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H. Equipment Required:

The

ARD®

UIDE®

Coaxial Biopsy Needle is designed for use with

ARD®

disposable

-C

ORE®

and

ONOPTY®

biopsy instruments and

ARD®

AGNUM®

and

IOPTY

-C

UT®

disposable biopsy needles. Refer to applicable Instructions

for Use.

I. Directions for Use:

Needle Preparation:

Prior to use, determine the appropriate gauge and length of the needle

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(See Figure 1)

. Using

aseptic technique, remove the needle from the package and from the
protective sheath.

Figure 1

ARD®

Biopsy

Instrument

(

ONOPTY®

with 11mm

Penetration)

*DXJH[/HQJWK

ARD®

Biopsy

Instrument

(

ONOPTY®

ZLWKPP

Penetration,

and

-C

ORE®

)

*DXJH[/HQJWK

ARD®

UIDE®

Coaxial

Biopsy

Needle

Reorder No.

ARD®

Biopsy

Needle

(

IOPTY

-C

UT®

and

AGNUM®

)

*DXJH[/HQJWK

ARD®

UIDE®

Coaxial

Biopsy

Needle

Reorder No.

[

* Note:

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ARD®

UIDE®

Coaxial Biopsy Needles. The blunt tip stylet may be used

to manipulate through soft tissue and around vasculature or other organs to
minimize the risk of unintentional damage to these areas.

Biopsy Procedure:

The biopsy procedure must be performed using appropriate aseptic
technique.

Recommendation:

Prior to performing the procedure, ensure the stylet

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Retighten the stylet into the cannula and ensure the stylet is fully seated in
the cannula prior to insertion into the patient.
1.

Prepare site as required. Adequate anesthesia should be administered
prior to incision of the skin.

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placement depth.

Determine which stylet is preferred. If the trocar tip stylet is selected,

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and turn the trocar tip stylet hub counter-clockwise to remove the trocar
tip stylet from the outer cannula.

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cannula needle hub and turn the blunt tip stylet needle hub clockwise
to engage the outer cannula hub.

Note:

For ease of insertion, puncture the skin with a scalpel at the entry site.

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ARD®

UIDE®

Coaxial

Biopsy needle proximal to the lesion to be biopsied using the depth
stop as an aid for proper placement and adjust as necessary.

Note:

The depth stop should be adjusted so that the needle is in proper

position when the depth stop is in contact with the skin. This will help
stabilize the

ARD®

UIDE®

Coaxial Biopsy Needle.

Hold the guiding cannula needle hub and turn the stylet hub
counterclockwise to remove the stylet from the outer cannula.

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ARD®

biopsy needle.

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ARD®

biopsy needle through the guiding cannula

to the lesion to be biopsied.

9. Perform the biopsy and remove the biopsy needle from the guiding

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ENGLISH

Содержание TRUGUIDE

Страница 1: ...Utiliza o BARD TRUGUIDE BARD TRUGUIDE engangs koaksial biopsikanyle Brugsanvisning BARD TRUGUIDE koaxial biopsin l f r eng ngsbruk Bruksanvisning Kertak ytt inen koaksiaalinen BARD TRUGUIDE biopsianeu...

Страница 2: ......

Страница 3: ...the presence RI VXVSLFLRXV UDGLRJUDSKLF QGLQJV GRHV QRW SUHFOXGH WKH SUHVHQFH of carcinoma 4 The BARD TRUGUIDE Disposable Coaxial Biopsy Needle has been designed for single use only Reusing this medi...

Страница 4: ...d in the cannula prior to insertion into the patient 1 Prepare site as required Adequate anesthesia should be administered prior to incision of the skin I SUHIHUUHG SODFH WKH VXSSOLHG GHSWK VWRS DW WK...

Страница 5: ...r and tear from normal use or defects resulting from misuse of this product are not covered by this limited warranty TO THE EXTENT ALLOWABLE BY APPLICABLE LAW THIS LIMITED PRODUCT WARRANTY IS IN LIEU...

Страница 6: ...our viter et ou pour traiter des complications ventuelles pouvant tre li es aux proc dures biopsiques 3 La collecte de plusieurs chantillons biopsiques l aiguille peut permettre la d tection de tout t...

Страница 7: ...D R f pour commander Remarque un stylet extr mit mousse suppl mentaire est livr avec toutes les aiguilles biopsie coaxiale TRUGUIDE BARD GLDPqWUH HW H VW OHW j H WUpPLWp PRXVVH SHXW rWUH XWLOLVp GDQV...

Страница 8: ...tirer l aiguille biopsie coaxiale TRUGUIDE BARD Garantie Bard Peripheral Vascular garantit l acheteur d origine que ce produit est exempt de d fauts mat riels et de malfa on pendant une p riode G XQ D...

Страница 9: ...dheitszustand des jeweiligen Patienten variieren Die Vitalfunktionen m ssen berwacht werden und andere Vorsichtsma nahmen sind zu ergreifen um potentielle mit den Biopsieverfahren einhergehende Kompli...

Страница 10: ...Siehe Abbildung 1 Unter Beachtung aseptischer Kautelen die Nadel aus der Verpackung und der Schutzh lse nehmen Abbildung 1 BARD Biopsieinstrument MONOPTY mit 11 mm Penetration Gauge Au en durchmesser...

Страница 11: ...die TRUGUIDE Kan le mit steriler feuchter Gaze reinigen Dies tr gt dazu bei dass sich die Biopsienadel zur Entnahme von Gewebezylindern ungehindert in der Kan le bewegen kann 11 Den Mandrin wieder ei...

Страница 12: ...auzioni per evitare e o curare potenziali complicanze associabili alle procedure bioptiche 3 Il prelievo di numerosi frustoli bioptici potrebbe facilitare il rilevamento di tessuti cancerogeni Una bio...

Страница 13: ...iopsie BARD TRUGUIDE di calibro H LQFOXGRQR XQ PDQGULQR IDFROWDWLYR D SXQWD VPXVVD 4XHVWR mandrino a punta smussa pu essere utilizzato per la manipolazione attraverso il tessuto molle e per aggirare i...

Страница 14: ...amente il mandrino ed estrarre l Ago Coassiale per Biopsie BARD TRUGUIDE Garanzia Bard Peripheral Vascular garantisce all acquirente originario che il prodotto sar esente da difetti di materiali e man...

Страница 15: ...e n cleos de aguja m ltiples puede contribuir a detectar cualquier tejido cancer geno Una biopsia negativa HQ SUHVHQFLD GH UHVXOWDGRV UDGLRJUi FRV VRVSHFKRVRV QR descarta la presencia de carcinoma 4 L...

Страница 16: ...el riesgo de da ar involuntariamente estas zonas Procedimiento de biopsia El procedimiento de biopsia se realizar con las t cnicas as pticas debidas Recomendaci n QWHV GH UHDOL DU HO SURFHGLPLHQWR DV...

Страница 17: ...ULYDGD GH OD JDUDQWtD OLPLWDGD GH HVWH SURGXFWR VH OLPLWDUi D OD UHSDUDFLyQ R VXVWLWXFLyQ GHO SURGXFWR GHIHFWXRVR VyOR D GLVFUHFLyQ GH DUG 3HULSKHUDO 9DVFXODU R DO UHHPEROVR GHO precio neto pagado Est...

Страница 18: ...te worden geobserveerd en andere voorzorgsmaatregelen te worden getroffen 3 Het verzamelen van meerdere naaldkernen kan meer zekerheid verschaffen bij het ontdekken van eventueel kankerweefsel Een neg...

Страница 19: ...UT en MAGNUM Dikte x lengte BARD TRUGUIDE coaxiale biopsienaald Bestelnr NB Alle BARD TRUGUIDE FRD LDOH ELRSVLHQDDOGHQ YDQ HQ LMQ voorzien van een optionele stilet met stompe punt De stilet met stompe...

Страница 20: ...coaxiale biopsienaald Garantie Bard Peripheral Vascular garandeert aan de oorspronkelijke koper van dit product dat dit product vrij is van materiaal en fabricagefouten gedurende een periode van n ja...

Страница 21: ...em tomar se outras precau es para evitar e ou tratar complica es potenciais que possam estar associadas a t cnicas de biopsia 3 A colheita de m ltiplas biopsias por pun o tecidular podem constituir um...

Страница 22: ...Biopsia Coaxial BARD TRUGUIDE N de encomenda Nota Inclui se um estilete opcional de ponta romba com todas as Agulhas de biopsia coaxial BARD TRUGUIDE GH FDOLEUH H O estilete de ponta romba poder ser...

Страница 23: ...l BARD TRUGUIDE Garantia A Bard Peripheral Vascular garante ao primeiro comprador deste produto que o mesmo estar isento de defeitos de materiais e de m o de obra durante o per odo de um ano a partir...

Страница 24: ...BARD TRUGUIDE XHU XHU BARD TRUGUIDE BARD BARD BARD JDXJH JDXJH JDXJH JDXJH JDXJH BARD JDXJH TRUGUIDE BARD JDXJH JDXJH BARD BARD TRUGUIDE BARD JDXJH 4 BARD TRUGUIDE 5 BARD TRUGUIDE...

Страница 25: ...DE BARD 0AX CORE 0ONOPTY BARD 0AGNUM IOPTY CUT ARD t t BARD MONOPTY DXJH t t BARD MONOPTY MAX CORE DXJH t TRUGUIDE BARD t BARD BIOPTY CUT MAGNUM DXJH t TRUGUIDE BARD TRUGUIDE JDXJH BARD WURFDU WURFDU...

Страница 26: ...TRUGUIDE BARD TRUGUIDE BARD BARD TRUGUIDE BARD TRUGUIDE TRUGUIDE BARD DUG 3HULSKHUDO 9DVFXODU DUG 3HULSKHUDO 9DVFXODU 5 3 5 3 5 9 6 8 5 DUG 3HULSKHUDO 9DVFXODU QF...

Страница 27: ...JUD VNH UHVXOWDWHU XGHOXNNHU LNNH WLOVWHGHY UHOVHQ af et carcinom 4 BARD TRUGUIDE koaksial biopsikanyle til engangsbrug er kun beregnet til engangsbrug Genbrug af anordningen indeb rer risiko for kryd...

Страница 28: ...ontroll r at stiletten er placeret helt inde i katetret forud for indf ringen i patienten 1 Klarg r stedet efter behov Tilstr kkelig an stesi skal indgives forud for incision i huden YLV GHW IRUHWU NN...

Страница 29: ...af produktet er ikke omfattet af denne begr nsede garanti I DEN UDSTR KNING DER ER TILLADT I G LDENDE LOV TR DER DEN BEGR NSEDE PRODUKTGARANTI I STEDET FOR ALLE ANDRE GARANTIER DET V RE SIG UDTRYKKEL...

Страница 30: ...t uppt cka eventuell cancerv vnad En negativ biopsi PHG EHWlQNOLJD U QWJHQRJUD VND I QG XWHVOXWHU LQWH I UHNRPVW av carcinom 4 BARD TRUGUIDE koaxial biopsin l f r eng ngsbruk r enbart avsedd f r eng n...

Страница 31: ...duren m ste utf ras p ett l mpligt aseptiskt s tt Rekommendation Innan ingreppet utf rs kontrollera att du l tt kan avskilja mandrinen fr n kanylen genom att lossa fattningarna Dra t mandrinen i kanyl...

Страница 32: ...LQJ DY HUODJW QHWWRSULV 1RUPDOW VOLWDJH HOOHU skador som uppkommit p grund av felaktig anv ndning av produkten t cks inte av denna begr nsade garanti OM DET R TILL TET ENLIGT G LLANDE LAG ERS TTER DEN...

Страница 33: ...a ja muita varotoimenpiteit noudattaa biopsiasta mahdollisesti aiheutuvien komplikaatioiden ehk isemiseksi hoitamiseksi 3 Useamman kuin yhden n ytteen ottaminen voi auttaa havaitsemaan mahdollisen sy...

Страница 34: ...ksiaalisten biopsianeulojen mukana toimitetaan valinnainen tylpp k rkinen mandriini Tylpp k rkist mandriinia voidaan k ytt manipulointiin pehmytkudoksen l pi ja verisuonten tai muiden elinten l hist l...

Страница 35: ...k valmistusvirheit yhteen vuoteen sen ensimm isest ostop iv st l htien ja Bard Peripheral Vascula rin vastuu t m n rajoitetun takuun nojalla rajoittuu viallisen tuotteen korjaamiseen tai vaihtamiseen...

Страница 36: ...GUIDE engangs koaksial biopsin l er utviklet kun for engangsbruk Dersom denne medisinske anordningen brukes om igjen inneb rer det en risiko for krysskontaminering av pasienter siden medisinske anordn...

Страница 37: ...skal gis tistrekkelig anestesi f r snitt i huden HUVRP QVNHOLJ NDQ PHGI OJHQGH G EGHVWRSSHU SODVVHUHV Sn forh ndsbestemt dybde 3 Bestem hvilken stilett som foretrekkes Dersom det velges stilett PHG W...

Страница 38: ...TT I GJELDENDE LOVVERK ER DENNE BEGRENSEDE PRODUKTGARANTIEN I STEDET FOR ALLE ANDRE GARANTIER ENTEN UTTRYKKELIGE ELLER UNDERFORST TTE INKLUDERT MEN IKKE BEGRENSET TIL EVENTUELLE UNDERFORST TTE GARANTI...

Страница 39: ...Uy QLFRZDQHM RSLHNL SR DELHJX E XQLNQ Z VW SLHQLD PR OLZ FK SRZLN D ZL DQ FK SU HSURZDG RQ ELRSVM D WDN H SRGF DV LFK OHF HQLD QDOH SRGM REVHUZDFM F QQR FL FLRZ FK SDFMHQWD L LQQH URGNL RVWUR QR FL 3...

Страница 40: ...XJR VSy RVLRZD LJ D ELRSV MQD BARD TRUGUIDE 1U SRZWyUQHJR DPyZLHQLD Uwaga RGDWNRZ PDQGU Q W S P NR FHP QDMGXMH VL Z HVWDZLH ZV VWNLFK ZVSy RVLRZ FK LJLH GR ELRSVML BARD TRUGUIDE R UR PLDUDFK L 0DQGU...

Страница 41: ...LRZ LJ ELRSV MQ BARD TRUGUIDE Gwarancja Firma Bard Peripheral Vascular gwarantuje pierwszemu nabywcy QLQLHMV HJR SURGXNWX H SURGXNW WHQ E G LH ZROQ RG ZDG PDWHULD RZ FK i wykonania przez okres jednego...

Страница 42: ...tja b rmilyen rosszindulat daganat felismer s nek es ly t A negat v biopszi s eredm ny J DQ W NHOW UDGLROyJLDL OHOHWHN PHOOHWW QHP iUMD NL D FDUFLQRPD OHKHW VpJpW 4 A BARD TRUGUIDE egyszer haszn latos...

Страница 43: ...amata ELRSV LiW PHJIHOHO DV HSWLNXV WHFKQLNiYDO NHOO HOYpJH QL Javaslat EHDYDWNR iV HOYpJ pVH HO WW J GM Q PHJ DUUyO KRJ D FVDWODNR yN PHJOD tWiViYDO D PDQGULQ QHKp VpJ QpON O HOYiODV WKDWy D NDQ OW O...

Страница 44: ...W WHUPpNV DYDWRVViJ V HULQWL MyWiOOiV D DUG 3HULSKHUDO 9DVFXODU NL iUyODJRV G QWpVH DODSMiQ D KLEiV WHUPpN MDYtWiViUD YDJ FVHUpMpUH YDJ D NL HWHWW QHWWy YpWHOiU YLVV D HWpVpUH WHUMHG NL JDUDQFLD QHP Y...

Страница 45: ...MLVWLW S tWRPQRVW UDNRYLQQp WNiQ 1HJDWLYQt ELRSVLH Y S tWRPQRVWL SRGH HO FK UDGLRJUD FN FK QiOH QHY OX XMH PR QRX S tWRPQRVW NDUFLQRPX 4 Jednor zov koaxi ln bioptick jehla BARD TRUGUIDE MH XU HQD SRX...

Страница 46: ...QWD VWLOHW FHOD usadil v kanyle 3 LSUDYWH PtVWR YSLFKX SRGOH SRW HE 3 HG SURYHGHQtP H X DMLVW WH YKRGQRX DQHVWH LL H OL WR YKRGQp XPtVW WH GRGDQRX KORXENRYRX DUi NX GR S HGHP XU HQp KORXEN YROWH YKRGQ...

Страница 47: ...WL DUG 3HULSKHUDO 9DVFXODU QHER QD YUiFHQt 9iPL DSODFHQp LVWp SHQ Qt iVWN 7DWR RPH HQi iUXND VH QHY WDKXMH QD RSRW HEHQt S VREHQp E Q P SRX tYiQtP QHER QD NRG S VREHQp QHVSUiYQ P SRX tYiQtP tohoto pro...

Страница 48: ...DQG NWDQ VRQUD EL RSVLQLQ QHJDWLI o NPDV NDUVLQRPD EXOXQPD RODV O Q WDPDPHQ RUWDGDQ NDOG UPD 4 BARD TRUGUIDE 7HN XOODQ PO N RDNVL DO L RSVL QHVL WHN NXOODQ P LoLQ WDVDUODQP W U 7 EEL FLKD ODU Q HOOLNO...

Страница 49: ...UHNWL L HNLOGH KD UOD Q HUL H JLULOPHGHQ QFH yeterli miktarda anestezi verilmelidir VWHUVHQL WHGDULN HGLOPL RODQ GHULQOL H D DUO GXUGXUXFX X QFHGHQ EHOLUOHQPL RODQ ELU GHULQOL H HUOH WLULQL DQJL PDQGU...

Страница 50: ...OX U Q DOQ FD DUG 3HULSKHUDO 9DVFXODU Q NHQGL NDUDU OD RQDU P D GD GH L WLUPH D GD GHGL LQL QHW DW JHUL YHUPH LOH V Q UO G U X U Q Q QRUPDO NXOODQ P QGDQ GR DQ D QPD YH SUDQPD D GD DQO NXOODQ P QGDQ G...

Страница 51: ...RUGUIDE BARD TRUGUIDE BARD BARD BARD BARD BARD 19 BARD TRUGUIDE BARD BARD B BARD TRUGUIDE C D E 1 2 3 4 BARD TRUGUIDE 5 BARD TRUGUIDE F 1 X CT R 3 G H BARD TRUGUIDE BARD MAX CORE MONOPTY BARD MAGNUM B...

Страница 52: ...1 BARD MONOPTY 11mm x BARD MONOPTY PP MAX CORE x BARD TRUGUIDE BARD BIOPTY CUT MAGNUM x BARD TRUGUIDE BARD TRUGUIDE 1 3 BARD TRUGUIDE BARD TRUGUIDE 7 BARD BARD 9 BARD TRUGUIDE 7 9 TRUGUIDE 11 BARD TRU...

Страница 53: ...Bard Peripheral Vascular Bard Peripheral Vascular BARD PERIPHERAL VASCULAR Bard Peripheral Vascular Inc...

Страница 54: ...A BARD TRUGUIDE BARD TRUGUIDE BARD BARD BARD BARD BARD BARD BARD 19 BARD TRUGUIDE B BARD TRUGUIDE 1 C D E 1 2 3 4 BARD TRUGUIDE 5 BARD TRUGUIDE F 1 X CT MR 3 G...

Страница 55: ...DE BARD MAX CORE MONOPTY BARD MAGNUM BIOPTY CUT I 1 1 BARD MONOPTY 11mm x BARD MONOPTY PP MAX CORE x BARD TRUGUIDE BARD BIOPTY CUT MAGNUM x BARD TRUGUIDE BARD TRUGUIDE 1 3 BARD TRUGUIDE BARD TRUGUIDE...

Страница 56: ...BARD TRUGUIDE 11 BARD TRUGUIDE Bard Peripheral Vascular 1 Bard Peripheral Vascular BARD PERIPHERAL VASCULAR 36 Bard Peripheral Vascular Inc...

Страница 57: ...3 BARD TRUGUIDE BARD TRUGUIDE BARD BARD BARD BARD BARD BARD TRUGUIDE BARD BARD BARD TRUGUIDE BARD TRUGUIDE BARD TRUGUIDE...

Страница 58: ...3 BARD TRUGUIDE BARD MAX CORE MONOPTY BARD MAGNUM BIOPTY CUT BARD MONOPTY BARD MONOPTY MAX CORE BARD TRUGUIDE BARD BIOPTY CUT MAGNUM BARD TRUGUIDE BARD TRUGUIDE...

Страница 59: ...3 BARD TRUGUIDE BARD TRUGUIDE BARD BARD BARD TRUGUIDE TRUGUIDE BARD TRUGUIDE DUG 3HULSKHUDO 9DVFXODU DUG 3HULSKHUDO 9DVFXODU 5 3 5 3 5 9 6 8 5 DUG 3HULSKHUDO 9DVFXODU QF...

Страница 60: ...ent vne opatrenia 2GREUDWLH YLDFQiVREQ FK KUXERLKORY FK Y RULHN P H SRP F DEH SH L GHWHNFLX DNpKRNR YHN UDNRYLQRYpKR WNDQLYD 1HJDWtYQD ELRSVLD SUL SRGR ULY FK UiGLRJUD FN FK QiOH RFK QHY OX XMH SUtWRP...

Страница 61: ...LWtP YKRGQHM DVHSWLFNHM WHFKQLN 2GSRU DQLH 3UHG Y NRQDQtP SRVWXSX VD XLVWLWH L MH PR Qp VW OHW MHGQRGXFKR RGGHOL RG NDQ O SURVWUHGQtFWYRP SRYROHQLD KODYtF 2SlWRYQH XWLDKQLWH VW OHW QD NDQ OH D SUHG DY...

Страница 62: ...obmedzen na opravu alebo Y PHQX FK EQpKR SURGXNWX D WR MHGLQH QD iNODGH UR KRGQXWLD VSROR QRVWL Bard Peripheral Vascular alebo preplaten m uhradenej ceny netto T to REPHG HQi iUXND VD QHY DKXMH QD RSR...

Страница 63: ......

Страница 64: ...OD V KORXENRY P GRUD HP D S tGDYQ P VW OHP V WXS P KURWHP HULQOLN XUGXUXFXVX LOH 7HN XOODQ PO N RDNVL DO L RSVL QHVL YH N QW 8oOX 0DQGUHO HGQRUD RYi NRD LiOQD LKOD QD ELRSVLX V K ENRYRX DUi NRX D SUtG...

Страница 65: ...ruk Kertak ytt inen Bare til engangsbruk 3URGXNW MHGQRUD RZHJR X WNX Egyszeri haszn latra MHGQRUi RYpPX SRX LWt 7HN XOODQ PO NW U 1 1D MHGQRUD RYp SRX LWLH Do Not Resterilize Ne pas rest riliser Nicht...

Страница 66: ...in der Europ ischen Gemeinschaft Rappresentante autorizzato nella Comunit Europea Representante autorizado en la Comunidad Europea Gemachtigde binnen de Europese Gemeenschap Representante autorizado n...

Страница 67: ...uide er varemerker og eller registrerte varemerker som tilh rer C R Bard Inc eller et tilknyttet selskap DUG LRSW LRSW XW 0DJQXP 0D RUH 0RQRSW L 7UX XLGH V QDNDPL WRZDURZ PL L OXE DVWU H RQ PL QDNDPL...

Страница 68: ...r Inc HVW UG 6WUHHW 7HPSH USA 7 www bardbiopsy com Manufacturer 3 5HY Authorised Representative in the European Community Bard Limited Forest House Tilgate Forest Business Park Brighton Road Crawley W...

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Bard TRUGUIDE, Инструкция по эксплуатации, Страница: 4 / 68

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