Atos Provox ActiValve Clinician 取扱説明書

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Provox® Brush

Provox® ActiValve® Lubricant

Provox® Plug

Prescriber 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

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

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

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

Patents and Trademarks

®® ActiValve® are registered trademarks owned by Atos Medical AB, Sweden.

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

3

Manufacturer; Hersteller; Fabrikant; Fabricant; Produttore; Fabricante; Fabricante; Tillverkare; Producent;

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

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

 製造業者; 제조사; 製造商; 制造商;

ןרציה;ןרציה;  

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

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



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

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

製造日;

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

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



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

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

 ვარგისია; 

 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; 

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

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

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



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

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



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

4

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



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





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;    

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





არასტერილური; 非滅菌; 무균 아님; 未

滅菌; 非无菌; רקועמ אל;רקועמ אל;  

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



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



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

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

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

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

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

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



შეინახეთ

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





tahari dan pastikan sentiasa kering; 直射日光および湿気禁止; 직사광선이 닿지 않게 하고 건조한 상태로 유

지하십시오; 避免日照並保持乾燥; 避免日照和保持干燥。; שבי םוקמב ןסחאלו שמשה רואמ קיחרהל שישבי םוקמב ןסחאלו שמשה רואמ קיחרהל שי

        

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

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

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

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

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

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

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



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 תלבגהןוסחא תרוטרפמט תלבגה

   

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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。; 실온에서 보관하십시오. 온도 범위내에서의 일시적인 편차(최대-최

소)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。;

.(םומינימ-םומיסקמ) הרוטרפמטה חווט ךותב תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי.(םומינימ-םומיסקמ) הרוטרפמטה חווט ךותב תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי

.( - )         .     

IFU

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





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

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

გამოყენების ინსტრუქცია; 

取扱説明書; 사용 지침; 使用說明;

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

6

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

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



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

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

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

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

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



გამოყენების ინსტრუქციები ექიმისთვის; 





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;



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

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

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

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

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

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

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

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

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





ti, rujuk arahan 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;    

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



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

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

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

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

医療機器; 의료 장치; 醫療裝置; 医疗器械; יאופר ןקתה;יאופר ןקתה;  

MD

IFU

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

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

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

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

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

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

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





გამოყენების ინსტრუქციები პაციენტისთვის; 



患者用の取扱説明書; 환

자 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

אפורל שומיש תוארוהאפורל שומיש תוארוה

   

7

EMERGENCY

TOTAL NECK BREATHER - NO VOCAL CORDS!

FOR HEALTH CARE PROFESSIONALS ONLY

If prosthesis is accidently removed, replace immediately with a 22.5 FR

all purpose catheter to prevent choking/aspiration.

VOICE

PROSTHESIS

USER

Patient name

Clinician/Doctor

Hospital/Clinic

Insertion date

10

11

Provox Brushes

Provox Plug

Provox ActiValve

Lubricant

Provox ActiValve

User cards

Emergency

card

Figure 1a

Figure 1b

5

1

4

32

6

7

8

9

8

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

9

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

10

Contents

EN - ENGLISH ......................................................................................................................................................11

DE - DEUTSCH .................................................................................................................................................... 17

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

FR - FRANÇAIS ....................................................................................................................................................29

IT - ITALIANO ...................................................................................................................................................... 36

ES - ESPAÑOL ......................................................................................................................................................42

PT - PORTUGUÊS ...............................................................................................................................................48

SV - SVENSKA .....................................................................................................................................................55

DA - DANSK .........................................................................................................................................................60

NO - NORSK .........................................................................................................................................................66

FI - SUOMI ............................................................................................................................................................72

IS - ÍSLENSKA ...................................................................................................................................................... 78

HU - MAGYAR ..................................................................................................................................................... 84

PL - POLSKI ..........................................................................................................................................................90

HR - HRVATSKI ....................................................................................................................................................97

EL - ΕΛΛΗΝΙΚΑ .................................................................................................................................................103

TR - TÜRKÇE.......................................................................................................................................................110

RU - РУССКИЙ ..................................................................................................................................................116

JA - 日本語 ........................................................................................................................................................123

KO - 한국어 .......................................................................................................................................................129

ZHTW - 繁體中文.............................. ..............................................................................................................135

AR - ......................................................................................................................................................145

Contents Accessories

PROVOX BRUSH ..............................................................................................................................................146

PROVOX PLUG .................................................................................................................................................166

PROVOX ACTIVALVE LUBRICANT ............................................................................................................190

11

ENGLISH

Provox® ActiValve® Voice Rehabilitation System



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

Stomal airway management

Emergency situations

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

and rescue breathing need to be administered to your stoma and not to your mouth or nose.

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

www.atosmedical.com/rescuebreathing





Elective situations

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

that the anesthesiologist and the doctor who is performing the procedure are aware that you are a neck breather and that

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

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

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

or come out.

1. Descriptive information

1.1 Indications for use

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

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



users, but not in all.

1.2 CONTRAINDICATIONS



• for insertion in a freshly made puncture,

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

1.3 Description of the device

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

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

standard voice prostheses to prevent inadvertent valve opening when the patient breathes or swallows.







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

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



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

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

nickel. The device can therefore also be used in patients with hypersensitivity to nickel. Care should however be taken not

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

Provox ActiValve Voice Prosthesis package

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

Clinician items (Fig. 1a)



 

 

 

 

12

 

(6) Safety strap.

 

 

 



 

 



Patient items (shall be given to the patient) (Fig. 1b)

• 

• 

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

• 

• 

• 

• 

Since the opening forces are not apparent upon simple visual inspection the device comes with Provox ActiValve User Cards

that also provide important information about the voice prosthesis. Please complete the user cards using a water resistant

permanent marking pen, and provide the cards to the patient.

The Emergency Card provides important information about emergency airway management. Advise the patient to carry a

user card and the emergency card with them at all times in case of emergency, consultation with healthcare providers (e.g.

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

1.4 WARNINGS

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

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

or tissue damage may occur (See also Section 3).



• 

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

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

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

• 

of manipulation of the voice prosthesis.

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

1.5 PRECAUTIONS

• 

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

• Carefully assess any patient on anticoagulant treatment or with bleeding disorders for the risk of bleeding prior to prosthesis

placement or replacement.

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



•              

prosthesis irreparably, leading to material destruction and valve malfunction.

• 

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

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

2. Instructions for use

Caution: Do not use the product if the package is damaged or opened.

2.1 Voice prosthesis replacement

Preparation

Determine the required length



13



be used to determine the length.

Determine the required strength. 





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

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

with a lower opening pressure, taking shorter device life into account.

Loading the voice prosthesis into the insertion tool:



pulling it into the narrower part of the slit (Fig. 3). CAUTION:

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

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













voice prosthesis is now prepared for placement.

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

forward which could cause device damage.

Inserting the new prosthesis into the puncture (Anterograde replacement).

Caution: Do not “inject” the prosthesis using the inserter like a syringe.

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



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



4. Check the prosthesis placement by holding the loading tube and inserter together and pulling them back through the puncture



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

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

this in position.

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

safety strap is pointing downwards.







now ready for use.

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

If the procedure has to be repeated more than twice,

Replacement by overshooting

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



can be entirely delivered into the esophageal lumen using the normal insertion procedure.

Procedure: 

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

to the inserter.



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

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

Retrograde replacement

Provox GuideWire



insertion must be performed by a clinician.

14

2.2 Device lifetime



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

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



months of simulated use. Usage beyond this limit is under the sole discretion of the prescriber.

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

indications such as problems with the puncture tract (See also Section 3).

2.3 Prosthesis maintenance

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

Use the Provox Brush and if possible also the Provox Flush to clean the prosthesis from food remnants and mucus. This

helps to increase the device life.

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

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



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

Lubrication

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

typically after sleep or a prolonged time of not speaking. Therefore instruct the patient that after cleaning the voice prosthesis

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



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

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



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

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

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



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

Note: 

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

to be cautious and avoid it.

2.4 Accessories

CAUTION: 

cause patient harm or product malfunction.

Accessories to facilitate insertion of the prosthesis (for clinician’s use)

• 

• 

used to temporarily block or stent the TE puncture.

• 

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

Accessories to maintain the device function (for patient’s use)

• 

• 

• 

2.5 Disposal

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

15

3. Adverse events/Trouble shooting information

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

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

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

Instruct your patient to consult a clinician if any of the following occurs:

• 

• there is leakage during drinking and cleaning the prosthesis does not help,

• 

• 

• there is bleeding or overgrowth of tissue around the device,

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

• the patient has chronic cough, trouble breathing, or blood in the mucus. These can be signs of a serious health condition, for



Prosthesis related

Problem:

device life.

Solution: 

the leakage, replace the voice prosthesis.

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

buttermilk1,2 , a probiotic

Lactobacillus Casei Shirota (Yakult®)2, probiotic bacteria Lactibacillus lactis 53 and Streptococcus

thermophilus

B3,4

casei Shirota45.

Problem: Speaking is sometimes not possible (valve does not open).

Probable cause: The valve lid sticks to the valve seat, preventing the valve from opening. This becomes more likely the

longer the valve has not been in use (e.g. overnight).

Solution: 



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

Probable cause: 

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

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

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

been damaged during the insertion.

Solution:

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

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

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



Handling related

Problem: 

Probable cause: 

Solution:

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



Problem: The prosthesis has been completely inserted into the esophagus (accidental overshooting).

Solution: 

Puncture related

Aspiration of the prosthesis or other components – 

Solution:

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

aspiration may cause obstruction or infection including pneumonia, atelectasis, bronchitis, lung abscess, bronchopulmonary

puncture and asthma.

16

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









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

situ for some time, white or yellow appearing Candida deposits may be visible on the device.

Ingestion of the prosthesis

obstruction (if any).

Solution: 

obstruction, bleeding or perforation occurs, or the object fails to pass through the intestinal tract, surgical removal must

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



device does not pass spontaneously, or if there are signs of obstruction (fever, vomiting, abdominal pain) a gastroenterologist

should be consulted.

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

see section above.

Hemorrhage/Bleeding of the puncture – 

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

evaluated for the risk of hemorrhage prior to placement or replacement of the prosthesis.

Infection and/or edema of the TE-puncture may increase the length of the puncture tract (e.g during radio therapy).

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

of the esophageal mucosa may also cause the prosthesis to protrude from the puncture on the tracheal side.

Solution: Temporarily replace the prosthesis with a longer one. Treatment with antibiotics with or without corticosteroids

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

catheter might be considered.

Granulation around the TE-puncture.

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

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

prosthesis is relatively short.

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

Protrusion and subsequent extrusion

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

puncture has closed.

Leakage around the prosthesis – Transient leakage may occur and can improve spontaneously.

Solution: The most common reason for persistent leakage around the voice prosthesis is that the device is too long. Replace





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

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

Tracheal and/or esophageal tissue damage

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

may happen more easily.

Solution:

puncture by endoscopy to avoid severe damage.

4. Additional information

4.1 Date of printing and user assistance information

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

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.

17

DEUTSCH

Provox® ActiValve® Stimmrehabilitationssystem







Wichtige Informationen für Patienten mit Tracheostoma

Notfallsituationen

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



Tracheostoma erfolgen muss.



www.atosmedical.com/rescuebreathing





Besondere Situationen





atmen und eine Stimmprothese tragen. Es ist wichtig, dass ihnen bewusst ist, dass die Stimmprothese nicht entfernt werden

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



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

verschoben wird oder herausrutscht.

1. Beschreibende Informationen

1.1Gebrauchsanweisung

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

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





1.2KONTRAINDIKATIONEN



• 

• 

handlung.

1.3Beschreibung des Produkts









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







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

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

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





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



Provox ActiValve-Stimmprothesen-Paket

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

18

Artikel für den Arzt (Abb.1a)



 

 

(3) Trachealer Flansch

 

 

(6) Sicherheitsfaden

 

 

 



 

 



Artikel für den Patienten (sollten dem Patienten ausgehändigt werden) (Abb.1b)

• 

• 



• 

• 

• 

• 



Produkts Provox ActiValve-Benutzerkarten



Der Notfallausweis 





1.4WARNHINWEISE











• 

• 

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

•               



•               





1.5VORSICHTSMASSNAHMEN

•                 





• 



•               



• 

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

•              

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

              

beschriebenen Ereignisse auftreten sollte.

19

2. Gebrauchsanweisungen

Vorsicht: Das Produkt nicht verwenden, wenn die Verpackung beschädigt oder geönet ist.

2.1Stimmprothese wechseln

Vorbereitung

Bestimmen Sie die erforderliche Länge der Stimmprothese, indem Sie die aktuelle (alte) Prothese als Vorlage nehmen.



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



Bestimmen Sie die erforderliche Stärke. 









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





Stimmprothese in das Einführinstrument einlegen:



VORSICHT: Befestigen Sie den



verschluckt werden.



             













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

VORSICHT:

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

Die neue Prothese in die Punktion einführen (anterograder Wechsel).

Vorsicht:











              











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







ActiValve Stimmprothese ist nun verwendungsbereit.

Hinweis:

werden, sofern der Sicherheitsfaden nicht abgeschnitten wurde. Wenn das Verfahren mehr als zwei Mal wiederholt werden

muss, geben Sie zusätzlich wasserlösliches Gleitmittel in den Ladetubus.

20

Wechsel durch Overshooting

 



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

Verfahren: 





befestigt.









Retrograder Wechsel

Der Provox GuideWire (Führungsdraht; REF 7215) kann für das anterograde Einführen der Stimmprothese verwendet

werden, wenn die Provox ActiValve nicht anterograd eingesetzt werden kann.



2.2 Nutzungsdauer des Produkts







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











2.3 Pege der Prothese



Speisereste und Schleim sollten mit der Provox BrushProvox Flush entfernt









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



Lubrikation

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

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

Daher muss der Patient darauf hingewiesen werden, dass bei der morgendlichen Reinigung der Stimmprothese das innere











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















Hinweis: 



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

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