Atos Provox® Brush Návod na používanie

Typ
Návod na používanie

Táto príručka je tiež vhodná pre

B
rush
IFU
MD
RT
1
1 2 43 65 7
98
16
12
17
1110 13 14
15
22
21201918
282726252423
3029
Fig. 1
3
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
Fig. 2
4
Fig. 3
5
Provox
Indwelling
Provox NID
(non-indwelling)
Fig. 4
Fig. 5
6
50 °C - 100 °C
122 °F - 212 °F
15 s
2 /250 ml (8,5 fl oz)
Fig. 6
Fig. 7
7
Fig. 8
Fig. 9
8
Provox
Indwelling
Provox NID
(non-indwelling)
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
Fig. 10
9
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.
Compatible Products;
Provox2 Voice Prosthesis
Provox Vega
Provox Vega XtraSeal
Provox Vega Puncture Set
Provox NID
Provox ActiValve
Provox ActiValve Lubricant
Provox LaryTube Fenestrated
Provox Life LaryTube Fenestrated
Provox Plug/Provox Vega Plug
10
CONTENTS
EN  ENGLISH ........................................................... 11
DE  DEUTSCH ......................................................... 12
NL  NEDERLANDS.................................................13
FR  FRANÇAIS .........................................................14
IT  ITALIANO ...........................................................15
ES  ESPAÑOL ...........................................................16
PT  PORTUGUÊS .................................................... 17
SV  SVENSKA ..........................................................18
DA  DANSK ..............................................................19
NO  NORSK ..............................................................20
FI  SUOMI ................................................................. 21
IS  ÍSLENSKA ........................................................... 22
ET  EESTI ...................................................................23
LV  LATVIEŠU .......................................................... 24
LT  LIETUVIŲ K........................................................25
CS  ČESKY ................................................................ 26
HU  MAGYAR .......................................................... 27
SK  SLOVENČINA ...................................................28
SL  SLOVENŠČINA ................................................29
PL  POLSKI ............................................................... 30
RO  ROMÂNĂ .........................................................31
HR  HRVATSKI .........................................................32
SR  SRPSKI ...............................................................33
EL  ΕΛΛΗΝΙΚΑ ........................................................ 34
TR  TÜRKÇE..............................................................35
KA  ქართული ...................................................36
HY  ......................................................37
AZ  ................................38
RU   ......................................................... 39
IDBAHASA INDONESIA.....................................40
MS  BAHASA MELAYU ........................................ 41
JA  日本語................................................................42
KO  한국어 ..............................................................43
ZHTW  繁體中文 ...................................................44
HE  תירבע .................................................................45
AR   ................................................................... 46
ORDERING INFORMATION .....................................47
11
ENGLISH
Intended Use

Provox Voice Prosthesis, for insertion of Provox Plug and Provox
Vega Plug, for applying lubricant and anti-candida agents and for

is intended for use by the patient.
Before use




• the bristles do not appear worn or are loose.


wings have not been removed.

shows any signs of damage, it must be replaced earlier.
Cleaning and disinfection



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.
12
Verwendungszweck





durch den Patienten bestimmt.
Vor dem Gebrauch

dass sie nicht beschädigt oder abgenutzt ist.








ausgetauscht werden.
Reinigung und Desinfektion



folgenden Methoden:




Hinweis
:
werden.
Vorsichtsmaßnahmen








Entsorgung


biologischer Gefährdung zu befolgen.
Meldung




DEUTSCH
13
Beoogd gebruik

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 reinigen van de


Vóór gebruik



• de beschermtip niet gebarsten is of loszit.
• de borstelharen er niet versleten uitzien of loszitten.


veiligheidsvleugels niet verwijderd zijn.


vervangen.
Reiniging en desinfectie


methoden:




Opmerking: Altijd r
Voorzorgsmaatregelen


• Het hulpmiddel mag niet op andere wijze worden gereinigd of




Afvoer


biologisch gevaar.
Meldingen



NEDERLANDS
14
Utilisation prévue


bouchons Provox Plug et Provox Vega Plug, pour appliquer des agents


Avant l’utilisation










plus tôt.
Nettoyage et désinfection








Remarque : 

Mise en garde






Élimination

concernant les risques biologiques lorsque vous mettez au rebut un

Signalement



FRANÇAIS ITALIANO
15
ITALIANO
Uso previsto



agenti anticandida e per la pulizia dei fori di fenestratura sulle cannule

Prima dell’uso

accertarsi che non sia rotto o usurato.
Prima di ogni utilizzo, assicurarsi che
• la punta protettiva non sia incrinata o allentata.



non siano state rimosse.


sostituito al più presto.
Pulizia e disinfezione







Nota: 
Precauzioni



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.
16
ESPAÑOL
Uso previsto

indicado para la limpieza de la prótesis de voz Provox, la inserción



para uso del paciente.
Antes del uso


Antes de cada uso, asegúrese de que




seguridad no se hayan desprendido.


.
Limpieza y desinfección



siguientes:




Nota: limpie y desinfecte siempre antes de usar.
Precaución







Eliminación


Noticación

en relación con el dispositivo se comunicará al fabricante y a la

PORTUGUÊS
17
PORTUGUÊS
Utilização prevista





produto destina-se a ser utilizado pelo paciente.
Antes de utilizar







foram removidas.


Limpeza e desinfeção







Nota: 
Precaução


cruzada.




Eliminação


Comunicação de incidentes

ocorrido, relacionado com o dispositivo, deve ser comunicado

ou o paciente residem.
18
SVENSKA
Avsedd användning





Före användning







inte har avlägsnats.


Rengöring och desinfektion







Obs: 
Försiktighetsåtgärd






Avfallshantering


Rapportering


myndigheten i det land där användaren och/eller patienten är bosatt.
19
DANSK
Tilsigtet anvendelse





til brug af patienten.
Før brug










Rengøring og desincering







Bemærk: 
Forholdsregel







Bortskaelse



Rapportering


i det land, hvor brugeren og/eller patienten opholder sig.
20
NORSK
Tiltenkt bruk





Før bruk










Rengjøring og desinsering







Merk: 
Forholdsregler







Avhending


Rapportering



SUOMI
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