PROVOX Vega 17Fr User manual
Vega™
Fr.
mm.
Fr.
mm.
IFU
MD
RT
Figures
2. Tracheo-esophageal speech
1. Provox Vega Voice Prosthesis
f)
d)
b)
e)
c)
a)
a) Prosthesis Hood
b) Prosthesis Shaft
c) Tracheal Flange
d) Radio-opaque fluoroplastic Valve Seat
e) Esophageal Flange
f) Valve Flap
A
A
3
3. Provox Brush
5. Provox Vega Plug
4. Provox Flush
4
Prescription information
CAUTION: United States Federal law restricts this device to sale, distribution and use
by or on order of a physician or a licensed practitioner. The availability of this product
without prescription outside the United States may vary from country to country.
Disclaimer
hereunder as to the lifetime of the product delivered, which may vary with individual
Patents and trademarks
®®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.
5
Manufacturer; Hersteller; Fabrikant; Fabricant; Produttore; Fabricante; Fab
ricante; Tillverkare; Producent; Produsent; Valmistaja; Framleiðandi; Tootja;
Üretici; მწარმოებელი;
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;
6
არ გამოიყენოთ ხელახლა;
Մեկանգամյա օգտագործման համար; Yenidən isfadə 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;
Jangan gunakan jika kemasan rusak; Jangan gunakan jika pakej rosak;
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
7
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
RT
MAX
MIN
შეინახეთ მზისგან დაცულ
ადგილას და მშრალ მდგომარეობაში;
Hindarkan dari sinar matahari dan simpan di tempat yang kering; Jauhkan
dari cahaya matahari dan pastikan sentiasa kering; 直射日光および湿気禁
止; 직사광선이 닿지 않게 하고 건조한 상태로 유지하십시오; 避免日
照並保持乾燥; 避免日照和保持干燥;
8
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;
9
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 תוארוהשומיש תוארוה
10
Contents
EN ENGLISH...............................................11
FR FRANÇAIS.............................................13
ES ESPAÑOL...............................................16
PT PORTUGUÊS........................................19
IS ÍSLENSKA...............................................21
ET EESTI.......................................................24
LT LIETUVIŲ KALBA ...............................26
CS ČESKY ....................................................29
HU MAGYAR ..............................................32
SK SLOVENČINA.......................................34
SL SLOVENŠČINA ....................................37
PL POLSKI...................................................40
RO ROMÂNĂ .............................................43
HR HRVATSKI.............................................45
SR SRPSKI ...................................................48
EL ΕΛΛΗΝΙΚΑ............................................51
TR TÜRKÇE .................................................54
KAქართული................................56
HY ՀԱՅԵՐԵՆ..............................................60
AZ AZƏRBAYCAN DİLİ......................63
RU .............................................66
ID BAHASA INDONESIA........................69
MS BAHASA MELAYU ............................72
JA - 日本語....................................................74
KO - 한국어...................................................78
ZHTW 繁體中文.......................................80
HE ...............................................86
AR .................................................89
11
Stomal airway management
Emergency situations
your stoma and not to your mouth or nose.
breathing from www.atosmedical.com/rescuebreathing
Elective situations
in your windpipe), it is very important that the anesthesiologist and the doctor who
is performing the procedure are aware that you are a neck breather and that you are
may get into your windpipe.
that the voice prosthesis does not dislodge or come out.
1. Glossary
Clinician Medical professional or properly licensed speech and language
therapist / pathologist or clinical specialist nurse who is trained
in voice rehabilitation procedures.
is lost when breathing through a tracheostoma.
pipe) where sound is created by vibration of tissue when using a
voice prosthesis.
Silicone A material often used in medical devices.
and the esophagus (food pipe).
Tracheostoma Breathing opening in the front of the neck, where the windpipe
puncture to allow speech by redirecting air to the esophagus
the trachea (wind pipe).
2. Descriptive information
2.1 Indications for use
ice Prosthesis is a sterile single use indwelling voice prosthesis
Cleaning of the voice prosthesis is performed by the patient while it remains in situ.
2.2 Description of the device
of medical grade silicone and fluoroplastic.
For illustration see Fig. 1.
a) Prosthesis Hood
b) Prosthesis Shaft
c) Tracheal Flange
f) Valve Flap
Provox Vega package
2.3 CONTRAINDICATIONS
prosthesis among patients already using prosthetic voice rehabilitation.
2.4 WARNINGS
Accidental aspir
ation
seek immediate
medical treatment. A foreign body in your airway may cause severe complications such
as acute respiratory distress and/or respiratory arrest, and has to be removed by a clinic
ian.
Accidental swallowing
contact your physician who will advise you further.
which could cause patient harm.
ENGLISH
12
2.5 PRECAUTIONS
Consult your clinician if
• There is leakage through or around the prosthesis (coughing; and/or change of mucus
color)
heat, swelling, traces of blood on the brush after brushing).
To reduce infection risk:
Make sure that your hands are thoroughly clean and dry before using your hands in the
area of your tracheostoma, and before cleaning your voice prosthesis and/or accessories.
Keep all devices clean that may enter or make any contact with your tracheostoma
and voice prosthesis.
To reduce risk of product damage:
the handling and cleaning of your prosthesis.
3. Instructions for use
3.1 Using the Provox Vega to speak
the prosthesis into your esophagus (Fig. 2).
That air stream causes vibration of the tissues in your esophagus, which produces
and speaking. A handsfree device enables speech without the need to close the
3.2 Cleaning the Provox Vega
so that air can pass through it. Regular cleaning of the prosthesis also helps to prolong
device life.
remnants from the prosthesis.
from the prosthesis, which helps increase the life of the device.
Note:
by the clinician to be able to consistently follow the instructions for use without
clinician supervision.
• Some dietary measures, like the daily intake of yogurt or butter milk containing
CAUTION: Only use genuine Provox accessories that are intended for use with
Provox Vega when cleaning your prosthesis. Other devices may cause personal
injury or damage to the voice prosthesis.
3.3 Accessories
The Provox Brush / Provox Brush XL is used by the patient to clean the inside of the
prosthesis (Fig. 3).
The Provox Flush
(Fig. 4).
The Provox Vega Plug
through the prosthesis (Fig. 5).
3.4 Additional devices
Provox HME:
humidifying, breathing resistance).
Provox FreeHands HME:
Provox LaryTube: A silicone tracheal cannula intended to support shrinking stomas
Provox LaryButton:
3.5 Disposal
disposing of a used medical device.
4. Adverse events/ Trouble shooting by symptom
voice rehabilitation and to instruct you what to do in case you may encounter adverse
Symptom: Coughing (triggered by drinking or eating) while the prosthesis is in place.
Most common reasons: Leakage through or around the prosthesis.
Measures:
remnants preventing the valve from proper closure.
13
If leakage continues:
or around the prosthesis.
a new prosthesis.
clinician that you may have leakage around your prosthesis.
Symptom:
Most common reasons: Valve obstruction, tissue swelling in the throat (e.g. during
radiotherapy).
Measures:
Symptoms: Pain, heat, swelling, and rash (together or alone) in the area of the
prosthesis or stoma.
Most common reasons:
Measures: Contact your clinician immediately.
Symptoms: Traces of blood are seen on the Brush after brushing.
Most common reasons:
Measures: Contact your clinician immediately.
5. Additional information
5.1 Compatibility with MRI, X-ray and radiation therapy
The Provox Vega
5.2 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 material
the device will eventually deteriorate.
6. 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.
Gestion des voies respiratoires avec trachéostomie
Situations d’urgence
www.atosmedical.com/rescuebreathing.
Situations non urgentes
1. Glossaire
FRANÇAIS
14
2. Description
2.1 Indications
2.2 Description du dispositif
a) Auvent
b) Fût
f) Clapet de la valve
Kit Provox Vega
2.3 CONTRE-INDICATIONS
2.4 AVERTISSEMENTS
Il y a un risque d’aspiration accidentelle
contactez immédiatement un médecin
soit avalée accidentellement.
2.5 PRÉCAUTIONS
Consultez votre médecin en cas de:
mucus) ;
utilisation).
Pour réduire le risque d’infection:
Pour réduire le risque d’abîmer la prothèse:
3. Mode d’emploi
3.1 Utiliser Provox Vega pour la phonation
15
3.2 Nettoyer la Provox Vega
les restes de nourriture.
Remarque :
AVERTISSEMENT : Utiliser exclusivement des accessoires Provox d’origine
spécialement conçus pour nettoyer la prothèse Provox Vega. Tout autre dispositif
risque de provoquer des lésions ou d’endommager la prothèse.
3.3 Accessoires
La brosse Provox Brush / Provox Brush XL
Provox Flush
Le Provox Vega Plug
3.4 Dispositifs supplémentaires
Provox HME :
respiratoire).
Provox FreeHands HME :
Provox LaryTube :
Provox LaryButton :
3.5 Élimination
4. Eets indésirables / Que faire en cas de
problème, en fonction du symptôme
Symptôme :
est en place.
Causes probables :
Mesures à prendre :
correcte de la valve.
Si le problème n’est pas résolu :
Symptôme :
Causes probables :
Mesures à prendre :
Symptômes :
Causes probables :
Mesures à prendre :
Symptômes :
Causes probables :
Mesures à prendre :
16
5. Informations complémentaires
5.1 Compatibilité avec l’IRM, la radiographie et la
radiothérapie
Provox Vega
5.2 Durée de vie du dispositif
la structure du dispositif.
6. Signalement
Tratamiento de las vías aéreas del estoma
Situaciones de emergencia
para la ayuda respiratoria de salvamento de www.atosmedical.com/rescuebreathing
Situaciones opcionales
1. Glosario
lenguaje adecuadamente titulado o personal de enfermería
2. Información general
2.1 Indicaciones de uso
2.2 Descripción del dispositivo
ESPAÑOL
17
Envase de Provox Vega
• 1 manual del paciente
2.3 CONTRAINDICACIONES
2.4 ADVERTENCIAS
Podría producirse una aspiración accidental
busque asistencia médica de inmediato
Se podría producir la deglución accidental
2.5 PRECAUCIONES
Consulte a su médico en caso de presentarse las siguientes
situaciones:
del moco).
Para reducir los riesgos de infección:
sus accesorios.
Para reducir el riesgo de dañar el producto:
3. Instrucciones de uso
3.1 Utilización de Provox Vega para hablar
cerrando su estoma directamente con un dedo.
3.2 Limpieza de Provox Vega
prolongar la vida útil del dispositivo.
Nota:
PRECAUCIÓN: Para limpiar su prótesis Provox Vega sólo debe utilizar los
accesorios originales Provox indicados para tal efecto. Otros dispositivos pueden
causar lesiones personales o daños en la prótesis de voz.
18
3.3 Accesorios
Provox Brush/Provox Brush XL
Provox Flush
Provox Vega Plug
3.4 Dispositivos adicionales
Provox HME:
Provox FreeHands HME: intercambiador de calor y humedad combinado con una
Provox LaryTube:
Provox LaryButton:
3.5 Eliminación
4. Acontecimientos adversos/solución de
problemas según los síntomas
Síntoma:
Motivos más habituales:
Manejo:
Si la fuga continúa:
Síntoma:
Motivos más habituales:
garganta (p. ej., durante la radioterapia).
Manejo:
Síntomas:
Motivos más habituales:
Manejo:
Síntomas: tras el cepillado se observan restos de sangre en el cepillo.
Motivos más habituales:
Manejo:
5. Información adicional
5.1 Compatibilidad con la RMN, las radiografías y la
radioterapia
Provox Vega
es visible en las radiografías.
5.2 Vida útil del dispositivo
individuales y no es posible predecir la integridad del dispositivo para un periodo de
6. Noticación
resida el usuario y/o el paciente.
19
Cuidados a ter com as vias aéreas do estoma
Situações de emergência
www.atosmedical.com/rescuebreathing
Situações electivas
1. Glossário
devidamente licenciado ou enfermeiro de especialidade clínica
2. Descrição
2.1 Indicação de utilização
2.2 Descrição do dispositivo
Embalagem de Provox Vega
2.3 CONTRA-INDICAÇÕES
2.4 ADVERTÊNCIAS
Poderá ocorrer aspiração acidental
procurar
tratamento médico imediato
Pode ocorrer deglutição acidental
PORTUGUÊS
20
2.5 PRECAUÇÕES
Consulte o seu médico se
muco)
Para reduzir o risco de infecção:
Para reduzir o risco de danos no produto:
3. Instruções de utilização
3.1 Utilização da Provox Vega para falar
simplesmente fechando o seu estoma directamente com o dedo.
com o dedo.
3.2 Limpeza da Provox Vega
a vida útil do dispositivo.
Nota:
de Candida.
ATENÇÃO: Utilize apenas acessórios genuínos Provox destinados a serem
utilizados com a Provox Vega quando limpar a sua prótese. Outros dispositivos
podem provocar ferimentos pessoais ou danos na prótese fonatória.
3.3 Acessórios
A Provox Brush / Provox Brush XL
Provox Flush
Provox Vega Plug
3.4 Dispositivos adicionais
Provox HME:
Provox FreeHands HME: Um Permutador de Calor e Humidade combinado com
Provox LaryTube:
Provox LaryButton:
3.5 Eliminação
4. Eventos adversos/ Resolução de problemas por
sintoma
This manual suits for next models
20
Table of contents
Languages:
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