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inhealth Blom-Singer LP 3100, Инструкция по эксплуатации

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inhealth Blom-Singer LP 3100 Скачать руководство пользователя страница 94

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37575-01I

Содержание Blom-Singer LP 3100

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 94: ...94 I 37575 01I...

Страница 95: ...37575 01I I 95...

Страница 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...

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