Atos Provox Brush Kullanma talimatları

Marka: Atos

Model: Provox Brush

Tip: Kullanma talimatları

Bu kılavuz için de uygundur

Provox® Brush

rush

IFU

Atos Medical AB

P.O. Box 183, SE-242 22 Hörby, Sweden

Tel: +46 (0)415 198 00 • Fax:+46 (0)415 198 98

info@atosmedical.com • www.atosmedical.com

REF 7204, 7225

Provox (1) ≤ 10 mm

REF 7208, 7200, 7201, 7202

Provox

Brush

REF 7204

Provox

Brush XL

REF 7225

Provox2 ≤ 10 mm

REF 7216, 7217, 7218, 7219

Provox ActiValve ≤ 10 mm

REF 7150, 7151, 7152, 7153, 7160, 7161,

7162, 7163, 7165, 7166, 7167, 7168

Provox2 ≥ 12.5 mm

REF 7221, 7224

Provox ActiValve ≥ 12.5 mm

REF 7154, 7164, 7169

Provox NID 17, 20 ≤ 10 mm

REF 7101, 7102, 7103, 7111, 7112, 7113

Provox NID 17, 20 ≥ 12 mm

REF 7104, 7105, 7106, 7114, 7115, 7116

Provox Vega ≤ 10 mm

REF 8110, 8111, 8112, 8113, 8120, 8121,

8122, 8123, 8130, 8131, 8132, 8133 X

Provox Vega ≥ 12.5 mm

REF 8114, 8115, 8124, 8125, 8134, 8135 X

1 2 43 65 7

1110 13 14

21201918

282726252423

3029

Provox

Indwelling

Provox NID

(non-indwelling)

The Provox® System is protected by several patents. Provox® is a registered trademark owned by Atos Medical AB, Sweden.

50 °C-100 °C

122 °F-212 °F

15 s

2 /250 ml (8,5 fl oz)

70% Ethanol

70% Isopropylalcohol

3% Hydrogenperoxide

10 min

60 min

Provox

Indwelling

Provox NID

(non-indwelling)

The Provox® System is protected by several patents. Provox® is a registered trademark owned by Atos Medical AB, Sweden.

50 °C-100 °C

122 °F-212 °F

15 s

2 /250 ml (8,5 fl oz)

70% Ethanol

70% Isopropylalcohol

3% Hydrogenperoxide

10 min

60 min

Provox

Indwelling

Provox NID

(non-indwelling)

The Provox® System is protected by several patents. Provox® is a registered trademark owned by Atos Medical AB, Sweden.

50 °C-100 °C

122 °F-212 °F

15 s

2 /250 ml (8,5 fl oz)

70% Ethanol

70% Isopropylalcohol

3% Hydrogenperoxide

10 min

60 min

Disclaimer

Atos Medical 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





particular purpose.

Patents and trademarks

Provox

is a registered trademark owned by Atos Medical AB,

Sweden. For information about protective rights (e.g. patents),

please refer to our web page www.atosmedical.com/patents

Contents

EN - ENGLISH ............................................................. 8

DE - DEUTSCH ........................................................... 9

NL - NEDERLANDS.................................................10

FR - FRANÇAIS .........................................................11

IT - ITALIANO ...........................................................12

ES - ESPAÑOL ...........................................................13

PT - PORTUGUÊS ....................................................14

SV - SVENSKA ..........................................................15

DA - DANSK ..............................................................16

NO - NORSK ..............................................................17

FI - SUOMI .................................................................18

IS - ÍSLENSKA ...........................................................19

ET - EESTI ...................................................................20

LT - LIETUVIŲ K. .....................................................21

CS - ČESKY ................................................................22

HU - MAGYAR ..........................................................23

SK - SLOVENČINA ...................................................24

SL - SLOVENŠČINA ................................................25

PL - POLSKI ...............................................................26

RO - ROMÂNĂ .........................................................27

HR - HRVATSKI .........................................................28

SR - SRPSKI ...............................................................29

EL - ΕΛΛΗΝΙΚΑ ........................................................30

TR - TÜRKÇE..............................................................31

KA -ქართული ......................................................32

HY .....................................................33

AZ -  ..................................34

RU - РУССКИЙ .........................................................35

ID - BAHASA INDONESIA ....................................36

MS - BAHASA MELAYU ........................................37

JA - 日本語 ................................................................38

󼨫󺈼󻪃

󼨫󺈼󻪃 .................................................................39

ZHTW - 繁體中文 ..................................................40

HE - תירבע ..................................................................41

AR -  ..................................................................42

ORDERING INFORMATION .................................43

ENGLISH

Intended Use

Provox Brush is a single patient use device intended for cleaning

Provox Voice Prosthesis, for insertion of Provox Plug and Provox

Vega Plug, for applying lubricant and anti-candida agents and



product is intended for use by the patient.

Before use



not broken or worn out.

Before each use, make sure that

• the protective tip is not cracked or loose.

• the bristles do not appear worn or are loose.

• the wires are not bent or broken.

• the entire handle is not cracked or broken and that the safety

wings have not been removed.

If any defects are found, the brush must be discarded.

Cleaning and disinfection



using drinking water.



methods:









Note: Always clean and disinfect before use.

Precaution



another patient may cause cross contamination.



cause product damage and injury.

Disposal

Always follow medical practice and national requirements

regarding biohazard when disposing of a used medical device.

Reporting

Please note that any serious incident that has occurred in relation

to the device shall be reported to the manufacturer and the national

authority of the country in which the user and/or patient resides.

DEUTSCH

ENGLISH

Verwendungszweck





zum Einsetzen der Stopfen Provox Plug und Provox Vega Plug, zum





durch den Patienten bestimmt.

Vor dem Gebrauch



dass sie nicht beschädigt oder abgenutzt ist.

Stellen Sie vor jedem Gebrauch sicher, dass



locker ist.

• die Borsten weder abgenutzt noch locker sind.









Reinigung und Desinfektion







folgenden Methoden:









Hinweis:



Vorsichtsmaßnahmen





Kreuzkontamination verursachen.

•



da dies Schäden am Produkt verursachen oder zu Verletzungen



Entsorgung

Bei der Entsorgung eines benutzten Medizinprodukts sind stets die

medizinischen Praktiken und nationalen Vorschriften hinsichtlich

biologischer Gefährdung zu befolgen.

Meldung

Bitte beachten Sie, dass alle schwerwiegenden Vorfälle, die sich im

Zusammenhang mit dem Produkt ereignet haben, dem Hersteller oder





DEUTSCH

Beoogd gebruik

Provox Brush (borstel) is een hulpmiddel voor gebruik bij één

patiënt bestemd voor het reinigen van Provox-stemprothesen, voor

het inbrengen van Provox Plug en Provox Vega Plug, voor het

aanbrengen van glijmiddel en anti-candida-middelen en voor het





Vóór gebruik



controleren of deze niet kapot of versleten is.

Zorg voorafgaand aan elk gebruik dat:

• de beschermtip niet gebarsten is of loszit.

• de borstelharen er niet versleten uitzien of loszitten.

• de draden niet gebogen of gebroken zijn.

• de gehele handgreep niet gebarsten of gebroken is en of de

veiligheidsvleugels niet verwijderd zijn.

Als er defecten worden ontdekt, dient de borstel weggegooid

te worden

Reiniging en desinfectie



kraanwater.



volgende methoden:







Gebruik het hulpmiddel pas weer als het helemaal droog is.

Opmerking: Altijd reinigen en desinfecteren voor gebruik.

Voorzorgsmaatregelen

• Het hulpmiddel is uitsluitend bestemd voor gebruik bij één patiënt.

Hergebruik bij een andere patiënt kan kruisinfectie veroorzaken.

• Het hulpmiddel mag niet op andere wijze worden gereinigd of

gedesinfecteerd, aangezien dit kan leiden tot schade aan het product.

Afvoer

Volg bij het afvoeren van een gebruikt medisch hulpmiddel altijd

de medische praktijk en nationale voorschriften met betrekking

tot biologisch gevaar.

Meldingen



heeft voorgedaan, moet worden gemeld aan de fabrikant en de

nationale autoriteit van het land waar de gebruiker en/of de

patiënt woont.

NEDERLANDS

FRANÇAIS

NEDERLANDS

Utilisation prévue



patient, conçu pour nettoyer la prothèse phonatoire Provox, pour

insérer les bouchons Provox Plug et Provox Vega Plug, pour







Avant l’utilisation

















Si des défauts sont découverts, ne pas utiliser la brosse.

Nettoyage et désinfection







méthodes ci-dessous :









Remarque : toujours nettoyer et désinfecter le dispositif



Mise en garde



réutilisation sur un autre patient peut entraîner une contamination

croisée.





Élimination



concernant les risques biologiques lorsque vous mettez au rebut

un dispositif médical usagé.

Signalement







FRANÇAIS

ITALIANO

Uso previsto

Provox Brush (spazzolino) è un dispositivo monopaziente per











Prima dell’uso



per accertarsi che non sia rotto o usurato.

Prima di ogni utilizzo, assicurarsi che

• la punta protettiva non sia incrinata o allentata.







sicurezza non siano state rimosse.

Se si riscontrano difetti, lo spazzolino deve essere scartato

Pulizia e disinfezione

Pulire il Provox Brush dopo ogni utilizzo come illustrato nelle













Nota: 

Precauzioni



paziente. Il riutilizzo tra pazienti può causare contaminazione

incrociata.



questo potrebbe causare danni al prodotto e lesioni al paziente.

Smaltimento

Attenersi sempre alle pratiche mediche e alle normative nazionali

sui materiali biopericolosi per lo smaltimento di un dispositivo

medico usato.

Segnalazioni



relazione al dispositivo deve essere segnalato al fabbricante e



il paziente.

ESPAÑOL

ITALIANO

ESPAÑOL

Uso previsto

El Provox Brush (cepillo) es un dispositivo para uso en un solo

paciente indicado para la limpieza de la prótesis de voz Provox, la

inserción del Provox Plug (tapón) y el Provox Vega Plug (tapón),

la aplicación de lubricantes y agentes anticándida y la limpieza



El producto está indicado para uso del paciente.

Antes del uso



de que no esté roto ni desgastado.

Antes de cada uso, asegúrese de que







• El mango no esté agrietado ni roto en ningún punto y las pestañas

de seguridad no se hayan desprendido.

Si se encuentra algún defecto, el cepillo debe desecharse.

Limpieza y desinfección







siguientes:









Nota: limpie y desinfecte siempre antes de usar.

Precaución

• El dispositivo se ha diseñado para utilizarse en un solo

paciente. Su reutilización en otro paciente podría provocar una

contaminación cruzada.



ya que esto podría dañarlo y producir lesiones.

Eliminación

Al desechar un dispositivo médico usado, siga siempre la práctica

médica y los requisitos nacionales sobre peligros biológicos.

Notificación



producido en relación con el dispositivo se comunicará al

fabricante y a la autoridad nacional del país en el que resida el

usuario y/o el paciente.

PORTUGUÊS

Utilização prevista

A Provox Brush (escova) é um dispositivo para utilização num



Provox, para inserção do tampão Provox Plug e do tampão Provox





O produto destina-se a ser utilizado pelo paciente.

Antes de utilizar



de que não está partida nem apresenta desgaste.



• a ponta protetora não está rachada nem solta.

• as cerdas não aparentam desgaste nem estão soltas.



• a pega não está rachada nem partida e as asas de segurança

não foram removidas.



Limpeza e desinfeção















Nota: 

Precaução



único paciente. A reutilização noutro paciente pode causar

contaminação cruzada.





Eliminação

Siga sempre as práticas médicas e os requisitos nacionais relativos

a riscos biológicos ao eliminar um dispositivo médico usado.

Comunicação de incidentes



ocorrido, relacionado com o dispositivo, deve ser comunicado



e/ou o paciente residem.

SVENSKA

PORTUGUÊS

SVENSKA

Avsedd användning











Före användning



att säkerställa att den inte är trasig eller utsliten.









• Hela handtaget inte är sprucket eller trasigt och att skyddsvingarna

inte har avlägsnats.



Rengöring och desinfektion















Obs: 

Försiktighetsåtgärd







det kan orsaka produkt- eller personskada.

Avfallshantering



biologiska risker vid kassering av en använd medicinsk anordning.

Rapportering



till produkten ska rapporteras till tillverkaren och den nationella

myndigheten i det land där användaren och/eller patienten är bosatt.

DANSK

Tilsigtet anvendelse

Provox Brush (børste) er en anordning til brug af en enkelt patient

beregnet til rengøring af Provox stemmeprotese, til indføring af



af smøremiddel og anti-candidaagenter og til rengøring af



til brug af patienten.

Før brug



ikke er i stykker eller slidt.

Kontrollér før hver brug, at





• Wirene ikke er bøjede eller i stykker.



sikkerhedsvingerne ikke er blevet fjernet.

Hvis der registreres defekter, skal børsten kasseres

Rengøring og desinficering



med drikkevand.











Bemærk: 

Forholdsregel









Bortskaffelse



i henhold til medicinsk praksis og nationale krav vedrørende

biologisk risiko.

Rapportering



til enheden, skal indberettes til fabrikanten og den nationale

myndighed i det land, hvor brugeren og/eller patienten opholder sig.

NORSK

DANSK

NORSK

Tiltenkt bruk



beregnet til rengjøring av Provox taleprotese, innsetting av



av smøremiddel og anti-candida-middel og til rengjøring av





Før bruk







• at beskyttelsestuppen ikke er sprukket eller løs

• at bustene ikke er slitt eller løse

• at ledningene ikke er bøyd eller ødelagt



sikkerhetsvingene ikke er fjernet



Rengjøring og desinfisering



bruk av vann av drikkekvalitet.









Ikke bruk anordningen før den er helt tørr.

Merk: 

Forholdsregler



annen pasient kan føre til krysskontaminasjon.





Avhending





Rapportering



i forbindelse med enheten, skal rapporteres til produsenten og

nasjonale myndigheter i landet der brukeren og/eller pasienten bor.

SUOMI

Käyttötarkoitus



tarkoitettu laite Provox-ääniproteesin puhdistamiseen, Provox

Plug- ja Provox Vega Plug -tulpan asettamiseen, voiteluaineen ja







Ennen käyttöä



että se ei ole rikki tai liian kulunut.







• langat eivät ole taipuneet tai rikkoutuneet

• koko kahva ei ole murtunut tai rikki ja että turvasiivekkeitä

ei ole poistettu.

Jos havaitset jonkin vian, harja on hävitettävä.

Puhdistus ja desinfiointi



mukaisesti juomavedellä.













Huomaa:

Varoitus





ristikontaminaation.



menetelmällä, jottei tuote vahingoitu tai potilas loukkaannu.

Hävittäminen



aineita koskevia kansallisia vaatimuksia lääkinnällistä laitetta

hävitettäessä.

Ilmoittaminen

Huomaa, että kaikki laitetta koskevat, vakavat tapahtumat

ilmoitetaan valmistajalle ja käyttäjän ja/tai potilaan asuinmaan

kansalliselle viranomaiselle.

ÍSLENSKA

SUOMI

ÍSLENSKA

Fyrirhuguð notkun











til notkunar af sjúklingi.

Fyrir notkun



















Þrif og sótthreinsun

















Athugið: 

Varúð









hjá sjúklingi.

Förgun





Tilkynningaskylda







EESTI

Kavandatud kasutus



Provox puhastamiseks, seadmete Provox Plug ja Provox Vega

Plug sisestamiseks, määrdeaine ja pärmseente vastaste ainete





Enne kasutamist



iga kasutuskorda, et veenduda, et see poleks katki ega kulunud.

Enne iga kasutuskorda veenduge, et

• kaitsev ots pole pragunenud ega lahti,

• harjased pole kulunud ega lahti,

• traadid pole kooldunud ega katki,

• terve käepide pole pragunenud ega katki ja et ohutustiivad

pole eemaldatud.



Puhastamine ja desinfitseerimine

Puhastage Provoxi harja pärast iga kasutuskorda puhta veega











Ärge kasutage seadet enne, kui see on täielikult kuiv.

Märkus. 

Ettevaatusabinõud



patsiendil kasutamine võib põhjustada ristsaastumise.



meetodeid, kuna see võib põhjustada toote kahjustusi ja vigastusi.

Kõrvaldamine

Kasutatud meditsiiniseadme kõrvaldamisel järgige alati meditsi-

inilisi tavasid ja bioloogilist ohtu käsitlevaid riiklikke nõudeid.

Teavitamine

Võtke arvesse, et kõigist seadmega seoses aset leidnud tõsis test

ohujuhtumitest tuleb teavitada tootjat ning kasutaja ja/või patsiendi

asukohariigi pädevat ametiasutust.

LIETUVIŲ K.

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Atos Provox Brush Kullanma talimatları

Marka: Atos

Model: Provox Brush

Tip: Kullanma talimatları

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Diğer dillerde

slovenčina: Atos Provox Brush Návod na používanie
dansk: Atos Provox Brush Betjeningsvejledning
română: Atos Provox Brush Instrucțiuni de utilizare

Atos Provox Brush Kullanma talimatları

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