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GuideWire

IFU

Summary of Contents for GuideWire

Page 1: ...G GuideWire IFU MD RT...

Page 2: ...Fig 1 1 1 1 2...

Page 3: ...3 2 1 2 2 2 3 2 4 2 6 Fig 2 2 5 Fig 2...

Page 4: ...4 3 1 3 2 3 3 3 4 3 5 3 6 Fig 3 Fig 3...

Page 5: ...5 Fig 4 4 1 4 2 4 3 Fig 4 4 1 4 2 4 3 Fig 4...

Page 6: ...dical 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 A...

Page 7: ...ummer Code de lot Codice lotto C digo de lote C digo do lote Batchkod Batchkode Batchkode Er numero Lotun mer Partii kood Partijas kods Partijos kodas K d ar e Sarzs k d K d ar e tevilka serije Kod pa...

Page 8: ...p ed slune n m z en m a udr ujte v suchu Tartsa a napf nyt l t vol s tartsa sz razon Chr te pred slne n m iaren m a uchov vajte v suchu Shranjujte na suhem in ne izpostavljajte son ni svetlobi Chroni...

Page 9: ...tom nyon bel l max min enged lyezett Uchov vajte pri izbovej teplote Do asn odch lky v r mci teplotn ho rozsahu max min s povolen Shranjujte pri sobni temperaturi Dovoljena so za asna odstopanja znotr...

Page 10: ...Medical Device Medizinprodukt Medisch hulpmiddel Dispositif m di cal Dispositivo medico Producto sanitario Dispositivo m dico Medi cinteknisk produkt Medicinsk udstyr Medisinsk utstyr L kinn llinen la...

Page 11: ...GU S 39 SV SVENSKA 44 DA DANSK 48 NO NORSK 52 FI SUOMI 56 IS SLENSKA 61 ET EESTI 65 LT LIETUVI KALBA 69 CS ESKY 74 HU MAGYAR 78 SK SLOVEN INA 82 SL SLOVEN INA 87 PL POLSKI 91 RO ROM N 96 HR HRVATSKI 1...

Page 12: ...eWire sterile Fig 1 1 Instructions for use Provox GuideWire non sterile The Provox GuideWire has two functional parts Fig 1 1 Stopper for transoral removal of the old Provox Voice Prosthesis made of A...

Page 13: ...rasping forceps Ingestion of parts of the Provox GuideWire or parts of the Provox System Accidental ingestion of parts of the Provox GuideWire or parts of the Provox System may occur As with any other...

Page 14: ...the puncture opening and is pulled back Careful traction on the GuideWire will bring the strap of the prosthesis into the TE puncture The voice prosthesis is carefully rotated into position with two...

Page 15: ...racheal flange removed the Stopper of the GuideWire will pull the remains of the old voice prosthesis into the esophagus and up through the mouth Discard the old voice prosthesis Placement of a steril...

Page 16: ...berhalb der Punktionsstelle oder schweren Trismus aufweist Betr chtliche pharyngeale Stenose kann das Einsetzen der Stimmprothese unm glich machen Schwerer Trismus kann einen angemessenen Schutz der P...

Page 17: ...ss bei bekannter oder vermutlicher pharyngealer Stenose vor Gebrauch des GuideWire eine Dilatation des Pharynx durchgef hrt wird DARAUF ACHTEN dass w hrend des Verfahrens stets aseptische Kautelen ein...

Page 18: ...e F hrungsdraht kann in der pharyngealen Schleimhautwand stecken bleiben oder durch sie behindert werden Der Provox GuideWire F hrungsdraht kann in der Regel durch leichten Druck nahe der Spitze gebog...

Page 19: ...ine tracheo sophageale Fistel mittels des Provox Trocar with Cannula anlegen ca 8 10 mm von der Kante des Tracheostomas Abb 3 2 3 Den Trokar nach Anlegen der Fistel entfernen w hrend die Trokarkan le...

Page 20: ...die tracheo sophageale Fistel gebracht Abb 4 2 VORSICHT Die Stimmprothese nicht mit dem GuideWire in Position ziehen 4 Den Trachealflansch der Stimmprothese mithilfe eines nicht gezahnten H mostats in...

Page 21: ...beletten waardoor oesofagusweefsel beschadigd kan raken 1 3 Beschrijving van het hulpmiddel De Provox GuideWire is een steriel eenmalig bruikbaar hulpmiddel voor het inbrengen en het vervangen van st...

Page 22: ...pen kan aspiratie van een onderdeel obstructie of infectie veroorzaken Acute symptomen zijn onder meer hoesten een fluitende ademhaling of abnormale ademgeluiden dyspneu ademhalingsstilstand gedeeltel...

Page 23: ...ksaanwijzing 2 1 Voorbereiding Controleer de integriteit van de steriele verpakking Gebruik het product niet als de verpakking beschadigd of open is 2 2 Gebruiksinstructies 2 2 1 De primaire punctie a...

Page 24: ...Anterograad versus retrograad inbrengen Als de steriele permanente stemprothese niet op anterograde wijze kan worden ingebracht kan de stemprothese met behulp van de Provox GuideWire op retrograde wij...

Page 25: ...punctie zorgt Provox Pharynx Protector farynxbeschermer roestvrijstalen instrument ter bescherming van de farynxwand tijdens de primaire TE punctie 3 Aanvullende informatie 3 1 Bestelinformatie Zie d...

Page 26: ...contamination crois e Le nettoyage et la rest rilisation peuvent endommager la structure du dispositif Pendant l insertion TOUJOURS proc der lentement et sans forcer pour tirer sur GuideWire L utilisa...

Page 27: ...estomactransitentg n ralementparletractusintestinal L extraction chirurgicale des corps trangers du tractus intestinal doit tre envisag e en pr sence d occlusion intestinale de saignement ou de perfor...

Page 28: ...e en place avec le GuideWire 6 Une fois la proth se phonatoire correctement positionn e couper la tige de s curit tout en la laissant attach e au GuideWire Tourner la proth se phonatoire pour que la p...

Page 29: ...de d un scalpel et la retirer Une fois la collerette trach ale enlev e l arr t du GuideWire tire les restes de l ancienne proth se phonatoire dans l sophage et jusqu la bouche liminer l ancienne proth...

Page 30: ...ia sterile a permanenza Provox 1 2 Controindicazioni Non utilizzare se il paziente affetto da anomalie anatomiche quali stenosi faringea grave sopra il sito della fistola o trisma grave Una stenosi fa...

Page 31: ...chio di infezioni Accertarsi SEMPRE che la stringa di sicurezza della protesi fonatoria sia opportunamente fissata al dispositivo GuideWire In assenza di fissaggio la protesi fonatoria pu staccarsi da...

Page 32: ...namento generalmente destinato a risolversi spontaneamente I pazienti sottoposti a terapia anticoagulante dovranno essere monitorati con attenzione al fine di evitare il rischio di emorragia prima del...

Page 33: ...in sede altrimenti la protesi stessa potrebbe bloccarsi 5 Collegare e fissare al connettore del dispositivo GuideWire la stringa di sicurezza di una protesi fonatoria di modello diametro e misura adeg...

Page 34: ...mentre si osserva la protesi fonatoria per escludere la presenza di perdite Tagliare la stringa di sicurezza mentre ancora fissata al dispositivo GuideWire e gettare quest ultimo Fig 4 3 2 3 Pulizia e...

Page 35: ...uso de la gu a Provox GuideWire no est riles La gu a Provox GuideWire tiene dos piezas funcionales Fig 1 1 Tap n para la extracci n transoral de la vieja pr tesis de voz Provox hecho de pl stico ABS F...

Page 36: ...y recuperado endosc picamente utilizando unas pinzas de sujeci n no dentadas Ingesti n de piezas de la gu a Provox GuideWire o del sistema Provox Se puede producir la ingesti n accidental de piezas d...

Page 37: ...ECAUCI N No conecte la pr tesis de voz cuando el Pharynx Protector est colocado dado que la pr tesis se puede atascar 5 La banda de seguridad de la pr tesis de voz del modelo di metro y tama o adecuad...

Page 38: ...av s de la faringe y saliendo por la boca Extracci n retr grada de la vieja pr tesis solo Provox 1 La vieja pr tesis de voz Provox 1 puede extraerse transoralmente mediante el uso de la gu a Provox Gu...

Page 39: ...l fabricante y a la autoridad nacional del pa s en el que resida el usuario y o el paciente PORTUGU S 1 Informa o descritiva 1 1 Indica es de utiliza o O Provox GuideWire um dispositivo de inser o est...

Page 40: ...os com anticoagulantes antes da coloca o ou substitui o da pr tese fonat ria CERTIFIQUE SE de que em caso de suspeita ou presen a de estenose far ngea a dilata o da faringe deve ser realizada antes da...

Page 41: ...ar para cima em direc o faringe Pare o procedimento se a curvatura geral n o ajudar Hemorragia sangramento da pun o Pode ocorrer sangramento ligeiro a partir dos bordos da pun o traqueoesof gica TE du...

Page 42: ...a pr tese fonat ria quando o endosc pio estiver colocado uma vez que a pr tese fonat ria pode ficar presa 5 A fita de seguran a da pr tese fonat ria de modelo di metro e tamanho adequado est fixa e pr...

Page 43: ...que n o existem fugas Corte a fita de seguran a enquanto ainda est presa ao GuideWire e elimine o GuideWire Fig 4 3 2 3 Limpeza e esteriliza o O Provox GuideWire fornecido est ril OE e destina se excl...

Page 44: ...stventilen tillverkat av ABS plast fig 1 1 2 Anslutning f r montering av en s kerhetsstr ng p Provox r stventil tillverkad av nylonplastmaterial polyamid fig 1 2 Slangen till Provox GuideWire ledare r...

Page 45: ...amt hur l ng tid det har g tt sedan f rem let svaldes Svalda delar som fastnat i esofagus matstrupen kan avl gsnas genom esofagoskopi eller h llas under uppsikt under en kortare tid F rem let kan spon...

Page 46: ...orrekt placerad sk rs s kerhetsstr ngen av medan den fortfarande r ansluten till GuideWire ledaren och r stventilen vrids s att den del d r s kerhetsstr ngen satt fast riktas ned t in i trakea luftstr...

Page 47: ...stventil Anslutningen till GuideWire ledaren befinner sig nu utanf r munnen fig 4 1 3 Anslut och f st den nya r stventilen i anslutningen till GuideWire ledaren Dra GuideWire ledaren ned t mot den bef...

Page 48: ...indf ring af stemmeprotesen Sv r trismus kan udelukke korrekt beskyttelse af sv lgv ggen under sekund r punktur og medf re beskadigelse af esophagusv v 1 3 Beskrivelse af instrumentet Provox GuideWir...

Page 49: ...le af Provox GuideWire eller dele af Provox System Ligesom med andre fremmedlegemer kan komplikationer fra aspiration af en komponent for rsage obstruktion eller infektion jeblikkelige symptomer kan i...

Page 50: ...ntegritet Produktet m ikke anvendes hvis emballagen er beskadiget eller bnet 2 2 Betjeningsvejledning 2 2 1 Placering af prim re punktur fig 2 1 Indf r Provox Pharynx Protector beskytter i det bne pha...

Page 51: ...n i visse tilf lde baseret p l gens vurdering udf res under fuld an stesi Anterograd fjernelse af den gamle protese ikke Provox 1 1 Tag fat i trachealflangen med en atraumatisk karklemme og tr k prote...

Page 52: ...4 Rapportering Bem rk at enhver alvorlig h ndelse der er opst et i relation til enheden skal indberettes til fabrikanten og den nationale myndighed i det land hvor brugeren og eller patienten opholde...

Page 53: ...or bl dning eller hemoragi f r plassering eller utskifting av taleprotesen S RG FOR utf re dilatasjon av pharynx f r GuideWire brukes i tilfeller der det er kjent eller mistanke om faryngeal stenose S...

Page 54: ...alueres n ye med hensyn til risiko for hemoragi f r sekund r punksjon og plassering av protesen Ruptur av trakeo sofagealvevet Hvis det oppst r ruptur av TE vevet m TE punksjonsprosedyren avsluttes og...

Page 55: ...rograd innsetting Hvis ikke den sterile inneliggende taleprotesen kan settes inn p anterograd m te kan retrograd innsetting ved bruk av Provox GuideWire utf res Utskiftingen skal utf res som poliklini...

Page 56: ...g V r oppmerksom p at enhver alvorlig hendelse som har oppst tt i forbindelse med enheten skal rapporteres til produsenten og nasjonale myndigheter i landet der brukeren og eller pasienten bor SUOMI 1...

Page 57: ...dasta Haittatapahtumat 1 5 VAROTOIMET Arvioi aina sopivuutta ennen kuin k yt t Provox GuideWire ohjainvaijeria potilaalle l k yt tuotetta tapauksissa jotka eiv t ole t h n sopivia VARMISTA ett ennen p...

Page 58: ...on kysytt v neuvoa gastroenterologilta Nielty esine voidaan poistaa hammastamattomien tarttumispihtien avulla Provox GuideWire ohjainvaijeri j kiinni nielun limakalvon sein m n Provox GuideWire ohjain...

Page 59: ...kaari punktion j lkeen J t troakaarikanyyli paikoilleen kuva 3 3 4 Vie Provox GuideWire ohjainvaijeri troakaarikanyylin l pi GuideWire ohjainvaijeria ty nnet n yl sp in skoopin l pi kunnes pys ytin py...

Page 60: ...TE punktioonhammastamattoman suonenpuristimen avulla K nn puheproteesia sitten niin ett varmistusnauha osoittaa alasp in henkitorvea kohti Anna potilaan juoda ja niell samalla kun tarkkailet puheprote...

Page 61: ...stoppara e stopper sem tla ur er til ess a fjarl gja leifar gamla talventilsins gegnum munninn Pakkning Provox GuideWire lei arav rsins inniheldur eftirfarandi hluti 1 Provox GuideWire lei arav r s f...

Page 62: ...etur anda g ti h sti hj lpa til vi a fjarl gja a skotahlutinn Fyrirsta a hluta ndunarvegar e a alger hindrun krefst tafarlauss inngrips til a fjarl gja a skotahlutinn Ef grunur er um a a skotahlutur h...

Page 63: ...rovox GuideWire lei arav rinn stefnuna fram aftur e anterioposterior gegnum op holn larinnar Tengi GuideWire lei arav rsins birtist gegnum efra op Pharynx Protector sem m fjarl gja mynd 2 4 VAR Ekki m...

Page 64: ...koki og t um munninn Eldri talventill a eins Provox 1 fjarl g ur stefnunni aftur bak H gt er a fjarl gja eldri Provox 1 talventil gegnum munn me hj lp Provox GuideWire lei arav rsins 1 Me an eldri tal...

Page 65: ...j klingur hefur b setu EESTI 1 Kirjeldav teave 1 1 N idustused Juhttraat Provox GuideWire on steriilne hekordseks kasutamiseks m eldud sisestusseade mis on ette n htud steriilse Provoxi sisemise h lep...

Page 66: ...a v i kahtlustatava neelu kitsenemise korral tuleks enne juhttraadi GuideWire kasutamist neelu laiendada KASUTAGE infektsiooni riski v ltimiseks protseduuri ajal alati aseptilisi meetodeid VEENDUGE et...

Page 67: ...e koe rebend TE koe rebendi korral tuleb TE punktsiooni protseduur katkestada ja rebend kohe kinni mmelda TE punktsiooni tohib korrata ainult siis kui kudesid on n uetekohaselt ravitud Juhttraat Provo...

Page 68: ...se turvarihm ra kui see on endiselt juhttraadi GuideWire k lge kinnitatud ja h leprotees keeratakse nii et osa kuhu turvarihm oli hendatud on suunatud allapoole hingetorusse joonis 3 6 2 2 3 Asendamis...

Page 69: ...statud TE punktsiooni kaudu juhitava l bip su juhttraadile GuideWire Neelukaitse Provox Pharynx Protector Roostevabast terasest instrument neeluseina kaitsmiseks esmase TE punktsiooni ajal 3 Lisateave...

Page 70: ...Veiksmai dedant VEIKSMUS ATLIKITE l tai ir traukdami GuideWire nenaudokite pernelyg didel s j gos Nesilaikant io nurodymo gali b ti pa eisti audiniai pasislinkti arba b ti i stumtos Provox GuideWire d...

Page 71: ...o pasi alinimas tur t vykti per 4 6 dienas Pacientui reikia nurodyti steb ti ar i matose n ra nuryto objekto Jei objektas nepasi alina savaime arba jei pastebima obstrukcijos po ymi kar iavimas v mima...

Page 72: ...ma auk tyn per endoskop kol j sustabdo stabdiklis atsir m s kaniul s gal Tada galima i imti endoskop 3 4 pav D MESIO Kai d tas endoskopas kalb jimo protezo netvirtinkite nes antraip jis gali strigti 5...

Page 73: ...ugin juostel ir i meskite GuideWire 4 3 pav 2 3 Valymas ir sterilizavimas Provox GuideWire tiekiama sterili EO skirta naudoti tik vien kart ir jos NEGALIMA valyti arba pakartotinai sterilizuoti 2 4 al...

Page 74: ...GuideWire obr 1 1 nesteriln n vod k pou it vodi e Provox GuideWire Vodi Provox GuideWire m dv funk n sou sti obr 1 1 Zar ka pro vyjmut star hlasov prot zy Provox p es stn dutinu vyrobena z ABS plastu...

Page 75: ...k n hodn mu spolknut st vodi e Provox GuideWire nebo st syst mu Provox Jako u jin ch ciz ch t les p znaky zp soben spolknut m st vodi e Provox GuideWire nebo st syst mu Provox z vis na velikosti polo...

Page 76: ...p sku prot zy do TE punkce Opatrn oto te hlasovou prot zu do spr vn polohy Dr te trache ln man etu pevn dv ma neozuben mi pe ny obr 2 5 UPOZORN N Nevtahujte hlasovou prot zu na m sto pomoc vodi e Guid...

Page 77: ...ikvidujte Um st n steriln hlasov prot zy Provox pro dlouhodob zaveden Konektor vodi e Guidewire je v tuto dobu venku z st obr 4 1 3 P ipojte ke konektoru vodi e GuideWire novou hlasovou prot zu a zaji...

Page 78: ...e r sa A Provox GuideWire egy steril egyszer haszn latos eszk z amely steril Provox bennmarad hangprot zis behelyez s re vagy cser j re szolg l A GuideWire eszk z n egy csatlakoz tal lhat az j hangpro...

Page 79: ...enes l gz si hang dyspnoe s l gz sle ll s r szleges vagy nem megfelel l gcsere s vagy aszimmetrikus l gz si mellkasmozg s A sz v dm nyek t bbek k zt t d gyullad s atelectasis bronchitis t d t lyog bro...

Page 80: ...trok rt mik zben a Trocar kan lt a hely n hagyja 2 3 bra 4 Vezesse be a Provox GuideWire eszk zt anteroposterior ir nyban a Trocar kan l ny l s n t A GuideWire csatlakoz ja kiny lik a Pharynx Protecto...

Page 81: ...zt A r gi prot zis retrogr d elt vol t sa csak Provox 1 A r gi Provox 1 hangprot zis a Provox GuideWire haszn lat val transzor lisan is elt vol that 1 Mik zben a r gi hangprot zis a hely n van vezess...

Page 82: ...ik cie pou itia Provox GuideWire je steriln zav dzacia pom cka na jednorazov pou itie ur en na umiestnenie sterilnej vn torne zav dzanej hlasovej prot zy Provox Voice Prosthesis po plnej laryngekt mii...

Page 83: ...vajte Pred umiestnen m alebo v menou hlasovej prot zy starostlivo VY ETRITE pacientov s krv cav mi poruchami alebo pacientov ktor podstupuj antikoagula n lie bu i u nich nehroz riziko krv cania alebo...

Page 84: ...a alebo sliznica hltana m e naru i jeho ovl danie Pri ahkom zatla en sa vodiaci dr t Provox GuideWire zvy ajne ohne v bl zkosti pi ky a sk zne nahor smerom k hltanu Ak tak to ohnutie nepom ha zastavte...

Page 85: ...m sa nezastav na zar ke na konci kanyly Potom mo no endoskop vybra obr 3 4 UPOZORNENIE Neprip jajte hlasov prot zu ak je zaveden endoskop preto e hlasov prot za m e uviaznu 5 Pripevnite bezpe nostn p...

Page 86: ...nostn popruh tak aby zostal pripojen k vodiacemu dr tu GuideWire a vodiaci dr t GuideWire zlikvidujte obr 4 3 2 3 istenie a steriliz cia Vodiaci dr t Provox GuideWire sa dod va steriln EO a je ur en i...

Page 87: ...ox GuideWire ima dva funkcijska dela Sl 1 1 zaustavljalnik za odstranitev stare govorne proteze Provox izdelane iz umetnega materiala ABS skozi usta Sl 1 1 2 konektor za pritrditev varnostnega traku g...

Page 88: ...x mo no odvisni od velikosti lokacije stopnje oviranja e obstaja ter dol ine asa prisotnosti Zau ite komponente ki so ostale v po iralniku je mogo e odstraniti z ezofagoskopijo ali opazovati kraj i as...

Page 89: ...a pravilno name ena varnostni trak odre ite ko je ta e vedno pritrjen na uvajalno ico GuideWire govorno protezo pa obrnite tako da bo del kjer je bil pritrjen varnostni trak obrnjen navzdol proti sapn...

Page 90: ...ne govorne proteze Provox Konektor GuideWire je zdaj zunaj ust Sl 4 1 3 Novo govorno protezo pritrdite in zavarujte na konektor GuideWire Uvajalno ico GuideWire povlecite navzdol proti obstoje i TE pu...

Page 91: ...gard a ponad miejscem punkcji lub ostry szczeko cisk Znaczne zw enie gard a mo e uniemo liwi wprowadzenie protezy g osowej Ostry szcz ko cisk mo e uniemo liwi odpowiedni ochron ciany gard a podczas w...

Page 92: ...na rozszerzenia gard a przed u yciem prowadnicy GuideWire NALE Yzawsze podczas zabiegu przestrzega zasad aseptyki aby zmniejszy ryzyko zaka enia NALE Ydopilnowa aby ko c wka z uchwytem protezy g osowe...

Page 93: ...kierunku gard a Je li og lne zagi cie nie pomaga nale y wstrzyma zabieg Krwawienie krwotok przetoki podczas zgodnego z przeznaczeniem stosowania prowadnicy Provox GuideWire mo e wyst pi lekkie krwawie...

Page 94: ...iejscu kaniul trokara rys 3 3 4 Wprowadzi prowadnic Provox GuideWire przez kaniul trokara Prowadnica GuideWire zostaje przepchni ta do g ry przez endoskop do chwili gdy zatrzyma j element oporowy Stop...

Page 95: ...prze ykowej Ostro ne poci ganie za prowadnic GuideWire wci ga ko c wk z uchwytem protezy g osowej do przetoki tchawiczo prze ykowej rys 4 2 PRZESTROGA Nie wolno przeci ga protezy g osowej na miejsce...

Page 96: ...a protezei vocale Trismusul sever poate mpiedica protejarea corespunz toare a peretelui faringian n timpul punc iei secundare duc nd la lezarea esutului esofagian 1 3 Descrierea dispozitivului Provox...

Page 97: ...omponentelor sistemului Provox Componentele tubului Provox GuideWire sau componentele sistemului Provox pot fi aspirate accidental Ca n cazul oric rui alt corp str in complica iile rezultate prin aspi...

Page 98: ...deWire Dispozitivul trebuie s fie recuperat cu un endoscop 2 Instruc iuni de utilizare 2 1 Preg tirea Verifica i integritatea ambalajului steril Nu utiliza i produsul dac ambalajul acestuia este deter...

Page 99: ...s n mod anterograd se poate efectua introducerea retrograd utiliz nd tubul Provox GuideWire nlocuirea trebuie s fie efectuat ca o procedur ambulatorie folosind anestezie local Ocazional n func ie de d...

Page 100: ...spate a acestor instruc iuni de utilizare 3 3 Informa ii despre asisten a pentru utilizatori Dac ave i nevoie de ajutor sau informa ii suplimentare consulta i coperta din spate a acestui manual pentr...

Page 101: ...rovox GuideWire te posljedi nog gutanja ili o te enja tkiva NE nastavljati ako se govorna proteza zaglavi u drijelu ili jednjaku jer bi to moglo o tetiti tkivo Dodatne informacije o tim doga ajima pot...

Page 102: ...t Ako predmet ne pro e samostalno ili ako postoje znakovi za epljenja vru ica povra anje abdominalna bol potrebno se posavjetovati s gastroenterologom Ure aj se mo e izvu i nenazubljenim klije tima za...

Page 103: ...Cannula izvedite TE punkciju otprilike 8 10 mm od ruba traheostome Sl 3 2 3 Uklonite troakar nakon punktiranja a kanilu troakara ostavite na mjestu Sl 3 3 4 Uvedite icu vodilicu Provox GuideWire kroz...

Page 104: ...im okrenite govornu protezu tako da sigurnosna traka pokazuje prema dolje unutar du nika Promatrajte govornu protezu dok pacijent pije i guta kako biste se uvjerili da ne curi Odre ite sigurnosnu trak...

Page 105: ...ire sterilna sl 1 1 uputstvo za upotrebu ice vodilje Provox GuideWire nesterilno Provox GuideWire ima dva funkcionalna dela sl 1 1 Grani nik za transoralno uklanjanje stare govorne proteze Provox Voic...

Page 106: ...oni strano telo Delimi na opstrukcija disajnih puteva ili potpuna opstrukcija disajnih puteva zahteva hitnu intervenciju radi uklanjanja predmeta Ako postoji sumnja na udisanje predmeta potrebno je en...

Page 107: ...u kada je titnik drela Pharynx Protector na mestu jer bi se govorna proteza mogla zaglaviti 5 Na priklju ak ice vodilje GuideWire stavlja se i pri vr uje sigurnosna traka govorne proteze odgovaraju eg...

Page 108: ...vodilju GuideWire kroz staru protezu i potisnite icu vodilju nagore kroz drelo i izvan usta 2 Uhvatite trahealnu prirubnicu proteze nenazubljenim hemostatom Skalpelom odsecite trahealnu prirubnicu i...

Page 109: ...1 Informacije o naru ivanju Videti zadnju stranu Uputstva za upotrebu 3 2 Datum tampanja Pogledajte broj verzije na zadnjoj stranici ovog Uputstva za upotrebu 3 3 Informacije o pru anju pomo i korisn...

Page 110: ...ideWire 1 1 Provox GuideWire Provox GuideWire 1 1 Provox ABS 1 1 2 Provox 1 2 Provox GuideWire PVC 1 4 GuideWire Provox GuideWire 1 5 Provox GuideWire GuideWire GuideWire GuideWire 1 6 Provox GuideWir...

Page 111: ...111 Provox GuideWire Provox Provox GuideWire Provox GuideWire Provox 4 6 Provox GuideWire Provox GuideWire Provox GuideWire Provox GuideWire Provox GuideWire Provox GuideWire GuideWire GuideWire...

Page 112: ...2 3 Trocar Trocar 2 3 4 Provox GuideWire Trocar GuideWire Pharynx Protector 2 4 Pharynx Protector 5 GuideWire Trocar GuideWire 2 5 GuideWire 6 GuideWire 2 6 2 2 2 3 1 3 1 2 Provox Trocar 8 10 mm 3 2...

Page 113: ...ideWire 3 6 2 2 3 4 Provox GuideWire Provox 1 1 2 GuideWire GuideWire Provox 1 Provox 1 Provox GuideWire 1 GuideWire GuideWire 2 GuideWire Provox GuideWire 4 1 3 GuideWire GuideWire GuideWire 4 2 Guid...

Page 114: ...ilmesi veya steril Provox kal c Ses Protezinin retrograd de i tirilmesi ama l steril tek kullan ml k bir yerle tirme cihaz d r 1 2 Kontrendikasyonlar Hastada ponksiyon b lgesi zerinde nemli farengeal...

Page 115: ...hasar geli ebilir Ses protezi farenks veya zofagusta tak l rsa devam ETMEY N nk doku hasar na yol a abilir Bu olaylar hakk nda daha fazla bilgi i in Olumsuz Olaylar k sm na bak n z 1 5 NLEMLER Provox...

Page 116: ...r tutma forsepsi kullan larak al nabilir Provox GuideWire farenjeal mukozal duvara tak l r Provox GuideWire farenjeal mukozal duvara tak labilir veya buras taraf ndan engellenebilir Hafif bas n la Pro...

Page 117: ...protezinin g venlik eridi GuideWire konekt r ne tak l r ve sabitlenir Trokar Kan l ponksiyon a kl ndan kar l r ve geri ekilir GuideWire n dikkatle ekilmesi ses protez eridini TE ponksiyonu i ine geti...

Page 118: ...t r ve TEM ZLENEMEZ veya TEKRAR STER L ZE ED LEMEZ 2 4 Atma Kullan lm bir t bbi cihaz atarken biyolojik tehlikelerle ilgili t bbi uygulamalara ve ulusal gerekliliklere daima uyun 2 5 Ek cihazlar Provo...

Page 119: ...Wire Provox GuideWire 8 Stopper Provox GuideWire 1 Provox GuideWire 1 1 Provox GuideWire Provox GuideWire 1 1 Stopper Provox ABS 1 1 2 Connector Provox 1 2 Provox GuideWire 1 4 GuideWire Provox GuideW...

Page 120: ...e GuideWire 1 6 Provox GuideWire Provox System Provox GuideWire Provox System Provox GuideWire Provox System Provox GuideWire Provox System GuideWire Provox System 4 6 Provox GuideWire Provox GuideWir...

Page 121: ...1 2 Provox Trocar Cannula TE 8 10 2 2 3 Trocar Trocar Cannula 2 3 4 Provox GuideWire Trocar Cannula GuideWire Pharynx Protector 2 4 Pharynx Protector 5 GuideWire Trocar Cannula GuideWire TE 2 5 GuideW...

Page 122: ...TE 3 5 GuideWire 6 GuideWire 3 6 2 2 3 4 Provox GuideWire Provox 1 1 TE 2 GuideWire TE GuideWire Provox 1 Provox 1 Provox GuideWire 1 GuideWire GuideWire 2 GuideWire Stopper Provox GuideWire Connecto...

Page 123: ...123 GuideWire GuideWire 4 3 2 3 Provox GuideWire EO 2 4 2 5 Provox Trocar TE Provox Trocar Cannula GuideWire TE Provox Pharynx Protector TE 3 3 1 3 2 3 3 4 1 1 1 Provox GuideWire Provox Provox...

Page 124: ...3 Provox GuideWire Provox GuideWire 8 Provox GuideWire 1 Provox GuideWire 1 1 Provox GuideWire Provox GuideWire 1 1 Provox 1 1 2 Provox 1 2 Provox GuideWire 1 4 GuideWire Provox GuideWire 1 5 Provox...

Page 125: ...125 GuideWire GuideWire GuideWire 1 6 Provox GuideWire Provox Provox GuideWire Provox Provox GuideWire Provox Provox GuideWire Provox GuideWire Provox 4 6 Provox GuideWire Provox GuideWire...

Page 126: ...e Provox GuideWire GuideWire GuideWire 2 2 1 2 2 2 2 1 2 1 Provox Pharynx Protector 2 1 2 Provox Trocar with Cannula 8 10 2 2 3 2 3 4 Provox GuideWire GuideWire Pharynx Protector 2 4 Pharynx Protector...

Page 127: ...h Cannula 8 10 3 2 3 3 3 4 Provox GuideWire GuideWire 3 4 5 GuideWire GuideWire 3 5 GuideWire 6 GuideWire 3 6 2 2 3 4 Provox GuideWire Provox 1 1 2 GuideWire GuideWire Provox 1 Provox 1 Provox GuideWi...

Page 128: ...rovox GuideWire 4 1 3 GuideWire GuideWire GuideWire 4 2 GuideWire 4 GuideWire GuideWire 4 3 2 3 Provox GuideWire 2 4 2 5 Provox Trocar with Cannula Provox GuideWire Provox Pharynx Protector 3 3 1 3 2...

Page 129: ...Penyumbat untuk pembuangan transoral Prostesis Suara Provox lama diperbuat daripada plastik ABS Raj 1 1 2 Penyambung untuk pemasangan bebat keselamatan Prostesis Suara Provox diperbuat daripada bahan...

Page 130: ...igi Penyedutan bahagian Provox GuideWire atau bahagian Provox System Penyedutan tanpa sengaja bahagian Provox GuideWire atau bahagian Provox System mungkin berlaku Seperti jasad asing yang lain gejala...

Page 131: ...nula Trocar dikeluarkan dari bukaan tebukan dan ditarik keluar Tarikan yang berhati hati terhadap GuideWire akan membawa bebat prostesis ke dalam tebukan TE Prostesis suara diputar dengan berhati hati...

Page 132: ...egang bebibir trakea prostesis dengan hemostat tanpa gigi Potong bebibir trakea dengan skalpel dan keluarkannya Dengan berbibir trakea dikeluarkan Penyumbat GuideWire akan menarik prostesis suara lama...

Page 133: ...n pengguna Untuk mendapatkan bantuan atau maklumat tambahan sila lihat kulit belakang manual ini untuk maklumat hubungan 4 Pelaporan Sila ambil perhatian bahawa sebarang kejadian serius yang berlaku b...

Page 134: ...GuideWire 1 5 Provox GuideWire GuideWire Guide Wire GuideWire 1 6 Provox GuideWire Provox System Provox GuideWire Provox System Provox GuideWire Provox System Provox GuideWire Provox System GuideWire...

Page 135: ...x GuideWire GuideWire GuideWire 2 2 1 2 2 2 2 1 2 1 Provox Pharynx Protector 2 1 2 Provox Trocar with Cannula 8 10 mm 2 2 3 Trocar Trocar Cannula 2 3 4 Provox GuideWire Trocar Cannula GuideWire Pharyn...

Page 136: ...per Cannula GuideWire 3 4 5 GuideWire Trocar Cannula GuideWire 2 3 5 GuideWire 6 GuideWire 3 6 2 2 3 4 Provox GuideWire Provox 1 1 2 GuideWire GuideWire Provox 1 Provox 1 Provox GuideWire 1 GuideWire...

Page 137: ...with Cannula Provox Trocar Cannula GuideWire Provox Pharynx Protector 3 3 1 3 2 3 3 4 1 1 1 1 1 1 Provox GuideWire Provox GuideWire 1 2 Provox Provox 1 2 1 2 2 1 3 1 3 Provox GuideWire Provox GuideWir...

Page 138: ...PVC 1 4 1 4 GuideWire Provox GuideWire 1 5 1 5 Provox GuideWire GuideWire GuideWire GuideWire 1 6 1 6 Provox GuideWire Provox Provox GuideWire Provox Provox GuideWire Provox Provox GuideWire Provox Pr...

Page 139: ...Wire Provox GuideWire Provox GuideWire GuideWire GuideWire 2 2 2 1 2 1 2 2 2 2 2 2 1 1 2 2 2 1 1 2 1 Provox Pharynx Protector 2 1 2 Provox Trocar with Cannula TE 8 10 mm 2 2 3 2 3 4 Provox GuideWire G...

Page 140: ...eWire 3 4 5 GuideWire GuideWire TE 2 3 5 GuideWire 6 GuideWire 3 6 2 2 3 4 2 2 3 4 Provox GuideWire Provox 1 Provox 1 1 TE 2 TE GuideWire GuideWire Provox 1 Provox 1 Provox 1 Provox GuideWire 1 GuideW...

Page 141: ...Trocar with Cannula 1 2 TE Provox TE GuideWire Provox Pharynx Protector Provox Pharynx Protector 1 TE 3 3 3 1 3 1 3 2 3 2 3 3 3 3 4 4 1 1 1 1 1 1 Provox GuideWire Provox GuideWire Provox Provox 1 2 1...

Page 142: ...deWire 1 5 1 5 Provox GuideWire GuideWire GuideWire GuideWire 1 6 1 6 Provox GuideWire Provox Provox GuideWire Provox Provox GuideWire Provox Provox GuideWire Provox Provox GuideWire Provox Provox Gui...

Page 143: ...Provox Trocar with Cannula 8 10 2 2 3 2 3 4 Provox GuideWire GuideWire Pharynx Protector Pharynx Protector 2 4 Pharynx Protector 5 GuideWire GuideWire 2 5 GuideWire 6 GuideWire 2 6 2 2 2 3 2 2 2 3 1 3...

Page 144: ...GuideWire Provox Provox GuideWire 4 1 3 GuideWire GuideWire GuideWire 4 2 GuideWire 4 GuideWire GuideWire 4 3 2 3 2 3 Provox GuideWire EO 2 4 2 4 2 5 2 5 Provox Trocar with Cannula Provox Trocar with...

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Page 156: ...No 10315 2019 12 10 Atos Medical AB Kraftgatan 8 P O Box 183 SE 242 22 H rby Sweden Tel 46 0 415 198 00 info atosmedical com Atos Medical AB Sweden...

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