Atos Medical Provox Vega XtraSeal User manual
Vega
™
XtraSeal
™
Instructions for Use
Clinicians
Voice Prosthesis with Insertion System
f)
g)
c)
d)
b)
e)
a)
Provox©Vega™ XtraSeal™ voice prosthesis
a) Size information (shaft diameter and length between
flanges)
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. 1
2.2 Preparation
Figure. 3
Figure. 4
h)
a) Insertion Pin
b) Folding Tool
c) Loading Tube
d) Attachment Slot
e) Distal grip surface
f) Proximal grip surface
Figure. 2
f)
d)
c)
b)
a)
e)
3
Figure. 5
Figure. 6
2.3 Overshoot Insertion
Figure. 7
Figure. 8
4
Figure. 9
Figure. 10
2.4 Assembly and reloading
Figure. 11
5
Figure. 12
2.5 Finalization
Figure. 14
Figure. 13
6
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
the purchaser hereunder as to the lifetime of the product delivered,
which may vary with individual use and biological conditions.
Patents and Trademarks
®
®
Vega
™
®Vega™XtraSeal™are trademarks of Atos Medical AB. For information
about protective rights (e.g. patents), please refer to the webpage www.atosmedical.
com/patents.
7
Contents
EN - ENGLISH...............................................................8
FR - FRANÇAIS..........................................................11
ES - ESPAÑOL............................................................15
PT - PORTUGUÊS.....................................................18
IS - ÍSLENSKA............................................................22
ET - EESTI.................................................................... 25
LT - LIETUVIŲ K. ......................................................28
CS - ČESKY .................................................................32
HU - MAGYAR ........................................................... 35
SK - SLOVENČINA....................................................38
SL - SLOVENŠČINA ................................................. 42
PL - POLSKI................................................................ 45
RO - ROMÂNĂ ..........................................................49
HR - HRVATSKI.......................................................... 52
SR - SRPSKI ................................................................56
EL - ΕΛΛΗΝΙΚΑ......................................................... 59
TR - TÜRKÇE ..............................................................63
HY...................................................... 66
RU - РУССКИЙ.......................................................... 70
MS - BAHASA MELAYU .........................................74
JA - 日本語................................................................78
KO - 한국어 ............................................................... 81
ZHTW - 繁體中文..................................................84
HE - ............................................................90
AR - ............................................................93
8
ENGLISH
Provox® Vega™ XtraSeal™
1. Descriptive information
1.1 Intended use
Cleaning of the voice prosthesis is performed by the patient while it remains in situ.
carried out by a medical doctor or a trained medical professional in accordance with
local or national guidelines.
The 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
Vega voice prosthesis is not a permanent implant, and needs periodic replacement. The
solve problems with leakage around the voice prosthesis.
System, sterile (Fig. 2)
1.3 CONTRAINDICATIONS
prosthesis among patients already using prosthetic voice rehabilitation.
1.4 WARNINGS
• Dislodgement or extrusion of the Provox Vega voice prosthesis
puncture and subsequent ingestion, aspiration or tissue damage may occur. A foreign
body in 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.
• Always use aseptic technique when handling the prosthesis in order to reduce
infection risk.
2. Instructions for use
2.1 Choose size of the Voice prosthesis
• Selecting shaft diameter
The Clinician should determine the proper diameter of the prosthesis appropriate for
the patient.
9
inserted.
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
used.
Note:
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
ring on the Loading Tube (Fig. 6).
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
(Fig. 7-10)
CAUTION:
means that the whole prosthesis is deployed in the esophagus and then retracted to
the intended position.
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. 7).
2. Enter the TE-puncture
resistance, dilatation and/or lubrication can ease the insertion.
3. Insert the voice prosthesis
is fully deployed in the esophagus, (Fig.9).
prosthesis is fully deployed in the esophagus, (Fig. 9).
4. Release the voice prosthesis
Pull the Loading Tube straight out from the puncture. The prosthesis remains in the
5. Finalize the procedure
2.4 Assembly and reloading the Provox Insertion System
Position voice prosthesis
1.
2. Attach the Safety Strap by leading it through the Attachment Slot from either side.
10
attached and with the tip of the pin positioned all the way into the blue ring of the
place. Pull the pin until the pin is snapped into the Folding Tool. (Fig. 11). The
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.
CAUTION:
alongside the shaft of the voice prosthesis and when rotated the voice prosthesis
should move freely. Rotating the voice prosthesis while at the same time slightly
the esophagus.
Test proper function
by asking the patient to speak and by observing that the prosthesis does not leak
Cut the Safety Strap
ready for use.
2.6 Disposal
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.
• Speech Training Sessions with a trained clinician are advised in order to acquire
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.
mucus and food remnants from the prosthesis.
from the prosthesis, 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
11
4.2 Device lifetime
not possible to predict the integrity of the device over a longer period of time. The
integrity of the device will eventually deteriorate.
4.3 Compatibility with antifungal medicine
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.
FRANÇAIS
Provox® Vega™ XtraSeal™
1. Description générale
1.1 Utilisation prévue
formé en conformité avec les directives locales ou nationales.
Le système d’insertion Provox Insertion System n’est pas conçu pour être utilisé pour
l’insertion d’une prothèse phonatoire dans une ponction réalisée récemment.
1.2 Description du dispositif
Généralités
et plusieurs longueurs.
1.3 CONTRE-INDICATIONS
vocale prothétique.
1.4 AVERTISSEMENTS
• Le déplacement ou l’extrusion de la prothèse phonatoire Provox Vega de la
lésions tissulaires, peuvent survenir. Un corps étranger dans les voies aériennes peut
arrêt respiratoire.
12
• Choisissez la bonne taille de prothèse.
• Indiquez au patient de consulter immédiatement un médecin en cas de signes
• Recommandez au patient de consulter un médecin
ou autour de la prothèse phonatoire. Une fuite pourrait entraîner une pneumonie
• En cas d’utilisation de canules de laryngectomie ou de boutons de trachéostomie,
insertion et leur retrait. Cela pourrait entraîner des lésions tissulaires graves et/ou la
prothèse pourrait être avalée accidentellement.
• Recommandez au patient d’utiliser uniquement les accessoires Provox
tout autre type de manipulation.
• La réutilisation et le retraitement peuvent provoquer une contamination croisée ou
1.5 PRÉCAUTIONS
place ou le remplacement de la prothèse.
2. Mode d’emploi
2.1 Sélection de la taille de la prothèse phonatoire
combinaisons de longueurs/diamètres.
• Sélection du diamètre de fût
Le praticien doit déterminer le diamètre de prothèse adapté au patient.
Si le diamètre sélectionné est plus grand que la précédente prothèse, la ponction doit être
ponction rétrécit au diamètre approprié.
• Sélection de la longueur de fût
comme instrument de mesure.
être employée.
employée.
Remarque :
2.2 Préparation
(Fig. 3-6)
Positionnement de la prothèse phonatoire
Déploiement de la collerette œsophagienne
de déploiement (la tige doit être encliquetée dans le dispositif de déploiement).
Chargement
Retrait de l’ancienne prothèse phonatoire
passer dans les voies intestinales. Les antécédents de maladies intestinales du
Préparation de la ponction (facultatif)
13
2.3 Insertion, procédure de remplacement antérograde
(Fig. 7-10)
MISE EN GARDE :
doit être mise en place par dépassement pour garantir le déploiement de la collerette
1. Retrait du dispositif de déploiement (facultatif)
déploiement en le déverrouillant et en le détachant du tube de chargement (Fig. 7).
2. Insertion dans la ponction trachéo-œsophagienne
3. Insertion de la prothèse phonatoire
4. Libération de la prothèse phonatoire
pivoter la prothèse phonatoire en place.
5. Finalisation de la procédure
section 2.5.
2.4 Assemblage et rechargement du système d’insertion
Provox Insertion System
Positionnement de la prothèse phonatoire
déploiement.
MISE EN GARDE :
2.5 Finalisation de la procédure
Après l’insertion :
dans une position idéale lorsque la tige de sécurité pointe vers le bas.
MISE EN GARDE :
Test du fonctionnement
que la prothèse fonctionne correctement en demandant au patient de parler et
Sectionnement de la tige de sécurité
2.6 Élimination
14
3. Informations importantes pour le patient
3.1 Généralités
Assurez-vous que le patient comprend qu’il doit contacter son praticien :
couleur du mucus) ;
sur la brosse après le nettoyage).
Informez également le patient que :
3.2 Entretien de la prothèse
la durée de vie de la prothèse.
MISE EN GARDE : utilisez uniquement des accessoires Provox d’origine, prévus
pour être utilisés avec la prothèse Provox Vega lors de son nettoyage.
permet de retirer le mucus et les restes de nourriture de la prothèse.
Remarque :
• Certaines mesures diététiques, telles que la prise de yaourt ou de babeurre
4. Informations supplémentaires
4.1 Compatibilité avec un examenIRM, la radiographie et la
radiothérapie
4.2 Durée de vie du dispositif
4.3 Compatibilité avec des médications antifongiques
5. Signalement
Noter que tout incident grave survenu en relation avec le dispositif doit être
et/ou le patient résident.
15
ESPAÑOL
Provox® Vega™ XtraSeal™
1. Información descriptiva
1.1 Uso previsto
esta permanece colocada.
sustitución lo lleva a cabo un médico o profesional médico capacitado, de acuerdo
a las normas nacionales o locales.
El Provox Insertion System no está indicado para utilizarse en la inserción de una
prótesis de voz en una punción reciente.
1.2 Descripción del dispositivo
General
1.3 CONTRAINDICACIONES
1.4 ADVERTENCIAS
• Puede producirse un desplazamiento o extrusión de la prótesis de voz Provox
Vega
• Seleccione el tamaño de prótesis adecuado.
• Indique al paciente que consulte a su médico
• Solicite al paciente que consulte con un médico si se produce una fuga a través
aspiración.
• Si se utilizan, seleccione tubos de laringectomía o botones de estoma con una
traqueal durante la inserción o retirada del tubo de laringectomía o el botón de
prótesis.
• Indique al paciente que utilice únicamente accesorios Provox originales del
cualquier otro tipo de manipulación.
• La reutilización y el reprocesamiento
deterioro del dispositivo, lo que podría provocar lesiones al paciente.
1.5 PRECAUCIONES
en tratamiento anticoagulante para ver el riesgo de hemorragia antes de la colocación
o sustitución de la prótesis.
el producto.
• Utilice siempre una técnica aséptica a la hora de manipular la prótesis para reducir el
riesgo de infección.
16
2. Instrucciones de uso
2.1 Seleccionar el tamaño de la prótesis de voz
paciente.
a insertar.
dispositivo de medición.
corta.
Nota:
2.2 Preparación
(Fig. 3-6)
Colocación de la prótesis de voz
Doblar la pestaña esofágica
Cargar
5. Presione la espiga de inserción hacia adelante hasta que se alinee la prótesis de
Retirar la prótesis de voz antigua
Preparar la punción (opcional)
normalmente no es necesario, pero puede facilitar la inserción en pacientes con
2.3 Procedimiento de inserción y sustitución anterógrada
(Fig. 7-10)
AVISO:
mediante la técnica de inserción de la totalidad de la prótesis en el esófago sobrepasando
en el esófago y, a continuación, se repliega a la posición prevista.
1. Retirar la herramienta de plegado (opcional)
2. Introducir la punción traqueoesofágica (TE)
con la punta del tubo de carga. Proceda con cuidado si encuentra resistencia. Si
3. Insertar la prótesis de voz
la fístula (inserción con rebasamiento) con la herramienta de plegado montada,
17
4. Liberar la prótesis de voz
Tire del tubo de carga directamente desde la punción. La prótesis permanece en
5. Finalizar el procedimiento
en la sección 2.5.
2.4 Montaje y recarga del Provox Insertion System
Colocación de la prótesis de voz
superior de la espiga de inserción.
cualquier lado.
de plegado.
sección 2.2.
AVISO:
2.5 Finalizar el procedimiento
Después de la inserción:
AVISO:
esófago.
Probar el correcto funcionamiento
funcionamiento de la prótesis solicitando al paciente que hable y observando
Cortar la banda de seguridad
2.6 Eliminación
los requisitos nacionales sobre peligros biológicos.
3. Información importante del paciente
3.1 Información general
Asegurarse de que el paciente entiende que debe ponerse en contacto con su
médico si:
mucosidad).
cepillarse).
Además, informar al paciente de que:
3.2 Mantenimiento de la prótesis
Vega XtraSeal. Limpiar la prótesis al menos dos veces al día puede prolongar la
18
AVISO: Utilice únicamente accesorios Provox originales indicados para su uso
con Provox Vega a la hora de limpiar la prótesis.
eliminar la mucosidad y los restos de comida de la prótesis.
dispositivo.
Nota:
pacientes que, evaluados por el médico que les prescribe el dispositivo, han
demostrado la capacidad para comprender y seguir de forma continuada las
instrucciones de uso sin la supervisión del médico.
• Algunas medidas dietéticas, como la ingesta diaria de yogur, mantequilla o leche
hongos.
consulte las instrucciones de cada accesorio.
4. Información adicional
4.1 Compatibilidad con IRM, rayos X y radioterapia
4.2 Vida útil del dispositivo
4.3 Compatibilidad con medicina antifúngica
5. Noticación
Tenga en cuenta que cualquier incidente grave que se haya producido en relación
el que resida el usuario y/o el paciente.
PORTUGUÊS
Provox® Vega™ XtraSeal™
1. Informação descritiva
1.1 Utilização prevista
colocada.
O Provox Insertion System não se destina a ser utilizado para a inserção de uma
prótese fonatória numa punção recente.
1.2 Descrição do dispositivo
Disposições gerais
19
1.3 CONTRAINDICAÇÕES
1.4 ADVERTÊNCIAS
• da
• Selecione o tamanho correto da prótese.
• Instrua o paciente para consultar imediatamente um médico se surgirem sinais
• Instrua o paciente para consultar um médico caso ocorram fugas através ou
• Se utilizados, escolha tubos de laringectomia ou botões de estoma com um
da prótese.
• Instrua o paciente para utilizar apenas acessórios Provox genuínos de tamanho
•
1.5 PRECAUÇÕES
• Avalie cuidadosamente quaisquer pacientes com coagulopatias ou submetidos
a tratamento anticoagulante quanto ao risco de sangramento ou hemorragia, antes da
2. Instruções de utilização
2.1 Seleção do tamanho da prótese fonatória
• Selecionar o diâmetro da haste
paciente.
Se estiver a ser inserida uma prótese com um diâmetro de haste menor, observe
• Selecionar o comprimento da haste
curta.
comprida.
Nota:
2.2 Preparação
(Figura 3-6)
Posicione a prótese fonatória
20
Carregue
Retire a prótese fonatória antiga
paciente relativamente a quaisquer patologias intestinais.
2.3 Inserção, procedimento de substituição anterógrada
(Figura 7-10)
ATENÇÃO:
1. Retire a ferramenta de dobragem (opcional)
2.
3. Insira a prótese fonatória
4. Liberte a prótese fonatória
5. Finalize o procedimento
2.4 Montagem e recarregamento do Provox Insertion System
Posicione a prótese fonatória
um dos lados.
ATENÇÃO:
2.5 Finalização do procedimento
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