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5

Instructions for Use
POST FOR USE BY ALL TRACHEOSTOMY CARE PERSONNEL

The primary user of this instructional material is the caregiver in a clinical environment such as the

adult or critical care units of a hospital, non-critical care units of a hospital, long term care facilities

and home care.

Description

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless (“tracheostomy tube”) is a dual cannula 

tracheostomy tube with a disposable inner cannula. It contains an integrated 15 mm connector for 

use with standard ventilation and anesthesia equipment. 
The tracheostomy tube has a radiopaque, bio compatible outer cannula constructed of polyvinyl 

chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two 

suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The 

smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for 

easy inspection and allows for airway maintenance.
This tracheostomy tube can be used with or without the disposable inner cannula included in the 

package (and also available separately; reference 10006780 for part numbers). However, use of the 

inner cannula is recommended.

Indications for Use

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is intended for use in 

providing tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is also intended 

for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures.
WARNINGS

•  When using a laser or electrosurgical device in conjunction with this or other tracheal tubes, 

care must be taken to avoid contact with the tube. Such contact, especially in the presence 
of oxygen-enriched mixtures or nitrous oxide containing mixtures, could result in rapid 
combustion of the tube with harmful thermal effects and with emission of corrosive and toxic 
combustion products, including hydrochloric acid (HCl).

•  The tracheostomy tube, neck strap, and disposable inner cannula cannot be adequately 

resterilized by the user in order to facilitate safe reuse and are therefore intended for single 
patient use. Attempts to resterilize this device may result in product failure and increased risks 
to the patient.

•  Sterile only if the protective tray and cover are not open, damaged, or broken. Do not 

resterilize. Do not store product at temperatures above 120˚F (49˚C).

en

Shiley

TM

Adult Flexible Tracheostomy Tube Cuffless
Disposable Inner Cannula

4UN65A

6.5 mm

5UN70A

7.0 mm

6UN75A

7.5 mm

7UN80A

8.0 mm

8UN85A

8.5 mm

9UN90A

9.0 mm

10UN10A 10.0 mm

Identification of a substance 

that is contained or present 

within the product or packaging.

Identification of a substance 

that is not contained or present 

within the product or packaging.

Содержание Shiley 10UN10A

Страница 1: ...saanwijzing it Istruzioni per l uso es Instrucciones de uso sv Bruksanvisning da Brugsanvisning no Bruksanvisning fi K ytt ohjeet pt Instru es de uso ru zh pl Instrukcja u ytkowania cs N vod k pou it...

Страница 2: ...alogowy slo d lu slo dielu tevilka dela Term ksz m Par a Numaras Cod pies Dalies numeris S hi u chi ti t Nomor Komponen ID Inside Diameter mm DI Diam tre interne mm ID Innendurchmesser mm ID Binnendia...

Страница 3: ...bare binnencanule mm Lunghezza contro cannula monouso mm Longitud de la c nula interna desechable mm L ngd p innerkanyl f r eng ngsbruk mm L ngden af inderkanylen til engangsbrug mm Lengde p engangs i...

Страница 4: ...lo Obtur tor Obt rat r Obturator ki iklis N t b t Obturator Neck Strap Attache cervicale Halteband Nekband Fettuccia di fissaggio Correa para el cuello Halsrem Halsrem Halsstropp Kiinnitysnauha Faixa...

Страница 5: ...r Cannula is intended for use in providing tracheal access for airway management The Shiley Adult Flexible Tracheostomy Tube Cuffless Disposable Inner Cannula is also intended for use with Cook Percut...

Страница 6: ...lator Do not use solutions or chemical agents other than sterile saline hydrogen peroxide or water and mild detergent as this may result in tube damage Precautions should be taken when discarding the...

Страница 7: ...e loading dilator is available separately 2 If using a guide wire with the obturator first insert the guide wire in the patient then thread it all the way through the obturator starting at the distal...

Страница 8: ...rne jetable fournie dans l emballage galement disponible s par ment r f rence 10006780 pour les num ros de pi ces Toutefois l utilisation de la chemise interne est recommand e Utilisation pr vue La ca...

Страница 9: ...n sur un seul patient ne doit pas d passer vingt neuf 29 jours Covidien ne recommande pas et n a pas valid l utilisation de ces dispositifs au del de cette dur e de 29 jours Les d cisions concernant l...

Страница 10: ...une fine couche de lubrifiant hydrosoluble sur l ext rieur de la canule de trach ostomie et sur la partie saillante de l introducteur Si un dilatateur de charge est utilis pour une trach otomie percu...

Страница 11: ...iegende f r den Einmalgebrauch bestimmte Innenkan le verwendet werden auch einzeln erh ltlich siehe 10006780 f r Artikelnummern Die Verwendung der Innenkan le wird jedoch empfohlen Indikationen Die Sh...

Страница 12: ...eweils nur f r einen Patienten verwendet werden Diese Ger te d rfen h chstens neunundzwanzig 29 Tage lang am Patienten verwendet werden Eine Nutzung ber die Dauer von 29 Tagen hinaus wird von Covidien...

Страница 13: ...Obturators aufgetragen werden Bei Verwendung eines Ladedilatators f r ein PDT Verfahren sollte zun chst gro z gig Gleitmittel auf der Oberfl che des entsprechenden Ladedilatators aufgetragen und ansch...

Страница 14: ...e verpakking bijgeleverde binnentube tevens los verkrijgbaar referentie 10006780 voor onderdeelnummers Het gebruik van de binnentube wordt echter aanbevolen Gebruiksindicaties De wegwerpbare binnentub...

Страница 15: ...ij n pati nt mag niet langer duren dan negenentwintig 29 dagen Covidien raadt het gebruik van deze hulpmiddelen langer dan 29 dagen niet aan en heeft dergelijk gebruik ook niet gevalideerd Beslissinge...

Страница 16: ...obturator worden aangebracht Bij gebruik van een laaddilatator voor een PDT procedure dient het oppervlak van de passende laaddilatator van een glijmiddel te worden voorzien en de tracheostomietube o...

Страница 17: ...ouso compresa nella confezione e disponibile separatamente riferimento 10006780 per i codici Tuttavia l uso della contro cannula consigliato Indicazioni per l uso La cannula tracheostomica flessibile...

Страница 18: ...co responsabile o dalla persona designata ed effettuata mediante tecniche e valutazioni mediche approvate I medici che introducono il dispositivo per via percutanea devono essere competenti in merito...

Страница 19: ...cannula sull introduttore Assicurarsi che la sezione rastremata dell introduttore a palloncino sia distante dalla punta distale della cannula tracheostomica di circa 2 cm NOTA l introduttore a pallon...

Страница 20: ...se puede utilizar con o sin la c nula interna desechable incluida en el envase y tambi n disponible por separado referencia 10006780 del n mero de pieza No obstante se recomienda utilizar la c nula in...

Страница 21: ...estos dispositivos m s all del plazo de 29 d as Las decisiones sobre los cambios de tubos de traqueostom a debe tomarlas el m dico responsable o la persona asignada utilizando las t cnicas y decisione...

Страница 22: ...para un procedimiento de PDT lubrique abundantemente la superficie del dilatador de carga del tama o adecuado y cargue el tubo de traqueostom a en el dilatador Aseg rese de que la secci n c nica del...

Страница 23: ...len Indikationer f r anv ndning Shiley flexibel trakeostomitub utan kuff f r vuxna med innerkanyl f r eng ngsbruk r avsedd att ge trakeal tkomst f r hantering av luftv garna Shiley flexibel trakeostom...

Страница 24: ...arande innan tuben anv nds Kontrollera f re anv ndningen att obturatorn kan f ras in och dras ut utan sv righet F r att underl tta placeringen av trakeostomituben ska ytan p dilatorn sm rjas gener st...

Страница 25: ...s distala spets OBS Dilatorn s ljs separat 2 Om du anv nder en ledare med obturaton f r f rst in ledaren i patienten och tr den sedan hela v gen genom obturaton med b rjan vid obturatorns distala spet...

Страница 26: ...tvejsh ndtering Shiley Fleksibel trakeostomitube til voksne uden cuff inderkanyle til engangsbrug er ogs beregnet til brug ved Cook PDT indgreb perkutan dilatationstrakeotomi ADVARSLER N r der anvende...

Страница 27: ...reng ringsmiddel da dette kan resultere i beskadigelse af tuben Tr f de rette foranstaltninger i forbindelse med trakeostomituben og dens tilbeh r Bortskaffelsen skal ske i overensstemmelse med g lde...

Страница 28: ...ledetr den f rst i patienten Derefter f res den hele vejen gennem obturatoren Start ved obturatorens distale spids ADVARSEL Hvis ledetr den beskadiges under indgrebet kan det v re vanskeligt at forts...

Страница 29: ...t for voksne med engangs innerkanyle er ogs beregnet brukt i Cook PDT prosedyrer Percutaneous Dilatational Tracheotomy ADVARSLER Hvis en laser eller elektrokirurgisk anordning brukes i forbindelse med...

Страница 30: ...sid eller vann og mild s pe da dette kan f re til skade p tuben Forholdsregler m tas ved avhending av trakeostomitube med tilbeh r Kassering m gj res i henhold til gjeldende institusjonelle standarder...

Страница 31: ...n f res f rst ledevaieren inn i pasienten og denne f res s helt gjennom obturatoren fra den distale tuppen p obturatoren ADVARSEL Hvis ledevaieren skades under prosedyren kan det v re vanskelig fortse...

Страница 32: ...t trakeostomiakanyyli voidaan k ytt pakkauksen sis lt m n kertak ytt isen sis kanyylin kanssa tai ilman sit lis ksi saatavana erikseen osanumeroiden viite 10006780 Sis kanyylin k ytt on kuitenkin suo...

Страница 33: ...yn henkil n on teht v trakeostomiakanyylin muutoksia koskevat p t kset hyv ksyttyj l kinn llisi menetelmi ja harkintaa k ytt en T m n laitteen perkutaanisesti asettavien kliinikkojen tulee olla p tevi...

Страница 34: ...aseta trakeostomiakanyyli dilaattoriin Varmista ett asetusdilaattorin kartiomainen osa ylitt trakeostomiakanyylin distaalik rjen noin 2 cm ll HUOMAUTUS asetusdilaattori on saatavana erikseen 2 Jos ohj...

Страница 35: ...raqueostomia pode ser usado com ou sem a c nula interna descart vel inclu da e dispon vel tamb m em separado n mero de pe a ref 10006780 Entretanto o uso da c nula interna recomendado Indica es de uso...

Страница 36: ...para al m do prazo de 29 dias As decis es sobre a substitui o de tubos de traqueostomia devem ser tomadas pelo m dico respons vel ou por quem este designar utilizando t cnicas e ju zo m dicos aceitos...

Страница 37: ...nente do obturador Se estiver sendo usado um dilatador para procedimento de TPD lubrifique generosamente a superf cie de um dilatador de tamanho adequado e introduza o tubo de traqueostomia no mesmo C...

Страница 38: ...38 Shiley 15 10006780 Shiley Shiley Cook HCl ru Shiley TM 4UN65A 6 5 5UN70A 7 0 6UN75A 7 5 7UN80A 8 0 8UN85A 8 5 9UN90A 9 0 10UN10A 10 0...

Страница 39: ...39 49 C 120 F Shiley 29 Covidien 29 29 PET...

Страница 40: ...40 65 C 1 1 1 1 2 Covidien 10006780 2 Cook Critical Care Ciaglia 2 2 1 2 2 a b 3 4 5 1 2 15 3...

Страница 41: ...41 Shiley 15 10006780 Shiley Shiley PDT HCI 49 C 120 F Shiley zh Shiley TM 4UN65A 6 5 5UN70A 7 0 6UN75A 7 5 7UN80A 8 0 8UN85A 8 5 9UN90A 9 0 10UN10A 10 0...

Страница 42: ...42 29 Covidien 29 29 X PET DEHP 65 C 1 1 1 1 2 Covidien CAP 10006780 2 Cook Ciaglia 2 ID OD PDT 2 1 PDT 2 cm 2 a b 3 4 5...

Страница 43: ...43 1 2 15 3...

Страница 44: ...dnorazowego u ytku w zestawie lub bez niej dost pn r wnie osobno patrz nr kat 10006780 Zaleca si jednak stosowanie kaniuli wewn trznej Wskazania do zastosowania Wewn trzna kaniula jednorazowego u ytku...

Страница 45: ...ego pacjenta nie powinna przekroczy dwudziestu dziewi ciu 29 dni Covidien nie zaleca i nie popiera stosowania tych urz dze przez okres powy ej 29 dni Decyzje o wymianie rurki tracheostomijnej powinny...

Страница 46: ...stw rozpuszczalnego w wodzie lubrykantu W przypadku stosowania rozszerzad a w procedurze PDT obficie posmarowa rodkiem po lizgowym powierzchni rozszerzad a o w a ciwym rozmiarze i nasun rurk tracheost...

Страница 47: ...ace k pou it Flexibiln tracheostomick trubice Shiley bez man ety pro dosp l pacienty vnit n kanyla k jednor zov mu pou it poskytuje p stup k trachei pro regulaci d chac ch cest Flexibiln tracheostomic...

Страница 48: ...tur tor zav st a vyjmout bez obt Aby bylo um st n tracheostomick trubice snaz dostate n lubrikujte povrch zav d c ho dilat toru Nepou vejte jin roztoky nebo chemick inidla ne steriln fyziologick rozto...

Страница 49: ...KA Zav d c dilat tor je dostupn samostatn 2 Pou v te li obtur tor s vodic m dr tem zave te do pacienta nejprve vodic dr t pot jej kompletn provl kn te obtur torem po naje dist ln m hrotem obtur toru V...

Страница 50: ...y odpor a Indik cie na pou itie Flexibiln tracheostomick kanyla pre dospel ch Shiley bez man ety jednorazov vn torn kanyla je ur en na pou itie pri zabezpe en trache lneho pr stupu kv li priechodnosti...

Страница 51: ...ybera Na u ah enie zav dzania tracheostomickej kanyly d kladne nama te povrch dilat tora zav dzania Nepou vajte roztoky ani chemick pr pravky in ako steriln fyziologick roztok peroxid vod ka voda a je...

Страница 52: ...racheostomickej kanyly POZN MKA Dilat tor zav dzania je k dispoz cii samostatne 2 Ak pou vate vodiaci dr t s obtur torom najprv vlo te vodiaci dr t do pacienta potom ho cel prevle te cez obtur tor pri...

Страница 53: ...uporabo Fleksibilna traheostomska cevka Shiley brez man ete za odrasle z notranjo kanilo za enkratno uporabo je namenjena za dostopanje do sapnika za upravljanje pretoka zraka Fleksibilna traheostomsk...

Страница 54: ...izvle e brez te av Za la je name anje traheostomske cevke z mazivom dobro nama ite povr ino polnilnega dilatatorja Ne uporabljajte drugih raztopin ali kemi nih snovi razen sterilne fiziolo ke raztopin...

Страница 55: ...2 cm OPOMBA Polnilni dilatator je na voljo lo eno 2 e s tesnilom uporabljate vodilno ico najprej v bolnika vstavite vodilno ico nato pa jo navijte vse skozi tesnilo za en i na konici tesnila OPOZORILO...

Страница 56: ...an llel vagy an lk l a kan l k l n is beszerezhet referencia a term ksz mokhoz 10006780 Ugyanakkor javasolt a bels kan l haszn lata Felhaszn l si javallatok A Shiley hajl kony tracheostomi s tubus fel...

Страница 57: ...uszonkilenc 29 napot A Covidien nem javasolja illetve nem t masztja al ezen eszk z k 29 napot meghalad haszn lat t A tracheostomi s tubus cser j vel kapcsolatos d nt seket a felel s orvosnak vagy a ki...

Страница 58: ...ez si dilat tor felsz n t s helyezze be a tracheostomi s tubust a dilat torba Bizonyosodjon meg arr l hogy a behelyez si dilat tor k pos r sze megk zel t leg 2 cm rel elker li a tracheostomi s tubus d...

Страница 59: ...59 Shiley 15 mm 10006780 Shiley Shiley PDT Cook HCl el Shiley TM 4UN65A 6 5 mm 5UN70A 7 0 mm 6UN75A 7 5 mm 7UN80A 8 0 mm 8UN85A 8 5 mm 9UN90A 9 0 mm 10UN10A 10 0 mm...

Страница 60: ...60 49 C 120 F Shiley 29 Covidien 29 29 PET latex DEHP 2 o o 65 1 1 1 1 2...

Страница 61: ...61 Covidien CAP 10006780 2 Cook Ciaglia 2 D OD 2 PDT 1 PDT 2 cm 2 a b 3 4 5 1 2 15 mm 3...

Страница 62: ...ek Kullan ml k Kan l solunum yolu y netimi i in trake eri imi sa lanmas nda kullan lmak zere tasarlanm t r Yeti kinler i in Shiley Kafs z Esnek Trakeostomi T p Tek Kullan ml k Kan l ayr ca Cook Perk t...

Страница 63: ...dilat r y zeyini bol miktarda ya lay n T pte hasara neden olabilece inden steril tuzlu su hidrojen peroksit veya su ve hafif deterjan d nda ba ka bir zelti veya kimyasal madde kullanmay n Trakeostomi...

Страница 64: ...hastaya tak n ve ard ndan obt rat r n distal ucundan ba layarak teli obt rat r n i inden tamamen ge irin UYARI K lavuz teli i lem s ras nda hasar g rd yse trakea i inde bir travma yaratmadan insersiy...

Страница 65: ...65 Shiley 15 10006780 Shiley Shiley Cook PDT HCl 120 49 Shiley ar Shiley TM 4UN65A 6 5 5UN70A 7 0 6UN75A 7 5 7UN80A 8 0 8UN85A 8 5 9UN90A 9 0 10UN10A 10 0...

Страница 66: ...66 29 Covidien 29 29 PET DEHP 65 2 1 1 1 1 10006780 CAP Covidien 2 Cook Ciaglia OD ID 2 PDT 2 1 1 PDT 2 2 2 a a b b 3 3 4 4 5 5 1 1 2 2 15 3 3...

Страница 67: ...67 Shiley 15 mm 10006780 Shiley Shiley Cook HCl bg Shiley TM 4UN65A 6 5 mm 5UN70A 7 0 mm 6UN75A 7 5 mm 7UN80A 8 0 mm 8UN85A 8 5 mm 9UN90A 9 0 mm 10UN10A 10 0 mm...

Страница 68: ...68 49 C 120 F Shiley 29 Covidien 29 29 PET DEHP 65...

Страница 69: ...69 1 1 1 1 2 Covidien CAP 10006780 2 Cook Ciaglia 2 ID OD 2 1 2 cm 2 a b 3 4 5 1 2 15 3...

Страница 70: ...utilizat cu sau f r canula intern de unic folosin inclus n ambalaj dar disponibil i separat consulta i 10006780 pentru codurile pieselor Cu toate acestea se recomand utilizarea canulei interne Indica...

Страница 71: ...stor dispozitive pe o perioad mai mare de 29 de zile Deciziile cu privire la schimbarea tuburilor de traheostomie trebuie luate de c tre medicul responsabil sau de c tre o persoan delegat utiliz ndu s...

Страница 72: ...unden suprafa a dilatatorului de nc rcare de dimensiunea potrivit i nc rca i tubul de traheostomie n dilatator Asigura i v c sec iunea conic a dilatatorului de nc rcare este la o distan de aproximativ...

Страница 73: ...Shiley 1 15mm PVC 2 1 1 10006780 1 Shiley 1 Shiley Cook PDT HCl 1 1 49 C 120 F 1 1 1 Shiley 1 ko Shiley TM 1 4UN65A 6 5mm 5UN70A 7 0mm 6UN75A 7 5mm 7UN80A 8 0mm 8UN85A 8 5mm 9UN90A 9 0mm 10UN10A 10 0...

Страница 74: ...74 1 1 1 29 Covidien 29 29 X PET DEHP 65 C 1 1 1 1 1 2 Covidien CAP 1 10006780 2 Cook Ciaglia 2 2 PDT 1 PDT 2cm...

Страница 75: ...75 2 a b 3 4 5 1 1 2 15mm 3...

Страница 76: ...duojama naudoti vidin kaniul Naudojimo paskirtis Shiley lankstusis suaugusi j tracheostominis vamzdelis be man et s ir su vienkartine vidine kaniule yra skirtas prieigai per trach j suteikti u tikrina...

Страница 77: ...esti ir i imti Nor dami palengvinti tracheostominio vamzdelio vedim gausiai patepkite ple iamojo vediklio pavir i lubrikantu Nenaudokite tirpal arba kit chemini valikli i skyrus steril fiziologin tirp...

Страница 78: ...o ma daug 2 cm atstumu PASTABA Ple iam j vedikl galima sigyti atskirai 2 Jei su ki ikliu naudojate kreipimo viel pirma pacient veskite viel tada j visu ilgiu perki kite per vis ki ikl prad dami nuo ki...

Страница 79: ...Shiley 15 obturator 10006780 Shiley Shiley Percutaneous Dilatational Tracheotomy PDT Cook HCl 49 C 120 F Shiley th Shiley TM 4UN65A 6 5 5UN70A 7 0 6UN75A 7 5 7UN80A 8 0 8UN85A 8 5 9UN90A 9 0 10UN10A 1...

Страница 80: ...80 29 Covidien 29 29 PET DEHP 65 1 1 1 1 2 Covidien CAP 10006780 2 Ciaglia Cook 2 ID OD 2 PDT 1 PDT 2 2 a b 3...

Страница 81: ...81 4 5 1 2 15 3...

Страница 82: ...g ng m kh qu n Shiley m m d o kh ng c b ng ch n d nh cho ng i l n N ng trong d ng m t l n c thi t k nh m t o l i v o n i kh qu n ki m so t ng th ng m kh qu n Shiley m m d o kh ng c b ng ch n d nh cho...

Страница 83: ...y tr c khi s d ng ng n y Tr c khi s d ng h y ki m tra r ng n t b t c th l p v th o d d ng d t ng m kh qu n b i tr n m b m t c a que nong d n ng Kh ng s d ng c c dung d ch ho c ch t h a h c ngo i n c...

Страница 84: ...m kh qu n kho ng 2 cm L U Que nong d n ng c b n r i 2 N u s d ng d y d n ng v i n t b t tr c h t h y ch c d y d n ng v o da b nh nh n sau lu n n xuy n qua n t b t b t u t i u xa c a n t b t C NH B O N...

Страница 85: ...pakai yang disertakan dalam kemasan dan juga tersedia secara terpisah referensi 10006780 untuk nomor komponen Namun penggunaan kanula bagian dalam direkomendasikan Indikasi Penggunaan Selang Trakeost...

Страница 86: ...idak merekomendasikan dan belum membuktikan penggunaan perangkat ini melebihi 29 hari Keputusan mengenai penggantian tabung trakeostomi harus dilakukan oleh dokter yang bertanggung jawab atau ditunjuk...

Страница 87: ...tuk prosedur PDT lumasi seluruh permukaan dilator pemuatan dengan ukuran yang sesuai dan muat tabung trakeostomi ke dilator Pastikan bahwa bagian lancip dilator pemuatan membersihkan ujung distal tabu...

Страница 88: ...brands are trademarks of their respective owners 2013 Covidien Covidien llc 15 Hampshire Street Mansfield MA 02048 USA Covidien Ireland Limited IDA Business Technology Park Tullamore www covidien com...

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