Taewoong Niti-S Скачать руководство пользователя страница 53

   

15. 

제품

 

손상

 

조치

 

사항

 

주의

안으

 

인하

 

제품에

 

손상이

 

있을

 

경우

환 에게

 

해를

 

져올

 

 

있으니

 

사용하

 

 
16. 

 

방법

   

- (

사용

 

길이

  50cm introducer

 

경우

피부간경

쓸개관조

  (PTC)  

 

경우

  Niti-S  &  ComVi 

스텐

 

위치

 

키기

 

전에

 

 

 

 

그리고

 

 

종양의

 

산을

 

대비

 

 

한다

.   

 

- (

사용

 

길이

  180cm introducer

 

경우

내 경

쓸개이 조

  (ERCP)  

 

경우

  Niti-S  &  ComVi 

 

위치

 

키기

 

전에

 

담 의

 

 

 

그리고

 

 

종양의

 

산을

 

대비

 

 

한다

.   

 

 

 

부위를

  endoscopy 

  fluoroscopy

 

진단한다

a)

 

 

부위의

  Proximal

  Distal 

부분을

 

내 경

 

그리고

/

또는

 

 

투 법으

 

주의

 

 

진단

 

 

한다

b)

 

내강의

 

경은

 

내 경

 

그리고

/

또는

 

형광

 

투 법으

 

반드

 

측정

 

 

한다

 

 

스텐

 

사이즈

 

결정

 

a)

 

 

 

부위의

 

길이를

 

측정한다

b)

 

병변의

 

양쪽

 

 

두를

 

충분히

 

덮을

 

 

측정된

 

병변의

 

길이 다

 

 

스텐 를

 

한다

. (   20-40mm) 

c)

 

 

부위의

 

 

측정

 

 

스텐 를

 

결정

 

하기

 

위해

 

필요한

 

사항이며

위치

 

키고

 

하는

 

부위의

 

 

 

경에서

  1 ~ 

4mm 

 

경의

 

스텐

 

안전하게

 

위치

 

킨다

 

 

스텐

  Deployment 

준비

 

Niti-S  &  ComVi 

스텐

 

형광

 

 

그리고

/

또는

 

경을

 

이용하

 

위치

 

 

 

있다

0.035” (0.89 mm) 

이드와이어를

 

 

부위까

 

통과 킨다

.   

 

A. Fluoroscopy 

 

 

a)

 

형광투

법을

 

이용하

 

스텐

 

위치할

 

곳에

 

이드와이어를

 

통과 킨다

 

b)

 

Introducer

 

앞쪽

 

부분에서

  Stylet

 

제거한다

.   

c)

 

스텐

 

 

  deploy

되는

 

것을

 

 

위해

, Inner Shaft

 

Outer Sheath

 

연결하는

  Y-

커넥터의

 

밸브를

 

 

방향으

 

 

있는

 

인한다

d)

 

Introducer 

스템의

 

내강에

  Flushing

 

한다

 
B. Endoscopy 

 

 

a)

 

내 경을

 

 

부위까

 

삽 한

 

내 경의

  working channel

 

통해

 

 

 

부위

 

이상

 

이드

 

와이어를

 

통과

 

 

Introducer 

스템이

 

위치

 

 

 

 

한다

b)

 

Introducer

 

앞쪽

 

부분에서

  Stylet

 

제거한다

c)

 

스텐

 

 

  deploy

되는

 

것을

 

 

위해

, Inner Shaft

 

Outer Sheath

 

연결하는

  Y-

커넥터의

 

밸브를

 

 

방향으

 

 

있는

 

인한다

d)

 

Introducer 

스템의

 

내강에

  Flushing

 

한다

 

C. Short wire 

 

 

a)

 

Shortwire 

고정장치

 

내 경에

 

제대

 

부 되었는

 

인한다

b)

 

이드와이어를

 

 

부위에

 

위치

킨다

 

c)

 

술 의

 

결정에

 

의해

 

괄 근

 

절개술이나

 

전 장술을

 

 

 

있다

d)

 

안전실린더와

 

스타

렛을

 

제거한다

e)

 

팁을

 

통해

 

이드와이어를

 

집어넣고

 

이드와이어

 

포 를

 

 

깥으

 

나오면

 

이드와이어와

 

딜리버리

 

스템은

 

나란

 

있게

 

된다

f)

 

딜리버리

 

스템을

 

전진 키고

 

스템이

 

내 경

 

안으

 

들어

 

 

 

이드와이어

 

장치를

 

푼다

g)

 

 

이드와이어

 

고정을

 

키고

 

 

디릴버리

 

스템을

 

전진 켜

 

 

부위에

 

위치

킨다

Содержание Niti-S

Страница 1: ...utilisation Achtung Gebrauchsanleitung beachten Attenzione consultare le istruzioni per l uso Atenci n consulte las instrucciones de uso Dikkat Kullan m talimatlar na bak n V r opm rksom konsult r br...

Страница 2: ...Tesla 128 MHz Excite HDx Software 14X M5 General Electric Healthcare Milwaukee WI MR systems 1 5 Tesla 3 Tesla MR system reported whole body averaged SAR 2 9 W kg 2 9 W kg Calorimetry measured values...

Страница 3: ...of Operation The outer sheath is pulled back by immobilizing the hub in one hand grasping the Y connector with the other hand and gently sliding the Y connector along the pusher towards the hub Retrac...

Страница 4: ...ic or percutaneous Recapturing a stent during its deployment is contraindicated 5 Warnings The safety and efficacy of this device for use in the vascular system has not been established The device sho...

Страница 5: ...with Minimum 3 2mm working channel 0 035 0 89mm stiff guidewire 8 Precautions Read the entire User s Manual thoroughly before using this device It should only be used by or under the supervision of p...

Страница 6: ...cement Stent Deployment Preparation The Niti S ComVi Stent can be placed with the aid of fluoroscopy and or endoscopy Pass a 0 035 0 89 mm guidewire to the level of the stricture A Fluoroscopy Procedu...

Страница 7: ...proximal valve of the Y connector by turning the valve more than twice in an anti clockwise direction c To begin stent deployment immobilize the hub in one hand and grasp the Y connector with the othe...

Страница 8: ...e retrieval string To reposition a Niti S ComVi Full Covered Stent immediately after deployment use forceps or a snare to grasp the retrieval string and gently adjust to the correct placement Please n...

Страница 9: ...s biliaires enti rement couvertes peuvent tre repositionn es apr s leur d ploiement voir Avertissements Figure 2 syst me d introduction par voie percutan e et endoscopique Le cath ter d introduction p...

Страница 10: ...rejette toute responsabilit en cas d instrument r utilis retransform ou rest rilis et ne donne aucune garantie explicite ou implicite y compris mais sans s y limiter concernant la qualit marchante ou...

Страница 11: ...nt Les endoproth ses non couvertes nues ne doivent pas tre retir es apr s avoir t enti rement d ploy es voir Contre indications Ne pas tenter de recapturer recharger l endoproth se une fois son d ploi...

Страница 12: ...particuli re doit tre exerc e lors de l ex cution de la dilatation apr s le d ploiement du stent car cette action peut entra ner une perforation des saignements le d logement du stent ou sa migration...

Страница 13: ...erse la st nose et le faire remonter dans les voies intra h patiques b Assurez vous que la valve du connecteur Y est bien verrouill e rotation de l extr mit de la valve proximale dans le sens des aigu...

Страница 14: ...ou ne tirez pas sur la poign e lorsque l endoproth se est partiellement d ploy e La poign e doit tre maintenue immobilis e Tout mouvement de la poign e par inadvertance peut entra ner un mauvais alig...

Страница 15: ...iement utilisez une pince ou une anse pour saisir le fil de retrait et proc dez d licatement l ajustement pour la placer en bonne position Remarque le stent peut uniquement tre repositionn et ou retir...

Страница 16: ...se Abbildung 2 Einf hrsystem perkutan und endoskopisch Die Nutzl nge des perkutanen Einf hrsystems betr gt 50 cm Die Nutzl nge des endoskopischen Einf hrsystems betr gt 180 cm Verwendung des perkutane...

Страница 17: ...en zu bernehmen Taewoong bernimmt keine Haftung f r Instrumente welche wiederverwendet wiederaufbereitet oder resterilisiert wurden und macht hinsichtlich derartiger Instrumente keine ausdr cklichen o...

Страница 18: ...n Die Position von beschichteten Stents kann unmittelbar nach der Freisetzung korrigiert werden Unbeschichtete Stents d rfen nach der vollst ndigen Entfaltung nicht mehr entfernt werden siehe Kontrain...

Страница 19: ...m entfalteter Stent sonst verrutschen kann Bei der Dilatation nach der Positionierung des Stents ist vorsichtig vorzugehen da diese zu einer Perforation zu Blutungen oder einer Stentmigration f hren k...

Страница 20: ...hrungsdraht von 0 89 mm bis auf H he der Stenose einf hren A Verfahren mittels R ntgendurchleuchtung a Unter fluoroskopischer Kontrolle einen F hrungsdraht durch die Stenose bis zu der Stelle einf hre...

Страница 21: ...n F hrungsdraht in der gew nschten Position arretieren und das System durch die Zielregion vorschieben bis der Stent die gew nschten Position erreicht hat Verfahren f r das Entlassen des Stents Abbild...

Страница 22: ...faltet hat Schieben Sie den inneren Katheter wieder zur ck in den u eren Katheter so wie es vor der Freisetzung war c Sofern der Arzt dies f r sinnvoll erachtet kann der Stent mittels Ballondilatation...

Страница 23: ...ch eine Wiederverwendung Wiederaufbereitung oder Resterilisation kann sich die Produktqualit t verschlechtern und oder es kann zu einer Funktionsst rung des Produkts kommen was wiederum eine Verletzun...

Страница 24: ...cm L introduttore endoscopico ha una lunghezza utile di 180 cm Il tipo percutaneo consigliato quando si intende seguire un approccio percutaneo Il tipo endoscopico consigliato quando si intende seguir...

Страница 25: ...ficati nelle istruzioni per l uso rimozione o riposizionamento di stent scoperti completamente dispiegati vedi il paragrafo Avvertenze perforazione sospetta o imminente pazienti per i quali sono contr...

Страница 26: ...ione della malattia sepsi colecistite acuta pancreatite colangite colestasi stitichezza diarrea infezione ascesso epatico peritonite occlusione da residui ulcerazioni 7 Attrezzatura richiesta Posizion...

Страница 27: ...Istruzioni in caso di danneggiamento ATTENZIONE controllare visivamente che il dispositivo non sia danneggiato NON UTILIZZARE un dispositivo che sia visibilmente danneggiato La mancata osservanza di...

Страница 28: ...Y che collega la guaina interna e la guaina esterna sia bloccata ruotando l estremit della valvola prossimale in senso orario d Lavare il lume interno dell introduttore C Procedura con guida corta a...

Страница 29: ...to biliare Gli stent di tipo Y e T possono essere dispiegati sotto guida fluoroscopica o endoscopica tuttavia la maglia centrale di questi stent dotata di interstizi di maggiori dimensioni caratterizz...

Страница 30: ...zare una pinzetta o un cappio per afferrare il filo di recupero e riposizionare correttamente il dispositivo Nota lo stent pu essere riposizionato e o rimosso solo dall estremit prossimale Precauzioni...

Страница 31: ...s Advertencias Figura 2 Sistema de introducci n Percut neo y Endosc pico El sistema de introducci n percut neo tiene una longitud utilizable de 50 cm El sistema de introducci n endosc pico tiene una l...

Страница 32: ...omercializaci n o adecuaci n a un objetivo en particular en relaci n con tales instrumentos 4 Contraindicaciones Los stents biliares Niti S y ComVi est n contraindicados en los siguientes casos entre...

Страница 33: ...mplicaciones relacionadas con los procedimientos Hemorragia Expansi n inadecuada o colocaci n incorrecta del stent Dolor Muerte no relacionada con el avance normal de la enfermedad Perforaci n intesti...

Страница 34: ...en Utilizar antes de No utilice el dispositivo despu s de la fecha de vencimiento indicada en la etiqueta Utilizar antes de Los stents Niti S y ComVi se entregan en condiciones est riles No los utilic...

Страница 35: ...ajo del endoscopio Avance hasta que el cable gu a cruce el estrechamiento a tratar hasta el lugar donde se colocar el sistema de introducci n del stent sobre el cable gu a b Retire el estilete del ext...

Страница 36: ...r completo Observe la figura 3 4 Figura 4 PRECAUCI N No empuje el centro hacia adelante ni lo tire hacia atr s con el stent parcialmente desplegado El centro debe estar inmovilizado de manera segura E...

Страница 37: ...cuerda de recuperaci n Para reubicar un stent Niti S y ComVi completamente recubierto inmediatamente despu s del despliegue utilice f rceps o un snare para tomar la cuerda de recuperaci n y ajustarlo...

Страница 38: ...lan labilir uzunlu u 50 cm dir Endoskopik introd ser sisteminin kullan labilir uzunlu u 180 cm dir Perk tan Tipin nerildi i durumlar Perk tan yolla yakla ld nda Endoskopik Tipin nerildi i durumlar End...

Страница 39: ...minal apse Koag lopati olan hastalar K lavuz telin ge i ine izin vermeyen daralmalar Kullan m endikasyonlar alt nda zellikle belirtilenler d nda her t rl kullan m Tam olarak yerle tirilmi a k plak ste...

Страница 40: ...m Normal hastal k progresyonuna ba l nedenler d nda Sepsis Akut Kolesistit Pankreatit Kolanjit Kolestaz Kab zl k Diyare Enfeksiyon Karaci er apsesi Peritonit Tortu okl zyonu lser olu umlar 7 Gereken e...

Страница 41: ...sterilize etmeyin ve veya kullanmay n 9 Hasar halinde yap lmas gerekenler UYARI Sistemde hasar belirtileri olup olmad n g zle inceleyin Sistemde g zle g r lebilir hasar varsa KULLANMAYIN Bu nleme uyu...

Страница 42: ...engellemek i in proksimal valf ucunu saat y n nde d nd rerek i ve d k l f ba layan Y konekt r valfinin kilitlendi inden emin olun d ntrod ser sisteminin i l menini bo alt n C K sa tel kullan m prosed...

Страница 43: ...ekmeyin G bek g venli bir ekilde sabitlenmelidir G be in istenmeden hareket etmesi stentin yanl yerle tirilmesine ve safra kanal nda olas hasara neden olabilir Y ve T Tip stentler floroskopik ya da e...

Страница 44: ...ska kullan n ve yava a do ru konumuna getirin Unutmay n Stent yaln zca proksimal olarak yerle tirilebilir ve veya kar labilir Yeniden Kullan m nlemi Bildirimi Sa lanan i erik STER L dir etilen oksit...

Страница 45: ...iliary Uncovered Stent Niti S Biliary Covered Stent ComVi Biliary Stent 1 Niti S 5 Niti S 5 2 Percutaneous Endoscopic 50cm percutaneous introducer 180cm endoscopic introducer Percutaneous Type Endosco...

Страница 46: ...Taewoong Medical Co LTD Taewoong Medical Co LTD Taewoong Medical Co LTD Taewoong Medical Co LTD Taewoong Medical Co LTD Taewoong Medical Co LTD 4 Niti S Comvi 5 5 4 6 Niti S ComVi...

Страница 47: ...7 Percutaneous Placement 0 035 0 89mm 180Cm 7Fr 8Fr Endoscopic Placement 0 035 0 89mm 450Cm 8Fr 3 7mm 8 X 9 10 50cm PTC Niti S ComVi 180cm ERCP Niti S ComVi...

Страница 48: ...X a X Distal Proximal b X a b 20 40mm c 1mm 4mm Niti S ComVi X 0 035 0 89 mm A X a X b c Y d B a b c Y d 3 a X b Y c Y Y d Y 3 4 4...

Страница 49: ...Y T X Y T X X a X b 3 5 c 11 a 1 3 b c d 12 Niti S Full Covered 5 Niti S ComVi Full Covered EO gas Taewoong Medical Co LTD 10 40 Niti S ComVi...

Страница 50: ...tent ComVi Biliary Stent 1 Introducer loading deployment Bile duct luminal radial force Niti S Full Covered benign stricture 5 Full Covered Deployment 5 2 Introducer Percutaneous Endoscopic 50cm Intro...

Страница 51: ...t Recapture 11 coagulopathies radiation colitis proctitis Chemoradiation therapy Radiotherapy Tumor shirinkage migration fracture Nickel Introducer Ethiodol Lipiodol Niti S Full Covered Niti S Full Co...

Страница 52: ...tion diarrhea infection peritonitis sludge occlusion ulceration 13 Percutaneous Placement 0 035 0 89mm 180cm preferably stiff or extra stiff Introducer Introducer sheath 7 Fr uncovered 8Fr covered End...

Страница 53: ...l b a b 20 40mm c 1 4mm Deployment Niti S ComVi 0 035 0 89 mm A Fluoroscopy a b Introducer Stylet c deploy Inner Shaft Outer Sheath Y d Introducer Flushing B Endoscopy a working channel Introducer b I...

Страница 54: ...r Y c Deployment Hub Y Pusher Hub d X Ray Marker deploy 3 4 4 deploy Hub Hub Hub T Y Fluoroscopy Endoscopic deploy T Y X ray marker 2 X ray marker bifurcation Deployment a Fluoroscope endoscope b Intr...

Страница 55: ...ed Stent 5 tumor in growth over growth forcep snare retrieval string retrieval string Niti S ComVi Full Covered deployment forcep snare retrieval string proximally EO gas 1 10 40 Niti S and ComVi Sten...

Страница 56: ...Fax 82 31 996 0646 E mail stent stent net Url www stent net DongBang Acuprime 1 The Forrest Units Hennock Road East Exeter EX2 8RU UK Tel 44 1392 829500 Fax 44 1392 823232 TAEWOONG UB Rev 7 15 08 19...

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