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ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: 800-927-4669;
Tel: +1 903-675-9321
www.argonmedical.com
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
+31 70 345 8570
Argon Medical Devices UK Ltd
Eastgate Business Centre
Eastern Avenue
Burton-on-Trent
Staffordshire
DE13 0AT
https://www.argonmedical.com/resources/product-information
The symbols glossary is located electronically at
English
www.argonmedical.com/symbols
Речникът на символите е наличен в електронен вид на адрес
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A szimbólumok összefoglalása elektronikusan itt található:
Hungarian
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Il glossario dei simboli è disponibile in formato elettronico all'indirizzo
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O glossário de símbolos está localizado eletronicamente no endereço
Portuguese
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Glosarul simbolurilor este stocat electronic la
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Glosár symbolov je v elektronickej podobe k dispozícii na stránkach
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Slovar simbolov se nahaja v elektronski obliki na
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Swedish
Symbolförklaringen hittas elektroniskt på www.argonmedical.com/symbols
Semboller sözlüğü elektronik ortamda www.argonmedical.com/symbols
Turkish
adresinde yer almaktadır
Arabic
‫ﯾﺗوﻓر ﻣﺳرد اﻟرﻣوز إﻟﻛﺗروﻧ ﯾ ً ﺎ ﻋﻠﻰ‬www.argonmedical.com/symbols
ENGLISH
Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.
INTENDED USE/PURPOSE: The SuperCore™ Biopsy Instrument is a semi-automatic biopsy
instrument used to obtain soft tissue biopsies.
DEVICE DESCRIPTION: The SuperCore™ Biopsy Instrument is composed of an echogenic
spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen
collection. The position of the needle may be visualized by x-ray, CT or ultrasound. The needle
has numerically ordered centimeter markings to facilitate precise depth placement. The
adjustable instrument allows for a throw of 1.2cm or 2.2cm exposing the specimen notch either
19mm or 9.5mm, providing clinical flexibility.
The SuperCore™ Biopsy Instrument packaged with a co-axial introducer needle has a
supplemental male/female Luer adapter to allow for length adjustment through the coaxial
introducer when the instrument is used at the 1.2cm throw.
INDICATIONS FOR USE: Disposable guillotine soft tissue instrument for obtaining percutaneous
or surgical histological samples, (e.g. lung, liver, spleen, kidney, prostate, lymph nodes, breast,
thyroid, and pancreas).
CONTRAINDICATIONS: These needles should be used by a physician familiar with the possible
side effects, typical findings, limitations, indications and contraindications of soft tissue biopsy.
Physician judgment is required when considering biopsy on patients with bleeding disorder or
receiving anti-coagulant medications.
Side Effect/Risk
• It is not uncommon for patients to experience bleeding, infection at insertion site, fever, pain
at the biopsy site, swelling at the biopsy site, adjacent tissue injury and hematoma after the
biopsy. When used as intended by a physician, the benefits of using the SuperCore Biopsy
Instrument outweigh the risks associated with the use of the device.
WARNINGS
• Contents are supplied sterile and are intended for single use only. Do not reuse, reprocess
or re-sterilize this device.
• Reuse or reprocessing
patient illness, infection or other injury.
• Inspect the package integrity before use.
• Do not use if package is open or damaged and if the expiry date has been exceeded.
• Do not continue to use if any of the component are damaged during the procedure.
• Functional tests are performed during manufacture. Do not try to "dry fire" the device.
PRECAUTIONS
• The device should be used by a qualified, licensed physician.
• Handle in a manner that will prevent accidental puncture.
• This instrument can be used with an appropriate Co-Axial Introducer Needle.
Caution: Other manufacturer's co-axial introducer needles have not been tested for
compatibility with the SuperCore™ Biopsy Instrument.
NOTE: These instructions are NOT meant to define or suggest any medical or surgical technique.
The individual practitioner is responsible for the proper procedure and techniques to be used with this
device.
PREPARATION AND DIRECTION FOR USE
1. Optional use of co-axial introducer needle with biopsy instrument: Advance the co-axial
introducer needle, using standard technique, to a position proximal to the lesion. Position
the adjustable needle stop proximal to the skin. Remove the stylet from the co-axial
introducer needle, leaving the cannula in position.
2. Cock the SuperCore™ biopsy instrument by pulling back on the plunger as in fig. 1 until a firm
click is felt at either the 1.2cm or 2.2cm position. (User selectable.)
1
2.1. If using the 1.2cm position with a co-axial introducer needle, install the male/female Luer
adapter onto the co-axial cannula as in fig 2. before proceeding.
2
1
©2013-2017 Argon Medical Devices, Inc. All rights Reserved
SuperCore™ is a trademark of Argon Medical Devices, Inc.
SuperCore™ Biopsy Instrument
has
not been evaluated and may lead to its failure and subsequent
X9585762/1120A

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Resumen de contenidos para Argon SuperCore

  • Página 1 Croatian www.argonmedical.com/symbols 2. Cock the SuperCore™ biopsy instrument by pulling back on the plunger as in fig. 1 until a firm click is felt at either the 1.2cm or 2.2cm position. (User selectable.) A szimbólumok összefoglalása elektronikusan itt található: Hungarian www.argonmedical.com/symbols...
  • Página 2: Предпазни Мерки

    игла, като оставите канюлата на място. careful not to push plunger past first stop during this step (fig. 5). 2. Заредете инструмента за биопсия SuperCore™, като издърпате назад буталото, както е показано на Фиг. 1, докато почувствате отчетливо щракване в положение 1,2 см или...
  • Página 3 Vyjměte stylet z koaxiální zaváděcí jehly a kanylu ponechte v poloze. 2. Natáhněte nástroj na biopsii SuperCore™ zatažením za píst, jak je znázorněno na obr. 1, dokud nepocítíte pevné cvaknutí na pozici 1,2 cm nebo 2,2 cm. (Volitelné uživatelem.) 5.
  • Página 4 SuperCore™ Biopsieinstrument 2. Sæt SuperCore™-biopsiinstrumentet i ved at trække stemplet tilbage som i fig. 1, indtil der mærkes et fast klik ved enten 1,2 cm eller 2,2 cm position. (Bruger kan vælge.) VERWENDUNGSZWECK: Bei dem SuperCore™ Biopsieinstrument handelt es sich um ein halbautomatisches Biopsieinstrument zur Entnahme von Weichgewebe-Biopsieproben.
  • Página 5 Koaxial-Einführungsnadel entfernen, die Kanüle aber in ihrer Position lassen. HINWEIS: Falls ein schwerwiegender Vorfall im Zusammenhang mit diesem Instrument 2. Den Kolben des SuperCore™ Biopsieinstruments wie in Abb. 1 kräftig zurückziehen, bis auftritt, sollte das Ereignis Argon Medical unter quality.regulatory@argonmedical.com an der 1,2- oder 2,2-cm-Position ein fester Klick spürbar ist.
  • Página 6 στη θέση του. ΑΠΟΘΉΚΕΥΣΗ: Αποθηκεύστε το σε κανονική θερμοκρασία περιβάλλοντος. 2. Οπλίστε το όργανο βιοψίας SuperCore™ τραβώντας προς τα πίσω το έμβολο όπως στην εικόνα 1 έως ότου νιώσετε ότι ασφαλίζει καλά είτε στη θέση 1,2 cm είτε στη θέση 2,2 cm.
  • Página 7 NOTA: En caso de que ocurra un incidente grave relacionado con este dispositivo, se 2. Prepare el instrumento para biopsia SuperCore™ tirando del émbolo como se muestra en la figura 1 hasta sentir un clic firme en la posición de 1,2 cm o 2,2 cm. (Seleccionable por debe informar el hecho a Argon Medical en quality.regulatory@argonmedical.com, así...
  • Página 8: Laitteen Kuvaus

    Aseta säädettävä neulastoppari proksimaalisesti ihoon nähden. Posta suuhakanen neulasta, jättäen kanyylin paikalleen. 2. Viritä SuperCore™ biopsiainstrumentti vetämällä mäntää kuten kuvassa 1, kunnes tuntuu sekä napsahdus joko 1,2 cm tai 2,2 cm kohdassa.. (Käyttäjän valittavissa.) 5. Tõmmake nõel välja. Tõmmake kolb tagasi 1,2 või 2,2 cm asendisse, laadides vedru uuesti.
  • Página 9 2. Armez l'instrument de biopsie SuperCore™ en tirant sur le piston comme illustré à la 5. Vedä neula ulos. Viritä jousi vetämällä mäntä takaisin 1,2 tai 2,2 cm asentoon. Vedä mäntä figure 1, jusqu'à ce qu'un déclic ferme soit ressenti à la position 1,2 cm ou 2,2 cm.
  • Página 10 NAMJENA: instrument za biopsiju SuperCore™ poluautomatski je instrument za biopsiju koji se koristi za obavljanje biopsija mekanog tkiva. OPIS UREĐAJA: instrument za biopsiju SuperCore™ sastoji se od ehogene igle za biopsiju 4. Pomaknite klip palcem do prvog graničnika, čime pomičete stilet i otkrivate urez za uzorak s oprugom, postavljene u plastičnu hvataljku koja omogućuje uzimanje uzorka jednom rukom.
  • Página 11 1,2 cm o 2,2 cm esponendo 19 mm o 9,5 mm dell’intaglio del campione in modo da offrire flessibilità per varie condizioni cliniche. Lo strumento per biopsia SuperCore™ fornito con ago introduttore coassiale è dotato di un 2.1. Ha koaxiális bevezető tűt 1,2 cm-es helyzetben használja, akkor a folytatás előtt adattatore Luer maschio/femmina supplementare, per consentire di regolare la lunghezza helyezze el az apa/anya Luer-adaptert a koaxiális kanülön a 2.
  • Página 12 Avvertenza: fare attenzione a non premere il pistone prima che l’ago sia nella ir hematomą. Kai „SuperCore“ biopsijos instrumentą gydytojas naudoja taip, kaip posizione desiderata. Verificare che la posizione dell’ago sia corretta.
  • Página 13: Piesardzības Pasākumi

    LAIKYMAS: laikykite įprastoje kambario temperatūroje. ievietota vajadzīgajā vietā. Pārbaudiet, vai adata atrodas pareizajā vietā. PASTABA: jei įvyksta su šiuo prietaisu susijęs svarbus incidentas, apie jį reikia pranešti „Argon Medical“ adresu quality.regulatory@argonmedical.com ir kompetentingai sveikatos priežiūros institucijai naudotojo / paciento gyvenamojoje vietoje.
  • Página 14 5. Izvelciet adatu. Pavelciet virzuli atpakaļ 1,2 vai 2,2 cm pozīcijā, atkārtoti uzvelkot atsperi. 2. Haak het SuperCore™-biopsie-instrument af door de plunjer terug te trekken zoals in fig. 1, Nospiediet virzuli līdz pirmajam atdurim, atklājot parauga iecirtumu. Izņemiet audu paraugu totdat een stevige klik wordt gevoeld op de 1,2 cm of 2,2 cm positie.
  • Página 15 2. Spenn hanen på SuperCore™ biopsiinstrumentet ved å trekke stempelet bakover som i POLISH fig. 1 til et tydelig klikk kjennes enten ved posisjon 1,2 cm eller 2,2 cm. (Kan velges av brukeren.)
  • Página 16 Utylizować zgodnie z obowiązującymi przepisami prawa i regulacjami. pozostawiając kaniulę na miejscu. 2. Ustawić urządzenie do biopsji SuperCore™, odciągając tłok, jak pokazano na rys. 1, do PRZECHOWYWANIE: przechowywać w temperaturze pokojowej. momentu usłyszenia głośnego kliknięcia w pozycji 1,2 cm lub 2,2 cm. (Zgodnie z wyborem użytkownika.)
  • Página 17 2. Arme o Instrumento de Biópsia SuperCore™ puxando o êmbolo para trás, conforme ARMAZENAMENTO: Guarde à temperatura ambiente normal. ilustrado na fig. 1, até sentir um “clique” firme na posição de 1,2 cm ou 2,2 cm.
  • Página 18: Bezpečnostné Upozornenia

    în locația dorită. Verificați locația corespunzătoare a acului. vpichu, horúčka, bolesť v mieste biopsie, opuch v mieste biopsie, poranenie susedného tkaniva a hematóm. Ak lekár používa inštrument na biopsiu SuperCore v súlade so zamýšľaným použitím, výhody plynúce z použitia inštrumentu prevyšujú riziká spojené...
  • Página 19: Previdnostni Ukrepi

    S koaksialne uvajalne igle odstranite stilet, vendar pustite kanilo na svojem mestu. 2. Inštrument SuperCore™ za biopsijo napnite tako, da bat povlečete nazaj, kot je prikazano na sliki 1, dokler se dobro ne zaskoči na mestu 1,2 ali 2,2 cm. (Po izbiri uporabnika.) 5.
  • Página 20 Ta bort sonden från den koaxiella införingsnålen och lämna kanylen på plats. 2. Spänn SuperCore™-biopsi-instrumentet genom att dra tillbaka kolven som visas i fig. 1 tills ett stadigt klick känns vid i antingen 1,2 cm- eller 2,2 cm-positionen. (Användaren kan välja.)
  • Página 21 2. SuperCore™ biyopsi cihazını, 1,2 cm veya 2,2 cm konumunda tamamen yerine oturduğu quality.regulatory@argonmedical.com adresinden Argon Medical'e ayrıca hissedilene kadar pistonu 1. şekildeki gibi geri çekerek sabitleyin. (Kullanıcı tarafından kullanıcının/hastanın ikamet ettiği yerdeki yetkili sağlık makamına bildirilmelidir.
  • Página 22 .‫ﯾﻣﻛن اﺳﺗﺧدام ھذه اﻷداة ﻣﻊ إﺑرة ﻏرز ﻣﺗﺣدة اﻟﻣﺣور ﻣﻧﺎﺳﺑﺔ‬ • .™ SuperCore ‫ﻟم ﯾﺗم اﺧﺗﺑﺎر إﺑر اﻟﻐرز ﻣﺗﺣدة اﻟﻣﺣور ﻣن ﻗﺑل اﻟﻣﺻﻧﻌﯾن اﻵﺧرﯾن ﻟﻠﺗﺄﻛد ﻣن ﺗواﻓﻘﮭﺎ ﻣﻊ أداة اﻟﺧزﻋﺔ‬ :‫ﺗﺣذﯾر‬ ‫: ﺑﻌد اﻻﺳﺗﺧدام، ﻗد ﯾﻣﺛل ھذا اﻟﻣﻧﺗﺞ ﺧطر ً ا ﺑﯾوﻟوﺟ ﯾ ًﺎ ﻣﺣﺗﻣﻼ ً . أﻣﺳك‬...

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