Atos Provox FreeHands FlexiVoice Manual de utilizare

FreeHands FlexiVoice™

IFU

MD

1 RT

Figure 2Figure 1

Figure 4Figure 3

Figure 6

Figure 5

Figure 8Figure 7

Provox FreeHands

HME

Provox Life™

FreeHands HME

3

Figure 10

Figure 9

Figure 13

Figure 11

Figure 15

Figure 14

Figure 16

Figure 12

4

2 /250 ml (8,5 fl oz)

15 min

35-45°C

95-113°F

Figure 20Figure 19

Figure 22Figure 21

Figure 23

20-40°C

68-104°F

35-45°C

95-113°F

70 % Ethanol (or)

70 % Isopropyl alcohol

10 min

2 h

Figure 18

CRACK!

Figure 17

5

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

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

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

Patents and trademarks

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

™® Life™ are trademarks of Atos Medical AB.

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

web page www.atosmedical.com/patents.

6

Manufacturer; Hersteller; Fabrikant; Fabricant; Produttore;







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

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

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

ןרציה;ןרציה;  

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

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



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

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

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



ვარგისია; 



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;   



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

-



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

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





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

製造日; 제조일자; 製造日

期; 制造日期; רוציי ךיראת;רוציי ךיראת;  

7



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



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

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

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



-

mer; Artikkelinumero; Tilvísunarnúmer vöru; Toote viitenumber;

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

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

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

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

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

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

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

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

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;   

-

           

          

-



       



  -



-

         

-



1

8



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

 

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

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



-

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

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

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

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



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

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

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

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

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

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

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

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

მზისგან დაცულ ადგილას და მშრალ მდგომარეობაში;

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

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

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



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。;

שבי םוקמב ןסחאלו שמשה רואמ קיחרהל שי;שבי םוקמב ןסחאלו שמשה רואמ קיחרהל שי;

        

        

        

   ერთი პაციენტი — მრავალჯერადი

მოხმარების;   



-

一

人の患者 - 複数回使用; 환자 일인-다목적 이용; 單一患者：多次使

用; 供一位患者多次使用; ימעפ בר שומיש - דיחי לפוטמימעפ בר שומיש - דיחי לפוטמ

  -  

9

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

bewaartemperatuur; Limite de température de stockage; Tempera-

ture di stoccaggio; Límite de temperatura de almacenamiento;



för förvaring; Opbevaringstemperaturbegrænsning; Oppbevar-

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





-

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

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

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

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

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

ლიმიტი; 



suhu penyimpanan; Had suhu 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;

   

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

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

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

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

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



-

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

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

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

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

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





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

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

გაფრთხილება, მოითხოვეთ გამოყენების ინსტრუქცია;

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





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

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;    

10

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



médico; Medicinteknisk produkt; Medicinsk udstyr; Medisinsk

utstyr; Lääkinnällinen laite; Lækningatæki; Meditsiiniseade;

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







სამედიცინო მოწყობილობა;

-

latan Medis; Peranti Perubatan; 医療機器; 의료 장치; 醫療裝置

医疗器械; יאופר ןקתה;יאופר ןקתה;  

MD

IFU

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

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

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

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

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

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

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

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

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

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

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

使用说明书; שומיש תוארוה;שומיש תוארוה;  

11

RT

MAX

MIN

Store at room temperature. Temporary deviations within the

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

lagern. Temperaturschwankungen innerhalb des Temperaturbereichs

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

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



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

Conservare a temperatura ambiente. Sono consentiti scostamenti

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

temperatura ambiente. Se permiten desviaciones temporales dentro

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

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

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

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

Opbevar ved rumtemperatur. Midlertidige afvigelser i temperaturin-

tervallet (maks-min) er tilladt; Oppbevares i romtemperatur. Mid-



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

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

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

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

-

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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







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

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

12

შეინახეთ ოთახის ტემპერატურაზე. დროებითი

გადახრები ტემპერატურის ფარგლებში (მაქს.-მინ.)

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



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

-



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



-

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

suhu (maks-min) adalah dibenarkan: 室温で保管。温度範囲（最

大～最小）内の温度逸脱は許容。; 실온에서 보관하십시오. 온

도 범위내에서의 일시적인 편차(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。;

תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי; תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי;

.(םומינימ-םומיסקמ) הרוטרפמטה חווט ךותב.(םומינימ-םומיסקמ) הרוטרפמטה חווט ךותב

   .     

.(  - )    



      

      

     

kan resirkuleres; Pakkaus on kierrätettävä; Umbúðirnar eru

     











     შეფუთვა

გადამუშავებადია

       

包装はリサイ

クル可能です; 패키지는 재활용 가능; 包裝可回收; 包装可回收;

רוזחמל תנתינ הזיראה;רוזחמל תנתינ הזיראה;

   

13

Contents

ENGLISH ........................................................................................................... 14

DEUTSCH ......................................................................................................... 19

NEDERLANDS ................................................................................................. 24

FRANÇAIS ........................................................................................................ 29

ITALIANO .......................................................................................................... 34

ESPAÑOL .......................................................................................................... 39

PORTUGUÊS .................................................................................................... 44

SVENSKA .......................................................................................................... 49

DANSK ............................................................................................................... 54

NORSK ............................................................................................................... 59

SUOMI ............................................................................................................... 64

ÍSLENSKA ......................................................................................................... 69

ČESKY ................................................................................................................ 74

MAGYAR ........................................................................................................... 79

SLOVENČINA .................................................................................................. 84

SLOVENŠČINA ................................................................................................ 89

POLSKI ............................................................................................................... 94

ROMÂNĂ .......................................................................................................... 99

EESTI ................................................................................................................104

LIETUVIŲ K. ....................................................................................................109

HRVATSKI .......................................................................................................114

SRPSKI .............................................................................................................119

ΕΛΛΗΝΙΚΑ .....................................................................................................124

TÜRKÇE ...........................................................................................................129

 ....................................................................................................134

РУССКИЙ .......................................................................................................139

BAHASA MELAYU........................................................................................144

日本語 ............................................................................................................. 149

󼨫󺈼󻪃 ..............................................................................................................154

繁體中文 ........................................................................................................159

.........................................................................................................166

............................................................................................................170

14

ENGLISH

1. Descriptive information

1.1 Intended use



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

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

voice prosthesis.

1.2 CONTRAINDICATIONS

The product shall not be used by patients with a decreased level of consciousness,

patients with reduced mobility of the arms and/or hands, or patients who are unable

to remove the device themselves.

1.3 Description of the devices



a speaking valve for single patient use and a disposable HME cassette (Fig. 1).

The speaking valve has two modes; automatic speaking mode and locked mode



speaking or the locked position. Manual occlusion is possible in both modes.

The 





voice prosthesis. The membrane opens again automatically when breathing in.



in the membrane (Fig. 4). This prevents the membrane from closing when

breathing heav

There are fou

light, medium,

The number of dots represents the strength of the membrane (Fig. 5).

1 dot = Light membrane (easiest to close)

2 dots = Medium membrane

3 dots = Strong membrane

4 dots = XtraStrong membrane

 accessory that can be used with the





(Fig. 6). Please note that in some positions the Arch may restrict the possibility

of manual occlusion.

HME

cassette from the speaking valve.

15

1.4 Technical data

Pressure

drop at

30 l/min*(Pa)

Pressure

drop at

60 l/min*(Pa)

Pressure

drop at

90 l/min* (Pa)

Moisture

loss at

VT=1000ml*

(mg/l)

FlexiVoice &

FreeHands

HME Moist 70 220 490 24

FlexiVoice &

FreeHands

HME Flow 65 210 470 25

FlexiVoice &

FreeHands

Life

™

HME

56

200 450 24

HME internal volume (Dead space)* max 7 ml

* According to ISO 9360

1.5 WARNINGS

     HME cassette      



stuck in the attachment holder when used by itself (Fig. 7).

 

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

the attachment device. The attachment device then has to be removed or may

be damaged, possibly leading to restricted breathing.

 

This may cause cross contamination. The device is intended for single

patient use only.

1.6 PRECAUTIONS

 

be lost. Consult your clinician if there is a problem with the device.

           

the product is not properly cleaned, it may cause infection and product

malfunction.

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

medication can become deposited in the device.

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

           



2. Operating instruction

Always test the function of the device prior to use. Check that the device is

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

sleep. The opening of the speaking valve may be covered or the speaking

valve may unintentionally be turned to speaking mode resulting in restricted



HME cassette (Fig. 8).

16

Membrane strength selection



of this membrane during normal breathing or light activity, try the Strong or the



the Medium membrane for speaking, try the Light membrane (1 dot). Make

sure the membrane does not close unintentionally during regular breathing.

You can also use a stronger membrane when you are more active and a lighter

one when you are less active.

Assembly

Place the HME cassette

Place the speaking valve on top of the HME cassette and push it straight down

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

HME cassette.

Insertion and usage



™ attachment (Fig. 11). Breathe normally. Switch

the device between the modes by rotating the top of the speaking valve until

it stops in each position (Fig. 12).

Caution:

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

of the attachment device.

Automatic speaking mode



membrane can move freely and is not locked by the hook (Fig. 3).

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

the membrane (Fig. 13).

Manual occlusion





used in both automatic speaking mode and in locked mode.





Coughing

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

happens, breathe normally and push the membrane back through the opening



Removal of the HME cassette from the speaking valve

The HME cassette

the end of the day or earlier if needed.

Caution: 

the impregnation essential for its function.



Life

™



HME cassette (Fig 18).

Cleaning



good working condition and to avoid build-up of microorganisms, it should be

cleaned and disinfected daily.

Caution:



17

for disinfection since these actions will damage the device. Clean the speaking



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

 





 

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

4. Put the speaking device in speaking mode and place the speaking device



 



speaking device, be sure that it is switched between speaking and locked

mode a couple of times during rinsing.

 

above if necessary.

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



is completely dry, it can either be used again or be placed in a clean, closed

container for storage.

Disinfection

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





someone with a respiratory infection, or any other gross contamination. Then





the following procedure:

 

above , without step 7. After cleaning, put the speaking device in speaking





Caution:

 

and leave it to air-dry for at least 2 hours (Fig. 23). Make sure that the

speaking valve is in speaking mode.

 

placed in a clean, closed container for storage.

Caution: 

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

of the airways.

2.1 Device lifetime



6 months as long as it is intact and functioning as intended.

The HME cassette is a single use device and must be replaced at least every

24 hours, or more often if needed.

2.2 Disposal

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

when disposing of a used medical device.

18

2.3 Compatible products

Caution: Use only original components. Other accessories may cause product

malfunction.

Provox FreeHands HME



Provox Life

™

FreeHands HME

™

attachment

™™™ LaryButtons).

HME DigiTop enable use of HME cassette without the speaking valve, and

can manually be occluded to enable speaking. For single patient use with a

device life time of 2 months.

Removal Aid 

the speaking valve.

Provox FreeHands FlexiVoice Arch is an accessory that can be used with the



3. 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.

19

DEUTSCH

1. Beschreibung

1.1Verwendungszweck



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





mit Stimmprothese.

1.2KONTRAINDIKATIONEN

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

Patienten mit eingeschränkter Mobilität der Arme und/oder Hände sowie



verwendet werden.

1.3 Beschreibung des Produkts



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

und wiederverwendet werden darf, und einer Einweg-HME-Kassette (Abb. 1).







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





Sprechmodus kann die Membran durch die ausgeatmete Luft automatisch

geleitet.





Öse an der Membran greift (Abb. 4). So wird verhindert, dass sich die Membran

bei schwerer Atm

Es stehen vier verschiedene Tracheostomaventile mit unterschiedlicher









2 Punkte = mittlere Membran

3 Punkte = starke Membran











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

Mit der Ent

HME-Kassettewerden.

20

1.4Technische Daten

Druckabfall

bei

30l/min*(Pa)

Druckabfall

bei

60l/min*(Pa)

Druckabfall

bei 90l/min*

(Pa)

Feuchtig-

keitsverlust

bei VT =

1000ml*

(mg/l)

FlexiVoice

und

FreeHands

HME Moist

70 220 490 24

FlexiVoice

und

FreeHands

HME Flow

65 210 470 25

FlexiVoice

und

FreeHands

Life

™

HME

56

200 450 24

Innenvolumen des HME (Totraum)* max. 7ml

* Gemäß ISO 9360

1.5WARNHINWEISE

 





alleine verwendet wird (Abb. 7).

          

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

      

         

Behinderung der Atmung kommen.

       



1.6VORSICHTSMASSNAHMEN

 





         

         



        



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

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

         



erwärmt ist, verwendet werden.

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Atos Provox FreeHands FlexiVoice Manual de utilizare

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