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COOK Medical BIGopsy BLB-024115, Инструкция по эксплуатации

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ENGLISH

BIGOPSY® BACKLOADING BIOPSY FORCEPS 

CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a 

physician (or properly licensed practitioner).

INTENDED USE

The BIGopsy® Backloading Biopsy Forceps is intended for obtaining tissue samples for 

pathological evaluation. The device may also be used for retrieval of specimens from the 

urinary tract. 

DEVICE DESCRIPTION

The BIGopsy® Backloading Biopsy Forceps is a stainless-steel biopsy device capable of a 4mm³ 

sample size. The forceps shaft is 2.4Fr 115cm long with a removable handle. 

CONTRAINDICATIONS

Contraindications include coagulopathy and those specific to the primary ureteroscopic 

procedure performed in gaining access to the desired biopsy or retrieval site.

POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to: allergic reaction to nickel, bleeding, 

fever, infection, nausea/vomiting, pain/discomfort, perforation.

PRECAUTIONS

This device is intended for use by physicians trained and experienced in ureteroscopic 

procedures. Standard techniques for urology should be employed.

This device should be used with a ureteral access sheath. Ensure the biopsy cups are closed 

before surgical introduction. Do not depress the button during use, the handle will release 

from the forceps.

Do not use this device for any purpose other than the stated intended use. 

Store in a dry location, away from temperature extremes.

WARNINGS

This device is designed for single use only. Attempts to reprocess, re-sterilize, and/or reuse 

may lead to device failure and/or transmission of disease.

This device is conductive. Avoid contact with any electrified instrument. Do not force the 

device during the procedure; proceed with caution if excessive resistance is encountered. 

Visually inspect the product to ensure no damage has occurred. If the package is opened or 

damaged when received, do not use. If an abnormality is detected that would prohibit proper 

working condition, do not use. Please notify Cook for return authorization.

INSTRUCTIONS FOR USE 

Illustrations

1.  Prior to attaching the handle, back load the BIGopsy® forceps into the working channel 

of the endoscope. Note: The BIGopsy® Backloading Biopsy Forceps component parts are 

indicated in Fig. 1.

Содержание BIGopsy BLB-024115

Страница 1: ...ioni per l uso BIGopsy apv rsti ievietojam s biopsijas spailes Lieto anas instrukcija BIGopsy i galo ki amos biopsijos nypl s Naudojimo nurodymai BIGopsy biopsitang for baklasting Bruksanvisning Klesz...

Страница 2: ...canalata Finestra di visualizzazione Anello per pollice Poga Pirkstu rull tis Skatlodzi k a gredzens Mygtukas Laikiklis pir tams Langelis Nyk io iedas Knapp Fingerspole Observasjonsvindu Tommelring Pr...

Страница 3: ...3...

Страница 4: ...4...

Страница 5: ...opic procedures Standard techniques for urology should be employed This device should be used with a ureteral access sheath Ensure the biopsy cups are closed before surgical introduction Do not depres...

Страница 6: ...orward Fig 4b Note Biopsy cups need to be in the closed position before surgical introduction 4 Through a previously placed ureteral access sheath advance endoscope with the forceps to the desired bio...

Страница 7: ...7 BIGOPSY BIGopsy BIGopsy 4 mm 2 4 Fr 115 cm...

Страница 8: ...8 Cook 1 BIGopsy BIGopsy 1 2 a b 2 c 3a 3b 3c 3 4a 4b 4 5 6 a b 2 7 BIGopsy 8...

Страница 9: ...PE NOSTN OPAT EN Tento prost edek je ur en k pou it l ka i kte jsou vy koleni v ureteroskopick ch v konech a maj s nimi zku enosti Je t eba pou vat standardn urologick techniky Toto za zen se mus pou...

Страница 10: ...hn te v eteno sm rem ke krou ku obr 4a Chcete li je zav t posu te v eteno dop edu obr 4b Pozn mka Bioptick elisti mus b t p ed chirurgick m zaveden m v zav en poloze 4 Endoskop s kle t mi posunujte p...

Страница 11: ...ehag perforation FORHOLDSREGLER Dette produkt er beregnet til anvendelse af l ger der er uddannet i og har erfaring med ureteroskopiske procedurer Der skal anvendes standardmetoder til urologi Denne a...

Страница 12: ...kke fingerspolen mod tommelfingerringen Fig 4a Skub fingerspolen fremad for at lukke kopperne Fig 4b Bem rk Biopsikopper skal v re i lukket position inden kirurgisk indf ring 4 F r endoskopet med tang...

Страница 13: ...zijn niet beperkt tot allergische reactie op nikkel bloeding koorts infectie misselijkheid braken pijn ongemak perforatie VOORZORGSMAATREGELEN Dit instrument is bestemd voor gebruik door artsen met t...

Страница 14: ...t voordat de tang wordt ingebracht voor het uitvoeren van de ingreep De bek van de biopsietang is standaard gesloten De bek van de biopsietang wordt geopend door de vingerklos naar de duimring te trek...

Страница 15: ...rforatsioon ETTEVAATUSABIN UD Antud seade on ette n htud kasutamiseks ainult uretroskoopiaprotseduuride alase koolituse ja kogemustega arstidele Kasutada tuleb standardseid uroloogilisi tehnikaid Sead...

Страница 16: ...poole Joon 4a Sulgemiseks l kake s rml litit ettepoole Joon 4b M rkus Enne kirurgilist sisestamist peavad biopsiatangide haaratsid olema suletud asendis 4 Paigaldage kusitile ligip su h lbustav mbris...

Страница 17: ...rables potentiels comprennent sans toutefois s y limiter r action allergique au nickel saignement fi vre infection naus es vomissements douleurs inconfort perforation MISES EN GARDE Ce dispositif est...

Страница 18: ...avant son introduction chirurgicale Les mors de la pince biopsie reviennent par d faut en position ferm e Pour ouvrir les mors de la pince biopsie tirer le d vidoir vers l anneau repose pouce Fig 4a...

Страница 19: ...ist f r die Verwendung durch rzte vorgesehen die in ureteroskopischen Verfahren geschult und erfahren sind Die Standardtechniken f r Urologie sind anzuwenden Das Instrument ist mit einer Ureterzugangs...

Страница 20: ...rgriffspule in Richtung Daumenring ziehen Abb 4a Zum Schlie en der Branchen die Fingergriffspule nach vorne schieben Abb 4b Hinweis Vor der chirurgischen Einf hrung m ssen sich die Biopsiebranchen in...

Страница 21: ...21 BIGOPSY BIGopsy BIGopsy 4 mm 2 4 Fr 115 cm...

Страница 22: ...22 Cook 1 BIGopsy BIGopsy 1 2 a b 2 c 3a 3b 3c 3 4a 4b 4 5 6 a b 2 7 BIGopsy 8...

Страница 23: ...nemk v natos esem nyek t bbek k z tt de nem kiz r lag allergi s reakci nikkelre v rz s l z fert z s melyg s h ny s f jdalom k nyelmetlens g rzet perfor ci VINT ZKED SEK Az eszk zt az ureteroszk pos e...

Страница 24: ...ogy a biopszi s mintagy jt m k d k pes llapotban van A biopszi s mintagy jt alap rtelmezett helyzetben z rva van A biopszi s mintagy jt kinyit s hoz h zza az ujjt maszt a h velykujjgy r fel 4a bra Z r...

Страница 25: ...ione allergica al nichel sanguinamento febbre infezione nausea vomito dolore disagio perforazione PRECAUZIONI L uso di questo dispositivo riservato ai medici debitamente addestrati e in possesso della...

Страница 26: ...sitivo verificare il funzionamento delle coppette bioptiche La posizione di partenza delle coppette bioptiche chiusa Per aprire le coppette bioptiche tirare la ghiera scanalata verso l anello per poll...

Страница 27: ...iju PIESARDZ BAS PAS KUMI ier ce paredz ta lieto anai rstiem kas apm c ti un kam ir pieredze ureteroskopijas proced ru veik an J izmanto parastie urolo ijas pa mieni o ier ci vajadz tu lietot ar urete...

Страница 28: ...i us pavelciet pirkstu rull ti k a gredzena virzien 4 a att Lai aizv rtu pastumiet pirkstu rull ti uz priek u 4 b att Piez me pirms irur iskas ievad anas biopsijas kausi iem j b t aizv rt st vokl 4 Ca...

Страница 29: ...as skausmas ir arba diskomfortas perforacija ATSARGUMO PRIEMON S is prietaisas skirtas naudoti gydytojams i mokytiems atlikti ureterskopines proced ras ir turintiems j atlikimo patirties Reikia taikyt...

Страница 30: ...lius patraukite laikikl pir tams nyk io iedo link 4a pav Nor dami suglausti kau elius pastumkite laikikl pir tams priek 4b pav Pastaba prie chirurgi kai terpiant kau eliai turi b ti suglausti 4 Per an...

Страница 31: ...kopiske prosedyrer Standard teknikker for urologi skal brukes Denne anordningen skal brukes med en uretertilgangshylse Pass p at biopsikoppene er lukket f r kirurgisk innf ring Ikke trykk ned knappen...

Страница 32: ...g 4b Merk Biopsikoppene trenger v re i lukket posisjon f r kirurgisk innf ring 4 Fremf r endoskopet med tangen gjennom en forh ndsplassert uretertilgangshylse til nsket biopsi eller uthentingssted og...

Страница 33: ...owadzanej w celu uzyskania dost pu do danego miejsca biopsji lub miejsca pobierania MO LIWE ZDARZENIA NIEPO DANE Mo liwe zdarzenia niepo dane to mi dzy innymi reakcja alergiczna na nikiel krwawienie g...

Страница 34: ...ie 3 Po zamocowaniu uchwytu i przed rozpocz ciem chirurgicznej procedury wprowadzania upewni si e cz ci chwytne kleszczyk w do biopsji dzia aj prawid owo Cz ci chwytne kleszczyk w do biopsji s domy ln...

Страница 35: ...mito dor desconforto perfura o PRECAU ES Este dispositivo deve ser utilizado por m dicos com forma o e experientes em procedimentos ureterosc picos Devem ser empregues t cnicas padr o para urologia D...

Страница 36: ...e cil ndrico para apoio de dedos na dire o do anel para o polegar Fig 4a Para fechar empurre o componente cil ndrico para apoio de dedos para a frente Fig 4b Nota Antes da introdu o cir rgica as ponta...

Страница 37: ...n iale includ dar f r a se limita la reac ie alergic la nichel s ngerare febr infec ie gre uri v rs turi durere disconfort perfora ie PRECAU II Acest dispozitiv este destinat utiliz rii de c tre medic...

Страница 38: ...func ionale nainte de introducerea lor chirurgical Pozi ia implicit a cupelor de biopsie este cea nchis Pentru a deschide cupele de biopsie trage i man onul pentru degete nspre inelul pentru police Fi...

Страница 39: ...nos vracanie boles nepohodlie perfor cia BEZPE NOSTN OPATRENIA Pou itie pom cky je vyhraden pre lek rov vy kolen ch a sk sen ch na v kon uteroskopick ch postupov Je potrebn uplatni tandardn urologick...

Страница 40: ...ri potiahnite prstov vreteno smerom ku kr ku na palec obr 4a Ak ich chcete zatvori prstov vreteno potla te dopredu obr 4b Pozn mka Pred chirurgick m zaveden m musia by bioptick misky v zatvorenej polo...

Страница 41: ...Las reacciones adversas posibles incluyen entre otras reacci n al rgica al n quel hemorragia fiebre infecci n n useas y v mitos dolor y molestias y perforaci n PRECAUCIONES Este dispositivo est conce...

Страница 42: ...e biopsia funcionan correctamente antes de la introducci n quir rgica Por defecto las cazoletas de biopsia est n en la posici n cerrada Para abrir las cazoletas de biopsia tire del carrete para dedos...

Страница 43: ...n r avsedd att anv ndas av l kare med utbildning i och erfarenhet av ureteroskopiska tekniker Urologiska standardtekniker ska till mpas Den h r anordningen ska anv ndas tillsammans med en hylsa f r ur...

Страница 44: ...ingerspolen mot tumringen figur 4a F r att st nga dem ska du trycka fingerspolen fram t figur 4b Obs Biopsit ngsk ftarna m ste vara st ngda innan de anv nds f r kirurgisk inf ring 4 F r in endoskopet...

Страница 45: ...45...

Страница 46: ...46...

Страница 47: ...47...

Страница 48: ...COOK IRELAND LTD O Halloran Road National Technology Park Limerick Ireland COPYRIGHT COOK 2019 STERILE EO 2 Rx ONLY 2019 04 www cookmedical com IFU0034 8...

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