Atos Provox Brush Kullanma talimatları

Atos
Marka
Atos
Model
Provox Brush
Tip
Kullanma talimatları
B
rush
MD
IFU
RT
1
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
© Atos Medical AB, 200807A, REF 90716
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
X
X
X
X
X
X
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
X
1 2 43 65 7
98
16
12
17
1110 13 14
15
22
21201918
282726252423
3029
3
1
3
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.
8
4
5
50°-100° C
122°-212° F
15 s
2 /250 ml (8,5 fl oz)
70 % Ethanol
or
70 % Isopropylalcohol
or
3 % Hydrogenperoxide
10 min
10 min
60 min
6
2
7
4
1
3
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.
8
4
5
50°-100° C
122°-212° F
15 s
2 /250 ml (8,5 fl oz)
70 % Ethanol
or
70 % Isopropylalcohol
or
3 % Hydrogenperoxide
10 min
10 min
60 min
6
2
7
5
1
3
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.
8
4
5
50°-100° C
122°-212° F
15 s
2 /250 ml (8,5 fl oz)
70 % Ethanol
or
70 % Isopropylalcohol
or
3 % Hydrogenperoxide
10 min
10 min
60 min
6
2
7
6
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
7
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   .........................................................35
ID  BAHASA INDONESIA ....................................36
MS  BAHASA MELAYU ........................................37
JA - 日本語 ................................................................38
KO - - 󼨫󺈼󻪃󼨫󺈼󻪃 .................................................................39
ZHTW - 繁體中文 ..................................................40
HE  תירבע ..................................................................41
AR   ..................................................................42
ORDERING INFORMATION .................................43
8
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
9
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
10
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
11
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
12
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
13
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.
Noticación

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.
14
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
15
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.
16
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 desincering

med drikkevand.





Bemærk: 
Forholdsregel




Bortskaelse

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
17
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 desinsering

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.
18
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 desinointi

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
19
ÍSLENSKA
Fyrirhuguð notkun





til notkunar af sjúklingi.
Fyrir notkun









Þrif og sótthreinsun








Athugið: 
Varúð




hjá sjúklingi.
Förgun


Tilkynningaskylda



20
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 desintseerimine
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.
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Atos Provox Brush Kullanma talimatları

Atos
Marka
Atos
Model
Provox Brush
Tip
Kullanma talimatları
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