Atos PROVOX Micron HME Manual de utilizare

Marca: Atos

Model: PROVOX Micron HME

Tip: Manual de utilizare

Micron HME

™

IFU

Figure 1 Figure 2

Figure 3 Figure 4

Prescription information

CAUTION: United States Federal law restricts this device to sale, distribution and use

by or on order of a physician or a licensed practitioner. The availability of this product

without prescription outside the United States may vary from country to country.

Disclaimer



hereunder as to the lifetime of the product delivered, which may vary with individual

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

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

Patents and Trademarks

® is a registered trademark owned by Atos Medical AB, Sweden.

Micron HME™ is a trademark of Atos Medical AB.

For information about protective rights (e.g. patents), please refer to our web page

www.atosmedical.com/patents.

Manufacturer; Hersteller; Fabrikant; Fabricant; Produttore;

Fabricante; Fabricante; Tillverkare; Producent; Produsent;







მწარმოებელი; 

dusen; Pengilang; 製造業者; 제조사; 製造商; 制造商;

ןרציה;ןרציה;  

Date of manufacture; Herstellungsdatum; Productiedatum; Date de



fabrico; Tillverkningsdatum; Fremstillingsdato; Produksjonsdato;

Valmistuspäivä; Framleiðsludagsetning; Valmistamise kuupäev;







 წარმოების

თარიღი; 

製造日; 제조

일자; 製造日期; 制造日期; רוציי ךיראת;רוציי ךיראת;  





Används senast: Anvendes inden; Brukes innen; Viimeinen käyt









 ვარგისია; 



gal; Tarikh guna sebelum; 使用期限; 사용 기한; 使用截止日期;使

用截止日期; שומישל ןורחא ךיראת;שומישל ןורחא ךיראת;   

Batch code; Chargencode; Partijnummer; Code de lot; Codice lotto;



Eränumero; Lotunúmer; Partii kood; Partijas kods; Partijos kodas;





Parti kodu; სერიის კოდი; 

 バッチコード; 배치 코드; 批

次代碼; 批号; הווצא דוק;הווצא דוק;  



mer product; Numéro de référence du produit; Numero riferimento

prodotto; Número de referencia del producto; Referência do produto;

Referensnummer; Produktreferencenummer; Produktreferansenum

mer; Artikkelinumero; Tilvísunarnúmer vöru; Toote viitenumber;











 პროდუქტის საკონტროლო

ნომერი; 



Nombor rujukan produk; 製品参照番号; 제품 참조 번호; 產品參

考號; 产品参考编号; רצומה לש ןיכומיס רפסמ;רצומה לש ןיכומיס רפסמ;   





vänd ej; Må ikke genanvendes; Skal ikke gjenbrukes; Ei uudel











 არ გამოიყენოთ

ხელახლა; Մեկանգամյա օգտագործման համար; Yenidən isfadə

etməyin; Не подлежит повторному использованию; Jangan

gunakan ulang; Jangan guna semula; 再利用不可; 재사용하지 마십

시오; 請勿重複使用; 请勿重复使用;

רזוח שומישל דעוימ וניא;רזוח שומישל דעוימ וניא;   

Keep away from sunlight and keep dry; Vor Sonnenlicht und



bewaren; Maintenir à l’abri de la lumière directe du soleil et de

l’humidité; Tenere all’asciutto e al riparo dalla luce del sole;



e da chuva; Håll borta från solljus och håll torr; Holdes bort fra

sollys og holdes tør; Unngå direkte sollys, holdes tørr; Säilytettävä























שבי םוקמב ןסחאלו שמשה רואמ קיחרהל שישבי םוקמב ןסחאלו שמשה רואמ קיחרהל שי

        



male bewaartemperatuur; Limite de température de stock

age; Temperature di stoccaggio; Límite de temperatura de



Temperaturgränser för förvaring; Opbevaringstemperaturbe

grænsning; Oppbevaringstemperaturgrense; Säilytyslämpötilan

















შენახვის

ტემპერატურის ლიმიტი; 





simpanan; 保管温度制限; 보관 온도 제한; 儲存溫度限制;

储存温度限制;

ןוסחא תרוטרפמט תלבגה;ןוסחא תרוטרפמט תלבגה;    



შეინახეთ

მზისგან დაცულ ადგილას და მშრალ მდგომარეობაში;







dan simpan di tempat yang kering; Jauhkan dari cahaya matahari dan

pastikan sentiasa kering; 直射日光および湿気禁止; 직사광선이

닿지 않게 하고 건조한 상태로 유지하십시오; 避免日照並保持

乾燥; 避免日照和保持干燥。;

MAX

MIN

Store at room temperature. Temporary deviations within the



lagern. Temperaturschwankungen innerhalb des Temperaturbereichs





toegestaan; Stocker à température ambiante Des écarts temporaires



Conservare a temperatura ambiente. Sono consentiti scostamenti



temperatura ambiente. Se permiten desviaciones temporales dentro









ved rumtemperatur. Midlertidige afvigelser i temperaturintervallet



avvik innenfor temperaturområdet (maks.–min.) er tillatt; Säilytä

































חווט ךותב תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי חווט ךותב תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי

.)םומינימ-םומיסקמ( הרוטרפמטה.)םומינימ-םומיסקמ( הרוטרפמטה

)        .     

.( -

















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



შეინახეთ

ოთახის ტემპერატურაზე. დროებითი გადახრები

ტემპერატურის ფარგლებში )მაქს.-მინ.( დასაშვებია;



















kan: 室温で保管。温度範囲（最大～最小）内の温度逸脱は許

容。; 실온에서 보관하십시오. 온도 범위내에서의 일시적인 편

차)최대-최소(는 허용됩니다; 室溫儲存。允許在溫度範圍內（

上限至下限）的溫度差異。; 室温下存放。允许温度范围内（

最高-最低）的暂时偏差。;











tion; Forsigtig, se brugsanvisning; Forsiktig, se bruksanvisningen;

Varoitus, katso käyttöohjeet; Varúð, lesið notkunarleiðbeiningarnar;



















inceleyin; გაფრთხილება, მოითხოვეთ გამოყენების

ინსტრუქცია; 







penggunaan; 注意、取扱説明書を参照;

주의, 사용 지침을 참조하십시오; 注意事項，參閱使用說明;

小心，参阅使用说明书;

שומישה תוארוהב ןייעל שי ,תוריהז; שומישה תוארוהב ןייעל שי ,תוריהז;     



médical; Dispositivo medico; Producto sanitario; Dispositivo médi

co; Medicinteknisk produkt; Medicinsk udstyr; Medisinsk utstyr;











სამედიცინო მოწყობილობა;



batan; 医療機器; 의료 장치; 醫療裝置; 医疗器械;

יאופר ןקתה;יאופר ןקתה;  

IFU

















გამოყენების ინსტრუქცია; 



gunaan; Arahan penggunaan; 取扱説明書; 사용 지침; 使用說明;

使用说明书; שומיש תוארוה;שומיש תוארוה;   

EN  ENGLISH .................................................................................... 13

DE  DEUTSCH .................................................................................. 16

NL  NEDERLANDS .......................................................................... 19

FR  FRANÇAIS .................................................................................. 22

IT  ITALIANO ..................................................................................... 25

ES  ESPAÑOL .................................................................................... 28

PT  PORTUGUÊS ............................................................................. 31

SV  SVENSKA .................................................................................... 34

DA  DANSK ....................................................................................... 37

NO  NORSK ....................................................................................... 40

FI  SUOMI .......................................................................................... 43

IS  ÍSLENSKA .................................................................................... 46

ET  EESTI ............................................................................................ 49

LT  LIETUVIŲ KALBA ...................................................................... 52

HU  MAGYAR .................................................................................... 55

SK  SLOVENČINA ............................................................................ 58

SL  SLOVENŠČINA .......................................................................... 61

PL  POLSKI ........................................................................................ 64

RO  ROMÂNĂ ................................................................................... 67

HR  HRVATSKI .................................................................................. 70

SR  SRPSKI ......................................................................................... 73

EL  ΕΛΛΗΝΙΚΑ ................................................................................. 76

TR  TÜRKÇE ....................................................................................... 79

HY  ՀԱՅԵՐԵՆ ............................................................................... 82

RU   .................................................................................. 85

MS - BAHASA MELAYU................................................................. 88

JA - 日本語........................................................................................ 91

KO  한국어 ......................................................................................... 94

ZHTW  繁體中文 ............................................................................ 97

HE  עברית .........................................................................................102

AR  ......................................................................................105

Contents

ENGLISH

Intended use



Micron HME

™





partially restores lost breathing resistance. For patients with a voice prosthesis







CONTRAINDICATIONS

This device shall not be used by patients who are unable to handle or remove the

device themselves when needed, unless the patient is under constant supervision



move their arms, patients with decreased levels of consciousness, or patients with

diseases that put them at a risk for unpredictable periodic loss of consciousness.

Description of the device







retained heat and moisture in the HME is given back to the lungs. HME use may

help improve the function of the lungs and reduce problems with e.g. coughing and





production may seem to increase. This is normal and means that the mucus is

getting thinner and easier to cough up.



production usually decreases.





automatically comes up and the airway passage opens.



normal use. Thereby, small airborne particles, e.g., bacteria, viruses, dust and pollen

are restricted from passing through the device into the lungs upon inspiration



Note:



Technical data

Pressure drop after 1 h at: 30 l/min 0.7 hPa

(According to ISO 9360) 60 l/min 1.9 hPa

90 l/min 3.5 hPa

Pressure drop after 24 h at: 30 l/min 0.7 hPa

(According to ISO 9360) 60 l/min 1.8 hPa

90 l/min 3.5 hPa

Moisture output: 22 mg/L

(According to ISO 9360)

Moisture loss at VT=1000 ml: 22 mg/L

(According to ISO 9360)

Bacterial Filtration Eciency (BFE): ≥ 99 %

(According to ASTM F2101)

Virus Filtration Eciency (VFE): ≥ 99 %

(According to MIL-M-36954C and ASTM F2101)

WARNING









lid, the airway passage is closed. Closing the airway in order to allow voicing



but may be unknown for patients without a voice prosthesis.

PRECAUTIONS



as long as there is no air leakage. However, since there are other pathways for

e.g. viruses and bacteria to enter the human body, total protection can never be

guaranteed.

The same device must not be used for more than 24 hours after initial use. This

can increase the risk for infection due to growth of e.g. bacteria.



and HME functions.



function.

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

medication can be deposited in the device.



HME will become too wet.

Instructions for use







HME and check for leakage.









needs to be cleaned from mucus.

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

Disposal

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

when disposing of a used medical device.

Device lifetime



same device must not be used for more than 24 hours after initial use. Always



disposing of a used medical device.

Attachment devices







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

Verwendungszweck

® Micron HME™



Tracheostoma atmen

Atemwegswiderstand teilweise wieder her. Bei Patienten mit einer Stimmprothese

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







KONTRAINDIKATIONEN

Das Produkt darf nicht bei Patienten verwendet werden, die nicht selbst damit





Nicht verwendet werden darf das Produkt beispielsweise bei Patienten, die ihre

Arme nicht bewegen können, die nicht vollkommen bei Bewusstsein sind oder



einem nicht vorhersehbaren Bewusstseinsverlust kommen kann.

Produktbeschreibung













von Komplikationen (wie beispielsweise Husten und Schleimbildung) beitragen.





kann die Schleimproduktion scheinbar gesteigert sein. Dies ist normal und darauf





voraussichtlich stabilisieren, und der Husten sowie die Schleimproduktion gehen























Hinweis:



Technische Daten

Druckverlust nach 1 Stunde bei: 30 l/min 0,7 hPa

(gemäß ISO 9360) 60 l/min 1,9 hPa

90 l/min 3,5 hPa

Druckverlust nach 24 Stunden bei: 30 l/min 0,7 hPa

(gemäß ISO 9360) 60 l/min 1,8 hPa

90 l/min 3,5 hPa

Feuchtigkeitsabgabe: 22 mg/l

(gemäß ISO 9360)

Feuchtigkeitsverlust bei VT = 1000 ml: 22 mg/l

(Gemäß ISO 9360)

Bakterienltrationsezienz (BFE): ≥ 99%

(gemäß ASTM F2101)

Virenltrationsezienz (VFE): ≥ 99%

(gemäß MIL-M-36954C und ASTM F2101)

WARNHINWEIS

Unbeabsichtigter oder unkontrollierter Druck auf den Deckel von













Verfahren, kann jedoch Patienten ohne Stimmprothese unbekannt sein.

VORSICHTSMASSNAHMEN









niemals gewährleistet.

Ein und dasselbe Produkt darf nicht länger als 24 Stunden verwendet werden.



Bakterienwachstum.

















Gebrauchsanweisung









Leckagen achten.



Hierdurch wird die Ausatemluft durch die Stimmprothese geleitet. Nach dem





wenn das Tracheostoma von Schleim gereinigt werden muss.

Sollten Sie Schwierigkeiten mit dem Produkt haben, wenden Sie sich bitte an



Entsorgung





befolgen.

Nutzungsdauer des Produkts



24 Stunden







Befestigungslösungen









Berichterstattung



mit dem Produkt ereignet haben, dem Hersteller sowie den nationalen Behörden

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

ansässig ist.

NEDERLANDS

Beoogd gebruik

® Micron HME™





verloren ademhalingsweerstand. Bij gebruikers met een stemprothese of chirurgisch







CONTRA-INDICATIES













Beschrijving van het hulpmiddel











kan de werking van de longen verbeteren en problemen met de luchtwegen,







toe lijken te nemen. Dit is normaal en betekent dat het slijm dunner wordt en

gemakkelijker op te hoesten is.



en wordt het hoesten en de slijmproductie meestal minder.



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



luchtweg open te staan.







longen terecht komen en bij uitademing de mensen om de persoon heen beschermd



Opmerking:

als persoonlijk beschermingsmiddel bij werk waar ademhalingsbescherming

voor vereist is.

Technische gegevens

Drukval na 1 uur bij: 30 l/min 0,7 hPa

(Conform ISO 9360) 60 l/min 1,9 hPa

90 l/min 3,5 hPa

Drukval na 24 uur bij: 30 l/min 0,7 hPa

(Conform ISO 9360) 60 l/min 1,8 hPa

90 l/min 3,5 hPa

Bevochtigingsgraad: 22 mg/l

(Conform ISO 9360)

Vochtverlies bij VT = 1000 ml: 22 mg/l

(Conform ISO 9360)

Bacteriële ltratie-eciëntie (BFE): ≥ 99 %

(volgens ASTM F2101)

Virale ltratie-eciëntie (VFE): ≥ 99 %

(Volgens MIL-M-36954C en ASTM F2101)

WAARSCHUWING















VOORZORGSMAATREGELEN







binnendringen, is totale bescherming nooit gegarandeerd.

Een apparaat mag nooit langer dan 24 uur vanaf het tijdstip van ingebruikname

worden gebruikt. Langduriger gebruik vergroot het infectierisico vanwege



Het hulpmiddel mag niet gewassen en hergebruikt worden. Door het hulpmiddel





verstoort de werking.

Pagina se încarcă...

Atos PROVOX Micron HME Manual de utilizare

Marca: Atos

Model: PROVOX Micron HME

Tip: Manual de utilizare

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