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Atos PROVOX VEGA, Инструкция по эксплуатации, Страница: 8 / 140

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c.   a means to facilitate a safe passage of the Guidewire when it is passed through

 

 

the pharynx and out of the mouth.

 

Introduce the instrument into the esophagus (Fig. 3.1). If an endotracheal tube is in situ, this tube 

should be removed if it obstructs proper dilatation and integral placement of the voice prosthesis.

 CAUTION:

 Always make sure that the instrument selected for pharynx protection does contains 

a lumen for safe passage of the Guidewire. Otherwise, there is risk for (sub) mucosal damage.

2.  Verify the correct location of the instrument by palpating the trachea at the intended puncture 

site. For additional visual and/or transilluminated guidance, a flexible endoscope could be used 

(Fig. 3.2).

3.  Insert the Puncture Needle at the correct puncture site (about 8-10 mm from the edge of the 

tracheostoma) until the tip of the needle reaches the inside wall of the instrument (Fig. 3.3).

4.  Insert the Guidewire into the hub of the Puncture Needle. Push the Guidewire into the needle, 

up through the lumen of instrument until it extends approx. 20 cm out through the distal end of 

the instrument (Fig. 3.4).

 

WARNING:

 Always verify that the Guidewire comes out through the lumen of the instrument 

chosen for pharynx protection. Otherwise there is a risk for (sub) mucosal damage and the 

procedure needs to be restarted (see Adverse Events and Troubleshooting Information as well 

as Instructions for Reload of the Puncture Set).

5.  Remove the Puncture Needle (Fig. 3.5). 

 

CAUTION:

 Always remove the needle before removing the instrument. There is a risk for 

damaging the esophageal tissue otherwise.

6.  Remove the instrument used for pharynx protection. Only the Guidewire should remain in situ 

before continuing (Fig. 3.6). 

7.  From the cranial side, insert the Guidewire into the narrow end of the Puncture Dilator and push 

the Guidewire until it extends approx. 10 cm through the Puncture Dilator exit hole (Fig. 3.7).

8.  Grab the tip of the Guidewire and insert it in the hole next to the exit hole of the Puncture Dilator 

(Fig. 3.8).

9.  Tighten the Guidewire by pulling it from the narrow end of the Puncture Dilator and verify that 

it is secured to the Puncture Dilator (Fig. 3.9).

 

CAUTION:

 Ensure that the Guidewire is tightly secured in the Wirelock of the Puncture 

Dilator. If the Guidewire is not securely locked into the Wirelock, the Guidewire could separate 

from the Puncture Dilator and the Puncture Dilator may end up in the esophagus requiring 

retrieval using additional instruments (e.g., laryngeal forceps).

10.  Using a continuous, smooth motion; dilate the puncture site by carefully pulling the Guidewire 

through the puncture site until the thick end of the Puncture Dilator has passed the puncture. 

During dilatation, support the TE tissue (for example with two fingers) to reduce dilatation force. 

For better control, firmly grasp the Guidewire close to the Puncture Dilator (Fig. 3.10).

 

CAUTION:

 Dilatation and integral placement of the voice prosthesis should be carried out in 

the anterior/caudal direction with limited lateral movement in order to limit the force applied to 

the TE wall.

11.  In the same continuous, smooth motion, carefully pull the Guidewire, Puncture Dilator and the 

Puncture Dilator loop through the puncture. The Puncture Dilator loop folds the tracheal flange 

of the voice prosthesis as the loop is pulled over the flange and through the puncture. The tracheal 

flange unfolds in the trachea when the loop releases it (Fig. 3.11). 

 

Stop pulling immediately when the tracheal flange is released by the Puncture Dilator loop. If 

the tracheal flange does not unfold completely, it can be rotated in place using two non-toothed 

hemostats.

12. Grasp the tracheal flange with a non-toothed hemostat, turn the prosthesis in the correct position 

and cut the safety strap (Fig. 3.12).

2.2.3 Reload of the Puncture Set

www.atosmedical.com/reload-of-the-puncture-set

CAUTION:

 Reload of the Provox Vega Puncture Set must not be performed if the voice prosthesis 

safety strap has been cut or damaged during the first placement attempt. 

If the procedure needs to be restarted the Provox Vega Puncture Set can be reloaded. 

In order to reload the system:

1.  Push the Guidewire from the narrow end of the Puncture Dilator until the Guidewire loosens 

from the Wirelock (Fig. 4.1-4.2).

2.  Pull the Guidewire through the Puncture Dilator (Fig. 4.3).

3.  Reload the Vega voice prosthesis in the Puncture Dilator ring (Fig. 4.4).

 

WARNING:

 The safety strap and tracheal flange of the voice prosthesis must be oriented towards 

the Puncture Dilator strap and the Wirelock when it is inserted into the Puncture Dilator loop 

(Fig. 4.4).

4.  If needed, the Guidewire can be straightened to facilitate reinsertion.

5.  Proceed according to “2.2 Operating Instructions”.

2.3 Cleaning and sterilization

The surgical components in the puncture set, as well as the voice prosthesis, are provided sterile (EO) 

and are intended for single use only and can NOT be cleaned or resterilized. 

After placement, the voice prosthesis requires regular cleaning by the patient while the prosthesis 

remains in situ (see prosthesis maintenance below).

2.4 Important patient information

Inform the patient that:

•  After a prosthesis placement traces of blood may be found in the sputum. 

•  Occasionally, mild leakage through or around the prosthesis may occur in the first weeks after 

insertion of a prosthesis. This often resolves spontaneously and does not require immediate 

replacement of the prosthesis.

•  Speech training sessions with a speech language pathologist are advised in order to acquire optimal 

voice sound, fluent speech, and optimal intelligibility.

Ensure that the patient understands to contact their clinician if:

•  Any changes in the appearance of the material of the prosthesis or in the way it fits in the puncture 

occur.

•  Leakage occurs during eating and/or drinking, and cleaning the prosthesis does not help. Provox 

Vega Plug can be used for temporary preventing leakage during eating and drinking until the device 

can be replaced.

•  Speaking becomes difficult (requires higher effort) and cleaning does not help.

•  There are any signs of inflammation or tissue change at or near the puncture tract.

•  Bleeding or overgrowth of tissue around the device.

•  Persistent pain or discomfort in the region of the Vega voice prosthesis.

•  Chronic cough, trouble breathing, or blood in the mucus. These can be signs of a serious health 

conditions that requires medical attention.

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Содержание PROVOX VEGA

Страница 1: ...Vega Pu Vega PunctureSet Instructions for Use U n r e g i s t e r e d c o p y...

Страница 2: ...offers no warranty neither expressed nor implied to the purchaser hereunder as to the lifetime of the product delivered which may vary with individual use and biological conditions Furthermore Atos M...

Страница 3: ...h 10 nederlands 17 fran ais 24 italiano 31 espa ol 38 portugu s 45 svenska 52 DANSk 58 NORSK 64 SUOMI 70 ESKY 76 POLSKI 82 HRVATSKI 89 T RK E 95 101 108 114 120 132 130 Ordering Information 139 U n r...

Страница 4: ...the intubation tube is inserted and removed carefully so that the voice prosthesis does not dislodge or come out 1 Descriptive information 1 1 Indications for use Provox Vega Puncture Set is a device...

Страница 5: ...he Guidewire back through the Puncture Needle Damage shearing and or scraping of the Guidewire may occur If the Guidewire must be withdrawn remove the Guidewire and the Puncture Needle simultaneously...

Страница 6: ...m depending on the size of the device During endoscopy reflections from the light source on the clear silicone rubber may be seen Also in prostheses that have been in situ for some time white or yello...

Страница 7: ...nding on surgical technique should be felt during palpation Fig 2 2 3 Insert the Puncture Needle at the correct puncture site about 8 10 mm from the edge of the tracheostoma until the tip of the needl...

Страница 8: ...carefully pull the Guidewire Puncture Dilator and the Puncture Dilator loop through the puncture The Puncture Dilator loop folds the tracheal flange of the voice prosthesis as the loop is pulled over...

Страница 9: ...longer period of time The material of the device will be affected by e g bacteria and yeast and the structural integrity of the device will eventually deteriorate Candida overgrowth of the prosthesis...

Страница 10: ...s der Intubationstubus vorsichtig eingef hrt und entfernt wird damit die Stimmprothese nicht verschoben wird oder herausrutscht 1 Beschreibende Informationen 1 1 Indikationen Das Provox Vega Punktions...

Страница 11: ...otektor entfernt wird Die Punktionskan le kann Gewebesch den verursachen wenn kein geeigneter Pharynxschutz verwendet wird DARAUF ACHTEN dass der Punktionsdilatator am sophagealen Ende des F hrungsdra...

Страница 12: ...en Wie bei jedem anderen Fremdk rper k nnen Komplikationen infolge der Aspiration eines Bestandteils eine Blockierung oder Infektion verursachen M gliche unmittelbare Symptome sind Husten pfeifendes A...

Страница 13: ...ewebeintegrit t im Bereich der TE Punktion beeintr chtigen k nnen z B gastro sophagealer Reflux oder Schilddr senfunktion in Betracht zu ziehen zu beurteilen und zu behandeln Bei einer Vergr erung der...

Страница 14: ...erwendet werden Abb 3 2 3 Die Punktionskan le an der richtigen Punktionsstelle etwa 8 10 mm vom Tracheostomarand entfernt einf hren bis die Kan lenspitze die Innenwand des Instruments erreicht Abb 3 3...

Страница 15: ...ie nach jeder Mahlzeit mit der Provox Brush Reinigungsb rste reinigen Dazu wird die B rste in die Prothese eingef hrt und mit einer Drehbewegung behutsam vor und zur ck bewegt Die B rste ist nach der...

Страница 16: ...Das Provox Zubeh r wurde so entwickelt dass es gefahrlos und wirksam in Verbindung mit der Provox Vega Stimmprothese verwendet werden kann Verwenden Sie kein anderes Zubeh r da es zu Verletzungen ode...

Страница 17: ...raakt of naar buiten komt 1 Beschrijving 1 1 Indicaties voor gebruik De Provox Vega Puncture Set is een hulpmiddel voor het uitvoeren van een primaire of secundaire TE punctie bij gelaryngectomeerden...

Страница 18: ...ctienaald dan samen als n geheel om te voorkomen dat de voerdraad door de punctienaald wordt beschadigd Gebruik GEEN getande vaatklemmen of andere instrumenten die het product kunnen beschadigen Secun...

Страница 19: ...elijk van de maat van het hulpmiddel Tijdens endoscopie kunnen reflecties van de lichtbron op het doorzichtige siliconenrubber te zien zijn Bij protheses die al enige tijd in situ zijn kunnen ook witt...

Страница 20: ...tosmedical com primary puncture 1 Breng na de laryngectomie en het aanleggen van het tracheostoma en v r het sluiten van de farynx de Pharynx Protector in de open farynx oesofagus in afb 2 1 2 Verifie...

Страница 21: ...ls de voerdraad niet stevig in de draadgrendel vastzit dan kan de voerdraad loskomen van de punctiekanaaldilatator De punctiekanaaldilatator kan dan in de oesofagus terechtkomen en met extra instrumen...

Страница 22: ...ectie van de accessoires De accessoires dienen conform de bijbehorende gebruiksaanwijzingen na elk gebruik te worden gereinigd en minstens eenmaal daags te worden gedesinfecteerd Tijdens ziekenhuisopn...

Страница 23: ...tie 3 1 Bestelinformatie Zie achterin deze gebruiksaanwijzing 3 2 Hulp voor de gebruiker Zie het achterblad van deze gebruiksaanwijzing voor contactgegevens voor aanvullende hulp of informatie U n r e...

Страница 24: ...uit et enlev d licatement afin de ne pas d bo ter ou faire sortir la proth se phonatoire 1 Description g n rale 1 1 Indications d emploi Le Provox Vega Puncture Set est un dispositif pr vu pour la r a...

Страница 25: ...de r aliser la dilatation dans le sens post ro ant rieur La dilatation r alis e dans le mauvais sens entra ne une mise en place invers e de la proth se phonatoire provoquant l aspiration et l incapaci...

Страница 26: ...aspiration du dispositif est soup onn e une TDM des poumons doit tre r alis e pour confirmer cette aspiration et rep rer le dispositif Si la TDM confirme l aspiration du dispositif il peut tre r cup...

Страница 27: ...ions vous trouverez des liens vers des vid os sous les titres de section ci dessous Mise en garde Ces vid os ne remplacent pas et ne pr sentent pas le contenu entier du mode d emploi et ou des informa...

Страница 28: ...aryngienne Avant de poursuivre l op ration seul le Guidewire doit rester in situ Fig 3 6 7 Du c t cr nien ins rer le Guidewire dans l extr mit troite du dilatateur et pousser le Guidewire jusqu ce qu...

Страница 29: ...tre indiqu mais il peut tre envisag comme mesure pr ventive en cas de prolif ration excessive de Candida sur la proth se Une vari t inconnue de substances chimiques pourrait alt rer le mat riau du dis...

Страница 30: ...r de la proth se Provox Flush Un dispositif de nettoyage suppl mentaire destin tre utilis par le patient pour rincer la proth se Provox Plug Un outil permettant au patient de boucher provisoirement la...

Страница 31: ...e rimosso con cautela per evitare di dislocare o asportare la protesi fonatoria 1 Informazioni descrittive 1 1 Indicazioni per l uso Il set per creazione fistola TE Provox Vega un dispositivo che per...

Страница 32: ...ilatazione deve essere eseguita in direzione posteroanteriore La dilatazione nella direzione errata causa il posizionamento inverso della protesi vocale con conseguente aspirazione e impossibilit di p...

Страница 33: ...te ascesso polmonare fistola broncopolmonare e asma Se il paziente riesce a respirare la tosse pu consentire l espulsione del corpo estraneo L ostruzione parziale o completa delle vie aeree richiede u...

Страница 34: ...tuisco n forniscono il contenuto completo delle istruzioni per l uso n delle informazioni per il medico prescrittore e non costituiscono un alternativa alla lettura dell intero contenuto delle istruzi...

Страница 35: ...e della faringe Prima di continuare assicurarsi che sia rimasto in situ solo il filo guida Fig 3 6 7 Inserire cranialmente il filo guida nell estremit sottile del dilatatore per fistola e farlo avanza...

Страница 36: ...va se si verifica una crescita eccessiva di Candida sulla protesi L uso di variet sconosciute di sostanze chimiche pu influire sulle propriet dei materiali del dispositivo Pertanto da valutare attenta...

Страница 37: ...per il paziente che blocca temporaneamente la protesi vocale Per maggiori informazioni visitare il sito www atosmedical com o rivolgersi al distributore di zona 3 Informazioni aggiuntive 3 1 Informaz...

Страница 38: ...tubo de intubaci n se inserte y extraiga con cuidado de modo que la pr tesis de voz no se desplace ni se salga 1 Informaci n descriptiva 1 1 Instrucciones de uso El set de punci n Provox Vega es un d...

Страница 39: ...aqueal La dilataci n debe realizarse en la direcci n posteroanterior La dilataci n en el sentido incorrecto provoca la colocaci n invertida de la pr tesis de voz lo cual provoca aspiraci n y no permit...

Страница 40: ...intervenci n inmediata para retirar el objeto Si se sospecha que se ha aspirado el dispositivo debe realizarse un TAC pulmonar para confirmar la aspiraci n y localizar el dispositivo Si el TAC confirm...

Страница 41: ...luyen el contenido completo de las instrucciones de uso o de la informaci n de prescripci n y no pueden reemplazar la revisi n del contenido completo de las instrucciones de uso Los v deos solo est n...

Страница 42: ...a Fig 3 6 7 Desde el lado del cr neo inserte la gu a en el extremo estrecho del dilatador de la punci n y empuje la gu a hasta que sobresalga unos 10 cm por el orificio de salida del dilatador Fig 3 7...

Страница 43: ...material del dispositivo En consecuencia deber evaluarse cuidadosamente la introducci n de medicamentos antif ngicos directamente o en las proximidades de la pr tesis de voz Las pruebas de laboratori...

Страница 44: ...rramienta para uso del paciente que bloquea temporalmente la pr tesis de voz Consulte www atosmedical com o p ngase en contacto con su distribuidor local para obtener m s informaci n 3 Informaci n adi...

Страница 45: ...nte que o tubo de intuba o seja inserido e removido cuidadosamente para que a pr tese fonat ria n o se desloque nem saia para fora 1 Informa o descritiva 1 1 Indica es de utiliza o O equipamento de pu...

Страница 46: ...rrada originar a coloca o invertida da pr tese fonat ria o que causar aspira o e incapacidade de falar N O retire o fio guia atrav s da agulha de pun o O fio guia pode ser danificado cortado e ou rasp...

Страница 47: ...tirado endoscopicamente utilizando uma pin a de apreens o n o dentada O inv lucro de silicone da pr tese fonat ria Vega tamb m pode ser localizado endoscopicamente Na TAC e durante a endoscopia o disp...

Страница 48: ...de utiliza o 2 1 Prepara o Antes da pun o determine sempre o tamanho e di metro da pr tese fonat ria a utilizar O tamanho e di metro apropriados dependem da anatomia do doente das pr ticas m dicas loc...

Страница 49: ...o e verifique que est bem preso ao dilatador Fig 3 9 ATEN O Assegure se de que o fio guia est bem preso ao imobilizador de fio do dilatador de pun o Se o fio guia n o estiver bem preso ao imobilizado...

Страница 50: ...ser limpos ap s cada utiliza o e desinfectados pelo menos uma vez por dia seguindo as suas instru es de utiliza o Durante a hospitaliza o h um risco acrescido de contamina o do dispositivo e infec o d...

Страница 51: ...omendas Consulte o fim destas instru es de utiliza o 3 2 Informa es para a assist ncia ao utilizador Para obter ajuda ou informa es adicionais consulte a informa o de contacto na contracapa destas ins...

Страница 52: ...ega Puncture Set punktionsset r en produkt som anv nds f r att utf ra en prim r eller sekund r trakeoesofagal TE punktion p laryngektomerade patienter med samtidig ins ttning av en Provox Vega r stven...

Страница 53: ...Protector farynxskyddet vid sekund r punktion Det ska endast anv ndas vid prim r punktion S KERST LL att farynx esofagusv vnaden r ordentligt skyddad t ex genom anv ndning av ett styvt endoskop innan...

Страница 54: ...ar g tt sedan f rem let svaldes Svalda delar som fastnat i nedre delen av matstrupen kan avl gsnas genom esofagoskopi eller h llas under uppsikt under en kortare tid F rem let kan spontant forts tta n...

Страница 55: ...genom Puncture Dilator tills den sticker ut ungef r 10 cm genom utg ngsh let p Puncture Dilator fig 2 7 8 Fatta tag i spetsen p Guidewire och f r in den i h let bredvid utg ngsh let fig 2 8 9 Dra t G...

Страница 56: ...lator och Wirelock ledarl set n r den r insatt i glan p Puncture Dilator fig 4 4 4 Vid behov kan Guidewire str ckas ut f r att underl tta terins ttningen 5 Forts tt enligt 2 2 Anv ndarhandledning 2 3...

Страница 57: ...ciellt silikonmaterialet i produkten kommer att p verkas bl a av bakterier och candida och produktens strukturella integritet kommer s sm ningom att f rs mras Indikationer f r utbyte av Provox Vega r...

Страница 58: ...tive situationer Hvis du skal have foretaget et indgreb der kr ver intubering indf ring af en vejrtr kningsslange i luftr ret er det meget vigtigt at an stesiologen og den l ge der udf rer indgrebet e...

Страница 59: ...relateret til punkturen f eks breddefor gelse granulation atrofi Det skal derfor sikres at v vsintegriteten er tilstr kkelig til dannelse af en TE punktur Under operationen Generelt V R SIKKER P at Ph...

Страница 60: ...r tilf ldet med ethvert andet fremmedlegeme kan komplikationer fra aspiration af en komponent medf re obstruktion eller infektion jeblikkelige symptomer kan inkludere hosten hv sen eller andre unormal...

Страница 61: ...nder Forsigtig Videoerne erstatter ikke og omtaler ikke hele indholdet af brugsanvisningen og eller informationen til den ordinerende l ge og kan ikke tr de i stedet for en gennemgang af hele brugsanv...

Страница 62: ...og verificer at den er fastgjort til punkturdilatatoren Fig 3 9 FORSIGTIG S rg for at guidewiren sidder godt fastsp ndt i punkturdilatatorens guidewirel s Hvis guidewiren ikke er forsvarligt l st ind...

Страница 63: ...spitalsindl ggelse er det derfor vigtigt at rense og desinficere tilbeh ret umiddelbart efter brug og igen lige inden brug og at skylle med sterilt vand snarere end med vandhanevand Se brugsanvisninge...

Страница 64: ...jernes kan v sker fra munnen spiser ret eller magen komme inn i puster ret Det er meget viktig at intubasjonsslangen settes inn og fjernes forsiktig slik at taleprotesen ikke l sner eller kommer ut 1...

Страница 65: ...nksjonskanylen fjernes f r Pharynx Protector fjernes Punksjonskanylen kan for rsake vevsskade uten riktig pharynx beskyttelse PASS P at punksjonsdilatatoren monteres p oesophagus enden av Guidewire og...

Страница 66: ...bekrefter aspirasjon av enheten kan enheten fjernes endoskopisk ved hjelp av en gripetang uten fortanning Silikonhuset p Vega taleprotesen kan ogs lokaliseres endoskopisk P en CT skann og under endos...

Страница 67: ...ssering av protesen www atosmedical com primary puncture 1 Etter fjerning av larynx og oppretting av trakeostoma og f r lukking av pharynx m Pharynx Protector settes inn i den pne pharynx oesophagus f...

Страница 68: ...jonsdilatatoren er gjennom punksjonen St tt TE vevet under dilatasjonen for eksempel med to fingre for redusere dilatasjonskraften Grip bestemt i Guidewire n r punksjonsdilatatoren for f bedre kontrol...

Страница 69: ...m f lger med Provox tilbeh ret 2 5 Levetid p Provox Vega taleprotesen Enhetens levetid varierer etter individuelle biologiske forhold og det er ikke mulig forutsi enhetens integritet over lengre tid M...

Страница 70: ...uheproteesin sijoittamiseen potilaille joille on tehty kurkunp npoisto Provox Vega puheproteesi on steriili kertak ytt inen paikalleen j v puheproteesi joka on tarkoitettu puhekuntoutukseen kurkunp n...

Страница 71: ...myytt Guidewire ohjainlankaa EI SAA vet pois punktioneulan l pi Guidewire ohjainlanka voi vaurioitua murtua ja tai naarmuuntua Jos Guidewire ohjainlanka t ytyy vet pois irrota se ja punktioneula sama...

Страница 72: ...gitysteihin laite voidaan ottaa pois endoskooppisesti hammastamattomien tarttumispinsettien avulla Vega puheproteesin silikoninen kotelo voidaan paikallistaa my s endoskooppisesti Laite voi n ytt TT k...

Страница 73: ...imary puncture 1 Aseta Pharynx Protector nielusuoja avoimeen nieluun ruokatorveen kurkunp n poiston ja trakeostooman muodostamisen j lkeen ennen nielun sulkemista kuva 2 1 2 Varmista TE punktion oikea...

Страница 74: ...et m ll varovasti Guidewire ohjainlanka punktiokohdan l pi kunnes punktiolaajennin on kulkenut punktion yli Tue TE kudosta laajentamisen aikana esimerkiksi kahdella sormella jotta laajentava voima pie...

Страница 75: ...ti k yt n j lkeen sek j lleen juuri ennen k ytt ja huuhdella steriilill vedell hanaveden sijasta Katso yksityiskohtia ja Provox lis varusteiden puhdistustapoja Provox lis varusteiden mukana tulevista...

Страница 76: ...heoezofage ln TE punkci u pacient po resekci hrtanu se sou asn m zaveden m hlasov prot zy Provox Vega Hlasov prot za Provox Vega je steriln za zen na jednor zov pou it a je ur en k dlouhodob mu zavede...

Страница 77: ...hlou jako jednu jednotku aby jej jehla nepo kodila Nepou vejte ozuben pe ny svorky nebo jin n stroje kter mohou v robek po kodit Sekund rn punkce Nepou vejte p ilo en chr ni hltanu Pharynx Protector p...

Страница 78: ...en spolknut m prot zy nebo komponenty hlasov ho rehabilita n ho syst mu z vis na velikosti poloze stupni obstrukce pokud existuje a uplynul dob Pokud spolknut komponenta z stala v doln sti j cnu lze j...

Страница 79: ...hltanu Pharynx Protector Jinak hroz riziko poran n tk n j cnu 6 Vyjm te chr ni hltanu Pharynx Protector Ne budete pokra ovat mus z stat in situ pouze vodi Guidewire obr 2 6 7 Konec vodi e Guidewire kt...

Страница 80: ...ud je nutno z krok zah jit znovu od za tku soupravu Provox Vega Puncture Set lze znovu zalo it Pro opakovan zalo en syst mu 1 Tla te vodi Guidewire ven z u ho konce punk n ho dilat toru a se vodi uvol...

Страница 81: ...le it informace pro pacienty Prot za nen trval implant t a mus se as od asu vym nit ivotnost za zen se bude li it v z vislosti na individu ln ch biologick ch okolnostech a nen mo n p edv dat jak bude...

Страница 82: ...sta do tchawicy Jest bardzo wa ne aby rurka intubacyjna by a wk adana i wyci gana ostro nie tak aby nie nast pi o przemieszczenie ani wypadni cie protezy g osowej 1 Opis 1 1 Wskazania do stosowania Ze...

Страница 83: ...acz gard a Pharynx Protector zosta wprowadzony dostatecznie g boko do prze yku przed wykonaniem punkcji tchawiczo prze ykowej Wykonanie punkcji bez prawid owego umieszczenia ochraniacza gard a mo e sp...

Страница 84: ...etoki od prowadnicy Guidewire i usun ochraniacz gard a Pharynx Protector Zobacz tak e punkt Powt rne za adowanie poni ej Powt rne za adowanie W niekt rych przypadkach mo e by konieczne powt rne za ado...

Страница 85: ...protezy g osowej Wyst powanie silniejszego podci nienia w odcinku gard owo prze ykowym podczas prze ykania Celem zbadania tego zjawiska nale y wykona poprzez stom inspekcj klapki zastawki protezy podc...

Страница 86: ...prze ykowej oraz c narz dzia u atwiaj cego bezpieczne przej cie prowadnicy Guidewire podczas jej przeprowadzania przez gard o i wyprowadzania ustami Wprowadzi narz dzie do prze yku rysunek 3 1 Je li...

Страница 87: ...ej zrozumia ej mowy Nale y dopilnowa aby pacjent rozumia e powinien skontaktowa si z lekarzem prowadz cym w nast puj cych przypadkach Wszelkie zmiany w wygl dzie materia u protezy lub sposobie jej osa...

Страница 88: ...dida prowadz ce do pogorszenia stanu materia w i lub potrzeba stosowania nadmiernego nacisku przy m wieniu Innym powodem wcze niejszej wymiany mog by przes anki medyczne takie jak problemy z kana em p...

Страница 89: ...ndarne traheoezofagealne du ni no jednja ne TE punkcije u laringektomiranim pacijentima s istovremenim postavljanjem govorne proteze Provox Vega Govorna proteza Provox Vega je sterilna ugradbena govor...

Страница 90: ...ze to uzrokuje uvla enje i nemogu nost govora NE izvla iti icu vodilicu Guidewire kroz punkcijsku iglu Mo e do i do o te ivanja smicanja i ili struganja ice vodilice Guidewire Ako trebate izvu i icu v...

Страница 91: ...o ure aj Ako snimka CT om potvrdi aspiraciju ure aja ure aj se mo e endoskopski izvu i nenazubljenim klije tima za hvatanje Silikonsko ku i te govorne proteze Vega mo e se locirati i endoskopski Na sn...

Страница 92: ...elu jednjaku Slika 2 1 2 Provjerite ispravnu lokaciju za TE otvor opipavanjem unutra njosti du nika na eljenom mjestu uboda Za vrijeme opipavanja trebali biste osjetiti kosi prednji otvor titnika drij...

Страница 93: ...nim smirenim potezom pro irite mjesto uboda pa ljivo povla e i icu vodilicu Guidewire kroz mjesto uboda dok debeli kraj dilatatora punkcije ne pro e punkciju Tijekom dilatacije pridr ite traheoezofage...

Страница 94: ...va no o istiti i dezinficirati dodatni pribor odmah nakon upotrebe i ponovno neposredno prije upotrebe a zatim ga isprati sterilnom vodom radije nego teku om vodom Vi e informacija i kako istiti doda...

Страница 95: ...rsa a z n zdan yemek borunuzdan veya midenizden gelen s v lar soluk borunuza ka abilir Ent basyon t p n n ses protezini yerinden oynatmayacak veya d ar kartmayacak ekilde yerle tirilmesi ve kar lmas o...

Страница 96: ...e tirilmesini SA LAYIN Ponksiyon nesinin Pharynx Protector kar lmadan nce kar lmas n SA LAYIN Ponksiyon nesi uygun farinks korumas yoksa doku hasar na yol a abilir Ponksiyon Dilat r n n Guidewire n tr...

Страница 97: ...BT taramas yap lmal d r BT taramas cihaz aspirasyonunu do rularsa cihaz endoskopik olarak bir di siz tutucu forseps kullan larak al nabilir Vega ses protezinin silikon muhafazas ayr ca endoskopik ola...

Страница 98: ...eden olabilir 2 2 1 Primer ponksiyon ve protez yerle tirme www atosmedical com primary puncture 1 Larinksin kar lmas ve trakeostoman n olu turulmas sonras nda farinks kapat lmadan nce Pharynx Protecto...

Страница 99: ...ntrol i in Guidewire Ponksiyon Dilat r ne yak n olarak tutun ekil 3 10 D KKAT Dilatasyon ve ses protezinin entegre yerle tirilmesi anterior kaudal y nde TE duvar na uygulanan g c s n rlamak zere s n r...

Страница 100: ...na bak n 2 5 Provox Vega ses protezinde cihaz mr Ayr biyolojik ko ullara g re cihaz mr de i ir ve cihaz n daha uzun s re boyunca b t nl n n g rmek olas de ildir Cihaz materyali rn bakteriler ve mayal...

Страница 101: ...5 2 2 105 2 2 1 105 2 2 2 105 2 2 3 106 2 3 106 2 4 106 2 5 Provox Vega 107 2 6 107 2 7 107 3 107 3 1 107 3 2 107 www atosmedical com rescuebreathing 1 1 1 Provox Vega Puncture Set Provox Vega Provox...

Страница 102: ...Wirelock 1 4 4 1 4 6 Guidewire Provox Vega 1 4 5 1 4 6 Wirelock 1 4 7 Wirelock Provox Vega Provox Vega 1 Provox Vega 1 1 Provox Vega 1 Provox Brush 1 Provox Brush 1 4 Pharynx Protector Pharynx Protec...

Страница 103: ...harynx Protector Guidewire Wirelock Guidewire Wirelock 1 6 1 6 1 Guidewire Pharynx Protector Pharynx Protector Pharynx Protector Pharynx Protector Pharynx Protector Guidewire Guidewire Pharynx Protect...

Страница 104: ...104 15 Candida 4 6 Vega 10 17 8 10 12 5 15 Candida 5 Candida 2 U n r e g i s t e r e d c o p y...

Страница 105: ...Protector 5 2 5 Pharynx Protector 6 Pharynx Protector Guidewire 2 6 7 Guidewire Guidewire 10 2 7 8 Guidewire 2 8 9 Guidewire 2 9 10 Guidewire Guidewire 2 10 11 Guidewire 2 11 12 2 12 2 2 2 www atosmed...

Страница 106: ...idewire Wirelock Guidewire 10 Guidewire Guidewire 3 10 11 Guidewire 3 11 12 3 12 2 2 3 www atosmedical com reload of the puncture set Provox Vega Provox Vega 1 Guidewire Guidewire Wirelock 4 1 4 2 2 G...

Страница 107: ...h Provox Flush Provox Flush Provox Flush Candida Vega Provox Provox 2 5 Provox Vega Candida Candida 2 4 Candida Provox Vega Candida 1 6 1 6 2 2 6 2 7 Provox Provox Vega Provox Brush Provox Brush XL Pr...

Страница 108: ...110 2 111 2 1 111 2 2 111 2 2 1 111 2 2 2 112 2 2 3 112 2 3 112 2 4 112 2 5 Provox Vega 113 2 6 113 2 7 113 3 113 3 1 113 3 2 113 www atosmedical com rescuebreathing 1 1 1 Provox Vega Provox Vega Pro...

Страница 109: ...4 5 1 4 7 1 4 6 Provox Vega 1 1 Provox Vega 1 Provox Brush 1 Provox Brush 1 1 4 Pharynx Protector Pharynx Protector Guidewire Pharynx Protector Pharynx Protector Pharynx Protector G u i d e w i r e Gu...

Страница 110: ...harynx Protector Guidewire P h a r y n x P r o t e c t o r Pharynx Protector Pharynx Protector Pharynx Protector Guidewire Guidewire Pharynx Protector 2 2 3 4 1 6 2 CT Provox Vega CT 10 17 mm 8 10 12...

Страница 111: ...x Protec tor 2 3 4 Guidewire Guidewire Pharynx Protector 20 cm Guidewire 2 4 Pharynx Protector Guidewire 5 2 5 Pharynx Protector 6 Pharynx Protector Guidewire 2 6 7 G u i d e w i r e 10 cm Guidewire 2...

Страница 112: ...Guidewire 3 4 P h a r y n x P r o t e c t o r G u i d e w i r e 5 3 5 6 Pharynx Protector Guidewire 3 6 7 Guidewire 10 cm Guidewire 3 7 8 Guidewire 3 8 9 Guidewire 3 9 Guidewire Guidewire Guidewire 10...

Страница 113: ...ovox Brush P r o v o x B r u s h Provox Brush Provox Brush Provox Flush Provox Flush 1 1 2 5 Provox Vega 2 4 1 6 1 6 2 2 6 2 7 Provox Brush Provox Brush XL Provox Flush Provox Brush Provox Plug www at...

Страница 114: ...17 2 2 1 117 2 2 2 118 2 2 3 118 2 3 118 2 4 118 2 5 Provox Vega 119 2 6 119 2 7 119 3 119 3 1 119 3 2 119 www atosmedical com rescuebreathing 1 1 1 Provox Vega TE Provox Vega Provox Vega 1 2 TE Provo...

Страница 115: ...vox Vega 1 1 Provox Vega 1 Provox Brush 1 Provox Brush 1 1 4 TE TE Pharynx Protector TE Pharynx Protector Guidewire TE Pharynx Protector Pharynx Protector Guidewire Guidewire Guidewire Guidewire Guide...

Страница 116: ...d e w i r e Pharynx Protector Pharynx Protector Pharynx Protector Pharynx Protector Guidewire Guidewire Pharynx Protector 2 2 3 4 1 6 2 TE CT CT Vega CT 10 17 mm 8 10 12 5 15 mm 4 6 Vega 10 17 mm 8 10...

Страница 117: ...tector 8 10 mm 2 3 4 Guidewire Guidewire Pharynx Protector 20 cm Guidewire 2 4 Guidewire Pharynx Protector 5 2 5 Pharynx Protector 6 Pharynx Protector Guidewire 2 6 7 Guidewire 10 cm Guidewire 2 7 8 G...

Страница 118: ...5 3 5 6 Guidewire 3 6 7 Guidewire 10 cm Guidewire 3 7 8 Guidewire 3 8 9 Guidewire Guidewire 3 9 G u i d e w i r e G u i d e w i r e Guidewire 10 G u i d e w i r e TE Guidewire 3 10 TE 11 Guidewire 3 1...

Страница 119: ...Flush Provox Vega Provox Flush Provox Flush Provox Flush Nystatin Fluconazole Mikonazol Vega Provox Provox 2 5 Provox Vega 2 4 Provox Vega 1 6 1 6 2 2 6 2 7 Provox Provox Vega Provox Brush Provox Brus...

Страница 120: ...2 123 2 123 2 1 123 2 2 123 2 2 1 124 2 2 2 125 2 2 3 125 2 3 125 2 4 125 2 5 Provox Vega 126 2 6 126 2 7 126 3 126 3 1 126 3 2 126 www atosmedical com rescuebreathing 1 1 1 Provox Vega Provox Vega TE...

Страница 121: ...4 1 4 6 Guidewire Provox Vega 1 4 5 1 4 7 1 4 6 Provox Vega Provox Vega 1 Provox Vega 1 1 Provox Vega 1 Provox Brush 1 Provox Brush 1 4 Pharynx Protector Pharynx Protector Guidewire Pharynx Protector...

Страница 122: ...harynx Protector Guidewire Guidewire Guidewire 1 6 1 6 1 Pharynx Protector Guidewire Pharynx Protector Pharynx Protector Pharynx Protector Pharynx Protector Guidewire Guidewire Pharynx Protector 2 2 3...

Страница 123: ...123 4 6 Vega 10 17 8 10 12 5 15 5 PE 2 2 1 2 2 2 2 1 www atosmedical com primary puncture 1 Pharynx Protector 2 1 2 Pharynx Protector 2 2 3 8 10 U n r e g i s t e r e d c o p y...

Страница 124: ...Guidewire 2 10 11 Guidewire 2 11 12 2 12 2 2 2 www atosmedical com secondary puncture and prosthesis placement Provox Vega Pharynx Protector 1 1 1 a b c Guidewire 3 1 Guidewire 2 3 2 3 8 10 3 3 4 Gui...

Страница 125: ...2 2 Guidewire 4 3 3 Vega 4 4 4 4 4 Guidewire 5 2 2 2 3 EO 2 4 Provox Vega Plug Vega Provox Provox Vega Provox Brush Provox Brush Provox Brush Provox Flush Provox Vega Provox Flush Provox Flush Provox...

Страница 126: ...126 1 6 1 6 2 2 6 2 7 Provox Vega Provox Brush Provox Brush XL Provox Flush Provox Plug www atosmedical com 3 3 1 3 2 U n r e g i s t e r e d c o p y...

Страница 127: ...rovox Flush Provox Flush Vega Provox Flush Provox Flush n Vega Mikonazol Fluconazole Nystatin Provox Provox Provox Vega 2 5 2 4 Provox Vega 1 6 1 6 2 2 6 2 7 Provox Vega Provox Provox Brush XL Provox...

Страница 128: ...ewire 3 5 5 Guidewire 6 3 6 Guidewire 7 3 7 10 Guidewire 3 8 Guidewire 8 Guidewire 9 3 9 Guidewire Guidewire Guidewire Guidewire 10 3 10 Guidewire Guidewire 11 3 11 3 12 12 2 2 3 www atosmedical com r...

Страница 129: ...8 10 3 2 3 Pharynx Protector Guidewire Guidewire 4 2 4 Pharynx Protector 20 Pharynx Protector Guidewire 2 5 5 Pharynx Protector Guidewire Pharynx Protector 6 2 6 Guidewire 7 10 Guidewire 2 7 2 8 Guide...

Страница 130: ...x Guidewire Protector Pharynx Protector Pharynx Protector Pharynx Protector Pharynx Protector Guidewire Pharynx Guidewire Protector 4 2 2 3 1 6 2 CT CT CT Vega 10 17 15 12 5 10 8 4 6 Vega 10 17 15 12...

Страница 131: ...Protector Pharynx Protector Pharynx Protector Guidewire Pharynx Protector Guidewire Guidewire Guidewire Guidewire Guidewire Guidewire Pharynx Protector Provox Vega Brush Provox Plug Flush 1 5 Pharynx...

Страница 132: ...om rescuebreathing 1 1 1 TE Provox Vega Puncture Set Provox Vega Provox Vega 1 2 Provox Vega Puncture Set TE Provox Vega Puncture Set 1 3 TE Provox Vega Puncture Set Provox Vega Provox Vega Provox Veg...

Страница 133: ...Brush Provox Flush Provox Flush Vega Provox Flush Provox Flush Vega Provox Provox Provox Vega 2 5 2 4 Provox Vega 1 6 1 6 2 2 6 2 7 Provox Vega Provox Provox Brush XL Provox Brush Provox Flush Provox...

Страница 134: ...3 5 5 3 6 Guidewire 6 Guidewire Guidewire 7 3 7 10 3 8 Guidewire 8 Guidewire 9 3 9 Guidewire Guidewire Guidewire Guidewire 10 3 10 Guidewire Guidewire 11 3 11 12 3 12 2 2 3 www atosmedical com reload...

Страница 135: ...8 3 2 3 Pharynx Protector 20 Guidewire Guidewire 4 2 4 Pharynx Protector Pharynx Protector Guidewire 2 5 5 Pharynx Protector Guidewire Pharynx Protector 6 2 6 Guidewire 7 2 7 10 Guidewire 2 8 Guidewi...

Страница 136: ...idewire Pharynx Protector Pharynx Protector Pharynx Protector Pharynx Protector Pharynx Protector Guidewire Pharynx Protector Guidewire 2 2 3 4 1 6 2 Vega 10 17 15 12 5 10 8 6 4 Vega 15 12 5 10 8 10 1...

Страница 137: ...rovox Vega Provox Brush Provox Brush 1 4 Pharynx Protector Pharynx Protector Pharynx Protector Guidewire Pharynx Protector Guidewire Guidewire Guidewire Guidewire Guidewire Guidewire Pharynx Protector...

Страница 138: ...2 134 2 2 3 134 2 3 134 2 4 133 Provox Vega 2 5 133 2 6 133 2 7 133 3 133 3 1 133 3 2 www atosmedical com rescuebreathing 1 1 1 Provox Vega Provox Vega Provox Vega 1 2 Provox Vega Provox Vega 1 3 Prov...

Страница 139: ...m 8141 Rx Provox Vega Puncture Set 17Fr 12 5 mm 8142 Rx Provox Vega Puncture Set 17Fr 15 mm 8143 Rx Provox Vega Puncture Set 20Fr 8 mm 8144 Rx Provox Vega Puncture Set 20Fr 10 mm 8145 Rx Provox Vega P...

Страница 140: ...l AB Kraftgatan 8 P O Box 183 SE 242 22 H rby Sweden Tel 46 0 415 198 00 Fax 46 0 415 198 98 www atosmedical com info atosmedical com Atos Medical AB 2015 No 10881 Edition 201512A U n r e g i s t e r...

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