USE
3(76XWXUHLVLQGLFDWHGIRUXVHLQJHQHUDOVRIWWLVVXHDSSUR[LPDWLRQ
and/or ligation.
The SharpShooter Surgical Sutures are designed to be used with the
SharpShooter Tissue Repair System for use in the repair of injuries to
the meniscus of the Knee.
CONTRAINDICATIONS
None known.
WARNINGS
'RQRWUHVWHULOL]H'LVFDUGRSHQXQXVHGVXWXUHV
Contents sterile unless package has been opened or
damaged.
2. Users should be familiar with surgical procedures and techniques
involving nonabsorbable sutures before employing PET suture for
wound closures, as the risk of wound dehiscence may vary with the
site of the application and the suture material used.
$FFHSWDEOHVXUJLFDOSUDFWLFHPXVWEHIROORZHGZLWKUHVSHFWWR
drainage and closure of infected or contaminated wounds.
PRECAUTIONS
,QKDQGOLQJWKLVRUDQ\RWKHUVXWXUHPDWHULDOFDUHVKRXOGEHWDNHQ
WRDYRLGGDPDJHIURPKDQGOLQJ$YRLGFUXVKLQJRUFULPSLQJGDPDJH
due to application of surgical instruments such as suture passers,
forceps, or needle holders.
$VZLWKDQ\VXWXUHPDWHULDODGHTXDWHNQRWVHFXULW\UHTXLUHVWKH
DFFHSWDEOHVXUJLFDOWHFKQLTXHRIÀDWVTXDUHWLHVZLWKDGGLWLRQDO
WKURZVDVZDUUDQWHGE\VXUJLFDOFLUFXPVWDQFHDQGWKHH[SHULHQFHRI
the surgeon.
8VHUVVKRXOGH[HUFLVHFDXWLRQZKHQKDQGOLQJVXUJLFDOQHHGOHVWR
avoid inadvertent needle sticks. Discard used needles in “sharps”
container.
Sharpshooter Surgical Suture is Single Use Only.
Do Not Reuse. Do Not Resterilize.
ADVERSE REACTIONS
3RO\HVWHU6XWXUHHOLFLWVDPLQLPDODFXWHLQÀDPPDWRU\UHDFWLRQLQ
tissues which is followed by gradual encapsulation of the suture by
¿EURXVFRQQHFWLYHWLVVXH3RO\HVWHU6XWXUHLVQRWDEVRUEHGQRULVDQ\
VLJQL¿FDQWFKDQJHLQWHQVLOHVWUHQJWKUHWHQWLRQNQRZQWRRFFXUin vivo.
$GYHUVHHIIHFWVDVVRFLDWHGZLWKWKHXVHRIWKLVGHYLFHLQFOXGHZRXQG
dehiscence, calculi formation in urinary and biliary tracts when
prolonged contact with salt solutions such as urine and bile occurs,
LQIHFWHGZRXQGVPLQLPDODFXWHLQÀDPPDWRU\WLVVXHUHDFWLRQDQGSDLQ
edema, and erythema at the wound site.
LIMITED WARRANTY, LIMITATION OF LIABILITY AND DISCLAIMER
OF OTHER WARRANTIES
This product is warranted to be free from defects in material and
ZRUNPDQVKLS,QWKHHYHQWLWLVGHWHUPLQHGWKHSURGXFWZDVGHIHFWLYH
ZKHQVKLSSHG,Y\6SRUWV0HGLFLQH¶V62/(UHVSRQVLELOLW\VKDOOEHWKH
replacement of the product.
7KHPDQXIDFWXUHUWKHLPSRUWHUDQGWKHVXSSOLHUVRI,Y\6SRUWV
Medicine products are not liable for complications or other effects
that might occur for reasons such as incorrect indications or surgical
technique, unsuitable choice of material or handling thereof,
unsuitable use or handling of the instruments, asepsis and so on. The
operating surgeon is responsible for any such complications or other
consequences.
RE-ORDERING:
SharpShooter®+DQGOH5HIHUHQFH1XPEHU
SharpShooter®6XUJLFDO6XWXUH5HIHUHQFH1XPEHU
SharpShooter®&DQQXODV5HIHUHQFH1XPEHUV
$QWHULRU
5LJKW/HIW
/HVVXWXUHVFKLUXUJLFDOHV6KDUS6KRRWHUVRQWFRQoXHVSRXUrWUHXWLOLVpHV
avec le système de réparation tissulaire SharpShooter dans le cadre de la
réparation des lésions méniscales du genou.
CONTRE-INDICATIONS
$XFXQHFRQWUHLQGLFDWLRQFRQQXH
AVERTISSEMENTS
1HSDVUHVWpULOLVHU-HWHUOHVVXWXUHVRXYHUWHVHWQRQ
XWLOLVpHV&RQWHQXVWpULOHVDXIVLO¶HPEDOODJHDpWpRXYHUW
ou endommagé.
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WHFKQLTXHVUHODWLYHVDX[VXWXUHVQRQDEVRUEDEOHVDYDQWG¶XWLOLVHUOHV
sutures en PET pour la fermeture des plaies. En effet, le risque de
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instruments utilisés pour la suture.
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contaminées.
PRÉCAUTIONS
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YHLOOHUjpYLWHUWRXWGRPPDJHSRVVLEOHeYLWHUG¶pFUDVHURXGHSLQFHUOHV
VXWXUHVORUVGHO¶XWLOLVDWLRQG¶LQVWUXPHQWVFKLUXUJLFDX[FRPPHOHVIRUFHSV
ou les porte-aiguilles.
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le respect des techniques chirurgicales appropriées concernant les
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FLUFRQVWDQFHVFKLUXUJLFDOHVHWGHO¶H[SpULHQFHGXFKLUXUJLHQ
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D¿QG¶pYLWHUOHVSLT€UHVDFFLGHQWHOOHV-HWHUOHVDLJXLOOHVXVDJpHVGDQVXQ
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La suture chirurgicale Sharpshooter est réservée à un
usage unique. Ne pas réutiliser. Ne pas restériliser.
RÉACTIONS INDÉSIRABLES
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(OOHQ¶HVWSDVDEVRUEpHHWDXFXQFKDQJHPHQWVLJQL¿FDWLIGHVDUpVLVWDQFHj
ODWUDFWLRQQ¶DSXrWUHREVHUYpin vivo.
/HVUpDFWLRQVLQGpVLUDEOHVDVVRFLpHVjO¶XWLOLVDWLRQGHFHGLVSRVLWLILQFOXHQW
déhiscence de la plaie, formation de calculs dans les voies urinaires ou
biliaires en cas de contact prolongé avec des solutions salines telles que
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ainsi que douleur, œdème et érythème sur le site de la plaie.
LIMITATION DE GARANTIE, LIMITE DE RESPONSABILITÉ
ET EXCLUSION DE TOUTE AUTRE GARANTIE
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ODOLYUDLVRQ,Y\6SRUWV0HGLFLQHHVW81,48(0(17WHQXHGHOHUHPSODFHU
/HIDEULFDQWO¶LPSRUWDWHXUHWOHVIRXUQLVVHXUVGHVSURGXLWV,Y\6SRUWV
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inadapté ou une manipulation inappropriée du produit, une utilisation ou une
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responsable de toutes les complications ou autres conséquences.
RÉAPPROVISIONNEMENT :
Poignée SharpShooter®UpIpUHQFH
Suture chirurgicale SharpShooter®UpIpUHQFH
Canules SharpShooter®UpIpUHQFHV
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“Use by date. . .
(Year, Month)”
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®
www.ivysportsmed.com
Polyester, Green Braided 91.4 cm (36”)
2-0 U.S.P. 3.0 Metric
Double-Armed Needles 33 cm (13”)
Long x 0.7 mm (0.026”) Dia.
SHARPSHOOTER SURGICAL SUTURE
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de feridas infectadas ou contaminadas.
REACCIONES ADVERSAS
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WHMLGRVVHJXLGDGHODHQFDSVXODFLyQJUDGXDOGHODVXWXUDSRUHOWHMLGRFRQHFWLYR
¿EURVR/DVXWXUDGHSROLpVWHUQRVHDEVRUEHQLWDPSRFRVHFRQRFHQLQJ~Q
FDPELRVLJQL¿FDWLYRHQODUHWHQFLyQGHODUHVLVWHQFLDWHQVRUDin vivo.
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KONTRAINDIKATIONEN
Keine bekannt.
WARNHINWEISE
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1DKWPDWHULDOHQWVRUJHQ'HU,QKDOWLVWQXUEHLXQEHVFKlGLJWHU
XQGXQJH|IIQHWHU9HUSDFNXQJVWHULO
$QZHQGHUPVVHQPLWGHQFKLUXUJLVFKHQ9HUIDKUHQXQG7HFKQLNHQEHLGHU
Verwendung von nicht resorbierbarem Nahtmaterial vertraut sein, bevor das
PET-Nahtmaterial zum Verschluss von Wunden verwendet wird, da das Risiko
HLQHU:XQGGHKLV]HQ]YRQGHU$QZHQGXQJVVWHOOHXQGGHPYHUZHQGHWHQ
Nahtmaterial abhängt.
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PXVVJHPl‰DQHUNDQQWHUFKLUXUJLVFKHU3UD[LVYRUJHJDQJHQZHUGHQ
VORSICHTSMASSNAHMEN
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%HLGHU9HUZHQGXQJYRQFKLUXUJLVFKHQ)KUXQJVLQVWUXPHQWHQ=DQJHQRGHU
1DGHOKDOWHUQGDUDXIDFKWHQGDVVGDV1DKWPDWHULDOQLFKWGXUFK4XHWVFKHQ
RGHU)DOWHQEHVFKlGLJWZLUG
2. Wie bei allen Nahtmaterialien muss zur ausreichenden Knotensicherheit die
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wobei je nach Gegebenheiten und Ermessen des Chirurgen zusätzliche
Schlingen verwendet werden.
%HLGHU+DQGKDEXQJFKLUXUJLVFKHU1DGHOQYRUVLFKWLJYRUJHKHQXPYHUVHhentliche Stichverletzungen zu vermeiden. Gebrauchte Nadeln in einem
Kanülenentsorgungsbehälter entsorgen.
SharpShooter Nahtmaterial ist nur zum einmaligen
Gebrauch bestimmt. Nicht wiederverwenden.
Nicht erneut sterilisieren.
EINGESCHRÄNKTE GARANTIE, HAFTUNGSBESCHRÄNKUNG UND
AUSSCHLUSS SONSTIGER GEWÄHRLEISTUNGEN
Es wird gewährleistet, dass dieses Produkt frei von Material- und VerarbeiWXQJVIHKOHUQLVW)DOOVIHVWJHVWHOOWZLUGGDVVGDV3URGXNWEHUHLWVEHLP9HUVDQG
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verantwortlich.
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Medicine übernehmen keine Haftung bei Komplikationen oder anderweitigen
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“Caution”
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INDICACIONES DE USO
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de tejido blando.
INDICAÇÕES DE UTILIZAÇÃO
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OLJDomRGRVWHFLGRVPROHV
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sistema di riparazione tessutale SharpShooter per la riparazione di lesioni al
menisco del ginocchio.
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meniscos de la rodilla.
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lesões no menisco do joelho.
CONTROINDICAZIONI
Nessuna nota.
CONTRAINDICACIONES
No se conoce ninguna.
CONTRA-INDICAÇÕES
Nenhuma conhecida.
AVVERTENZE
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sia stata aperta o danneggiata.
ADVERTENCIAS
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El contenido se suministra estéril, a menos que el envase se
haya abierto o dañado.
AVISOS
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2FRQWH~GRGDHPEDODJHPHVWiHVWHULOL]DGRDPHQRVTXH
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2. Gli operatori devono avere dimestichezza con le procedure e le tecniche
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la sutura in PET per la chiusura di ferite, in quanto il rischio di deiscenza
della ferita può variare a seconda del sito di applicazione e del materiale
della sutura utilizzata.
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TXLU~UJLFRVTXHLQYROXFUDQHOXVRGHVXWXUDVQRDEVRUELEOHVDQWHVGHHPSHODU
la sutura PET para cerrar heridas, ya que el riesgo de dehiscencia de las
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utilizado.
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DVWpFQLFDVFLU~UJLFDVXWLOL]DGRVFRPVXWXUDVQmRDEVRUYtYHLVDQWHVGH
XWLOL]DUHPDVXWXUDHP3(7SDUDIHFKDUIHULGDVSRLVRULVFRGHGHLVFrQFLD
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riguarda il drenaggio e la chiusura di ferite infette e contaminate.
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de heridas infectadas o contaminadas.
PRECAUZIONI
0DQLSRODUHTXHVWRRTXDOVLDVLDOWURPDWHULDOHGHOODVXWXUDFRQFDXWHOD
per evitare possibili danni. Evitare di schiacciare o piegare la sutura con
strumenti chirurgici quali passa-sutura, pinze o porta-aghi.
PRECAUCIONES
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SRUDSODVWDPLHQWRRFRUWHGHELGRDODDSOLFDFLyQGHLQVWUXPHQWRVTXLU~UJLFRV
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PRECAUÇÕES
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ou porta-agulhas.
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GHEHHPSOHDUODWpFQLFDTXLU~UJLFDDFHSWDEOHGHDWDGXUDVFXDGUDGDV\SODQDV
FRQSDVDGDVDGLFLRQDOHVVHJ~QORLQGLTXHQODVFLUFXQVWDQFLDVTXLU~UJLFDV\OD
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el punzado accidental. Desecha las agujas usadas en envases para objetos
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SUySULRVSDUDREMHFWRVD¿DGRV
La sutura quirúrgica Sharpshooter está diseñada
exclusivamente para un solo uso. No reutilizar.
No reesterilizar.
A Sutura cirúrgica Sharpshooter destina-se apenas a
uma única utilização. Não reutilize. Não reesterilize.
2. Come con qualsiasi altro materiale di sutura, per ottenere una sicurezza
del nodo adeguata utilizzare la tecnica chirurgica accettata di legature
quadrate piane e passaggi aggiuntivi, qualora indicati in base alle
FLUFRVWDQ]HHDOO¶HVSHULHQ]DGHOFKLUXUJR
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per prevenire punture accidentali. Gettare gli aghi usati in recipienti
riservati a strumenti acuminati.
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monouso. Non riutilizzare. Non risterilizzare.
UNERWÜNSCHTE EREIGNISSE
Polyester-Nahtmaterial verursacht eine minimale akute Entzündungsreaktion im
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Bindegewebe. Polyester-Nahtmaterial wird nicht resorbiert. Es sind auch keine
VLJQL¿NDQWHQbQGHUXQJHQEHLP(UKDOWGHU5HL‰IHVWLJNHLWin vivo bekannt.
8QHUZQVFKWH(UHLJQLVVHLQ=XVDPPHQKDQJPLWGHU9HUZHQGXQJGLHVHV
3URGXNWVVLQGXD:XQGGHKLV]HQ].RQNUHPHQWELOGXQJLQGHU*DOOHXQGLQGHQ
+DUQZHJHQEHLOlQJHUHP.RQWDNWPLW6DO]O|VXQJHQ]%8ULQXQG*DOOHQVlXUH
:XQGLQIHNWLRQHQPLQLPDOHDNXWH(QW]QGXQJVUHDNWLRQLP*HZHEH6FKPHU]HQ
Ödeme und Erytheme an der Wundstelle.
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INDICAZIONI PER L’USO
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di tessuto molle.
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EFFETTI INDESIDERATI
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nei tessuti, seguita dal graduale incapsulamento della sutura nel tessuto
FRQQHWWLYR¿EURVR/DVXWXUDGLSROLHVWHUHQRQYLHQHDVVRUELWDHin vivo non
qVWDWDRVVHUYDWDDOFXQDPRGL¿FDVLJQL¿FDWLYDGHOOHSURSULHWjGLUHVLVWHQ]D
alla trazione.
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de feridas infectadas ou contaminadas.
REACCIONES ADVERSAS
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¿EURVR/DVXWXUDGHSROLpVWHUQRVHDEVRUEHQLWDPSRFRVHFRQRFHQLQJ~Q
FDPELRVLJQL¿FDWLYRHQODUHWHQFLyQGHODUHVLVWHQFLDWHQVRUDin vivo.
REACÇÕES ADVERSAS
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FRQMXQWLYR¿EURVR$6XWXUDHPSROLpVWHUQmRpDEVRUYLGDQHPVHFRQKHFHP
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deiscenza della ferita, formazione di calcoli negli apparati urinario e biliare
qualora vi sia un contatto prolungato con soluzioni saline quali urina e bile,
LQIH]LRQLDOODIHULWDOLHYLVVLPDUHD]LRQHLQ¿DPPDWRULDDFXWDGHOWHVVXWR
nonché dolore, edema ed eritema in corrispondenza del sito della ferita.
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GHKLVFHQFLDGHODKHULGDIRUPDFLyQGHFiOFXORVHQORVWUDFWRVXULQDULR\ELOLDU
cuando se produce el contacto prolongado con soluciones salinas tales como la
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y dolor, edema y eritema en el lugar de la herida.
2VHIHLWRVDGYHUVRVDVVRFLDGRVjXWLOL]DomRGHVWHGLVSRVLWLYRLQFOXHP
GHLVFrQFLDGDIHULGDIRUPDomRGHFiOFXORVQRVWUDFWRVXULQiULRHELOLDUHP
FDVRGHFRQWDFWRSURORQJDGRFRPVROXo}HVVDOLQDVFRPRDXULQDHDEtOLV
LQIHFomRGDIHULGDUHDFomRLQÀDPDWyULDDJXGDPtQLPDGRVWHFLGRVGRU
edema e eritema no local da ferida.
GARANZIA LIMITATA, LIMITAZIONE DELLE RESPONSABILITÀ E
DISCONOSCIMENTO DI ALTRE GARANZIE
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del prodotto.
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che possono presentarsi per cause quali indicazioni o tecnica chirurgica
non corrette, scelta del materiale o manipolazione non idonee, uso o
manipolazione degli strumenti non adeguata, asepsi e così via. Eventuali
FRPSOLFD]LRQLGLTXHVWRWLSRRDOWUHFRQVHJXHQ]HVRQRGLUHVSRQVDELOLWjGHO
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GARANTÍA LIMITADA, LIMITACIÓN DE RESPONSABILIDAD Y EXCLUSIÓN
DE OTRAS GARANTÍAS
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En caso de que se determine que el producto estaba defectuoso cuando se
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producto.
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no se hacen responsables de complicaciones u otros efectos que se puedan
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LQFRUUHFWDGHOPDWHULDORODPDQLSXODFLyQGHOPLVPRXVRLQDSURSLDGRGHORV
instrumentos, asepsia, etc. El cirujano es el responsable de cualquiera de estas
complicaciones u otras consecuencias.
GARANTIA LIMITADA, LIMITAÇÃO DE RESPONSABILIDADE E RECUSA
DE OUTRAS GARANTIAS
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Caso se determine que o produto apresentava algum defeito aquando do
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do produto.
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escolha inadequada de material ou manuseamento indevido do mesmo,
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RIORDINO:
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Sutura chirurgica SharpShooter®FRGLFH
Cannule SharpShooter®FRGLFL
$QWHULRUH
GHVWUDVLQLVWUD
“Do not re-use”
“Do not resterilize”
“Sterilized using irradiation”
PEDIDOS:
Mango SharpShooter®Q~PHURGHUHIHUHQFLD
6XWXUDTXLU~UJLFD6KDUS6KRRWHU®Q~PHURGHUHIHUHQFLD
Cánulas SharpShooter®Q~PHURGHUHIHUHQFLD
$QWHULRU
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Rx Only
Authorized EC representative:
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
ENCOMENDAR:
Pega SharpShooter®UHIHUrQFLD
6XWXUDFLU~UJLFD6KDUS6KRRWHU®UHIHUrQFLD
Cânulas SharpShooter®UHIHUrQFLDV
$QWHULRU
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Manufacturer:
Ivy Sports Medicine
545 Penobscot Drive
Redwood City, CA 94063
USA
www.ivysportsmed.com
5296-Ed.-A 01/2013
BACKER 1
BLACK
4/13
CZ
195621
PT-BR
DA
FI
HU
JA
SHARPSHOOTER SURGICAL SUTURE
CHIRURGICKÝ STEH SHARPSHOOTER
KIRURGISK SHARPSHOOTER -SUTUR
SHARPSHOOTER -OMMEL
SHARPSHOOTER SEBÉSZI VARRÓANYAG
SHARPSHOOTER® 外科用縫合針・縫合糸
Poliéster, trançada verde 91,4 cm (36”)
2-0 U.S.P. 3,0 métrico
Agulhas de braços duplos com 33 cm (13”) de
comprimento x 0,7 mm (0,026”) de diâmetro
Polyester, zelený, pletený, 91,4 cm (36”)
Velikost 2-0 dle U.S.P., 3,0 metrická
Dvojité jehly 33 cm (13”)
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3RO\HVWHUJU¡QÁHWWHWFPµ
2-0 U.S.P. 3,0 metrisk
Dobbeltarmede nåle 33 cm (13”)
lange x 0,7 mm (0,026”) i diameter
Polyesteri, vihreä punos 91,4 cm (36”)
2-0 U.S.P. 3,0 metrijärjestelmä
Kaksivartiset neulat 33 cm (13”)
Pitkä x 0,7 mm (0,026”) Halk.
Poliészter, zöld, fonott, 91,4 cm (36”)
2/0 U.S.P. 3/0 metrikus
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網状ポリエステル（緑）91.4cm（36”）
USPサイズ2-0/メートル式寸法3.0
両端針 33cm（13”）
長さ x 0.7mm（0.026”）直径
®
®
®
®
®
Informações importantes para o cirurgião
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Vigtige oplysninger til den opererende kirurg
Tärkeitä tietoja leikkaavalle kirurgille
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重要な情報（執刀医向け）
DESCRIÇÃO
POPIS
BESKRIVELSE
KUVAUS
LEÍRÁS
製品概要
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SRQWDWURFDUWHGHFP´GHFRPSULPHQWRSRUPP´GHGLkPHWUR
$VXWXUDpSUHSDUDGDDSDUWLUGH¿EUDVOLQHDUHVGHSROLpVWHUGHFDGHLDORQJDHHOHYDGR
peso molecular, com anéis aromáticos recorrentes como componente integral.
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FRPUHYHVWLPHQWRGHVLOLFRQHHWLQWXUDYHUGH2SLJPHQWRYHUGHGDVXWXUDpR'&
9HUGH1R2SURGXWRDWHQGHDWRGRVRVUHTXLVLWRVHVWDEHOHFLGRVSHOD)DUPDFRSHLD
GRV(VWDGRV8QLGRV863SDUDVXWXUDVFLU~UJLFDVQmRDEVRUYtYHLV
Chirurgický steh SharpShooter®MHQHYVWĜHEDWHOQêVWHULOQtFKLUXUJLFNêVWHKY\UREHQê
]HVSOpWDQpKRSRO\HW\OpQWHUHIWDOiWX3(7DSĜLSRMHQêNGYRMLWpURYQpMHKOH
VWURNDURYêPKURWHPGpONRXFP´DSUĤPČUHPPP´7HQWR
VWHKMHY\UREHQ]YOiNHQY\VRNRPROHNXOiUQtFKOLQHiUQtFKSRO\HVWHUĤVGORXKêP
ĜHWČ]FHPNWHUpPDMtMDNRLQWHJUiOQtVRXþiVWRSDNXMtFtVHDURPDWLFNiMiGUD6WHK
PiGpONXFP´YHOLNRVWGOH863PHWULFNiMHVSOpWDQêDGRGiYi
VHVHVLOLNRQRYRXSRYUFKRYRXYUVWYRXDREDUYHQêQD]HOHQR3LJPHQWSUR]HOHQČ
]EDUYHQêVWHKMHEDUYLYR'&*UHHQ1R9êUREHNVSOĖXMHYãHFKQ\SRåDGDYN\
VWDQRYHQp8638QLWHG6WDWHV3KDUPDFRSHLDSURQHYVWĜHEDWHOQpFKLUXUJLFNpVWHK\
Kirurgisk SharpShooter®-sutur er en ikke-absorberbar, steril, kirugisk sutur, der består
DIÀHWWHWSRO\HW\OHQWHUHSKWKDODW3(7VRPHUSnVDWGREEHOWDUPHGHQnOHPHG
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IRUEHUHGHVDI¿EUHDIK¡MPROHNXO UY JWODQJN GHWOLQH USRO\HVWHUPHGJHQWDJQH
DURPDWLVNHULQJHVRPHQLQWHJUDONRPSRQHQW6XWXUHQHUFP´863
PHWULVNÀHWWHWOHYHUHVPHGHQVLOLNRQHEHO JQLQJRJHUIDUYHWJU¡Q3LJPHQWHW
IRUGHQJU¡QQHVXWXUHU'&*UHHQQU3URGXNWHWRSI\OGHUDOOHNUDYIDVWVDWDI8QLWHG
6WDWHV3KDUPDFRSHLD863YHGU¡UHQGHLNNHDEVRUEHUEDUNLUXUJLVNVXWXU
SharpShooter®-ommel on kirurginen ei-absorboituva ja steriili ommel, joka on
valmistettu PET-punoksesta (polyetyleeni tereftalaatti) ja joka kiinnitetään kaksivartisiin
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PP´2PPHORQYDOPLVWHWWXVXXUHQPROHN\\OLSDLQRQSLWNlNHWMXLVLVWD
lineaarisista polyesterikuiduista joiden kiinteänä osana ovat toistuvat aromaattiset
UHQNDDW2PPHORQFP´863PHWULMlUMHVWHOPlQSXQRWWXRPPHO
ja se toimitetaan silikonipinnoitettuna ja värjättynä (vihreä). Vihreänä värinä on
'&*UHHQQUR7XRWHWl\WWllNDLNNL863Q8QLWHG6WDWHV3KDUPDFRSHLDHL
absorboituville kirurgisille ompeleille asettamat vaatimukset.
本品は、網状ポリエステル（PET）から構成される非吸収性滅菌外
科用縫合糸が取り付けられた長さFP（”）、直径0.7mm（0.026”）の
両端針（直針、
トロカール型）
です。本縫合糸は、不可欠な構成要素
として連続する芳香環を持つ高分子量の長鎖線状ポリエステル
、USPサイズ2-0/
繊維で製造されています。本縫合糸は、FP（”）
メートル式寸法で、網状にし、
シリコンでコーティング、着色（緑）
されて提供されます。緑の縫合糸の着色に使用した染料は、
「D&C
緑色6号」
です。本品は、米国薬局方（USP）規定の非吸収性縫合糸
の要件をすべて満たしています。
INDICAÇÕES DE USO
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INDIKAATIOT
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WHUHIWDOiWEyO3(7NpV]OWIRQDOPHO\QHNPLQGNpWYpJHFP´KRVV]~pV
PP´iWPpUĘMĦHJ\HQHVWURNiUKHJ\ĦWĦNEHYDQEHIĦ]YH$YDUUyDQ\DJ
QDJ\PROHNXODV~O\~KRVV]~OiQF~OLQHiULVSROLpV]WHUURVWRNEyONpV]OWPHO\HNQHN
LQWHJUiQVUpV]HLD]LVPpWOĘGĘDURPiVJ\ĦUĦN$YDUUyDQ\DJFP´KRVV]~
863PHWULNXVPpUHWĦIRQRWWV]LOLNRQEHYRQDWWDOHOOiWRWWpVV]tQH]HWW
]|OG$]|OGV]tQĦYDUUyDQ\DJRW'&*UHHQ1RV]tQH]pNNHOIHVWHWWpNPHJ
$WHUPpNPHJIHOHOD]$PHULNDL(J\HVOWÈOODPRN*\yJ\V]HUN|Q\YH8QLWHG6WDWHV
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N|YHWHOPpQ\pQHN
$VXWXUD3(7pLQGLFDGDSDUDDSUR[LPDomRHRXOLJDomRGHWHFLGRVPROHV
genéricos.
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SRGYD]RYiQt
Kirurgiske SharpShooter-suturer er fremstillet til brug med SharpShooterY YVUHSDUDWLRQVV\VWHPHWWLOEUXJLUHSDUDWLRQHQDIVNDGHUSnNQ PHQLVNHQ
PET-ommel on tarkoitettu käytettäväksi tavallisissa pehmytkudosten
approksimaatioissa ja/tai ligaatioissa.
ALKALMAZÁSI JAVALLATOK
$VVXWXUDVFLU~UJLFDV6KDUS6KRRWHUVmRSURMHWDGDVSDUDVHUHPXWLOL]DGDVFRPR
Sistema de reparo de tecido SharpShooter no reparo de lesões no menisco do
joelho.
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KONTRAINDIKATIONER
SharpShooter-ompeleita voidaan käyttää yhdessä SharpShooterkudoskorjausjärjestelmän kanssa polven nivelkierukan vammojen korjauksessa.
ポリエステル製縫合糸は、一般的な軟部組織の接近および/また
は結紮で使用を意図したものです。
本品は、膝の半月板損傷の修復に使用するため、
「SharpShooter
組織修復システム」
と併用するために設計されています。
CONTRAINDICAÇÕES
KONTRAINDIKACE
ADVARSLER
Desconhecidas.
Nejsou známy.
VAROVÁNÍ
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fechamento da área infectada ou contaminada.
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PRECAUÇÕES
832=251Č1Ì
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operatéra.
A sutura cirúrgica Shapshooter é para uso único.
Não reutilize. Não reesterilize.
REAÇÕES ADVERSAS
KONTRAINDIKAATIOT
Ei tunneta.
VAROITUKSET
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involverer ikke-absorberbare suturer ved anvendelse af PET-sutur til sårlukning,
da risikoen for sårruptur kan variere, alt efter applikationsstedet og det anvendte
suturmateriale.
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FORHOLDSREGLER
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undgå skade i forbindelse med håndtering. Undgå skade i form af knusning eller
presning i forbindelse med anvendelsen af kirurgiske instrumenter som f.eks.
suturpassere, klemmer eller nåleholdere.
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ei ole vahingoittunut.
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sillä haavan avautumisen riski voi vaihdella operoitavan kohdan ja käytettävän
ommelmateriaalin mukaan.
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VAROTOIMET
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vaurioittamasta materiaaleja. Toimi varovasti, jotta et murskaa tai vaurioita
kirurgisia instrumentteja, kuten ompeleiden kuljettimia, pihtejä tai neulapidikkeitä.
既知の禁忌はありません。
警告
FIGYELMEZTETÉSEK
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csomagolást nem bontották fel és nem sérült meg.
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ÓVINTÉZKEDÉSEK
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Kirurgisk Sharpshooter-sutur er kun til engangsbrug.
Må ikke genbruges. Må ikke resteriliseres.
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BIVIRKNINGER
Sharpshooter-ompeleet ovat kertakäyttöisiä.
Älä käytä uudelleen. Älä steriloi uudelleen.
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GARANTIA LIMITADA, LIMITAÇÃO DE RESPONSABILIDADE E
EXCLUSÃO DE OUTRAS GARANTIAS
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Caso seja determinado que o produto estava defeituoso quando da remessa,
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produto.
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BEGRÆNSET GARANTI, BEGRÆNSET ANSVAR OG
ANSVARSFRASKRIVELSE FOR ANDRE GARANTIER
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Medicines ENESTE ansvar at udskifte produktet.
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er ikke ansvarlige for eventuelle komplikationer eller andre problemer, der måtte
opstå, såsom ukorrekt indicering eller kirurgisk teknik, uegnet valg af materiale
eller håndtering af dette, uegnet brug eller håndtering af instrumenterne, aseptik
osv. Den opererende kirurg er ansvarlig for sådanne komplikationer eller andre
konsekvenser.
HAITTAVAIKUTUKSET
Polyesteriompeleisiin liittyy erittäin pieni akuutin tulehdusreaktion riski kudoksissa,
mitä seuraa ompeleen vähittäinen kapseloituminen säikeiseen sidekudokseen.
Polyesteriommel ei absorboidu, eikä in vivo -kokeissa ole todettu vetolujuuden
retentiossa merkittävää muutosta.
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avautuminen, kivenmuodostus virtsa- ja sappiteissä, kun kyseessä on pitkittynyt
kosketus suolaliuoksiin esimerkiksi virtsa- ja sappiteissä, haavan infektoituminen,
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haava-alueella.
RAJOITETTU TAKUU, VASTUUNRAJOITUS JA
VASTUUVAPAUSLAUSEKE MUISTA TAKUISTA
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tuotteen vaihtaminen.
SharpShooter®KnQGWDJUHIHUHQFHQXPPHU
,Y\6SRUWV0HGLFLQHWXRWWHLGHQYDOPLVWDMDPDDKDQWXRMDMDMlOOHHQP\\MlWHLYlWROH
vastuussa komplikaatioista tai muista vaikutuksista, joita voi tapahtua eri syistä,
kuten virheelliset indikaatiot tai leikkaustekniikka, sopimaton materiaalivalinta tai
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/HLNNDDYDNLUXUJLRQYDVWXXVVDWlOODLVLVWDNRPSOLNDDWLRLVWDWDLPXLVWDVHXUDXNVLVWD
Kirurgisk SharpShooter®VXWXUUHIHUHQFHQXPPHU
TILAAMINEN:
SharpShooter®NDQ\OHUUHIHUHQFHQXPPHU
SharpShooter®NDKYDYLLWHQXPHUR
SharpShooter®RPPHOYLLWHQXPHUR
GENBESTILLING:
NOVOS PEDIDOS:
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SharpShooter®Q~PHURGHUHIHUrQFLD
Chirurgický steh SharpShooter®UHIHUHQþQtþtVOR
SharpShooter® Surgical SutureQ~PHURGHUHIHUrQFLD
Kanyly SharpShooter UHIHUHQþQtþtVOD
SharpShooter NDQ\\OLWYLLWHQXPHURW
SharpShooter®Q~PHURVGHUHIHUrQFLD
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禁忌
Nem ismertek.
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DIWU NVW\UNHQin vivo.
適応
ELLENJAVALLATOK
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neulanpistojen välttämiseksi. Hävitä käytetyt neulat siirtämällä ne käytetyille
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LQÀDPDWyULDDJXGDPtQLPDGHWHFLGRGRUHGHPDHHULWHPDQRORFDOGDOHVmR
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alkalmazni.
2. Kuten kaikkien muidenkin ommelmateriaalien kanssa, solmujen pitävyys on
varmistettava. Niiden on oltava kirurgisesti hyväksyttyjä, litteitä ja tasaisia, ja
tarvittaessa niiden pitävyys on varmistettava tekemällä ylimääräisiä silmukoita
olosuhteiden ja kirurgin kokemuksen mukaan.
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VXWXUDGHSROLpVWHUQmRpDEVRUYLGDHQmRKiUHJLVWURVGHRFRUUrQFLDGHTXDOTXHU
DOWHUDomRVLJQL¿FDWLYDQDUHWHQomRGDUHVLVWrQFLDjWUDomRin vivo.
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QmRVmRUHVSRQViYHLVSRUFRPSOLFDo}HVRXRXWURVHIHLWRVTXHSRVVDPRFRUUHU
GHYLGRDLQGLFDo}HVRXWpFQLFDVFLU~UJLFDVLQFRUUHWDVHVFROKDRXPDQXVHLR
inadequado do material, uso ou manuseio incorreto dos instrumentos, assepsia
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er sterilt, medmindre pakken er blevet åbnet eller er beskadiget.
ADVERTÊNCIAS
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SLFDGDVDFLGHQWDLV'HVFDUWHDVDJXOKDVXVDGDVHPFRQWrLQHUVHVSHFt¿FRVSDUD
objetos pontiagudos.
BRUGERVEJLEDNING
A SharpShooter sebészi varróanyag kizárólag
egyszer használatos. Ne használja fel újra.
Ne sterilizálja újra.
再滅菌しないでください。開封済み、未使用の製品
は廃棄してください。梱包を開封していない、
また
は梱包が破損していない場合に限り、内容物は滅
菌された状態となります。
2. 創傷開離の危険性は適用部位及び使用された縫合材料により
異なる場合があるため、創傷縫合にポリエステル製縫合糸を使
用するにあたり、術者は非吸収性縫合糸にかかわる外科的処置
ないし手技を習熟しておく必要があります。
感染もしくは汚染創の排膿と縫合に関しては条件を満たした外
科診療に従ってください。
使用上の注意
本品またはその他の縫合材料を取り扱う際には、取り扱いによ
る破損を避けるように注意する必要があります。縫合糸通し具、
鉗子や持針器などの器具で縫合糸を押し潰すことや、折り目を
つけることを避けてください。
2. 他の縫合材料と同様、適切な固さの結び目を作るには、平坦な
男結びに加えて手術の環境や術者の経験によっては別の結び
方も必要となります。
術者は、外科用縫合針が刺さらないよう針の取り扱いに注意す
る必要があります。使用済みの針は、
「鋭利物」廃棄容器に廃棄
してください。
本品は、単回使用製品です。再使用しないでくだ
さい。再滅菌しないでください。
副作用
NEMKÍVÁNATOS REAKCIÓK
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YDUUyDQ\DJLVPHUHWHLQNV]HULQWQHPV]tYyGLNIHOin vivoN|UOPpQ\HNN|]|WWpV
V]DNtWyV]LOiUGViJiEDQVHPM|QOpWUHV]LJQL¿NiQVYiOWR]iV
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VHEV]pWYiOiVNĘNpS]ĘGpVDK~J\XWDNEDQpVD]HSHXWDNEDQKDDYDUUyDQ\DJ
KRVV]~LGHLJpULQWNH]LNRO\DQVyWDUWDOP~ROGDWRNNDOPLQWSpOGiXODYL]HOHWYDJ\D]
HSHIHUWĘ]|WWVHEHNPLQLPiOLVDNXWJ\XOODGiVRVV]|YHWLUHDNFLypVIiMGDORP|GpPD
pVEĘUStUDVHEWHUOHWpQ
.25/É72=277*$5$1&,$$)(/(/Ę66e*.25/É72=É6$e6
AZ EGYÉB GARANCIÁK KIZÁRÁSA
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YRQDWNR]LN+DEL]RQ\RVViJRWQ\HUKRJ\DWHUPpNNLV]iOOtWiVNRUKLEiVYROWD],Y\
6SRUWV0HGLFLQHIHOHOĘVVpJH.,=È5Ï/$*DWHUPpNNLFVHUpOpVpUHNRUOiWR]yGLN
$],Y\6SRUWV0HGLFLQHWHUPpNHLQHNJ\iUWyMDLPSRUWiOyMDpVpUWpNHVtWĘLQHP
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RO\DQRNRNEyON|YHWNH]QHNEHPLQWSODKHO\WHOHQLQGLNiFLyYDJ\VHEpV]LWHFKQLND
D]DQ\DJKHO\WHOHQPHJYiODV]WiVDpVDQQDNKDV]QiODWDD]HV]N|]|NQHP
PHJIHOHOĘKDV]QiODWDYDJ\NH]HOpVHQHPPHJIHOHOĘDV]HSV]LVDONDOPD]iVDVWE
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RUYRVDIHOHOĘV
ÚJRARENDELÉS:
ポリエステル製縫合糸は、組織内でわずかな急性炎症反応を引き
起こし、
これに続いて線維性結合組織による段階的なカプセル化
が起こります。ポリエステル製縫合糸は、吸収性がなく、in vivo（生
体内）
で起こるとされている引張強度保持率において著しい変化
は見られていません。
本品使用に関連する副作用には、以下が含まれます。創傷開離、
尿や胆汁など塩溶液に長時間触れた場合に起こる尿路および胆
道内での結石形成、感染創、わずかな急性炎症反応、創部の疼痛、
浮腫および紅斑。
制限付き保証、責任の制限および免責
本品は、材質や仕上がりに欠陥がないものであることを保証しま
す。納入時に欠陥が認められた場合、弊社単独の責任として、製品
の交換を行うものとします。
製造業者、輸入業者および弊社サプライヤーは、使用方法に反し
た適応、手技、不適切な材質の選択や不適切な取り扱い、および、
器具、無菌法などの不適切な使用や取り扱いによる、合併症また
はその他の影響の責任を負わないものとします。当該合併症また
はその他の結果は、執刀医に責任となります。
再発注：
SharpShooter® ハンドル、参照番号：
SharpShooter® 縫合針・縫合糸、参照番号：
SharpShooter® カニューレ、参照番号：
前部
（右）、（左）
SharpShooter®PDUNRODWUHIHUHQFLDV]iP
SharpShooter®VHEpV]LYDUUyDQ\DJUHIHUHQFLDV]iP
SharpShooter®NDQO|NUHIHUHQFLDV]iP
“Use by date. . .
(Year, Month)”
PT-BR
“Consult operating instructions”
“Caution”
CZ
“Do not use if package
is damaged”
“Keep dry”
“Do not re-use”
DA
“Do not resterilize”
“Sterilized using irradiation”
$QWHULRU
MREERVNLYLWHOEDORVNLYLWHO
Authorized EC representative:
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Rx Only
FI
Manufacturer:
Ivy Sports Medicine
545 Penobscot Drive
Redwood City, CA 94063
USA
HU
www.ivysportsmed.com
5296-Ed.-A 01/2013
JA
SHARPSHOOTER SURGICAL SUTURE
CHIRURGICKÝ STEH SHARPSHOOTER
KIRURGISK SHARPSHOOTER -SUTUR
SHARPSHOOTER -OMMEL
SHARPSHOOTER SEBÉSZI VARRÓANYAG
SHARPSHOOTER® 外科用縫合針・縫合糸
Poliéster, trançada verde 91,4 cm (36”)
2-0 U.S.P. 3,0 métrico
Agulhas de braços duplos com 33 cm (13”) de
comprimento x 0,7 mm (0,026”) de diâmetro
Polyester, zelený, pletený, 91,4 cm (36”)
Velikost 2-0 dle U.S.P., 3,0 metrická
Dvojité jehly 33 cm (13”)
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3RO\HVWHUJU¡QÁHWWHWFPµ
2-0 U.S.P. 3,0 metrisk
Dobbeltarmede nåle 33 cm (13”)
lange x 0,7 mm (0,026”) i diameter
Polyesteri, vihreä punos 91,4 cm (36”)
2-0 U.S.P. 3,0 metrijärjestelmä
Kaksivartiset neulat 33 cm (13”)
Pitkä x 0,7 mm (0,026”) Halk.
Poliészter, zöld, fonott, 91,4 cm (36”)
2/0 U.S.P. 3/0 metrikus
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FPµKRVV]~DN[PPµiWPpUęMħHN
網状ポリエステル（緑）91.4cm（36”）
USPサイズ2-0/メートル式寸法3.0
両端針 33cm（13”）
長さ x 0.7mm（0.026”）直径
®
®
®
®
®
Informações importantes para o cirurgião
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Vigtige oplysninger til den opererende kirurg
Tärkeitä tietoja leikkaavalle kirurgille
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重要な情報（執刀医向け）
DESCRIÇÃO
POPIS
BESKRIVELSE
KUVAUS
LEÍRÁS
製品概要
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SRQWDWURFDUWHGHFP´GHFRPSULPHQWRSRUPP´GHGLkPHWUR
$VXWXUDpSUHSDUDGDDSDUWLUGH¿EUDVOLQHDUHVGHSROLpVWHUGHFDGHLDORQJDHHOHYDGR
peso molecular, com anéis aromáticos recorrentes como componente integral.
$VXWXUDpWUDQoDGDHFRQWpPFP´863PpWULFRVHQGRIRUQHFLGD
FRPUHYHVWLPHQWRGHVLOLFRQHHWLQWXUDYHUGH2SLJPHQWRYHUGHGDVXWXUDpR'&
9HUGH1R2SURGXWRDWHQGHDWRGRVRVUHTXLVLWRVHVWDEHOHFLGRVSHOD)DUPDFRSHLD
GRV(VWDGRV8QLGRV863SDUDVXWXUDVFLU~UJLFDVQmRDEVRUYtYHLV
Chirurgický steh SharpShooter®MHQHYVWĜHEDWHOQêVWHULOQtFKLUXUJLFNêVWHKY\UREHQê
]HVSOpWDQpKRSRO\HW\OpQWHUHIWDOiWX3(7DSĜLSRMHQêNGYRMLWpURYQpMHKOH
VWURNDURYêPKURWHPGpONRXFP´DSUĤPČUHPPP´7HQWR
VWHKMHY\UREHQ]YOiNHQY\VRNRPROHNXOiUQtFKOLQHiUQtFKSRO\HVWHUĤVGORXKêP
ĜHWČ]FHPNWHUpPDMtMDNRLQWHJUiOQtVRXþiVWRSDNXMtFtVHDURPDWLFNiMiGUD6WHK
PiGpONXFP´YHOLNRVWGOH863PHWULFNiMHVSOpWDQêDGRGiYi
VHVHVLOLNRQRYRXSRYUFKRYRXYUVWYRXDREDUYHQêQD]HOHQR3LJPHQWSUR]HOHQČ
]EDUYHQêVWHKMHEDUYLYR'&*UHHQ1R9êUREHNVSOĖXMHYãHFKQ\SRåDGDYN\
VWDQRYHQp8638QLWHG6WDWHV3KDUPDFRSHLDSURQHYVWĜHEDWHOQpFKLUXUJLFNpVWHK\
Kirurgisk SharpShooter®-sutur er en ikke-absorberbar, steril, kirugisk sutur, der består
DIÀHWWHWSRO\HW\OHQWHUHSKWKDODW3(7VRPHUSnVDWGREEHOWDUPHGHQnOHPHG
OLJHWURNDUSXQNWGHUHUFP´ODQJHRJPP´LGLDPHWHU6XWXUHQ
IRUEHUHGHVDI¿EUHDIK¡MPROHNXO UY JWODQJN GHWOLQH USRO\HVWHUPHGJHQWDJQH
DURPDWLVNHULQJHVRPHQLQWHJUDONRPSRQHQW6XWXUHQHUFP´863
PHWULVNÀHWWHWOHYHUHVPHGHQVLOLNRQHEHO JQLQJRJHUIDUYHWJU¡Q3LJPHQWHW
IRUGHQJU¡QQHVXWXUHU'&*UHHQQU3URGXNWHWRSI\OGHUDOOHNUDYIDVWVDWDI8QLWHG
6WDWHV3KDUPDFRSHLD863YHGU¡UHQGHLNNHDEVRUEHUEDUNLUXUJLVNVXWXU
SharpShooter®-ommel on kirurginen ei-absorboituva ja steriili ommel, joka on
valmistettu PET-punoksesta (polyetyleeni tereftalaatti) ja joka kiinnitetään kaksivartisiin
QHXORLKLQVHRQVXRUDWURDNDDULNlUNLQHQFP´SLWNlMDKDONDLVLMDOWDDQ
PP´2PPHORQYDOPLVWHWWXVXXUHQPROHN\\OLSDLQRQSLWNlNHWMXLVLVWD
lineaarisista polyesterikuiduista joiden kiinteänä osana ovat toistuvat aromaattiset
UHQNDDW2PPHORQFP´863PHWULMlUMHVWHOPlQSXQRWWXRPPHO
ja se toimitetaan silikonipinnoitettuna ja värjättynä (vihreä). Vihreänä värinä on
'&*UHHQQUR7XRWHWl\WWllNDLNNL863Q8QLWHG6WDWHV3KDUPDFRSHLDHL
absorboituville kirurgisille ompeleille asettamat vaatimukset.
本品は、網状ポリエステル（PET）から構成される非吸収性滅菌外
科用縫合糸が取り付けられた長さFP（”）、直径0.7mm（0.026”）の
両端針（直針、
トロカール型）
です。本縫合糸は、不可欠な構成要素
として連続する芳香環を持つ高分子量の長鎖線状ポリエステル
、USPサイズ2-0/
繊維で製造されています。本縫合糸は、FP（”）
メートル式寸法で、網状にし、
シリコンでコーティング、着色（緑）
されて提供されます。緑の縫合糸の着色に使用した染料は、
「D&C
緑色6号」
です。本品は、米国薬局方（USP）規定の非吸収性縫合糸
の要件をすべて満たしています。
INDICAÇÕES DE USO
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INDIKAATIOT
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PP´iWPpUĘMĦHJ\HQHVWURNiUKHJ\ĦWĦNEHYDQEHIĦ]YH$YDUUyDQ\DJ
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genéricos.
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PET-ommel on tarkoitettu käytettäväksi tavallisissa pehmytkudosten
approksimaatioissa ja/tai ligaatioissa.
ALKALMAZÁSI JAVALLATOK
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Sistema de reparo de tecido SharpShooter no reparo de lesões no menisco do
joelho.
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KONTRAINDIKATIONER
SharpShooter-ompeleita voidaan käyttää yhdessä SharpShooterkudoskorjausjärjestelmän kanssa polven nivelkierukan vammojen korjauksessa.
ポリエステル製縫合糸は、一般的な軟部組織の接近および/また
は結紮で使用を意図したものです。
本品は、膝の半月板損傷の修復に使用するため、
「SharpShooter
組織修復システム」
と併用するために設計されています。
CONTRAINDICAÇÕES
KONTRAINDIKACE
ADVARSLER
Desconhecidas.
Nejsou známy.
VAROVÁNÍ
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fechamento da área infectada ou contaminada.
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PRECAUÇÕES
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operatéra.
A sutura cirúrgica Shapshooter é para uso único.
Não reutilize. Não reesterilize.
REAÇÕES ADVERSAS
KONTRAINDIKAATIOT
Ei tunneta.
VAROITUKSET
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involverer ikke-absorberbare suturer ved anvendelse af PET-sutur til sårlukning,
da risikoen for sårruptur kan variere, alt efter applikationsstedet og det anvendte
suturmateriale.
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FORHOLDSREGLER
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undgå skade i forbindelse med håndtering. Undgå skade i form af knusning eller
presning i forbindelse med anvendelsen af kirurgiske instrumenter som f.eks.
suturpassere, klemmer eller nåleholdere.
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ei ole vahingoittunut.
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PHQHWHOPlWMDWHNQLLNDWHQQHQ3(7RPPHOWHQNl\WW|lKDDYRMHQRPSHOXVVD
sillä haavan avautumisen riski voi vaihdella operoitavan kohdan ja käytettävän
ommelmateriaalin mukaan.
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VAROTOIMET
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vaurioittamasta materiaaleja. Toimi varovasti, jotta et murskaa tai vaurioita
kirurgisia instrumentteja, kuten ompeleiden kuljettimia, pihtejä tai neulapidikkeitä.
既知の禁忌はありません。
警告
FIGYELMEZTETÉSEK
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csomagolást nem bontották fel és nem sérült meg.
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pVWHFKQLNiNDWPLYHODVHEV]pWYiOiVNRFNi]DWDDIHOKDV]QiOiVKHO\pWĘOpVD
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ÓVINTÉZKEDÉSEK
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Kirurgisk Sharpshooter-sutur er kun til engangsbrug.
Må ikke genbruges. Må ikke resteriliseres.
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BIVIRKNINGER
Sharpshooter-ompeleet ovat kertakäyttöisiä.
Älä käytä uudelleen. Älä steriloi uudelleen.
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GARANTIA LIMITADA, LIMITAÇÃO DE RESPONSABILIDADE E
EXCLUSÃO DE OUTRAS GARANTIAS
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Caso seja determinado que o produto estava defeituoso quando da remessa,
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produto.
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Medicines ENESTE ansvar at udskifte produktet.
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er ikke ansvarlige for eventuelle komplikationer eller andre problemer, der måtte
opstå, såsom ukorrekt indicering eller kirurgisk teknik, uegnet valg af materiale
eller håndtering af dette, uegnet brug eller håndtering af instrumenterne, aseptik
osv. Den opererende kirurg er ansvarlig for sådanne komplikationer eller andre
konsekvenser.
HAITTAVAIKUTUKSET
Polyesteriompeleisiin liittyy erittäin pieni akuutin tulehdusreaktion riski kudoksissa,
mitä seuraa ompeleen vähittäinen kapseloituminen säikeiseen sidekudokseen.
Polyesteriommel ei absorboidu, eikä in vivo -kokeissa ole todettu vetolujuuden
retentiossa merkittävää muutosta.
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avautuminen, kivenmuodostus virtsa- ja sappiteissä, kun kyseessä on pitkittynyt
kosketus suolaliuoksiin esimerkiksi virtsa- ja sappiteissä, haavan infektoituminen,
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haava-alueella.
RAJOITETTU TAKUU, VASTUUNRAJOITUS JA
VASTUUVAPAUSLAUSEKE MUISTA TAKUISTA
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tuotteen vaihtaminen.
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vastuussa komplikaatioista tai muista vaikutuksista, joita voi tapahtua eri syistä,
kuten virheelliset indikaatiot tai leikkaustekniikka, sopimaton materiaalivalinta tai
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TILAAMINEN:
SharpShooter®NDQ\OHUUHIHUHQFHQXPPHU
SharpShooter®NDKYDYLLWHQXPHUR
SharpShooter®RPPHOYLLWHQXPHUR
GENBESTILLING:
NOVOS PEDIDOS:
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SharpShooter®Q~PHURGHUHIHUrQFLD
Chirurgický steh SharpShooter®UHIHUHQþQtþtVOR
SharpShooter® Surgical SutureQ~PHURGHUHIHUrQFLD
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禁忌
Nem ismertek.
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DIWU NVW\UNHQin vivo.
適応
ELLENJAVALLATOK
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neulanpistojen välttämiseksi. Hävitä käytetyt neulat siirtämällä ne käytetyille
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alkalmazni.
2. Kuten kaikkien muidenkin ommelmateriaalien kanssa, solmujen pitävyys on
varmistettava. Niiden on oltava kirurgisesti hyväksyttyjä, litteitä ja tasaisia, ja
tarvittaessa niiden pitävyys on varmistettava tekemällä ylimääräisiä silmukoita
olosuhteiden ja kirurgin kokemuksen mukaan.
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er sterilt, medmindre pakken er blevet åbnet eller er beskadiget.
ADVERTÊNCIAS
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objetos pontiagudos.
BRUGERVEJLEDNING
A SharpShooter sebészi varróanyag kizárólag
egyszer használatos. Ne használja fel újra.
Ne sterilizálja újra.
再滅菌しないでください。開封済み、未使用の製品
は廃棄してください。梱包を開封していない、
また
は梱包が破損していない場合に限り、内容物は滅
菌された状態となります。
2. 創傷開離の危険性は適用部位及び使用された縫合材料により
異なる場合があるため、創傷縫合にポリエステル製縫合糸を使
用するにあたり、術者は非吸収性縫合糸にかかわる外科的処置
ないし手技を習熟しておく必要があります。
感染もしくは汚染創の排膿と縫合に関しては条件を満たした外
科診療に従ってください。
使用上の注意
本品またはその他の縫合材料を取り扱う際には、取り扱いによ
る破損を避けるように注意する必要があります。縫合糸通し具、
鉗子や持針器などの器具で縫合糸を押し潰すことや、折り目を
つけることを避けてください。
2. 他の縫合材料と同様、適切な固さの結び目を作るには、平坦な
男結びに加えて手術の環境や術者の経験によっては別の結び
方も必要となります。
術者は、外科用縫合針が刺さらないよう針の取り扱いに注意す
る必要があります。使用済みの針は、
「鋭利物」廃棄容器に廃棄
してください。
本品は、単回使用製品です。再使用しないでくだ
さい。再滅菌しないでください。
副作用
NEMKÍVÁNATOS REAKCIÓK
$SROLpV]WHUYDUUyDQ\DJDV]|YHWHNEHQPLQLPiOLVDNXWJ\XOODGiVRVUHDNFLyWYiOW
NLPDMGDYDUUyDQ\DJRWIRNR]DWRVDQEHQ|YLDURVWRVN|WĘV]|YHW$SROLpV]WHU
YDUUyDQ\DJLVPHUHWHLQNV]HULQWQHPV]tYyGLNIHOin vivoN|UOPpQ\HNN|]|WWpV
V]DNtWyV]LOiUGViJiEDQVHPM|QOpWUHV]LJQL¿NiQVYiOWR]iV
$MHOHQHV]N|]KDV]QiODWiYDONDSFVRODWRVQHPNtYiQDWRVKDWiVRNDN|YHWNH]ĘN
VHEV]pWYiOiVNĘNpS]ĘGpVDK~J\XWDNEDQpVD]HSHXWDNEDQKDDYDUUyDQ\DJ
KRVV]~LGHLJpULQWNH]LNRO\DQVyWDUWDOP~ROGDWRNNDOPLQWSpOGiXODYL]HOHWYDJ\D]
HSHIHUWĘ]|WWVHEHNPLQLPiOLVDNXWJ\XOODGiVRVV]|YHWLUHDNFLypVIiMGDORP|GpPD
pVEĘUStUDVHEWHUOHWpQ
.25/É72=277*$5$1&,$$)(/(/Ę66e*.25/É72=É6$e6
AZ EGYÉB GARANCIÁK KIZÁRÁSA
$MHOHQWHUPpNJDUDQFLiMDD]DQ\DJLpVNLYLWHOH]pVLKLEiNWyOYDOyPHQWHVVpJUH
YRQDWNR]LN+DEL]RQ\RVViJRWQ\HUKRJ\DWHUPpNNLV]iOOtWiVNRUKLEiVYROWD],Y\
6SRUWV0HGLFLQHIHOHOĘVVpJH.,=È5Ï/$*DWHUPpNNLFVHUpOpVpUHNRUOiWR]yGLN
$],Y\6SRUWV0HGLFLQHWHUPpNHLQHNJ\iUWyMDLPSRUWiOyMDpVpUWpNHVtWĘLQHP
YiOODOQDNIHOHOĘVVpJHWD]RNpUWDV]|YĘGPpQ\HNpUWYDJ\HJ\pEKDWiVRNpUWDPHO\HN
RO\DQRNRNEyON|YHWNH]QHNEHPLQWSODKHO\WHOHQLQGLNiFLyYDJ\VHEpV]LWHFKQLND
D]DQ\DJKHO\WHOHQPHJYiODV]WiVDpVDQQDNKDV]QiODWDD]HV]N|]|NQHP
PHJIHOHOĘKDV]QiODWDYDJ\NH]HOpVHQHPPHJIHOHOĘDV]HSV]LVDONDOPD]iVDVWE
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RUYRVDIHOHOĘV
ÚJRARENDELÉS:
ポリエステル製縫合糸は、組織内でわずかな急性炎症反応を引き
起こし、
これに続いて線維性結合組織による段階的なカプセル化
が起こります。ポリエステル製縫合糸は、吸収性がなく、in vivo（生
体内）
で起こるとされている引張強度保持率において著しい変化
は見られていません。
本品使用に関連する副作用には、以下が含まれます。創傷開離、
尿や胆汁など塩溶液に長時間触れた場合に起こる尿路および胆
道内での結石形成、感染創、わずかな急性炎症反応、創部の疼痛、
浮腫および紅斑。
制限付き保証、責任の制限および免責
本品は、材質や仕上がりに欠陥がないものであることを保証しま
す。納入時に欠陥が認められた場合、弊社単独の責任として、製品
の交換を行うものとします。
製造業者、輸入業者および弊社サプライヤーは、使用方法に反し
た適応、手技、不適切な材質の選択や不適切な取り扱い、および、
器具、無菌法などの不適切な使用や取り扱いによる、合併症また
はその他の影響の責任を負わないものとします。当該合併症また
はその他の結果は、執刀医に責任となります。
再発注：
SharpShooter® ハンドル、参照番号：
SharpShooter® 縫合針・縫合糸、参照番号：
SharpShooter® カニューレ、参照番号：
前部
（右）、（左）
SharpShooter®PDUNRODWUHIHUHQFLDV]iP
SharpShooter®VHEpV]LYDUUyDQ\DJUHIHUHQFLDV]iP
SharpShooter®NDQO|NUHIHUHQFLDV]iP
“Use by date. . .
(Year, Month)”
“Consult operating instructions”
“Caution”
“Keep dry”
“Do not use if package
is damaged”
“Do not re-use”
“Do not resterilize”
“Sterilized using irradiation”
Rx Only
$QWHULRU
MREERVNLYLWHOEDORVNLYLWHO
Authorized EC representative:
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Manufacturer:
Ivy Sports Medicine
545 Penobscot Drive
Redwood City, CA 94063
USA
www.ivysportsmed.com
5296-Ed.-A 01/2013
FRONT 2
BLACK
4/13
NO
195621
KO
RO
NL
SV
AR
SHARPSHOOTER®ϲΣ΍ήΠϟ΍ςϴΨϟ΍
SHARPSHOOTER ਦਪଵ ऴฏহ
SHARPSHOOTER KIRURGISK SUTUR
),5'(68785ă&+,585*,&$/6+$536+227(5
SHARPSHOOTER KIRURGISK SUTUR
SHARPSHOOTER -HECHTDRAAD
ූࡦ૫ੈൕ࡛- ‫ێ‬ৈ ෉஼ 91/4cm)36”*
2.0 U/S/P/ 3/0 ࣢ോ ‫ְ୏ܜ‬
୴௥ ઻ ࣯‫ ܃‬33cm)13”*
،୴ x 0/7mm)0/026”* ௽֮
3RO\HVWHUJU¡QQÁHWWHWFPµ
2-0 U.S.P. 3,0 metrisk
Toarmede nåler 33 cm (13”)
Lang x 0,7 mm (0,026”) dia.
Din poliester, împletit, verde, 91,4 cm (36”)
2-0 în sistem U.S.P. 3,0 în sistem metric
Ace la ambele capete, 33 cm (13”)
lungime x 0,7 mm (0,026”) diametru
3RO\HVWHUJU|QÁlWDGFPµ
2-0 USP 3,0 metrisk
Sutur med dubbla nålar 33 cm (13”)
Lång x 0,7 mm (0,026”) dia.
Polyester, groen gevlochten, 91,4 cm (36”)
2-0 USP 3,0 metrisch
Dubbel gearmeerde naalden, 33 cm (13”)
lang x diam. 0,7 mm (0,026”)
ਦਪ ଦׂ୯࡞ ୏ซ ௜ମ பब
Viktig informasjon for kirurgen som foretar operasjonen
,QIRUPDġLLLPSRUWDQWHSHQWUXFKLUXUJXOFDUHRSHUHD]Ą
Viktig information till den opererande kirurgen
Belangrijke informatie voor de chirurg
ৣࢥ
BESKRIVELSE
DESCRIERE
BESKRIVNING
BESCHRIJVING
SharpShooter® ਦਪଵ ऴฏহ‫෉ ܂‬஼ ූࡦ)૫ඛࠕ ൕࠓ෻ഹࠓ୴ඊ*
)PET*ࠨ ‫מ‬৪‫ ݦ‬॥຅ਦ৪ ࢢ‫ ׻‬ਦਪଵ ऴฏহ୴࢟ 0.7mm)0.026”*
௽֮૫ ،୴թFP)”*୶ ௽ৡึ ൳ׄೇ஧୯ ୴௥ ઻ ࣯‫܃‬૫
ू౜ฉ૳ হଵฏ܏‫ܙ‬/ ऴฏহ‫ ܂‬คਦ ‫מ‬৪ ମਂࠨ ࣳभ৪ ࣼผ ֵࡦթ
୾‫ࠈஂॄֵ ܂‬୯ ؊হੋ ৡึ ූࡦ૫ੈൕ࡛ ০ୗࠨ ࡰ‫އ‬૦੎܏‫ܙ‬/
ऴฏহ‫܂‬FP)”*୯ ෉஼‫ ݦ‬2.0 U.S.P.-࣢ോ ‫ ࢟୴ְ୏ܜ‬੕ࡦ೼
೺ඟ ࣭ ૺৈ)‫ێ‬ৈ*‫ ݦ‬৅ീࠨ ஬‫ܙ܏ݩ׀‬/ ‫ێ‬ৈୠࠨ ૺৈซ ऴฏহ୯
઴࠻‫ ܂‬D&C Green No. 6୼܏‫ܙ‬/ ஬෪ୢ ॥຅ਦ৪ ਦਪଵ ऴฏহ૫ ‫ܫ‬ฒ
࣢‫ ן‬ૌத)U.S.P.*૫ঢ় ࢥੑซ ࢨ‫ ޅ‬ମ֏૫ ूฏฏ܏‫ܙ‬/
SharpShooter®NLUXUJLVNVXWXUHUHQLNNHDEVRUEHUHQGHVWHULONLUXUJLVNVXWXUDYÀHWWHW
SRO\HW\OHQWHUHIWDODW3(7VRPHUIHVWHWWLOWRDUPHWHQnOHUUHWWHWURNDUSXQNWFP
´ODQJHRJPHGHQGLDPHWHUSnPP´6XWXUHQHUODJHWDY¿EUHPHG
K¡\PROHN\OYHNWODQJNMHGHWHOLQH UHSRO\HVWHUHVRPKDUWLOEDNHYHQGHQGHDURPDWLVNH
ULQJHUVRPHQLQWHJUHUWGHO6XWXUHQHUFP´863PHWULVNÀHWWHWRJ
XWVW\UWPHGHWVLOLNRQEHOHJJRJHUIDUJHWJU¡QQ3LJPHQWHWIRUGHQJU¡QQIDUJHGH
VXWXUHQHU'&*U¡QQQU3URGXNWHWRSSI\OOHUDOOHNUDYHQHIUD8QLWHG6WDWHV
Pharmacopeia (U.S.P.) for kirurgisk sutur som ikke er absorberbar.
SharpShooter® kirurgisk sutur är en icke absorberbar, steril, kirurgisk sutur som
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UDNDWURDNDUVSHWVFP´OnQJDPHGHQGLDPHWHUSnPP´
6XWXUHQEHVWnUDY¿EUHUDYOLQMlUDOnQJNHGMLJDSRO\HVWUDUPHGK|JPROHN\OYLNW
och återkommande aromatiska ringar som en inbyggd komponent. Suturen är
FP´863PHWULVNÀlWDGI|UVHGGPHGHQVLOLNRQEHOlJJQLQJRFK
IlUJDGJU|Q3LJPHQWHWLGHQJU|QIlUJDGHVXWXUHQlU'&*UHHQQU3URGXNWHQ
XSSI\OOHUDOODNUDYVRPIDVWVWlOOWVDY8638QLWHG6WDWHV3KDUPDFRSHLDI|UHQLFNH
absorberbar kirurgisk sutur.
হଵ ઴‫ڝ‬
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EO¡WYHY
)LUXOGHVXWXUăFKLUXUJLFDO6KDUS6KRRWHU®HVWHXQ¿UGHVXWXUăQHUHVRUEDELOVWHULO
UHDOL]DWGLQSROLHWLOHQWHUHIWDODW3(7vPSOHWLWFXDFHODDPEHOHFDSHWHGUHSWHFX
YkUIGHWLSWURFDUFXOXQJLPHDGHFP´úLGLDPHWUXOGHPP´)LUXO
GHVXWXUăHVWHUHDOL]DWGLQ¿EUHGHSROLHVWHULOLQLDULFXODQĠOXQJúLPDVăPROHFXODUă
PDUHFDUHSUH]LQWăvQFRPSRQHQĠDORUPDLPXOWHLQHOHDURPDWLFH)LUXOGHVXWXUă
HVWHGHFP´vQVLVWHP863vQVLVWHPPHWULFvPSOHWLWFXvQYHOLú
GLQVLOLFRQúLYRSVLWYHUGH3LJPHQWXOXWLOL]DWSHQWUX¿UXOGHVXWXUăYRSVLWFX
YHUGHHVWH'&*UHHQ1R3URGXVXOvQGHSOLQHúWHWRDWHFHULQĠHOHVWDELOLWHGH
)DUPDFRSHHD$PHULFDQă863vQFHHDFHSULYHúWH¿UHOHGHVXWXUăFKLUXUJLFDOH
neresorbabile.
,1',&$Ġ,,
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eller ligering.
SharpShooter®-hechtdraad is een niet-oplosbare, steriele hechtdraad
gemaakt van gevlochten poly(ethyleentereftalaat) (PET) en bevestigd
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met een diameter van 0,7 mm (0,026”). De hechtdraad is gemaakt van
vezels van lange lineaire polyesterketens met een hoog molecuulgewicht
en terugkerende aromatische ringen als een integrale component. De
KHFKWGUDDGLVFP´863PHWULVFKJHYORFKWHQHQ
voorzien van een siliconendeklaag en kleur (groen). Het pigment voor de
groengekleurde hechtdraad is quinizarine-groen SS (D&C green no. 6). Het
product voldoet aan alle vereisten die zijn vastgesteld door de United States
Pharmacopeia (USP) voor niet-oplosbare hechtdraad.
®
PET ऴฏহ‫ࣳ୷ ܂‬ண୶ ૶஼௽ ந‫࣭ ׿‬0߃‫ࣃ ܂‬୥ਪ૫ হଵฏ܏‫ܙ‬/
®
INDIKASJONER FOR BRUK
®
®
INDIKATIONER FÖR ANVÄNDNING
SharpShooter ਦਪଵ ऴฏহ‫ࡥࣁ ܂‬୯ ࣳୃ৅ ૶ֹ ਅ৅ भ‫מ‬૫
হଵฉ‫ ܂‬SharpShooter ஼௽ भ‫ מ‬ੑੈ൙ׂ ฎ‫ ض‬হଵฉ‫ࠩݓ‬
ֵ઴‫ݥ‬૦੎܏‫ܙ‬/
SharpShooter kirurgisk sutur er laget for bruk sammen med SharpShooter
reparasjonssystemet for vev til bruk ved reparasjon av skader i menisken i kneet.
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úLVDXOLJDWXUDUHDĠHVXWXULORUPRL
KONTRAINDIKASJONER
‫؃‬؈ হฑ
,QJHQNMHQWH
ષࠛ௾ হฑ୴ ૤੎܏‫ܙ‬/
)LUHOHGHVXWXUă6KDUS6KRRWHUVXQWSURLHFWDWHSHQWUXD¿XWLOL]DWHvQDVRFLHUHFX
6LVWHPXOGHUHSDUDUHDĠHVXWXULORU6KDUS6KRRWHUvQYHGHUHDUHSDUăULLOH]LXQLORUGH
menisc de la nivelul genunchiului.
ADVARSLER
&2175$,1',&$Ġ,,
,QJDNlQGD
1XH[LVWăFRQWUDLQGLFDĠLLFXQRVFXWH
VARNINGAR
AVERTISMENTE
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I|USDFNQLQJ,QQHKnOOHWlUVWHULOWLR|SSQDGRVNDGDGI|USDFNQLQJ
ֵ֮
!ஏࢢ‫׻‬ฉ௼ ࡮੘ੑଊ/ ջऴน֍‫ڌ‬- হଵฉ௼ શୢ
ऴฏহ‫ ܂‬ා؈ฉ੘ੑଊ/ ී஍୴ ջऴ‫ݥ‬૦֍‫ڌ‬
ਅ৅‫ݥ‬௼ શୢ ซ ‫ڝ‬ଵࣆୢ ࢢ‫ ׻‬৅ീ୼܏‫ܙ‬/
2. !ணଵ ू୏ ࣭ হଵฉ‫ ܂‬ऴฏহ ࣆఀ૫ ‫ ߯ޙ‬৅౵թ ऐ૚௼‫୏ ܂‬ย
ப‫ݓ‬թ ‫ܙ‬૓ฉࣝࠨ হଵஂ‫ ܂‬৅౵ ऴฏ૫ PET ऴฏহ࡞ ౦ുฉ؈
த૫ ॥຅ਦ৪ ऴฏহଗ ׄࠝซ ਦਪ ஥౛ ࣭ ؈ओୣ ਧ௼ฒો
ฏ܏‫ܙ‬/
!հૺ ߃‫ ܂‬ଊૺ‫ ݦ‬৅౵୯ ࣾૃ ࣭ ऴฏ૫ ׄฒ ଵ୶‫ ܂ݥ‬ਦਪ ׄบୣ
௞ਦฒો ฏ܏‫ܙ‬/
௜୯ হฑ
!୴ ࣆఀ୴‫ ࡝ܙ ڌ‬ऴฏহ ࣆఀୣ ಭ؄ฌ ‫ ܂ޣ‬ಭ؄ୠࠨ ୶ซ ਅ৅ୣ
ࣼ௼ฉ؈ ୏ฒ ௜୯࡞ ؈ହ૳ો ฏ܏‫ܙ‬/ ऴฏহ ௜୼؈- ః֜߃‫ ܃࣯ ܂‬฾ܵଗ ոୢ ଦׂ ؈‫ מ‬হଵୠࠨ ୶ฒ ूঢ়௼֍‫ ڌ‬௜࡟୴
৏؈௼ શ‫ ࠩݓ‬ฉ੘ੑଊ/
2. !‫ ࡝ܙ‬ऴฏহ ࣆఀׂ ࡮ౝթ௼ࠨ ண஥ซ ࡽ‫ ފ‬઴தୣ ୏ฒঢ়‫܂‬
ଦׂண ৅๊ ࣭ ଦׂ୯୯ ֮ย୴ ब௻ฉ‫ ࠨܫ ܂‬ಡթ ऴฏ ‫ ׂޝ‬ฎ‫ض‬
෎෎ซ ௽ժ ࡽ‫ފ‬୯ ଵ୶‫ ܂ݥ‬ଦׂண ؈ओ୴ คମฏ܏‫ܙ‬/
!হଵஂ‫ ܂‬ଦׂ ࣯‫ ܃‬ಭ؄ ੑ ௜୯࡞ ؈ହ૳ ू௜୯ࠨ ࣯‫܃‬૫ ౕࡦ௼
શ‫ ࠩݓ‬ฒો ฏ܏‫ܙ‬/ হଵซ ࣯‫܃‬ୢ “ਅ৅৪” ා؈ࣆ தଵ ଵ؈૫
‫ܣ‬લ ා؈ฏ܏‫ܙ‬/
Sharpshooter ਦਪଵ ऴฏহ‫୷ ܂‬๐ଵ୼܏‫ܙ‬/
ஏহଵฉ௼ ࡮੘ੑଊ/ ஏࢢ‫׻‬ฉ௼ ࡮੘ੑଊ/
ूஃଵ
ූࡦ૫ੈൕ࡛ ऴฏহ‫ ܂‬஼௽૫ঢ় ಘਂ୯ ؄৪ ૺ௻৪ ࣳ୨ୣ
୷ୠമ࢟ ‫୴ݸ‬૚ ০ୗ ֩ฏ ஼௽ୠࠨ ୶ซ ऴฏহ୯ ஧௾ண ก࡯
ึ৪୴ ୷૚‫ܙ܏ڕ‬/ ූࡦ૫ੈൕ࡛ ऴฏহ‫ ܂‬຅ਦ‫ݥ‬௼ શୠ࢟ ৏౾
‫ڝ‬૫ঢ় ࣵ৏ซ‫ ֵܙ‬ષࠛ௾ ୶஍ յ‫ ݓ‬ୗ௼୯ ୯࣢ ୾‫ ܂‬णๅ‫ݓ‬
૤੎܏‫ܙ‬/
୴ ஍ು୯ হଵׂ ׄࠝ‫ू ݦ‬ஃଵ૫‫ܙ ܂‬୥୴ ීฎ‫ܙ܏ݩ‬/ ৅౵
ऐ૚ం- ਂण ࣭ ‫ܣ‬௹ׂ ոୢ ૺࡓૃׂ ஍؈ணୠࠨ ந಍ ੑ ମࠨ ࣭
‫ݓܣ‬୯ ֩৞ ึ৪- ৅౵ հૺ- ಘਂ୯ ؄৪ ૺ௻৪ ஼௽ ࣳ୨- ൩௻ू௄- ‫ ֵࡦ׽‬৅౵ ू୏୯ ใࣳ/
஬ซ ब௻- ౧୻ ஬ซ ࣭ ब௻ ౧୻ ू୶
୴ ஬෪ୢ ஏ࠻ ࣭ ஬஼ ֩ฎ୴ ૤‫֕ ܂ܙ‬ୣ!ब௻ฏ܏‫ܙ‬/ ࣾ਋ ੑ
஬෪૫ ֩ฎ୴ ୾‫ ֵܙ‬ඣ‫֮ ݧܜ‬ଶ- ஬෪ ‫็י‬ୢ,Y\6SRUWV0HGLFLQH୯
‫ ݔܜ‬౧୻୼܏‫ܙ‬/
,Y\6SRUWV0HGLFLQH஬෪୯ ஬஼ૣ౾- ਦ୼ૣ౾- ‫׀‬؄ૣ౾‫ू ܂‬பๆซ
௼ೇ୴‫ ڌ‬ଦׂ ؈ओ- ूணฏซ ஏ࠻ ৡു୴‫ ڌ‬ಭ؄- ूணฏซ ؈‫מ‬ࣁ‫ ׻‬؈ओ୯ হଵ୴‫ ڌ‬ಭ؄ ‫ ׂތ‬ոୢ ୴ୗࠨ ୶ฒ ࣵ৏ฌ ਦ ୾‫܂‬
ฏन௻୴‫ ڌ‬؈ശ ूஃଵ૫ ‫ܫ‬ฒ લࣁࠋ ౧୻୴ ૤੎܏‫ܙ‬/ ਦਪ
ଦׂ୯թ ‫ࠉ׽‬ซ ฏन௻୴‫ ڌ‬؈ശ ׂ֩૫ ‫ܫ‬ซ ౧୻ୣ ః܏‫ܙ‬/
ஏ௜ࣄ;
SharpShooter® ด‫އ‬- ౠ஼ ऎ฻;
SharpShooter® ਦਪଵ ऴฏহ- ౠ஼ ऎ฻;
SharpShooter ূׄ- ౠ஼ ऎ฻;
®
தࣼ
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LNNHDEVRUEHUHQGHVXWXUHUI¡UGHEUXNHU3(7VXWXUWLOOXNNLQJDYVnUHWWHUVRP
risikoen for sår som åpner seg varierer med bruksstedet og suturmaterialet som
brukes.
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eller forurensede sår.
FORHOLDSREGLER
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for å unngå skade ved håndteringen. Unngå skader på grunn av klemming eller
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nålholdere.
2. Som med alt annet suturmateriale krever knutesikkerhet kirurgisk teknikk med
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og kirurgens erfaring.
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nålestikk. Kast brukte nåler i avfallsbeholdere som er spesielle til dette bruket.
SharpShooter kirurgisk sutur er kun til engangsbruk.
Må ikke brukes på nytt. Må ikke steriliseres på nytt.
BIVIRKNINGER
Polyestersutur fremkaller minimale akutte betennelsesreaksjoner i vev som
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Polyestersutur absorberes ikke, det kjennes heller ikke til noen betydelig endring i
strekkbarheten in vivo.
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LQ¿VHUWHVnUPLQGUHEHWHQQHOVHVUHDNVMRQHULYHYHWVPHUWH¡GHPRJHU\WHPSn
sårstedet.
BEGRENSET GARANTI, ANSVARSBEGRENSNING OG
FRASKRIVELSE AV ANDRE GARANTIER
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,GHWWLOIHOOHWGHWEOLUDYJMRUWDWSURGXNWHWYDUGHIHNWGDGHWEOHVHQGWVNDO,Y\6SRUWV
0HGLFLQHV(1(67(DQVYDUY UHnHUVWDWWHSURGXNWHW
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ikke ansvarlige for komplikasjoner eller andre effekter som kan oppstå av grunner
som f.eks. feilaktige indikasjoner eller kirurgisk teknikk, uegnet valg av materiale
eller behandlingen av dette, uegnet bruk eller håndtering av instrumenter, aseptikk
osv. Den opererende kirurgen er ansvarlig for alle slike komplikasjoner eller andre
konsekvenser.
BESTILLE PÅ NYTT:
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SharpShooter NLUXUJLVNVXWXUUHIHUDQVHQXPPHU
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ambalajul nu este deschis sau deteriorat.
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WLSXODSOLFDWRDUHORUGH¿UHGHVXWXUăSHQVHORUVDXVXSRUWXULORUGHDFH
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SharpShooter-vävnadsreparationssystem vid reparation av skador på menisken
i knät.
KONTRAINDIKATIONER
$QYlQGDUHVNDYDUDI|UWURJQDPHGNLUXUJLVNDLQJUHSSRFKWHNQLNHUVRPLQQHIDWWDU
LFNHDEVRUEHUEDUDVXWXUHULQQDQHQ3(7VXWXUDQYlQGVI|UVnUVOXWQLQJDUHIWHUVRP
ULVNHQI|UDWWVnUHWVNDVSULFNDXSSNDQYDULHUDEHURHQGHSnDSSOLFHULQJVVWlOOH
och vilket suturmaterial som används.
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av infekterade eller kontaminerade sår.
FÖRSIKTIGHETSÅTGÄRDER
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att undvika skador vid hanteringen. Undvik kläm- och veckskador på grund av
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3UHFLVVRPI|UDQQDWVXWXUPDWHULDONUlYHUHQDGHNYDWNQXWVlNHUKHWYHGHUWDJHQ
NLUXUJLVNWHNQLNLIRUPDYSODWWDI\UNDQWLJDNQXWDUPHGH[WUDRPVODJEHURHQGHSn
de kirurgiska omständigheterna och kirurgens erfarenhet.
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RDYVLNWOLJDQnOVWLFN.DVVHUDDQYlQGDQnODULEHKnOODUHI|UVNlUDQGHVWLFNDQGH
avfall.
Sharpshooter kirurgisk sutur är endast avsedd
för engångsbruk. Får inte återanvändas. Får inte
omsteriliseras.
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BIVERKNINGAR
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DFWXDOHQXVXIHUăPRGL¿FăULVHPQL¿FDWLYHvQFHHDFHSULYHúWHUH]LVWHQĠDODUXSHUH
in vivo.
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GHVFKLGHUHDSOăJLLIRUPDUHDGHFDOFXOLSHWUDFWXOXULQDUúLELOLDUvQFD]XOFRQWDFWXOXL
SUHOXQJLWFXVROXĠLLFDUHFRQĠLQVDUHSUHFXPXULQDúLELODLQIHFWDUHDSOăJLLUHDFĠLH
LQÀDPDWRULHDFXWăPLQLPDOăODQLYHOXOĠHVXWXOXLGXUHUHHGHPúLHULWHPODORFXOSOăJLL
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LQWHRFKVnYLWWNlQWXSSVWnUKHOOHULQJHQVLJQL¿NDQWI|UlQGULQJDYGUDJKnOOIDVWKHWHQ
in vivo.
)|OMDQGHELYHUNQLQJDUlUDVVRFLHUDGHPHGDQYlQGQLQJHQDYGHQQDSURGXNW
uppsprickande sår, stenbildning i urinvägar och gallgångar vid långvarig kontakt
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BEGRÄNSAD GARANTI, ANSVARSBEGRÄNSNING OCH
FRISKRIVNINGSKLAUSUL AVSEENDE GARANTIER
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produsului.
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grund av felaktiga indikationer eller felaktig kirurgisk teknik, olämpligt material eller
hantering av det, olämplig användning eller hantering av instrumenten, asepsis
RVY'HQRSHUHUDQGHNLUXUJHQDQVYDUDUI|UVnGDQDNRPSOLNDWLRQHUHOOHUDQGUD
konsekvenser.
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UăVSXQ]ăWRULSHQWUXFRPSOLFDĠLLVDXDOWHHIHFWHFDUHSRWVXUYHQLGLQPRWLYHSUHFXP
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PDQLSXODUHDQHFRUHVSXQ]ăWRDUHDLQVWUXPHQWHORUDVHSVLHHWF&KLUXUJXOFDUH
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FRQVHFLQĠH
REPETAREA COMENZII:
BESTÄLLA:
SharpShooter®KDQGWDJDUWLNHOQXPPHU
SharpShooter®NLUXUJLVNVXWXUDUWLNHOQXPPHU
SharpShooter®NDQ\OHUDUWLNHOQXPPHU
$QWHULRU
K|JHUYlQVWHU
Mâner SharpShooter®QXPăUGHUHIHULQĠă
)LUGHVXWXUăFKLUXUJLFDO6KDUS6KRRWHU®QXPăUGHUHIHULQĠă
“Use by date. . .
(Year, Month)”
KO
“Consult operating instructions”
$QWHULRDUH
“Caution”
NO
GUHDSWDVWkQJD
“Do not use if package
is damaged”
“Keep dry”
ΔλϮΑ36Ϣγ91.4έϮϔπϣήπΧ΃ήΘδϴϟϮΑ
3.0ϱήΘϣˬU.S.P 2-0
ΔλϮΑ13Ϣγ33ϝϮτΑΔϳϮϘΘϟ΍ΔΟϭΩΰϣήΑ·
˵
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ϒλϮϟ΍
INDICATIES VOOR GEBRUIK
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ligatie van zacht weefsel.
SharpShooter-hechtdraad is bedoeld voor gebruik met het SharpShooterweefselreparatiesysteem, voor gebruik bij de reparatie van letsel aan de
meniscus.
“Do not re-use”
RO
2. Gebruikers moeten bekend zijn met chirurgische procedures en
technieken waaraan niet-oplosbare hechtdraad te pas komt, voordat
zij PET-hechtdraad gebruiken voor het sluiten van wonden, omdat het
risico op wonddehiscentie per plaats van toepassing en het gebruikte
hechtmateriaal kan verschillen.
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de geaccepteerde medische praktijk worden gevolgd.
VOORZORGSMAATREGELEN
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om schade door het hanteren te voorkomen. Vermijd plet- of kreukschade
door het gebruik van chirurgische instrumenten, zoals draadvoerders,
forceps of naaldvoerders.
2. Net als bij elk hechtmateriaal is voor een adequate knoopvastheid een
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indien wenselijk met het oog op de operatieve omstandigheden en de
ervaring van de chirurg.
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hechtnaalden om ongewenste naaldprikken te voorkomen. Werp gebruikte
naalden in de naaldencontainer.
Sharpshooter-hechtdraad is uitsluitend bedoeld voor
eenmalig gebruik. Niet hergebruiken. Niet opnieuw
steriliseren.
BIJWERKINGEN
Polyester hechtdraad veroorzaakt een minimale acute ontstekingsreactie in
de huid, die wordt gevolgd door geleidelijke inkapseling van de hechtdraad
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voor zover bekend, in vivoHHQVLJQL¿FDQWHZLM]LJLQJLQWUHNYDVWKHLGSODDWV
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wonddehiscentie, steenvorming in de urine- en galwegen indien langdurig
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wonden, minimale acute ontstekingsreactie van het weefsel en pijn, oedeem
en erytheem op de plaats van de wond.
BEPERKTE GARANTIE, BEPERKING VAN AANSPRAKELIJKHEID EN
AFWIJZING VAN ANDERE GARANTIES
Dit product is gegarandeerd vrij van gebreken in materiaal en vakmanschap.
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(1,*(YHUDQWZRRUGHOLMNKHLGYDQ,Y\6SRUWV0HGLFLQHXLWKHWYHUYDQJHQYDQ
het product.
De fabrikant, de importeur en de leveranciers van de producten van
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effecten die zich kunnen voordoen om redenen zoals een onjuiste indicatie
of operatietechniek, ongeschikte keuze of hantering van materiaal, verkeerd
gebruik of hantering van de instrumenten, asepsis, enzovoort. De chirurg is
verantwoordelijk voor dergelijke complicaties of andere consequenties.
“Do not resterilize”
“Sterilized using irradiation”
Authorized EC representative:
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Rx Only
SHARPSHOOTER KIRURGISK SUTUR
SHARPSHOOTER -HECHTDRAAD
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2-0 USP 3,0 metrisk
Sutur med dubbla nålar 33 cm (13”)
Lång x 0,7 mm (0,026”) dia.
Polyester, groen gevlochten, 91,4 cm (36”)
2-0 USP 3,0 metrisch
Dubbel gearmeerde naalden, 33 cm (13”)
lang x diam. 0,7 mm (0,026”)
ਦਪ ଦׂ୯࡞ ୏ซ ௜ମ பब
Viktig informasjon for kirurgen som foretar operasjonen
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Viktig information till den opererande kirurgen
Belangrijke informatie voor de chirurg
ৣࢥ
BESKRIVELSE
DESCRIERE
BESKRIVNING
BESCHRIJVING
SharpShooter® ਦਪଵ ऴฏহ‫෉ ܂‬஼ ූࡦ)૫ඛࠕ ൕࠓ෻ഹࠓ୴ඊ*
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ऴฏহ‫܂‬FP)”*୯ ෉஼‫ ݦ‬2.0 U.S.P.-࣢ോ ‫ ࢟୴ְ୏ܜ‬੕ࡦ೼
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઴࠻‫ ܂‬D&C Green No. 6୼܏‫ܙ‬/ ஬෪ୢ ॥຅ਦ৪ ਦਪଵ ऴฏহ૫ ‫ܫ‬ฒ
࣢‫ ן‬ૌத)U.S.P.*૫ঢ় ࢥੑซ ࢨ‫ ޅ‬ମ֏૫ ूฏฏ܏‫ܙ‬/
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SRO\HW\OHQWHUHIWDODW3(7VRPHUIHVWHWWLOWRDUPHWHQnOHUUHWWHWURNDUSXQNWFP
´ODQJHRJPHGHQGLDPHWHUSnPP´6XWXUHQHUODJHWDY¿EUHPHG
K¡\PROHN\OYHNWODQJNMHGHWHOLQH UHSRO\HVWHUHVRPKDUWLOEDNHYHQGHQGHDURPDWLVNH
ULQJHUVRPHQLQWHJUHUWGHO6XWXUHQHUFP´863PHWULVNÀHWWHWRJ
XWVW\UWPHGHWVLOLNRQEHOHJJRJHUIDUJHWJU¡QQ3LJPHQWHWIRUGHQJU¡QQIDUJHGH
VXWXUHQHU'&*U¡QQQU3URGXNWHWRSSI\OOHUDOOHNUDYHQHIUD8QLWHG6WDWHV
Pharmacopeia (U.S.P.) for kirurgisk sutur som ikke er absorberbar.
SharpShooter® kirurgisk sutur är en icke absorberbar, steril, kirurgisk sutur som
EHVWnUDYÀlWDGSRO\HW\OHQWHUHIWDODW3(7RFKlUIlVWDGPHOODQGXEEODQnODU
UDNDWURDNDUVSHWVFP´OnQJDPHGHQGLDPHWHUSnPP´
6XWXUHQEHVWnUDY¿EUHUDYOLQMlUDOnQJNHGMLJDSRO\HVWUDUPHGK|JPROHN\OYLNW
och återkommande aromatiska ringar som en inbyggd komponent. Suturen är
FP´863PHWULVNÀlWDGI|UVHGGPHGHQVLOLNRQEHOlJJQLQJRFK
IlUJDGJU|Q3LJPHQWHWLGHQJU|QIlUJDGHVXWXUHQlU'&*UHHQQU3URGXNWHQ
XSSI\OOHUDOODNUDYVRPIDVWVWlOOWVDY8638QLWHG6WDWHV3KDUPDFRSHLDI|UHQLFNH
absorberbar kirurgisk sutur.
হଵ ઴‫ڝ‬
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EO¡WYHY
)LUXOGHVXWXUăFKLUXUJLFDO6KDUS6KRRWHU®HVWHXQ¿UGHVXWXUăQHUHVRUEDELOVWHULO
UHDOL]DWGLQSROLHWLOHQWHUHIWDODW3(7vPSOHWLWFXDFHODDPEHOHFDSHWHGUHSWHFX
YkUIGHWLSWURFDUFXOXQJLPHDGHFP´úLGLDPHWUXOGHPP´)LUXO
GHVXWXUăHVWHUHDOL]DWGLQ¿EUHGHSROLHVWHULOLQLDULFXODQĠOXQJúLPDVăPROHFXODUă
PDUHFDUHSUH]LQWăvQFRPSRQHQĠDORUPDLPXOWHLQHOHDURPDWLFH)LUXOGHVXWXUă
HVWHGHFP´vQVLVWHP863vQVLVWHPPHWULFvPSOHWLWFXvQYHOLú
GLQVLOLFRQúLYRSVLWYHUGH3LJPHQWXOXWLOL]DWSHQWUX¿UXOGHVXWXUăYRSVLWFX
YHUGHHVWH'&*UHHQ1R3URGXVXOvQGHSOLQHúWHWRDWHFHULQĠHOHVWDELOLWHGH
)DUPDFRSHHD$PHULFDQă863vQFHHDFHSULYHúWH¿UHOHGHVXWXUăFKLUXUJLFDOH
neresorbabile.
,1',&$Ġ,,
3(7VXWXUlULQGLFHUDGI|UDQYlQGQLQJYLGJHQHUHOOPMXNGHOVDSSUR[LPHULQJRFK
eller ligering.
SharpShooter®-hechtdraad is een niet-oplosbare, steriele hechtdraad
gemaakt van gevlochten poly(ethyleentereftalaat) (PET) en bevestigd
DDQGXEEHOJHDUPHHUGHQDDOGHQUHFKWWURFDUSXQWFP´ODQJ
met een diameter van 0,7 mm (0,026”). De hechtdraad is gemaakt van
vezels van lange lineaire polyesterketens met een hoog molecuulgewicht
en terugkerende aromatische ringen als een integrale component. De
KHFKWGUDDGLVFP´863PHWULVFKJHYORFKWHQHQ
voorzien van een siliconendeklaag en kleur (groen). Het pigment voor de
groengekleurde hechtdraad is quinizarine-groen SS (D&C green no. 6). Het
product voldoet aan alle vereisten die zijn vastgesteld door de United States
Pharmacopeia (USP) voor niet-oplosbare hechtdraad.
®
®
INDIKATIONER FÖR ANVÄNDNING
SharpShooter ਦਪଵ ऴฏহ‫ࡥࣁ ܂‬୯ ࣳୃ৅ ૶ֹ ਅ৅ भ‫מ‬૫
হଵฉ‫ ܂‬SharpShooter ஼௽ भ‫ מ‬ੑੈ൙ׂ ฎ‫ ض‬হଵฉ‫ࠩݓ‬
ֵ઴‫ݥ‬૦੎܏‫ܙ‬/
SharpShooter kirurgisk sutur er laget for bruk sammen med SharpShooter
reparasjonssystemet for vev til bruk ved reparasjon av skader i menisken i kneet.
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úLVDXOLJDWXUDUHDĠHVXWXULORUPRL
KONTRAINDIKASJONER
‫؃‬؈ হฑ
,QJHQNMHQWH
ષࠛ௾ হฑ୴ ૤੎܏‫ܙ‬/
)LUHOHGHVXWXUă6KDUS6KRRWHUVXQWSURLHFWDWHSHQWUXD¿XWLOL]DWHvQDVRFLHUHFX
6LVWHPXOGHUHSDUDUHDĠHVXWXULORU6KDUS6KRRWHUvQYHGHUHDUHSDUăULLOH]LXQLORUGH
menisc de la nivelul genunchiului.
ADVARSLER
&2175$,1',&$Ġ,,
,QJDNlQGD
1XH[LVWăFRQWUDLQGLFDĠLLFXQRVFXWH
VARNINGAR
AVERTISMENTE
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I|USDFNQLQJ,QQHKnOOHWlUVWHULOWLR|SSQDGRVNDGDGI|USDFNQLQJ
2. !ணଵ ू୏ ࣭ হଵฉ‫ ܂‬ऴฏহ ࣆఀ૫ ‫ ߯ޙ‬৅౵թ ऐ૚௼‫୏ ܂‬ย
ப‫ݓ‬թ ‫ܙ‬૓ฉࣝࠨ হଵஂ‫ ܂‬৅౵ ऴฏ૫ PET ऴฏহ࡞ ౦ുฉ؈
த૫ ॥຅ਦ৪ ऴฏহଗ ׄࠝซ ਦਪ ஥౛ ࣭ ؈ओୣ ਧ௼ฒો
ฏ܏‫ܙ‬/
!հૺ ߃‫ ܂‬ଊૺ‫ ݦ‬৅౵୯ ࣾૃ ࣭ ऴฏ૫ ׄฒ ଵ୶‫ ܂ݥ‬ਦਪ ׄบୣ
௞ਦฒો ฏ܏‫ܙ‬/
௜୯ হฑ
!୴ ࣆఀ୴‫ ࡝ܙ ڌ‬ऴฏহ ࣆఀୣ ಭ؄ฌ ‫ ܂ޣ‬ಭ؄ୠࠨ ୶ซ ਅ৅ୣ
ࣼ௼ฉ؈ ୏ฒ ௜୯࡞ ؈ହ૳ો ฏ܏‫ܙ‬/ ऴฏহ ௜୼؈- ః֜߃‫ ܃࣯ ܂‬฾ܵଗ ոୢ ଦׂ ؈‫ מ‬হଵୠࠨ ୶ฒ ूঢ়௼֍‫ ڌ‬௜࡟୴
৏؈௼ શ‫ ࠩݓ‬ฉ੘ੑଊ/
2. !‫ ࡝ܙ‬ऴฏহ ࣆఀׂ ࡮ౝթ௼ࠨ ண஥ซ ࡽ‫ ފ‬઴தୣ ୏ฒঢ়‫܂‬
ଦׂண ৅๊ ࣭ ଦׂ୯୯ ֮ย୴ ब௻ฉ‫ ࠨܫ ܂‬ಡթ ऴฏ ‫ ׂޝ‬ฎ‫ض‬
෎෎ซ ௽ժ ࡽ‫ފ‬୯ ଵ୶‫ ܂ݥ‬ଦׂண ؈ओ୴ คମฏ܏‫ܙ‬/
!হଵஂ‫ ܂‬ଦׂ ࣯‫ ܃‬ಭ؄ ੑ ௜୯࡞ ؈ହ૳ ू௜୯ࠨ ࣯‫܃‬૫ ౕࡦ௼
શ‫ ࠩݓ‬ฒો ฏ܏‫ܙ‬/ হଵซ ࣯‫܃‬ୢ “ਅ৅৪” ා؈ࣆ தଵ ଵ؈૫
‫ܣ‬લ ා؈ฏ܏‫ܙ‬/
Sharpshooter ਦਪଵ ऴฏহ‫୷ ܂‬๐ଵ୼܏‫ܙ‬/
ஏহଵฉ௼ ࡮੘ੑଊ/ ஏࢢ‫׻‬ฉ௼ ࡮੘ੑଊ/
ूஃଵ
ූࡦ૫ੈൕ࡛ ऴฏহ‫ ܂‬஼௽૫ঢ় ಘਂ୯ ؄৪ ૺ௻৪ ࣳ୨ୣ
୷ୠമ࢟ ‫୴ݸ‬૚ ০ୗ ֩ฏ ஼௽ୠࠨ ୶ซ ऴฏহ୯ ஧௾ண ก࡯
ึ৪୴ ୷૚‫ܙ܏ڕ‬/ ූࡦ૫ੈൕ࡛ ऴฏহ‫ ܂‬຅ਦ‫ݥ‬௼ શୠ࢟ ৏౾
‫ڝ‬૫ঢ় ࣵ৏ซ‫ ֵܙ‬ષࠛ௾ ୶஍ յ‫ ݓ‬ୗ௼୯ ୯࣢ ୾‫ ܂‬णๅ‫ݓ‬
૤੎܏‫ܙ‬/
୴ ஍ು୯ হଵׂ ׄࠝ‫ू ݦ‬ஃଵ૫‫ܙ ܂‬୥୴ ීฎ‫ܙ܏ݩ‬/ ৅౵
ऐ૚ం- ਂण ࣭ ‫ܣ‬௹ׂ ոୢ ૺࡓૃׂ ஍؈ணୠࠨ ந಍ ੑ ମࠨ ࣭
‫ݓܣ‬୯ ֩৞ ึ৪- ৅౵ հૺ- ಘਂ୯ ؄৪ ૺ௻৪ ஼௽ ࣳ୨- ൩௻ू௄- ‫ ֵࡦ׽‬৅౵ ू୏୯ ใࣳ/
஬ซ ब௻- ౧୻ ஬ซ ࣭ ब௻ ౧୻ ू୶
୴ ஬෪ୢ ஏ࠻ ࣭ ஬஼ ֩ฎ୴ ૤‫֕ ܂ܙ‬ୣ!ब௻ฏ܏‫ܙ‬/ ࣾ਋ ੑ
஬෪૫ ֩ฎ୴ ୾‫ ֵܙ‬ඣ‫֮ ݧܜ‬ଶ- ஬෪ ‫็י‬ୢ,Y\6SRUWV0HGLFLQH୯
‫ ݔܜ‬౧୻୼܏‫ܙ‬/
,Y\6SRUWV0HGLFLQH஬෪୯ ஬஼ૣ౾- ਦ୼ૣ౾- ‫׀‬؄ૣ౾‫ू ܂‬பๆซ
௼ೇ୴‫ ڌ‬ଦׂ ؈ओ- ूணฏซ ஏ࠻ ৡു୴‫ ڌ‬ಭ؄- ूணฏซ ؈‫מ‬ࣁ‫ ׻‬؈ओ୯ হଵ୴‫ ڌ‬ಭ؄ ‫ ׂތ‬ոୢ ୴ୗࠨ ୶ฒ ࣵ৏ฌ ਦ ୾‫܂‬
ฏन௻୴‫ ڌ‬؈ശ ूஃଵ૫ ‫ܫ‬ฒ લࣁࠋ ౧୻୴ ૤੎܏‫ܙ‬/ ਦਪ
ଦׂ୯թ ‫ࠉ׽‬ซ ฏन௻୴‫ ڌ‬؈ശ ׂ֩૫ ‫ܫ‬ซ ౧୻ୣ ః܏‫ܙ‬/
ஏ௜ࣄ;
SharpShooter® ด‫އ‬- ౠ஼ ऎ฻;
SharpShooter® ਦਪଵ ऴฏহ- ౠ஼ ऎ฻;
SharpShooter ূׄ- ౠ஼ ऎ฻;
®
தࣼ
)ଊ࡝మ*-)ନమ*
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,QQKROGHWHUVWHULOWPHGPLQGUHSDNQLQJHQHUnSQHW
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LNNHDEVRUEHUHQGHVXWXUHUI¡UGHEUXNHU3(7VXWXUWLOOXNNLQJDYVnUHWWHUVRP
risikoen for sår som åpner seg varierer med bruksstedet og suturmaterialet som
brukes.
$NVHSWDEHONLUXUJLVNSUDNVLVPnI¡OJHVQnUGHWJMHOGHUGUHQRJOXNNLQJDYLQ¿VHUW
eller forurensede sår.
FORHOLDSREGLER
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for å unngå skade ved håndteringen. Unngå skader på grunn av klemming eller
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nålholdere.
2. Som med alt annet suturmateriale krever knutesikkerhet kirurgisk teknikk med
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og kirurgens erfaring.
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nålestikk. Kast brukte nåler i avfallsbeholdere som er spesielle til dette bruket.
SharpShooter kirurgisk sutur er kun til engangsbruk.
Må ikke brukes på nytt. Må ikke steriliseres på nytt.
BIVIRKNINGER
Polyestersutur fremkaller minimale akutte betennelsesreaksjoner i vev som
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Polyestersutur absorberes ikke, det kjennes heller ikke til noen betydelig endring i
strekkbarheten in vivo.
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XULQRJJDOOHJDQJHQHYHGODQJYDULJNRQWDNWPHGVDOWO¡VQLQJHUVRPXULQRJJDOOH
LQ¿VHUWHVnUPLQGUHEHWHQQHOVHVUHDNVMRQHULYHYHWVPHUWH¡GHPRJHU\WHPSn
sårstedet.
BEGRENSET GARANTI, ANSVARSBEGRENSNING OG
FRASKRIVELSE AV ANDRE GARANTIER
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,GHWWLOIHOOHWGHWEOLUDYJMRUWDWSURGXNWHWYDUGHIHNWGDGHWEOHVHQGWVNDO,Y\6SRUWV
0HGLFLQHV(1(67(DQVYDUY UHnHUVWDWWHSURGXNWHW
3URGXVHQWHQLPSRUW¡UHQRJOHYHUDQG¡UHUDY,Y\6SRUWV0HGLFLQHSURGXNWHUHU
ikke ansvarlige for komplikasjoner eller andre effekter som kan oppstå av grunner
som f.eks. feilaktige indikasjoner eller kirurgisk teknikk, uegnet valg av materiale
eller behandlingen av dette, uegnet bruk eller håndtering av instrumenter, aseptikk
osv. Den opererende kirurgen er ansvarlig for alle slike komplikasjoner eller andre
konsekvenser.
BESTILLE PÅ NYTT:
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SharpShooter NLUXUJLVNVXWXUUHIHUDQVHQXPPHU
®
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ambalajul nu este deschis sau deteriorat.
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SUHVXSXQXWLOL]DUHDGH¿UHGHVXWXUăQHUHVRUEDELOHvQDLQWHGHXWLOL]DUHD¿UHORUGH
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6HYRUUHVSHFWDSUDFWLFLOHFKLUXUJLFDOHDSUREDWHvQFHHDFHSULYHúWHGUHQDMXOúL
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35(&$8Ġ,,
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GHWHULRUDUHDSULQVWULYLUHVDXSUHVDUHVXEDFĠLXQHDLQVWUXPHQWHORUFKLUXUJLFDOHGH
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SUHVXSXQHXWLOL]DUHDWHKQLFLLFKLUXUJLFDOHDSUREDWHDQRGXULORUSODWHvQXQJKL
GUHSWFXSDúLVXSOLPHQWDULvQFRQIRUPLWDWHFXFLUFXPVWDQĠHOHFKLUXUJLFDOHúLFX
H[SHULHQĠDFKLUXUJXOXL
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LQVWUXPHQWHÄDVFXĠLWH´
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SharpShooter-vävnadsreparationssystem vid reparation av skador på menisken
i knät.
KONTRAINDIKATIONER
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LFNHDEVRUEHUEDUDVXWXUHULQQDQHQ3(7VXWXUDQYlQGVI|UVnUVOXWQLQJDUHIWHUVRP
ULVNHQI|UDWWVnUHWVNDVSULFNDXSSNDQYDULHUDEHURHQGHSnDSSOLFHULQJVVWlOOH
och vilket suturmaterial som används.
9HGHUWDJHQNLUXUJLVNSUD[LVPnVWHI|OMDVDYVHHQGHGUlQDJHRFKVOXWQLQJ
av infekterade eller kontaminerade sår.
FÖRSIKTIGHETSÅTGÄRDER
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att undvika skador vid hanteringen. Undvik kläm- och veckskador på grund av
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3UHFLVVRPI|UDQQDWVXWXUPDWHULDONUlYHUHQDGHNYDWNQXWVlNHUKHWYHGHUWDJHQ
NLUXUJLVNWHNQLNLIRUPDYSODWWDI\UNDQWLJDNQXWDUPHGH[WUDRPVODJEHURHQGHSn
de kirurgiska omständigheterna och kirurgens erfarenhet.
$QYlQGDUHVNDLDNWWDI|UVLNWLJKHWYLGKDQWHULQJDYNLUXUJLVNDQnODUI|UDWWXQGYLND
RDYVLNWOLJDQnOVWLFN.DVVHUDDQYlQGDQnODULEHKnOODUHI|UVNlUDQGHVWLFNDQGH
avfall.
Sharpshooter kirurgisk sutur är endast avsedd
för engångsbruk. Får inte återanvändas. Får inte
omsteriliseras.
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XQLFĄIRORVLQġĄ$QXVHUHXWLOL]D$QXVHUHVWHULOL]D
BIVERKNINGAR
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DFWXDOHQXVXIHUăPRGL¿FăULVHPQL¿FDWLYHvQFHHDFHSULYHúWHUH]LVWHQĠDODUXSHUH
in vivo.
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GHVFKLGHUHDSOăJLLIRUPDUHDGHFDOFXOLSHWUDFWXOXULQDUúLELOLDUvQFD]XOFRQWDFWXOXL
SUHOXQJLWFXVROXĠLLFDUHFRQĠLQVDUHSUHFXPXULQDúLELODLQIHFWDUHDSOăJLLUHDFĠLH
LQÀDPDWRULHDFXWăPLQLPDOăODQLYHOXOĠHVXWXOXLGXUHUHHGHPúLHULWHPODORFXOSOăJLL
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LQWHRFKVnYLWWNlQWXSSVWnUKHOOHULQJHQVLJQL¿NDQWI|UlQGULQJDYGUDJKnOOIDVWKHWHQ
in vivo.
)|OMDQGHELYHUNQLQJDUlUDVVRFLHUDGHPHGDQYlQGQLQJHQDYGHQQDSURGXNW
uppsprickande sår, stenbildning i urinvägar och gallgångar vid långvarig kontakt
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BEGRÄNSAD GARANTI, ANSVARSBEGRÄNSNING OCH
FRISKRIVNINGSKLAUSUL AVSEENDE GARANTIER
*$5$1Ġ,$/,0,7$7ă/,0,7$5($5ă6381'(5,,ú,1(*$5($
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$FHVWSURGXVHVWHJDUDQWDWD¿IăUăGHIHFWHGHPDWHULDOHúLPDQRSHUăÌQ
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UHVSRQVDELOLWDWHD(;&/86,9ĂD,Y\6SRUWV0HGLFLQHYDFRQVWDvQvQORFXLUHD
produsului.
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lULQWHDQVYDULJDI|UNRPSOLNDWLRQHUHOOHUDQGUDYHUNQLQJDUVRPNDQXSSVWnSn
grund av felaktiga indikationer eller felaktig kirurgisk teknik, olämpligt material eller
hantering av det, olämplig användning eller hantering av instrumenten, asepsis
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konsekvenser.
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UăVSXQ]ăWRULSHQWUXFRPSOLFDĠLLVDXDOWHHIHFWHFDUHSRWVXUYHQLGLQPRWLYHSUHFXP
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REPETAREA COMENZII:
BESTÄLLA:
SharpShooter®KDQGWDJDUWLNHOQXPPHU
SharpShooter®NLUXUJLVNVXWXUDUWLNHOQXPPHU
SharpShooter®NDQ\OHUDUWLNHOQXPPHU
$QWHULRU
K|JHUYlQVWHU
Mâner SharpShooter®QXPăUGHUHIHULQĠă
)LUGHVXWXUăFKLUXUJLFDO6KDUS6KRRWHU®QXPăUGHUHIHULQĠă
“Use by date. . .
(Year, Month)”
“Consult operating instructions”
“Caution”
$QWHULRDUH
“Keep dry”
GUHDSWDVWkQJD
“Do not use if package
is damaged”
ϲΣ΍ήΠϟ΍ΏϮϠγϷ΍ωΎΒΗ΍ΐΠϳˬΔϴΣ΍ήΠϟ΍ρϮϴΨϠϟΩ΍Ϯϣϱ΃ϊϣϝΎΤϟ΍ϲϫΎϤϛ
ΔϳϮΘδϤϟ΍ΔτΑέϷ΍ϡ΍ΪΨΘγΎΑϚϟΫϥϮϜϳϭˬΪϘ˵όϠϟϢ΋ϼϤϟ΍ΖϴΒΜΘϟ΍ϥΎϤπϟϝϮΒϘϤϟ΍
Ρ΍ήΠϟ΍ΓήΒΧϭΔΣ΍ήΠϟ΍ϑϭήχϪΑ΢ϤδΗΎϣΐδΣΔϴϓΎο·ΔϴτϏ΃ϊϣˬΔόΑήϤϟ΍ϭ
˷
νήόΘϟ΍ΐϨΠΘϟΔϴΣ΍ήΠϟ΍ήΑϹ΍ϡ΍ΪΨΘγ΍ΪϨϋέάΤϟ΍ϥϮϣΪΨΘδϤϟ΍ϰΧϮΘϳϥ΃ΐΠϳ3
ϡΎδΟϷ΍´ΔϳϭΎΣϲϓΔϣΪΨΘδϤϟ΍ήΑϹ΍Ϧϣκ͉ϠΨΗΓήΑϹΎΑΩϮμϘϤϟ΍ήϴϏΰΧϮϠϟ
³ΓΩΎΤϟ΍
ςϘϓΓΪΣ΍ϭΓήϤϟSharpshooterϲΣ΍ήΠϟ΍ςϴΨϟ΍ϡΪ˴ ΨΘδ˵ϳ
ϪϤϴϘόΗΓΩΎϋΈΑϢϘΗϻϭϪϣ΍ΪΨΘγ΍ΓΩΎϋΈΑϢϘΗϻ
ΔϴδϜόϟ΍ΕϼϋΎϔΘϟ΍
ϲϓΓΩΎΤϟ΍ΕΎΑΎϬΘϟϻ΍ϦϣϞϋΎϔΗϞϗ΃ήΘδϴϟϮΒϟ΍ϦϣωϮϨμϤϟ΍ϲΣ΍ήΠϟ΍ςϴΨϟ΍ήϴΜϳ
˱
ϲϔϴϠϟ΍ΞϴδϨϟ΍Δτγ΍ϮΑϲΣ΍ήΠϟ΍ςϴΨϠϟϲΠϳέΪΗϒϴϠϐΘΑΎϋϮΒΘϣϥϮϜϳϱάϟ΍ϭΔΠδϧϷ΍
ή˷ϴϐΗϱ΃ΙϭΪΣϞΠδ˵
˷ ϳϢϟϭˬιΎμΘϣϼϟϞΑΎϗήϴϏϲΣ΍ήΠϟ΍ήΘδϴϟϮΒϟ΍ςϴΧϡΎπϟ΍
ϲΤϟ΍ϢδΠϟ΍ϲϓΪθϟ΍ΓϮϘΑυΎϔΘΣϻ΍ϲϓήϴΒϛ
˷
ϦϳϮϜΗϭΡήΠϟ΍έΰϔΗϲϠϳΎϣίΎϬΠϟ΍΍άϫϡ΍ΪΨΘγΎΑΔτΒΗήϤϟ΍ΔϴδϜόϟ΍έΎΛϵ΍ϦϤπΘΗ
ϦϴΑΔϠϳϮσΓήΘϔϟΔδϣϼϣΙϭΪΣΪϨϋΔϳϭ΍ήϔμϟ΍ϭΔϴϟϮΒϟ΍ϚϟΎδϤϟ΍ϲϓΕ΍ϮμΣ
ϦϣΩϭΪΤϣϞϋΎϔΗϭˬΔΑΎμϤϟ΍ΡϭήΠϟ΍ϭˬ˯΍ήϔμϟ΍ϭϝϮΒϟ΍ϞΜϣˬΔϴΤϠϤϟ΍ϞϴϟΎΤϤϟ΍
ΡήΠϟ΍ϊοϮϣϲϓϲϣΎϤΣϭΔϣΫϭϭϢϟ΃ϭΩΎΤϟ΍ΔΠδϧϷ΍ΏΎϬΘϟ΍
˵
ϯήΧϷ΍
ϑΎθΘϛ΍ΔϟΎΣϲϓϭϊϴϨμΘϟ΍ϭΩ΍ϮϤϟ΍ϲϓΏϮϴϋϱ΃ϦϣΎ˱ϣΎϤΗϝΎΧΞΘϨϤϟ΍΍άϫ
˳
ΔϴϟϭΆδϣϥϮϜΘγˬϦΤθϟ΍ΪϨϋΐϴόϣΞΘϨϤϟ΍ϥ΃IVY SPORTS MEDICINE
ΞΘϨϤϟ΍ϝ΍ΪΒΘγ΍ϲϫΓΪϴΣϮϟ΍
ΕΎΠΘϨϤϟΔό˷ϨμϤϟ΍Δϛήθϟ΍ϥ·IVY SPORTS MEDICINEΩέϮΘδϤϟ΍ϭ
ΐΒδΑΙΪΤΗΪϗϲΘϟ΍ϯήΧϷ΍έΎΛϵ΍ϭ΃ΕΎϔϋΎπϤϟ΍ϦϋϦϴϟϭΆδϣήϴϏϦϳΩέϮϤϟ΍ϭ
ΓΩΎϤϠϟϢ΋ϼϤϟ΍ήϴϏέΎϴΘΧϻ΍ϭˬ΢ϴΤμϟ΍ήϴϏϲΣ΍ήΠϟ΍ΏϮϠγϷ΍ϭ΃ϝΎϤόΘγϻ΍ϲϋ΍ϭΩ
ϭ΃Ε΍ϭΩϸϟΔϤϴϠδϟ΍ήϴϏΔϟϭΎϨϤϟ΍ϭ΃ϡ΍ΪΨΘγϻ΍ϭˬαΎγϷ΍΍άϫϰϠϋΎϬόϣϞϣΎόΘϟ΍ϭ΃
˷
ϦϋΔϴϟϭΆδϤϟ΍ΔϴϠϤόϟ΍˯΍ήΟΈΑϢ΋ΎϘϟ΍Ρ΍ήΠϟ΍ϞϤΤΘϳϭΏΎΒγ΃ϦϣϚϟΫήϴϏϭϢ
ϘόϤϟ΍
˷
ΐϗ΍Ϯόϟ΍ϦϣΎϫήϴϏϭ΃ΕΎϔϋΎπϤϟ΍ϩάϫϦϣϱ΃
ΐϠτϟ΍ΓΩΎϋ·
ϲόΟήϤϟ΍Ϣϗήϟ΍ˬSharpShooter®ξΒϘϣ
ϲόΟήϤϟ΍Ϣϗήϟ΍ˬSharpShooter®ϲΣ΍ήΟςϴΧ
ϲόΟήϤϟ΍Ϣϗήϟ΍ˬSharpShooter®ΕΎ˷ϴϨϗ
ϯήδϴϟ΍ˬϰϨϤϴϟ΍
ΔϴϣΎϣϷ΍ ®
“Do not re-use”
www.ivysportsmed.com
“Do not resterilize”
“Sterilized using irradiation”
ΔϴϠϤόϟ΍˯΍ήΟΈΑϢ΋ΎϘϟ΍Ρ΍˷ήΠϠϟΔϤϬϣΕΎϣϮϠόϣ
ϒλϮϟ΍
INDICATIES VOOR GEBRUIK
3(7KHFKWGUDDGLVEHGRHOGYRRUJHEUXLNELMDOJHPHQHDSSUR[LPDWLHHQRI
ligatie van zacht weefsel.
SharpShooter-hechtdraad is bedoeld voor gebruik met het SharpShooterweefselreparatiesysteem, voor gebruik bij de reparatie van letsel aan de
meniscus.
®
͉
ϞΑΎϗήϴϏϭϢϘόϣϲΣ΍ήΟςϴΧϦϋΓέΎΒϋSharpShooter
ϲΣ΍ήΠϟ΍ςϴΨϟ΍
ϪϓήτΑϖΤϠϣϭέϮϔπϤϟ΍PETΕϻΎΜϓήϴΗϦϴϠϴΜϳ·ϲϟϮΒϟ΍Ϧϣϥ˷ϮϜϣιΎμΘϣϼϟ
˵
˸
ήτϗϲϓΔλϮΑ13Ϣγ33ϝϮτΑˬϝΰΒϣ˶ ϦγΕ΍ΫΔϤϴϘΘδϣϭΔϳϮϘΘϟ΍ΔΟϭΩΰϣήΑ·
ϲτΨϟ΍ήΘδϴϟϮΒϟ΍ϑΎϴϟ΃ϦϣϲΣ΍ήΠϟ΍ςϴΨϟ΍ήϴπΤΗϢΘϳΔλϮΑϢϣ
ΓέήϜΘϣΔϴΗΎϣϭέ΃ΕΎϘϠΣϰϠϋϱϮΘΤϳϭˬϲϟΎόϟ΍ϲΌϳΰΠϟ΍ϥίϮϟ΍ϱΫΔϠδϠδϟ΍ϞϳϮσ
ˬΔλϮΑϢγϲΣ΍ήΠϟ΍ςϴΨϟ΍ϝϮσώϠΒϳϪϨϣ΃ΰΠΘϳϻ˯ΰΠϛ
ϥϮϠϟΎΑύϮΒμϣϭϥϮϜϴϠδϟ΍ϦϣΔϘΒτΑΩ˷ϭΰϣϭέϮϔπϣϮϫϭˬ863ϱήΘϣ
D&CήπΧ΃ϲϫήπΧϷ΍ϥϮϠϟΎΑύϮΒμϤϟ΍ϲΣ΍ήΠϟ΍ςϴΨϟ΍ΔϐΒλήπΧϷ΍
ΔϳϭΩϷ΍έϮΘγΩϲϓΓΩΪΤϤϟ΍ΕΎΒϠτΘϤϟ΍ϊϴϤΠΑΞΘϨϤϟ΍΍άϫϲϔϳϭ*UHHQ1R
ιΎμΘϣϼϟϞΑΎϘϟ΍ήϴϏϲΣ΍ήΠϟ΍ςϴΨϠϟ863ϲϜϳήϣϷ΍
ϝΎϤόΘγϻ΍ϲϋ΍ϭΩ
ΔϴϠϤϋϲϓΕϻΎΜϓήϴΗϦϴϠϴΜϳ·ϲϟϮΒϟ΍ϦϣωϮϨμϤϟ΍ϲΣ΍ήΠϟ΍ςϴΨϟ΍ϝΎϤόΘγΎΑϰλϮ˵ϳ
ΔϣΎόϟ΍ΓϮΧήϟ΍ΔΠδϧϷ΍ςΑέϭ΃ϭΐϳήϘΗ
ΔΠδϧϷ΍Ρϼλ·ίΎϬΟϊϣϡ΍ΪΨΘγϼϟΔϤϤμϣSharpShooterΔϴΣ΍ήΠϟ΍ρϮϴΨϟ΍
ΔΒϛήϟΎΑϲϟϼϬϟ΍ϑϭήπϐϟ΍ΕΎΑΎλ·Ρϼλ·ϲϓϡ˴ΪΨΘδϤϟ΍SharpShooter
ϝΎϤόΘγϻ΍ϊϧ΍Ϯϣ
ΔϓϭήόϣήϴϏ
Ε΍ήϳάΤΗ
ήϴϏΔϴΣ΍ήΠϟ΍ρϮϴΨϟ΍Ϧϣκ˷ϠΨΗϢϴϘόΘϟ΍ΓΩΎϋΈΑϢϘΗϻ1
ΓϮΒόϟ΍΢ΘϓϢΘϳϢϟΎϣΔϤϘόϣΕΎϳϮΘΤϤϟ΍ΎϬΤΘϓϢΗϲΘϟ΍Δϣ˴ΪΨΘδϤϟ΍
ΎϬϓϼΗ·ϭ΃
CONTRA-INDICATIES
Geen bekend.
WAARSCHUWINGEN
1LHWRSQLHXZVWHULOLVHUHQ*RRLJHRSHQGHRQJHEUXLNWH
KHFKWGUDDGZHJ,QKRXGVWHULHOWHQ]LMGHYHUSDNNLQJ
geopend of beschadigd is.
2. Gebruikers moeten bekend zijn met chirurgische procedures en
technieken waaraan niet-oplosbare hechtdraad te pas komt, voordat
zij PET-hechtdraad gebruiken voor het sluiten van wonden, omdat het
risico op wonddehiscentie per plaats van toepassing en het gebruikte
hechtmateriaal kan verschillen.
9RRUGUDLQDJHHQKHWVOXLWHQYDQJHwQIHFWHHUGHRIEHVPHWWHZRQGHQPRHW
de geaccepteerde medische praktijk worden gevolgd.
VOORZORGSMAATREGELEN
%LMKHWJHEUXLNYDQGLWRIDQGHUKHFKWPDWHULDDOPRHW]RUJZRUGHQEHWUDFKW
om schade door het hanteren te voorkomen. Vermijd plet- of kreukschade
door het gebruik van chirurgische instrumenten, zoals draadvoerders,
forceps of naaldvoerders.
2. Net als bij elk hechtmateriaal is voor een adequate knoopvastheid een
DFFHSWDEHOHRSHUDWLHWHFKQLHNYDQSODWWHNQRSHQQRGLJPHWH[WUDOXVVHQ
indien wenselijk met het oog op de operatieve omstandigheden en de
ervaring van de chirurg.
'HJHEUXLNHUGLHQWYRRU]LFKWLJKHLGWHEHWUDFKWHQELMKHWJHEUXLNYDQ
hechtnaalden om ongewenste naaldprikken te voorkomen. Werp gebruikte
naalden in de naaldencontainer.
Sharpshooter-hechtdraad is uitsluitend bedoeld voor
eenmalig gebruik. Niet hergebruiken. Niet opnieuw
steriliseren.
BIJWERKINGEN
Polyester hechtdraad veroorzaakt een minimale acute ontstekingsreactie in
de huid, die wordt gevolgd door geleidelijke inkapseling van de hechtdraad
GRRU¿EUHXVELQGZHHIVHO3RO\HVWHUKHFKWGUDDGORVWQLHWRSQRFKYLQGWHU
voor zover bekend, in vivoHHQVLJQL¿FDQWHZLM]LJLQJLQWUHNYDVWKHLGSODDWV
%LMZHUNLQJHQGLHYHUEDQGKRXGHQPHWKHWJHEUXLNYDQGLWSURGXFW]LMQ
wonddehiscentie, steenvorming in de urine- en galwegen indien langdurig
FRQWDFWSODDWVYLQGWPHW]RXWRSORVVLQJHQDOVXULQHHQJDOJHwQIHFWHHUGH
wonden, minimale acute ontstekingsreactie van het weefsel en pijn, oedeem
en erytheem op de plaats van de wond.
BEPERKTE GARANTIE, BEPERKING VAN AANSPRAKELIJKHEID EN
AFWIJZING VAN ANDERE GARANTIES
Dit product is gegarandeerd vrij van gebreken in materiaal en vakmanschap.
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(1,*(YHUDQWZRRUGHOLMNKHLGYDQ,Y\6SRUWV0HGLFLQHXLWKHWYHUYDQJHQYDQ
het product.
De fabrikant, de importeur en de leveranciers van de producten van
,Y\6SRUWV0HGLFLQH]LMQQLHWDDQVSUDNHOLMNYRRUFRPSOLFDWLHVRIDQGHUH
effecten die zich kunnen voordoen om redenen zoals een onjuiste indicatie
of operatietechniek, ongeschikte keuze of hantering van materiaal, verkeerd
gebruik of hantering van de instrumenten, asepsis, enzovoort. De chirurg is
verantwoordelijk voor dergelijke complicaties of andere consequenties.
Rx Only
5296-Ed.-B 01/2013
ΔλϮΑ36Ϣγ91.4έϮϔπϣήπΧ΃ήΘδϴϟϮΑ
3.0ϱήΘϣˬU.S.P 2-0
ΔλϮΑ13Ϣγ33ϝϮτΑΔϳϮϘΘϟ΍ΔΟϭΩΰϣήΑ·
˵
ΔλϮΑ0.026Ϣϣ0.7ήτϗî
ϲΘϟ΍ΔϴΣ΍ήΠϟ΍Ε΍˯΍ήΟϹ΍ϭΐϴϟΎγϷΎΑΔϳ΍έΩϰϠϋϥϮϣΪΨΘδϤϟ΍ϥϮϜϳϥ΃ΐΠϳ
˱
ϲΣ΍ήΠϟ΍ςϴΨϟ΍ϡ΍ΪΨΘγ΍ϞΒϗιΎμΘϣϼϟΔϠΑΎϗήϴϏΔϴΣ΍ήΟΎσϮϴΧϦϤπΘΗ
˷
ΡήΠϟ΍έΰϔΗήτΧϥϷ˭ΡϭήΠϟ΍ϕϼϏϹΕϻΎΜϓήϴΗϦϴϠϴΜϳ·ϲϟϮΒϟ΍ϦϣωϮϨμϤϟ΍
ϡ˴ΪΨΘδϤϟ΍ϲΣ΍ήΠϟ΍ςϴΨϟ΍ωϮϧϭϡ΍ΪΨΘγϻ΍ϊοϮϤϟΎ˱όΒΗϒϠΘΨϳ
ΡϭήΠϟ΍ϦϣϞ΋΍Ϯδϟ΍ΐΤδΑϖϠόΘϳΎϣϲϓϝϮΒϘϤϟ΍ϲΣ΍ήΠϟ΍˯΍ήΟϹ΍ωΎΒΗ΍ΐΠϳ3
ΎϬϗϼϏ·ϭΔΛϮϠϤϟ΍ϭ΃ΔΑΎμϤϟ΍
Δϴ΋ΎϗϮϟ΍ήϴΑ΍ΪΘϟ΍
ΐΠϳˬήΧ΁ϲΣ΍ήΟςϴΧϱ΃ϭ΃ΔϴΣ΍ήΠϟ΍ρϮϴΨϟ΍ϦϣωϮϨϟ΍΍άϫϙΎδϣ·ΪϨϋ1
ϲϨΜϟ΍ϭ΃ήϴδϜΘϟ΍ϒϠΗΐ˷ϨΠΗϪϛΎδϣ·ϦϋΞΗΎϨϟ΍έήπϟ΍ΐϨΠΘϟέάΤϟ΍ϲΧϮΗ
ϭ΃ΔϴΣ΍ήΠϟ΍ρϮϴΨϟ΍ήϳήϤΗΕ΍ϭΩ΃ϞΜϣΔϴΣ΍ήΟΕ΍ϭΩ΃ϡ΍ΪΨΘγ΍ϦϋϢΟΎϨϟ΍
ήΑϹ΍Ϟϣ΍ϮΣϭ΃ςϗϼϤϟ΍
ϲΣ΍ήΠϟ΍ΏϮϠγϷ΍ωΎΒΗ΍ΐΠϳˬΔϴΣ΍ήΠϟ΍ρϮϴΨϠϟΩ΍Ϯϣϱ΃ϊϣϝΎΤϟ΍ϲϫΎϤϛ
ΔϳϮΘδϤϟ΍ΔτΑέϷ΍ϡ΍ΪΨΘγΎΑϚϟΫϥϮϜϳϭˬΪϘ˵όϠϟϢ΋ϼϤϟ΍ΖϴΒΜΘϟ΍ϥΎϤπϟϝϮΒϘϤϟ΍
Ρ΍ήΠϟ΍ΓήΒΧϭΔΣ΍ήΠϟ΍ϑϭήχϪΑ΢ϤδΗΎϣΐδΣΔϴϓΎο·ΔϴτϏ΃ϊϣˬΔόΑήϤϟ΍ϭ
˷
νήόΘϟ΍ΐϨΠΘϟΔϴΣ΍ήΠϟ΍ήΑϹ΍ϡ΍ΪΨΘγ΍ΪϨϋέάΤϟ΍ϥϮϣΪΨΘδϤϟ΍ϰΧϮΘϳϥ΃ΐΠϳ3
ϡΎδΟϷ΍´ΔϳϭΎΣϲϓΔϣΪΨΘδϤϟ΍ήΑϹ΍Ϧϣκ͉ϠΨΗΓήΑϹΎΑΩϮμϘϤϟ΍ήϴϏΰΧϮϠϟ
³ΓΩΎΤϟ΍
ςϘϓΓΪΣ΍ϭΓήϤϟSharpshooterϲΣ΍ήΠϟ΍ςϴΨϟ΍ϡΪ˴ ΨΘδ˵ϳ
ϪϤϴϘόΗΓΩΎϋΈΑϢϘΗϻϭϪϣ΍ΪΨΘγ΍ΓΩΎϋΈΑϢϘΗϻ
ΔϴδϜόϟ΍ΕϼϋΎϔΘϟ΍
ϲϓΓΩΎΤϟ΍ΕΎΑΎϬΘϟϻ΍ϦϣϞϋΎϔΗϞϗ΃ήΘδϴϟϮΒϟ΍ϦϣωϮϨμϤϟ΍ϲΣ΍ήΠϟ΍ςϴΨϟ΍ήϴΜϳ
˱
ϲϔϴϠϟ΍ΞϴδϨϟ΍Δτγ΍ϮΑϲΣ΍ήΠϟ΍ςϴΨϠϟϲΠϳέΪΗϒϴϠϐΘΑΎϋϮΒΘϣϥϮϜϳϱάϟ΍ϭΔΠδϧϷ΍
ή˷ϴϐΗϱ΃ΙϭΪΣϞΠδ˵
˷ ϳϢϟϭˬιΎμΘϣϼϟϞΑΎϗήϴϏϲΣ΍ήΠϟ΍ήΘδϴϟϮΒϟ΍ςϴΧϡΎπϟ΍
ϲΤϟ΍ϢδΠϟ΍ϲϓΪθϟ΍ΓϮϘΑυΎϔΘΣϻ΍ϲϓήϴΒϛ
˷
ϦϳϮϜΗϭΡήΠϟ΍έΰϔΗϲϠϳΎϣίΎϬΠϟ΍΍άϫϡ΍ΪΨΘγΎΑΔτΒΗήϤϟ΍ΔϴδϜόϟ΍έΎΛϵ΍ϦϤπΘΗ
ϦϴΑΔϠϳϮσΓήΘϔϟΔδϣϼϣΙϭΪΣΪϨϋΔϳϭ΍ήϔμϟ΍ϭΔϴϟϮΒϟ΍ϚϟΎδϤϟ΍ϲϓΕ΍ϮμΣ
ϦϣΩϭΪΤϣϞϋΎϔΗϭˬΔΑΎμϤϟ΍ΡϭήΠϟ΍ϭˬ˯΍ήϔμϟ΍ϭϝϮΒϟ΍ϞΜϣˬΔϴΤϠϤϟ΍ϞϴϟΎΤϤϟ΍
ΡήΠϟ΍ϊοϮϣϲϓϲϣΎϤΣϭΔϣΫϭϭϢϟ΃ϭΩΎΤϟ΍ΔΠδϧϷ΍ΏΎϬΘϟ΍
˵
ϯήΧϷ΍
ϑΎθΘϛ΍ΔϟΎΣϲϓϭϊϴϨμΘϟ΍ϭΩ΍ϮϤϟ΍ϲϓΏϮϴϋϱ΃ϦϣΎ˱ϣΎϤΗϝΎΧΞΘϨϤϟ΍΍άϫ
˳
ΔϴϟϭΆδϣϥϮϜΘγˬϦΤθϟ΍ΪϨϋΐϴόϣΞΘϨϤϟ΍ϥ΃IVY SPORTS MEDICINE
ΞΘϨϤϟ΍ϝ΍ΪΒΘγ΍ϲϫΓΪϴΣϮϟ΍
ΕΎΠΘϨϤϟΔό˷ϨμϤϟ΍Δϛήθϟ΍ϥ·IVY SPORTS MEDICINEΩέϮΘδϤϟ΍ϭ
ΐΒδΑΙΪΤΗΪϗϲΘϟ΍ϯήΧϷ΍έΎΛϵ΍ϭ΃ΕΎϔϋΎπϤϟ΍ϦϋϦϴϟϭΆδϣήϴϏϦϳΩέϮϤϟ΍ϭ
ΓΩΎϤϠϟϢ΋ϼϤϟ΍ήϴϏέΎϴΘΧϻ΍ϭˬ΢ϴΤμϟ΍ήϴϏϲΣ΍ήΠϟ΍ΏϮϠγϷ΍ϭ΃ϝΎϤόΘγϻ΍ϲϋ΍ϭΩ
ϭ΃Ε΍ϭΩϸϟΔϤϴϠδϟ΍ήϴϏΔϟϭΎϨϤϟ΍ϭ΃ϡ΍ΪΨΘγϻ΍ϭˬαΎγϷ΍΍άϫϰϠϋΎϬόϣϞϣΎόΘϟ΍ϭ΃
˷
ϦϋΔϴϟϭΆδϤϟ΍ΔϴϠϤόϟ΍˯΍ήΟΈΑϢ΋ΎϘϟ΍Ρ΍ήΠϟ΍ϞϤΤΘϳϭΏΎΒγ΃ϦϣϚϟΫήϴϏϭϢ
ϘόϤϟ΍
˷
ΐϗ΍Ϯόϟ΍ϦϣΎϫήϴϏϭ΃ΕΎϔϋΎπϤϟ΍ϩάϫϦϣϱ΃
NABESTELLEN:
SharpShooter®JUHHSUHIHUHQWLHQXPPHU
SharpShooter®KHFKWGUDDGUHIHUHQWLHQXPPHU
SharpShooter®FDQXOHVUHIHUHQWLHQXPPHU
DQWHULHXU
UHFKWVOLQNV
Canule SharpShooter®QXPHUHGHUHIHULQĠă
Δϴ΋ΎϗϮϟ΍ήϴΑ΍ΪΘϟ΍
ΐΠϳˬήΧ΁ϲΣ΍ήΟςϴΧϱ΃ϭ΃ΔϴΣ΍ήΠϟ΍ρϮϴΨϟ΍ϦϣωϮϨϟ΍΍άϫϙΎδϣ·ΪϨϋ1
ϲϨΜϟ΍ϭ΃ήϴδϜΘϟ΍ϒϠΗΐ˷ϨΠΗϪϛΎδϣ·ϦϋΞΗΎϨϟ΍έήπϟ΍ΐϨΠΘϟέάΤϟ΍ϲΧϮΗ
ϭ΃ΔϴΣ΍ήΠϟ΍ρϮϴΨϟ΍ήϳήϤΗΕ΍ϭΩ΃ϞΜϣΔϴΣ΍ήΟΕ΍ϭΩ΃ϡ΍ΪΨΘγ΍ϦϋϢΟΎϨϟ΍
ήΑϹ΍Ϟϣ΍ϮΣϭ΃ςϗϼϤϟ΍
AR
Din poliester, împletit, verde, 91,4 cm (36”)
2-0 în sistem U.S.P. 3,0 în sistem metric
Ace la ambele capete, 33 cm (13”)
lungime x 0,7 mm (0,026”) diametru
!ஏࢢ‫׻‬ฉ௼ ࡮੘ੑଊ/ ջऴน֍‫ڌ‬- হଵฉ௼ શୢ
ऴฏহ‫ ܂‬ා؈ฉ੘ੑଊ/ ී஍୴ ջऴ‫ݥ‬૦֍‫ڌ‬
ਅ৅‫ݥ‬௼ શୢ ซ ‫ڝ‬ଵࣆୢ ࢢ‫ ׻‬৅ീ୼܏‫ܙ‬/
ΡϭήΠϟ΍ϦϣϞ΋΍Ϯδϟ΍ΐΤδΑϖϠόΘϳΎϣϲϓϝϮΒϘϤϟ΍ϲΣ΍ήΠϟ΍˯΍ήΟϹ΍ωΎΒΗ΍ΐΠϳ3
ΎϬϗϼϏ·ϭΔΛϮϠϤϟ΍ϭ΃ΔΑΎμϤϟ΍
SHARPSHOOTER®ϲΣ΍ήΠϟ΍ςϴΨϟ΍
),5'(68785ă&+,585*,&$/6+$536+227(5
ֵ֮
ϲΘϟ΍ΔϴΣ΍ήΠϟ΍Ε΍˯΍ήΟϹ΍ϭΐϴϟΎγϷΎΑΔϳ΍έΩϰϠϋϥϮϣΪΨΘδϤϟ΍ϥϮϜϳϥ΃ΐΠϳ
˱
ϲΣ΍ήΠϟ΍ςϴΨϟ΍ϡ΍ΪΨΘγ΍ϞΒϗιΎμΘϣϼϟΔϠΑΎϗήϴϏΔϴΣ΍ήΟΎσϮϴΧϦϤπΘΗ
˷
ΡήΠϟ΍έΰϔΗήτΧϥϷ˭ΡϭήΠϟ΍ϕϼϏϹΕϻΎΜϓήϴΗϦϴϠϴΜϳ·ϲϟϮΒϟ΍ϦϣωϮϨμϤϟ΍
ϡ˴ΪΨΘδϤϟ΍ϲΣ΍ήΠϟ΍ςϴΨϟ΍ωϮϧϭϡ΍ΪΨΘγϻ΍ϊοϮϤϟΎ˱όΒΗϒϠΘΨϳ
NL
SV
3RO\HVWHUJU¡QQÁHWWHWFPµ
2-0 U.S.P. 3,0 metrisk
Toarmede nåler 33 cm (13”)
Lang x 0,7 mm (0,026”) dia.
PET ऴฏহ‫ࣳ୷ ܂‬ண୶ ૶஼௽ ந‫࣭ ׿‬0߃‫ࣃ ܂‬୥ਪ૫ হଵฏ܏‫ܙ‬/
ϝΎϤόΘγϻ΍ϊϧ΍Ϯϣ
ΔϓϭήόϣήϴϏ
Ε΍ήϳάΤΗ
ήϴϏΔϴΣ΍ήΠϟ΍ρϮϴΨϟ΍Ϧϣκ˷ϠΨΗϢϴϘόΘϟ΍ΓΩΎϋΈΑϢϘΗϻ1
ΓϮΒόϟ΍΢ΘϓϢΘϳϢϟΎϣΔϤϘόϣΕΎϳϮΘΤϤϟ΍ΎϬΤΘϓϢΗϲΘϟ΍Δϣ˴ΪΨΘδϤϟ΍
ΎϬϓϼΗ·ϭ΃
Manufacturer:
Ivy Sports Medicine
545 Penobscot Drive
Redwood City, CA 94063
USA
SHARPSHOOTER KIRURGISK SUTUR
INDIKASJONER FOR BRUK
ΔΠδϧϷ΍Ρϼλ·ίΎϬΟϊϣϡ΍ΪΨΘγϼϟΔϤϤμϣSharpShooterΔϴΣ΍ήΠϟ΍ρϮϴΨϟ΍
ΔΒϛήϟΎΑϲϟϼϬϟ΍ϑϭήπϐϟ΍ΕΎΑΎλ·Ρϼλ·ϲϓϡ˴ΪΨΘδϤϟ΍SharpShooter
WAARSCHUWINGEN
1LHWRSQLHXZVWHULOLVHUHQ*RRLJHRSHQGHRQJHEUXLNWH
KHFKWGUDDGZHJ,QKRXGVWHULHOWHQ]LMGHYHUSDNNLQJ
geopend of beschadigd is.
ූࡦ૫ੈൕ࡛- ‫ێ‬ৈ ෉஼ 91/4cm)36”*
2.0 U/S/P/ 3/0 ࣢ോ ‫ְ୏ܜ‬
୴௥ ઻ ࣯‫ ܃‬33cm)13”*
،୴ x 0/7mm)0/026”* ௽֮
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ϝΎϤόΘγϻ΍ϲϋ΍ϭΩ
ΔϴϠϤϋϲϓΕϻΎΜϓήϴΗϦϴϠϴΜϳ·ϲϟϮΒϟ΍ϦϣωϮϨμϤϟ΍ϲΣ΍ήΠϟ΍ςϴΨϟ΍ϝΎϤόΘγΎΑϰλϮ˵ϳ
ΔϣΎόϟ΍ΓϮΧήϟ΍ΔΠδϧϷ΍ςΑέϭ΃ϭΐϳήϘΗ
CONTRA-INDICATIES
Geen bekend.
SHARPSHOOTER ਦਪଵ ऴฏহ
®
®
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ϞΑΎϗήϴϏϭϢϘόϣϲΣ΍ήΟςϴΧϦϋΓέΎΒϋSharpShooter
ϲΣ΍ήΠϟ΍ςϴΨϟ΍
ϪϓήτΑϖΤϠϣϭέϮϔπϤϟ΍PETΕϻΎΜϓήϴΗϦϴϠϴΜϳ·ϲϟϮΒϟ΍Ϧϣϥ˷ϮϜϣιΎμΘϣϼϟ
˵
˸
ήτϗϲϓΔλϮΑ13Ϣγ33ϝϮτΑˬϝΰΒϣ˶ ϦγΕ΍ΫΔϤϴϘΘδϣϭΔϳϮϘΘϟ΍ΔΟϭΩΰϣήΑ·
ϲτΨϟ΍ήΘδϴϟϮΒϟ΍ϑΎϴϟ΃ϦϣϲΣ΍ήΠϟ΍ςϴΨϟ΍ήϴπΤΗϢΘϳΔλϮΑϢϣ
ΓέήϜΘϣΔϴΗΎϣϭέ΃ΕΎϘϠΣϰϠϋϱϮΘΤϳϭˬϲϟΎόϟ΍ϲΌϳΰΠϟ΍ϥίϮϟ΍ϱΫΔϠδϠδϟ΍ϞϳϮσ
ˬΔλϮΑϢγϲΣ΍ήΠϟ΍ςϴΨϟ΍ϝϮσώϠΒϳϪϨϣ΃ΰΠΘϳϻ˯ΰΠϛ
ϥϮϠϟΎΑύϮΒμϣϭϥϮϜϴϠδϟ΍ϦϣΔϘΒτΑΩ˷ϭΰϣϭέϮϔπϣϮϫϭˬ863ϱήΘϣ
D&CήπΧ΃ϲϫήπΧϷ΍ϥϮϠϟΎΑύϮΒμϤϟ΍ϲΣ΍ήΠϟ΍ςϴΨϟ΍ΔϐΒλήπΧϷ΍
ΔϳϭΩϷ΍έϮΘγΩϲϓΓΩΪΤϤϟ΍ΕΎΒϠτΘϤϟ΍ϊϴϤΠΑΞΘϨϤϟ΍΍άϫϲϔϳϭ*UHHQ1R
ιΎμΘϣϼϟϞΑΎϘϟ΍ήϴϏϲΣ΍ήΠϟ΍ςϴΨϠϟ863ϲϜϳήϣϷ΍
NABESTELLEN:
SharpShooter®JUHHSUHIHUHQWLHQXPPHU
SharpShooter®KHFKWGUDDGUHIHUHQWLHQXPPHU
SharpShooter®FDQXOHVUHIHUHQWLHQXPPHU
DQWHULHXU
UHFKWVOLQNV
Canule SharpShooter®QXPHUHGHUHIHULQĠă
®
Authorized EC representative:
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Manufacturer:
Ivy Sports Medicine
545 Penobscot Drive
Redwood City, CA 94063
USA
ΐϠτϟ΍ΓΩΎϋ·
ϲόΟήϤϟ΍Ϣϗήϟ΍ˬSharpShooter®ξΒϘϣ
ϲόΟήϤϟ΍Ϣϗήϟ΍ˬSharpShooter®ϲΣ΍ήΟςϴΧ
ϲόΟήϤϟ΍Ϣϗήϟ΍ˬSharpShooter®ΕΎ˷ϴϨϗ
ϯήδϴϟ΍ˬϰϨϤϴϟ΍
ΔϴϣΎϣϷ΍ www.ivysportsmed.com
5296-Ed.-B 01/2013
BACKER 2
BLACK
4/13
RU
®
NICI CHIRURGICZNE SHARPSHOOTER
Poliestrowe, zielone, plecione, 91,4 cm (36”)
rozmiar U.S.P. 2-0, metryczny 3,0
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OPIS
Nici chirurgiczne SharpShooter®WRQLHZFKáDQLDOQHMDáRZHQLFLFKLUXUJLF]QH
wykonane z plecionego poli(tereftalanu etylenu) (PET) i przymocowane
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nici chirurgicznych.
WSKAZANIA DO STOSOWANIA
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ɐɃɋɎɋȾɃɒɀɌɅɃɄɓɉȽɈɖɄɇȻɍɀɋɃȻɆ
SHARPSHOOTER®
Ɋɩɦɣɸɯɣɫɨɶɠɪɦɠɭɠɨɶɠɨɣɭɣɢɠɦɠɨɩɞɩɱɝɠɭɛɟɦɣɨɛ
ɬɧµ
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ȿɝɩɤɨɶɠɣɞɦɶɟɦɣɨɛɬɧµ
ȿɣɛɧɠɭɫɧɧµ
Ƚɛɡɨɛɺɣɨɯɩɫɧɛɱɣɺɟɦɺɰɣɫɮɫɞɛ
ɉɊɃɌȻɈɃɀ
ɏɢɪɭɪɝɢɱɟɫɤɢɣɲɨɜɧɵɣɦɚɬɟɪɢɚɥ6KDUS6KRRWHU®ɩɪɟɞɫɬɚɜɥɹɟɬɫɨɛɨɣ
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ɩɨɥɢɷɬɢɥɟɧɬɟɪɟɮɬɚɥɚɬɧɵɯɉɗɌɩɥɟɬɟɧɵɯɧɢɬɟɣɩɪɢɤɪɟɩɥɟɧɧɵɯɤɩɪɹɦɵɦ
ɞɜɨɣɧɵɦɢɝɥɚɦɫɬɪɨɚɤɚɪɧɵɦɤɨɧɰɨɦɞɥɢɧɨɣɫɦ”ɢɞɢɚɦɟɬɪɨɦ
ɦɦ”ɒɨɜɧɵɣɦɚɬɟɪɢɚɥɢɡɝɨɬɨɜɥɟɧɢɡɜɨɥɨɤɨɧɥɢɧɟɣɧɵɯ
ɩɨɥɢɷɮɢɪɨɜɫɞɥɢɧɧɨɣɰɟɩɶɸɢɜɵɫɨɤɢɦɦɨɥɟɤɭɥɹɪɧɵɦɜɟɫɨɦɫɨ
ɜɫɬɪɨɟɧɧɵɦɢɰɢɤɥɢɱɟɫɤɢɦɢɚɪɨɦɚɬɢɱɟɫɤɢɦɢɤɨɥɶɰɚɦɢɇɢɬɶɢɦɟɟɬɞɥɢɧɭ
ɫɦ”ɤɚɬɟɝɨɪɢɸ863ʋPHWULFɹɜɥɹɟɬɫɹɩɥɟɬɟɧɨɣ
ɩɨɫɬɚɜɥɹɟɬɫɹɫɫɢɥɢɤɨɧɨɜɵɦɩɨɤɪɵɬɢɟɦɢɨɤɪɚɲɟɧɚɜɡɟɥɟɧɵɣɰɜɟɬ
Ⱦɥɹɧɢɬɢɡɟɥɟɧɨɝɨɰɜɟɬɚɢɫɩɨɥɶɡɭɟɬɫɹɤɪɚɫɢɬɟɥɶ'&*UHHQ1Rɉɪɨɞɭɤɬ
ɫɨɨɬɜɟɬɫɬɜɭɟɬɜɫɟɦɬɪɟɛɨɜɚɧɢɹɦɎɚɪɦɚɤɨɩɟɢɋɒȺ863ɜɨɬɧɨɲɟɧɢɢ
ɧɟɪɚɫɫɚɫɵɜɚɸɳɟɝɨɫɹɲɨɜɧɨɝɨɦɚɬɟɪɢɚɥɚ
ɊɉɅȻɂȻɈɃɚɅɊɋɃɇɀɈɀɈɃə
ɉɗɌɧɢɬɶɩɪɟɞɧɚɡɧɚɱɟɧɚɞɥɹɨɛɳɟɝɨɫɛɥɢɠɟɧɢɹɦɹɝɤɢɯɬɤɚɧɟɣɢɢɥɢ
ɥɢɝɢɪɨɜɚɧɢɹ
ɏɢɪɭɪɝɢɱɟɫɤɢɣɲɨɜɧɵɣɦɚɬɟɪɢɚɥ6KDUS6KRRWHUɩɪɟɞɧɚɡɧɚɱɟɧɞɥɹ
ɢɫɩɨɥɶɡɨɜɚɧɢɹɜɦɟɫɬɟɫɫɢɫɬɟɦɨɣɞɥɹɜɨɫɫɬɚɧɨɜɥɟɧɢɹɬɤɚɧɟɣ6KDUS6KRRWHU
ɩɪɢɜɨɫɫɬɚɧɨɜɥɟɧɢɢɩɨɜɪɟɠɞɟɧɢɣɦɟɧɢɫɤɚɤɨɥɟɧɚ
ɊɋɉɍɃȽɉɊɉɅȻɂȻɈɃɚ
ɇɟɢɡɜɟɫɬɧɵ
ɊɋɀȿɎɊɋɀɁȿɀɈɃɚ
ɇɟɫɬɟɪɢɥɢɡɨɜɚɬɶɩɨɜɬɨɪɧɨɂɡɜɥɟɱɟɧɧɵɣɢɡɭɩɚɤɨɜɤɢ
ɢɧɟɢɫɩɨɥɶɡɨɜɚɧɧɵɣɲɨɜɧɵɣɦɚɬɟɪɢɚɥɫɥɟɞɭɟɬ
ɭɬɢɥɢɡɢɪɨɜɚɬɶɜɨɬɯɨɞɵȿɫɥɢɭɩɚɤɨɜɤɚɧɟɜɫɤɪɵɬɚɢɥɢɧɟ
ɩɨɜɪɟɠɞɟɧɚɬɨɟɟɫɨɞɟɪɠɢɦɨɟɹɜɥɹɟɬɫɹɫɬɟɪɢɥɶɧɵɦ
ɉɟɪɟɞɢɫɩɨɥɶɡɨɜɚɧɢɟɦɉɗɌɧɢɬɟɣɞɥɹɡɚɤɪɵɬɢɹɪɚɧɵɩɨɥɶɡɨɜɚɬɟɥɢ
ɞɨɥɠɧɵɨɡɧɚɤɨɦɢɬɶɫɹɫɦɟɬɨɞɚɦɢɢɬɟɯɧɢɤɚɦɢɯɢɪɭɪɝɢɱɟɫɤɢɯɩɪɨɰɟɞɭɪ
ɜɤɥɸɱɚɸɳɢɯɩɪɢɦɟɧɟɧɢɟɧɟɪɚɫɫɚɫɵɜɚɸɳɟɝɨɫɹɲɨɜɧɨɝɨɦɚɬɟɪɢɚɥɚɬɚɤ
ɤɚɤɢɦɟɟɬɫɹɪɢɫɤɪɚɫɯɨɠɞɟɧɢɹɤɪɚɟɜɪɚɧɵɤɨɬɨɪɵɣɡɚɜɢɫɢɬɨɬɦɟɫɬɚ
ɧɚɥɨɠɟɧɢɹɲɜɨɜɢɢɫɩɨɥɶɡɭɟɦɨɝɨɲɨɜɧɨɝɨɦɚɬɟɪɢɚɥɚ
ɋɥɟɞɭɟɬɫɨɛɥɸɞɚɬɶɫɨɨɬɜɟɬɫɬɜɭɸɳɢɟɯɢɪɭɪɝɢɱɟɫɤɢɟɩɪɚɤɬɢɤɢɜɨɬɧɨɲɟɧɢɢ
ɞɪɟɧɢɪɨɜɚɧɢɹɢɡɚɤɪɵɬɢɹɢɧɮɢɰɢɪɨɜɚɧɧɵɯɢɥɢɡɚɝɪɹɡɧɟɧɧɵɯɪɚɧ
ɇɀɋɖɊɋɀȿɉɌɍɉɋɉɁɈɉɌɍɃ
ɋɥɟɞɭɟɬɫɨɛɥɸɞɚɬɶɨɫɬɨɪɨɠɧɨɫɬɶɩɪɢɨɛɪɚɳɟɧɢɢɫɥɸɛɵɦɲɨɜɧɵɦ
ɦɚɬɟɪɢɚɥɨɦɱɬɨɛɵɧɟɞɨɩɭɫɬɢɬɶɟɝɨɩɨɜɪɟɠɞɟɧɢɹɇɟɞɨɩɭɫɤɚɟɬɫɹ
ɫɦɢɧɚɧɢɟɢɥɢɫɠɚɬɢɟɩɪɢɢɫɩɨɥɶɡɨɜɚɧɢɢɬɚɤɢɯɯɢɪɭɪɝɢɱɟɫɤɢɯɢɧɫɬɪɭɦɟɧɬɨɜ
ɤɚɤɫɲɢɜɚɸɳɢɟɚɩɩɚɪɚɬɵɩɢɧɰɟɬɵɢɥɢɢɝɥɨɞɟɪɠɚɬɟɥɢ
Ʉɚɤɢɜɫɥɭɱɚɟɫɥɸɛɵɦɲɨɜɧɵɦɦɚɬɟɪɢɚɥɨɦɧɚɞɟɠɧɵɟɭɡɥɵɬɪɟɛɭɸɬ
ɫɨɨɬɜɟɬɫɬɜɭɸɳɟɣɯɢɪɭɪɝɢɱɟɫɤɨɣɬɟɯɧɢɤɢɡɚɜɹɡɵɜɚɧɢɹɩɥɨɫɤɢɯ
ɤɜɚɞɪɚɬɧɵɯɭɡɥɨɜɫɞɨɩɨɥɧɢɬɟɥɶɧɵɦɢɧɚɛɪɨɫɚɦɢɫɭɱɟɬɨɦɨɛɫɬɨɹɬɟɥɶɫɬɜ
ɯɢɪɭɪɝɢɱɟɫɤɨɣɩɪɨɰɟɞɭɪɵɢɤɜɚɥɢɮɢɤɚɰɢɢɯɢɪɭɪɝɚ
ɉɨɥɶɡɨɜɚɬɟɥɢɞɨɥɠɧɵɫɨɛɥɸɞɚɬɶɨɫɬɨɪɨɠɧɨɫɬɶɩɪɢɨɛɪɚɳɟɧɢɢɫ
ɯɢɪɭɪɝɢɱɟɫɤɢɦɢɢɝɥɚɦɢɱɬɨɛɵɧɟɞɨɩɭɫɬɢɬɶɫɥɭɱɚɣɧɵɯɭɤɨɥɨɜɢɝɥɨɣɂɝɥɵ
ɫɥɟɞɭɟɬɭɬɢɥɢɡɢɪɨɜɚɬɶɜɤɨɧɬɟɣɧɟɪɞɥɹɢɝɥ
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Ʉɧɟɛɥɚɝɨɩɪɢɹɬɧɵɦɹɜɥɟɧɢɹɦɫɜɹɡɚɧɧɵɦɫɢɫɩɨɥɶɡɨɜɚɧɢɟɦɞɚɧɧɨɝɨɢɡɞɟɥɢɹ
ɨɬɧɨɫɹɬɫɹɪɚɫɯɨɠɞɟɧɢɟɤɪɚɟɜɪɚɧɵɨɛɪɚɡɨɜɚɧɢɟɤɚɦɧɟɣɜɦɨɱɟɜɵɜɨɞɹɳɢɯ
ɢɠɟɥɱɧɵɯɩɭɬɹɯɩɪɢɞɥɢɬɟɥɶɧɨɦɤɨɧɬɚɤɬɟɫɫɨɥɟɜɵɦɢɪɚɫɬɜɨɪɚɦɢɦɨɱɚɢ
ɠɟɥɱɶɢɧɮɢɰɢɪɨɜɚɧɢɟɪɚɧɵɫɥɚɛɚɹɨɫɬɪɚɹɜɨɫɩɚɥɢɬɟɥɶɧɚɹɪɟɚɤɰɢɹɬɤɚɧɟɣ
ɛɨɥɶɨɬɟɤɢɩɨɤɪɚɫɧɟɧɢɟɜɨɛɥɚɫɬɢɪɚɧɵ
“Use by date. . .
(Year, Month)”
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Ɋɭɤɨɹɬɤɚ6KDUS6KRRWHU®ɧɨɦɟɪɩɨɤɚɬɚɥɨɝɭ
ɏɢɪɭɪɝɢɱɟɫɤɢɣɲɨɜɧɵɣɦɚɬɟɪɢɚɥ6KDUS6KRRWHU®ɧɨɦɟɪɩɨɤɚɬɚɥɨɝɭ
Ʉɚɧɸɥɢ6KDUS6KRRWHU®ɧɨɦɟɪɩɨɤɚɬɚɥɨɝɭ
ɉɟɪɟɞɧɹɹ
ɩɪɚɜɚɹɥɟɜɚɹ
Poliestrowe, zielone, plecione, 91,4 cm (36”)
rozmiar U.S.P. 2-0, metryczny 3,0
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ɬɤɚɧɹɯɩɨɫɥɟɤɨɬɨɪɨɣɩɪɨɢɫɯɨɞɢɬɩɨɫɬɟɩɟɧɧɚɹɢɧɤɚɩɫɭɥɹɰɢɹɲɜɚɜɨɥɨɤɧɢɫɬɨɣ
ɫɨɟɞɢɧɢɬɟɥɶɧɨɣɬɤɚɧɶɸɉɨɥɢɷɮɢɪɧɚɹɧɢɬɶɧɟɚɛɫɨɪɛɢɪɭɟɬɫɹɚɫɥɭɱɚɢ
ɢɡɦɟɧɟɧɢɹɟɟɩɪɨɱɧɨɫɬɢɧɚɪɚɡɪɵɜin vivoɧɟɢɡɜɟɫɬɧɵ
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ɩɟɨɩɫɛɢɩɝɩɞɩɣɬɪɩɦɷɢɩɝɛɨɣɺɈɠɣɬɪɩɦɷɢɩɝɛɭɷɪɩɝɭɩɫɨɩ
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Ⱦɥɹɧɚɫɬɨɹɳɟɝɨɢɡɞɟɥɢɹɝɚɪɚɧɬɢɪɭɟɬɫɹɨɬɫɭɬɫɬɜɢɟɞɟɮɟɤɬɨɜɫɬɨɱɤɢɡɪɟɧɢɹ
ɤɚɱɟɫɬɜɚɦɚɬɟɪɢɚɥɚɢɢɡɝɨɬɨɜɥɟɧɢɹȿɫɥɢɛɭɞɟɬɭɫɬɚɧɨɜɥɟɧɨɱɬɨɢɡɞɟɥɢɟ
ɢɦɟɥɨɞɟɮɟɤɬɵɩɪɢɨɬɝɪɭɡɤɟɂɋɄɅɘɑɂɌȿɅɖɇɍɘɨɬɜɟɬɫɬɜɟɧɧɨɫɬɶɡɚɡɚɦɟɧɭ
ɢɡɞɟɥɢɹɧɟɫɟɬɤɨɦɩɚɧɢɹ,Y\6SRUWV0HGLFLQH
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ɧɟɧɟɫɭɬɨɬɜɟɬɫɬɜɟɧɧɨɫɬɢɡɚɨɫɥɨɠɧɟɧɢɹɢɥɢɞɪɭɝɢɟɷɮɮɟɤɬɵɤɨɬɨɪɵɟ
ɦɨɝɭɬɩɪɨɢɡɨɣɬɢɩɨɬɚɤɢɦɩɪɢɱɢɧɚɦɤɚɤɧɟɜɟɪɧɵɟɩɨɤɚɡɚɧɢɹɢɥɢɬɟɯɧɢɤɚ
ɩɪɨɜɟɞɟɧɢɹɨɩɟɪɚɰɢɢɧɟɧɚɞɥɟɠɚɳɢɣɜɵɛɨɪɦɚɬɟɪɢɚɥɨɜɢɥɢɢɯɨɛɪɚɛɨɬɤɚ
ɧɟɧɚɞɥɟɠɚɳɟɟɢɫɩɨɥɶɡɨɜɚɧɢɟɨɛɪɚɳɟɧɢɟɢɥɢɚɫɟɩɬɢɱɟɫɤɚɹɨɛɪɚɛɨɬɤɚ
ɢɧɫɬɪɭɦɟɧɬɨɜɢɬɞɈɬɜɟɬɫɬɜɟɧɧɨɫɬɶɡɚɥɸɛɵɟɩɨɞɨɛɧɵɟɨɫɥɨɠɧɟɧɢɹɢɥɢ
ɢɧɵɟɩɨɫɥɟɞɫɬɜɢɹɧɟɫɟɬɨɩɟɪɢɪɭɸɳɢɣɯɢɪɭɪɝ
PL
195621
PL
<(1ù'(16ù3$5ùú
SharpShooter®6DS5HIHUDQV1XPDUDVÕ
SharpShooter®&HUUDKL6WU5HIHUDQV1XPDUDVÕ
SharpShooter®.DQOOHU5HIHUDQV1XPDUDVÕ
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6D÷6RO
“Caution”
“Keep dry”
“Do not use if package
is damaged”
“Do not re-use”
“Do not resterilize”
“Sterilized using irradiation”
Rx Only
Authorized EC representative:
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Manufacturer:
Ivy Sports Medicine
545 Penobscot Drive
Redwood City, CA 94063
USA
www.ivysportsmed.com
5296-Ed.-B 01/2013
Rx Only
Authorized EC representative:
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Manufacturer:
Ivy Sports Medicine
545 Penobscot Drive
Redwood City, CA 94063
USA
www.ivysportsmed.com
5296-Ed.-B 01/2013
TR
ɐɃɋɎɋȾɃɒɀɌɅɃɄɓɉȽɈɖɄɇȻɍɀɋɃȻɆ
SHARPSHOOTER®
Ɋɩɦɣɸɯɣɫɨɶɠɪɦɠɭɠɨɶɠɨɣɭɣɢɠɦɠɨɩɞɩɱɝɠɭɛɟɦɣɨɛ
ɬɧµ
863ʌPHWULF
ȿɝɩɤɨɶɠɣɞɦɶɟɦɣɨɛɬɧµ
ȿɣɛɧɠɭɫɧɧµ
Ƚɛɡɨɛɺɣɨɯɩɫɧɛɱɣɺɟɦɺɰɣɫɮɫɞɛ
ɉɊɃɌȻɈɃɀ
ɏɢɪɭɪɝɢɱɟɫɤɢɣɲɨɜɧɵɣɦɚɬɟɪɢɚɥ6KDUS6KRRWHU®ɩɪɟɞɫɬɚɜɥɹɟɬɫɨɛɨɣ
ɧɟɪɚɫɫɚɫɵɜɚɸɳɢɣɫɹɫɬɟɪɢɥɶɧɵɣɲɨɜɧɵɣɦɚɬɟɪɢɚɥɫɨɫɬɨɹɳɢɣɢɡ
ɩɨɥɢɷɬɢɥɟɧɬɟɪɟɮɬɚɥɚɬɧɵɯɉɗɌɩɥɟɬɟɧɵɯɧɢɬɟɣɩɪɢɤɪɟɩɥɟɧɧɵɯɤɩɪɹɦɵɦ
ɞɜɨɣɧɵɦɢɝɥɚɦɫɬɪɨɚɤɚɪɧɵɦɤɨɧɰɨɦɞɥɢɧɨɣɫɦ”ɢɞɢɚɦɟɬɪɨɦ
ɦɦ”ɒɨɜɧɵɣɦɚɬɟɪɢɚɥɢɡɝɨɬɨɜɥɟɧɢɡɜɨɥɨɤɨɧɥɢɧɟɣɧɵɯ
ɩɨɥɢɷɮɢɪɨɜɫɞɥɢɧɧɨɣɰɟɩɶɸɢɜɵɫɨɤɢɦɦɨɥɟɤɭɥɹɪɧɵɦɜɟɫɨɦɫɨ
ɜɫɬɪɨɟɧɧɵɦɢɰɢɤɥɢɱɟɫɤɢɦɢɚɪɨɦɚɬɢɱɟɫɤɢɦɢɤɨɥɶɰɚɦɢɇɢɬɶɢɦɟɟɬɞɥɢɧɭ
ɫɦ”ɤɚɬɟɝɨɪɢɸ863ʋPHWULFɹɜɥɹɟɬɫɹɩɥɟɬɟɧɨɣ
ɩɨɫɬɚɜɥɹɟɬɫɹɫɫɢɥɢɤɨɧɨɜɵɦɩɨɤɪɵɬɢɟɦɢɨɤɪɚɲɟɧɚɜɡɟɥɟɧɵɣɰɜɟɬ
Ⱦɥɹɧɢɬɢɡɟɥɟɧɨɝɨɰɜɟɬɚɢɫɩɨɥɶɡɭɟɬɫɹɤɪɚɫɢɬɟɥɶ'&*UHHQ1Rɉɪɨɞɭɤɬ
ɫɨɨɬɜɟɬɫɬɜɭɟɬɜɫɟɦɬɪɟɛɨɜɚɧɢɹɦɎɚɪɦɚɤɨɩɟɢɋɒȺ863ɜɨɬɧɨɲɟɧɢɢ
ɧɟɪɚɫɫɚɫɵɜɚɸɳɟɝɨɫɹɲɨɜɧɨɝɨɦɚɬɟɪɢɚɥɚ
ɊɉɅȻɂȻɈɃɚɅɊɋɃɇɀɈɀɈɃə
ɉɗɌɧɢɬɶɩɪɟɞɧɚɡɧɚɱɟɧɚɞɥɹɨɛɳɟɝɨɫɛɥɢɠɟɧɢɹɦɹɝɤɢɯɬɤɚɧɟɣɢɢɥɢ
ɥɢɝɢɪɨɜɚɧɢɹ
ɏɢɪɭɪɝɢɱɟɫɤɢɣɲɨɜɧɵɣɦɚɬɟɪɢɚɥ6KDUS6KRRWHUɩɪɟɞɧɚɡɧɚɱɟɧɞɥɹ
ɢɫɩɨɥɶɡɨɜɚɧɢɹɜɦɟɫɬɟɫɫɢɫɬɟɦɨɣɞɥɹɜɨɫɫɬɚɧɨɜɥɟɧɢɹɬɤɚɧɟɣ6KDUS6KRRWHU
ɩɪɢɜɨɫɫɬɚɧɨɜɥɟɧɢɢɩɨɜɪɟɠɞɟɧɢɣɦɟɧɢɫɤɚɤɨɥɟɧɚ
ɊɋɉɍɃȽɉɊɉɅȻɂȻɈɃɚ
ɇɟɢɡɜɟɫɬɧɵ
ɊɋɀȿɎɊɋɀɁȿɀɈɃɚ
ɇɟɫɬɟɪɢɥɢɡɨɜɚɬɶɩɨɜɬɨɪɧɨɂɡɜɥɟɱɟɧɧɵɣɢɡɭɩɚɤɨɜɤɢ
ɢɧɟɢɫɩɨɥɶɡɨɜɚɧɧɵɣɲɨɜɧɵɣɦɚɬɟɪɢɚɥɫɥɟɞɭɟɬ
ɭɬɢɥɢɡɢɪɨɜɚɬɶɜɨɬɯɨɞɵȿɫɥɢɭɩɚɤɨɜɤɚɧɟɜɫɤɪɵɬɚɢɥɢɧɟ
ɩɨɜɪɟɠɞɟɧɚɬɨɟɟɫɨɞɟɪɠɢɦɨɟɹɜɥɹɟɬɫɹɫɬɟɪɢɥɶɧɵɦ
ɉɟɪɟɞɢɫɩɨɥɶɡɨɜɚɧɢɟɦɉɗɌɧɢɬɟɣɞɥɹɡɚɤɪɵɬɢɹɪɚɧɵɩɨɥɶɡɨɜɚɬɟɥɢ
ɞɨɥɠɧɵɨɡɧɚɤɨɦɢɬɶɫɹɫɦɟɬɨɞɚɦɢɢɬɟɯɧɢɤɚɦɢɯɢɪɭɪɝɢɱɟɫɤɢɯɩɪɨɰɟɞɭɪ
ɜɤɥɸɱɚɸɳɢɯɩɪɢɦɟɧɟɧɢɟɧɟɪɚɫɫɚɫɵɜɚɸɳɟɝɨɫɹɲɨɜɧɨɝɨɦɚɬɟɪɢɚɥɚɬɚɤ
ɤɚɤɢɦɟɟɬɫɹɪɢɫɤɪɚɫɯɨɠɞɟɧɢɹɤɪɚɟɜɪɚɧɵɤɨɬɨɪɵɣɡɚɜɢɫɢɬɨɬɦɟɫɬɚ
ɧɚɥɨɠɟɧɢɹɲɜɨɜɢɢɫɩɨɥɶɡɭɟɦɨɝɨɲɨɜɧɨɝɨɦɚɬɟɪɢɚɥɚ
ɋɥɟɞɭɟɬɫɨɛɥɸɞɚɬɶɫɨɨɬɜɟɬɫɬɜɭɸɳɢɟɯɢɪɭɪɝɢɱɟɫɤɢɟɩɪɚɤɬɢɤɢɜɨɬɧɨɲɟɧɢɢ
ɞɪɟɧɢɪɨɜɚɧɢɹɢɡɚɤɪɵɬɢɹɢɧɮɢɰɢɪɨɜɚɧɧɵɯɢɥɢɡɚɝɪɹɡɧɟɧɧɵɯɪɚɧ
ɇɀɋɖɊɋɀȿɉɌɍɉɋɉɁɈɉɌɍɃ
ɋɥɟɞɭɟɬɫɨɛɥɸɞɚɬɶɨɫɬɨɪɨɠɧɨɫɬɶɩɪɢɨɛɪɚɳɟɧɢɢɫɥɸɛɵɦɲɨɜɧɵɦ
ɦɚɬɟɪɢɚɥɨɦɱɬɨɛɵɧɟɞɨɩɭɫɬɢɬɶɟɝɨɩɨɜɪɟɠɞɟɧɢɹɇɟɞɨɩɭɫɤɚɟɬɫɹ
ɫɦɢɧɚɧɢɟɢɥɢɫɠɚɬɢɟɩɪɢɢɫɩɨɥɶɡɨɜɚɧɢɢɬɚɤɢɯɯɢɪɭɪɝɢɱɟɫɤɢɯɢɧɫɬɪɭɦɟɧɬɨɜ
ɤɚɤɫɲɢɜɚɸɳɢɟɚɩɩɚɪɚɬɵɩɢɧɰɟɬɵɢɥɢɢɝɥɨɞɟɪɠɚɬɟɥɢ
Ʉɚɤɢɜɫɥɭɱɚɟɫɥɸɛɵɦɲɨɜɧɵɦɦɚɬɟɪɢɚɥɨɦɧɚɞɟɠɧɵɟɭɡɥɵɬɪɟɛɭɸɬ
ɫɨɨɬɜɟɬɫɬɜɭɸɳɟɣɯɢɪɭɪɝɢɱɟɫɤɨɣɬɟɯɧɢɤɢɡɚɜɹɡɵɜɚɧɢɹɩɥɨɫɤɢɯ
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PONOWNE ZAMAWIANIE:
Uchwyt SharpShooter®QXPHUUHIHUHQF\MQ\
Nici chirurgiczne SharpShooter®QXPHUUHIHUHQF\MQ\
Kaniule SharpShooter®QXPHU\UHIHUHQF\MQH
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ɊɉȽɍɉɋɈɖɄɂȻɅȻɂ
Ɋɭɤɨɹɬɤɚ6KDUS6KRRWHU®ɧɨɦɟɪɩɨɤɚɬɚɥɨɝɭ
ɏɢɪɭɪɝɢɱɟɫɤɢɣɲɨɜɧɵɣɦɚɬɟɪɢɚɥ6KDUS6KRRWHU®ɧɨɦɟɪɩɨɤɚɬɚɥɨɝɭ
Ʉɚɧɸɥɢ6KDUS6KRRWHU®ɧɨɦɟɪɩɨɤɚɬɚɥɨɝɭ
ɉɟɪɟɞɧɹɹ
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