inhealth Blom-Singer LP 3100, Instructions For Use Manual

Page 1: ...37575 01I I 1 Blom Singer Gel Cap Insertion System INSTRUCTIONS FOR USE...

Page 2: ...atn od janu ra 2020 Efectivo a partir de enero de 2020 G ller fr n januari 2020 Ge erlilik Tarihi Ocak 2020 Blom Singer and InHealth Technologies are registered trademarks of Freudenberg Medical LLC P...

Page 3: ...Use 1 2 1 3 1 4 1 5 1 6 DIAGRAMS Diagramet Dijagrami Sch mata Diagrammer Afbeeldingen Diagrammid Kaaviot Diagrammes Abbildungen br k Sk ringarmyndir Diagrammi Diagrammas Diagramos Diagrammer Schematy...

Page 4: ...4 I 37575 01I Blom Singer Gel Cap Insertion System Instructions for Use 1 7 1 9 1 10 1 11 1 12 1 8...

Page 5: ...8 LT Gelinio dangtelio terpimo sistema 60 NO Innsettingssystem for gelkapsel 63 PL System wprowadzania kapturk w elowych 65 PT Sistema de Inser o de C psula de Gel 68 RO Sistem de introducere a capsul...

Page 6: ...rtion System is a medically prescribed device Instruction in its use must be provided by a qualified medical professional trained in the use of this particular device The Blom Singer Gel Cap Insertion...

Page 7: ...p is securely in place 5 Fully insert the appropriate sized pushrod into the center of voice prosthesis at the base of the neck strap Place a finger on the tip of the gel cap to hold it in place while...

Page 8: ...ed with the device or have any questions please contact productcomplaints inhealth com Telephone 1 800 477 5969 Fax 1 888 371 1530 Any serious incident that has occurred in relation to the device shou...

Page 9: ...37575 01I I 9 Blom Singer Blom Singer Blom Singer Blom Singer Eric D Blom 16 Fr 16Fr 16Fr 1 2c 3 16 Fr 16 Fr 20 Fr 20 Fr 2 4 5 3 2b 6 7 1 4 16 Fr 20 Fr 8 9 5 10 6 11...

Page 10: ...th com InHealth Technologies 1110 Mark Avenue Carpinteria CA 93013 2918 1 800 477 5969 1 888 371 1530 order inhealth com 1 805 684 9337 InHealth Technologies productcomplaints inhealth com 1 800 477 5...

Page 11: ...Singer Blom Singer BLOM SINGER 16 Fr 20 Fr Blom Singer 1 16 Fr 20 Fr Blom Singer 1 10 20 Fr 1 16 Fr 1 20 Fr Blom Singer 16 Fr 20 Fr 1 Blom Singer Blom Singer 16 Fr 20 Fr Blom Singer Blom Singer Blom...

Page 12: ...12 I 37575 01I Blom Singer Eric D Blom 16 Fr 16 Fr 16 Fr 1 2c 3 16 Fr 16 Fr 20 Fr 20 Fr 2 5 4 3 2b 7 6 1 4 16 Fr 20 Fr 8 9 5 10 6 11 7 12...

Page 13: ...nHealth Technologies 1110 Mark Avenue Carpinteria CA 93013 2918 1 800 477 5969 1 888 371 1530 E l order inhealth com InHealth Technologies 1 805 684 9337 EU productcomplaints inhealth com 1 800 477 59...

Page 14: ...jn t pak shilluesh m rekomandimin e pajisjes ose procedur s s caktuar Sistemi i vendosjes s kapsul s xhelatinore Blom Singer sht nj produkt mjek sor q duhet t p rdoret vet m nga individ me p rvoj dhe...

Page 15: ...e N se proteza t rhiqet shum dhe shk putet nga instrumenti i vendosjes s kapsul s xhelatinore kthehuni te hapi 1 4 Nxirrni nga mbajt sja kapsul n xhelatinore 16 Fr ose 20 Fr q korrespondon me diametri...

Page 16: ...POROSITJEN SHBA Porosi n internet www inhealth com SHBA InHealth Technologies 1110 Mark Avenue Carpinteria CA 93013 2918 Sh rbimi i klientit 1 800 477 5969 Faks 1 888 371 1530 Email order inhealth com...

Page 17: ...37575 01I I 17 Blom Singer Blom Singer 20 16 Blom Singer Blom Singer Blom Singer Blom Singer 16 16 2c 1 16 3 20 20 4 2 5 2b 3 6 7 1 20 16 4 8 9 Blom Singer...

Page 18: ...InHealth Technologies 1110 Mark Avenue Carpinteria CA 93013 2918 1 800 477 5969 1 888 371 1530 order inhealth com 1 805 684 9337 InHealth Technologies productcomplaints inhealth com 1 800 477 5969 1 8...

Page 19: ...lom Singer BLOM SINGER Blom Singer 16 Fr 20 Fr Blom Singer 1 16 Fr 20 Fr Blom Singer 1 10 16 Fr 10 20 Fr 1 16 Fr 1 20 Fr Blom Singer 16 Fr 20 Fr Blom Singer Blom Singer 16 Fr 20 Fr Blom Singer Blom Si...

Page 20: ...20 I 37575 01I Blom Singer Blom Singer Eric D Blom Ph D 16 Fr 16 Fr 16 Fr 1 2 top 3 16 Fr 16 Fr 20 Fr 20 Fr 2 4 5 3 2 6 7 1 4 16 Fr 20 Fr 8 9 5 10 6 11...

Page 21: ...th com InHealth Technologies 1110 Mark Avenue Carpinteria CA 93013 2918 1 800 477 5969 1 888 371 1530 order inhealth com InHealth Technologies 1 805 684 9337 productcomplaints inhealth com 1 800 477 5...

Page 22: ...stupak Sustav za umetanje s gel kapicom Blom Singer medicinski je proizvod koji smiju upotrebljavati samo osobe s obukom i iskustvom u njegovoj upotrebi i odr avanju UPOZORENJA I MJERE OPREZA Sustav z...

Page 23: ...pice stavite u otvor alata za postavljanje s preklopljenom prirubnicom proteze dijagram 9 Gel kapica treba stati u utor i prekriti vrh proteze Provjerite je li gel kapica dobro postavljena 5 Umetnite...

Page 24: ...ho zav d c ho n stroje gelov krytky u ivatel nasad kapsli gelovou krytku na konec hlasov prot zy pro umo n n zaveden do tracheoezofage ln punkce otvor vytvo en chirurgem mezi pr du nic a j cnem pro u...

Page 25: ...nto postup p edstavuje n vod ke vlo en hlasov prot zy do gelov krytky Syst m pro zaveden gelov krytky hlasov prot za a ruce u ivatele mus b t v dy pe liv o i t ny aby nedo lo k zaveden kontaminac do t...

Page 26: ...ohlo doj t k vdechnut stic vl ken nebo tkaniny do d chac ch cest Po pe liv m o i t n a vysu en du ln ho zav d c ho n stroje gelov krytky a posunovac ho segmentu je mo n je ulo it v ist m opakovan uzav...

Page 27: ...ger gelkapselindf ringssystemet er et medicinsk produkt der udelukkende m anvendes af personer der har erfaring med og er uddannet i brug og pasning af det ADVARSLER OG FORHOLDSREGLER Gelkapselindf ri...

Page 28: ...krave diagram 9 Gelkapslen skal passe ind i rillen og d kke protesens spids Verificer at gelkapslen sidder sikkert fast 5 S t skubbestaven i den rigtige st rrelse helt ind i midten af stemmeprotesen v...

Page 29: ...pje over de punt van de stemprothese om het mogelijk te maken deze te plaatsen in de tracheo oesofageale punctie opening gemaakt door chirurg tussen trachea en oesofagus voor plaatsing van een stempro...

Page 30: ...tie op materialen van het hulpmiddel GEBRUIKSAANWIJZING Het gelkapje inbrengen Raadpleeg de afbeeldingen aan het begin van deze instructiehandleiding De volgende procedure wordt gegeven door Eric D Bl...

Page 31: ...den ingebracht Raadpleeg de instructiehandleiding geleverd bij uw stemprothese voor instructies over het inbrengen van het hulpmiddel INSTRUCTIES VOOR REINIGING EN VERZORGING Was het dubbele inbrengsy...

Page 32: ...lt kasutamiseks Kui geelkapsleid kasutatakse etten htud viisil siis need lahustuvad ja neid ei saa korduskasutada N IDUSTUSED Seadme v i protseduuri m ramise p hjused Blom Singeri geelkapsli sisestuss...

Page 33: ...laselt ja ettevaatlikult hoides h leproteesi korpust kaelarihma alaosast joonis 2b kuni h leproteesi s gitoru rik hakkab ettesuunas augu sees lahti minema rge proteesi sellest kohast le t mmake Kui pr...

Page 34: ...477 5969 Faks 1 888 371 1530 Mis tahes t sisest seadmega tekkinud intsidendist tuleb teatada Freudenberg Medical LLC ile nagu on lalpool m rgitud ja selle ELi liikmesriigi p devale asutusele kus kasut...

Page 35: ...iintyv n Blom Singer geelisuojan asetusj rjestelm n k yt n yhteydess Niihin kuuluvat Puheproteesin repeytyminen tai muu vaurio geelisuojan asetusty kalun virheellisen k yt n vuoksi Komponenttien aspir...

Page 36: ...settimen tai puheproteesin kuivaamiseen koska nukkaa tai kangashiukkasia voidaan hengitt sis n proteesin asettamisen yhteydess Kun kaksoisgeelisuojan asetusty kalu ja ty nt tanko on puhdistettu ja kui...

Page 37: ...proc dure sp cifique est d conseill e Le syst me d insertion capsule de gel Blom Singer est un produit m dical qui doit tre uniquement utilis par des personnes form es son utilisation et son entretien...

Page 38: ...proth se au del de ce point Si la proth se est tir e trop loin et qu elle se d gage de l outil d insertion capsule gel revenir l tape 1 4 Retirer du contenant de capsules de gel la capsule de 16 ou 20...

Page 39: ...UITS INCIDENTS GRAVES DANS L UE Si le dispositif ne donne pas satisfaction ou pour toute question envoyer un message l adresse suivante productcomplaints inhealth com T l phone 1 800 477 5969 Fax 1 88...

Page 40: ...geliefert wurde Gehen Sie mit der Stimmprothese und der Gelkappeneinf hrhilfe vorsichtig um um eine Besch digung zu vermeiden Verwenden Sie keine besch digte Stimmprothese oder Gelkappeneinf hrhilfe D...

Page 41: ...n Sie vorsichtig bis der gefaltete sophageale Flansch vollst ndig in der Gelkappe positioniert ist 6 Nehmen Sie die Fingerspitze von der Gelkappe und dr cken Sie vorsichtig mit dem Schubstab in die au...

Page 42: ...ZWISCHENF LLE Wenn Sie mit dem Produkt nicht zufrieden sind oder Fragen haben wenden Sie sich bitte per E Mail an productcomplaints inhealth com Telefon 1 800 477 5969 Fax 1 888 371 1530 Jeder schwerw...

Page 43: ...37575 01I I 43 Blom Singer Blom Singer Blom Singer Blom Singer Eric D Blom Ph D 16 Fr 16 Fr 16 Fr 1 2c top 3 16 Fr 16 Fr 20 Fr 20 Fr 2 4 5 3 2b 6 7...

Page 44: ...44 I 37575 01I Blom Singer 1 4 16 Fr 20 Fr 8 9 5 10 6 11 7 12 www inhealth com InHealth Technologies 1110 Mark Avenue Carpinteria CA 93013 2918 1 800 477 5969 1 888 371 1530 E mail order inhealth com...

Page 45: ...h com 1 800 477 5969 1 888 371 1530 Freudenberg Medical LLC Blom Singer BLOM SINGER Blom Singer Blom Singer 20 Fr 16 Fr 1 16 10 1 20 Fr 16 Fr Blom Singer 1 20 Fr 1 16 Fr 20 Fr 10 Fr Blom Singer 20 Fr...

Page 46: ...46 I 37575 01I 16 Fr 16 Fr 16 Fr 2 1 20 Fr 16 Fr 16 Fr 3 20 Fr 4 2 5 2 3 7 6 1 1 20 Fr 16 Fr 4 8 9 5 10 6 11 12 7 Blom Singer...

Page 47: ...trachea s az oesophagus k z tt ahov a hangprot zist helyezik A g lkapszula behelyez rendszer 1 bra a 16 Fr vagy 20 Fr Blom Singer alacsony nyom s hangprot zis behelyez s hez sz ks ges al bbi eszk z k...

Page 48: ...k helytelen haszn lata miatt Az eszk z r szeinek aspir l sa l gutakba ker l se Allergi s reakci az eszk z b rmely anyag ra HASZN LATI UTAS T S A g lkapszula bet lt se K rj k tekintse meg a haszn lati...

Page 49: ...ket g zzel vagy sz lmentes ruh val Soha ne haszn ljon pap r zsebkend t vagy v c pap rt a dual g lkapszula bet lt eszk z a behelyez eszk z s a hangprot zis sz r t s hoz mivel a sz sz k vagy a sz vet d...

Page 50: ...Singer 16 Fr e a 20 Fr Low Pressure talventil FR BENDINGAR st ur sem gera a r legt a v sa tilteknu t ki e a a ger Blom Singer setningarkerfi me hlauphylki er l kningat ki sem eing ngu einstaklingar s...

Page 51: ...sk ringarmynd 8 Setji opna enda hlauphylkisins gati hle slut kinu ar sem samanbrotni kragi talventilsins er sk ringarmynd 9 Hlauphylki a passa raufina og hylja enda talventilsins Gangi r skugga um a...

Page 52: ...di un cappuccio in gel appositamente progettato l utente posiziona una capsula cappuccio in gel sopra la punta della protesi fonatoria per consentire l inserimento nella puntura tracheoesofagea apertu...

Page 53: ...da utilizzo errato dello strumento per il caricamento del cappuccio in gel Aspirazione dei componenti Reazione allergica a qualsiasi materiale del dispositivo ISTRUZIONI PER L USO Caricamento del cap...

Page 54: ...i spinta dalla protesi La protesi fonatoria ora completamente caricata nel cappuccio in gel e pronta per l inserimento nella maniera consueta Fare riferimento al manuale di Istruzioni per l uso fornit...

Page 55: ...ersi all indirizzo productcomplaints inhealth com Telefono 1 800 477 5969 Fax 1 888 371 1530 Eventuali incidenti gravi che si sono verificati in relazione al dispositivo devono essere comunicati a Fre...

Page 56: ...56 I 37575 01I Blom Singer Blom Singer Eric D Blom Ph D 16 Fr 16 Fr 16 Fr 1 2c 3 16 Fr 16 Fr 20 Fr 20 Fr 2 4 5 3 2b 6 7 1 4 16 Fr 20 Fr 8 9 5 10 6 11...

Page 57: ...com InHealth Technologies 1110 Mark Avenue Carpinteria CA 93013 2918 1 800 477 5969 1 888 371 1530 order inhealth com InHealth Technologies 1 805 684 9337 EU productcomplaints inhealth com 1 800 477 5...

Page 58: ...zstr d jums ko dr kst lietot tikai personas kas ir pieredz ju as un apm c tas t s lieto an un apkop BR DIN JUMI UN PIESARDZ BAS PAS KUMI Gela v ci u ievieto anas sist ma ir ier ce kuras lieto anu para...

Page 59: ...uzgali P rliecinieties ka gela v ci dro i turas viet 5 L dz galam ievietojiet atbilsto izm ra b dstieni balss prot zes centr pie kakla siksnas pamatnes Uzlieciet pirkstu uz gela v ci a uzga a lai not...

Page 60: ...d ti Gelinio dangtelio terpimo sistem 1 pav sudaro toliau i vardyti b tinieji komponentai skirti 16 Fr arba 20 Fr statyti Blom Singer emo sl gio balso protezas vienas 1 dvigubas gelinio dangtelio u d...

Page 61: ...dangtelio u d jimo instrumentas st miklis ir j s rankos yra visi kai sausos Jei to nepadarysite gelinis dangtelis gali per anksti i tirpti Prie prad dami proced r i imkite i komplekto komponentus kur...

Page 62: ...st mikl jie gali b ti laikomi variame pakartotinai sandarinamame plastikiniame mai elyje SPECIALIOS LAIKYMO IR ARBA NAUDOJIMO S LYGOS Tik geliniams dangteliams supakuotiems kartu su taisu taikomos spe...

Page 63: ...isinsk produkt som kun skal brukes av personer med erfaring og oppl ring i bruk og vedlikehold av dette ADVARSLER OG FORHOLDSREGLER Innsettingssystemet for gelkapsel er en medisinsk foreskrevet enhet...

Page 64: ...l passe inn i sporet og dekke protesespissen Kontroller at gelkapselen er ordentlig p plass 5 Sett innf ringsstangen av riktig st rrelse helt inn i midten av stemmeprotesen nederst p nakkestroppen Pla...

Page 65: ...ywaj c specjalnego narz dzia do zak adania kapturk w elowych u ytkownik umieszcza kapsu kapturek elowy wok ko c wki protezy g osowej aby umo liwi wprowadzenie protezy w spos b bezurazowy do nak ucia t...

Page 66: ...elowych Blom Singer stwierdzono cho rzadko wyst powanie wymienionych poni ej powik a Nale do nich powstawanie rozdar lub innych uszkodze protezy g osowej spowodowane nieprawid owym u yciem narz dzia...

Page 67: ...zia do zak adania kapturk w elowych schemat 12 Uchwyci protez przy nasadzie paska na szyj i usun popychacz z protezy Proteza g osowa zosta a teraz umieszczona w pozycji ostatecznej w kapturku elowym i...

Page 68: ...aste impulsora de 20 Fr Use apenas C psulas de Gel de 16 Fr ou 20 Fr Blom Singer com este dispositivo A ferramenta de carregamento de c psulas de gel e as hastes impulsoras s o reutiliz veis As c psul...

Page 69: ...rreia do pesco o da pr tese vocal diagrama 2c no orif cio de tamanho apropriado da ferramenta de carregamento de c psulas de gel dupla no lado marcado como superior top diagrama 3 Uma pr tese de di me...

Page 70: ...ardadas em um saco pl stico limpo e ressel vel CONDI ES ESPECIAIS DE ARMAZENAMENTO E OU MANUSEIO Apenas as c psulas de gel embaladas com o dispositivo t m condi es especiais de armazenagem e ou manuse...

Page 71: ...e recomandat prescrierea dispozitivului sau efectuarea procedurii Sistemul de introducere a capsulelor de gel Blom Singer este un produs medical care trebuie utilizat doar de persoane care de in exper...

Page 72: ...de nc rcare a capsulelor de gel reveni i la pasul 1 4 Din recipientul cu capsule de gel scoate capsulele de gel de 16 Fr sau 20 Fr care corespund diametrului protezelor dvs fonatorii Elimina i cap tul...

Page 73: ...918 Serviciul de rela ii cu clien ii 1 800 477 5969 Fax 1 888 371 1530 E mail order inhealth com INTERNA IONAL Contacta i Serviciul de rela ii cu clien ii al InHealth Technologies la 1 805 684 9337 pe...

Page 74: ...74 I 37575 01I Blom Singer Blom Singer Blom Singer 16 Fr 20 Fr 16 20 Fr Blom Singer Blom Singer Blom Singer Blom Singer...

Page 75: ...37575 01I I 75 Blom Singer 16 Fr 16 Fr 16 Fr 1 2c 3 16 Fr 16 Fr 20 Fr 20 Fr 2 4 5 3 2b 6 7 1 4 16 Fr 20 Fr 8 9 5 10 6 11 7 12...

Page 76: ...nog otvora otvor koji je napravio hirurg izme u traheje i jednjaka radi postavljanja glasovne proteze Sistem za umetanje kapsula sa gelom slika 1 sadr i slede e neophodne delove za umetanje 16 Fr ili...

Page 77: ...akcija na bilo koji od materijala ure aja UPUTSTVO ZA UPOTREBU Umetanje kapsule sa gelom Pogledajte crte e na prednjoj strani ovog priru nika sa uputstvima Sledec i postupak pru a Eric D Blom dr Sc ka...

Page 78: ...h proteza jer se estice dla ica ili tkanine mogu udahnuti u disajne puteve nakon umetanja proteze Nakon i c enja i temeljnog su enja alata za umetanje dvojne kapsule sa gelom i uvodnika oni se mogu uv...

Page 79: ...ebo z kroku nevhodn Syst m na nasunutie g lovej krytky Blom Singer je zdravotn cky produkt ktor maj pou va len osoby so sk senos ami a kolen m o jeho pou van a starostlivosti o VAROVANIA A BEZPE NOSTN...

Page 80: ...oren koniec g lovej krytky do otvoru n stroja na nasunutie s ohnutou pr rubou prot zy obr zok 9 G lov krytka by mala pasova do dr ky a prekr va vrchol prot zy Uistite sa e je g lov krytka pevne na svo...

Page 81: ...ca una c psula de gel sobre la punta de la pr tesis fonatoria para permitir la inserci n en la punci n traqueoesof gica abertura practicada por el cirujano entre la tr quea y el es fago para colocar l...

Page 82: ...CCIONES DE USO Carga de la c psula de gel Consulte los diagramas del principio de este manual de instrucciones El siguiente procedimiento lo ha dise ado Eric D Blom doctor como instrucciones para carg...

Page 83: ...a de la forma habitual Consulte el manual de instrucciones proporcionado con su pr tesis fonatoria para conocer las indicaciones de inserci n del dispositivo INSTRUCCIONES DE LIMPIEZA Y CUIDADO Lave b...

Page 84: ...tt l sas upp och kan inte teranv ndas INDIKATIONER Anledningar att ordinera enheten eller ingreppet Blom Singer system f r ins ttning av gelkapsel r utformat f r att anv ndas av personer som har genom...

Page 85: ...s fram t inne i h let bild 7 Dra inte protesen f rbi denna punkt Om protesen dras f r l ngt och frig rs fr n laddningsverktyget f r gelkapslar ska du terg till steg 1 4 Ta ur 16 Fr eller 20 Fr gelkaps...

Page 86: ...U medlemsstat d r anv ndaren och eller patienten har sin hemvist T RK E Blom Singer D k Bas n l Ses Protezleri i in BLOM SINGER JEL KAPAK TAKMA S STEM R N TANIMI Jel Kapak Takma Sistemi bir 16 Fr veya...

Page 87: ...nde y rt lma veya di er hasar Bile en aspirasyonu Cihaz malzemelerinin herhangi birine kar alerjik reaksiyon KULLANIM TAL MATLARI Jel Kapa Y kleme L tfen bu kullan m k lavuzunun n y z ndeki diyagramla...

Page 88: ...iftik veya kuma par alar hava yoluna solunabilece i i in ift jel kapak y kleme arac n yerle tiriciyi veya ses protezini asla bir k t havlu veya tuvalet k d ile kurulamay n ift jel kapak y kleme arac v...

Page 89: ...symbol Symbolliste Verklaring van symbolen S mbolite s nastik Symbolisanasto Glossaire des symboles Symbolglossar Jelmagyar zat Or alisti yfir t kn Glossario dei simboli Simbolu glos rijs Simboli ody...

Page 90: ...het Var Alr kisl g Bandar kin takmarka s lu essa b na ar vi l kna e a samkv mt fyrirm lum l knis Attenzione la legge federale degli Stati Uniti limita la vendita del presente dispositivo ai medici o s...

Page 91: ...agem Pentru a indica num rul de unit i dintr un ambalaj Za ozna avanje broja komada u pakovanju Ozna uje po et s ast v balen Indica el n mero de piezas en el envase Anger antalet delar i f rpackningen...

Page 92: ...15223 1 2016 Do not use if package is damaged 5 2 8 Indicates a medical device that should not be used if the packaged has been damaged or opened EN ISO 15223 1 2016 Consult instructions for use 5 4 3...

Page 93: ...37575 01I I 93 Blom Singer Gel Cap Insertion System Instructions for Use...

Page 94: ...94 I 37575 01I...

Page 95: ...37575 01I I 95...

Page 96: ...Medical LLC 1110 Mark Avenue Carpinteria CA 93013 2918 USA www inhealth com UNITED STATES 1110 Mark Avenue Carpinteria CA 93013 2918 USA Toll Free 800 477 5969 Toll Free Fax 888 371 1530 INTERNATIONAL...