Atos Provox Vega Clinician Insertion System 取扱説明書

Vega

™

IFU

MD

RT

f)

g)

c)

d)

b)

e)

a)

a) Size information

b) Prosthesis Hood

c) Esophageal Flange

d) Tracheal Flange

e) Safety Strap

f) Valve Flap

g) Prosthesis Shaft

h) Radio-opaque fluoroplastic Valve Seat

Figure. 2

Figure. 3

Figure. 4

Figure. 1

h)

a) Insertion Pin

b) Folding Tool

c) Loading Tube

d) Attachment Slot

e) Distal grip surface

f) Proximal grip surface

f)

e)

d)

c)

b)

a)

2.2 Preparation

3

Figure. 5

Figure. 6

Figure. 7

Figure. 8

2.3.1 Method 1 System Insertion

2.3.2 Method 2 Tube Insertion

4

Figure. 9

Figure. 11

Figure. 12

Figure. 10

2.3.3 Method 3 Overshoot Insertion

5

Figure. 13

Figure. 14

Figure. 15

Figure. 16

2.3.4 Method 4 Capsule Insertion

2.4 Assembly and reloading

6

Figure. 18

Figure. 19

Figure. 17

2.5 Finalization

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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

®® Vega™

is a trademark of Atos Medical AB. For information about protective rights (e.g. patents),

please refer to the webpage www.atosmedical.com/patents.

8

Manufacturer; Hersteller; Fabrikant; Fabricant; Produttore; Fabricante; Fab

ricante; Tillverkare; Producent; Produsent; Valmistaja; Framleiðandi; Toot



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

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

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

ןרציה;ןרציה;  

Date of manufacture; Herstellungsdatum; Productiedatum; Date de

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

Tillverkningsdatum; Fremstillingsdato; Produksjonsdato;Valmistuspäi

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



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



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

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

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

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

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

senast: Anvendes inden; Brukes innen; Viimeinen käyttöpäivä; Síðasti



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

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

 ვარგისია;



sebelum tanggal; 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;   

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





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

 სერიის კოდი;



pok; バッチコード; 배치 코드; 批次代碼; 批号; הווצא דוק;הווצא דוק;  

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



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

mer; Produktreferencenummer; Produktreferansenummer; Artikkelinumero;

Tilvísunarnúmer vöru; Toote viitenumber; Produkta atsauces numurs;



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





 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;   

9

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







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

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

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

 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 마십시오; 請勿重複使用; 请勿重复使用;

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









ved hjelp av etylenoksid; Steriloitu eteenioksidilla; Dauðhreinsað með















სტერილიზებულია ეთილენის ოქსიდის გამოყენებით;

Ստերիլիզացված է էթիլենի օքսիդի միջոցով; 



etilena oksida; Disterilkan menggunakan etilena oksida; エチレンオキサ

イド滅菌; 에틸렌옥사이드를 사용하여 멸균처리됨; 使用環氧乙烷滅

菌; 已经使用环氧乙烷灭菌; דיסקוא ןליתא תועצמאב רוקיעדיסקוא ןליתא תועצמאב רוקיע

   

Do not use if package is damaged; Produkt nicht verwenden, wenn die































არ გამოიყენოთ, თუ შეფუთვა დაზიანებულია; 





パッケージに損傷が

ある場合、使用不可; 패키지가 손상된 경우 사용하지 마십시오;

若包裝受損，請勿使用; 如包装损坏，请勿使用;

המוגפ הזיראה םא שמתשהל ןיא;המוגפ הזיראה םא שמתשהל ןיא;       

Keep away from sunlight and keep dry; Vor Sonnenlicht und Feuchtigkeit





10

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

        

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



Límite de temperatura de almacenamiento; Limite da temperatura de





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

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

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

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

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

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

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

შენახვის ტემპერატურის ლიმიტი;



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

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;    

Store at room temperature. Temporary deviations within the temperature

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



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



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



Sono consentiti scostamenti temporanei entro i limiti di temperatura

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

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

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

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

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







შეინახეთ მზისგან დაცულ ადგილას

და მშრალ მდგომარეობაში; 



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

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

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

지 않게 하고 건조한 상태로 유지하십시오; 避免日照並保持乾燥;

避免日照和保持干燥。;

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

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

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

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



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

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

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

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

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

su privremena odstupanja unutar temperaturnog opsega (maks.–min.);

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



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





ilir; შეინახეთ ოთახის ტემპერატურაზე. დროებითი გადახრები

ტემპერატურის ფარგლებში (მაქს.-მინ.) დასაშვებია

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

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

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



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



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

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

室温で保管。温度範囲（最大～最小）内の温度逸脱は許容。; 실온

에서 보관하십시오. 온도 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。;

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

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

.( - )        .     

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

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

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



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

siktig, se bruksanvisningen; Varoitus, katso käyttöohjeet; Varúð, lesið not

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



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

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

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

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

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



გაფრთხილება,

მოითხოვეთ გამოყენების ინსტრუქცია; 



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

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

naan; 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;    









არასტერილური; 

非滅菌; 무균 아님; 未滅菌; 非无菌;

רקועמ אל;רקועמ אל;  

12

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

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





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

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

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

გამოყენების ინსტრუქცია; 

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

Arahan penggunaan; 取扱説明書; 사용 지침; 使用說明; 使用说明书;

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

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

cinteknisk produkt; Medicinsk udstyr; Medisinsk utstyr; Lääkinnällinen

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

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

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

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

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

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

Medis; Peranti Perubatan; 医療機器; 의료 장치; 醫療裝置; 医疗器械;

יאופר ןקתה;יאופר ןקתה;  

MD

IFU





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



visning avsedd för läkaren; Brugsanvisning tiltænkt kliniker; Bruksanvisning



















გამოყენების ინსტრუქციები ექიმისთვის; 





Petunjuk penggunaan khusus untuk tenaga medis; Arahan penggunaan untuk

klinisian; 医師用の取扱説明書; 의사 사용 지침; 臨床醫生專用使用說明;

适用于临床医生的使用说明书; אפורל שומיש תוארוהאפורל שומיש תוארוה

   

IFU





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

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

avsedd för patienten; Brugsanvisning tiltænkt patient; Bruksanvisning









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

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





გამოყენების

ინსტრუქციები პაციენტისთვის; 





tunjuk penggunaan khusus untuk pasien; Arahan penggunaan untuk pesakit;

患者用の取扱説明書; 환자 사용 지침; 患者專用使用說明; 适用于患者

的使用说明书; לפוטמל שומיש תוארוה;לפוטמל שומיש תוארוה;    

IFU

שומיש תוארוה;שומיש תוארוה;  

13

Contents

EN - ENGLISH ........................................................... 14

DE - DEUTSCH ......................................................... 18

NL - NEDERLANDS................................................. 23

FR - FRANÇAIS .........................................................28

IT - ITALIANO ........................................................... 33

ES - ESPAÑOL ........................................................... 38

PT - PORTUGUÊS ....................................................43

SV - SVENSKA ..........................................................47

DA - DANSK .............................................................. 52

NO - NORSK .............................................................. 56

FI - SUOMI ................................................................. 61

CS - ČESKY ................................................................ 65

HU - MAGYAR .......................................................... 70

PL - POLSKI ............................................................... 74

HR - HRVATSKI ......................................................... 79

TR - TÜRKÇE ............................................................. 84

RU - РУССКИЙ ......................................................... 88

JA - 日本語 ................................................................ 93

KO - 한국어 ............................................................... 98

ZHTW - 繁體中文 ...............................................102

HE - .........................................................110

AR - ...........................................................114

14

ENGLISH

Provox® Vega™

1. Descriptive information

1.1 Intended use





of the voice prosthesis is performed by the patient while it remains in situ.





out by a medical doctor or a trained medical professional in accordance with local or

national guidelines.

Provox Insertion System is not intended to be used for insertion of a voice prosthesis

in a freshly made puncture.

1.2 Description of the device

General



for speech, while reducing the risk of fluids and food entering the trachea.

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



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





           

sterile (Fig. 2)

 

 

 

 

1.3 CONTRAINDICATIONS



prosthesis among patients already using prosthetic voice rehabilitation.

1.4 WARNINGS

• Dislodgement or extrusion of Provox Vega voice prosthesis 



the airway may cause severe complications such as acute respiratory distress and/or

respiratory arrest.

• Select the proper prosthesis size.

• Instruct the patient to consult a physician immediately if there are any signs of



• Instruct the patient to consult a physician if leakage through or around the voice

prosthesis occurs. Leakage may cause aspiration pneumonia.

• If used, choose laryngectomy tubes or stoma buttons with a suitable shape that do



during insertion and removal of the laryngectomy tube or stoma button. This may

lead to severe tissue damage and/or accidental ingestion of the prosthesis.

• Instruct the patient to use only genuine Provox accessories 

(Brush, Flush, Plug) for maintenance and to avoid all other kinds of manipulation.

• Re-use and re-processing       

device, which could cause patient harm.

1.5 PRECAUTIONS

• Carefully assess any patient with bleeding disorders or who is undergoing

anticoagulant treatment for the risk of bleeding or hemorrhage prior to placement or

replacement of the prosthesis.

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

product.

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

infection risk.

15

2. Instructions for use

2.1 Choose size of the Voice prosthesis

Choosing the right shaft diameter and length of the replacement prosthesis





• Selecting shaft diameter

The Clinician should determine the proper diameter of the prosthesis appropriate for

the patient.

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



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

puncture shrinks to the appropriate diameter.

• Selecting shaft length

To select the correct length, you may use the current prosthesis as its own measuring

device.

 

Flange of the old prosthesis and the mucosal wall, a shorter prosthesis should be



2.2 Preparation

(Fig. 3-6)

Position voice prosthesis

 

attached, and with the tip of the pin positioned all the way into the blue ring of





 

Pin shall be snapped into the Folding Tool).

 

 

Loading Tube until it locks in place (Fig. 5).

 

Load

 



Remove the old voice prosthesis

 





prosthesis is then pushed into the esophagus for passage through the intestinal



before using this method.

Prepare the puncture (optional)

7. The puncture may be dilated to prepare for the insertion of the voice prosthesis.

This is usually not necessary but may facilitate insertion in patients with angled

or tight punctures that easily collapse.

2.3 Insertion, Anterograde replacement procedure

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

System. The choice of method is at the clinician´s discretion.

 

 

 

and then retracted to the intended position.

 

insertion.

2.3.1 Method 1: System Insertion

1. Enter the TE-puncture

 



resistance, dilatation and/or lubrication can ease the insertion.

2. Insert the voice prosthesis

 

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



prosthesis is entirely unfolded in the esophagus.

3. Release the voice prosthesis

Pull the Loading Tube and Folding Tool together straight out from the puncture.

The voice prosthesis remains in the puncture; still firmly attached to the



4. Finalize the procedure

 

16

2.3.2 Method 2: Tube Insertion

To enhance visibility, the Folding Tool can be removed once the prosthesis has been

pushed into the Loading Tube.

Note:



1. Remove the Folding Tool

Remove the Folding Tool by unlocking and disconnecting it from the Loading

Tube (Fig. 8).

2. Enter the TE-puncture

 



resistance, dilatation and/or lubrication can ease the insertion.

3. Insert the voice prosthesis

 



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

4. Release the voice prosthesis

 





and pull the Loading Tube straight out from the puncture. This will release the



Note:



rotate the voiceprosthesis into place.

5. Finalize the procedure

 

2.3.3 Method 3: Overshoot Insertion





1. Remove the Folding Tool (Optional)

After the prosthesis has been pushed into the Loading Tube, remove the Folding

Tool by unlocking and disconnecting it from the Loading Tube (Fig. 8).

2. Enter the TE-puncture

 



resistance, dilatation and/or lubrication can ease the insertion.

3. Insert the voice prosthesis

 



prosthesis is fully deployed in the esophagus (Fig.11).

 

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

is fully deployed in the esophagus (Fig. 12).

4. Release the voice prosthesis

Pull the Loading Tube straight out from the puncture. The prosthesis remains in





5. Finalize the procedure

 

2.3.4 Method 4: Capsule Insertion

Intended use

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

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

Description of the device

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



WAR NINGS

• Always ensure that the voice prosthesis is folded correctly and that it is properly

           

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

attachment of the Capsule.

 

 

           

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

prosthesis after insertion.

PRECAUTIONS

• 

may damage the voice prosthesis.

 

the voice prosthesis.

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



procedure the Loading Tube is not used.

1. Insert the prosthesis into Provox Capsule

 





17

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



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

2. Check proper loading

 







of the voice prosthesis is secured to the insertion pin intended for inserting the

prosthesis into the puncture.

3. 

points 6 and 7).

4. Insert capsule into the puncture

 



strap of the voice prosthesis to ensure it is in the proper position.

5. Release the voice prosthesis

Remove the insertion pin from the voice prosthesis. The voice prosthesis remains

in the puncture.

6. Finalize the procedure

 



2.4 Assembly and reloading Provox Insertion System





Position voice prosthesis

 

Pin.

2. Attach the Safety Strap by leading it through the Attachment Slot from either side.

 

attached and with the tip of the pin positioned all the way into the blue ring of the



Connect the Folding Tool

 

in place. Pull the pin until the pin is snapped into the Folding Tool (Fig. 16).



as described above in section 2.2.

CAUTION: 

any signs of damage, do not use the voice prosthesis.

2.5 Finalize the procedure

After insertion:



 



Strap is pointing downwards.

Test proper function

 

by asking the patient to speak and by observing that the prosthesis does not leak

while the patient drinks water (Fig. 18).

Cut the Safety Strap

 



now ready for use.

2.6 Disposal

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

when disposing of a used medical device.

3. Important patient information

3.1 General information

Ensure that the patient understands to contact their clinician if:

• There is leakage through or around the prosthesis (coughing and/or change of mucus

color).

 

       

stoma region (pain, redness, heat, swelling, traces of blood on the brush after

brushing).

Also inform the patient that:

• After a prosthesis replacement traces of blood may be found in the sputum. This may



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

prosthesis.

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

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

18

3.2 Prosthesis maintenance



Cleaning the prosthesis at least twice a day can help prolong the device life.

CAUTION: Only use genuine Provox accessories that are intended for use with

Provox Vega when cleaning the prosthesis.

 

and food remnants from the prosthesis.

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

the prosthesis, which can help increase the life of the device.

Note:         

clinician who prescribes the device, have demonstrated ability to understand and

consistently follow the instructions for use without clinician supervision.

• Some dietary measures, like the daily intake of yogurt or butter milk containing

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

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

each accessory.

4. Additional information

4.1 Compatibility with MRI, X-ray and radiation

therapy

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









4.2 Device lifetime

Depending on individual biological circumstances the device life varies, and it is

not possible to predict the integrity of the device over a longer period of time. The

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

integrity of the device will eventually deteriorate.

Laboratory testings of simulated usage for a test period of 12 months show that, in

the absence of bacteria and yeasts, the device will maintain its structural integrity for

this time period. The device has not been tested for usage beyond 12 months. Usage

beyond this limit is under the sole discretion of the prescriber.

4.3 Compatibility with antifungal medicine



voice prosthesis and components when using the following antifungal medications:



5. 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

Provox® Vega™

1. Beschreibung

1.1Verwendungszweck













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

in Übereinstimmung mit lokalen oder nationalen Richtlinien.

Das Provox Insertion System ist nicht dafür vorgesehen, eine Stimmprothese in eine

neu angelegte tracheo-ösophageale Punktion einzusetzen.

19

1.2Produktbeschreibung

Allgemeines





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



werden. Die Prothese (Abb. 1) ist in verschiedenen Durchmessern und Längen







          



 

 

 

 

1.3KONTRAINDIKATIONEN

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

Stimmprothese bei Patienten, die bereits eine Stimmprothese tragen, bekannt.

1.4WARNHINWEISE

       Provox Vega Stimmprothese verrutscht

oder aus der tracheo-ösophagealen Punktion herausgedrückt und in der

        

         



• Wählen Sie die richtige Prothesengröße aus.      



• Weisen Sie den Patienten an, sofort einen Arzt zu konsultieren, wenn er



• Weisen Sie den Patienten an, sofort einen Arzt zu konsultieren, wenn Leckagen

          



• Sofern verwendet, sind Laryngektomiekanülen oder Tracheostoma-Buttons



    



      

Verschlucken der Prothese die Folge sein.

• Weisen Sie den Patienten darauf hin, ausschließlich Original-Provox-Zubehör



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

• Wiederverwendung und Wiederaufbereitung   

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

Folgen haben könnte.

1.5VORSICHTSMASSNAHMEN

         



Austauschen der Prothese sorgfältig beurteilt werden.

 



• Achten Sie beim Umgang mit der Prothese auf ein aseptisches Vorgehen, um das



2. Gebrauchsanweisung

2.1 Auswahl der richtigen Stimmprothesengröße

Auswahl des korrekten Schaftdurchmessers und der korrekten Länge der

Ersatzprothese





unterschiedlichen Längen erhältlich.

• Auswahl des Schaftdurchmessers

 

Prothese ermitteln.

           

   



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

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

Durchmesser einschrumpft.

• Auswahl der Schaftlänge

           

verwendet werden.

               



            



20

2.2 Vorbereitung

(Abb. 3–6)

Stimmprothese platzieren

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





Ösophagealen Flansch falten

 

muss im Faltinstrument eingerastet sein).

 

 

und drehen Sie den Ladetubus so lange, bis er in seiner Position einrastet (Abb. 5).

 

Laden

 



Alte Stimmprothese entfernen

 







Ösophagus geschoben werden, sodass er durch den Darmtrakt transportiert und





Punktion vorbereiten (optional)

 



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

vereinfachen.

2.3 Einsetzen – anterograder Prothesenwechsel







 

          

entfernt.

        

        



 



2.3.1 Methode 1: Einsetzen mit System

1. Sondieren der tracheo-ösophagealen Punktion

 







2. Stimmprothese einsetzen

 





Flansch der Stimmprothese wird nun vollständig im Ösophagus entfaltet.

3. Stimmprothese lösen

 

heraus. Die Stimmprothese verbleibt in der Punktion und ist noch immer fest am



 



2.3.2 Methode 2: Einsetzen mit Tubus



werden, sobald die Prothese in den Ladetubus geschoben wurde.

Hinweis:



ösophageale Flansch korrekt gefaltet wird.

1. Faltinstrument entfernen

Lösen Sie das Faltinstrument, indem Sie es entsichern und vom Ladetubus trennen

(Abb. 8).

2. Sondieren der tracheo-ösophagealen Punktion

 







3. Stimmprothese einsetzen

 



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Atos Provox Vega Clinician Insertion System 取扱説明書

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