Beaded Breast Localization Wire

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Beaded Breast Localization Wire
GHIATAS® Beaded Breast Localization Wire
Instructions for Use
MR
Fil métallique de localisation mammaire à billes GHIATAS®
Mode d’emploi
GHIATAS® Brustlokalisationsdraht mit Verdickungen
Gebrauchsanweisung
Filo per localizzazione mammaria nervato GHIATAS®
Istruzioni per l’uso
Guía de localización mamaria con rebordes GHIATAS®
Instrucciones de uso
GHIATAS® mammalokalisatiedraad met kralen
Gebruiksaanwijzing
Fio de Localização Mamária com Esferas GHIATAS®
Instruções de utilização
ȈȪȡȝĮİȞIJȠʌȚıȝȠȪȕȜȐȕȘȢȝĮıIJȠȪȝİıijĮȚȡȓįȚĮGHIATAS®
ȅįȘȖȓİȢȤȡȒıȘȢ
GHIATAS® perlebetrukket brystlokaliseringstråd
Brugervejledning
GHIATAS® bröstindikeringstråd med markörer
Bruksanvisning
Helmen sisältävä rintojen GHIATAS®-paikannuslanka
Käyttöohjeet
GHIATAS® brystlokaliseringstråd med markører
Bruksanvisning
Drut GHIATAS® z koralikami do lokalizacji zmian w piersi
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Ghiatas® 珠狀乳房定位導線
使用說明
Ghiatas® 비드 유방 위치결정 와이어
사용 지침
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Instructions for Use
GHIATAS® Beaded Breast Localization Wire
Product Codes:
47519
19g x 5cm needle with 15cm barbed wire
47919
19g x 9cm needle with 20cm barbed wire
47320
20g x 3cm needle with 15cm barbed wire
47520
20g x 5cm needle with 15cm barbed wire
47720
20g x 7cm needle with 20cm barbed wire
47920
20g x 9cm needle with 20cm barbed wire
47020*
20g x 14cm needle with 35cm barbed wire
GHIATAS® Beaded Breast Localization Wire with Stiffened Section
Product Codes:
49520
20g x 5cm needle with 15cm barbed wire
49720
20g x 7cm needle with 20cm barbed wire
49920
20g x 9cm needle with 20cm barbed wire
MR GHIATAS® Beaded Breast Localization Wire MR
Product Codes:
475201*
20g x 5cm needle with 15cm barbed wire
477201*
20g x 7cm needle with 20cm barbed wire
479201*
20g x 9cm needle with 20cm barbed wire
470201*
20g x 14cm needle with 35cm barbed wire
*Product Codes 47020, 475201, 477201, 479201, and 470201 do not have the ultrasound enhancement.
In addition, Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance.
Figure 1
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3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
Introducer needle
Ultrasound enhancement
1cm depth reference marks
Orientation marks
Barb
Marking beads
Localization wire
Palpable deployment bead
A. General Information and Device Description:
The GHIATAS® Beaded Breast Localization Wire consists of an introducer needle and a semi-rigid localization
wire. The introducer needle is comprised of a plastic molded hub, 1cm depth reference marks, and an ultrasound
enhancement on the distal end to aid in needle placement. *The semi-rigid localization wire has 1cm marking
beads at the distal end of the wire and a palpable deployment bead to signify the point at which the barb at the
distal end of the wire will be deployed. Product Codes 49520, 49720 and 49920 have longer beads at the distal
end of the wire which add a stiffening effect to the wire.
B. How Supplied:
The GHIATAS® Beaded Breast Localization Wire is supplied sterile and non-pyrogenic unless the package has been
damaged or opened. Sterilized using Ethylene Oxide. For single use only. Do not reuse. Do not resterilize.
C. Indications for Use:
This device is intended for use during breast lesion surgery as a guide for the surgeon to follow in the excision
of the lesion.
D. Contraindications for Use:
None known.
E. Warnings:
1.
3.
5.
6.
8.
Once the barb has been deployed into the breast, the wire must be removed surgically. Do not attempt
to reposition, move, or pull on the wire or damage/breakage may result.
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Exercise caution during surgical excision of the lesion to avoid cutting the wire with a scalpel.
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to pull wire backwards into or inside the needle or barb damage may result.
Do not attempt to reshape the barb of the wire in any manner; this may cause the barb to fracture.
If the barb of the wire is deformed or bent incorrectly, discard product.
Caution should be exercised when using any localization wire on patients with breast prostheses
so as not to puncture them during placement or transportation.
7KHGHIATAS® Beaded Breast Localization Wire has been designed for single use only. Reusing this
medical device bears the risk of cross-patient contamination as medical devices – particularly those
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can promote the contamination of the device with pyrogens or microorganisms which may lead
to infectious complications.
Do not resterilize the GHIATAS® Beaded Breast Localization Wire. After resterilization, the sterility
of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or
microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or
resterilization of the present medical device increases the probability that the device will malfunction
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changes.
1
ENGLISH
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
ENGLISH
127(: After use, these products may be potential biohazards. Handle and dispose of in accordance with
acceptable medical practice and applicable local, state, and federal laws and regulations.
F.
Precautions:
1.
This device should only be used by a physician trained in its indicated use, limitations, and possible
complications of percutaneous needle techniques.
The introduction of the device into the body should be carried out under imaging control.
Before using, inspect the device for damage that would prevent proper function. If the components are
damaged or bent, DO NOT USE.
2.
3.
G. Potential Complications:
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H.
Equipment Required:
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I.
Directions for Use:
1.
Inspect the package and product for damage and expiration date. If undamaged and unexpired, open the
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2. Remove the wire from the introducer needle and verify that the product was not damaged during shipping
(Figure 2).
127( The localization wire is packaged in the needle with the barb facing out of the needle hub to prevent
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Figure 2
3.
4.
Locate the lesion using the appropriate imaging technique.
Insert the localization needle into the breast, directing it to the lesion (preferably parallel to the chest wall to
reduce the possible risk of pneumothorax). Use the depth reference marks to position the needle point into
the breast lesion (depth reference marks are 1cm apart) (Figure 3).
Figure 3
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The localization wire may then be inserted into the introducer needle by sliding the wire into the needle hub
and advancing the wire until the beginning of the palpable deployment bead on the wire is at the proximal end
of the needle hub. To insure the barb will deploy in the proper direction, line the barb up with the orientation
marks on the hub when feeding the wire into the needle (Figure 4).
Figure 4
8.
To deploy the barb, the localization wire should be held in place and the needle withdrawn approximately
1.5cm (Figure 5). Note: The barb will deploy when the palpable deployment bead on the wire is completely
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Figure 5
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barb. Note: The beads on the wire offer visual and palpable reference to the location of the barb and lesion.
10. The remaining exposed wire should be secured to the skin surface, using an appropriate method to prevent
the wire from moving during transport to surgery (Figure 6). The wire clip may be placed on the wire at the
VNLQVXUIDFHWRKHOSDYRLGZLUHPLJUDWLRQ8VHVXI¿FLHQWSUHVVXUHWRSODFHWKHZLUHFOLSRQWKHZLUH(Figure 7).
Figure 6
Figure 7
2
This device is MR Conditional:
The following codes can be can be placed and imaged under MR:
470201
475201
477201
479201
Non-clinical testing has demonstrated that the MR GHIATAS® Localization Wire is MR Conditional. It can be scanned
safely under the following conditions:
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In non-clinical testing, the MR GHIATAS® Localization Wire product codes produced a temperature rise of less than
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PLQXWHVRI05VFDQQLQJLQD7HVOD6LJQD05V\VWHP([FLWHSODWIRUP*%VRIWZDUH*(+HDOWKFDUH
Milwaukee, WI).
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the
position of the MR GHIATAS® Localization Wire. Therefore, it may be necessary to optimize MR imaging parameters
for the presence of this metallic implant.
Warranty
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product warranty will be limited to repair or replacement of the defective product, in Bard Peripheral Vascular’s sole
discretion or refunding your net price paid. Wear and tear from normal use or defects resulting from misuse of this
product are not covered by this limited warranty.
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last page of this booklet. In the event 36 months have elapsed between this date and product use, the user should
contact Bard Peripheral Vascular to see if additional product information is available.
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3
ENGLISH
11. Prior to surgery the BARD® Blunt Tip Stiffening Cannula may be guided over the GHIATAS® Beaded Breast
Localization Wire to aid in providing a palpable indication of the course of the wire and location of the wire tip.
FRANÇAIS
Mode d’emploi
Fil métallique de localisation mammaire à billes GHIATAS®
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Fil métallique de localisation mammaire à billes GHIATAS® avec section rigide
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Fil métallique de localisation mammaire à billes GHIATAS® pour IRM MR
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*Les produits portant les références 47020, 475201, 477201, 479201 et 470201 ne sont pas munis de l’aide
échographique. Par ailleurs, les produits portant les références 475201, 477201, 479201 et 470201 peuvent être
mis en place sous guidage par IRM.
Figure 1
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Repères de profondeur espacés de 1 cm
Marques d’orientation
Pointe
Billes de marquage
Fil métallique de localisation
Bille de déploiement détectable par palpation
A. Informations d’ordre général et description du dispositif :
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de localisation semi-rigide. L’aiguille d’introduction est constituée d’un raccord moulé en plastique, de repères
de profondeur espacés de 1 cm, ainsi que d’une aide échographique à son extrémité distale pour faciliter la mise
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à son extrémité distale et une bille de déploiement détectable par palpation pour indiquer le point où la pointe de
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de billes plus longues à leur extrémité distale, ce qui leur confère une certaine rigidité.
B. Conditionnement :
/H¿OPpWDOOLTXHGHORFDOLVDWLRQPDPPDLUHjELOOHV*HIATAS® est fourni stérile et apyrogène, sauf si l’emballage a été
ouvert ou endommagé. Stérilisé à l’oxyde d’éthylène. À usage unique. Ne pas réutiliser. Ne pas procéder à une
nouvelle stérilisation.
C. Indications :
Ce dispositif doit être utilisé en tant que guide par le chirurgien, lors de l’excision de lésions mammaires.
D. Contre-indications :
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E. Mises en garde :
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avec le scalpel.
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la pointe.
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XQHUXSWXUHGHODSRLQWH(QFDVGHGpIRUPDWLRQRXGHFRXUEXUHLQFRUUHFWHGHODSRLQWHGX¿OPHWWUH
le produit au rebut.
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du transfert de la patiente.
/H¿OPpWDOOLTXHGHORFDOLVDWLRQPDPPDLUHjELOOHVGHIATAS® a été conçu pour un usage unique.
La réutilisation de ce dispositif médical comporte un risque de contamination entre les patients,
car les dispositifs médicaux – en particulier ceux dotés de lumières longues et petites, de joints
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contact pendant une période indéterminable avec des liquides ou des tissus corporels susceptibles
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favoriser la contamination du dispositif par des pyrogènes ou des micro-organismes, ce qui peut
conduire à des complications infectieuses.
4
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la stérilité du produit n’est pas garantie en raison d’un degré indéterminable de contamination
pyrogène ou microbienne potentielle pouvant conduire à des complications infectieuses. Le nettoyage,
le retraitement et/ou la restérilisation de ce dispositif médical augmente le risque de dysfonctionnement
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et/ou mécaniques.
REMARQUE : Après utilisation, ce produit peut représenter un risque biologique. La manipulation et la
mise au rebut doivent s’effectuer conformément aux pratiques médicales acceptées et aux réglementations
locales, nationales et fédérales en vigueur.
1.
2.
Ce dispositif ne doit être manipulé que par un médecin ayant connaissance de ses indications et limites et des
complications possibles des techniques faisant intervenir une aiguille percutanée.
L’introduction du dispositif dans le corps doit être guidée par imagerie.
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G. Complications éventuelles :
Les complications éventuelles dépendent du site et peuvent prendre les formes suivantes : hématome, hémorragie,
infection, lésion des tissus avoisinants, douleurs, saignement, hémoptysie, hémothorax, perforation des organes,
des vaisseaux ou des tissus non ciblés et pneumothorax.
H. Matériel requis :
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Module d’imagerie approprié
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Mode d’emploi :
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de péremption. Si le conditionnement n’est pas endommagé et si la date de péremption n’est pas dépassée,
ouvrir le conditionnement et placer le produit sur un champ stérile en respectant les règles d’asepsie.
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le transport (Figure 2).
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de localisation de manière à faire glisser en premier la pointe dans le raccord de l’aiguille.
Figure 2
3.
4.
Localiser la lésion à l’aide de la technique d’imagerie appropriée.
Introduire l’aiguille de localisation dans le sein, en l’orientant vers la lésion (de préférence parallèlement à la
paroi thoracique pour réduire le risque de pneumothorax). Positionner la pointe de l’aiguille dans la lésion
mammaire à l’aide des repères de profondeur (ces repères sont espacés de 1 cm) (Figure 3).
Figure 3
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le déploiement de la pointe dans le sens approprié, aligner la pointe sur les repères d’orientation du raccord
ORUVGHO¶LQWURGXFWLRQGX¿OGDQVO¶DLJXLOOH(Figure 4).
Figure 4
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(Figure 5). Remarque : La pointe se déploie lorsque la bille de déploiement détectable par palpation se
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GHODSRLQWHULVTXHG¶HQGRPPDJHUGHFDVVHUOH¿O
Figure 5
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la mise en place de la pointe. Remarque :/HVELOOHVVLWXpHVVXUOH¿OPpWDOOLTXHVHUYHQWGHUHSqUHVYLVXHOV
et de repères détectables par palpation pour l’emplacement de la pointe et de la lésion.
5
FRANÇAIS
F. Précautions à prendre :
FRANÇAIS
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qu’il ne se déplace lors du transfert en chirurgie (Figure 6). Une pince adaptée peut être placée sur le
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GHODPLVHHQSODFHGHODSLQFHVXUOH¿O(Figure 7).
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Figure 7
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métallique de localisation mammaire à billes GHIATAS®SRXUDLGHUjREWHQLUXQUHSqUHSDOSDEOHGXWUDMHWGX¿O
HWGHO¶HPSODFHPHQWGHO¶H[WUpPLWpGX¿O
Ce dispositif peut être utilisé en résonance magnétique (RM) sous certaines conditions :
Les produits portant les références suivantes peuvent être mis en place sous guidage par IRM et visualisés par IRM :
470201
475201
477201
479201
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sous certaines conditions. Pour un examen par RM sûr, respecter les conditions suivantes :
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Champ magnétique statique inférieur ou égal à 3 Tesla
‡
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/RUVG¶XQHXWLOLVDWLRQQRQFOLQLTXHOHV¿OVPpWDOOLTXHVGHORFDOLVDWLRQGHIATAS® pour IRM portant les références
précédemment citées produisent une augmentation de température inférieure à + 0,9 ºC pour un taux d’absorption
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DYHFXQV\VWqPHGH506LJQDGH7HVODSODWHIRUPH([FLWHORJLFLHO*%*(+HDOWKFDUH0LOZDXNHH
WI, États Unis).
La qualité des images de RM risque d’être réduite si la zone d’intérêt se situe exactement dans la même zone,
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Garantie
Bard Peripheral Vascular, garantit ce produit à l’acheteur initial contre tout défaut de matériaux et de fabrication
SHQGDQWXQHGXUpHG¶XQDQjFRPSWHUGHODGDWHGHO¶DFKDWODUHVSRQVDELOLWpTXLGpFRXOHGHFHWWHJDUDQWLH
est limitée à la réparation ou au remplacement du produit défectueux, à la seule discrétion de Bard Peripheral
Vascular, ou au remboursement du prix net payé par l’acheteur. La responsabilité de Bard Peripheral Vascular,
en vertu de cette garantie limitée, ne s’étend pas à un emploi abusif de ce produit ou à une usure résultant d’une
utilisation normale.
'$16/(6/,0,7(6$8725,6((63$5/(6/2,6(19,*8(85&(77(*$5$17,(/,0,7((5(03/$&(
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Certains états ou pays n’autorisent pas l’exclusion des garanties implicites et des dommages incidents ou
conséquentiels. Il est possible que les lois de votre état ou pays vous donnent droit à des recours supplémentaires.
La dernière page de ce livret comporte la date de publication ou de révision et le numéro de version de ces
instructions, à titre d’information. Si 36 mois se sont écoulés entre cette date et l’utilisation du produit, l’utilisateur
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Gebrauchsanweisung
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GHIATAS® Brustlokalisationsdraht mit Verdickungen
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J[FP1DGHOPLWFP+DNHQGUDKW
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MR GHIATAS® Brustlokalisationsdraht mit Verdickungen MR
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*Produktcodes 47020, 475201, 477201, 479201 und 470201 sind nicht mit der Ultraschallverstärkung
ausgestattet. Darüber hinaus können Produktcodes 475201, 477201, 479201 und 470201 unter MRT-Führung
positioniert werden.
Abbildung 1
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
Einführnadel
Ultraschallverstärkung
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Orientierungsmarkierungen
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Verdickungen als Referenzpunkte
Lokalisationsdraht
Tastbarer Positionierungsmarker
A. Allgemeine Informationen und Produktbeschreibung:
Der GHIATAS® Brustlokalisationsdraht mit Verdickungen besteht aus einer Einführnadel und einem halbstarren
/RNDOLVDWLRQVGUDKW'LH(LQIKUQDGHOEHVLW]WHLQHQJHJRVVHQHQ.XQVWVWRII+XE7LHIHQPDUNLHUXQJHQLQFP
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'HUKDOEVWDUUH/RNDOLVDWLRQVGUDKWKDWLQ$EVWlQGHQYRQFPDQJHEUDFKWH9HUGLFNXQJHQDOV5HIHUHQ]SXQNWH
am distalen Ende des Drahts sowie einen tastbaren Positionierungsmarker zur Kennzeichnung der Stelle,
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haben längere Vertiefungen am distalen Drahtende, wodurch sich ein drahtversteifender Effekt ergibt.
B. Lieferzustand:
Der GHIATAS® Brustlokalisationsdraht mit Verdickungen ist bei ungeöffneter und unbeschädigter Verpackung
steril und pyrogenfrei. Sterilisiert mit Ethylenoxid. Nur zum einmaligen Gebrauch. Nicht wiederverwenden.
Nicht resterilisieren.
C. Anwendungsgebiete:
Dieses Produkt wird während der chirurgischen Behandlung einer Brustläsion als Führung für den Chirurgen
bei der Exzision der Läsion verwendet.
D. Gegenanzeigen:
Keine bekannt.
E. Warnhinweise:
1.
3.
4.
5.
6.
7.
Nach dem Einsetzen des Hakens in das Brustgewebe muss der Draht chirurgisch entfernt werden.
Nicht versuchen, den Draht neu auszurichten, zu verschieben oder zu ziehen - er kann dadurch
beschädigt werden und/oder brechen.
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Bei der chirurgischen Exzision der Läsion sorgfältig darauf achten, dass der Draht nicht mit einem
Skalpell durchschnitten wird.
Den Draht nur vom Hub durch die Nadel bis zur Nadelspitze vorschieben. Nicht versuchen, den Draht
rückwärts in die oder in der Nadel zu ziehen - dabei kann der Haken beschädigt werden.
Nicht versuchen, den Haken des Drahts wieder in die richtige Form zu bringen; dadurch kann der
Haken abbrechen. Ist der Haken deformiert oder falsch gebogen, das Produkt entsorgen.
Bei Verwendung eines Lokalisationsdrahts bei Patienten mit Brustprothesen ist vorsichtig
YRU]XJHKHQGDPLWGLH3URWKHVHZlKUHQGGHV(LQVHW]HQVRGHU7UDQVSRUWVQLFKWSXQNWLHUWZLUG
Der GHIATAS® Brustlokalisationsdraht (gesickt) ist nur für den einmaligen Gebrauch bestimmt. Bei einer
Wiederverwendung dieses medizinischen Produkts besteht die Gefahr einer Kreuzkontamination
zwischen Patienten, da medizinische Produkte, insbesondere Produkte mit langen und schmalen
Lumina, Verbindungen und/oder Spalten zwischen den Komponenten schwierig oder unmöglich zu
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Kontamination für eine unbestimmte Dauer mit dem medizinischen Produkt in Kontakt waren.
Verbleibende biologische Materialien können die Kontamination des Produkts mit Pyrogenen
oder Mikroorganismen fördern, was zu Infektionskomplikationen führen kann.
7
Der GHIATAS® Brustlokalisationsdraht (gesickt) darf nicht erneut sterilisiert werden. Die Sterilität
des Produktsist nach der Resterilisation nicht gewährleistet, da eine unbestimmbare potenzielle
Kontamination mit Pyrogenen oder Mikroorganismen zu Infektionskomplikationen führen kann.
Die Reinigung, Wiederaufbereitung und/oder Resterilisation dieses medizinischen Produkts erhöht
die Wahrscheinlichkeit, dass das Produkt aufgrund von potenziellen unerwünschten Wirkungen auf
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HINWEIS: Die Produkte können nach ihrer Benutzung ein potenzielles biologisches Risiko darstellen.
Handhabung und Entsorgung müssen nach anerkannten medizinischen Vorgehensweisen und
im Einklang mit den geltenden Gesetzen und Vorschriften erfolgen.
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8.
F. Vorsichtsmaßnahmen:
2.
3.
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Das Produkt sollte unter Kontrolle durch bildgebende Verfahren in den Körper eingeführt werden.
Vor der Verwendung das Produkt auf Beschädigungen überprüfen, die seine einwandfreie Funktion
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G. Mögliche Komplikationen:
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,QIHNWLRQHQ9HUOHW]XQJHQGHVDQJUHQ]HQGHQ*HZHEHV6FKPHU]HQ%OXWXQJHQ+lPRSW\VH+lPRWKRUD[
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H. Erforderliche Ausrüstung:
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I.
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Lokalanästhetikum
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Gebrauchsanweisung:
1.
Verpackung und Produkt auf Beschädigungen und Verfallsdatum überprüfen. Wenn die Verpackung
unbeschädigt und das Verfallsdatum noch nicht erreicht ist, Verpackung öffnen und Produkt mit aseptischem
Verfahren in das Sterilfeld legen.
2. Den Draht aus der Einführnadel herausnehmen und sicherstellen, dass das Produkt während des Transports
nicht beschädigt wurde (Abbildung 2).
HINWEIS:'DPLWGHU+DNHQQLFKWEHVFKlGLJWZLUGLVWGHU/RNDOLVDWLRQVGUDKWVRLQGHU1DGHOYHUSDFNWGDVVGHU
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ZHUGHQVRGDVVHUPLWGHP+DNHQYRUDQGXUFKGHQ1DGHO+XEJHVFKREHQZLUG
Abbildung 2
3
4.
Die Läsion anhand des angemessenen bildgebenden Verfahrens lokalisieren.
Die Lokalisationsnadel in die Brust zur Läsion einführen (vorzugsweise parallel zur Brustwand, um ein
P|JOLFKHV3QHXPRWKRUD[ULVLNR]XYHUULQJHUQ0LW+LOIHGHU7LHIHQPDUNLHUXQJHQGLH1DGHOVSLW]HLQGHU
%UXVWOlVLRQSRVLWLRQLHUHQGLH7LHIHQPDUNLHUXQJHQVLQGMHZHLOVLP$EVWDQGYRQFPDQJHEUDFKW
(Abbildung 3).
Abbildung 3
5.
6.
Die Position der Nadel mit dem angemessenen bildgebenden Verfahren bestätigen.
Wenn nötig, die Nadel neu positionieren und die Position erneut prüfen.
-HW]WNDQQGHU/RNDOLVDWLRQVGUDKWLQGLH(LQIKUQDGHOHLQJHIKUWZHUGHQGD]XGHQ'UDKWLQGHQ1DGHO+XE
VFKLHEHQXQGGHQ'UDKWYRUVFKLHEHQELVGHU$QIDQJGHVWDVWEDUHQ3RVLWLRQLHUXQJVPDUNHUVDP'UDKWGDV
SUR[LPDOH(QGHGHV1DGHO+XEVHUUHLFKWKDW'DPLWGHU+DNHQLQGHUULFKWLJHQ5LFKWXQJJUHLIWGHQ+DNHQ
EHLP(LQIKUHQGHV'UDKWVLQGLH1DGHODXIGLH2ULHQWLHUXQJVPDUNLHUXQJHQDP+XEDXVULFKWHQ(Abbildung 4).
Abbildung 4
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(Abbildung 5). Hinweis: 'HU+DNHQZLUGIUHLJHJHEHQZHQQGHUWDVWEDUH3RVWLRQLHUXQJVPDUNHUDP'UDKWVLFK
YROOVWlQGLJLP1DGHO+XEEH¿QGHW-HGHU9HUVXFKQDFK)UHLJDEHGHV+DNHQVGHQ'UDKWQHXDXV]XULFKWHQ
NDQQ]X%HVFKlGLJXQJ%UXFKGHV'UDKWVIKUHQ
Abbildung 5
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GHV+DNHQVEHUSUIWZHUGHQHinweis: Die Vertiefungen auf dem Draht dienen als visuelle und tastbare
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Abbildung 6
Abbildung 7
11. Vor dem Eingriff kann die BARD® Versteifungskanüle mit stumpfer Spitze über den GHIATAS®
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Drahtverlauf und die Lage der Drahtspitze bereitzustellen.
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Die Produkte mit den folgenden Codes sind zur Positionierung und Bildgebung unter MR-Einsicht geeignet:
470201
475201
477201
479201
In nicht klinischen Tests wurde nachgewiesen, dass der MR GHIATAS® Lokalisationsdraht bedingt MR-sicher
(MR Conditional) ist. Er kann unter den folgenden Bedingungen sicher in MRT-Untersuchungen verwendet werden:
‡
Statisches Magnetfeld von 3 Tesla oder weniger
‡
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In nicht klinischen Tests führten die MR GHIATAS® Lokalisationsdraht-Produktcodes zu einem Temperaturanstieg
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Die MR-Bildqualität kann beeinträchtigt sein, wenn der Bereich, auf den sich das Interesse richtet, genau in dem
selben Bereich wie oder relativ nahe bei der Position des MR GHIATAS® Lokalisationsdrahts liegt. Daher kann
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einzustellen.
Garantie
Bard Peripheral Vascular, garantiert dem Erstkäufer dieses Produkts, dass dieses Produkt für den Zeitraum eines
-DKUHVQDFK.DXIGDWXPIUHLYRQ0DWHULDOXQG9HUDUEHLWXQJVIHKOHUQLVWXQGGDVVGLH+DIWXQJLP5DKPHQGLHVHU
eingeschränkten Produktgarantie und im Ermessen von Bard Peripheral Vascular auf die Reparatur, den Ersatz
HLQHVGHIHNWHQ*HUlWVRGHUGLH5FNHUVWDWWXQJGHVGDIUJH]DKOWHQ1HWWRSUHLVHVEHVFKUlQNWLVW$EQXW]XQJ
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HLQJHVFKUlQNWH*DUDQWLHQLFKWDEJHGHFNW
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352'8.7*$5$17,($//($1'(5(1*$5$17,(16(,(1',(6((;3/,=,72'(5,03/,=,7*(*(%(1
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Rechtsbehelfe zur Verfügung.
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Seite dieser Broschüre. Sollten zwischen diesem Datum und der Verwendung des Produkts 36 Monate verstrichen
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aktuellere Produktinformationen vorliegen.
Zusammengebaut in Mexiko.
9
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Draht beim Transport in den OP nicht bewegt (Abbildung 6). Zur Verhinderung der Drahtmigration kann der
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den Draht aufsetzen (Abbildung 7).
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Istruzioni per l’uso
Filo per localizzazione mammaria nervato GHIATAS®
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Filo per localizzazione mammaria nervato GHIATAS® con sezione rigida
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Filo per localizzazione mammaria nervato GHIATAS® per RM MR
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prodotto 475201, 477201, 479201 e 470201 possono essere inseriti con l’ausilio di guida RM.
Fig. 1
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Contrassegni di 1 cm per riferimento profondità
Contrassegni di orientamento
Sezione uncinata
Nervature indicatrici
Filo per localizzazione
Nervatura palpabile di applicazione
A. Cenni generali e descrizione del dispositivo:
Il Filo per localizzazione mammaria nervato GHIATAS®FRQVLVWHGLXQDJRLQWURGXWWRUHHGLXQ¿ORSHUORFDOL]]D]LRQH
semirigido. L’ago introduttore consta di un attacco in plastica sagomata, contrassegni di 1 cm come riferimento
SHUODSURIRQGLWjHXQHFRDPSOL¿FDWRUHVXOO¶HVWUHPLWjGLVWDOHSHUDJHYRODUHODFROORFD]LRQHGHOO¶DJR,O¿ORSHU
localizzazione semirigido include nervature di 1 cm sull’estremità distale e una nervatura palpabile di applicazione
FKHFRUULVSRQGHDOSXQWRGRYHODVH]LRQHXQFLQDWDVXOO¶HVWUHPLWjGLVWDOHGHO¿ORVDUjDSSOLFDWD,FRGLFLSURGRWWR
HSUHVHQWDQRQHUYDWXUHSLOXQJKHVXOO¶HVWUHPLWjGLVWDOHGHO¿ORFKHFRQWULEXLVFRQR
ad irrigidirlo.
B. Formato di vendita:
Il Filo per localizzazione mammaria nervato GHIATAS® viene fornito sterile e apirogeno nella confezione chiusa
e intatta. Sterilizzato mediante ossido di etilene. Esclusivamente monouso. Non riutilizzare. Non risterilizzare.
C. Indicazioni per l’uso:
Questo dispositivo è destinato all’uso negli interventi chirurgici su lesioni mammarie, come guida per il chirurgo
nell’asportazione delle lesioni.
D. Controindicazioni all’uso:
Nessuna nota.
E. Avvertenze:
1.
Dopo aver applicato la sezione uncinata in sede mammaria è necessario rimuovere chirurgicamente
LO¿OR1RQWHQWDUHGLULSRVL]LRQDUHVSRVWDUHRWLUDUHLO¿ORPHWDOOLFRDOWULPHQWLVLULVFKLDGL
danneggiarlo/spezzarlo.
,O¿ORGHYHHVVHUHXVDWRHVFOXVLYDPHQWHFRPHJXLGD121XVDUORFRPHGLYDULFDWRUH
3URFHGHUHFRQFXUDDOO¶DVSRUWD]LRQHFKLUXUJLFDGHOOHOHVLRQLSHUHYLWDUHGLUHFLGHUHLO¿ORFRQLOELVWXUL
,O¿ORYDDYDQ]DWRXQLFDPHQWHDWWUDYHUVRO¶DJRGDOO¶DWWDFFR¿QRDOODSXQWD1RQFHUFDUHGLWLUDUHLO¿OR
all’indietro per reinserirlo nell’ago, altrimenti la sezione uncinata può subire danni.
1RQWHQWDUHGLULVDJRPDUHLQDOFXQPRGRODVH]LRQHXQFLQDWDGHO¿ORFKHDOWULPHQWLSRWUHEEH
URPSHUVL6HODVH]LRQHXQFLQDWDGHO¿ORVLGHIRUPDRVLSLHJDLQPRGRVEDJOLDWRJHWWDUHLOSURGRWWR
)DUHDWWHQ]LRQHGXUDQWHO¶XVRGLTXDOVLDVL¿ORORFDOL]]DWRUHVXSD]LHQWLFRQSURWHVLPDPPDULH
a scanso di perforazione durante l’inserimento o il trasporto.
,O¿ORQHUYDWRSHUORFDOL]]D]LRQHPDPPDULDGHIATAS® è esclusivamente monouso. Il riutilizzo del
dispositivo comporta il rischio di contaminazione crociata fra pazienti, poiché i dispositivi medici,
LQSDUWLFRODUHTXHOOLFRQOXPLOXQJKLHVWUHWWLJLXQWLHRIHVVXUHWUDLFRPSRQHQWLVRQRGLI¿FLOL
o impossibili da pulire, dopo il contatto del dispositivo per un periodo di tempo non determinabile
FRQÀXLGLRWHVVXWLRUJDQLFLFRQSRVVLELOHFRQWDPLQD]LRQHPLFURELFDRFRQSLURJHQL,UHVLGXL
di materiale biologico possono promuovere la contaminazione del dispositivo con pirogeni
o microrganismi che possono provocare complicanze infettive.
1RQULVWHULOL]]DUHLO¿ORQHUYDWRSHUORFDOL]]D]LRQHPDPPDULDGHIATAS®. Dopo la risterilizzazione
la sterilità del prodotto non è garantita, a causa del grado non determinabile di possibile
contaminazione microbica o con pirogeni che può provocare complicanze infettive. La pulizia,
il ritrattamento e/o la risterilizzazione del presente dispositivo aumentano la probabilità di guasti
GHOGLVSRVLWLYRDFDXVDGLSRVVLELOLGDQQLDLFRPSRQHQWLFKHSRVVRQRVXELUHPRGL¿FD]LRQLWHUPLFKH
e/o meccaniche.
10
F. Precauzioni:
1.
2.
L’uso di questo dispositivo è riservato ai soli medici con esperienza nelle indicazioni, limitazioni e possibili
complicanze delle tecniche percutanee con ago.
Procedere all’inserimento del dispositivo in presenza di controllo visivo.
3ULPDGLXWLOL]]DUHLOGLVSRVLWLYRYHUL¿FDUHFKHQRQSUHVHQWLGDQQLLQJUDGRGLFRPSURPHWWHUQHLOFRUUHWWR
IXQ]LRQDPHQWR,QFDVRGLFRPSRQHQWLGDQQHJJLDWLRSLHJDWL12186$5(,/',6326,7,92
G. Possibili complicanze:
/HSRWHQ]LDOLFRPSOLFDQ]HGLSHQGRQRGDOVLWRVSHFL¿FRHSRVVRQRLQFOXGHUHHPDWRPDHPRUUDJLDLQIH]LRQHOHVLRQH
GHOWHVVXWRFRQWLJXRGRORUHVDQJXLQDPHQWRHPRWWLVLHPRWRUDFHWHVVXWLQRQWDUJHWSHUIRUD]LRQHGLRUJDQLRYDVL
e pneumotorace.
H. La procedura richiede:
‡
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Un’idonea modalità di visualizzazione
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$QHVWHVLDORFDOH
$OWULSURGRWWLVHFRQGRQHFHVVLWj
I.
Istruzioni per l’uso:
,VSH]LRQDUHODFRQIH]LRQHHLOSURGRWWRSHUHVFOXGHUHGDQQLHYHUL¿FDUHODGDWDGLVFDGHQ]D6HLOGLVSRVLWLYR
è integro e la sua la data di scadenza non è stata superata, aprire la confezione e trasferirlo nel campo sterile
avvalendosi di una tecnica asettica.
(VWUDUUHLO¿ORGDOO¶DJRLQWURGXWWRUHHFRQWUROODUHFKHLOSURGRWWRQRQDEELDVXELWRGDQQLGXUDQWHLOWUDVSRUWR
(Fig. 2).
NB:,O¿ORSHUORFDOL]]D]LRQHqFRQIH]LRQDWRDOO¶LQWHUQRGHOO¶DJRFRQODVH]LRQHXQFLQDWDYHUVRO¶HVWHUQRGHOO¶DWWDFFR
SHUHYLWDUHGDQQL$OPRPHQWRGLFROORFDUHLO¿ORUXRWDUORDI¿QFKpODVH]LRQHXQFLQDWDSDVVLSHUSULPDDWWUDYHUVR
l’attacco dell’ago.
Fig. 2
3.
Localizzare la lesione utilizzando la corretta tecnica di visualizzazione.
,QVHULUHLO¿ORSHUORFDOL]]D]LRQHLQVHGHPDPPDULDRULHQWDQGRORYHUVRODOHVLRQHSUHIHULELOPHQWHSDUDOOHOR
alla parete toracica per alleviare il rischio di pneumotorace). Ricorrere ai contrassegni di riferimento per
la profondità come guida nel collocare la punta dell’ago nella lesione mammaria (tali contrassegni sono
a distanza di 1 cm) (Fig. 3).
Fig. 3
5.
6.
Confermare la collocazione dell’ago mediante una tecnica idonea di visualizzazione.
Se necessario, riposizionare l’ago e riconfermarne la posizione.
$TXHVWRSXQWRqSRVVLELOHLQVHULUHLO¿ORSHUORFDOL]]D]LRQHQHOO¶DJRLQWURGXWWRUHLQ¿ODQGRORQHOO¶DWWDFFRGHOO¶DJR
HDYDQ]DQGROR¿QRDTXDQGRODSDUWHLQL]LDOHGHOODQHUYDWXUDSDOSDELOHGLDSSOLFD]LRQHVLWURYDDOO¶HVWUHPLWj
prossimale dell’attacco dell’ago. Per applicare la sezione uncinata nel senso corretto, allinearla rispetto
DLFRQWUDVVHJQLGLRULHQWDPHQWRVXOO¶DWWDFFRPHQWUHLO¿ORYLHQHSURJUHVVLYDPHQWHLQVHULWRQHOO¶DJR(Fig. 4).
Fig. 4
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l’ago viene ritratto di 1,5 cm (Fig. 5). NB: La sezione uncinata risulta applicata quando la nervatura
SDOSDELOHVXO¿ORqFRPSOHWDPHQWHLQVHULWDQHOO¶DWWDFFRGHOO¶DJR(YHQWXDOLWHQWDWLYLGLULSRVL]LRQDUHLO¿OR
GRSRO¶DSSOLFD]LRQHGHOODVH]LRQHXQFLQDWDSRVVRQRGDQQHJJLDUHVSH]]DUHLO¿OR
Fig. 5
2UDqSRVVLELOHULPXRYHUHO¶DJRHGHVHJXLUHXQDUDGLRJUD¿DHRHFRJUD¿DDFRQIHUPDGHOODFROORFD]LRQHGHOOD
sezione uncinata. NB:/HQHUYDWXUHVXOODOXQJKH]]DGHO¿ORRIIURQRXQULIHULPHQWRYLVLYRHSDOSDELOHGHOOD
posizione della sezione uncinata e della lesione.
,OUHVWDQWH¿ORHVSRVWRGHYHHVVHUH¿VVDWRDOODFXWH8WLOL]]DUHXQPHWRGRLGRQHRDSUHYHQ]LRQHGHOOR
VSRVWDPHQWRGXUDQWHLOWUDJLWWR¿QRDOODVDODRSHUDWRULD(Fig. 6),OIHUPDJOLRSXzHVVHUHDSSOLFDWRDO¿OR
VXOODFXWHSHUVFRUDJJLDUQHORVSRVWDPHQWR(VHUFLWDUHVXI¿FLHQWHSUHVVLRQHSHUFROORFDUHLOIHUPDJOLRVXO¿OR
(Fig. 7).
11
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NB: Dopo l’uso questi prodotti possono costituire un potenziale rischio biologico. Maneggiarlo e smaltirlo
ai sensi della pratica medica comunemente accettata e di tutte le norme e i regolamenti locali, statali
e federali pertinenti.
Fig. 7
,7$/,$12
Fig. 6
11. Prima dell’intervento è possibile guidare la Cannula di rinforzo a punta smussa BARD® sul Filo per localizzazione
mammaria nervato GHIATAS®SHUDYHUHXQ¶LQGLFD]LRQHSDOSDELOHGHOSHUFRUVRGHO¿ORHGHOODSRVL]LRQHGHOOD
sua punta.
Questo dispositivo offre sicurezza condizionale per la RM:
I seguenti codici prodotto consentono l’inserimento e la visualizzazione con RM:
470201
475201
477201
479201
I test non clinici hanno attestato che il Filo per localizzazione GHIATAS® per RM offre sicurezza condizionale per
la RM. Può essere soggetto a scansione in modo sicuro nei casi seguenti:
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Campo magnetico statico di 3 Tesla o meno
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In test non clinici i codici prodotto del Filo per localizzazione GHIATAS® per RM hanno generato un aumento della
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*%*(+HDOWKFDUH0LOZDXNHH:,
La qualità delle immagini di RM può risultare compromessa se l’area di interesse corrisponde esattamente o si
trova relativamente vicina alla posizione del Filo per localizzazione GHIATAS® per RM. Pertanto, potrebbe essere
necessario ottimizzare i parametri di visualizzazione della RM per la presenza di questo impianto metallico.
Garanzia
Bard Peripheral Vascular, garantisce all’acquirente originario che il prodotto sarà esente da difetti di materiali
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la nostra responsabilità riguarderà unicamente la riparazione o sostituzione del prodotto difettoso, ad esclusiva
discrezione della Bard Peripheral Vascular, oppure il rimborso del prezzo netto pagato dall’acquirente. La presente
garanzia limitata non include il consumo e il logoramento derivati dal normale uso, né i difetti risultati dall’uso
improprio di questo prodotto.
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possono aver diritto ad ulteriori rivendicazioni ai sensi delle leggi vigenti nelle rispettive nazioni.
Per informazione dell’utilizzatore sono inclusi una data di pubblicazione o revisione e un numero di revisione
in quarta di copertina dell’opuscolo. Nel caso in cui siano passati 36 mesi da tale data all’uso del prodotto, si prega
l’utente di rivolgersi alla Bard Peripheral Vascular per appurare la disponibilità di ulteriori informazioni relative
al prodotto.
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12
Instrucciones de empleo
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Marcas de referencia a 1 cm de profundidad
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Parte dentada
Rebordes marcadores
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A. Información general y descripción del dispositivo:
/DJXtDGHORFDOL]DFLyQPDPDULDFRQUHERUGHVGHIATAS® FRQVWDGHXQDDJXMDLQWURGXFWRUD\XQDJXtDGHORFDOL]DFLyQ
VHPLUtJLGD/DDJXMDLQWURGXFWRUDHVWiIRUPDGDSRUXQFRQRPROGHDGRGHSOiVWLFRPDUFDVGHUHIHUHQFLDDFPGH
SURIXQGLGDG\XQUHDOFHHFRJUi¿FRHQHOH[WUHPRGLVWDOSDUDIDFLOLWDUODFRORFDFLyQGHODDJXMD/DJXtDGHORFDOL]DFLyQ
VHPLUtJLGDWLHQHUHERUGHVPDUFDGRUHVDFPHQHOH[WUHPRGLVWDO\XQUHERUGHGHDSOLFDFLyQSDOSDEOHSDUDVHxDODU
HOSXQWRHQHOTXHVHFRORFDUiODSDUWHGHQWDGDGHOH[WUHPRGLVWDOGHODJXtD/RVSURGXFWRVFRQFyGLJRV
\WLHQHQUHERUGHVPiVODUJRVHQHOH[WUHPRGLVWDOGHODJXtDTXHSURGXFHQXQHIHFWRGHUHIXHU]RHQODJXtD
B. Forma de suministro:
/DJXtDGHORFDOL]DFLyQPDPDULDFRQUHERUGHVGHIATAS®VHVXPLQLVWUDHVWpULO\DSLUyJHQDDPHQRVTXHHO
HQYDVHKD\DVLGRDELHUWRRGDxDGR(VWHULOL]DGRPHGLDQWHy[LGRGHHWLOHQRPara un solo uso exclusivamente.
No reutilizar. No reesterilizar.
C. Indicaciones de uso:
(VWHGLVSRVLWLYRVHKDGLVHxDGRSDUDXVDUORGXUDQWHLQWHUYHQFLRQHVTXLU~UJLFDVGHOHVLRQHVPDPDULDVFRPRXQDJXtD
SDUDTXHHOFLUXMDQRODVLJDGXUDQWHODHVFLVLyQGHODOHVLyQ
D. Contraindicaciones de uso:
Ninguna conocida.
E. Avisos:
2.
4.
6.
7.
8.
8QDYH]TXHVHKD\DFRORFDGRODSDUWHGHQWDGDHQODPDPDODJXtDVHGHEHH[WUDHUTXLU~UJLFDPHQWH
No intente reubicar, mover o tirar de la guía, ya que se podrían producir daños o se podría romper.
La guía se ha concebido exclusivamente como una guía. NO la use como separador.
7HQJDFXLGDGRGXUDQWHODHVFLVLyQTXLU~UJLFDGHODOHVLyQSDUDHYLWDUFRUWDUODJXtDFRQXQELVWXUt
Sólo se debe hacer avanzar la guía a través de la aguja desde el cono hasta la punta de la aguja.
No intente tirar de la guía hacia el interior o dentro de la aguja, ya que la aguja o la parte dentada
podrían quedar dañadas.
1RLQWHQWHYROYHUDPRGHODUODSDUWHGHQWDGDGHODJXtDGHQLQJ~QPRGRVLORKDFHVHSRGUtDURPSHU
la parte dentada. Si la parte dentada de la guía está deformada o doblada incorrectamente, deseche
el producto.
Debe tener cuidado cuando utilice una guía de localización en pacientes con prótesis mamarias para
no perforarlas durante su colocación o transporte.
La guía de localización mamaria con rebordes GHIATAS® se ha diseñado para utilizarse sólo una vez.
La reutilización de este dispositivo médico conlleva el riesgo de contaminación entre pacientes, ya que los
dispositivos médicos – especialmente aquéllos con luces largas y pequeñas, articulaciones y/o hendiduras
entre componentes – son difíciles o imposibles de limpiar una vez que los tejidos o líquidos corporales con
potencial de contaminación pirógena o microbiana han entrado en contacto con el dispositivo médico por
un período de tiempo indeterminable. Los residuos del material biológico pueden promover la contaminación
del dispositivo con pirógenos o microorganismos que pueden producir complicaciones por infecciones.
No resterilice la guía de localización mamaria con rebordes GHIATAS®. Después de la reesterilización no se
garantiza la esterilidad del producto debido a un grado indeterminable de posible contaminación pirógena
o microbiana que puede causar complicaciones por infecciones. La limpieza, el reprocesamiento y/o la
reesterilización del actual dispositivo médico aumentan la probabilidad de funcionamiento incorrecto del
mismo debido a posibles efectos adversos sobre los componentes, que se ven afectados por los cambios
mecánicos y/o térmicos.
13
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a la práctica médica aceptada y a las leyes y normativas locales, estatales y federales correspondientes.
F. Precauciones:
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SRVLEOHVFRPSOLFDFLRQHVGHODVWpFQLFDVFRQDJXMDVSHUFXWiQHDV
/DLQWURGXFFLyQGHOGLVSRVLWLYRHQHOFXHUSRGHEHKDFHUVHFRQFRQWUROGHLPiJHQHV
$QWHVGHXVDULQVSHFFLRQHHOGLVSRVLWLYRSRUVLDFDVRSUHVHQWDGDxRVTXHLPSLGDQHOIXQFLRQDPLHQWRFRUUHFWR
6LORVFRPSRQHQWHVHVWiQGDxDGRVRGREODGRV1286(HOGLVSRVLWLYR
G. Posibles complicaciones:
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KHPRUUDJLDLQIHFFLyQOHVLyQGHORVWHMLGRVDG\DFHQWHVGRORUVDQJUDGRKHPRSWLVLVKHPRWyUD[SHUIRUDFLyQGHWHMLGRV
yUJDQRVRYDVRVQRREMHWLYR\QHXPRWyUD[
H. Equipo necesario:
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Otros equipos necesarios
I.
Instrucciones de uso:
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GDxDGRVQLFDGXFDGRVDEUDHOHQYDVH\WUDVODGHHOSURGXFWRDOFDPSRHVWpULOXWLOL]DQGRXQDWpFQLFDDVpSWLFD
5HWLUHODJXtDGHODDJXMDLQWURGXFWRUD\FRPSUXHEHTXHHOSURGXFWRQRVHKD\DGHWHULRUDGRGXUDQWHHOHQYtR
(Figura 2).
127$/DJXtDGHORFDOL]DFLyQHVWiHQYDVDGDHQODDJXMDFRQODSDUWHGHQWDGDRULHQWDGDKDFLDIXHUDGHOFRQRGHOD
DJXMDSDUDHYLWDUTXHVHGHWHULRUH(QHOPRPHQWRGHFRORFDUODODJXtDGHORFDOL]DFLyQWHQGUiTXHJLUDUVHSDUDTXH
ODSDUWHGHQWDGDDWUDYLHVHSULPHURHOFRQRGHODDJXMD
Figura 2
4.
/RFDOLFHODOHVLyQXVDQGRODWpFQLFDGHREWHQFLyQGHLPiJHQHVDSURSLDGD
,QWURGX]FDODDJXMDGHORFDOL]DFLyQHQODPDPDGLUHFWDPHQWHHQODOHVLyQSUHIHULEOHPHQWHSDUDOHODDODSDUHG
WRUiFLFDSDUDUHGXFLUHOSRVLEOHULHVJRGHQHXPRWyUD[8WLOLFHODVPDUFDVGHUHIHUHQFLDGHSURIXQGLGDGSDUDVLWXDU
ODSXQWDGHODDJXMDHQODOHVLyQPDPDULDODVPDUFDVGHUHIHUHQFLDGHSURIXQGLGDGHVWiQVHSDUDGDVSRUFP
(Figura 3).
Figura 3
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/DJXtDGHORFDOL]DFLyQVHSXHGHLQWURGXFLUHQWRQFHVHQODDJXMDLQWURGXFWRUDGHVOL]DQGRODJXtDKDFLDHOLQWHULRU
GHOFRQRGHODDJXMD\DYDQ]DQGRODJXtDKDVWDTXHHOSULQFLSLRGHOUHERUGHGHDSOLFDFLyQSDOSDEOHGHODJXtDVH
HQFXHQWUHHQHOH[WUHPRSUR[LPDOGHOFRQRGHODDJXMD3DUDDVHJXUDUVHGHTXHODSDUWHGHQWDGDVHFRORFDHQOD
GLUHFFLyQFRUUHFWDDOLQHHODSDUWHGHQWDGDFRQODVPDUFDVGHRULHQWDFLyQGHOFRQRDOLQWURGXFLUODJXtDHQODDJXMD
(Figura 4).
Figura 4
3DUDFRORFDUODSDUWHGHQWDGDODJXtDGHORFDOL]DFLyQVHGHEHPDQWHQHUHQHOVLWLR\H[WUDHUODDJXMD
aproximadamente 1,5 cm (Figura 5). Nota:/DSDUWHGHQWDGDVHFRORFDUiFXDQGRHOUHERUGHGHDSOLFDFLyQSDOSDEOH
GHODJXtDHVWpWRWDOPHQWHGHQWURGHOFRQRGHODDJXMD&XDOTXLHULQWHQWRGHUHXELFDUODJXtDGHVSXpVGHFRORFDU
ODSDUWHGHQWDGDSRGUtDGDxDUODJXtDRURPSHUOD
Figura 5
$KRUDVHSXHGHUHWLUDUODDJXMD\KDFHUXQDUDGLRJUDItD\RHFRJUDItDSDUDFRQ¿UPDUODFRORFDFLyQGHODSDUWH
dentada. Nota:/RVUHERUGHVGHODJXtDRIUHFHQXQDUHIHUHQFLDYLVXDO\SDOSDEOHSDUDODORFDOL]DFLyQGHODSDUWH
GHQWDGD\ODOHVLyQ
(OUHVWRGHODJXtDTXHTXHGDH[SXHVWDVHGHEH¿MDUDODVXSHU¿FLHFXWiQHDVLJXLHQGRXQPpWRGRDGHFXDGRSDUD
HYLWDUTXHODJXtDVHPXHYDGXUDQWHHOWUDVODGRKDVWDODFLUXJtD(Figura 6)/DSLQ]DGHODJXtDVHSXHGHLQVWDODU
HQODJXtDHQODVXSHU¿FLHFXWiQHDSDUDD\XGDUDHYLWDUTXHVHGHVSODFH(MHU]DODVX¿FLHQWHSUHVLyQSDUDLQVWDODU
ODSLQ]DHQODJXtD (Figura 7).
14
Figura 6
Figura 7
ESPAÑOL
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\ODXELFDFLyQGHODSXQWDGHODJXtD
(VWHGLVSRVLWLYRVHSXHGHXVDUFRQ50EDMRFRQGLFLRQHVHVSHFt¿FDV
/RVVLJXLHQWHVFyGLJRVVHSXHGHQFRORFDUFRQ50\FDSWDUHQLPiJHQHVGH50
470201
475201
477201
479201
/DVSUXHEDVQRFOtQLFDVKDQGHPRVWUDGRTXHODJXtDGHORFDOL]DFLyQGHIATAS®SDUD50VHSXHGHXWLOL]DUFRQ50EDMR
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‡
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GHODWHPSHUDWXUDGHPHQRVGHž&FRQXQDWDVDGHDEVRUFLyQHVSHFt¿FD6$5SRUVXVVLJODVHQLQJOpVPi[LPD
SURPHGLDGDSDUDWRGRHOFXHUSR\QRWL¿FDGDSRUHOVLVWHPDGH50GH:NJGXUDQWHPLQXWRVGHH[SORUDFLyQSRU
50HQXQVLVWHPDGH50GH7HVOD6LJQDSODWDIRUPD([FLWHVRIWZDUH*%*(+HDOWKFDUH0LOZDXNHH:,
/DFDOLGDGGHODVLPiJHQHVGH50SXHGHYHUVHDIHFWDGDVLOD]RQDGHLQWHUpVHVWiH[DFWDPHQWHHQODPLVPD]RQD
RUHODWLYDPHQWHFHUFDGHOOXJDUGRQGHHVWiFRORFDGDODJXtDGHORFDOL]DFLyQGHIATAS®SDUD503RUORWDQWRSRGUtDVHU
QHFHVDULRRSWLPL]DUORVSDUiPHWURVGHREWHQFLyQGHLPiJHQHVSRU50SRUODSUHVHQFLDGHHVWHLPSODQWHPDJQpWLFR
Garantía
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IDEULFDFLyQGXUDQWHXQSHUtRGRGHXQDxRGHVGHODIHFKDGHODSULPHUDFRPSUD/DUHVSRQVDELOLGDGVHJ~QHVWDJDUDQWtD
OLPLWDGDGHOSURGXFWRVHOLPLWDUiDODUHSDUDFLyQRVXVWLWXFLyQGHOSURGXFWRGHIHFWXRVRDGLVFUHFLyQGH%DUG3HULSKHUDO
Vascular, o al reembolso del precio neto pagado. El desgaste producido por un uso normal o los defectos resultantes
GHOXVRLQFRUUHFWRGHHVWHSURGXFWRQRHVWiQFXELHUWRVSRUHVWDJDUDQWtDOLPLWDGD
(1/$0(','$3(50,7,'$325/$/(*,6/$&,Ï1$3/,&$%/((67$*$5$17Ë$/,0,7$'$'(352'8&72
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el producto.
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15
NEDERALANDS
Gebruiksaanwijzing
GHIATAS® mammalokalisatiedraad met kralen
Productcodes:
47519
19 g x 5 cm naald met 15 cm draad met weerhaak
47919
19 g x 9 cm naald met 20 cm draad met weerhaak
47320
20 g x 3 cm naald met 15 cm draad met weerhaak
47520
20 g x 5 cm naald met 15 cm draad met weerhaak
47720
20 g x 7 cm naald met 20 cm draad met weerhaak
47920
20 g x 9 cm naald met 20 cm draad met weerhaak
47020*
20 g x 14 cm naald met 35 cm draad met weerhaak
GHIATAS® PDPPDORNDOLVDWLHGUDDGPHWNUDOHQHQVWLMYHUGHHO
Productcodes:
49520
20 g x 5 cm naald met 15 cm draad met weerhaak
49720
20 g x 7 cm naald met 20 cm draad met weerhaak
49920
20 g x 9 cm naald met 20 cm draad met weerhaak
MR GHIATAS® mammalokalisatiedraad met kralen MR
Productcodes:
475201*
20 g x 5 cm naald met 15 cm draad met weerhaak
477201*
20 g x 7 cm naald met 20 cm draad met weerhaak
479201*
20 g x 9 cm naald met 20 cm draad met weerhaak
470201*
20 g x 14 cm naald met 35 cm draad met weerhaak
*De producten met code 47020, 475201, 477201, 479201 en 470201 hebben geen versterkt echogene marker. De
producten met code 475201, 477201, 479201 en 470201 kunnen bovendien onder MRI-controle worden geplaatst.
Afbeelding 1
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
Inbrengnaald
Echomarker
Centimeterschaal voor dieptemarkering
Oriëntatiemarkeringen
Weerhaak
Markeringskralen
Lokalisatiedraad
Voelbare plaatsingskraal
A. Algemene informatie en beschrijving van het hulpmiddel:
De GHIATAS® mammalokalisatiedraad met kralen bestaat uit een inbrengnaald en een semi-rigide lokalisatiedraad.
De inbrengnaald bestaat uit een gegoten plastic aanzetstuk en is voorzien van een centimeterschaal voor
GLHSWHPDUNHULQJHQYDQHHQHFKRPDUNHUDDQKHWGLVWDOHXLWHLQGHRPELMKHWSODDWVHQYDQGHQDDOGWHKHOSHQ
*De semi-rigide lokalisatiedraad heeft markeringskralen met een tussenruimte van 1 cm aan het distale uiteinde
en een voelbare plaatsingskraal die het punt aangeeft waarop de weerhaak aan het distale uiteinde van de draad
loskomt. De producten met code 49520, 49720 en 49920 hebben langere kralen aan het distale uiteinde van de
GUDDGZDWGHGUDDGVWLMYHUPDDNW
% $ÀHYHULQJ
De GHIATAS®PDPPDORNDOLVDWLHGUDDGPHWNUDOHQZRUGWVWHULHOHQS\URJHHQYULMJHOHYHUGWHQ]LMGHYHUSDNNLQJJHRSHQGRI
EHVFKDGLJGLV*HVWHULOLVHHUGPHWEHKXOSYDQHWK\OHHQR[LGHUitsluitend voor eenmalig gebruik. Niet hergebruiken.
Niet opnieuw steriliseren.
C. Indicaties voor gebruik:
'LWKXOSPLGGHOLVEHGRHOGRPELMPDPPDFKLUXUJLHWHZRUGHQJHEUXLNWDOVJLGVYRRUGHFKLUXUJELMGHH[FLVLHYDQ
de laesie.
D. Contra-indicaties:
*HHQEHNHQG
E. Waarschuwingen:
1.
3.
4.
5.
6.
7.
Als de weerhaak eenmaal is vrijgegeven in het borstweefsel moet de draad chirurgisch worden
verwijderd. Probeer niet de draad te herpositioneren, te verplaatsen of aan de draad te trekken
aangezien deze dan kan beschadigen/breken.
'HGUDDGLVXLWVOXLWHQGDOVJLGVEHGRHOG*HEUXLNKHP1,(7DOVUHWUDFWRU
Let er bij de chirurgische verwijdering van de laesie op dat de draad niet met een scalpel wordt
doorgesneden.
De draad dient uitsluitend in voorwaartse richting door de naald te worden bewogen van het
aanzetstuk naar de naaldpunt. Probeer niet de draad weer in of door de naald terug te trekken,
anders kan de weerhaak beschadigd raken.
Probeer niet de vorm van de weerhaak op enigerlei wijze te veranderen; hierdoor kan de weerhaak
afbreken. Als de weerhaak van de draad vervormd of verkeerd gebogen is, werp het product dan weg.
Bij gebruik van een lokalisatiedraad bij patiënten met een borstprothese moet voorzichtig worden
gewerkt om de prothese niet aan te prikken bij het plaatsen of bij het vervoer.
De GHIATAS® mammalokalisatiedraad met kralen is uitsluitend bestemd voor eenmalig gebruik.
Hergebruik van dit medische hulpmiddel brengt het risico met zich mee van kruiscontaminatie
tussen patiënten, omdat medische hulpmiddelen – met name hulpmiddelen met lange en smalle
lumina, gewrichten en/of spleten tussen de onderdelen – moeilijk of onmogelijk te reinigen zijn
als lichaamsvloeistoffen of weefsel met mogelijk pyrogene of microbiële contaminatie eenmaal
gedurende onbepaalde tijd in contact zijn gekomen met het medische hulpmiddel. Resten biologisch
materiaal kunnen de verontreiniging van het hulpmiddel met pyrogenen of micro-organismen
bevorderen, waardoor infectieuze complicaties kunnen optreden.
16
F. Voorzorgsmaatregelen:
1.
Dit hulpmiddel dient uitsluitend te worden gebruikt door een arts die geoefend is in het bedoelde gebruik,
HQGLHRSGHKRRJWHLVYDQGHEHSHUNLQJHQHQPRJHOLMNHFRPSOLFDWLHVYDQSHUFXWDQHQDDOGWHFKQLHNHQ
+HWLQEUHQJHQYDQKHWKXOSPLGGHOLQKHWOLFKDDPGLHQWRQGHUEHHOGYRUPLQJWHJHVFKLHGHQ
,QVSHFWHHUKHWKXOSPLGGHOYyyUJHEUXLNRSEHVFKDGLJLQJHQGLHHHQMXLVWHZHUNLQJ]RXGHQEHOHPPHUHQ
$OVGHRQGHUGHOHQEHVFKDGLJGRIJHEURNHQ]LMQ1,(7*(%58,.(1
G. Mogelijke complicaties:
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LQIHFWLHEHVFKDGLJLQJYDQKHWDDQOLJJHQGHZHHIVHOSLMQEORHGLQJKHPRSW\VLVKHPRWKRUD[SQHXPRWKRUD[
en perforatie van ander weefsel, organen of vaten.
H. Benodigde apparatuur:
‡
‡
‡
‡
*HVFKLNWHEHHOGYRUPHQGHDSSDUDWXXU
Chirurgische handschoenen en afdeklakens
Lokaal anestheticum
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I.
Gebruiksaanwijzing:
1.
Controleer de verpakking en het product op beschadigingen en op de vervaldatum. Open de verpakking,
LQGLHQRQEHVFKDGLJGHQQRJQLHWYHUYDOOHQHQEUHQJKHWKXOSPLGGHORSDVHSWLVFKHZLM]HQDDUKHWVWHULHOH
veld over.
9HUZLMGHUGHGUDDGXLWGHLQEUHQJQDDOGHQYHUL¿HHUGDWKHWSURGXFWQLHWEHVFKDGLJGLVWLMGHQVKHWWUDQVSRUW
(Afbeelding 2).
NB: De lokalisatiedraad is in de naald geschoven, met de weerhaak buitenwaarts gericht aan de kant van het
DDQ]HWVWXNYDQGHQDDOGRPEHVFKDGLJLQJYDQGHZHHUKDDNWHYRRUNRPHQ%LMSODDWVLQJPRHWGHORNDOLVDWLHGUDDG
worden omgedraaid zodat de kant met de weerhaak eerst door het aanzetstuk van de naald schuift.
Afbeelding 2
3.
Lokaliseer de laesie met de geschikte doorlichtingstechniek.
%UHQJGHORNDOLVDWLHQDDOGLQGHERUVWJHULFKWRSGHODHVLHELMYRRUNHXUSDUDOOHODDQGHWKRUD[ZDQGRPGH
NDQVRSSQHXPRWKRUD[WHYHUNOHLQHQ*HEUXLNGHGLHSWHPDUNHULQJHQRPGHSXQWYDQGHQDDOGLQGHODHVLH
in de mamma te plaatsen (de dieptemarkeringen liggen 1 cm uit elkaar) (Afbeelding 3).
Afbeelding 3
5.
6.
7.
Bevestig de ligging van de naald met de geschikte beeldvormende techniek.
Verplaats, indien nodig, de naald en bevestig daarna opnieuw de ligging.
De lokalisatiedraad kan dan in de inbrengnaald worden gebracht door deze in het aanzetstuk van de naald
WHVWHNHQHQGHGUDDGRSWHYRHUHQWRWKHWEHJLQYDQGHYRHOEDUHSODDWVLQJVNUDDORSGHGUDDG]LFKELMKHW
proximale uiteinde van het aanzetstuk van de naald bevindt. Om te zorgen dat de weerhaak in de goede
ULFKWLQJRSHQJDDWPRHWXGHZHHUKDDNLQppQOLMQPHWGHRULsQWDWLHPDUNHULQJRSKHWDDQ]HWVWXNEUHQJHQ
als u de draad in de naald schuift (Afbeelding 4).
Afbeelding 4
2PGHZHHUKDDNYULMWHJHYHQPRHWGHORNDOLVDWLHGUDDGRS]LMQSODDWVZRUGHQJHKRXGHQWHUZLMOGHQDDOG
ongeveer 1,5 cm wordt teruggetrokken (Afbeelding 5). NB:'HZHHUKDDN]DOZRUGHQYULMJHJHYHQDOVGH
voelbare plaatsingskraal op de draad zich helemaal in het aanzetstuk van de naald bevindt. Iedere poging
GHGUDDGWHUHSRVLWLRQHUHQQDGDWGHZHHUKDDNLVYULMJHJHYHQNDQGHGUDDGEHVFKDGLJHQGRHQEUHNHQ
Afbeelding 5
17
NEDERALANDS
De GHIATAS® mammalokalisatiedraad met kralen mag niet opnieuw worden gesteriliseerd.
Na hersterilisatie kan de steriliteit van het product niet worden gegarandeerd omdat een onbepaalde
mate van mogelijk pyrogene of microbiële verontreiniging aanwezig kan zijn, die tot infectieuze
complicaties kan leiden. Door het betreffende medische hulpmiddel te reinigen, opnieuw gereed
te maken voor gebruik en/of opnieuw te steriliseren, neemt de kans toe dat het hulpmiddel slecht
functioneert wegens het mogelijk negatieve effect op de onderdelen die worden beïnvloed door
thermische en/of mechanische veranderingen.
NB: Na gebruik kunnen deze producten een biologisch gevaar vormen. Dit product moet worden
gehanteerd en weggeworpen zoals algemeen gebruikelijk is in de medische praktijk en conform
de van toepassing zijnde plaatselijke en landelijke wet- en regelgeving.
8.
NEDERALANDS
'HQDDOGNDQQXZRUGHQYHUZLMGHUGHQHHQU|QWJHQIRWRHQRIHFKREHHOGJHPDDNWWHUEHYHVWLJLQJYDQGH
plaatsing van de weerhaak. NB: De kralen op de draad geven een zichtbare en voelbare referentie voor
de plaats van de weerhaak en de laesie.
+HWUHVWHUHQGHEORRWOLJJHQGHGHHOYDQGHGUDDGPRHWRSKHWKXLGRSSHUYODNZRUGHQYDVWJH]HWPHWHHQ
JHVFKLNWHPHWKRGHRPWHYHUKLQGHUHQGDWGHGUDDGEHZHHJWWLMGHQVKHWWUDQVSRUWQDDUGHRSHUDWLHNDPHU
(Afbeelding 6). De draadclip kan op de draad worden vastgezet tegen het huidoppervlak aan om verplaatsing
van de draad te helpen voorkomen. Oefen voldoende druk uit om de clip op de draad te zetten
(Afbeelding 7).
Afbeelding 6
Afbeelding 7
9yyUGHRSHUDWLHNDQGHBARD® YHUVWLMYLQJVFDQXOHPHWVWRPSHSXQWRYHUGHGHIATAS® mammalokalisatiedraad
PHWNUDOHQZRUGHQJHVFKRYHQDOVKXOSPLGGHORPHHQSDOSDEHOHLQGLFDWLHWHYHUNULMJHQYDQGHULFKWLQJHQGH
locatie van de punt van de draad.
Dit hulpmiddel is onder voorwaarden geschikt voor MRI:
De producten met de volgende codes kunnen worden geplaatst en afgebeeld met behulp van MRI:
470201
475201
477201
479201
Uit niet-klinisch onderzoek is gebleken dat de MR GHIATAS®ORNDOLVDWLHGUDDG05,EHVWHQGLJLV+LMNDQRQGHU
de volgende omstandigheden veilig worden gescand:
‡
Statisch magnetisch veld van 3 Tesla of minder
‡
5XLPWHOLMNJUDGLsQWYHOG*DXVVFPRIPLQGHU
%LMQLHWNOLQLVFKRQGHU]RHNSURGXFHHUGHQGH05GHIATAS® lokalisatiedraden met de betreffende productcodes een
WHPSHUDWXXUVWLMJLQJYDQPLQGHUGDQž&ELMHHQPD[LPDOHYRRUHHQ05,V\VWHHPJHUDSSRUWHHUGHJHPLGGHOGH
VSHFL¿HNHDEVRUSWLH6$5YDQ:NJELMPLQXWHQVFDQQHQLQHHQ6LJQD05,V\VWHHPPHW7HVOD([FLWH
SODWIRUP*%VRIWZDUH*(+HDOWKFDUH0LOZDXNHH:,96
'HNZDOLWHLWYDQGH05,RSQDPHQNDQVOHFKWHU]LMQDOVKHWDIWHEHHOGHQJHELHGSUHFLHVVDPHQYDOWPHWRI]LFK
UHODWLHIGLFKWELMGHSRVLWLHYDQGH05GHIATAS®ORNDOLVDWLHGUDDGEHYLQGW+HWNDQGDDURPQRGLJ]LMQGH05,
afbeeldingsparameters te optimaliseren voor de aanwezigheid van dit metalen implantaat.
Garantie
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PDWHULDDOHQIDEULFDJHIRXWHQJHGXUHQGHHHQSHULRGHYDQppQMDDUYDQDIGHGDWXPYDQGHRRUVSURQNHOLMNH
DDQNRRS'HDDQVSUDNHOLMNKHLGRQGHUGH]HEHSHUNWHSURGXFWJDUDQWLHLVEHSHUNWWRWKHUVWHORIYHUYDQJLQJYDQ
het defectieve product, uitsluitend ter beoordeling van Bard Peripheral Vascular, of tot terugbetaling van het door
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als gevolg van verkeerd gebruik van dit product.
,1=29(55(*(225/22)'.5$&+7(16'(9$172(3$66,1*=,-1'(:(7*(9,1*9(59$1*7
'(=(%(3(5.7(352'8&7*$5$17,($//($1'(5(*$5$17,(6+(7=,-8,7'58..(/,-.(+(7=,-
*(Í03/,&((5'(*$5$17,(6,1&/86,()0$$51,(7%(3(5.7727(9(178(/(*(Í03/,&((5'(
*$5$17,(69$19(5+$1'(/%$$5+(,'2)*(6&+,.7+(,'9225(1,*63(&,),(.'2(/
%$5'3(5,3+(5$/9$6&8/$5,6,1*((1*(9$/-(*(168$$1635$.(/,-.9225(1,*(
215(&+7675((.6(,1&,'(17(/(2)*(92/*6&+$'(',(+(7*(92/*,69$18:+$17(5,1*
2)*(%58,.9$1',7352'8&7
6RPPLJHVWDWHQODQGHQVWDDQJHHQXLW]RQGHULQJYDQLPSOLFLHWHJDUDQWLHVELMNRPHQGHVFKDGHRIJHYROJVFKDGHWRH
+HWLVPRJHOLMNGDWXUHFKWKHEWRSDDQYXOOHQGYHUKDDONUDFKWHQVGHZHWWHQYDQXZVWDDWODQG
7HULQIRUPDWLHYDQGHJHEUXLNHUZRUGWHURSGHODDWVWHSDJLQDYDQGLWERHNMHHHQXLWJLIWHRIUHYLVLHGDWXPHQHHQ
UHYLVLHQXPPHUYRRUGH]HDDQZLM]LQJHQJHJHYHQ$OVHUPDDQGHQ]LMQYHUVWUHNHQWXVVHQGH]HGDWXPHQKHW
JHEUXLNYDQKHWSURGXFWPRHWGHJHEUXLNHUFRQWDFWRSQHPHQPHW%DUG3HULSKHUDO9DVFXODURPWHYHUL¿sUHQ
of er aanvullende productinformatie beschikbaar is.
*HDVVHPEOHHUGLQ0H[LFR
18
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)LRGH/RFDOL]DomR0DPiULDFRP(VIHUDVGHIATAS® para RM MR
&yGLJRVGRSURGXWR
DJXOKDGHJ[FPFRP¿RGHIDUSDGHFP
DJXOKDGHJ[FPFRP¿RGHIDUSDGHFP
DJXOKDGHJ[FPFRP¿RGHIDUSDGHFP
DJXOKDGHJ[FPFRP¿RGHIDUSDGHFP
2VSURGXWRVFRPRVFyGLJRVHQmRWrPRDX[LOLDUGHLQWHQVL¿FDomR
GDLPDJHPHFRJUi¿FD$OpPGLVVRRVSURGXWRVFRPRVFyGLJRVHSRGHPVHU
colocados sob orientação por IRM.
Figura 1
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
$JXOKDLQWURGXWRUD
$X[LOLDUGHLQWHQVL¿FDomRGDLPDJHPHFRJUi¿FD
Marcas de referência de profundidade espaçadas 1 cm
Marcas de orientação
Farpa
Esferas de marcação
Fio de localização
(VIHUDGHSRVLFLRQDPHQWRSDOSiYHO
A. Informação geral e descrição do dispositivo:
2)LRGH/RFDOL]DomR0DPiULDFRP(VIHUDVGHIATAS®FRQVLVWHHPXPDDJXOKDLQWURGXWRUDHXP¿RGHORFDOL]DomR
VHPLUtJLGR$DJXOKDLQWURGXWRUDpFRPSRVWDGHXPFRQHFWRUHPSOiVWLFRPROGDGRPDUFDVGHUHIHUrQFLDGH
SURIXQGLGDGHVHSDUDGDVGHFPHXPDX[LOLDUGHLQWHQVL¿FDomRGDLPDJHPHFRJUi¿FDQDH[WUHPLGDGHGLVWDO
SDUDDMXGDUDSRVLFLRQDUDDJXOKD2¿RGHORFDOL]DomRVHPLUtJLGRWHPHVIHUDVGHPDUFDomRDLQWHUYDORVGHFP
QDH[WUHPLGDGHGLVWDOGR¿RHXPDHVIHUDGHSRVLFLRQDPHQWRSDOSiYHOSDUDDVVLQDODURSRQWRGHFRORFDomRGD
IDUSDGDH[WUHPLGDGHGLVWDOGR¿R2VSURGXWRVFRPRVFyGLJRVHWrPHVIHUDVPDLVORQJDV
QDH[WUHPLGDGHGLVWDOGR¿RRTXHDXPHQWDDULJLGH]GR¿R
B. Apresentação:
2)LRGH/RFDOL]DomR0DPiULDFRP(VIHUDVGHIATAS® é fornecido estéril e apirogénico, a menos que a embalagem
WHQKDVLGRGDQL¿FDGDRXDEHUWD(VWHULOL]DGRPHGLDQWHy[LGRGHHWLOHQR([FOXVLYDPHQWHSDUDXWLOL]DomR~QLFD
Não reutilizar. Não reesterilizar.
C. Indicações de utilização:
(VWHGLVSRVLWLYRGHVWLQDVHDVHUXWLOL]DGRGXUDQWHDFLUXUJLDGHOHVmRPDPiULDFRPRJXLDGRFLUXUJLmRGXUDQWH
a excisão da lesão.
D. Contra-indicações:
Não se conhecem.
( $GYHUWrQFLDV
7.
$VVLPTXHDIDUSDWLYHUVLGRSRVLFLRQDGDQRLQWHULRUGDPDPDR¿RWHPGHVHUUHPRYLGRFLUXUJLFDPHQWH
1mRWHQWHUHSRVLFLRQDUGHVORFDURXSX[DUR¿RSRLVWDOSRGHUHVXOWDUHPGDQRTXHEUDGRPHVPR
2¿RGHVWLQDVHDSHQDVDVHUYLUFRPRJXLD1­2RXWLOL]HFRPRUHWUDFWRU
7HQKDFXLGDGRGXUDQWHDH[FLVmRFLU~UJLFDGDOHVmRGHPRGRDHYLWDUFRUWDUR¿RFRPRELVWXUL
'HYHDYDQoDUR¿RDWUDYpVGDDJXOKDDSHQDVGRFRQHFWRUDWpjSRQWDGDDJXOKD1mRWHQWHLQWURGX]LU
R¿RRXID]rORDYDQoDUHPVHQWLGRLQYHUVRGHQWURGDDJXOKDSRLVWDOSRGHGDQL¿FDUDIDUSD
1mRWHQWHUHPRGHODUDIDUSDGR¿RVHMDGHTXHIRUPDIRULVWRSRGHTXHEUDUDIDUSD6HDIDUSD
GR¿RHVWLYHUGHIRUPDGDRXGREUDGDGHIRUPDLQFRUUHFWDHOLPLQHRSURGXWR
'HYHWHUVHFXLGDGRDRXWLOL]DUTXDOTXHU¿RGHORFDOL]DomRHPGRHQWHVFRPSUyWHVHVPDPiULDV
de modo a não perfurar as mesmas durante o posicionamento ou o transporte.
O guia de localização mamária com rebordo GHIATAS® foi concebido apenas para uma utilização.
A reutilização deste dispositivo médico acarreta o risco de contaminação cruzada de doentes, uma
YH]TXHRVGLVSRVLWLYRVPpGLFRV±SDUWLFXODUPHQWHRVTXHSRVVXHPO~PHQHVMXQo}HVHRXIHQGDV
ORQJDVHSHTXHQDVHQWUHRVFRPSRQHQWHV±VmRGLItFHLVRXLPSRVVtYHLVGHOLPSDUGHSRLVGRVÀXLGRV
ou tecidos corporais com possível contaminação pirogénica ou microbiana terem estado em contacto
com o dispositivo médico durante um período de tempo indeterminável. O resíduo de material
biológico pode promover a contaminação do dispositivo com pirogéneos ou microrganismos
que podem provocar complicações infecciosas.
19
32578*8ÊS
Instruções de Utilização
Não reesterilizar o guia de localização mamária com rebordo GHIATAS®. Após a reesterilização,
a esterilidade do produto não é garantida uma vez que um grau indeterminável de possível
contaminação pirogénica ou microbiana pode provocar complicações infecciosas. A limpeza,
o reprocessamento e/ou a reesterilização do presente dispositivo médico aumenta a probabilidade
de mau funcionamento do dispositivo devido a possíveis efeitos adversos nos componentes que
VmRLQÀXHQFLDGRVSRUDOWHUDo}HVWpUPLFDVHRXPHFkQLFDV
127$ Depois de utilizados, estes produtos poderão constituir um risco biológico potencial. Manusear
e eliminar de acordo com as práticas médicas aprovadas e com a legislação e regulamentos locais,
estatais e federais aplicáveis.
32578*8ÊS
8.
F. Precauções:
(VWHGLVSRVLWLYRVyGHYHVHUXWLOL]DGRSRUXPPpGLFRFRPIRUPDomRQDXWLOL]DomRLQGLFDGDQDVVXDV
OLPLWDo}HVHSRVVtYHLVFRPSOLFDo}HGDVWpFQLFDVGHLQWHUYHQomRFRPDJXOKDVSHUFXWkQHDV
$LQWURGXomRGRGLVSRVLWLYRQRFRUSRGHYHVHUHIHFWXDGDVREFRQWURORLPDJLROyJLFR
$QWHVGHXWLOL]DULQVSHFFLRQHRGLVSRVLWLYRQRTXHUHVSHLWDDGDQRVTXHSRVVDPLPSHGLURVHXIXQFLRQDPHQWR
FRUUHFWR1­287,/,=$5VHRVFRPSRQHQWHVHVWLYHUHPGDQL¿FDGRVRXGREUDGRV
G. Possíveis complicações:
$VSRWHQFLDLVFRPSOLFDo}HVVmRHVSHFt¿FDVGRORFDOHSRGHUmRFRQVLVWLUHPKHPDWRPDKHPRUUDJLDLQIHFomR
OHVmRGRVWHFLGRVDGMDFHQWHVGRUVDQJUDPHQWRKHPRSWLVHKHPRWyUD[SHUIXUDomRGHWHFLGRyUJmRRXYDVRQmR
DOYRHSQHXPRWyUD[
H. Equipamento necessário:
‡
‡
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Modalidade de imagiologia apropriada
/XYDVHFDPSRVFLU~UJLFRV
$QHVWpVLFRORFDO
2XWURHTXLSDPHQWRFRQIRUPHQHFHVViULR
I.
Instruções de utilização:
1.
Inspeccione a embalagem e o produto relativamente a danos e ao prazo de validade. Caso a embalagem
QmRDSUHVHQWHGDQRVQHPVHHQFRQWUHIRUDGRSUD]RGHYDOLGDGHDEUDDHWUDQV¿UDRSURGXWRSDUDRFDPSR
estéril utilizando técnicas assépticas.
5HPRYDR¿RGDDJXOKDLQWURGXWRUDHYHUL¿TXHTXHRSURGXWRQmRIRLGDQL¿FDGRGXUDQWHRWUDQVSRUWH
(Figura 2).
127$2¿RGHORFDOL]DomRHVWiHPEDODGRQDDJXOKDFRPDIDUSDYLUDGDSDUDIRUDGRFRQHFWRUGDDJXOKDSDUD
DSURWHJHUFRQWUDGDQRV1DDOWXUDGRSRVLFLRQDPHQWRR¿RGHORFDOL]DomRWHUiGHVHUYLUDGRSDUDDIDUSDGHVOL]DU
primeiro através do conector da agulha.
Figura 2
4.
/RFDOL]HDOHVmRXWLOL]DQGRDWpFQLFDLPDJLROyJLFDDSURSULDGD
Insira a agulha de localização na mama dirigindo-a para a lesão (de preferência paralelamente à parede
WRUiFLFDSDUDUHGX]LURSRVVtYHOULVFRGHSQHXPRWyUD[8WLOL]HDVPDUFDVGHUHIHUrQFLDGHSURIXQGLGDGHSDUD
SRVLFLRQDUDSRQWDGDDJXOKDQDOHVmRPDPiULDDVPDUFDVGHUHIHUrQFLDGHSURIXQGLGDGHHVWmRDIDVWDGDV
entre si 1 cm) (Figura 3).
Figura 3
&RQ¿UPHRSRVLFLRQDPHQWRGDDJXOKDXWLOL]DQGRDWpFQLFDLPDJLROyJLFDDSURSULDGD
6HQHFHVViULRUHSRVLFLRQHDDJXOKDHUHFRQ¿UPHRSRVLFLRQDPHQWR
(PVHJXLGDR¿RGHORFDOL]DomRSRGHVHULQVHULGRQDDJXOKDLQWURGXWRUDID]HQGRGHVOL]DUR¿RSDUDGHQWURGR
FRQHFWRUGDDJXOKDHDYDQoDQGRRDWpRLQtFLRGDHVIHUDGHSRVLFLRQDPHQWRSDOSiYHOGR¿R¿FDUSRVLFLRQDGR
QDH[WUHPLGDGHSUR[LPDOGRFRQHFWRUGDDJXOKD3DUDJDUDQWLUTXHDIDUSDVHSRVLFLRQDUiQDGLUHFomR
DSURSULDGDDOLQKHDIDUSDFRPDVPDUFDVGHRULHQWDomRGRFRQHFWRUHQTXDQWRLQWURGX]R¿RQDDJXOKD
(Figura 4).
Figura 4
3DUDFRORFDUDIDUSDR¿RGHORFDOL]DomRGHYHVHUPDQWLGRQROXJDUHDDJXOKDUHWLUDGDFHUFDGHFP
(Figura 5). Nota:$IDUSD¿FDUiSRVLFLRQDGDTXDQGRDHVIHUDGHSRVLFLRQDPHQWRSDOSiYHOGR¿RHVWLYHU
FRPSOHWDPHQWHFRORFDGDQRLQWHULRUGRFRQHFWRUGDDJXOKD4XDOTXHUHVIRUoRGHUHSRVLFLRQDPHQWRGR¿R
DSyVSRVLFLRQDPHQWRGDIDUSDSRGHUiGDQL¿FDUTXHEUDUR¿R
Figura 5
$DJXOKDSRGHDJRUDVHUUHPRYLGDHHIHFWXDUVHXPDUDGLRJUD¿DHRXHFRJUD¿DSDUDFRQ¿UPDU
o posicionamento da farpa. Nota:$VHVIHUDVGR¿RSURSRUFLRQDPXPDUHIHUrQFLDYLVXDOHSDOSiYHO
à localização da farpa e da lesão.
20
Figura 6
Figura 7
$QWHVGDFLUXUJLDD&kQXODGH5HIRUoRGH3RQWD$UUHGRQGDGDBARD® pode ser guiada sobre o Fio de
/RFDOL]DomR0DPiULDFRP(VIHUDVGHIATAS®SDUDDMXGDUDREWHUXPDLQGLFDomRSDOSiYHOGRSHUFXUVR
GR¿RHGDORFDOL]DomRGDVXDSRQWD
Este dispositivo tem utilização condicionada em RM:
2VSURGXWRVFRPRVFyGLJRVVHJXLQWHVSRGHPVHUFRORFDGRVHYLVXDOL]DGRVSRU50
470201
475201
477201
479201
7HVWHVQmRFOtQLFRVGHPRQVWUDUDPTXHR)LRGH/RFDOL]DomRGHIATAS® para RM tem utilização condicionada
HP503RGHVHUVXMHLWRDLPDJLRORJLDGHIRUPDVHJXUDQDVVHJXLQWHVFRQGLo}HV
‡
&DPSRPDJQpWLFRHVWiWLFRGH7HVODRXLQIHULRU
‡
&DPSRGHJUDGLHQWHHVSDFLDOGH*DXVVFPRXLQIHULRU
(PWHVWHVQmRFOtQLFRVRVSURGXWRVFRPRFyGLJRGH)LRGH/RFDOL]DomR GHIATAS® para RM produziram um aumento
GHWHPSHUDWXUDLQIHULRUDƒ&SDUDXPDWD[DGHDEVRUomRHVSHFt¿FD6$5PpGLDUHODWLYDDRFRUSRWRGRGH
:NJSDUDPLQXWRVGHLPDJLRORJLDGH50QXPVLVWHPDGH506LJQDGH7HVODSODWDIRUPD([FLWHVRIWZDUH
*%*(+HDOWKFDUH0LOZDXNHH:,(8$
$TXDOLGDGHGDLPDJHPGH50SRGH¿FDUFRPSURPHWLGDVHDiUHDGHLQWHUHVVHIRUH[DFWDPHQWHDPHVPD
RXUHODWLYDPHQWHSUy[LPDGRORFDORQGHVHHQFRQWUDR)LRGH/RFDOL]DomR*HIATAS® para RM. Por conseguinte,
SRGHVHUQHFHVViULRRSWLPL]DURVSDUkPHWURVGHLPDJLRORJLDGH50SDUDWHUHPFRQWDDSUHVHQoDGHVWH
LPSODQWHPHWiOLFR
Garantia
$%DUG3HULSKHUDO9DVFXODUJDUDQWHDRSULPHLURFRPSUDGRUGHVWHSURGXWRTXHRPHVPRVHHQFRQWUDOLYUHGH
GHIHLWRVGHPDWHULDOHGHPmRGHREUDSRUXPSHUtRGRGHXPDQRDFRQWDUGDGDWDGDSULPHLUDDTXLVLomRHVWDQGR
a responsabilidade ao abrigo desta garantia limitada do produto limitada à reparação ou substituição do produto
GHIHLWXRVRVHJXQGRRFULWpULRH[FOXVLYRGD%DUG3HULSKHUDO9DVFXODURXDRUHHPEROVRGRSUHoROtTXLGRSDJR
pelo produto. O desgaste resultante da utilização normal do produto, ou os defeitos resultantes da sua utilização
indevida, não estão cobertos por esta garantia limitada.
1$0(','$3(50,7,'$3(/$/(*,6/$d­2$3/,&È9(/(67$*$5$17,$/,0,7$'$'2352'872
68%67,78,72'$6$62875$6*$5$17,$6(;3/Ë&,7$628,03/Ë&,7$6,1&/8,1'20$61­2
6(/,0,7$1'2$48$/48(5*$5$17,$,03/Ë&,7$'(&20(5&,$/,=$d­228$'(48$d­2
$80'(7(50,1$'2),0(0&,5&8167Æ1&,$$/*80$$%$5'3(5,3+(5$/9$6&8/$5
6(5(63216$%,/,=$3(5$17(6,32548$,648(5'$126,1',5(&726,1&,'(17$,628
&216(48(1&,$,65(68/7$17(6'26(80$186($0(1722887,/,=$d­2'(67(352'872
$OJXQVHVWDGRVSDtVHVQmRSHUPLWHPDH[FOXVmRGDVJDUDQWLDVLPSOtFLWDVHGDQRVGLUHFWDRXLQGLUHFWDPHQWH
HPHUJHQWHV$RDEULJRGDOHJLVODomRGRVHXHVWDGRSDtVSRGHUiWHUGLUHLWRDUHFXUVRVVXSOHPHQWDUHV
$GDWDGHHGLomRRXQ~PHURGHUHYLVmRGHVWDVLQVWUXo}HVHVWmRLQFOXtGRVQD~OWLPDSiJLQDGHVWHIROKHWR
para informação do utilizador. No caso de terem decorrido 36 meses entre esta data e a utilização do produto,
RXWLOL]DGRUGHYHUiFRQWDFWDUD%DUG3HULSKHUDO9DVFXODUSDUDYHUL¿FDUVHH[LVWHLQIRUPDomRDGLFLRQDOVREUH
o produto.
Montado no México.
21
32578*8ÊS
2¿RUHVWDQWHH[SRVWRGHYHVHU¿[DGRjVXSHUItFLHGDSHOHXWLOL]DQGRXPPpWRGRDSURSULDGRSDUDHYLWDUTXH
ele se desloque durante o transporte para a cirurgia (Figura 6)2FOLSHGR¿RSRGHFRORFDUVHVREUHR¿R
QDVXSHUItFLHFXWkQHDSDUDHYLWDUDPLJUDomRGRPHVPR([HUFHUSUHVVmRVX¿FLHQWHSDUDSRVLFLRQDURFOLSH
VREUHR¿R(Figura 7).
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IJȠıȘȝİȓȠıIJȠȠʌȠȓȠʌȡȩțİȚIJĮȚȞĮİțʌIJȣȤșİȓȘĮțȓįĮIJȠȣĮʌȠȝĮțȡȣıȝȑȞȠȣȐțȡȠȣIJȠȣıȪȡȝĮIJȠȢȅȚțȦįȚțȠȓ
ʌȡȠȧȩȞIJȠȢțĮȚįȚĮșȑIJȠȣȞȝĮțȡȪIJİȡĮıijĮȚȡȓįȚĮıIJȠĮʌȠȝĮțȡȣıȝȑȞȠȐțȡȠIJȠȣıȪȡȝĮIJȠȢ
ȖİȖȠȞȩȢʌȠȣʌȡȠıșȑIJİȚĮțĮȝȥȓĮıIJȠıȪȡȝĮ
Ǻ ȉȡȩʌȠȢįȚȐșİıȘȢ
ȉȠıȪȡȝĮİȞIJȠʌȚıȝȠȪȕȜȐȕȘȢȝĮıIJȠȪȝİıijĮȚȡȓįȚĮGHIATAS®ʌĮȡȑȤİIJĮȚıIJİȓȡȠțĮȚȝȘʌȣȡİIJȠȖȩȞȠİțIJȩȢțĮȚ
ĮȞȘıȣıțİȣĮıȓĮȑȤİȚȣʌȠıIJİȓȗȘȝȚȐȒȑȤİȚĮȞȠȚȤșİȓǹʌȠıIJİȚȡȦȝȑȞȠȝİĮȚșȣȜİȞȠȟİȓįȚȠīȚĮȝȓĮȝȩȞȠȤȡȒıȘ
ȂȘȞİʌĮȞĮȤȡȘıȚȝȠʌȠȚİȓIJİȂȘȞİʌĮȞĮʌȠıIJİȚȡȫȞİIJİ
ī ǼȞįİȓȟİȚȢȤȡȒıȘȢ
ǾʌĮȡȠȪıĮıȣıțİȣȒʌȡȠȠȡȓȗİIJĮȚȖȚĮȤȡȒıȘțĮIJȐIJȘįȚȐȡțİȚĮİȖȤİȚȡȒıİȦȢįȚĮĮȜȜȠȚȫıİȚȢȝĮıIJȠȪȦȢȑȞĮȢȠįȘȖȩȢ
țĮșȠįȘȖȒıİȦȢįȚĮIJȠȞȤİȚȡȠȪȡȖȠțĮIJȐIJȘȞİțIJȠȝȒIJȘȢĮȜȜȠȓȦıȘȢ
ǻ ǹȞIJİȞįİȓȟİȚȢȤȡȒıȘȢ
ȅȣįİȝȓĮȖȞȦıIJȒ
Ǽ ȆȡȠİȚįȠʌȠȚȒıİȚȢ
ǼijȩıȠȞȑȤİȚİțʌIJȣȤșİȓȘĮțȓįĮİȞIJȩȢIJȠȣȝĮıIJȠȪIJȩIJİIJȠıȪȡȝĮʌȡȑʌİȚȞĮĮijĮȚȡİșİȓȤİȚȡȠȣȡȖȚțȐ
ȂȘȞİʌȚȤİȚȡȒıİIJİȞĮIJȠʌȠșİIJȒıİIJİİțȞȑȠȣȞĮȝİIJĮțȚȞȒıİIJİȒȞĮIJȡĮȕȒȟİIJİIJȠıȪȡȝĮįȚȩIJȚİȞįȑȤİIJĮȚ
ȞĮʌȡȠțȪȥİȚȗȘȝȓĮĮʌȠțȠʌȒ
ȉȠıȪȡȝĮıțȠʌȩȑȤİȚȝȩȞȠȞIJȘȞțĮșȠįȒȖȘıȘȂǾȃIJȠȤȡȘıȚȝȠʌȠȚİȓIJİȦȢĮʌĮȖȦȖȑĮ
ǻȫıIJİȝİȖȐȜȘʌȡȠıȠȤȒțĮIJȐIJȘįȚȐȡțİȚĮIJȘȢİțIJȠȝȒȢIJȘȢĮȜȜȠȚȫıİȦȢȫıIJİȞĮĮʌȠijİȣȤșİȓ
ȘĮʌȠțȠʌȒIJȠȣıȪȡȝĮIJȠȢȝİȑȞĮȞȣıIJȑȡȚ
ȉȠıȪȡȝĮʌȡȑʌİȚȞĮʌȡȠȦșİȓIJĮȚȝȩȞȠȞȝȑıȦIJȘȢȕİȜȩȞĮȢĮʌȩIJȠȞȠȝijĮȜȩȑȦȢIJȠȐțȡȠIJȘȢȕİȜȩȞĮȢ
ȂȘȞİʌȚȤİȚȡȒıİIJİȞĮIJȡĮȕȒȟİIJİʌȡȠȢIJĮʌȓıȦIJȠıȪȡȝĮİȞIJȩȢȒȝȑıĮıIJȘȕİȜȩȞĮįȚȩIJȚİȞįȑȤİIJĮȚ
ȞĮʌȡȠțȪȥİȚȗȘȝȓĮIJȘȢĮțȓįĮȢ
ȂȘȞİʌȚȤİȚȡȒıİIJİȞĮȝȠȡijȠʌȠȚȒıİIJİİțȞȑȠȣIJȘȞĮțȓįĮIJȠȣıȪȡȝĮIJȠȢȝİȠȚȠȞįȒʌȠIJİIJȡȩʌȠįȚȩIJȚ
İȞįȑȤİIJĮȚȞĮʌȡȠțȜȘșİȓșȡȣȝȝĮIJȚıȝȩȢIJȘȢĮțȓįĮȢǼȐȞįȚĮıIJȡİȕȜȦșİȓȘĮțȓįĮIJȠȣıȪȡȝĮIJȠȢȒİȐȞ
țĮȝijșİȓİıijĮȜȝȑȞĮĮʌȠȡȡȓȥIJİIJȠʌȡȠȧȩȞ
ȅijİȓȜİIJİȞĮʌȡȠıȑȟİIJİȚįȚĮȚIJȑȡȦȢȩIJĮȞȤȡȘıȚȝȠʌȠȚİȓIJİȠʌȠȚȠįȒʌȠIJİıȪȡȝĮİȞIJȩʌȚıȘȢıİĮıșİȞİȓȢȝİ
ʌȡȠșȑıİȚȢȝĮıIJȠȪȑIJıȚȫıIJİȞĮȝȘȞIJȚȢIJȡȣʌȒıİIJİțĮIJȐIJȘįȚȐȡțİȚĮIJȘȢIJȠʌȠșȑIJȘıȘȢȒIJȘȢȝİIJĮijȠȡȐȢ
ȉȠıȪȡȝĮİȞIJȠʌȚıȝȠȪȕȜȐȕȘȢȝĮıIJȠȪȝİıijĮȚȡȓįȚĮGHIATAS®İȓȞĮȚıȤİįȚĮıȝȑȞȠȖȚĮȝȓĮȝȩȞȠȤȡȒıȘ
ǾİʌĮȞĮȤȡȘıȚȝȠʌȠȓȘıȘĮȣIJȒȢIJȘȢȚĮIJȡȚțȒȢıȣıțİȣȒȢİȞȑȤİȚIJȠȞțȓȞįȣȞȠįȚĮıIJĮȣȡȠȪȝİȞȘȢİʌȚȝȩȜȣȞıȘȢ
IJȦȞĮıșİȞȫȞțĮșȫȢȠȚȚĮIJȡȚțȑȢıȣıțİȣȑȢ±ȚįȚĮȓIJİȡĮĮȣIJȑȢȝİȝĮțȡȠȪȢțĮȚȝȚțȡȠȪȢĮȣȜȠȪȢĮȡșȡȫıİȚȢ
ȒțĮȚıȤȚıȝȑȢȝİIJĮȟȪIJȦȞıIJȠȚȤİȓȦȞ±İȓȞĮȚįȪıțȠȜȠȒĮįȪȞĮIJȠȞĮțĮșĮȡȚıIJȠȪȞİijȩıȠȞIJĮıȦȝĮIJȚțȐ
ȣȖȡȐȒȠȚȚıIJȠȓȝİʌȚșĮȞȒʌȣȡİIJȠȖȩȞȠȒȝȚțȡȠȕȚĮțȒȝȩȜȣȞıȘȑȤȠȣȞȑȡșİȚıİİʌĮijȒȝİIJȘȞȚĮIJȡȚțȒ
ıȣıțİȣȒȖȚĮĮʌȡȠıįȚȩȡȚıIJȘȤȡȠȞȚțȒʌİȡȓȠįȠȉĮțĮIJȐȜȠȚʌĮȕȚȠȜȠȖȚțȠȪȣȜȚțȠȪİȓȞĮȚįȣȞĮIJȩȞĮ
İȣȞȠȒıȠȣȞIJȘȝȩȜȣȞıȘIJȘȢıȣıțİȣȒȢȝİʌȣȡİIJȠȖȩȞĮȒȝȚțȡȠȠȡȖĮȞȚıȝȠȪȢʌȠȣİȞįİȤȠȝȑȞȦȢ
ȞĮʌȡȠțĮȜȑıȠȣȞȜȠȚȝȫįİȚȢİʌȚʌȜȠțȑȢ
22
ȂȘȞİʌĮȞĮʌȠıIJİȚȡȫȞİIJİIJȠıȪȡȝĮİȞIJȠʌȚıȝȠȪȕȜȐȕȘȢȝĮıIJȠȪȝİıijĮȚȡȓįȚĮGHIATAS®ȂİIJȐĮʌȩ
İʌĮȞĮʌȠıIJİȓȡȦıȘįİȞįȚĮıijĮȜȓȗİIJĮȚȘıIJİȚȡȩIJȘIJĮIJȠȣʌȡȠȧȩȞIJȠȢȜȩȖȦʌȚșĮȞȒȢʌȣȡİIJȠȖȩȞȠȣ
ȒȝȚțȡȠȕȚĮțȒȢȝȩȜȣȞıȘȢĮʌȡȠıįȚȠȡȓıIJȠȣȕĮșȝȠȪȘȠʌȠȓĮİȞįȑȤİIJĮȚȞĮʌȡȠțĮȜȑıİȚȜȠȚȝȫįİȚȢ
İʌȚʌȜȠțȑȢȅțĮșĮȡȚıȝȩȢȘİʌĮȞİʌİȟİȡȖĮıȓĮȒțĮȚȘİʌĮȞĮʌȠıIJİȓȡȦıȘIJȘȢʌĮȡȠȪıĮȢȚĮIJȡȚțȒȢ
ıȣıțİȣȒȢĮȣȟȐȞİȚIJȘȞʌȚșĮȞȩIJȘIJĮįȣıȜİȚIJȠȣȡȖȓĮȢIJȘȢȜȩȖȦʌȚșĮȞȫȞĮȞİʌȚșȪȝȘIJȦȞĮȞIJȚįȡȐıİȦȞ
ıIJĮıIJȠȚȤİȓĮʌȠȣİʌȘȡİȐȗȠȞIJĮȚĮʌȩșİȡȝȚțȑȢȒțĮȚȝȘȤĮȞȚțȑȢĮȜȜĮȖȑȢ
ȈǾȂǼǿȍȈǾȂİIJȐIJȘȤȡȒıȘIJĮʌȡȠȧȩȞIJĮĮȣIJȐİȞįȑȤİIJĮȚȞĮĮʌȠIJİȜȠȪȞįȣȞȘIJȚțȩȕȚȠȜȠȖȚțȩțȓȞįȣȞȠ
ȅȤİȚȡȚıȝȩȢțĮȚȘĮʌȩȡȡȚȥȘʌȡȑʌİȚȞĮȖȓȞȠȞIJĮȚıȪȝijȦȞĮȝİIJȘȞĮʌȠįİțIJȒȚĮIJȡȚțȒʌȡĮțIJȚțȒțĮȚIJȠȣȢ
ȚıȤȪȠȞIJİȢIJȠʌȚțȠȪȢʌȠȜȚIJİȚĮțȠȪȢțĮȚȠȝȠıʌȠȞįȚĮțȠȪȢȞȩȝȠȣȢțĮȚțĮȞȠȞȚıȝȠȪȢ
ǾʌĮȡȠȪıĮıȣıțİȣȒʌȡȑʌİȚȞĮȤȡȘıȚȝȠʌȠȚİȓIJĮȚȝȩȞȠȞĮʌȩȑȞĮȚĮIJȡȩİțʌĮȚįİȣȝȑȞȠıIJȚȢİȞįİȓȟİȚȢȤȡȒıȘȢIJȘȢ
ıIJȠȣȢʌİȡȚȠȡȚıȝȠȪȢțĮȚıIJȚȢİȞįİȤȩȝİȞİȢİʌȚʌȜȠțȑȢIJȦȞįȚĮįİȡȝȚțȫȞIJİȤȞȚțȫȞȝİȤȡȒıȘȕİȜȩȞĮȢ
ǾİȚıĮȖȦȖȒIJȘȢıȣıțİȣȒȢİȞIJȩȢIJȠȣıȫȝĮIJȠȢʌȡȑʌİȚȞĮįȚİȟȐȖİIJĮȚțȐIJȦĮʌȩĮʌİȚțȠȞȚıIJȚțȩȑȜİȖȤȠ
ȆȡȚȞIJȘȤȡȒıȘİȜȑȖȟIJİIJȘıȣıțİȣȒȖȚĮIJȣȤȩȞȗȘȝȓĮȘȠʌȠȓĮșĮİȝʌȩįȚȗİIJȘȞțĮIJȐȜȜȘȜȘȜİȚIJȠȣȡȖȓĮIJȘȢ
ǼȐȞIJĮİȟĮȡIJȒȝĮIJĮȑȤȠȣȞȣʌȠıIJİȓȗȘȝȚȐȒȑȤȠȣȞțĮȝijșİȓȂǾȃȋȇǾȈǿȂȅȆȅǿǾȈǼȉǼȉǾȈȊȈȀǼȊǾ
ǽ ǼȞįİȤȩȝİȞİȢǼʌȚʌȜȠțȑȢ
ȅȚʌȚșĮȞȑȢİʌȚʌȜȠțȑȢİȓȞĮȚİȚįȚțȑȢȦȢʌȡȠȢIJȘșȑıȘIJȘȢİʌȑȝȕĮıȘȢțĮȚİȞįȑȤİIJĮȚȞĮʌİȡȚȜĮȝȕȐȞȠȣȞĮȚȝȐIJȦȝĮ
ĮȚȝȠȡȡĮȖȓĮȜȠȓȝȦȟȘțȐțȦıȘʌĮȡĮțİȓȝİȞȠȣȚıIJȠȪʌȩȞȠĮʌȫȜİȚĮĮȓȝĮIJȠȢĮȚȝȩʌIJȣıȘĮȚȝȠșȫȡĮțĮİʌȑȝȕĮıȘ
ıİȝȘıIJȠȤİȣȩȝİȞȠȚıIJȩįȚȐIJȡȘıȘȠȡȖȐȞȠȣȒĮȖȖİȓȠȣțĮȚʌȞİȣȝȠșȫȡĮțĮ
Ǿ ǹʌĮȚIJȠȪȝİȞȠȢǼȟȠʌȜȚıȝȩȢ
‡
‡
‡
‡
ȀĮIJȐȜȜȘȜĮĮʌİȚțȠȞȚıIJȚțȐȝȘȤĮȞȒȝĮIJĮ
ȋİȚȡȠȣȡȖȚțȐȖȐȞIJȚĮțĮȚȠșȩȞȚĮ
ȉȠʌȚțȒĮȞĮȚıșȘıȓĮ
DZȜȜȠȢİȟȠʌȜȚıȝȩȢȩʌȦȢĮʌĮȚIJİȓIJĮȚ
Ĭ ȅįȘȖȓİȢȤȡȒıȘȢ
ǼʌȚșİȦȡȒıĮIJİIJȠʌȡȠȧȩȞțĮȚIJȘȞȘȝİȡȠȝȘȞȓĮȜȒȟİȦȢȩʌȦȢțĮȚIJȘıȣıțİȣĮıȓĮIJȠȣʌȡȠȧȩȞIJȠȢȖȚĮIJȣȤȩȞȗȘȝȓĮ
ǼȐȞįİȞȣʌȐȡȤİȚȗȘȝȓĮțĮȚįİȞȑȤİȚʌĮȡȑȜșİȚȘȘȝİȡȠȝȘȞȓĮȜȒȟİȦȢĮȞȠȓȟIJİIJȘıȣıțİȣĮıȓĮțĮȚȝİIJĮijȑȡİIJİ
IJȠʌȡȠȧȩȞİʌȓİȞȩȢĮʌȠıIJİȚȡȦȝȑȞȠȣʌİįȓȠȣȤȡȘıȚȝȠʌȠȚȫȞIJĮȢȐıȘʌIJȘIJİȤȞȚțȒ
ǹijĮȚȡȑıIJİIJȠıȪȡȝĮĮʌȩIJȘȕİȜȩȞĮİȚıĮȖȦȖȒȢțĮȚİʌȚȕİȕĮȚȫıIJİȩIJȚIJȠʌȡȠȧȩȞįİȞİȓȤİȣʌȠıIJİȓȗȘȝȓĮțĮIJȐ
IJȘȝİIJĮijȠȡȐIJȠȣǼȚțȩȞĮ.
ȈǾȂǼǿȍȈǾȉȠıȪȡȝĮİȞIJȠʌȚıȝȠȪİȓȞĮȚıȣıțİȣĮıȝȑȞȠİȞIJȩȢIJȘȢȕİȜȩȞĮȢȝİIJȘȞĮțȓįĮıIJȡĮȝȝȑȞȘȑȟȦĮʌȩIJȠȞ
ȠȝijĮȜȩIJȘȢȕİȜȩȞĮȢȖȚĮȞĮĮʌȠijİȣȤșİȓȕȜȐȕȘIJȘȢĮțȓįĮȢȉȘȞȫȡĮIJȘȢIJȠʌȠșȑIJȘıȘȢIJȠıȪȡȝĮİȞIJȠʌȚıȝȠȪșĮ
ȤȡİȚĮıIJİȓȞĮʌİȡȚıIJȡĮijİȓȑIJıȚȫıIJİȘĮțȓįĮȞĮȠȜȚıșȒıİȚʌȡȫIJĮįȚĮȝȑıȠȣIJȠȣȠȝijĮȜȠȪIJȘȢȕİȜȩȞĮȢ
ǼȚțȩȞĮ
ǼȞIJȠʌȓıIJİIJȘȞĮȜȜȠȓȦıȘȤȡȘıȚȝȠʌȠȚȫȞIJĮȢIJȘȞțĮIJȐȜȜȘȜȘIJİȤȞȚțȒĮʌİȚțȩȞȚıȘȢ
ǼȚıȐȖİIJİIJȘȕİȜȩȞĮİȞIJȠʌȚıȝȠȪİȞIJȩȢIJȠȣȝĮıIJȠȪțĮIJİȣșȪȞȠȞIJȐȢIJȘȞʌȡȠȢIJȘȞĮȜȜȠȓȦıȘțĮIJȐʌȡȠIJȓȝȘıȘ
ʌĮȡĮȜȜȒȜȦȢʌȡȠȢIJȠIJȠȓȤȦȝĮIJȠȣșȫȡĮțĮȖȚĮȞĮȝİȚȦșİȓȠİȞįİȤȩȝİȞȠȢțȓȞįȣȞȠȢʌȞİȣȝȠșȫȡĮțĮ
ȋȡȘıȚȝȠʌȠȚȒıIJİIJȚȢıȘȝȐȞıİȚȢĮȞĮijȠȡȐȢȕȐșȠȣȢȖȚĮIJȘȞIJȠʌȠșȑIJȘıȘIJȠȣȐțȡȠȣIJȘȢȕİȜȩȞĮȢİȞIJȩȢ
IJȘȢĮȜȜȠȓȦıȘȢIJȠȣȝĮıIJȠȪȠȚıȘȝȐȞıİȚȢĮȞĮijȠȡȐȢȕȐșȠȣȢȕȡȓıțȠȞIJĮȚĮȞȐFPǼȚțȩȞĮ.
ǼȚțȩȞĮ
ǼʌȚȕİȕĮȚȫıIJİIJȘȞIJȠʌȠșȑIJȘıȘIJȘȢȕİȜȩȞĮȢȝİIJȘȞțĮIJȐȜȜȘȜȘIJİȤȞȚțȒĮʌİȚțȩȞȚıȘȢ
ǼȐȞİȓȞĮȚĮʌĮȡĮȓIJȘIJȠIJȠʌȠșİIJȒıIJİİțȞȑȠȣIJȘȕİȜȩȞĮțĮȚİʌȚȕİȕĮȚȫıIJİİțȞȑȠȣIJȘȞIJȠʌȠșȑIJȘıȘIJȘȢ
ȉȠıȪȡȝĮİȞIJȠʌȚıȝȠȪȝʌȠȡİȓIJȩIJİȞĮİȚıĮȤșİȓıIJȘȕİȜȩȞĮİȚıĮȖȦȖȒȢȠȜȚıșĮȓȞȠȞIJĮȢIJȠıȪȡȝĮİȞIJȩȢIJȠȣ
ȠȝijĮȜȠȪIJȘȢȕİȜȩȞĮȢțĮȚʌȡȠȦșȫȞIJĮȢIJȠıȪȡȝĮȑȦȢȩIJȠȣȘĮȡȤȒIJȠȣȥȘȜĮijȘIJȠȪıijĮȚȡȚįȓȠȣȑțʌIJȣȟȘȢıIJȠ
ıȪȡȝĮȞĮȕȡȓıțİIJĮȚıIJȠİȖȖȪȢȐțȡȠIJȠȣȠȝijĮȜȠȪIJȘȢȕİȜȩȞĮȢīȚĮȞĮİȟĮıijĮȜȚıIJİȓȩIJȚȘĮțȓįĮșĮİțʌIJȣȤșİȓ
ʌȡȠȢIJȘıȦıIJȒțĮIJİȪșȣȞıȘıIJȠȚȤȓıIJİIJȘȞĮțȓįĮȝİIJȚȢıȘȝȐȞıİȚȢʌȡȠıĮȞĮIJȠȜȚıȝȠȪİʌȓIJȠȣȠȝijĮȜȠȪțĮIJȐ
IJȘįȚȐȡțİȚĮIJȘȢʌȡȠȫșȘıȘȢIJȠȣıȪȡȝĮIJȠȢİȞIJȩȢIJȘȢȕİȜȩȞĮȢǼȚțȩȞĮ.
ǼȚțȩȞĮ
ǻȚĮIJȘȞȑțʌIJȣȟȘIJȘȢĮțȓįĮȢʌȡȑʌİȚIJȠıȪȡȝĮİȞIJȩʌȚıȘȢȞĮıȣȖțȡĮIJİȓIJĮȚıIJȘșȑıȘIJȠȣțĮȚȘȕİȜȩȞĮȞĮ
ĮʌȠıȪȡİIJĮȚțĮIJȐʌȡȠıȑȖȖȚıȘFPǼȚțȩȞĮ. ȈȘȝİȓȦıȘǾĮțȓįĮșĮİțʌIJȣȤșİȓȩIJĮȞIJȠȥȘȜĮijȘIJȩ
ıijĮȚȡȓįȚȠȑțʌIJȣȟȘȢİʌȓIJȠȣıȪȡȝĮIJȠȢȑȤİȚİȚıȤȦȡȒıİȚʌȜȒȡȦȢıIJȠȞȠȝijĮȜȩIJȘȢȕİȜȩȞĮȢǾȠȚĮįȒʌȠIJİ
ʌȡȠıʌȐșİȚĮIJȠʌȠșȑIJȘıȘȢİțȞȑȠȣIJȠȣıȪȡȝĮIJȠȢȝİIJȐĮʌȩIJȘȞȑțʌIJȣȟȘIJȘȢĮțȓįĮȢșĮȝʌȠȡȠȪıİȞĮ
ʌȡȠțĮȜȑıİȚȗȘȝȚȐșȡĮȪıȘIJȠȣıȪȡȝĮIJȠȢ
ǼȚțȩȞĮ
23
ǼȁȁǾȃǿȀǹ
ȈȉȆȡȠijȣȜȐȟİȚȢ
ǼȁȁǾȃǿȀǹ
ȉȫȡĮȝʌȠȡİȓȞĮĮʌȠȝĮțȡȣȞșİȓȘȕİȜȩȞĮțĮȚȞĮȖȓȞİȚȝȓĮĮțIJȚȞȠȖȡĮijȓĮțĮȚȒȣʌȑȡȘȤȠȢȖȚĮIJȘȞİʌȚȕİȕĮȓȦıȘ
IJȘȢIJȠʌȠșȑIJȘıȘȢIJȘȢĮțȓįĮȢȈȘȝİȓȦıȘȉĮıijĮȚȡȓįȚĮİʌȓIJȠȣıȪȡȝĮIJȠȢʌĮȡȑȤȠȣȞȠʌIJȚțȒțĮȚȥȘȜĮijȘIJȒ
ĮȞĮijȠȡȐIJȘȢșȑıȘȢIJȘȢĮțȓįĮȢțĮȚIJȘȢĮȜȜȠȓȦıȘȢ
ȉȠȣʌȩȜȠȚʌȠİțIJİșİȚȝȑȞȠıȪȡȝĮʌȡȑʌİȚȞĮĮıijĮȜȚıIJİȓıIJȘȞİʌȚijȐȞİȚĮIJȠȣįȑȡȝĮIJȠȢȤȡȘıȚȝȠʌȠȚȫȞIJĮȢ
IJȘȞțĮIJȐȜȜȘȜȘȝȑșȠįȠȫıIJİȞĮĮʌȠIJȡĮʌİȓȘȝİIJĮțȓȞȘıȘIJȠȣıȪȡȝĮIJȠȢțĮIJȐIJȘįȚȐȡțİȚĮIJȘȢȝİIJĮijȠȡȐȢ
ıIJȠȤİȚȡȠȣȡȖİȓȠǼȚțȩȞĮȅıȣȞįİIJȒȡĮȢIJȠȣıȪȡȝĮIJȠȢȑȤİȚIJȘįȣȞĮIJȩIJȘIJĮȞĮIJȠʌȠșİIJȘșİȓıIJȠıȪȡȝĮ
ıIJȘȞİʌȚijȐȞİȚĮIJȠȣįȑȡȝĮIJȠȢȑIJıȚȫıIJİȞĮĮʌȠijİȣȤșİȓȘȝİIJĮȞȐıIJİȣıȘIJȠȣıȪȡȝĮIJȠȢǹıțȒıIJİİʌĮȡțȒ
ʌȓİıȘȖȚĮȞĮIJȠʌȠșİIJȒıİIJİIJȠȞıȣȞįİIJȒȡĮIJȠȣıȪȡȝĮIJȠȢıIJȠıȪȡȝĮǼȚțȩȞĮ.
ǼȚțȩȞĮ
ǼȚțȩȞĮ
ȆȡȚȞĮʌȩIJȘȞİȖȤİȓȡȘıȘȠıȦȜȘȞȓıțȠȢİȞȓıȤȣıȘȢBARD®ȝİĮȝȕȜȪȐțȡȠȝʌȠȡİȓȞĮȠįȘȖȘșİȓʌȐȞȦĮʌȩ
IJȠıȪȡȝĮİȞIJȠʌȚıȝȠȪȕȜȐȕȘȢȝĮıIJȠȪȝİıijĮȚȡȓįȚĮGHIATAS®ȑIJıȚȫıIJİȞĮįȚİȣțȠȜȣȞșİȓȘʌĮȡȠȤȒȝȓĮȢ
ȥȘȜĮijȘIJȒȢȑȞįİȚȟȘȢIJȘȢʌȠȡİȓĮȢIJȠȣıȪȡȝĮIJȠȢțĮȚIJȘȢșȑıȘȢIJȠȣȐțȡȠȣIJȠȣıȪȡȝĮIJȠȢ
ǾʌĮȡȠȪıĮıȣıțİȣȒİȓȞĮȚıȣȝȕĮIJȒȝİ05ȣʌȩȠȡȚıȝȑȞİȢıȣȞșȒțİȢ
ȅȚĮțȩȜȠȣșȠȚțȦįȚțȠȓȑȤȠȣȞIJȘįȣȞĮIJȩIJȘIJĮIJȠʌȠșȑIJȘıȘȢțĮȚĮʌİȚțȩȞȚıȘȢȣʌȩ05
470201
475201
477201
479201
ȅİȟȦțȜȚȞȚțȩȢȑȜİȖȤȠȢȑȤİȚțĮIJĮįİȓȟİȚȩIJȚIJȠıȪȡȝĮİȞIJȠʌȚıȝȠȪ05GHIATAS® İȓȞĮȚıȣȝȕĮIJȩȝİ05ȣʌȩȠȡȚıȝȑȞİȢ
ıȣȞșȒțİȢDzȤİȚIJȘįȣȞĮIJȩIJȘIJĮȞĮıĮȡȦșİȓĮıijĮȜȫȢțȐIJȦĮʌȩIJȚȢĮțȩȜȠȣșİȢıȣȞșȒțİȢ
‡
ȈIJĮIJȚțȩȝĮȖȞȘIJȚțȩʌİįȓȠIJȦȞ7HVODȒȝȚțȡȩIJİȡȠ
‡
ȆİįȓȠțȜȓıȘȢȤȫȡȠȣIJȦȞ*DXVVFPȒȝȚțȡȩIJİȡȠ
ȈİİȟȦțȜȚȞȚțȒİȟȑIJĮıȘȠȚțȦįȚțȠȓʌȡȠȧȩȞIJȠȢIJȠȣıȪȡȝĮIJȠȢİȞIJȩʌȚıȘȢ05GHIATAS®ʌĮȡȑȤȠȣȞȝȓĮĮȪȟȘıȘIJȘȢ
șİȡȝȠțȡĮıȓĮȢȝȚțȡȩIJİȡȘIJȦȞž&İȞȫıİȝȑȖȚıIJȠıȪıIJȘȝĮ05ĮȞĮijȑȡșȘțİȝȑıȠȢȡȣșȝȩȢİȚįȚțȒȢĮʌȠȡȡȩijȘıȘȢ
ȠȜȠțȜȒȡȠȣIJȠȣıȫȝĮIJȠȢ6$5IJȦȞ:NJıIJĮȜİʌIJȐIJȘȢıȐȡȦıȘȢ05ıİȑȞĮıȪıIJȘȝĮ7HVOD6LJQD05
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ǾʌȠȚȩIJȘIJĮIJȘȢĮʌİȚțȩȞȚıȘȢ05İȞįȑȤİIJĮȚȞĮįȚĮțȣȕİȣIJİȓİȐȞȘʌİȡȚȠȤȒİȞįȚĮijȑȡȠȞIJȠȢİȓȞĮȚİʌĮțȡȚȕȫȢȘȓįȚĮ
ʌİȡȚȠȤȒȒȕȡȓıțİIJĮȚıȤİIJȚțȐʌȜȘıȓȠȞIJȘȢșȑıȘȢIJȠȣıȪȡȝĮIJȠȢİȞIJȩʌȚıȘȢ05GHIATAS®ȈȣȞİʌȫȢİȞįȑȤİIJĮȚ
ȞĮțĮIJĮıIJİȓĮȞĮȖțĮȓĮȘȕİȜIJȓȦıȘIJȦȞʌĮȡĮȝȑIJȡȦȞĮʌİȚțȩȞȚıȘȢ05ȖȚĮIJȘȞʌĮȡȠȣıȓĮĮȣIJȠȪIJȠȣȝİIJĮȜȜȚțȠȪ
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ǾİIJĮȚȡİȓĮ%DUG3HULSKHUDO9DVFXODUİȖȖȣȐIJĮȚıIJȠȞĮȡȤȚțȩĮȖȠȡĮıIJȒIJȠȣʌĮȡȩȞIJȠȢʌȡȠȧȩȞIJȠȢȩIJȚIJȠʌĮȡȩȞ
ʌȡȠȧȩȞįİȞșĮİȓȞĮȚİȜĮIJIJȦȝĮIJȚțȩıİȣȜȚțȐțĮȚIJİȤȞȚțȒĮȡIJȚȩIJȘIJĮįȚĮIJȠȤȡȠȞȚțȩįȚȐıIJȘȝĮIJȠȣİȞȩȢȑIJȠȣȢĮʌȩIJȘȞ
ȘȝİȡȠȝȘȞȓĮIJȘȢʌȡȫIJȘȢĮȖȠȡȐȢǾİȣșȪȞȘıȣȝijȫȞȦȢʌȡȠȢIJȘȞʌĮȡȠȪıĮʌİȡȚȠȡȚıȝȑȞȘİȖȖȪȘıȘIJȠȣʌȡȠȧȩȞIJȠȢ
șĮʌİȡȚȠȡȓȗİIJĮȚıIJȘȞİʌȚıțİȣȒȒIJȘȞĮȞIJȚțĮIJȐıIJĮıȘIJȠȣİȜĮIJIJȦȝĮIJȚțȠȪʌȡȠȧȩȞIJȠȢțĮIJȐIJȘȞĮʌȠțȜİȚıIJȚțȒțȡȓıȘ
IJȘȢ%DUG3HULSKHUDO9DVFXODUȒıIJȘȞİʌȚıIJȡȠijȒIJȘȢțĮșĮȡȒȢIJȚȝȒȢʌȠȣȑȤİȚțĮIJĮȕȜȘșİȓǾijȣıȚȠȜȠȖȚțȒijșȠȡȐ
ȜȩȖȦijȣıȚȠȜȠȖȚțȒȢȤȡȒıȘȢȒIJĮİȜĮIJIJȫȝĮIJĮʌȠȣʌȡȠȑȡȤȠȞIJĮȚĮʌȩIJȘȞĮțĮIJȐȜȜȘȜȘȤȡȒıȘIJȠȣʌĮȡȩȞIJȠȢʌȡȠȧȩȞIJȠȢ
įİȞțĮȜȪʌIJȠȞIJĮȚĮʌȩIJȘȞʌĮȡȠȪıĮʌİȡȚȠȡȚıȝȑȞȘİȖȖȪȘıȘ
ǼȍȈȉȅȊǼȆǿȉȇǼȆȉȅȊȅȇǿȅȊǹȆȅȉǾȃǼȃǿȈȋȊȈȋǼȉǿȀǾȃȅȂȅĬǼȈǿǹǾȆǹȇȅȊȈǹȆǼȇǿȅȇǿȈȂǼȃǾ
ǼīīȊǾȈǾȉȅȊȆȇȅȎȅȃȉȅȈǹȃȉǿȀǹĬǿȈȉǹȅȁǼȈȉǿȈǹȁȁǼȈǼīīȊǾȈǼǿȈǼǿȉǼȇǾȉǼȈdzǼȂȂǼȈǼȈ
ȈȊȂȆǼȇǿȁǹȂǺǹȃȅȂǼȃȍȃǹȁȁǹǹȃǼȊȆǼȇǿȅȇǿȈȂȅȊȈǼǹȊȉǼȈȅǿȍȃǻǾȆȅȉǼȈȊȃǼȆǹīȅȂǼȃȍȃ
ǼīīȊǾȈǼȍȃǼȂȆȅȇǼȊȈǿȂȅȉǾȉǹȈdzȀǹȉǹȁȁǾȁȅȉǾȉǹȈīǿǹǼȃǹȃȈȊīȀǼȀȇǿȂǼȃȅȈȀȅȆȅȈǼ
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ǹȆǼȃǹȃȉǿȈǹȈǻǿǹȉǿȈȅǿǼȈǻǾȆȅȉǼǼȂȂǼȈǼȈȈȊȂȆȉȍȂǹȉǿȀǼȈdzȈȊȃǼȆǹīȅȂǼȃǼȈǽǾȂǿǼȈȆȅȊ
ȆȇȅǼȇȋȅȃȉǹǿǹȆȅȉȅȃȋǼǿȇǿȈȂȅdzȉǾȋȇǾȈǾȉȅȊȆǹȇȅȃȉȅȈȆȇȅȎȅȃȉȅȈǹȆȅȂǼȇȅȊȈȈǹȈ
ȈİȠȡȚıȝȑȞİȢȤȫȡİȢįİȞİʌȚIJȡȑʌİIJĮȚȘİȟĮȓȡİıȘIJȦȞȑȝȝİıȦȞİȖȖȣȒıİȦȞțĮșȫȢțĮȚIJȦȞIJȣȤĮȓȦȞȒʌĮȡİʌȩȝİȞȦȞ
ȗȘȝȚȫȞȆȚșĮȞȩȞȞĮȑȤİIJİʌİȡĮȚIJȑȡȦįȚțĮȚȫȝĮIJĮĮʌȠȗȘȝȓȦıȘȢıȪȝijȦȞĮȝİIJȘȞȠȝȠșİıȓĮIJȘȢȤȫȡĮȢıĮȢ
ǾȘȝİȡȠȝȘȞȓĮȑțįȠıȘȢȒĮȞĮșİȫȡȘıȘȢȩʌȦȢțĮȚȑȞĮȢĮȡȚșȝȩȢĮȞĮșİȫȡȘıȘȢIJȦȞİȞȜȩȖȦȠįȘȖȚȫȞ
ıȣȝʌİȡȚȜĮȝȕȐȞİIJĮȚȖȚĮIJȘȞʌȜȘȡȠijȩȡȘıȘIJȠȣȤȡȒıIJȘıIJȘȞIJİȜİȣIJĮȓĮıİȜȓįĮIJȠȣʌĮȡȩȞIJȠȢijȣȜȜĮįȓȠȣȈIJȘȞ
ʌİȡȓʌIJȦıȘʌȠȣȑȤȠȣȞʌĮȡȑȜșİȚȝȒȞİȢȝİIJĮȟȪIJȘȢİȞȜȩȖȦȘȝİȡȠȝȘȞȓĮȢțĮȚIJȘȢȤȡȒıȘȢIJȠȣʌȡȠȧȩȞIJȠȢ
ȠȤȡȒıIJȘȢȠijİȓȜİȚȞĮİʌȚțȠȚȞȦȞȒıİȚȝİIJȘȞ%DUG3HULSKHUDO9DVFXODUȑIJıȚȫıIJİȞĮİȟĮțȡȚȕȫıİȚİȐȞİȓȞĮȚįȚĮșȑıȚȝȘ
İʌȚʌȡȩıșİIJȘʌȜȘȡȠijȩȡȘıȘȖȚĮIJȠʌȡȠȧȩȞ
ȈȣȞĮȡȝȠȜȠȖȒșȘțİıIJȠȂİȟȚțȩ
24
Brugervejledning
DANSK
GHIATAS® perlebetrukket brystlokaliseringstråd
Produktkoder:
47519
19 g x 5 cm kanyle med 15 cm pigtråd
47919
19 g x 9 cm kanyle med 20 cm pigtråd
47320
20 g x 3 cm kanyle med 15 cm pigtråd
47520
20 g x 5 cm kanyle med 15 cm pigtråd
47720
20 g x 7 cm kanyle med 20 cm pigtråd
47920
20 g x 9 cm kanyle med 20 cm pigtråd
47020*
20 g x 14 cm kanyle med 35 cm pigtråd
GHIATAS® perlebetrukket brystlokaliseringstråd med afstivet sektion
Produktkoder:
49520
20 g x 5 cm kanyle med 15 cm pigtråd
49720
20 g x 7 cm kanyle med 20 cm pigtråd
49920
20 g x 9 cm kanyle med 20 cm pigtråd
MR GHIATAS® perlebetrukket brystlokaliseringstråd MR
Produktkoder:
475201*
20 g x 5 cm kanyle med 15 cm pigtråd
477201*
20 g x 7 cm kanyle med 20 cm pigtråd
479201*
20 g x 9 cm kanyle med 20 cm pigtråd
470201*
20 g x 14 cm kanyle med 35 cm pigtråd
3URGXNWNRGHURJKDULNNHXOWUDO\GIRUVW UNQLQJ+HUXGRYHU
kan produktkoder 475201, 477201, 479201 og 470201 placeres under MRI styring.
Figur 1
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
Introducerkanyle
Ultralyd forstærkning
Referencemarkeringer 1 cm dybde
Orienteringsmarkeringer
Pig
Markeringsperler
Lokaliseringstråd
Palpabel anbringelsesperle
A. Generelle oplysninger og beskrivelse af udstyr:
GHIATAS® perlebetrukket brystlokaliseringstråd består af en introducerkanyle og en halvstiv lokaliserings-tråd.
Introducerkanylen består af en plasticstøbt hub, referencemarkeringer 1 cm dybde samt en ultralyd forstærkning
på den distale ende for at støtte placeringen af kanylen. *Den halvstive lokaliseringstråd har 1 cm markeringsperler
ved trådens distale ende og en palpabel anbringelsesperle for at tilkendegive det punkt, hvor piggen ved den
distale ende af tråden skal anbringes. Produktkoder 49520, 49720 og 49920 har længere perler ved trådens
GLVWDOHHQGHVRPWLOI¡MHUHQDIVWLYHQGHYLUNQLQJWLOWUnGHQ
B. Leveringsmåde:
GHIATAS® perlebetrukket lokaliseringstråd leveres steril og non-pyrogen med mindre emballagen er beskadiget eller
åbnet. Steriliseret med ethylenoxid. Kun til éngangsbrug. Må ikke genbruges. Må ikke resteriliseres.
C. Brugervejledning:
'HWWHXGVW\UHUEHUHJQHWWLOEUXJYHGEU\VWO VLRQVLQGJUHEVRPHQYHMOHGQLQJIRUNLUXUJHQYHGH[FLVLRQDIO VLRQHQ
D. Kontraindikationer for brug:
Ingen kendte.
E. Advarsler:
1nUSLJJHQHULQGVDWLEU\VWHWVNDOWUnGHQIMHUQHVNLUXUJLVN)RUV¡JLNNHDWÀ\WWHEHY JHHOOHUWU NNH
LWUnGHQGDGHWNDQUHVXOWHUHLDWGHQEHVNDGLJHVHOOHUNQ NNHU
7UnGHQHUNXQW QNWVRPHQVW\ULQJ0c,..($19(1'(6WLOWLOEDJHWU NQLQJ
'HUVNDOXGYLVHVIRUVLJWLJKHGXQGHUNLUXUJLVNH[FLVLRQDIO VLRQHQIRUDWXQGJnRYHUVN ULQJDIWUnGHQ
med en skalpel.
7UnGHQPnNXQIUHPI¡UHVJHQQHPNDQ\OHQIUDKXE¶HQWLONDQ\OHSXQNWHW)RUV¡JLNNHDWWU NNHWUnGHQ
tilbage til eller inde i kanylen.
)RUV¡JLNNHDW QGUHWUnGHQVSLJJHSnQRJHQPnGHGDGHWWHNDQPHGI¡UHDWSLJJHQNQ NNHU
Hvis trådens pigge deformeres eller bøjes forkert, bortskaffes produktet.
6. Der skal udvises forsigtighed, når en brystlokaliseringstråd anvendes på patienter med brystproteser
for ikke at punktere dem under anbringelse eller transport.
7. GHIATAS® perlebetrukket brystlokaliseringstråd er udelukkende beregnet til engangsbrug. Genbrug
DIGHWWHPHGLFLQVNHXGVW\ULQGHE UHUULVLNRIRUNU\GVNRQWDPLQHULQJPHOOHPSDWLHQWHULGHWPHGLFLQVN
XGVW\U±VSHFLHOWPHGODQJHRJVPnOXPHQVDPOLQJHURJHOOHUVSU NNHUPHOOHPNRPSRQHQWHU±HU
YDQVNHOLJHHOOHUXPXOLJHDWUHQJ¡UHQnUNURSVY VNHUHOOHUY YPHGSRWHQWLHOS\URJHQHOOHUPLNURELHO
NRQWDPLQDWLRQKDUY UHWLNRQWDNWPHGGHWPHGLFLQVNHXGVW\ULHQXEHVWHPWSHULRGH5HVWHUDI
biologisk materiale kan fremme kontamination af udstyret med pyrogener eller mikroorganismer,
der kan medføre infektiøse komplikationer.
8. GHIATAS® perlebetrukket brystlokaliseringstråd må ikke resteriliseres. Efter resterilisering kan
produktets sterilitet ikke garanteres på grund af en ubestemmelig grad af pyrogen eller mikrobiel
kontamination, der kan medføre infektiøse komplikationer. Rengøring, genbehandling og/eller
resterilisering af dette medicinske udstyr øger sandsynligheden for, at udstyret vil svigte grundet
SRWHQWLHOOHX¡QVNHGHK QGHOVHUPHGNRPSRQHQWHUGHUHUSnYLUNHWDIWHUPLVNHRJHOOHUPHNDQLVNH
QGULQJHU
NB: Efter brug kan disse produkter udgøre en potentiel biologisk risiko. Håndter og bortskaf produktet
LRYHUHQVVWHPPHOVHPHGDFFHSWDEHOPHGLFLQVNSUDNVLVRJJ OGHQGHORNDOHRJQDWLRQDOHORYHRJIRUVNULIWHU
25
F. Forsigtighedsregler:
DANSK
1.
2.
Dette udstyr må kun anvendes af en læge, der uddannet i dets indikerede brug, begrænsninger og eventuelle
komplikationer ved perkutane kanyleteknikker.
Indføringen af udstyret i kroppen skal udføres under billedkontrol.
,QGHQEUXJVNDOXGVW\UHWLQVSLFHUHVIRUEHVNDGLJHOVHGHUNXQQHIRUKLQGUHNRUUHNWIXQNWLRQ+YLVNRPSRQHQWHUQH
HUEHVNDGLJHWHOOHUE¡MHW0c'(,..($19(1'(6
G. Potentielle komplikationer:
3RWHQWLHOOHNRPSOLNDWLRQHUHUVWHGVSHFL¿NNHRJNDQRPIDWWHK PDWRPK PRUDJLLQIHNWLRQVNDGHSnWLOVW¡GHQGH
væv, smerter, blødning, hæmoptyse, hæmothorax, perforation af ikke-målorganer, -kar eller -væv, samt
pneumothorax.
H. Nødvendigt udstyr:
‡
‡
‡
‡
I.
Relevant billedudstyr
Kirurgiske handsker og beklædning
Lokalanæstesi
$QGHWXGVW\UHIWHUEHKRY
Brugervejledning:
,QVSLFpUHPEDOODJHQIRUEHVNDGLJHOVHRJXGO¡EVGDWR+YLVHPEDOODJHQHUXEHVNDGLJHWRJLNNHXGO¡EHW
åbnes den og produktet placeres på det sterile område ved anvendelse af aseptisk teknik.
)MHUQWUnGHQIUDLQWURGXFHUNDQ\OHQRJYHUL¿FpUDWSURGXNWHWLNNHEOHYEHVNDGLJHWXQGHUIRUVHQGHOVH(Figur 2).
NB: Lokaliseringstråden er emballeret i kanylen med piggen vendende ud fra kanylehub’en for at forhindre
EHVNDGLJHOVHDISLJJHQ9HGSODFHULQJVNDOORNDOLVHULQJVWUnGHQGUHMHVUXQGWVnOHGHVDWSLJJHQJOLGHUJHQQHP
kanylehub’en først.
Figur 2
3.
4.
Lokalisér læsionen ved anvendelse af den relevante billedteknik.
Indfør lokaliseringskanylen i brystet og ret den mod læsionen (fortrinsvis parallelt med brystvæggen for
at mindske risikoen for pneumothorax). Brug dybde referencemarkeringerne for at positionere kanylen
i brystlæsionen (afstanden mellem dybde referencemarkeringerne er 1 cm) (Figur 3).
Figur 3
5.
7.
Bekræft kanylens placering med relevant billedteknik.
+YLVGHWHUQ¡GYHQGLJWUHSRVLWLRQHUHVNDQ\OHQRJSODFHULQJHQJHQEHNU IWHV
Lokaliseringstråden kan derefter indsættes i introducerkanylen ved at lade tråden glide ind i kanylehub’en og
IUHPI¡UHWUnGHQWLOEHJ\QGHOVHQDIGHQSDOSDEOHDQEULQJHOVHVSHUOHSnWUnGHQEH¿QGHUVLJYHGGHQSURNVLPDOH
HQGHDINDQ\OHKXE¶HQ)RUDWVLNUHDWSLJJHQLQGV WWHVLGHQULJWLJHUHWQLQJSODFHUHVSLJJHQSnOLQMHPHG
orienteringsmarkeringerne på hub’en, når tråden indføres i kanylen (Figur 4).
Figur 4
8.
For at anbringe piggen skal lokaliseringstråden holdes på plads og tråden trækkes tilbage ca.1,5 cm (Figur 5).
NB:3LJJHQYLOY UHDQEUDJWQnUGHQSDOSDEOHDQEULQJHOVHVSHUOHSnWUnGHQEH¿QGHUVLJKHOWLNDQ\OHKXE¶HQ
(WKYHUWIRUV¡JSnDWUHSRVLWLRQHUHWUnGHQHIWHUDWSLJJHQHUDQEUDJWNDQEHVNDGLJHNQ NNHWUnGHQ
Figur 5
.DQ\OHQNDQQXIMHUQHVRJHQU¡QWJHQRJHOOHUXOWUDO\GNDQXGI¡UHVIRUDWEHNU IWHSLJJHQVSODFHULQJ
NB: Perlerne på tråden giver visuel og palpabel reference til placeringen af piggen og læsionen.
'HQWLOEDJHY UHQGHV\QOLJHWUnGVNDOVLNUHVWLOKXGHQVRYHUÀDGHYHGDQYHQGHOVHDIHQUHOHYDQWPHWRGH
for at forhindre tråden i at bevæge sig under transport til operation (Figur 6). Trådklemmen kan placeres
SnWUnGHQYHGKXGHQVRYHUÀDGHIRUDWXQGJnPLJUDWLRQDIWUnGHQ%UXJWLOVWU NNHOLJWWU\NWLODWSODFHUH
trådklemmen på tråden (Figur 7).
Figur 6
Figur 7
11. Inden operation kan BARD® afstivende kanyle med stump spids dirigeres over GHIATAS® perlebetrukket
brystlokaliseringstråd for at støtte en palpabel indikation af trådspidsens placering.
26
I ikke-kliniske tests frembragte MR GHIATAS® lokaliseringstråd produktkoder en temperaturstigning på mindre
HQGž&YHGHWPDNVLPXP05V\VWHPUDSSRUWHUHWHQIRUKHOHNURSSHQVSHFL¿NJHQQHPVQLWOLJDEVRUEWLRQVUDWH
6$5Sn:NJYHGPLQ05VNDQQLQJLHW7HVOD6LJQD05V\VWHP(NVLWHUHWSODWIRUP*%VRIWZDUH
*(+HDOWKFDUH0LOZDXNHH:,
MR billedkvaliteten kan nedsættes, hvis interesseområdet er i præcis samme område eller relativt tæt på MR
GHIATAS®’ lokaliseringstråd. Det kan derfor være nødvendigt at optimere MR billedparametre for tilstedeværelsen
af dette metalliske implantat.
Garanti
Bard Peripheral Vascular garanterer over for den første køber af dette product, at dette produkt er frit for materialeRJSURGXNWLRQVP VVLJHIHMOLHQSHULRGHSnpWnUIUDI¡UVWHN¡EVGDWRRJDQVYDUXQGHUGHQQHEHJU QVHGH
SURGXNWJDUDQWLYLOY UHEHJU QVHWWLOUHSDUDWLRQHOOHURPE\WQLQJDIGHWIHMOEHK IWHGHSURGXNWHIWHU%DUG3HULSKHUDO
Vascular’s suveræne skøn eller refusion af den erlagte nettopris. Slitage ved normal brug eller defekter opstået
ved forkert brug af dette produkt er ikke dækket af denne begrænsede garanti.
,'(720)$1**/'(1'(/29*,91,1*7,//$'(5'(775'(5'(11(%(*516('(
352'8.7*$5$17,,67('(7)25$//($1'5(*$5$17,(58'75<..(/,*((//(5
81'(5)2567c('(,1./86,9(0(1,..(%(*516(77,/(1+9(581'(5)2567c(7*$5$17,
)2520677(/,*+('(//(5(*1(7+('7,/(7%(67(07)250c/,,17(77,/)/'(9,/%$5'
3(5,3+(5$/9$6&8/$53c7$*(6,*$169$5)2512*(1,1',5(.7(+1'(/,*((//(5
)‘/*(6.$'(59('+c1'7(5,1*(//(5%58*$)'(77(352'8.7
9LVVHVWDWHUODQGHWLOODGHULNNHHNVNOXVLRQDIVWLOWLHQGHJDUDQWLHUWLOI OGLJHVNDGHUHOOHUI¡OJHVNDGHU'XNDQLÀJ
ORYHQHLGHQGHWDNWXHOOHVWDWODQGY UHEHUHWWLJHWWLO\GHUOLJHUHUHWVPLGOHU
En udstedelses- eller revisionsdato samt et revisionsnummer på disse instruktioner er til brugerens oplysning anført
på sidste side i denne brochure. Såfremt der er gået 36 måneder mellem denne dato og brug af produktet, bør
brugeren kontakte Bard Peripheral Vascular for at undersøge, om der er fremkommet yderligere produktinformation.
Samlet i Mexico.
27
DANSK
Dette udstyr er MR betinget:
Følgende koder kan placeres og afbildes under MR:
470201
475201
477201
479201
Ikke-klinisk test har påvist, at MR GHIATAS® lokaliseringstråd er MR betinget. Den kan skannes sikkert under
følgende betingelser:
‡
Statisk magnetisk felt på 3Tesla eller mindre
‡
6SDWLDOWJUDGLHQWIHOWSn*DXVVFPHOOHUPLQGUH
SVENSKA
Bruksanvisning
GHIATAS® bröstindikeringstråd med markörer
$UWLNHOQU
J[FPQnOPHGFPKXOOLQJI|UVHGGWUnG
47919
19 g x 9 cm nål med 20 cm hullingförsedd tråd
47320
20 g x 3 cm nål med 15 cm hullingförsedd tråd
47520
20 g x 5 cm nål med 15 cm hullingförsedd tråd
47720
20 g x 7 cm nål med 20 cm hullingförsedd tråd
47920
20 g x 9 cm nål med 20 cm hullingförsedd tråd
47020*
20 g x 14 cm nål med 35 cm hullingförsedd tråd
GHIATAS® bröstindikeringstråd med markörer och förstyvad del
$UWLNHOQU
J[FPQnOPHGFPKXOOLQJI|UVHGGWUnG
49720
20 g x 7 cm nål med 20 cm hullingförsedd tråd
49920
20 g x 9 cm nål med 20 cm hullingförsedd tråd
MR GHIATAS® bröstindikeringstråd med markörer MR
$UWLNHOQU
J[FPQnOPHGFPKXOOLQJI|UVHGGWUnG
477201*
20 g x 7 cm nål med 20 cm hullingförsedd tråd
479201*
20 g x 9 cm nål med 20 cm hullingförsedd tråd
470201*
20 g x 14 cm nål med 35 cm hullingförsedd tråd
$UWLNHOQURFKVDNQDUXOWUDOMXGVI|UVWlUNQLQJHQ'HVVXWRPNDQDUWLNHOQU
475201, 477201, 479201 och 470201 inplaceras under MRT-vägledning.
Figur 1
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
Introducer-nål
8OWUDOMXGVI|UVWlUNQLQJ
FPGMXSUHIHUHQVPDUNHULQJDU
Orienteringsmarkeringar
+XOOLQJ
8SSK|MGDPDUN|UHU
Indikeringstråd
Palpabel lägesmarkör
A. Allmän information och beskrivning av produkten:
GHIATAS® bröstindikeringstråd består av en introducer-nål och en halvstyv ståltråd för indikering. Introducer-nålen
EHVWnUDYHWWJMXWHWSODVWQDYFPGMXSUHIHUHQVPDUNHULQJDURFKHQXOWUDOMXGVI|UVWlUNQLQJSnGHQGLVWDODlQGHQ
för att underlätta nålplacering.*Den halvstyva ståltråden har 1 cm-markeringar vid trådens distala ände och en
SDOSDEHOOlJHVPDUN|UVRPEHWHFNQDUSXQNWHQGlUKXOOLQJHQYLGWUnGHQVGLVWDODlQGHIlOOVXW$UWLNHOQU
RFKKDUOlQJUHXSSK|MGDPDUN|UHUYLGWUnGHQVGLVWDODlQGHI|UI|UVW\YQLQJDYWUnGHQ
B. Leveransform:
GHIATAS™ bröstindikeringstråd levereras steril och icke pyrogen förutsatt att förpackningen inte skadats eller
öppnats. Steriliserad med etylenoxid. Endast för engångsbruk. Får ej återanvändas. Omsterilisera inte.
C. Användningsområde:
Denna produkt är avsedd att användas under bröstlesionskirurgi som ledning för kirurgen vid excisionen av lesionen.
D. Kontraindikationer för användning:
Inga kända.
E. Varningar:
1lUKXOOLQJHQKDUIlOOWVXWLEU|VWHWPnVWHWUnGHQDYOlJVQDVNLUXUJLVNW)|UV|NLQWHlQGUDOlJHÀ\WWD
eller dra i tråden, eftersom den kan skadas/gå av.
7UnGHQlUHQGDVWDYVHGGVRPYlJOHGQLQJ'HQInU,17(DQYlQGDVVRPHQUHWUDNWRU
3. Var försiktig under kirurgisk excision av lesionen så att du inte skär av tråden med en skalpell.
7UnGHQVNDI|UDVLQJHQRPQnOHQIUnQQDYHWWLOOQnOVSHWVHQ)|UV|NLQWHDWWGUDWUnGHQEDNOlQJHV
in i eller inuti nålen; då kan hullingen skadas.
7UnGHQVKXOOLQJInULQWHRPIRUPDVSnQnJRWVlWWGnNDQKXOOLQJHQEU\WDVDY2PWUnGHQVKXOOLQJ
är deformerad eller böjd på fel sätt ska produkten kasseras.
6. Var försiktig när du använder en indikeringstråd på patienter med bröstproteser så att du inte
punkterar dem under placering eller transport.
7. GHIATAS®EU|VWLQGLNHULQJVWUnGPHGPDUN|UHUlUHQEDUWDYVHGGI|UHQJnQJVEUXNcWHUDQYlQGQLQJ
av detta medicinska instrument medför en risk för korskontaminering för patienten, eftersom
medicinska instrument – särskilt de med långa och små lumen, anslutningar och/eller springor mellan
komponenterna – är svåra eller omöjliga att rengöra när kroppsvätskor eller vävnader med potentiell
pyrogen eller mikrobakteriell kontaminering varit i kontakt med det medicinska instrumentet under
en obestämbar tidsperiod. Resterna av biologiskt material kan bidra till kontaminering av instrumentet
med pyrogener eller mikroorganismer, vilket kan leda till infektiösa komplikationer.
8. GHIATAS® bröstindikeringstråd med markörer får inte omsteriliseras. Efter omsterilisering kan
inte produktens sterilitet garanteras på grund av en obestämbar grad av potentiell pyrogen eller
mikrobakteriell kontaminering, vilket kan leda till infektiösa komplikationer. Rengöring, desinfektion
RFKHOOHURPVWHULOLVHULQJDYGHWEH¿QWOLJDPHGLFLQVNDLQVWUXPHQWHW|NDUVDQQROLNKHWHQI|UDWW
instrumentet fungerar felaktigt, på grund av potentiella negativa effekter på komponenter som
påverkas av termiska och/eller mekaniska förändringar.
OBS: Efter användning kan dessa produkter utgöra en potentiell biologisk risk. Hantera och kassera
i enlighet med vedertagen medicinsk praxis och gällande lokala och nationella lagar och föreskrifter.
28
F. Försiktighetsmått:
2.
3.
Denna produkt får endast användas av en läkare med utbildning i dess angivna användning och begränsningar
RFKLP|MOLJDNRPSOLNDWLRQHUYLGSHUNXWDQDQnOWHNQLNHU
Införandet av produkten i kroppen ska utföras under genomlysning.
Före användning ska produkten inspekteras avseende skador som kan förhindra korrekt funktion.
2PNRPSRQHQWHUQDlUVNDGDGHHOOHUE|MGD$19b1',17(SURGXNWHQ
G. Potentiella komplikationer:
3RWHQWLHOODNRPSOLNDWLRQHUlUVSHFL¿NDI|ULQJUHSSVVWlOOHWRFKLQNOXGHUDUKHPDWRPKHPRUUDJLLQIHNWLRQVNDGRUSn
angränsande vävnad, smärta, blödning, hemoptys, hemotorax, missad målvävnad, perforation av organ eller kärl
och pneumotorax.
H. Utrustning som behövs:
‡
‡
‡
‡
Lämplig genomlysningsenhet
Kirurghandskar och operationslakan
Lokalbedövningsmedel
Övrig utrustning efter behov
I.
Anvisningar för användning:
1.
Inspektera förpackning och produkt avseende skador och utgångsdatum. Öppna förpackningen, om den
är oskadad och har giltigt datum, och lägg produkten i det sterila fältet med användning av aseptisk teknik.
2. Ta bort tråden från introducer-nålen och bekräfta att produkten inte skadats under transporten (Figur 2).
OBS: Indikeringstråden är förpackad i nålen med hullingen riktad ut ur nålnavet för att förhindra att hullingen
skadas. Vid placeringen måste tråden vändas så att hullingen glider genom nålnavet först.
Figur 2
4.
/RNDOLVHUDOHVLRQHQPHGKMlOSDYOlPSOLJJHQRPO\VQLQJVWHNQLN
För in indikeringsnålen i bröstet och rikta den mot lesionen (helst parallellt med bröstväggen för att reducera
HYHQWXHOOULVNI|USQHXPRWRUD[$QYlQGGMXSUHIHUHQVPDUNHULQJDUQDI|UDWWSODFHUDQnOVSHWVHQLEU|VWOHVLRQHQ
GMXSUHIHUHQVPDUNHULQJDUQDKDUFPPHOODQUXP(Figur 3).
Figur 3
5.
Bekräfta nålens placering med lämplig genomlysningsteknik.
9LGEHKRYÀ\WWDQnOHQRFKEHNUlIWDSODFHULQJHQLJHQ
6HGDQNDQGXI|UDLQLQGLNHULQJVWUnGHQLLQWURGXFHUQnOHQJHQRPDWWVNMXWDLQWUnGHQLQnOQDYHWRFKI|UDWUnGHQ
WLOOE|UMDQDYGHQSDOSDEODOlJHVPDUN|UHQYLGQnOQDYHWVSUR[LPDODlQGH6HWLOODWWKXOOLQJHQIlOOVXWLUlWW
riktning genom att rikta in hullingen med orienteringsmarkeringarna på navet när du matar in tråden i nålen
(Figur 4).
Figur 4
8.
För att fälla ut hullingen ska du hålla indikeringstråden på plats och nålen dras tillbaka cirka 1,5 cm (Figur 5).
Obs:+XOOLQJHQIlOOVXWQlUGHQSDOSDEODOlJHVPDUN|UHQSnWUnGHQlUKHOWLQQHLQnOQDYHW$OODI|UV|NDWWÀ\WWD
WUnGHQHIWHUGHWDWWKXOOLQJHQIlOOWVXWNDQVNDGDEU\WDWUnGHQ
Figur 5
1XNDQGXDYOlJVQDQnOHQRFKWDHQU|QWJHQELOGRFKHOOHUHWWXOWUDOMXGI|UDWWEHNUlIWDKXOOLQJHQVOlJHObs:
'HXSSK|MGDPDUN|UHUQDSnWUnGHQXWJ|UV\QOLJDRFKSDOSDEODUHIHUHQVHUWLOOKXOOLQJHQVRFKOHVLRQHQVOlJH
10. Resten av den exponerade tråden ska fästas vid hudytan med en lämplig metod så att tråden inte rör sig
under transporten till operation (Figur 6). Trådklämman kan placeras på tråden vid hudytan för att undvika
DWWWUnGHQI|UÀ\WWDV$QYlQGWLOOUlFNOLJWWU\FNQlUGXVlWWHUWUnGNOlPPDQSnWUnGHQ (Figur 7).
Figur 6
Figur 7
29
SVENSKA
1.
SVENSKA
11. Före operationen kan BARD® trubbig förstyvande kanyl ledas över GHIATAS® bröstindikeringstråd för att ge en
palpabel indikation om trådens riktning och trådspetsens placering.
Denna produkt kan utsättas för MR:
)|OMDQGHDUWLNHOQUNDQSODFHUDVRFKDYELOGDVXQGHU05
470201
475201
477201
479201
Icke-kliniska tester har visat att MR GHIATAS® indikeringstråd kan utsättas för MR. Den kan skannas säkert under
I|OMDQGHYLOONRU
‡
Statiskt magnetfält på 3 tesla eller mindre
‡
6SDWLDOWJUDGLHQWIlOWSnJDXVVFPHOOHUPLQGUH
I icke-kliniska tester (MR-systemrapport) framkallade artikelnumren för MR GHIATAS® indikeringstråd en
WHPSHUDWXUK|MQLQJSnPLQGUHlQž&YLGHQPD[LPDOVSHFL¿NDEVRUSWLRQVIUHNYHQV6$5I|UKHONURSSSn
LPHGHOWDO:NJXQGHUPLQXWHUV05VNDQQLQJLHWWWHVOD6LJQD05V\VWHP([FLWHSODWWIRUP*%
SURJUDPYDUD*(+HDOWKFDUH0LOZDXNHH:,
MR-bilden kan förlora i kvalitet om området av intresse ligger precis i eller relativt nära positionen för MR GHIATAS®
lokaliseringstråd. Därför kan det vara nödvändigt att optimera MR-avbildningens parametrar avseende förekomsten
av detta metallimplantat.
Garanti
Bard Peripheral Vascular garanterar förstahandsköparen av denna produkt att produkten är felfri beträffande
material och utförande under ett år från och med datumet för förstahandsköpet, och ansvars-skyldigheten enligt
denna begränsade produktgaranti är begränsad till reparation eller ersättning av den felaktiga produkten enligt
%DUG3HULSKHUDO9DVFXODUVJRWW¿QQDQGHHOOHUnWHUEHWDOQLQJDYHUODJWQHWWRSULV)|UVOLWQLQJSnJUXQGDYQRUPDO
användning eller defekter som uppstått på grund av felaktig användning av denna produkt täcks inte av denna
begränsade garanti.
,'(120)$771,1*'(7b57,//c7(7(1/,*7*b//$1'(/$*(56b77(5'(11$%(*5b16$'(
352'8.7*$5$17,$//$g95,*$*$5$17,(5%c'(877$/$'(2&+81'(5)g567c''$,1./86,9(
0(1(-%(*5b16$77,//$//$81'(5)g567c''$*$5$17,(520b1'$0c/6(/,*+(7(//(5
/b03/,*+(7)g5(779,6676<)7(81'(5,1*$2067b1',*+(7(5b5%$5'3(5,3+(5$/
9$6&8/$56.</',*$$77(56b77$',*)g5,1',5(.7$(//(52)g5876(''$6.$'25(//(5
)g/-'6.$'2562083367c57,//)g/-'$9',1+$17(5,1*(//(5$19b1'1,1*$9352'8.7(1
9LVVDGHOVWDWHUOlQGHUWLOOnWHULQWHXWHVOXWDQGHDYXQGHUI|UVWnGGDJDUDQWLHUWLOOIlOOLJDHOOHUHIWHUI|OMDQGHVNDGRUHOOHU
VNDGHVWnQGVDQVSUnN.XQGHQNDQRFNVnKDUlWWWLOO\WWHUOLJDUHJRWWJ|UHOVHUHQOLJWODJVWLIWQLQJLNXQGHQVGHOVWDWODQG
(WWXWJLYQLQJVHOOHUUHYLVLRQVGDWXPRFKHWWUHYLVLRQVQXPPHUI|UGHVVDDQYLVQLQJDU¿QQVPHGVRPLQIRUPDWLRQ
till användaren på sista sidan i denna bipacksedel. Om det skulle ha gått 36 månade mellan detta datum
och produktanvändningen bör användaren kontakta Bard Peripheral Vascular för att höra efter om ytterligare
produktinformation tillkommit.
Monterad i Mexiko.
30
Käyttöohjeet
+HOPHQVLVlOWlYlULQWRMHQGHIATAS®SDLNDQQXVODQNDMRVVDRQMl\NNlRVD
7XRWHNRRGLW
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
+HOPHQVLVlOWlYlULQWRMHQGHIATAS®-MRI-paikannuslanka MR
7XRWHNRRGLW
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
7XRWHNRRGHLVVDMDHLROHXOWUDllQLYDKYLVWXVWD/LVlNVLWXRWHNRRGHMD
MDYRLGDDQNl\WWllPDJQHHWWLNXYDXNVHVVD
Kuva 1
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
Sisäänvientineula
Ultraäänivahvistus
Syvyysmerkit 1 cm:n välein
Suuntamerkit
Väkänen
Merkkihelmet
Paikannuslanka
Tunnusteltava vapautushelmi
$ <OHLVWLHWRDMDODLWWHHQNXYDXV
+HOPHQVLVlOWlYlULQWRMHQ GHIATAS®SDLNDQQXVODQNDNRRVWXXVLVllQYLHQWLQHXODVWDMDSXROLMl\NlVWl
paikannuslangasta. Sisäänvientineula koostuu muovikannasta, 1 cm:n välein olevista syvyysmerkeistä
VHNlGLVWDDOLSllVVlROHYDVWDXOWUDllQLYDKYLVWXNVHVWDMRNDDXWWDDQHXODQVLMRLWXNVHVVD3XROLMl\NlVVl
paikannuslangassa on distaalipäässä 1 cm:n merkkihelmet sekä tunnusteltava vapautushelmi osoittamassa
NRKWDDMRVWDODQJDQGLVWDDOLSllVVlROHYDYlNlQHQYDSDXWHWDDQ7XRWHNRRGHLVVDMD
RQODQJDQGLVWDDOLSllVVlSLWHPPlWKHOPHWMRWNDOLVllYlWODQJDQMl\NN\\WWl
% 7RLPLWXVWDSD
+HOPHQVLVlOWlYlULQWRMHQGHIATAS®SDLNDQQXVODQNDRQWRLPLWHWWDHVVDVWHULLOLMDS\URJHHQLWRQPLNlOLSDNNDXV
RQDYDDPDWRQMDHKMl6WHULORLWXHWHHQLRNVLGLOODKertakäyttöinen. Ei saa käyttää uudestaan. Ei saa steriloida
uudestaan.
C. Käyttöaiheet:
/DLWHWWDNl\WHWllQNLUXUJLQDSXQDRKMDXVYlOLQHHQlULQWDOHHVLROHLNNDXNVHVVD
D. Vasta-aiheet:
(LWXQQHWWXMDYDVWDDLKHLWD
E. Varoitukset:
1.
Kun väkänen on laukaistu rintaan, lanka täytyy poistaa kirurgisesti. Lankaa ei saa yrittää siirtää,
liikuttaa eikä vetää; tästä voi olla seurauksena langan vaurio tai katkeaminen.
Lanka on tarkoitettu vain ohjausvälineeksi. Sitä EI saa käyttää retraktorina.
Leesion kirurgisen poiston aikana on varottava leikkaamasta lankaa veitsellä.
Langan saa viedä neulan läpi vain neulan kannasta sen kärkeen. Lankaa ei saa yrittää vetää
taaksepäin neulan sisällä tai sen sisään, sillä väkänen voi vaurioitua.
/DQJDQYlNlVHQPXRWRDHLVDD\ULWWllPXXWWDDVLOOlYlNlQHQYRLPXUWXD-RVODQJDQYlNlQHQ
on väärän muotoinen tai väärin taipunut, tuote on hävitettävä.
6. Varovaisuutta on noudatettava käytettäessä paikannuslankoja potilailla, joilla on rintaproteeseja,
etteivät nämä puhkea väkästen sijoittamisen tai potilaan kuljettamisen aikana.
7. Palloja sisältävä rintojen GHIATAS®SDLNDQQXVODQNDRQVXXQQLWHOWXNHUWDNl\WW|LVHNVL7lPlQODLWWHHQ
uudelleen käyttöön liittyy ristikontaminaation riski, sillä lääkintälaitteita – varsinkin sellaisia, joissa on
pitkiä ja kapeita luumenia, liitoksia ja/tai rakoja – on vaikea tai mahdoton puhdistaa, kun ne ovat olleet
kosketuksissa mahdollisesti pyrogeenisesti tai mikrobisesti kontaminoituneiden ruumiinnesteiden
tai kudosten kanssa määrittämättömän ajan. Biologisen aineksen jäämät edistävät laitteen pyrogeenitai mikrobikontaminaatiota, mikä voi aiheuttaa infektioita.
bOlVWHULORLXXGHOOHHQSDOORMDVLVlOWlYllULQWRMHQGHIATAS®SDLNDQQXVODQNDD7XRWWHHQVWHULLOL\WWl
ei voida taata uudelleen steriloinnin jälkeen, sillä mahdollinen infektioihin johtava pyrogeeni- tai
mikrobikontaminaatio ei ole määritettävissä. Puhdistus, välinehuolto ja/tai uudelleen sterilointi
OLVllYlWODLWWHHQWRLPLQWDKlLUL|QPDKGROOLVXXWWD7lPlMRKWXXPDKGROOLVLVWDRVLLQNRKGLVWXYLVWD
haittavaikutuksista, jotka aiheutuvat lämpömuutoksista ja/tai mekaanisista muutoksista.
HUOMAA: Nämä tuotteet saattavat olla terveysriski käytön jälkeen. Käsittele laitetta hyväksyttävien
lääketieteellisten toimintatapojen ja soveltuvien paikallisten ja kansallisten lakien ja määräysten
mukaisesti ja hävitä se samoja periaatteita noudattaen.
2.
3.
4.
31
SUOMI
+HOPHQVLVlOWlYlULQWRMHQGHIATAS®-paikannuslanka
7XRWHNRRGLW
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
J[FPQQHXODMRVVDRQFPQYlNlVHOOLQHQODQND
F. Varotoimenpiteet:
SUOMI
2.
3.
7lWlODLWHWWDVDDYDWNl\WWllYDLQOllNlULWMRLOODRQNRXOXWXVWDVHQNl\WW|DLKHLVWDMDUDMRLWXNVLVWDVHNl
perkutaanisten neulatekniikoiden mahdollisista komplikaatioista.
Laite tulee viedä rintaan kuvantamislaitteella seuraamalla.
Tarkista ennen käyttöä, onko laitteessa sen oikeaa toimintaa estäviä vaurioita. Jos osat ovat vaurioituneet
WDLWDLSXQHHWb/b.b<7b
G. Mahdolliset komplikaatiot:
0DKGROOLVHWNRPSOLNDDWLRWOLLWW\YlWWRLPHQSLGHNRKWDDQMDQLLWlYRLYDWROODKHPDWRRPDKHPRUUDJLDLQIHNWLR
ympäröivän kudoksen vaurioituminen, kipu, verenvuoto, veriyskökset, veririnta, muiden kudosten, elinten tai
YHULVXRQWHQSHUIRUDDWLRMDLOPDULQWD
+ 7DUYLWWDYDWYlOLQHHW
‡
‡
‡
‡
I.
$VLDQPXNDLVHWNXYDQWDPLVODLWWHHW
/HLNNDXVNlVLQHHWMDOLLQDW
Paikallispuudutusainetta
Muita tarvittavia välineitä
Käyttöohjeet:
7DUNDVWDRQNRSDNNDXNVHVVDWDLWXRWWHHVVDYDXULRLWDMDSDQHPHUNLOOHYLLPHLQHQNl\WW|SlLYl-RVWXRWHRQ
HKMlHLNlYLLPHLQHQNl\WW|SlLYlROHNXOXQXWXPSHHQRWDWXRWHSDNNDXNVHVWDMDDVHWDVHVWHULLOLOOHDOXHHOOH
aseptisella tekniikalla.
3RLVWDODQNDVLVllQYLHQWLQHXODVWDMDWDUNLVWDHWWHLWXRWHROHYDXULRLWXQXWNXOMHWXNVHQDLNDQD(kuva 2).
+820$8786Paikannuslanka on pakattu neulaan väkänen poispäin neulan kannasta väkäsvaurion välttämiseksi.
Paikannuslankaa asetettaessa se on käännettävä ympäri siten, että väkänen liukuu ensin neulan kannan läpi.
Kuva 2
3.
4.
Paikanna leesio sopivalla kuvantamistekniikalla.
Työnnä paikannusneula rintaan leesiota kohti (mieluiten rinnan seinämän kanssa samansuuntaisesti
LOPDULQQDQULVNLQYlKHQWlPLVHNVL6LMRLWDQHXODQNlUNLOHHVLRRQYHUWDLOXPHUNNLHQDYXOODV\Y\\VPHUNLWRYDW
1 cm:n päässä toisistaan) (kuva 3).
Kuva 3
9DKYLVWDQHXODQVLMDLQWLVRSLYDOODNXYDQWDPLVWHNQLLNDOOD
6LLUUlQHXODWDUYLWWDHVVDRLNHDDQNRKWDDQMDYDKYLVWDVHQVLMDLQWLXXGHOOHHQ
3DLNDQQXVODQNDYRLGDDQVLWWHQW\|QWllVLVllQYLHQWLQHXODDQOLX¶XWWDPDOODODQNDQHXODQNDQWDDQMDYLHPlOOl
lankaa eteenpäin, kunnes sen tunnusteltavan vapautushelmen alkuosa on neulan kannan proksimaalipäässä.
Jotta varmistetaan väkäsen vapautuminen oikeaan suuntaan, väkänen tulee kohdistaa kannassa oleviin
suuntamerkkeihin syötettäessä lankaa neulaan (kuva 4).
Kuva 4
9lNlVHQYDSDXWWDPLVHNVLSDLNDQQXVODQNDWXOHHSLWllSDLNDOODDQMDQHXODDWXOHHYHWllWDNDLVLQQRLQFP
(kuva 5). Huomaa: Väkänen vapautuu, kun langan tunnusteltava vapautushelmi on täysin neulan kannan
VLVlOOl-RVODQNDD\ULWHWllQVLLUWllYlNlVHQYDSDXWWDPLVHQMlONHHQODQNDYRLYDXULRLWXDNDWNHWD
Kuva 5
1HXODYRLGDDQQ\WSRLVWDDMDYlNlVHQVLMDLQWLWDUNLVWDDU|QWJHQOlSLYDODLVXOODWDLXOWUDllQHOOlHuomaa: Langan
KHOPHWDQWDYDWYLVXDDOLVHQMDWXQQXVWHOWDYDQYLLWWHHQYlNlVHQMDOHHVLRQVLMDLQQLVWD
1lN\YLVVlROHYDODQNDWXOHHNLLQQLWWllLKRQSLQWDDQDVLDQPXNDLVHOODPHQHWHOPlOOlMRWWDODQNDHLSllVH
liikkumaan, kun potilas siirretään leikkaussaliin (kuva 6). Klipsi voidaan asettaa iholla olevan langan päälle
estämään langan siirtyminen. Paina riittävän voimakkaasti kiinnittäessäsi klipsin lankaan (kuva 7).
Kuva 6
Kuva 7
11. Ennen leikkausta tylppäkärkinen BARD®Ml\NLVW\VNDQ\\OLYRLGDDQRKMDWDKHOPHQVLVlOWlYlQULQWRMHQGHIATAS®SDLNDQQXVODQJDQSllOOHMRWWDVDDGDDQWXQQXVWHOWDYDPHUNNLODQJDQNXONXUHLWLVWlMDODQJDQSllQVLMDLQQLVWD
32
Ei-kliinisissä testeissä magneettikuvaukseen sopivan GHIATAS®-MRI-paikannuslangan tuotekoodit tuottivat alle
ž&QOlPS|WLODQQRXVXQ05,MlUMHVWHOPlQLOPRLWWDPDQVXXULPPDQNRNRNHKRQNHVNLDUYRLVHQVSHVL¿VHQ
DEVRUSWLRQRSHXGHQ6$5ROOHVVD:NJPLQXXWLQPDJQHHWWLNXYDXNVHQDLNDQDWHVODQWHKRLVHOOD6LJQD05,
MlUMHVWHOPlOOl([FLWHDOXVWD*%RKMHOPLVWR*(+HDOWKFDUH0LOZDXNHH:,
0DJQHHWWLNXYDQODDWXYRLNlUVLlMRVWXWNLWWDYDDOXHRQWlVPlOOHHQVDPDNXLQGHIATAS®-MRI-paikannuslangan
VLMDLQWLSDLNNDWDLVXKWHHOOLVHQOlKHOOlVLWl6LNVLVDDWWDDROODWDUSHHQRSWLPRLGDPDJQHHWWLNXYDXNVHQSDUDPHWULW
tämän metallisen istutteen paikallaoloa varten.
7DNXX
%DUG3HULSKHUDO9DVFXODUWDNDDWXRWWHHQHQVLPPlLVHOOHRVWDMDOOHHWWHLWXRWWHHVVDROHPDWHULDDOLHLNl
YDOPLVWXVYLUKHLWl\KWHHQYXRWHHQVHQHQVLPPlLVHVWlRVWRSlLYlVWlOlKWLHQMD%DUG3HULSKHUDO9DVFXODULQYDVWXX
WlPlQUDMRLWHWXQWDNXXQQRMDOODUDMRLWWXXYLDOOLVHQWXRWWHHQNRUMDDPLVHHQWDLYDLKWDPLVHHQ\KWL|QRPDQKDUNLQQDQ
PXNDDQWDLPDNVHWXQQHWWRKLQQDQK\YLWWlPLVHHQ7lPlUDMRLWHWWXWDNXXHLNDWDQRUPDDOLNl\W|VVlDLKHXWXQXWWD
NXOXPLVWDHLNlWXRWWHHQYllULQNl\W|VWlDLKHXWXYLDYLNRMD
629(/789$1/$,138,77(,66$7b0b5$-2,7(7787827(7$.88.259$$.$,..,0887,/0$,6787
-$.21./8'(177,6(77$.88708.$$1/8.,(10877$1,,+,15$-2,7780$77$.$,..,2/(7(787
7$.88778277((1.$83$77$988'(67$7$,623,988'(67$7,(77<<1.b<77g7$5.2,78.6((1
%$5'3(5,3+(5$/9$6&8/$5(,0,66bb17$3$8.6(66$9$67$$0,67bb16$7811$,6,67$7$,
(3b6825,67$9$+,1*2,67$-27.$-2+789$77b0b178277((1.b6,77(/<67b7$,.b<7g67b
Joidenkin maiden lainsäädäntö ei hyväksy konkludenttisten takuiden sivuuttamista liitännäis- tai
VHXUDDPXVYDKLQNRMHQRVDOWD6LQXOODYRLROODRLNHXVOLVlNRUYDXNVLLQRPDQPDDVLODNLHQPXNDLVHVWL
1lLGHQRKMHLGHQMXONDLVXWDLWDUNLVWXVSlLYlMDYHUVLRQQXPHURRQDQQHWWXNl\WWlMlQWLHGRNVLWlPlQRKMHNLUMDVHQ
YLLPHLVHOOlVLYXOOD-RVDQQHWXVWDSlLYlPllUlVWlRQNXOXQXWYlOLQHHQNl\WW|KHWNHOOlNXXNDXWWDNl\WWlMlQWXOHH
RWWDD\KWH\WWl%DUG3HULSKHUDO9DVFXODULLQVDDGDNVHHQPDKGROOLVLDOLVlWLHWRMDWXRWWHHVWD
Koottu Meksikossa.
33
SUOMI
Laite on varauksin turvallinen magneettikuvauksissa:
Seuraavat koodit sopivat magneettikuvaukseen:
470201
475201
477201
479201
Ei-kliiniset testit ovat osoittaneet, että GHIATAS®-MRI-paikannuslanka on varauksin turvallinen magneettikuvauksissa.
Sitä voidaan magneettikuvata turvallisesti seuraavissa olosuhteissa:
‡
Staattinen magneettikenttä on korkeintaan 3 teslaa
‡
6SDWLDDOLQHQJUDGLHQWWLNHQWWlRQNRUNHLQWDDQ*DXVVLDFP
NORSK
Bruksanvisning
GHIATAS® brystlokaliseringstråd med markører
Produktnumre:
47519
19 g x 5 cm nål med 15 cm tråd med mothake
47919
19 g x 9 cm nål med 20 cm tråd med mothake
47320
20 g x 3 cm nål med 15 cm tråd med mothake
47520
20 g x 5 cm nål med 15 cm tråd med mothake
47720
20 g x 7 cm nål med 20 cm tråd med mothake
47920
20 g x 9 cm nål med 20 cm tråd med mothake
47020*
20 g x 14 cm nål med 35 cm tråd med mothake
GHIATAS® avstivet brystlokaliseringstråd med markører
Produktnumre:
49520
20 g x 5 cm nål med 15 cm tråd med mothake
49720
20 g x 7 cm nål med 20 cm tråd med mothake
49920
20 g x 9 cm nål med 20 cm tråd med mothake
MR GHIATAS® brystlokaliseringstråd med markører MR
Produktnumre:
475201*
20 g x 5 cm nål med 15 cm tråd med mothake
477201*
20 g x 7 cm nål med 20 cm tråd med mothake
479201*
20 g x 9 cm nål med 20 cm tråd med mothake
470201*
20 g x 14 cm nål med 35 cm tråd med mothake
*Produktnummer 47020, 475201, 477201, 479201 og 470201 er ikke tilpasset ultralyd. Produktnummer 475201,
477201, 479201 og 470201 kan settes inn under NMR-veiledning.
Figur 1
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
Introducernål
Ultralydtilpasning
1 cm dybdereferansemerker
Orienteringsmerker
Mothake
Markører
Lokaliseringstråd
Palpabel plasseringsmarkør
A. Generell informasjon og beskrivelse av anordningen:
GHIATAS® brystlokaliseringstråd med markør består av en introducernål og en halvstiv lokaliseringstråd.
Introducernålen består av en formet plastmuffe, 1 cm dybdereferansemerker og en ultralydtilpasning på
GLVWDOHQGHQIRUnKMHOSHWLOPHGSODVVHULQJHQDYQnOHQ'HQKDOYVWLYHORNDOLVHULQJVWUnGHQKDUFPPDUN¡UHU
i distalenden av tråden og en palpabel plasseringsmarkør for å vise punktet der mothaken ved trådens distalende
IROGHUVHJXW3URGXNWQXPPHURJKDUOHQJUHPDUN¡UHULGLVWDOHQGHQDYWUnGHQRJGHWWHJM¡U
tråden stivere.
B. Levering:
GHIATAS® brystlokaliseringstråd med markør leveres steril og pyrogenfri med mindre pakningen er åpnet eller
skadet. Sterilisert med etylenoksid. Kun til engangsbruk. Ikke til gjenbruk. Skal ikke resteriliseres.
C. Indikasjoner:
'HQQHDQRUGQLQJHQHUPHQWnY UHHQYHLOHGQLQJIRUNLUXUJHQYHGHNVLVMRQDYOHVMRQHUXQGHUEU\VWOHVMRQVNLUXUJL
D. Kontraindikasjoner:
,QJHQNMHQWH
E. Advarsler:
1.
Når mothaken har foldet seg ut i brystet må tråden fjernes kirurgisk. Ikke forsøk å reposisjonere
WUnGHQÀ\WWHSnGHQHOOHUWUHNNHLGHQ±GHWNDQI¡UHWLOVNDGHUHOOHUDWGHQULYHVLVW\NNHU
7UnGHQHUEDUHPHQWWLOYHLOHGQLQJ0n,..(EUXNHVVRPUHWUDNWRU
3. Utvis forsiktighet under kirurgisk eksisjon av lesjoner for å unngå at tråden kuttes av skalpellen.
7UnGHQVNDOEDUHI¡UHVLQQJMHQQRPQnOHQIUDPXIIHQWLOQnOHVSLVVHQ,NNHIRUV¡NnWUHNNHWUnGHQ
bakover inn i eller inni nålen – mothaken kan bli skadet.
5. Ikke forsøk å omforme mothaken på tråden på noen måte. Det kan føre til at mothaken brekker.
Dersom trådens mothake er deformert eller feil bøyd, skal produktet kastes.
6. Utvis forsiktighet når du bruker lokaliseringstråd på pasienter med brystproteser, slik at protesene
ikke punkteres under plassering eller transport.
7. GHIATAS® belagt lokaliseringstråd til brystkirurgi er utviklet kun for engangsbruk. Gjenbruk av denne
medisinske enheten medfører risiko for kryss-pasientkontaminering idet medisinske enheter - spesielt
enheter med lang og liten lumena, ledd og/eller furer mellom komponentene - er vanskelige eller
XPXOLJHnUHQJM¡UHKYLVNURSSVY VNHUHOOHUYHYPHGSRWHQVLHOOS\URJHQHOOHUPLNURELHOONRQWDPLQDVMRQ
har hatt kontakt med den medisinske enheten i en ubestemt tidsperiode. Restene av biologisk
materiale kan fremme kontaminasjon av enheten med pyrogener eller mikroorganismer. Dette kan føre
til infeksjonskomplikasjoner.
8. GHIATAS® belagt lokaliseringstråd til brystkirurgi må ikke resteriliseres. Etter resterilisering kan ikke
produktets sterilitet garanteres på grunn av en ubestemt grad potensiell pyrogen eller mikrobiell
kontaminasjon som kan føre til infeksjonskomplikasjoner. Rengjøring, reprosessering og/eller
resterilisering av den aktuelle medisinske enheten øker sannsynligheten for at enheten vil svikte
på grunn av potensielle ugunstige virkninger på komponentene som påvirkes av termiske og/eller
mekaniske endringer.
MERK: Etter bruk kan disse produktene utgjøre en mulig biologisk fare. Håndteres og kasseres i henhold
til godkjent medisinsk praksis og gjeldende lover og regler.
34
F. Forsiktighetsregler:
1.
G. Potensielle komplikasjoner:
0XOLJHNRPSOLNDVMRQHUHURPUnGHVSHVL¿NNHRJNDQEHVWnDYKHPDWRPKHPRUDJLLQIHNVMRQVNDGHSnWLOVW¡WHQGHYHY
smerte, blødning, hemoptyse, hemotoraks, vev som ikke er målvev, organ- eller karperforering og pneumotoraks.
H. Nødvendig utstyr:
‡
‡
‡
‡
Relevant bildemodalitet
2SHUDVMRQVKDQVNHURJODNHQ
Lokalanestesi
$QQHWXWVW\UHWWHUEHKRY
I.
Bruksanvisning:
1.
Inspiser pakningen og produktet for skade og utløpsdato. Dersom det er uskadet og datoen ikke er utløpt,
VNDOSDNQLQJHQnSQHVRJSURGXNWHWRYHUI¡UHVWLOGHWVWHULOHIHOWHWYHGKMHOSDYDVHSWLVNWHNQLNN
2. Ta tråden fra introducernålen og bekreft at produktet ikke ble skadet under forsendelsen ¿JXU.
MERK: Lokaliseringstråden er pakket i nålen slik at mothaken vender ut av nålemuffen for å forhindre skade
SnPRWKDNHQ3nSODVVHULQJVWLGVSXQNWHWPnORNDOLVHULQJVWUnGHQVQXVUXQGWVOLNDWPRWKDNHQJOLUJMHQQRP
nålemuffen først.
Figur 2
/RNDOLVHUOHVMRQHQYHGKMHOSDYUHOHYDQWELOGHWHNQLNN
6HWWORNDOLVHULQJVQnOHQLQQLEU\VWHWRJUHWWGHQPRWOHVMRQHQIRUWULQQVYLVSDUDOOHOWWLOEU\VWYHJJHQIRU
nUHGXVHUHPXOLJULVLNRIRUSQHXPRWRUDNV%UXNG\EGHUHIHUDQVHPHUNHQHWLOnSRVLVMRQHUHQnOHVSLVVHQ
LEU\VWOHVMRQHQGHWHUFPPHOORPURPPHOORPUHIHUDQVHPHUNHQH¿JXU.
Figur 3
5.
7.
Bekreft nåleplassering med relevant bildeteknikk.
2PQ¡GYHQGLJUHSRVLVMRQHUQnOHQRJEHNUHIWSODVVHULQJSnQ\WW
Lokaliseringstråden kan deretter settes inn i introducernålen ved å skyve tråden inn i nålemuffen, og føre
tråden inn til begynnelsen av den palpable utfoldingsdelen på tråden er ved nålemuffens proksimalende.
)RUnVLNUHDWPRWKDNHQIROGHVXWLULNWLJUHWQLQJVNDOPRWKDNHQVWLOOHVSnOLQMHPHGRULHQWHULQJVPHUNHQH
på muffen når tråden føres inn i nålen ¿JXU.
Figur 4
8.
Mothaken foldes ut ved å holde lokaliseringstråden på plass og trekke nålen tilbake ca. 1,5 cm ¿JXU.
Merk: Mothaken folder seg ut når den palpable plasseringsmarkøren på tråden er helt inni nålemuffen.
(YHQWXHOOHIRUV¡NSnRJUHSRVLVMRQHUHWUnGHQHWWHUDWPRWKDNHQKDUIROGHWVHJXWNDQVNDGH¡GHOHJJHWUnGHQ
Figur 5
1nOHQNDQQnIMHUQHVRJGHWNDQWDVU¡QWJHQRJHOOHUXOWUDO\GIRUnEHNUHIWHSODVVHULQJHQDYPRWKDNHQMerk:
0DUN¡UHQHSnWUnGHQJLUHQYLVXHOORJSDOSDEHOUHIHUDQVHWLOVWHGHWGHUPRWKDNHQRJOHVMRQHQEH¿QQHUVHJ
5HVWHQDYGHQHNVSRQHUWHWUnGHQVNDOIHVWHVWLOKXGRYHUÀDWHQSnHQKHQVLNWVPHVVLJPnWHIRUnIRUKLQGUHDW
den beveger seg under transport til kirurgi ¿JXU7UnGNOHPPHQNDQSODVVHUHVSnWUnGHQYHGKXGRYHUÀDWHQ
IRUnELGUDWLOnXQQJnPLJUDVMRQDYWUnGHQ%UXNWLOVWUHNNHOLJWU\NNIRUnSODVVHUHWUnGNOHPPHQSnWUnGHQ
¿JXU.
Figur 6
Figur 7
)¡URSHUDVMRQHQNDQBARD® avstivningskanyle med butt spiss føres over GHIATAS® brystlokaliseringstrådfor
nJLHQSDOSDEHOLQGLNDVMRQSnNXUVHQSnWUnGHQRJKYRUWUnGVSLVVHQEH¿QQHUVHJ
35
NORSK
Denne anordningen skal bare brukes av leger som er opplært i indisert bruk, begrensninger, og mulige
NRPSOLNDVMRQHUYHGSHUNXWDQHQnOHWHNQLNNHU
,QWURGXNVMRQHQDYDQRUGQLQJHQLQQLNURSSHQPnXWI¡UHVPHGELOGHNRQWUROO
)¡UEUXNPnDQRUGQLQJHQLQVSLVHUHVIRUVNDGHVRPIRUKLQGUHUULNWLJIXQNVMRQ'HUVRPNRPSRQHQWHQH
HUVNDGGHHOOHUE¡\GH0c$125'1,1*(1,..(%58.(6
NORSK
$QRUGQLQJHQHU05EHWLQJHW
Følgende kodenummer kan plasseres og avbildes under MR:
470201
475201
477201
479201
Ikke-klinisk testing har demonstrert at MR GHIATAS® lokaliseringstråd er MR-betinget. Den kan skannes sikkert
under følgende forhold:
‡ Statisk magnetfelt på 3 Tesla eller mindre
‡ 5RPOLJJUDGLHQWIHOWSnJDXVVFPHOOHUPLQGUH
Ved ikke-klinisk testing produserte produktnumrene for MR GHIATAS® lokaliseringstråd en temperaturøkning på
PLQGUHHQQž&YHGHQ05V\VWHPUDSSRUWHUWKHONURSSVJMHQQRPVQLWWOLJDEVRUSVMRQVUDWH6$5Sn:
NJYHGPLQXWWHUV05VNDQQLQJLHW7HVOD6LJQD05V\VWHP([FLWHSODWWIRUP*%SURJUDPYDUH
*(+HDOWKFDUH0LOZDXNHH:,
MR-bildekvalitet kan kompromitteres hvis interesseområdet er i nøyaktig samme område eller relativt nær
SRVLVMRQHQWLO05GHIATAS® lokaliseringstråd. Det kan derfor bli nødvendig å optimere MR-bildeparametrene
for tilstedeværelsen av dette metallimplantatet.
Garanti
%DUG3HULSKHUDO9DVFXODUJDUDQWHUHURYHUIRUI¡UVWHNM¡SHUDYGHWWHSURGXNWHWDWSURGXNWHWHUIULWWIRUGHIHNWHU
LPDWHULDOHURJXWI¡UHOVHLHQSHULRGHSnHWWnUIUDI¡UVWHNM¡SVGDWRRJDQVYDUHWLKHQKROGWLOGHQQHEHJUHQVHWH
SURGXNWJDUDQWLHQHUEHJUHQVHWWLOUHSDUDVMRQHOOHUXWVNLIWQLQJDYGHWGHIHNWHSURGXNWHWHWWHU%DUG3HULSKHUDO
9DVFXODUVVNM¡QQHOOHUUHIXVMRQDYEHWDOWQHWWRSULV6OLWDVMHYHGQRUPDOEUXNHOOHUGHIHNWHUVRPVN\OGHVIHLOEUXN
av produktet dekkes ikke av denne begrensede garantien.
,'(1*5$'5(/(9$17(/29(57,//$7(5'(77((567$77(5'(11(%(*5(16('(
352'8.7*$5$17,(1$//($1'5(*$5$17,(5(17(1875<..(/,*((//(5,11)2567c77(
'(5,%/$170(1,..(%(*5(16(77,/(1+9(5,11)2576c77*$5$17,)25206(77(/,*+(7
(//(5(*1(7+(77,/(763(6,(/7)250c/81'(5,1*(12067(1',*+(7(56.$/%$5'
3(5,3+(5$/9$6&8/$595($169$5/,*29(5)25'(*)25(9(178(//(,1',5(.7(
7,/)(/',*(6.$'(5(//(5)‘/*(6.$'(5620(5)25c56$.(7$9',1(*(1+c1'7(5,1*
(//(5%58.$9'(77(352'8.7(7
(QNHOWHGHOVWDWHUODQGWLOODWHULNNHHQXWHODWHOVHDYLPSOLVHUWHJDUDQWLHUWLOIHOGLJHHOOHUI¡OJHVNDGHU'XNDQY UH
EHUHWWLJHWWLO\WWHUOLJHUHHUVWDWQLQJLI¡OJHORYHQHLGHOVWDWHQODQGHWGLWW
(QXWJLYHOVHVHOOHUUHYLVMRQVGDWRVDPWHWUHYLVMRQVQXPPHUIRUGLVVHDQYLVQLQJHQHHULQNOXGHUWIRUEUXNHUHQV
LQIRUPDVMRQSnVLVWHVLGHLGHWWHKHIWHW+YLVGHWKDUJnWWPnQHGHUIUDGHQQHGDWRHQRJWLOSURGXNWHWEUXNHV
E¡UEUXNHUHQNRQWDNWH%DUG3HULSKHUDO9DVFXODUIRUn¿QQHXWRPQ\HUHSURGXNWLQIRUPDVMRQHUWLOJMHQJHOLJ
Montert i Mexico.
36
,QVWUXNFMDXĪ\FLD
Drut GHIATAS®]NRUDOLNDPLGRORNDOL]DFML]PLDQZSLHUVL]F]ĊĞFLąXV]W\ZQLRQą
3URGXNW\R]QDF]RQHNRGHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
Drut GHIATAS®]NRUDOLNDPLGRORNDOL]DFML]PLDQZSLHUVLGRVWRVRZDQLDSRGNRQWUROąUH]RQDQVXPDJQHW\F]QHJR
(MR)
MR
3URGXNW\R]QDF]RQHNRGHP
LJáD*[FP]GUXWHPFP]KDF]\NDPL
LJáD*[FP]GUXWHPFP]KDF]\NLHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
3URGXNW\RNRGDFKLQLHPDMąZ]PRFQLHQLDGODREUD]X86*3RQDGWR
SURGXNW\RNRGDFKLPRJąE\üXPLHV]F]DQHSRGNRQWUROą05,
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1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
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Oznaczenia ustawienia
+DF]\N
Koraliki oznaczenia
'UXWGRORNDOL]DFML
Wyczuwalny koralik
A. Informacje ogólne i opis wyrobu:
Drut GHIATAS®]NRUDOLNDPLGRORNDOL]DFML]PLDQZSLHUVLVNáDGDVLĊ]LJá\ZSURZDG]DMąFHMLSyáV]W\ZQHJRGUXWX
,JáDZSURZDG]DMąFDPDXIRUPRZDQ\SODVWLNRZ\NLHOLFKLR]QDF]HQLDJáĊERNRĞFLZRGVWĊSDFKFPRUD]Z]PRFQLHQLH
GODREUD]X86*QDG\VWDOQHMNRĔFyZFHXáDWZLDMąFHXPLHV]F]HQLHLJá\3yáV]W\ZQ\GUXWGRORNDOL]DFMLPDQD
]DNRĔF]HQLXG\VWDOQ\PR]QDF]HQLDZIRUPLHNRUDOLNyZZRGVWĊSDFKFRFPLZ\F]XZDOQ\NRUDOLNR]QDF]DMąF\
SXQNWZNWyU\P]RVWDQLHXPLHV]F]RQ\KDF]\NQD]DNRĔF]HQLXG\VWDOQ\P3URGXNW\R]QDF]RQHNRGDPL
LPDMąGáXĪV]HNRUDOLNLQDG\VWDOQ\P]DNRĔF]HQLXGUXWXSRZRGXMąFHXV]W\ZQLHQLHGUXWX
B. Opakowanie:
Drut GHIATAS®]NRUDOLNDPLGRORNDOL]DFML]PLDQZSLHUVLMHVWGRVWDUF]DQ\ZVWDQLHMDáRZ\PLDSLURJHQQ\P
MHĞOLRSDNRZDQLHQLH]RVWDáRRWZDUWHDQLXV]NRG]RQH3URGXNWVWHU\OL]RZDQ\WOHQNLHPHW\OHQX:\áąF]QLH
GRMHGQRUD]RZHJRVWRVRZDQLD1LHXĪ\ZDüSRQRZQLH1LHVWHU\OL]RZDüSRQRZQLH
C. Wskazania do stosowania:
3URGXNWMHVWSU]H]QDF]RQ\GRVWRVRZDQLDSRGF]DVRSHUDFML]PLDQSLHUVLMDNRSRPRFGODFKLUXUJDZVND]XMąFD
PLHMVFHGRZ\FLĊFLD]PLDQ\
D. Przeciwwskazania do stosowania:
1LHVą]QDQH
( 2VWU]HĪHQLD
7.
3RXPLHV]F]HQLXKDF]\NDZSLHUVLGUXWPRĪQDXVXQąüZ\áąF]QLHFKLUXUJLF]QLH1LHZROQRXVLáRZDü
]PLHQLDüSR]\FMLSU]HVXZDüDQLSRFLąJDüGUXWXSRQLHZDĪPRĪHWRVSRZRGRZDüXV]NRG]HQLH]áDPDQLH
'UXWMHVWSU]H]QDF]RQ\Z\áąF]QLHGRR]QDF]HQLDPLHMVFD1,(8ĩ<:$ûGUXWXGRZFLąJDQLD
1DOHĪ\]DFKRZDüRVWURĪQRĞüSRGF]DV]DELHJXZ\FLQDQLD]PLDQ\DE\XQLNQąüSU]HFLĊFLDGUXWX
skalpelem.
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XVLáRZDüSRFLąJDüZVWHF]GRLJá\OXEZHZQąWU]LJá\SRQLHZDĪPRĪHWRVSRZRGRZDüXV]NRG]HQLH
haczyka.
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KDF]\ND-HĞOLKDF]\NGUXWX]RVWDQLH]GHIRUPRZDQ\OXEQLHSUDZLGáRZR]JLĊW\SURGXNWQDOHĪ\
Z\U]XFLü
1DOHĪ\]DFKRZDüRVWURĪQRĞüSRGF]DVXĪ\ZDQLDGUXWXGRR]QDF]DQLDORNDOL]DFML]PLDQXSDFMHQWHN
]SURWH]DPLSLHUVLDE\LFKQLHSU]HNáXüSRGF]DVSURFHGXU\XPLHV]F]DQLDOXEWUDQVSRUWXSDFMHQWNL
Drut z koralikami do lokalizacji zmian w piersi GHIATAS®MHVWZ\áąF]QLHMHGQRUD]RZHJRXĪ\WNX
3RQRZQHXĪ\FLHQLQLHMV]HJRZ\UREXPRĪHVSRZRGRZDüU\]\NRVNDĪHQLDNU]\ĪRZHJRLQQHJRSDFMHQWD
SRQLHZDĪZ\URE\PHG\F]QH±ZV]F]HJyOQRĞFLZ\URE\]GáXJLPLLZąVNLPLNDQDáDPLSRáąF]HQLDPL
LOXEV]F]HOLQDPLSRPLĊG]\HOHPHQWDPL±VąWUXGQHOXEQLHPRĪOLZHGRRF]\V]F]HQLDMHĞOLGRV]áRGR
NRQWDNWXZ\UREXPHG\F]QHJR]Sá\QDPLXVWURMRZ\PLOXEWNDQNDPLSRWHQFMDOQLHVNDĪRQ\PLSLURJHQDPL
OXEPLNURELRORJLF]QLHSU]H]QLHRNUHĞORQ\RNUHVF]DVX3R]RVWDáRĞFLPDWHULDáXELRORJLF]QHJRPRJą
VSU]\MDüVNDĪHQLXZ\UREXSLURJHQDPLOXEGUREQRXVWURMDPLNWyUHPRJąSRZRGRZDüSRZLNáDQLD
]DNDĪHQLD
37
POLSKI
Drut GHIATAS®]NRUDOLNDPLGRORNDOL]DFML]PLDQZSLHUVL
3URGXNW\R]QDF]RQHNRGHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
LJáD*[FP]GUXWHPFP]KDF]\NLHP
1LHZROQRSRZWyUQLHVWHU\OL]RZDüGUXWX]NRUDOLNDPLGRORNDOL]DFML]PLDQZSLHUVLGHIATAS®. Po ponownej
VWHU\OL]DFMLQLHPRĪQD]DJZDUDQWRZDüVWHU\OQRĞFLSURGXNWXZ]ZLą]NX]QLHRNUHĞORQ\PVWRSQLHPVNDĪHQLD
SLURJHQDPLOXEGUREQRXVWURMDPLNWyUHPRJąSRZRGRZDüSRZLNáDQLD]DNDĪHQLD&]\V]F]HQLHSRQRZQH
SU]\JRWRZDQLHLOXESRQRZQDVWHU\OL]DFMDREHFQHJRZ\UREXPHG\F]QHJR]ZLĊNV]DSUDZGRSRGRELHĔVWZR
XVWHUHNZ\UREXZ]ZLą]NX]SRWHQFMDOQ\PQLHSRĪąGDQ\PG]LDáDQLHPZ\VRNLFKWHPSHUDWXULOXE]PLDQ
PHFKDQLF]Q\FKQDHOHPHQW\VNáDGRZHZ\UREX
UWAGA: 3RXĪ\FLXQLQLHMV]HSURGXNW\PRJąVWDQRZLüSRWHQFMDOQH]DJURĪHQLHELRORJLF]QH1DOHĪ\VLĊ]QLP
REFKRG]LüLXVXZDü]JRGQLH]SU]\MĊWąSUDNW\NąPHG\F]QąRUD]RERZLą]XMąF\PLORNDOQ\PLNUDMRZ\PL
i federalnymi przepisami i procedurami.
POLSKI
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:SURZDG]HQLHSURGXNWXGRFLDáDSDFMHQWNLSRZLQQRRGE\ZDüVLĊSRGNRQWUROąREUD]X
3U]HGXĪ\FLHPQDOHĪ\REHMU]HüSURGXNWSRGNąWHPXV]NRG]HĔNWyUHXQLHPRĪOLZLá\E\SUDZLGáRZH
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VąVLHGQLFKWNDQHNEyONUZDZLHQLHNUZLRSOXFLHNUZLDNRSáXFQHM]PLDQ\ZREUĊELHLQQHMWNDQNLSHUIRUDFMĊQDF]\Ĕ
NUZLRQRĞQ\FKOXEQDU]ąGyZRUD]RGPĊRSáXFQRZą
+ :\PDJDQHZ\SRVDĪHQLH
‡
‡
‡
‡
2GSRZLHGQLVSU]ĊWGRREUD]RZDQLD
5ĊNDZLF]NLLREáRĪHQLDFKLUXUJLF]QH
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,QQHZ\SRVDĪHQLHZUD]LHNRQLHF]QRĞFL
, 6SRVyEXĪ\FLD
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SU]HWHUPLQRZDQ\RWZRU]\üRSDNRZDQLHLSU]HQLHĞüSURGXNWQDSROHMDáRZHVWRVXMąFPHWRGĊDVHSW\F]Qą
:\MąüGUXW]LJá\ZSURZDG]DMąFHMLVSUDZG]LüF]\SURGXNWQLH]RVWDáXV]NRG]RQ\SRGF]DVWUDQVSRUWX(Rys. 2.).
UWAGA: 'UXWGRORNDOL]DFMLMHVWXPLHV]F]RQ\ZLJOH]KDF]\NLHPVNLHURZDQ\PQD]HZQąWU]NLHOLFKDLJá\ZFHOX
XQLNQLĊFLDXV]NRG]HQLDKDF]\ND3RGF]DVXPLHV]F]DQLDGUXWGRORNDOL]DFMLQDOHĪ\REUyFLüWDNDE\KDF]\NZVXZDá
VLĊMDNRSLHUZV]\SU]H]NLHOLFKLJá\
Rys. 2
=ORNDOL]RZDü]PLDQĊFKRURERZą]DSRPRFąRGSRZLHGQLHMPHWRG\REUD]RZDQLD
:SURZDG]LüLJáĊGRSLHUVLNLHUXMąFMąZNLHUXQNX]PLDQ\SUHIHURZDQHMHVWZSURZDG]DQLHUyZQROHJOHGR
ĞFLDQ\NODWNLSLHUVLRZHMZFHOX]PQLHMV]HQLDHZHQWXDOQHJRU\]\NDRGP\RSáXFQRZHM:\NRU]\VWDüR]QDF]HQLH
JáĊERNRĞFLZFHOXXPLHV]F]HQLD]DNRĔF]HQLDLJá\Z]PLDQLHSLHUVLR]QDF]HQLDJáĊERNRĞFL]QDMGXMąVLĊ
ZRGVWĊSDFKFP(rys. 3).
Rys. 3
3RWZLHUG]LüSUDZLGáRZHXPLHV]F]HQLHLJá\]DSRPRFąRGSRZLHGQLHMPHWRG\REUD]RZDQLD
-HĞOLWRNRQLHF]QH]PLHQLüSR]\FMĊLJá\LSRQRZQLHSRWZLHUG]LüXPLHV]F]HQLH
1DVWĊSQLHGUXWGRORNDOL]DFMLPRĪHE\üZSURZDG]RQ\GRLJá\ZSURZDG]DMąFHMSU]H]ZVXQLĊFLHJRGRNLHOLFKD
LJá\LSU]HVXZDQLHDĪSRF]ąWHNZ\F]XZDOQHJRNRUDOLNDQDGUXFLH]QDMG]LHVLĊZSURNV\PDOQ\P]DNRĔF]HQLX
NLHOLFKDLJá\$E\XSHZQLüVLĊĪHKDF]\NUR]áRĪ\VLĊZRGSRZLHGQLPNLHUXQNXQDOHĪ\JRXVWDZLü]JRGQLH
]R]QDF]HQLDPLNLHUXQNXQDNLHOLFKXSRGF]DVZSURZDG]DQLDGUXWXGRLJá\ (rys. 4).
Rys. 4
:FHOXUR]áRĪHQLDKDF]\NDGUXWGRORNDOL]DFMLQDOHĪ\SU]\WU]\PDüZPLHMVFXLZ\FRIDüLJáĊRRNRáRFP
(rys. 5). Uwaga:+DF]\NUR]áRĪ\VLĊJG\Z\F]XZDOQ\NRUDOLNUR]PLHV]F]HQLDQDGUXFLH]QDMG]LHVLĊFDáNRZLFLH
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Rys. 5
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Uwaga:.RUDOLNLQDGUXFLH]DSHZQLDMąZ]URNRZHLGRW\NRZHZVND]DQLHPLHMVFDKDF]\NDL]PLDQ\
38
Rys. 6
Rys. 7
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Z]JOĊGQLHEOLVNRPLHMVFDZNWyU\P]QDMGXMHVLĊGUXWGHIATAS®GRORNDOL]DFMLGRVWRVRZDQLDSRGNRQWUROąUH]RQDQVX
PDJQHW\F]QHJR05:]ZLą]NX]REHFQRĞFLąPHWDORZHJRLPSODQWXPRĪHE\üNRQLHF]QDRSW\PDOL]DFMD
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Gwarancja
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ZDGPDWHULDáRZ\FKLZDGZ\NRQDZVWZDSU]H]RNUHVMHGQHJRURNXRGGDW\SLHUZV]HJR]DNXSXD]RERZLą]DQLD
Z\QLNDMąFH]W\WXáXWHMRJUDQLF]RQHMJZDUDQFMLSURGXNWXEĊGąRJUDQLF]RQHGRQDSUDZ\OXEZ\PLDQ\ZHGáXJ
Z\áąF]QHJRX]QDQLD¿UP\%DUG3HULSKHUDO9DVFXODUOXE]ZURWX]DSáDFRQHMFHQ\QHWWR=XĪ\FLHVSRZRGRZDQH
XĪ\FLHP]JRGQ\P]SU]H]QDF]HQLHPOXEZDG\Z\QLNDMąFH]QLHZáDĞFLZHJRXĪ\FLDWHJRSURGXNWXQLHSRGOHJDMą
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:=$.5(6,('2386=&=$/1<02%2:,Ą=8-Ą&<035$:(01,1,(-6=$2*5$1,&=21$*:$5$1&-$
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VWURQLHQLQLHMV]HMXORWNL:SU]\SDGNXJG\XSá\QĊáRPLHVLĊF\SRPLĊG]\QLQLHMV]ąGDWąLGDWąXĪ\FLDSURGXNWX
XĪ\WNRZQLNSRZLQLHQVNRQWDNWRZDüVLĊ]¿UPą%DUG3HULSKHUDO9DVFXODUDE\X]\VNDüLQIRUPDFMĊF]\GRVWĊSQH
VąGRGDWNRZHLQIRUPDFMH
Produkt montowany w Meksyku.
39
POLSKI
3R]RVWDáąRGVáRQLĊWąF]ĊĞüGUXWXQDOHĪ\SU]\PRFRZDüGRSRZLHU]FKQLVNyU\]DSRPRFąRGSRZLHGQLHM
PHWRG\DE\]DSRELHFSU]HVXQLĊFLXGUXWXSRGF]DVWUDQVSRUWXSDFMHQWNLGRVDOLRSHUDF\MQHM(rys. 6). Na drucie
QDSRZLHU]FKQLVNyU\PRĪQDXPLHĞFLü]DFLVNGUXWXDE\EDUG]LHMXQLHUXFKRPLüGUXW=DVWRVRZDüRGSRZLHGQL
QDFLVNDE\XPLHĞFLü]DFLVNGUXWXQDGUXFLH(rys. 7).
0$*<$5
Használati utasítás
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7HUPpNNyGRN
J[FPHVWĦWVNpYHOHOOiWRWWFPHVGUyWWDO
J[FPHVWĦWVNpYHOHOOiWRWWFPHVGUyWWDO
J[FPHVWĦWVNpYHOHOOiWRWWFPHVGUyWWDO
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J[FPHVWĦWVNpYHOHOOiWRWWFPHVGUyWWDO
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J[FPHVWĦWVNpYHOHOOiWRWWFPHVGUyWWDO
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7HUPpNNyGRN
J[FPHVWĦWVNpYHOHOOiWRWWFPHVGUyWWDO
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J[FPHVWĦWVNpYHOHOOiWRWWFPHVGUyWWDO
MR GHIATAS®NLGRPERURGyMHO]pVHNNHOHOOiWRWWHPOĘV]|YHWORNDOL]iOyGUyWMR
7HUPpNNyGRN
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J[FPHVWĦWVNpYHOHOOiWRWWFPHVGUyWWDO
$pVNyG~WHUPpNHNQHPUHQGHONH]QHNXOWUDKDQJRVMHO]pVVHO7RYiEEiD
pVNyG~WHUPpNHN05,LUiQ\tWiVDODWWLVEHOWHWKHWĘN
1. ábra
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
%HYH]HWĘWĦ
8OWUDKDQJRVMHO]pV
FPHVPpO\VpJMHO]ĘMHO]pVHN
2ULHQWiFLyVMHO]pVHN
Tüske
.LGRPERURGyMHO]pVHN
/RNDOL]iOyGUyW
7DSLQWKDWyEHOWHWpVWMHO]ĘNLGRPERURGiV
$ ÈOWDOiQRVLQIRUPiFLypVD]HV]N|]OHtUiVD
$GHIATAS®NLGRPERURGyMHO]pVHNNHOHOOiWRWWHPOĘV]|YHWORNDOL]iOyGUyWHJ\EHYH]HWĘWĦEĘOpVHJ\IpOPHUHY
WVNpYHOHOOiWRWWORNDOL]iOyGUyWEyOiOO$EHYH]HWĘWĦHJ\IRUPi]RWWPĦDQ\DJQ\tOiVVDOFPWpUN|]ĦPpO\VpJMHO]Ę
MHOHNNHOpVDWĦEHKHO\H]pVpQHNPHJN|QQ\tWpVpUHDGLV]WiOLVYpJHQHJ\XOWUDKDQJJDONLPXWDWKDWyMHO]pVVHOYDQ
HOOiWYD$IpOPHUHYORNDOL]iOyGUyWGLV]WiOLVYpJpQFPHVNLGRPERURGyMHO]pVHNWDOiOKDWyNWRYiEEiWDOiOKDWyUDMWD
HJ\EHOWHWpVWMHO]ĘWDSLQWKDWyNLGRPERURGiVD]RQSRQWMHO]pVpUHDKRODGUyWGLV]WiOLVYpJpQOHYĘWVNHEHOWHWpVUH
NHUO$pVNyG~WHUPpNHNDGUyWGLV]WiOLVYpJpQKRVV]DEENLGRPERURGiVRNNDOYDQQDNHOOiWYD
DPHO\HNPHUHYHEEpWHV]LNDGUyWRW
B. A csomagolás módja:
$GHIATAS®NLGRPERURGyMHO]pVHNNHOHOOiWRWWHPOĘV]|YHWORNDOL]iOyGUyWVWHULOHQpVSLURJpQPHQWHVHQNHUO
V]iOOtWiVUDNLYpYHKDDFVRPDJROiVVpUOWYDJ\IHOOHWWQ\LWYD(WLOpQR[LGGDOVWHULOL]iOYDKizárólag egyszeri
KDV]QiODWUDÒMEyOLIHOKDV]QiOiVDWLORVÒMUDVWHULOL]iOiVDWLORV
C. Felhasználási javallatok:
(]D]HV]N|]HPOĘHOYiOWR]iVRNPLDWWLPĦWpWLEHDYDWNR]iVRNVRUiQDVHEpV]iOWDOD]HOYiOWR]iVNLPHWV]pVHNRU
N|YHWHQGĘYH]HWĘGUyWNpQWDONDOPD]DQGy
D. Ellenjavallatok:
Nem ismertek.
E. Figyelmeztetések:
5.
7.
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iWKHO\H]pVpWPR]JDWiViWYDJ\K~]iViWPHUWH]NiURVRGiVWW|UpVWRNR]KDW
$GUyWNL]iUyODJYH]HWĘGUyWNpQWKDV]QiOKDWy1(KDV]QiOMDUHWUDNWRUNpQW
$]HOYiOWR]iVVHEpV]HWLNLPHWV]pVHNRUN|UOWHNLQWĘHQNHOOHOMiUQLDGUyWV]LNpYHOW|UWpQĘiWYiJiViQDN
elkerülésére.
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PHJDGUyWRWYLVV]DK~]QLDWĦEHYDJ\YLVV]DIHOpK~]QLDQQDNEHOVHMpEHQPHUWH]DWVNpNNiURVRGiViW
okozhatja.
A drót tüskéjének alakját semmilyen módon ne kísérelje meg átalakítani; ez a tüske törését okozhatja.
+DDGUyWWVNpMHGHIRUPiOyGRWWYDJ\QHPPHJIHOHOĘPyGRQPHJKDMORWWVHPPLVtWVHPHJD]HV]N|]W
%iUPLO\HQORNDOL]iOyGUyWPHOOSURWp]LVHVEHWHJHNHQW|UWpQĘDONDOPD]iVDNRUN|UOWHNLQWĘHQNHOOHOMiUQL
DPHOOSURWp]LVQHNDGUyWEHKHO\H]pVHYDJ\EHYH]HWpVHVRUiQW|UWpQĘPHJV]~UiViQDNHONHUOpVpUH
A GHIATAS®NLGRPERURGyMHO]pVHNNHOHOOiWRWWHPOĘV]|YHWORNDOL]iOyGUyWRWFVDNHJ\V]HULKDV]QiODWUD
WHUYH]WpN(]HQRUYRVLHV]N|]~MUDIHOKDV]QiOiVDDEHWHJHNN|]WLV]HQQ\H]ĘGpVNRFNi]DWiYDOMiUPLYHO
D]RUYRVLHV]N|]|N±NO|Q|VHQDKRVV]~pVNLVPpUHWĦOXPHQQHOFVDWODNR]yNNDOpVYDJ\D]DONDWUpV]HN
N|]|WWLUpVHNNHOUHQGHONH]ĘN±PHJWLV]WtWiVDQHKp]YDJ\OHKHWHWOHQD]WN|YHWĘHQKRJ\D]RUYRVL
eszköz meghatározatlan ideig érintkezett potenciálisan pirogénekkel vagy mikróbákkal szennyezett
WHVWQHGYHNNHOYDJ\V]|YHWHNNHO$ELROyJLDLDQ\DJPDUDGYiQ\HOĘVHJtWKHWLD]HV]N|]V]HQQ\H]ĘGpVpW
SLURJpQHNNHOYDJ\PLNURRUJDQL]PXVRNNDODPLIHUWĘ]pVHVV]|YĘGPpQ\HNKH]YH]HWKHW
40
1HVWHULOL]iOMD~MUDDGHIATAS®NLGRPERURGyMHO]pVHNNHOHOOiWRWWHPOĘV]|YHWORNDOL]iOyGUyWRW
ÒMUDVWHULOL]iOiVXWiQDWHUPpNVWHULOLWiVDQHPJDUDQWiOWDPHJKDWiUR]KDWDWODQIRN~OHKHWVpJHVSLURJpQ
YDJ\PLNURELiOLVV]HQQ\H]ĘGpVPLDWWDPLIHUWĘ]pVHVV]|YĘGPpQ\HNKH]YH]HWKHW(]HQRUYRVLHV]N|]
WLV]WtWiVD~MUDIHOGROJR]iVDpVYDJ\~MUDVWHULOL]iOiVDQ|YHOLD]HV]N|]QHPPHJIHOHOĘPĦN|GpVpQHN
YDOyV]tQĦVpJpWDKĘpVYDJ\PHFKDQLNDLYiOWR]iVRNiOWDOEHIRO\iVROWDONDWUpV]HNHWpUWOHKHWVpJHV
nemkívánatos hatások miatt.
0(*-(*<=e6Használat után a termékek potenciális biológiai veszélyt jelenthetnek. Kezelését és
megsemmisítését az elfogadott orvosi gyakorlatnak, valamint a vonatkozó helyi, állami és szövetségi
MRJV]DEiO\RNQDNpVUHQGHONH]pVHNQHNPHJIHOHOĘHQYpJH]]H.
(]WD]HV]N|]WNL]iUyODJD]HV]N|]MDYDOORWWIHOKDV]QiOiVEDQpVNRUOiWR]iVDLEDQYDODPLQWDWĦYHOYpJ]HWW
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+DV]QiODWHOĘWWHOOHQĘUL]]HD]HV]N|]WpVJ\Ę]ĘGM|QPHJDUUyOKRJ\QHPV]HQYHGHWWRO\DQNiURVRGiVWDPHO\
PHJDNDGiO\R]KDWMDPHJIHOHOĘPĦN|GpVpW1(+$6=1È/-$)(/KDD]DONDWUpV]HNVpUOWHNYDJ\J|UEOWHN
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QHPFpO]RWWV]|YHWLV]HUYLYDJ\pUSHUIRUiFLypVSQHXPRWKRUD[
H. Szükséges felszerelés:
‡
‡
‡
‡
0HJIHOHOĘNpSDONRWyPyGV]HU
6HEpV]HWLNHV]W\ĦpVPĦWpWLL]ROiOyN
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Szükség esetén egyéb felszerelés
I.
Használati utasítás:
(OOHQĘUL]]HDFVRPDJROiVWpVDWHUPpNHWpVJ\Ę]ĘGM|QPHJDUUyOKRJ\QHPVpUOWHNHOOHQĘUL]]HDOHMiUDWL
GiWXPRW+DQLQFVVpUOpVpVDWHUPpNDOHMiUDWLLGĘQEHOOYDQQ\LVVDIHODFVRPDJROiVWpVDV]HSWLNXV
WHFKQLNiWDONDOPD]YDKHO\H]]HDWHUPpNHWDVWHULOWHUOHWUH
2. 7iYROtWVDHODGUyWRWDEHYH]HWĘWĦEĘOpVHOOHQĘUL]]HKRJ\D]HV]N|]QHPVpUOWHPHJDV]iOOtWiVVRUiQ
(2. ábra).
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DWVNHDWĦPĦDQ\DJQ\tOiViQNLIHOpQp]]HQ$EHOWHWpVNRUDORNDOL]iOyGUyWRWPHJNHOOIRUGtWDQL~J\KRJ\HOĘV]|U
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2. ábra
1.
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9H]HVVHDORNDOL]iOyWĦWD]HPOĘEHpVLUiQ\tWVDD]HOYiOWR]iVKR]OHKHWĘVpJV]HULQWDPHOONDVIDOiYDO
SiUKX]DPRVDQDSQHXPRWKRUD[HVHWOHJHVNRFNi]DWiQDNFV|NNHQWpVpUH$WĦKHJ\pQHND]HPOĘHOYiOWR]iVED
W|UWpQĘSR]LFLRQiOiViKR]KDV]QiOMDDPpO\VpJMHO]ĘMHOHNHWDPpO\VpJMHO]ĘMHOHNHJ\PiVWyOFPUHYDQQDN
elhelyezve) (3. ábra).
3. ábra
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pVDGUyWHOĘUHWROiViYDODGGLJDPtJDGUyWRQWDOiOKDWyEHOWHWpVWMHO]ĘWDSLQWKDWyNLGRPERURGiVHOHMHHOpULDWĦ
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5. ábra
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41
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7. ábra
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Ez az eszköz bizonyos feltételekkel MR kompatibilis:
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Obrázek 1
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
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1HSRNRXãHMWHVHåiGQêP]SĤVREHPPČQLWWYDURVWQXGUiWXSURWRåHE\PRKORGRMtWNH]ORPHQtRVWQX
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3ĜLSRXåLWtMDNpKRNROLYORNDOL]DþQtKRGUiWXXSDFLHQWĤVKUXGQtPLQiKUDGDPLMHWĜHEDSRVWXSRYDW
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komplikací.
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43
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pneumothorax.
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9\MPČWHGUiW]H]DYiGČFtMHKO\D]NRQWUROXMWH]GDQHE\OYêUREHNSĜLGRSUDYČSRãNR]HQ(obrázek 2).
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Obrázek 2
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=DYHćWHORNDOL]DþQtMHKOXGRKUXGQtNXWDNDE\VPČĜRYDODNOp]LSRNXGPRåQRURYQREČåQČVKUXGQtVWČQRX
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GRKUXGQtOp]HUHIHUHQþQtKORXENRYp]QDþN\MVRX]QDþHQ\YUR]HVWXSXSRFP(obrázek 3).
Obrázek 3
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9SĜtSDGČSRWĜHE\SĜHPtVWČWHMHKOXD]QRYXRYČĜWHMHMtXPtVWČQt
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WDNDE\VH]DþiWHNKPDWQp]DYiGČFtQiYOHþN\QDGUiWXGRVWDOQDSUR[LPiOQtNRQHFNyQXVXMHKO\$E\E\OR
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]QDþNDPLQDNyQXVX(obrázek 4).
Obrázek 4
3UR]DYHGHQtRVWQXMHWĜHEDSĜLGUåRYDWORNDOL]DþQtGUiWQDPtVWČDY\WiKQRXWMHKOXDVLRFP(obrázek
5). Poznámka:2VWHQVH]DYHGHDåEXGHKPDWQi]DYiGČFtQiYOHþNDQDGUiWX]FHODXYQLWĜNyQXVXMHKO\
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Obrázek 5
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SRK\EXGUiWXEČKHPSĜHSUDY\QDRSHUDFL(obrázek 6)3UR]DPH]HQtSRK\EXGUiWXMHPRåQpQDGUiW
XSRYUFKXSRNRåN\XPtVWLWVSRQX3URXPtVWČQtVSRQ\QDGUiWSRXåLMWHGRVWDWHþQêWODN(obrázek 7).
Obrázek 6
Obrázek 7
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44
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VRIWZDUH*%*(+HDOWKFDUH0LOZDXNHH:LVFRQVLQ
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]SĤVREHQpEČåQêPSRXåtYiQtPQHER]iYDG\]SĤVREHQpQHVSUiYQêPSRXåLWtPWRKRWRYêURENX
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48
使用說明
繁體中文
GHIATAS® 珠狀乳房定位導線
產品編碼:
47519
47919
47320
47520
47720
47920
47020*
帶 15cm 珠狀導線的 19g x 5cm 針具
帶 20cm 珠狀導線的 19g x 9cm 針具
帶 15cm 珠狀導線的 20g x 3cm 針具
帶 15cm 珠狀導線的 20g x 5cm 針具
帶 20cm 珠狀導線的 20g x 7cm 針具
帶 20cm 珠狀導線的 20g x 9cm 針具
帶 35cm 珠狀導線的 20g x 14cm 針具
GHIATAS® 帶加強部份的珠狀乳房定位導線
產品編碼:
49520
帶 15cm 珠狀導線的 20g x 5cm 針具
49720
帶 20cm 珠狀導線的 20g x 7cm 針具
49920
帶 20cm 珠狀導線的 20g x 9cm 針具
MR GHIATAS® 珠狀乳房定位導線 MR
產品編碼:
475201*
477201*
479201*
470201*
帶 15cm 珠狀導線的 20g x 5cm 針具
帶 20cm 珠狀導線的 20g x 7cm 針具
帶 20cm 珠狀導線的 20g x 9cm 針具
帶 35cm 珠狀導線的 20g x 14cm 針具
*產品編碼 47020、475201、477201、479201 和 470201 沒有超音波增強器。另外,產品編碼 475201、477201、
479201 和 470201 可在 MRI 導引下放置。
圖1
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
導引器針
超音波增強器
1cm 深度參考標記
方向標記
倒鈎
標記珠
定位導線
觸診植入珠
A. 一般資訊與裝置說明:
GHIATAS® 珠狀乳房定位導線包含導引器針和半剛性定位導線。導引器針由塑料模制轂部,1cm 深度參考標記,以及
位於遠端上協助放針的超音波增強器組成。半剛性定位導線在導線遠端上有 1cm 標記珠和表明位於導線遠端的倒鈎
的植入點的觸診植入珠。產品編碼 49520、49720 和 49920 在導線遠端有更長的珠子,其給導線增加了加強效果。
B. 供應方式:
除非包裝已受損或開封,否則 GHIATAS® 珠狀乳房定位導線皆以無菌和無熱原方式供應。使用環氧乙烷消毒。
僅供一次性使用。請勿重複使用。請勿重複消毒。
C. 使用指示:
這項裝置適用於在乳房病灶手術時作為外科醫師切除病灶的導引器使用。
D. 使用禁忌:
無已知使用禁忌。
E. 警告:
1.
2.
3.
4.
5.
6.
7.
8.
一旦倒鈎已被植入乳房內,就必須通過手術取出導線。請勿嘗試重新定位、移動或拉動導線,否則可能導致損
害 破裂。
導線僅是一種引導器。請勿將其作為牽開器使用。
在手術切除病灶期間請小心,以避免手術刀切斷導線。
僅可從轂部經由針具推進導線至針尖。請勿嘗試將導線向後拉入針中或針內向後拉動導線,否則可能導致倒鈎
受損。
請勿嘗試以任何方式對導線的倒鈎進行改造;這可能造成倒鈎折斷。如果導線的倒鈎出現不正確的變形或彎
曲,請丟棄產品。
對有乳房贗復體的病患使用任何定位導線時應保持謹慎,以便在放置或運送時不會刺穿它們。
GHIATAS® 珠狀乳房定位導線僅供一次性使用。重複使用本醫療裝置有病患交叉污染的風險,因為一旦有潛在熱
原或微生物污染之體液或組織與醫療裝置接觸的時間不確定,醫療裝置(尤其是部件之間有長型小內腔、接縫
和 或裂縫者)便很難或無法清理。生物材料殘留物可能助長熱原或微生物污染裝置,進而導致感染性的併發
症。
請勿重複消毒 GHIATAS® 珠狀乳房定位導線。重複消毒後,無法保證本產品的無菌狀態,因為潛在熱原或微生物
污染的程度不確定,可能導致感染性的併發症。清潔、再製和 或重複消毒目前的醫療裝置,會提高裝置故障
的可能性,因為部件受熱和 或機械變更影響,可能出現不良影響。
註:這類產品使用後可能成為生物危害。請遵照公認的醫療常規以及適用的當地、州與聯邦法律和規定處理與棄置。
49
繁體中文
F. 注意事項:
1.
2.
3.
針對指示用途、限制和經皮穿刺術可能併發症受過訓練的醫師,才能使用此裝置。
應在造影控制下將裝置導入體內。
使用前,請檢查裝置是否受到可能妨礙正常功能的損害。如果部件受損或彎曲,請勿使用。
G. 潛在併發症:
潛在併發症具有部位特異性,並可能包含血腫、出血、感染、鄰近組織受傷、疼痛、流血、咳血、血胸、非靶組織或
器官或血管穿孔,以及氣胸。
H.
‡
‡
‡
‡
I.
必須使用的器材:
適當的造影型態
手術手套和手術巾
局部麻醉劑
其他器材(視需要)
使用說明:
1. 檢查包裝和產品是否受損或過期。如果未受損並且未過期,請開啟包裝並利用無菌技術轉移產品至無菌場所。
2. 從導引器針具中取出導線並確認產品並未在運送時受損(圖 2)。
註:定位導線被包裝在針具中,倒鈎朝向針轂外側以防倒鈎受損。放置時,定位導線需要被轉向以便倒鈎首先滑動
穿過針轂。
圖2
3.
4.
使用適當的造影技術定位病灶。
將定位針插入乳房中,同時使其朝向病灶(最好平行於胸壁以降低氣胸的可能風險)。使用深度參考標記將針
尖放入乳房病灶中(深度參考標記間隔為 1cm)(圖 3)。
圖3
5.
6.
7.
使用適當的造影技術確認針的放置。
視需要,重新放針並重新確認。
然後可通過將導線滑入針轂,並推進導線直到導線上的觸診植入珠的開端位於針轂近端,將定位導線插入導引
器針中。若要確保倒鈎被植入正確的方向,將導線放入針具時使倒鈎與轂上的方向標記對直(圖 4)。
圖4
8.
若要植入倒鈎,應握住定位導線不動並將針抽出大約 1.5cm(圖 5)。註:當導線上的觸診植入珠完全位於針轂
內時,便可植入倒鈎。植入倒鈎後,為重新定位導線所作的任何嘗試皆可能導致導線受損 破裂。
圖5
此時針具可被移除,並可採用 X 光和或超音波的方式確認倒鈎的放置。註:導線上的珠子提供了倒鈎和病灶位
置的目視和觸診參考。
10. 應使用適當的方法將剩餘外露導線緊固至皮膚表面以防導線在運送至手術時發生移動(圖 6)。線夾可放在皮膚
表面的導線上協助避免導線遷移。使用足夠的壓力將線夾放在導線上(圖 7)。
9.
圖6
圖7
50
11. 手術前,可在 GHIATAS® 珠狀乳房定位導線上方對 BARD® 鈍尖端加強套管進行引導,以便協助提供導線路線和導線
尖端位置的觸診指示。
在非臨床測試中,將 MR GHIATAS® 定位導線產品編碼在 3 特斯拉的 Signa MR 系統(Excite platform;
*%VRIWZDUH,*(+HDOWKFDUH,Milwaukee,WI)中進行 15 分鐘的 MR 掃描,在 MR 系統報告全身平均比
吸收率(6$5)上限為 3 W kg 時,會產生小於 +0.9°C 的溫升。
如果感興趣區與 MR GHIATAS® 定位導線的位置在完全相同的區域中,或者與其較為接近,MR 影像質量可能會受
損。因此,可能需要針對此金屬植體的存在優化 MR 造影參數。
保固
Bard Peripheral Vascular 向本產品原始購買人保證,自原始購買日起一年,本產品沒有材質與工藝方面的瑕疵,而
且此有限產品保固中的責任,由 Bard Peripheral Vascular 自行酌定,限於維修或更換瑕疵產品,或是退還已付淨
價。正常使用造成的磨損或是不當使用本產品所致的瑕疵,不在本有限保固範圍之內。
在適用法律允許的範圍內,此有限產品保固已排除一切其他明示或暗示保固,包括但不限於可銷售或適用特定目的
任何暗示保固。針對處理或使用本產品引起之任何間接、附帶或衍生損害,BARD PERIPHERAL VASCULAR 均不
承擔任何責任。
某些地區
施。
國家不允許排除暗示保固、附帶或衍生損害。根據您所在地區
國家法律,您可能有權享有其他補救措
本手冊最後一頁的使用者資訊,隨附這些說明的發行或修訂日期及修訂編號。如果這個日期和產品使用之間已經相隔
36 個月,使用者必須聯絡 Bard Peripheral Vascular,瞭解是否有其他產品資訊。
組裝地:墨西哥。
51
繁體中文
這項裝置與 MR 有條件相容:
下列編碼可在 MR 下放置和造影:
470201
475201
477201
479201
非臨床測試已證明 MR GHIATAS® 定位導線與 MR 有條件相容:它在以下條件下可以執行安全掃描:
‡
特斯拉或更小的靜磁場
‡
高斯 釐米或更小的空間梯度磁場
한국어
사용 지침
GHIATAS® 비드 유방 위치결정 와이어
제품 코드:
47519
47919
47320
47520
47720
47920
47020*
19g, 15cm 갈고리형 와이어가 달린 5cm 바늘
19g, 20cm 갈고리형 와이어가 달린 9cm 바늘
20g, 15cm 갈고리형 와이어가 달린 3cm 바늘
20g, 15cm 갈고리형 와이어가 달린 5cm 바늘
20g, 20cm 갈고리형 와이어가 달린 7cm 바늘
20g, 20cm 갈고리형 와이어가 달린 9cm 바늘
20g, 35cm 갈고리형 와이어가 달린 14cm 바늘
GHIATAS® 강성 보강부 포함 비드 유방 위치결정 와이어
제품 코드:
49520
20g, 15cm 갈고리형 와이어가 달린 5cm 바늘
49720
20g, 20cm 갈고리형 와이어가 달린 7cm 바늘
49920
20g, 20cm 갈고리형 와이어가 달린 9cm 바늘
MR GHIATAS® 비드 유방 위치결정 와이어
제품 코드:
475201*
477201*
479201*
470201*
MR
20g, 15cm 갈고리형 와이어가 달린 5cm 바늘
20g, 20cm 갈고리형 와이어가 달린 7cm 바늘
20g, 20cm 갈고리형 와이어가 달린 9cm 바늘
20g, 35cm 갈고리형 와이어가 달린 14cm 바늘
*제품 코드 47020, 475201, 477201, 479201, 470201에는 초음파 증강부가 없습니다. 또한, 제품 코드 475201,
477201, 479201, 470201은 MRI 영상을 보면서 배치할 수 있습니다.
그림 1
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
유도관 바늘
초음파 증강부
1cm 깊이 기준 표시
방향 표시
갈고리
표시 비드
위치결정 와이어
촉지성 배치 비드
A. 일반 정보 및 기기 설명:
GHIATAS® 비드 유방 위치결정 와이어는 유도관 바늘과 반경성 위치결정 와이어로 구성되어 있습니다. 유도관 바늘은
플라스틱 성형 허브, 1cm 깊이 기준 표시, 바늘 배치를 보조하기 위한 원위부 말단의 초음파 증강부로 구성되어
있습니다. *반경성 위치결정 와이어의 원위부 말단에는 1cm 표시 비드와 와이어 원위부 말단의 갈고리가 배치되는
위치를 나타내기 위한 촉지성 배치 비드가 있습니다. 제품 코드 49520, 49720, 49920의 와이어 원위부 말단에는
와이어에 강성 보강 효과를 추가하는 더 긴 비드가 있습니다.
B. 공급 방법:
GHIATAS® 비드 유방 위치결정 와이어는 포장이 개봉되거나 손상되지 않은 경우 멸균 상태 및 비발열성 상태로
제공됩니다. 산화에틸렌으로 멸균 처리된 제품입니다. 본 제품은 1회 사용으로 제한됩니다. 재사용하지 마십시오.
재멸균 처리하지 마십시오.
C. 적용 사항:
이 기기는 유방 병변 수술 중에 외과의사가 병변 적출 시 방향을 지시하기 위한 유도 기구로 사용되도록
고안되었습니다.
D. 사용 시 금기 사항:
알려진 사항이 없습니다.
E. 경고:
1.
2.
3.
4.
5.
6.
7.
8.
갈고리가 유방 내에 배치되면, 와이어를 수술적 방법으로 제거해야 합니다. 와이어를 위치 이동하거나,
움직이거나 잡아당기려 하지 마십시오. 손상/파손이 발생할 수 있습니다.
와이어는 유도 기구로만 사용할 수 있습니다. 리트랙터로 사용하지 마십시오.
병변의 수술적 적출 중에 와이어를 메스로 절단하지 않도록 주의하십시오.
와이어는 허브에서 바늘을 통해서 바늘 끝으로 밀어넣어야만 합니다. 와이어를 뒤로 당겨 바늘 안으로 넣으려
하지 마십시오. 갈고리가 손상될 수 있습니다.
와이어 갈고리의 모양을 어떤 방법으로든 바꾸려 하지 마십시오. 갈고리가 부러질 수 있습니다. 와이어
갈고리가 올바르지 않게 변형되거나 휘어질 경우, 제품을 폐기하십시오.
유방 보형물을 삽입한 환자에게 위치결정 와이어를 사용할 때 배치 또는 이동 중에 유방 보형물에 구멍을 내지
않도록 주의해야 합니다.
GHIATAS® 비드 유방 위치결정 와이어는 1회만 사용하도록 고안되었습니다. 발열성 오염 또는 미생물성 오염이
있을 수 있는 체액이나 조직이 알 수 없는 기간 동안 의료 기기와 접촉한 경우, 특히 길고 작은 박편, 연결부
및/또는 구성품 사이의 틈새가 있는 의료 기기는 세척하기가 어렵거나 불가능할 수 있으므로 이 의료 기기를
재사용하면 환자 간 교차 오염이 발생할 위험이 있습니다. 생물학적 물질이 있을 경우 발열성 물질이나
미생물로 기기가 오염되어 감염성 합병증을 유발할 수 있습니다.
GHIATAS® 비드 유방 위치결정 와이어를 재멸균 처리하지 마십시오. 재멸균한 후에는 감염성 합병증을 유발할 수
있는 발열성 또는 미생물 오염의 정도를 확인할 수 없으므로 제품이 멸균 상태임을 보장할 수 없습니다. 의료
기기를 세척하고, 재처리하고, 재살균하면 열 및/또는 의학적 변화로 인해 영향을 받는 구성품에 대한 부정적
효과 때문에 기기가 고장날 가능성이 높아집니다.
유의 사항: 사용 후, 이 제품은 잠재적으로 위험할 수 있습니다. 수용 가능한 의료 관행 및 지역, 시/도, 국가 법규에
따라 취급하고 폐기하십시오.
52
F. 주의 사항:
이 기기는 경피 주사 기법의 표시된 용도, 제한과 가능한 합병증에 대해 훈련받은 의사만 사용해야 합니다.
영상 촬영 화면을 보면서 몸에 기기를 삽입해야 합니다.
사용하기 전에, 기기를 검사하여 올바른 기능을 방해하는 손상이 있는지 확인하십시오. 구성 부품이
손상되거나 휘어진 경우 사용하지 마십시오.
G. 잠재적 합병증:
잠재적 합병증은 부위 고유의 합병증이며 혈종, 출혈, 감염, 인접 조직 손상, 통증, 출혈, 객혈, 혈흉, 의도하지 않은
조직, 기관 또는 혈관 천공, 기흉을 포함할 수 있습니다.
H.
‡
‡
‡
‡
I.
필요한 기기:
적절한 영상 촬영 기법
수술용 장갑 및 드레이프
국소 마취제
기타 필요 기기
사용 지침:
포장 및 제품의 손상 여부와 유통기한을 확인합니다. 손상되지 않고 유통기한이 경과되지 않은 경우, 포장을
개봉하고 무균 기법을 사용하여 제품을 멸균 영역으로 옮깁니다.
2. 와이어를 유도관 바늘에서 제거하여 제품이 운반 중에 손상되지 않았는지 확인합니다(그림 2).
유의 사항: 위치결정 와이어는 갈고리 손상을 방지하기 위해 갈고리를 바늘 허브의 외부를 향하게 하여 바늘에
포장되어 있습니다. 배치 시 갈고리가 바늘 허브를 먼저 통과하도록 위치결정 와이어를 회전시켜야 합니다.
그림 2
1.
3.
4.
적합한 영상촬영 방법을 사용하여 병변 위치를 파악합니다.
위치결정 바늘을 유방에 삽입하여 병변을 향하게 합니다(기흉의 위험을 줄이기 위해서 흉벽과 평행하게 하는
것이 좋음). 깊이 기준 표시를 사용하여 바늘 끝을 유방 병변에 삽입합니다(깊이 기준 표시의 간격은 1cm)
(그림 3).
그림 3
5.
6.
7.
적절한 영상촬영 기법으로 바늘 배치를 확인합니다.
필요한 경우, 바늘의 위치를 조정한 후 배치를 다시 확인합니다.
그런 다음 위치결정 와이어를 바늘 허브에 밀어 넣고 와이어의 촉지성 배치 비드가 바늘 허브의 근위부 말단에
올 때까지 밀어 넣어 유도관 안에 삽입할 수 있습니다. 갈고리가 올바른 방향으로 배치되게 하기 위해서
와이어를 바늘에 넣을 때 갈고리를 허브의 방향 표시와 정렬합니다(그림 4).
그림 4
8.
갈고리를 배치하려면, 위치결정 와이어를 제자리에 고정하고 바늘을 1.5cm 정도 뒤로 당겨야 합니다(그림 5).
유의 사항: 와이어의 촉지성 배치 비드가 바늘 허브 안에 완전히 들어가면 갈고리가 배치됩니다. 갈고리가
배치된 와이어를 위치 이동하려는 경우 와이어가 손상되거나 부러질 수 있습니다.
그림 5
이제 바늘을 제거하고 X선 및또는 초음파 촬영을 하여 갈고리 배치를 확인할 수 있습니다. 유의 사항: 와이어의
비드는 갈고리와 병변의 위치를 시각적 및 촉지적으로 나타냅니다.
10. 나머지 노출 와이어는 피부에 고정해야 하고 적합한 방법을 사용하여 수술 부위로 이동하는 동안 와이어가
움직이지 않도록 해야 합니다(그림 6). 와이어 이동 방지를 위해서 와이어 클립을 피부에 있는 와이어에 배치할
수 있습니다. 충분한 압력을 사용하여 와이어 클립을 와이어에 장착합니다(그림 7).
9.
그림 6
그림 7
53
한국어
1.
2.
3.
한국어
11. 수술 전에 와이어 진행 방향과 와이어 팁 위치를 촉지적으로 나타내는 데 도움이 되도록 BARD® 뭉툭한 팁 강성
보강 캐뉼러를 GHIATAS® 유방 위치결정 와이어 위로 유도할 수 있습니다.
이 기기는 MR 조건부 안전 기기입니다:
다음 코드를 MR을 사용하여 배치 및 영상 촬영할 수 있습니다:
470201
475201
477201
479201
비임상 시험은 MR GHIATAS® 위치결정 와이어가 MR 조건부 안전 기기임을 보여주었습니다. 다음과 같은 조건에서
안전하게 스캔할 수 있습니다:
‡
테슬라 이하의 정자기장
‡
*DXVVFP이하의 공간 경사 자기장
비임상 시험에서, MR GHIATAS® 위치결정 와이어 제품 코드는 3테슬라, Signa MR 시스템(Excite 플랫폼*%
소프트웨어*(+HDOWKFDUH0LOZDXNHH:,에서 15분 간의 MR 스캔 중에:NJ의 전신 평균 특이 흡수율6$5을
나타내는 최대 MR 시스템에서 +0.9 ºC 미만의 온도 상승을 유발했습니다.
촬영 부위가 MR GHIATAS® 위치결정 와이어의 위치와 정확히 동일한 부위이거나 상대적으로 가까운 위치에 있을
경우, MR 영상 품질이 저하될 수 있습니다. 따라서 본 금속 삽입물을 고려한 MR 영상 파라미터의 최적화가 필요할
수 있습니다.
제품 보증
Bard Peripheral Vascular는 본 제품의 최초 구매자에 대해 최초 구매일로부터 1년 동안 본 제품이 소재 및 공정상의
결함이 없음을 보증하며, 본 제한적 제품 보증하의 책임은 Bard Peripheral Vascular의 고유 재량에 따라 결함 있는
제품을 수리 또는 교환하거나 순지불 가격을 환불하는 것으로 제한됩니다. 통상적인 사용으로 인한 마모 및 파열
또는 제품을 잘못 사용하여 발생한 결함은 본 제한적 보증의 대상이 아닙니다.
해당 법률에서 허용하는 정도까지, 본 제한적 제품 보증은 다른 모든 보증을 대신하며 여기에는 명시적이거나
묵시적인 보증을 포함하며 특정 목적을 위한 상품성 또는 적합성에 대한 묵시적 보증을 포함하나 여기에 국한되는
것은 아닙니다. 어떤 경우에도 BARD PERIPHERAL VASCULAR는 본 제품의 취급 또는 사용으로 인한 간접적,
우발적 또는 결과적 피해에 대해 책임지지 않습니다.
일부 시도국가의 경우에는 묵시적 보증, 우발적 또는 결과적 피해의 제외를 허용하지 않습니다. 거주 국가의 법률에
따라 추가적인 구제 수단이 제공될 수 있습니다.
본 설명서의 발행일 또는 개정일 및 개정 번호는 본 책자의 마지막 페이지의 사용자 정보에 포함되어 있습니다.
본 날짜로부터 36개월 이후에 제품을 사용하는 경우 사용자는 Bard Peripheral Vascular에 문의하여 추가적인 제품
정보가 있는지 확인해야 합니다.
멕시코에서 조립되었습니다.
54
ɂɧɫɬɪɭɤɰɢɢɩɨɩɪɢɦɟɧɟɧɢɸ
ɉɪɨɜɨɞɧɢɤɞɥɹɥɨɤɚɥɢɡɚɰɢɢɩɨɪɚɠɟɧɢɣɦɨɥɨɱɧɨɣɠɟɥɟɡɵGHIATAS®ɫɪɟɥɶɟɮɧɵɦɢɛɭɫɢɧɨɨɛɪɚɡɧɵɦɢ
ɦɚɪɤɟɪɚɦɢɢɠɟɫɬɤɨɣɫɟɤɰɢɟɣ
Ʉɨɞɵɢɡɞɟɥɢɹ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɉɪɨɜɨɞɧɢɤɞɥɹɥɨɤɚɥɢɡɚɰɢɢɩɨɪɚɠɟɧɢɣɦɨɥɨɱɧɨɣɠɟɥɟɡɵ05GHIATAS®ɫɪɟɥɶɟɮɧɵɦɢɛɭɫɢɧɨɨɛɪɚɡɧɵɦɢ
ɦɚɪɤɟɪɚɦɢMR
Ʉɨɞɵɢɡɞɟɥɢɹ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɡɞɟɥɢɹɫɤɨɞɚɦɢɢɧɟɢɦɟɸɬɭɱɚɫɬɤɚɩɨɜɵɲɟɧɧɨɣɷɯɨɝɟɧɧɨɫɬɢ
ɄɪɨɦɟɬɨɝɨɢɡɞɟɥɢɹɫɤɨɞɚɦɢɢɦɨɠɧɨɭɫɬɚɧɚɜɥɢɜɚɬɶɩɨɞɆɊɌɧɚɜɟɞɟɧɢɟɦ
Ɋɢɫ
1
2
3
5
7
4
6
8
1.
2.
3.
4.
5.
6.
7.
8.
ɂɝɥɚɢɧɬɪɨɞɶɸɫɟɪ
ɍɱɚɫɬɨɤɩɨɜɵɲɟɧɧɨɣɷɯɨɝɟɧɧɨɫɬɢ
Ɉɬɦɟɬɤɢɝɥɭɛɢɧɵɜɜɟɞɟɧɢɹɱɟɪɟɡɫɦ
ɂɧɞɢɤɚɬɨɪɵɨɪɢɟɧɬɚɰɢɢ
ɍɫɢɤ
Ɋɟɥɶɟɮɧɵɟɛɭɫɢɧɨɨɛɪɚɡɧɵɟɦɚɪɤɟɪɵ
Ʌɨɤɚɥɢɡɚɰɢɨɧɧɵɣɩɪɨɜɨɞɧɢɤ
ɉɚɥɶɩɢɪɭɟɦɵɣɛɭɫɢɧɨɨɛɪɚɡɧɵɣɦɚɪɤɟɪɞɥɹɤɨɧɬɪɨɥɹɪɚɫɤɪɵɬɢɹ
Ⱥ Ɉɛɳɚɹɢɧɮɨɪɦɚɰɢɹɢɨɩɢɫɚɧɢɟɭɫɬɪɨɣɫɬɜɚ
ɉɪɨɜɨɞɧɢɤɞɥɹɥɨɤɚɥɢɡɚɰɢɢɩɨɪɚɠɟɧɢɣɦɨɥɨɱɧɨɣɠɟɥɟɡɵGHIATAS®ɫɪɟɥɶɟɮɧɵɦɢɛɭɫɢɧɨɨɛɪɚɡɧɵɦɢ
ɦɚɪɤɟɪɚɦɢɫɨɫɬɨɢɬɢɡɢɝɥɵɢɧɬɪɨɞɶɸɫɟɪɚɢɩɨɥɭɠɟɫɬɤɨɝɨɥɨɤɚɥɢɡɚɰɢɨɧɧɨɝɨɩɪɨɜɨɞɧɢɤɚɂɝɥɚɢɧɬɪɨɞɶɸɫɟɪ
ɢɦɟɟɬɥɢɬɭɸɩɥɚɫɬɢɤɨɜɭɸɤɚɧɸɥɸɨɬɦɟɬɤɢɝɥɭɛɢɧɵɜɜɟɞɟɧɢɹɱɟɪɟɡɤɚɠɞɵɣɫɦɢɭɱɚɫɬɨɤɩɨɜɵɲɟɧɧɨɣ
ɷɯɨɝɟɧɧɨɫɬɢɧɚɞɢɫɬɚɥɶɧɨɦɤɨɧɰɟɨɛɥɟɝɱɚɸɳɢɣɪɚɡɦɟɳɟɧɢɟɢɝɥɵɉɨɥɭɠɟɫɬɤɢɣɥɨɤɚɥɢɡɚɰɢɨɧɧɵɣ
ɩɪɨɜɨɞɧɢɤɫɧɚɛɠɟɧɪɟɥɶɟɮɧɵɦɢɦɚɪɤɟɪɚɦɢɜɮɨɪɦɟɛɭɫɢɧɧɚɞɢɫɬɚɥɶɧɨɦɤɨɧɰɟɪɚɫɩɨɥɨɠɟɧɧɵɦɢ
ɱɟɪɟɡɫɦɢɩɚɥɶɩɢɪɭɟɦɵɦɛɭɫɢɧɨɨɛɪɚɡɧɵɦɦɚɪɤɟɪɨɦɞɥɹɤɨɧɬɪɨɥɹɪɚɫɤɪɵɬɢɹɭɤɚɡɵɜɚɸɳɟɣɧɚɬɨɱɤɭ
ɜɤɨɬɨɪɨɣɭɫɢɤɧɚɞɢɫɬɚɥɶɧɨɦɤɨɧɰɟɩɪɨɜɨɞɧɢɤɚɪɚɫɤɪɵɜɚɟɬɫɹɂɡɞɟɥɢɹɫɤɨɞɚɦɢɢ
ɫɧɚɛɠɟɧɵɛɭɫɢɧɨɨɛɪɚɡɧɵɦɢɦɚɪɤɟɪɚɦɢɛɨɥɶɲɟɣɞɥɢɧɵɧɚɞɢɫɬɚɥɶɧɨɦɤɨɧɰɟɩɪɨɜɨɞɧɢɤɚɱɬɨɩɪɢɞɚɟɬ
ɩɪɨɜɨɞɧɢɤɭɠɟɫɬɤɨɫɬɶ
Ȼ Ɏɨɪɦɚɩɨɫɬɚɜɤɢ
ɉɪɨɜɨɞɧɢɤɞɥɹɥɨɤɚɥɢɡɚɰɢɢɩɨɪɚɠɟɧɢɣɦɨɥɨɱɧɨɣɠɟɥɟɡɵGHIATAS®ɫɪɟɥɶɟɮɧɵɦɢɛɭɫɢɧɨɨɛɪɚɡɧɵɦɢ
ɦɚɪɤɟɪɚɦɢɩɨɫɬɚɜɥɹɟɬɫɹɫɬɟɪɢɥɶɧɵɦɢɚɩɢɪɨɝɟɧɧɵɦɩɪɢɭɫɥɨɜɢɢɱɬɨɭɩɚɤɨɜɤɚɧɟɩɨɜɪɟɠɞɟɧɚɢ
ɧɟɜɫɤɪɵɬɚɋɬɟɪɢɥɢɡɨɜɚɧɨɷɬɢɥɟɧɨɤɫɢɞɨɦɌɨɥɶɤɨɞɥɹɨɞɧɨɤɪɚɬɧɨɝɨɩɪɢɦɟɧɟɧɢɹɉɨɜɬɨɪɧɨɟ
ɢɫɩɨɥɶɡɨɜɚɧɢɟɡɚɩɪɟɳɟɧɨɉɨɜɬɨɪɧɚɹɫɬɟɪɢɥɢɡɚɰɢɹɡɚɩɪɟɳɟɧɚ
ȼ ɉɨɤɚɡɚɧɢɹɞɥɹɩɪɢɦɟɧɟɧɢɹ
Ⱦɚɧɧɨɟɭɫɬɪɨɣɫɬɜɨɩɪɟɞɧɚɡɧɚɱɟɧɨɞɥɹɢɫɩɨɥɶɡɨɜɚɧɢɹɩɪɢɯɢɪɭɪɝɢɱɟɫɤɨɦɥɟɱɟɧɢɢɩɨɪɚɠɟɧɢɣɦɨɥɨɱɧɨɣ
ɠɟɥɟɡɵɢɫɥɭɠɢɬɧɚɩɪɚɜɥɹɸɳɟɣɞɥɹɯɢɪɭɪɝɚɩɪɢɭɞɚɥɟɧɢɢɨɱɚɝɚɩɨɪɚɠɟɧɢɹ
Ƚ ɉɪɨɬɢɜɨɩɨɤɚɡɚɧɢɹɞɥɹɩɪɢɦɟɧɟɧɢɹ
ɇɟɢɡɜɟɫɬɧɵ
Ⱦ ɉɪɟɞɭɩɪɟɠɞɟɧɢɹ
ɉɨɫɥɟɬɨɝɨɤɚɤɭɫɢɤɪɚɫɤɪɵɬɜɦɨɥɨɱɧɨɣɠɟɥɟɡɟɩɪɨɜɨɞɧɢɤɞɨɥɠɟɧɭɞɚɥɹɬɶɫɹɯɢɪɭɪɝɢɱɟɫɤɢɦ
ɩɭɬɟɦɇɟɩɵɬɚɣɬɟɫɶɢɡɦɟɧɢɬɶɩɨɥɨɠɟɧɢɟɩɪɨɜɨɞɧɢɤɚɩɟɪɟɦɟɫɬɢɬɶɟɝɨɢɥɢɬɹɧɭɬɶɡɚ
ɩɪɨɜɨɞɧɢɤɗɬɨɦɨɠɟɬɩɪɢɜɟɫɬɢɤɟɝɨɩɨɜɪɟɠɞɟɧɢɸɢɥɢɨɬɥɚɦɵɜɚɧɢɸ
ɉɪɨɜɨɞɧɢɤɩɪɟɞɧɚɡɧɚɱɟɧɞɥɹɢɫɩɨɥɶɡɨɜɚɧɢɹɬɨɥɶɤɨɜɤɚɱɟɫɬɜɟɧɚɩɪɚɜɥɹɸɳɟɣɇȿɢɫɩɨɥɶɡɭɣɬɟ
ɟɝɨɤɚɤɪɟɬɪɚɤɬɨɪ
Ȼɭɞɶɬɟɨɫɬɨɪɨɠɧɵɩɪɢɯɢɪɭɪɝɢɱɟɫɤɨɦɭɞɚɥɟɧɢɢɩɨɪɚɠɟɧɢɹɱɬɨɛɵɧɟɩɟɪɟɪɟɡɚɬɶɩɪɨɜɨɞɧɢɤ
ɫɤɚɥɶɩɟɥɟɦ
ɉɪɨɜɨɞɧɢɤɞɨɥɠɟɧɩɪɨɞɜɢɝɚɬɶɫɹɜɢɝɥɟɬɨɥɶɤɨɩɨɧɚɩɪɚɜɥɟɧɢɸɨɬɤɚɧɸɥɢɤɤɨɧɱɢɤɭɢɝɥɵɇɟ
ɩɵɬɚɣɬɟɫɶɜɬɹɧɭɬɶɩɪɨɜɨɞɧɢɤɜɢɝɥɭɢɥɢɩɪɨɬɹɧɭɬɶɟɝɨɜɧɭɬɪɢɢɝɥɵɜɨɛɪɚɬɧɨɦɧɚɩɪɚɜɥɟɧɢɢɜɨ
ɢɡɛɟɠɚɧɢɟɩɨɜɪɟɠɞɟɧɢɹɭɫɢɤɚ
ɇɟɩɵɬɚɣɬɟɫɶɤɚɤɢɦɛɵɬɨɧɢɛɵɥɨɨɛɪɚɡɨɦɢɡɦɟɧɢɬɶɮɨɪɦɭɭɫɢɤɚɩɪɨɜɨɞɧɢɤɚɬɚɤɤɚɤɷɬɨ
ɦɨɠɟɬɩɪɢɜɟɫɬɢɤɨɬɥɚɦɵɜɚɧɢɸɭɫɢɤɚȿɫɥɢɭɫɢɤɩɪɨɜɨɞɧɢɤɚɞɟɮɨɪɦɢɪɨɜɚɧɢɥɢɧɟɩɪɚɜɢɥɶɧɨ
ɢɡɨɝɧɭɬɜɵɛɪɨɫɶɬɟɢɡɞɟɥɢɟ
55
3ɍɋɋɄɂɃ
ɉɪɨɜɨɞɧɢɤɞɥɹɥɨɤɚɥɢɡɚɰɢɢɩɨɪɚɠɟɧɢɣɦɨɥɨɱɧɨɣɠɟɥɟɡɵGHIATAS®ɫɪɟɥɶɟɮɧɵɦɢɛɭɫɢɧɨɨɛɪɚɡɧɵɦɢ
ɦɚɪɤɟɪɚɦɢ
Ʉɨɞɵɢɡɞɟɥɢɹ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
ɂɝɥɚ*[ɫɦɢɩɪɨɜɨɞɧɢɤɫɭɫɢɤɨɦɫɦ
3ɍɋɋɄɂɃ
ɉɪɨɹɜɥɹɣɬɟɨɫɬɨɪɨɠɧɨɫɬɶɩɪɢɢɫɩɨɥɶɡɨɜɚɧɢɢɥɨɤɚɥɢɡɚɰɢɨɧɧɨɝɨɩɪɨɜɨɞɧɢɤɚɭɩɚɰɢɟɧɬɨɤ
ɫɢɦɩɥɚɧɬɢɪɨɜɚɧɧɵɦɩɪɨɬɟɡɨɦɦɨɥɨɱɧɨɣɠɟɥɟɡɵɱɬɨɛɵɧɟɩɪɨɤɨɥɨɬɶɟɝɨɩɪɢɭɫɬɚɧɨɜɤɟ
ɩɪɨɜɨɞɧɢɤɚɢɥɢɩɪɢɬɪɚɧɫɩɨɪɬɢɪɨɜɤɟɩɚɰɢɟɧɬɤɢ
ɉɪɨɜɨɞɧɢɤɞɥɹɥɨɤɚɥɢɡɚɰɢɢɩɨɪɚɠɟɧɢɣɦɨɥɨɱɧɨɣɠɟɥɟɡɵGHIATAS®ɫɪɟɥɶɟɮɧɵɦɢ
ɛɭɫɢɧɨɨɛɪɚɡɧɵɦɢɦɚɪɤɟɪɚɦɢɩɪɟɞɧɚɡɧɚɱɟɧɬɨɥɶɤɨɞɥɹɨɞɧɨɤɪɚɬɧɨɝɨɩɪɢɦɟɧɟɧɢɹɉɨɜɬɨɪɧɨɟ
ɢɫɩɨɥɶɡɨɜɚɧɢɟɷɬɨɝɨɦɟɞɢɰɢɧɫɤɨɝɨɭɫɬɪɨɣɫɬɜɚɫɨɩɪɹɠɟɧɨɫɪɢɫɤɨɦɩɟɪɟɤɪɟɫɬɧɨɝɨɡɚɪɚɠɟɧɢɹ
ɩɚɰɢɟɧɬɨɜɩɨɫɤɨɥɶɤɭɦɟɞɢɰɢɧɫɤɢɟɭɫɬɪɨɣɫɬɜɚ²ɜɱɚɫɬɧɨɫɬɢɬɟɤɨɬɨɪɵɟɢɦɟɸɬɞɥɢɧɧɵɣɢ
ɭɡɤɢɣɩɪɨɫɜɟɬɬɨɱɤɢɫɨɟɞɢɧɟɧɢɹɢɢɥɢɡɚɡɨɪɵɦɟɠɞɭɤɨɦɩɨɧɟɧɬɚɦɢ²ɬɪɭɞɧɨɢɥɢɧɟɜɨɡɦɨɠɧɨ
ɨɱɢɫɬɢɬɶɩɨɫɥɟɤɨɧɬɚɤɬɚɫɧɢɦɢɛɢɨɥɨɝɢɱɟɫɤɢɯɠɢɞɤɨɫɬɟɣɢɥɢɬɤɚɧɟɣɩɨɬɟɧɰɢɚɥɶɧɨ
ɫɨɞɟɪɠɚɳɢɯɩɢɪɨɝɟɧɧɵɟɜɟɳɟɫɬɜɚɢɥɢɦɢɤɪɨɨɪɝɚɧɢɡɦɵɜɬɟɱɟɧɢɟɧɟɨɩɪɟɞɟɥɟɧɧɨɝɨɩɟɪɢɨɞɚ
ɜɪɟɦɟɧɢɈɫɬɚɬɤɢɛɢɨɥɨɝɢɱɟɫɤɨɝɨɦɚɬɟɪɢɚɥɚɦɨɝɭɬɫɩɨɫɨɛɫɬɜɨɜɚɬɶɡɚɝɪɹɡɧɟɧɢɸɭɫɬɪɨɣɫɬɜɚ
ɩɢɪɨɝɟɧɧɵɦɢɜɟɳɟɫɬɜɚɦɢɢɥɢɦɢɤɪɨɨɪɝɚɧɢɡɦɚɦɢɤɨɬɨɪɵɟɦɨɝɭɬɩɪɢɜɟɫɬɢɤɢɧɮɟɤɰɢɨɧɧɵɦ
ɨɫɥɨɠɧɟɧɢɹɦ
ɇɟɩɨɞɜɟɪɝɚɣɬɟɩɪɨɜɨɞɧɢɤɞɥɹɥɨɤɚɥɢɡɚɰɢɢɩɨɪɚɠɟɧɢɣɦɨɥɨɱɧɨɣɠɟɥɟɡɵGHIATAS®ɫ
ɪɟɥɶɟɮɧɵɦɢɛɭɫɢɧɨɨɛɪɚɡɧɵɦɢɦɚɪɤɟɪɚɦɢɩɨɜɬɨɪɧɨɣɫɬɟɪɢɥɢɡɚɰɢɢɉɨɫɥɟɩɨɜɬɨɪɧɨɣ
ɫɬɟɪɢɥɢɡɚɰɢɢɧɟɥɶɡɹɝɚɪɚɧɬɢɪɨɜɚɬɶɫɬɟɪɢɥɶɧɨɫɬɶɢɡɞɟɥɢɹɢɡɡɚɧɟɜɨɡɦɨɠɧɨɫɬɢɨɩɪɟɞɟɥɟɧɢɹ
ɫɬɟɩɟɧɢɡɚɝɪɹɡɧɟɧɢɹɩɢɪɨɝɟɧɧɵɦɢɜɟɳɟɫɬɜɚɦɢɢɥɢɦɢɤɪɨɨɪɝɚɧɢɡɦɚɦɢɱɬɨɦɨɠɟɬɩɪɢɜɟɫɬɢ
ɤɢɧɮɟɤɰɢɨɧɧɵɦɨɫɥɨɠɧɟɧɢɹɦɈɱɢɫɬɤɚɩɨɜɬɨɪɧɵɟɨɛɪɚɛɨɬɤɚɢɢɥɢɫɬɟɪɢɥɢɡɚɰɢɹɞɚɧɧɨɝɨ
ɦɟɞɢɰɢɧɫɤɨɝɨɭɫɬɪɨɣɫɬɜɚɩɨɜɵɲɚɸɬɜɟɪɨɹɬɧɨɫɬɶɟɝɨɧɟɢɫɩɪɚɜɧɨɫɬɢɢɡɡɚɨɬɪɢɰɚɬɟɥɶɧɵɯ
ɩɨɫɥɟɞɫɬɜɢɣɜɵɡɜɚɧɧɵɯɬɟɪɦɢɱɟɫɤɨɣɨɛɪɚɛɨɬɤɨɣɢɢɥɢɦɟɯɚɧɢɱɟɫɤɢɦɢɢɡɦɟɧɟɧɢɹɦɢɟɝɨ
ɤɨɦɩɨɧɟɧɬɨɜ
ɉɊɂɆȿɑȺɇɂȿɉɨɫɥɟɩɪɢɦɟɧɟɧɢɹɞɚɧɧɵɟɢɡɞɟɥɢɹɦɨɝɭɬɩɪɟɞɫɬɚɜɥɹɬɶɛɢɨɥɨɝɢɱɟɫɤɭɸɨɩɚɫɧɨɫɬɶ
Ɉɛɪɚɳɚɣɬɟɫɶɫɧɢɦɢɢɭɬɢɥɢɡɢɪɭɣɬɟɢɯɜɫɨɨɬɜɟɬɫɬɜɢɢɫɩɪɢɧɹɬɨɣɦɟɞɢɰɢɧɫɤɨɣɩɪɚɤɬɢɤɨɣɢ
ɞɟɣɫɬɜɭɸɳɢɦɢɦɟɫɬɧɵɦɢɪɟɝɢɨɧɚɥɶɧɵɦɢɢɮɟɞɟɪɚɥɶɧɵɦɢɡɚɤɨɧɚɦɢɢɩɨɥɨɠɟɧɢɹɦɢ
ȿ Ɇɟɪɵɩɪɟɞɨɫɬɨɪɨɠɧɨɫɬɢ
ɗɬɨɭɫɬɪɨɣɫɬɜɨɞɨɥɠɧɨɢɫɩɨɥɶɡɨɜɚɬɶɫɹɬɨɥɶɤɨɜɪɚɱɨɦɩɪɨɲɟɞɲɢɦɨɛɭɱɟɧɢɟɩɨɟɝɨɩɪɢɦɟɧɟɧɢɸɩɨ
ɧɚɡɧɚɱɟɧɢɸɨɡɧɚɤɨɦɥɟɧɧɵɦɫɨɝɪɚɧɢɱɟɧɢɹɦɢɢɜɨɡɦɨɠɧɵɦɢɨɫɥɨɠɧɟɧɢɹɦɢɩɪɢɢɫɩɨɥɶɡɨɜɚɧɢɢɢɝɥɵ
ɞɥɹɱɪɟɫɤɨɠɧɵɯɜɦɟɲɚɬɟɥɶɫɬɜ
ȼɜɟɞɟɧɢɟɭɫɬɪɨɣɫɬɜɚɜɬɟɥɨɞɨɥɠɧɨɜɵɩɨɥɧɹɬɶɫɹɩɨɞɤɨɧɬɪɨɥɟɦɜɢɡɭɚɥɢɡɚɰɢɢ
ɉɟɪɟɞɢɫɩɨɥɶɡɨɜɚɧɢɟɦɨɫɦɨɬɪɢɬɟɭɫɬɪɨɣɫɬɜɨɢɭɛɟɞɢɬɟɫɶɜɨɬɫɭɬɫɬɜɢɢɩɨɜɪɟɠɞɟɧɢɣɫɩɨɫɨɛɧɵɯ
ɧɚɪɭɲɢɬɶɟɝɨɮɭɧɤɰɢɨɧɢɪɨɜɚɧɢɟɉɪɢɧɚɥɢɱɢɢɩɨɜɪɟɠɞɟɧɧɵɯɢɥɢɢɡɨɝɧɭɬɵɯɞɟɬɚɥɟɣɇȿ
ɂɋɉɈɅɖɁɍɃɌȿɭɫɬɪɨɣɫɬɜɨ
ɀ ȼɨɡɦɨɠɧɵɟɨɫɥɨɠɧɟɧɢɹ
ȼɨɡɦɨɠɧɵɟɨɫɥɨɠɧɟɧɢɹɡɚɜɢɫɹɬɨɬɨɛɥɚɫɬɢɜɜɟɞɟɧɢɹɭɫɬɪɨɣɫɬɜɚɢɦɨɝɭɬɜɤɥɸɱɚɬɶɝɟɦɚɬɨɦɵ
ɤɪɨɜɨɢɡɥɢɹɧɢɹɢɧɮɟɤɰɢɢɩɨɜɪɟɠɞɟɧɢɹɛɥɢɡɥɟɠɚɳɟɣɬɤɚɧɢɛɨɥɶɤɪɨɜɨɬɟɱɟɧɢɟɤɪɨɜɨɯɚɪɤɚɧɶɟ
ɝɟɦɨɬɨɪɚɤɫɩɪɨɧɢɤɧɨɜɟɧɢɟɜɧɟɰɟɥɟɜɭɸɬɤɚɧɶɩɟɪɮɨɪɚɰɢɸɨɪɝɚɧɚɢɥɢɫɨɫɭɞɚɚɬɚɤɠɟɩɧɟɜɦɨɬɨɪɚɤɫ
Ɂ ɇɟɨɛɯɨɞɢɦɨɟɨɛɨɪɭɞɨɜɚɧɢɟ
‡
‡
‡
‡
ɋɨɨɬɜɟɬɫɬɜɭɸɳɚɹɫɢɫɬɟɦɚɜɢɡɭɚɥɢɡɚɰɢɢ
ɏɢɪɭɪɝɢɱɟɫɤɢɟɩɟɪɱɚɬɤɢɢɫɚɥɮɟɬɤɢ
Ɇɟɫɬɧɵɣɚɧɟɫɬɟɬɢɤ
Ⱦɪɭɝɨɟɧɟɨɛɯɨɞɢɦɨɟɨɛɨɪɭɞɨɜɚɧɢɟ
ɂ ɍɤɚɡɚɧɢɹɩɨɩɪɢɦɟɧɟɧɢɸ
Ɉɫɦɨɬɪɢɬɟɭɩɚɤɨɜɤɭɢɢɡɞɟɥɢɟɧɚɧɚɥɢɱɢɟɩɨɜɪɟɠɞɟɧɢɣɢɩɪɨɜɟɪɶɬɟɫɪɨɤɝɨɞɧɨɫɬɢȿɫɥɢɩɨɜɪɟɠɞɟɧɢɣ
ɧɟɬɢɫɪɨɤɝɨɞɧɨɫɬɢɧɟɢɫɬɟɤɨɬɤɪɨɣɬɟɭɩɚɤɨɜɤɭɢɩɟɪɟɦɟɫɬɢɬɟɭɫɬɪɨɣɫɬɜɨɜɫɬɟɪɢɥɶɧɨɟɩɨɥɟɫ
ɢɫɩɨɥɶɡɨɜɚɧɢɟɦɚɫɟɩɬɢɱɟɫɤɢɯɦɟɬɨɞɢɤ
ɂɡɜɥɟɤɢɬɟɩɪɨɜɨɞɧɢɤɢɡɢɝɥɵɢɧɬɪɨɞɶɸɫɟɪɚɢɭɛɟɞɢɬɟɫɶɜɬɨɦɱɬɨɢɡɞɟɥɢɟɧɟɩɨɜɪɟɠɞɟɧɨɩɪɢ
ɬɪɚɧɫɩɨɪɬɢɪɨɜɤɟɊɢɫ.
ɉɊɂɆȿɑȺɇɂȿȼɭɩɚɤɨɜɤɟɥɨɤɚɥɢɡɚɰɢɨɧɧɵɣɩɪɨɜɨɞɧɢɤɩɨɦɟɳɟɧɜɢɝɥɟɬɚɤɱɬɨɭɫɢɤɜɵɯɨɞɢɬɢɡɤɚɧɸɥɢ
ɢɝɥɵɷɬɨɩɪɟɞɨɬɜɪɚɳɚɟɬɩɨɜɪɟɠɞɟɧɢɟɭɫɢɤɚȼɨɜɪɟɦɹɭɫɬɚɧɨɜɤɢɥɨɤɚɥɢɡɚɰɢɨɧɧɵɣɩɪɨɜɨɞɧɢɤɧɟɨɛɯɨɞɢɦɨ
ɩɟɪɟɜɟɪɧɭɬɶɱɬɨɛɵɩɪɨɩɭɫɬɢɬɶɭɫɢɤɱɟɪɟɡɤɚɧɸɥɸɢɝɥɵɜɩɟɪɜɭɸɨɱɟɪɟɞɶ
Ɋɢɫ
Ɉɩɪɟɞɟɥɢɬɟɦɟɫɬɨɧɚɯɨɠɞɟɧɢɟɨɱɚɝɚɩɨɪɚɠɟɧɢɹɢɫɩɨɥɶɡɭɹɫɨɨɬɜɟɬɫɬɜɭɸɳɢɣɦɟɬɨɞɜɢɡɭɚɥɢɡɚɰɢɢ
ȼɜɟɞɢɬɟɥɨɤɚɥɢɡɚɰɢɨɧɧɭɸɢɝɥɭɜɦɨɥɨɱɧɭɸɠɟɥɟɡɭɧɚɩɪɚɜɢɜɟɟɜɫɬɨɪɨɧɭɩɨɪɚɠɟɧɢɹɠɟɥɚɬɟɥɶɧɨ
ɩɚɪɚɥɥɟɥɶɧɨɫɬɟɧɤɟɝɪɭɞɧɨɣɤɥɟɬɤɢɱɬɨɛɵɭɦɟɧɶɲɢɬɶɜɨɡɦɨɠɧɵɣɪɢɫɤɩɧɟɜɦɨɬɨɪɚɤɫɚ
ȼɨɫɩɨɥɶɡɭɣɬɟɫɶɨɬɦɟɬɤɚɦɢɝɥɭɛɢɧɵɜɜɟɞɟɧɢɹɱɬɨɛɵɩɨɦɟɫɬɢɬɶɤɨɧɱɢɤɢɝɥɵɜɨɱɚɝɩɨɪɚɠɟɧɢɹ
ɦɨɥɨɱɧɨɣɠɟɥɟɡɵɨɬɦɟɬɤɢɝɥɭɛɢɧɵɪɚɫɩɨɥɨɠɟɧɵɱɟɪɟɡɫɦɊɢɫ.
Ɋɢɫ
ɉɨɞɬɜɟɪɞɢɬɟɦɟɫɬɨɧɚɯɨɠɞɟɧɢɟɢɝɥɵɫɩɨɦɨɳɶɸɫɨɨɬɜɟɬɫɬɜɭɸɳɟɝɨɦɟɬɨɞɚɜɢɡɭɚɥɢɡɚɰɢɢ
ɉɪɢɧɟɨɛɯɨɞɢɦɨɫɬɢɢɡɦɟɧɢɬɟɩɨɥɨɠɟɧɢɟɢɝɥɵɢɫɧɨɜɚɩɨɞɬɜɟɪɞɢɬɟɩɪɚɜɢɥɶɧɨɫɬɶɟɟɪɚɫɩɨɥɨɠɟɧɢɹ
ɉɨɫɥɟɷɬɨɝɨɥɨɤɚɥɢɡɚɰɢɨɧɧɵɣɩɪɨɜɨɞɧɢɤɦɨɠɧɨɜɫɬɚɜɢɬɶɜɢɝɥɭɢɧɬɪɨɞɶɸɫɟɪɩɪɨɩɭɫɬɢɜɩɪɨɜɨɞɧɢɤ
ɜɤɚɧɸɥɸɢɝɥɵɢɩɪɨɞɜɢɝɚɹɩɪɨɜɨɞɧɢɤɜɩɟɪɟɞɩɨɤɚɧɚɱɚɥɨɩɚɥɶɩɢɪɭɟɦɨɣɛɭɫɢɧɵɞɥɹɤɨɧɬɪɨɥɹ
ɪɚɫɤɪɵɬɢɹɧɚɩɪɨɜɨɞɧɢɤɟɧɟɨɤɚɠɟɬɫɹɭɩɪɨɤɫɢɦɚɥɶɧɨɝɨɤɨɧɰɚɤɚɧɸɥɢɢɝɥɵɑɬɨɛɵɨɛɟɫɩɟɱɢɬɶ
ɪɚɫɤɪɵɬɢɟɭɫɢɤɚɜɩɪɚɜɢɥɶɧɨɦɧɚɩɪɚɜɥɟɧɢɢɩɪɢɩɪɨɞɜɢɠɟɧɢɢɩɪɨɜɨɞɧɢɤɚɜɢɝɥɭɧɚɩɪɚɜɶɬɟɭɫɢɤɜ
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Ɋɢɫ
56
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ɩɚɥɶɩɢɪɭɟɦɵɟɨɬɦɟɬɤɢɭɤɚɡɵɜɚɸɳɢɟɧɚɦɟɫɬɨɧɚɯɨɠɞɟɧɢɟɭɫɢɤɚɢɨɱɚɝɚɩɨɪɚɠɟɧɢɹ
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ɩɪɟɞɨɬɜɪɚɳɚɸɳɢɦɫɦɟɳɟɧɢɟɩɪɨɜɨɞɧɢɤɚɩɪɢɬɪɚɧɫɩɨɪɬɢɪɨɜɤɟɩɚɰɢɟɧɬɤɢɜɨɩɟɪɚɰɢɨɧɧɭɸɊɢɫɇɚ
ɩɨɜɟɪɯɧɨɫɬɢɤɨɠɢɧɚɩɪɨɜɨɞɧɢɤɦɨɠɧɨɧɚɥɨɠɢɬɶɡɚɠɢɦɱɬɨɛɵɢɡɛɟɠɚɬɶɟɝɨɫɦɟɳɟɧɢɹɍɫɬɚɧɚɜɥɢɜɚɹ
ɡɚɠɢɦɧɚɩɪɨɜɨɞɧɢɤɩɪɢɥɨɠɢɬɟɞɨɫɬɚɬɨɱɧɨɟɭɫɢɥɢɟɊɢɫ.
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ɠɟɥɟɡɵGHIATAS®ɫɛɭɫɢɧɨɨɛɪɚɡɧɵɦɢɦɚɪɤɟɪɚɦɢɠɟɫɬɤɭɸɤɚɧɸɥɸɫɬɭɩɵɦɤɨɧɰɨɦBARD®ɱɬɨɛɵɨɛɟɫɩɟɱɢɬɶ
ɫɩɨɦɨɳɶɸɨɫɹɡɚɧɢɹɤɨɧɬɪɨɥɶɡɚɧɚɩɪɚɜɥɟɧɢɟɦɩɪɨɜɨɞɧɢɤɚɢɦɟɫɬɨɧɚɯɨɠɞɟɧɢɟɦɟɝɨɧɚɤɨɧɟɱɧɢɤɚ
ȾɚɧɧɨɟɭɫɬɪɨɣɫɬɜɨɭɫɥɨɜɧɨɩɪɢɝɨɞɧɨɞɥɹɆɊɜɢɡɭɚɥɢɡɚɰɢɢ
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ɆɊɜɢɡɭɚɥɢɡɚɰɢɢȿɝɨɦɨɠɧɨɛɟɡɨɩɚɫɧɨɩɨɞɜɟɪɝɚɬɶɫɤɚɧɢɪɨɜɚɧɢɸɩɪɢɫɥɟɞɭɸɳɢɯɭɫɥɨɜɢɹɯ
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ɋɨɛɪɚɧɨɜɆɟɤɫɢɤɟ
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3ɍɋɋɄɂɃ
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GHIATAS® Beaded Breast Localization Wire
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주의, 사용 지침 참조
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Contents
Contenu
Inhalt
Contenuto
Contenido
Inhoud
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ȆİȡȚİȤȩȝİȞȠ
Indhold
Innehåll
Sisältö
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Tartalom
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裝物
내용물
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Obsah
Catalogue Number
Numéro de catalogue
Katalognummer
Numero di catalogo
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Catalogusnummer
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Katalognummer
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Luettelonumero
Katalognummer
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目錄編號
카탈로그 번호
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MR Conditional
Conditions d’utilisation en RM
MR Conditional (bedingt MR-sicher)
Sicurezza condizionale con la RM
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Onder voorwaarden geschikt voor MRI
Utilização condicionada em RM
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MR-betinget
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MR-betinget
Warunkowo stosowany w MR
Bizonyos feltételekkel MR kompatibilis
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與 MR 有條件相容
MR 조건부
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Lot Number
Numéro de lot
Lot Nummer
Numero di lotto
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Lotnummer
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批號
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Manufacturer
Fabricant
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Produttore
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Do Not Resterilize
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Authorised Representative in the European Community
Représentant autorisé au sein de la Communauté européenne
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Rappresentante autorizzato nella Comunità Europea
Representante autorizado en la Comunidad Europea
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Representante autorizado na Comunidade Europeia
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Sterilized Using Ethylene Oxide
Stérilisé à l’oxyde d’éthylène
Sterilisiert mit Ethylenoxid
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Steriliserad med etylenoxid
Steriloitu etyleenioksidilla
Sterilisert med etylenoksid
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Sterilizované etylénoxidom
Do Not Use if the Product Sterilization Barrier or its Packaging is Compromised
Ne pas utiliser si la barrière de stérilisation ou l’emballage du produit est endommagé
Nicht verwenden, wenn die Sterilisationsabdeckung oder die Verpackung des Produkts beschädigt ist
Non utilizzare se la barriera sterile del prodotto o la confezione è compromessa
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Niet gebruiken wanneer de sterilisatiebarrière van het product of de verpakking is aangetast
Não utilizar se a barreira de esterilização do produto ou respectiva embalagem estiverem comprometidas
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Må ikke anvendes, hvis produktets steriliseringsbarriere eller emballagen er kompromitteret
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如果產品消毒屏障或包裝受損,請勿使用
제품의 멸균 장벽이나 포장이 손상된 경우 사용하지 마십시오.
Ɂɚɩɪɟɳɚɟɬɫɹɩɪɢɦɟɧɹɬɶɢɡɞɟɥɢɟɟɫɥɢɫɬɟɪɢɥɶɧɚɹɭɩɚɤɨɜɤɚɢɥɢɜɧɟɲɧɹɹɭɩɚɤɨɜɤɚɩɨɜɪɟɠɞɟɧɚ
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Bard, Chesbrough, Ghiatas, and UltraWire are trademarks and/or registered trademarks of C. R. Bard, Inc. or an
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C. R. Bard, Inc. eller et tilknyttet selskap
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Bard,Chesbrough,*KLDWDV和 UltraWire 是 C. R. Bard, Inc. 或其附屬機構的商標和 或註冊商標。
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Copyright ©2012 C. R. Bard, Inc. All rights reserved.
Copyright © 2012 C. R. Bard, Inc. Tous droits réservés.
&RS\ULJKW‹&5%DUG,QF$OOH5HFKWHYRUEHKDOWHQ
Copyright © 2012 C. R. Bard, Inc. Tutti i diritti riservati.
Copyright © 2012, C. R. Bard, Inc. Reservados todos los derechos.
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Copyright © 2012 C. R. Bard, Inc. Todos os direitos reservados.
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&RS\ULJKW‹&5%DUG,QF(IWHUWU\FNI|UEMXGHV
Copyright © 2012, C. R. Bard, Inc. Kaikki oikeudet pidätetään.
Copyright © 2012 C. R. Bard, Inc. Med enerett.
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Copyright 2012 C. R. Bard, Inc. 保留所有權利。
Copyright
2012 C. R. Bard Inc. 모든 권리는 당사가 소유합니다.
Ⱥɜɬɨɪɫɤɢɟɩɪɚɜɚ‹ɝɤɨɦɩɚɧɢɹ&5%DUG,QFȼɫɟɩɪɚɜɚɡɚɳɢɳɟɧɵ
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Manufacturer:
Bard Peripheral Vascular, Inc.
1625 West 3rd Street
7HPSH$=
86$
TEL: 1-480-894-9515
1-800-321-4254
)$; 1-800-440-5376
www.bardbiopsy.com
Authorised Representative
in the European Community
Bard Limited
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Tilgate Forest Business Park
Brighton Road, Crawley
West Sussex
5+%38.
PK1279600 Rev. 

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