Atos Medical Provox Vega XtraSeal User manual
Vega
™
XtraSeal
™
IFU
MD
RT
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
2.3.1 Method 1 System Insertion
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 our web page
www.atosmedical.com/patents.
7
Manufacturer; Hersteller; Fabrikant; Fabricant; Produttore; Fabricante; Fab
ricante; Tillverkare; Producent; Produsent; Valmistaja; Framleiðandi; Toot
Üretici; მწარმოებელი;
Produsen; Pengilang; 製造業者; 제조사; 製造商; 制造商;
ןרציה;ןרציה;
Date of manufacture; Herstellungsdatum; Productiedatum; Date de
Tillverkningsdatum; Fremstillingsdato; Produksjonsdato;Valmistuspäi
Üretim tarihi; წარმოების თარიღი;
製造日;
제조일자; 製造日期; 制造日期; רוציי ךיראת;רוציי ךיראת;
senast: Anvendes inden; Brukes innen; Viimeinen käyttöpäivä; Síðasti
ვარგისია;
sebelum tanggal; Tarikh guna sebelum; 使用期限; 사용 기한; 使用截止日
期; 使用截止日期; שומישל ןורחא ךיראת;שומישל ןורחא ךיראת;
სერიის კოდი;
pok; バッチコード; 배치 코드; 批次代碼; 批号; הווצא דוק;הווצא דוק;
mer; Produktreferencenummer; Produktreferansenummer; Artikkelinumero;
Tilvísunarnúmer vöru; Toote viitenumber; Produkta atsauces numurs;
პროდუქტის
საკონტროლო ნომერი;
製品参照番号; 제품 참조 번호; 產品參
考號; 产品参考编号; רצומה לש ןיכומיס רפסמ;רצומה לש ןיכומיס רפסמ;
8
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;
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
9
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;
dan pastikan sentiasa kering; 直射日光および湿気禁止; 직사광선이 닿
지 않게 하고 건조한 상태로 유지하십시오; 避免日照並保持乾燥;
避免日照和保持干燥。;
10
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;
11
გამოყენების ინსტრუქცია;
Arahan penggunaan; 取扱説明書; 사용 지침; 使用說明; 使用说明书;
cinteknisk produkt; Medicinsk udstyr; Medisinsk utstyr; Lääkinnällinen
სამედიცინო მოწყობილობა;
Medis; Peranti Perubatan; 医療機器; 의료 장치; 醫療裝置; 医疗器械;
יאופר ןקתה;יאופר ןקתה;
MD
IFU
visning avsedd för läkaren; Brugsanvisning tiltænkt kliniker; Bruksanvisning
გამოყენების ინსტრუქციები ექიმისთვის;
Petunjuk penggunaan khusus untuk tenaga medis; Arahan penggunaan untuk
klinisian; 医師用の取扱説明書; 의사 사용 지침; 臨床醫生專用使用說明;
适用于临床医生的使用说明书; אפורל שומיש תוארוהאפורל שומיש תוארוה
IFU
avsedd för patienten; Brugsanvisning tiltænkt patient; Bruksanvisning
გამოყენების
ინსტრუქციები პაციენტისთვის;
tunjuk penggunaan khusus untuk pasien; Arahan penggunaan untuk pesakit;
患者用の取扱説明書; 환자 사용 지침; 患者專用使用說明; 适用于患者
的使用说明书; לפוטמל שומיש תוארוה;לפוטמל שומיש תוארוה;
IFU
שומיש תוארוה;שומיש תוארוה;
12
Contents
EN - ENGLISH............................................................13
DE - DEUTSCH.......................................................... 16
NL - NEDERLANDS..................................................20
FR - FRANÇAIS..........................................................24
IT - ITALIANO ............................................................ 27
ES - ESPAÑOL............................................................ 31
PT - PORTUGUÊS.....................................................35
SV - SVENSKA ........................................................... 38
DA - DANSK...............................................................42
NO - NORSK...............................................................45
FI - SUOMI..................................................................49
CS - ČESKY ................................................................. 52
HU - MAGYAR ........................................................... 55
PL - POLSKI................................................................59
HR - HRVATSKI..........................................................63
TR - TÜRKÇE ..............................................................66
RU - РУССКИЙ.......................................................... 69
JA - 日本語................................................................. 73
KO - 한국어 ................................................................ 77
ZHTW - 繁體中文.................................................. 80
HE - ............................................................87
AR - ............................................................90
13
ENGLISH
Provox® Vega™ XtraSeal™
1. Descriptive information
1.1 Intended use
of the voice prosthesis is performed by the patient while it remains in situ.
out by a medical doctor or a trained medical professional in accordance with local or
national guidelines.
Provox Insertion System is not intended to be used for insertion of a voice prosthesis
in a freshly made puncture.
1.2 Description of the device
General
prosthesis is not a permanent implant, and needs periodic replacement. The prosthesis
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 Provox Vega voice prosthesis
the airway may cause severe complications such as acute respiratory distress and/or
respiratory arrest.
• Select the proper prosthesis size.
• Instruct the patient to consult a physician immediately if there are any signs of
• Instruct the patient to consult a physician if leakage through or around the voice
prosthesis occurs. Leakage may cause aspiration pneumonia.
• If used, choose laryngectomy tubes or stoma buttons with a suitable shape that do
during insertion and removal of the laryngectomy tube or stoma button. This may
lead to severe tissue damage and/or accidental ingestion of the prosthesis.
• Instruct the patient to use only genuine Provox accessories
(Brush, Flush, Plug) for maintenance and to avoid all other kinds of manipulation.
• Re-use and re-processing
device, which could cause patient harm.
1.5 PRECAUTIONS
• Carefully assess any patient with bleeding disorders or who is undergoing
anticoagulant treatment for the risk of bleeding or hemorrhage prior to placement or
replacement of the prosthesis.
product.
infection risk.
14
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.
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
15
2.4 Assembly and reloading Provox Insertion System
Position voice prosthesis
Pin.
2. Attach the Safety Strap by leading it through the Attachment Slot from either side.
attached and with the tip of the pin positioned all the way into the blue ring of the
in place. Pull the pin until the pin is snapped into the Folding Tool. (Fig. 11).
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
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.
3.2 Prosthesis maintenance
Cleaning the prosthesis at least twice a day can help prolong the device life.
CAUTION: Only use genuine Provox accessories that are intended for use with
Provox Vega when cleaning the prosthesis.
and food remnants from the prosthesis.
the prosthesis, 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.
16
4. Additional information
4.1 Compatibility with MRI, X-ray and radiation therapy
4.2 Device lifetime
Depending on individual biological circumstances the device life varies, and it is
not possible to predict the integrity of the device over a longer period of time. The
integrity of the device will eventually deteriorate.
4.3 Compatibility with antifungal medicine
voice prosthesis and components when using the following antifungal medications:
4.4 User assistance information
for contact 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.
DEUTSCH
Provox® Vega™ XtraSeal™
1. Beschreibung
1.1Verwendungszweck
in Übereinstimmung mit lokalen oder nationalen Richtlinien.
Das Provox Insertion System ist nicht dafür vorgesehen, eine Stimmprothese in eine
neu angelegte tracheo-ösophageale Fistel einzusetzen.
1.2Produktbeschreibung
Allgemeines
Dauerimplantat und muss regelmäßig gewechselt werden. Die Prothese (Abb. 1) ist in
verschiedenen Durchmessern und Längen erhältlich.
Flansch, der etwaige Probleme mit Undichtigkeiten rund um die Stimmprothese lösen soll.
1.3KONTRAINDIKATIONEN
Stimmprothese bei Patienten, die bereits eine Stimmprothese tragen, bekannt.
17
1.4WARNHINWEISE
Provox Vega Stimmprothese verrutscht
oder aus der tracheo-ösophagealen Punktion herausgedrückt und in der
• Wählen Sie die richtige Prothesengröße aus.
• Weisen Sie den Patienten an, sofort einen Arzt zu konsultieren, wenn er
• Weisen Sie den Patienten an, sofort einen Arzt zu konsultieren, wenn Leckagen
• Sofern verwendet, sind Laryngektomiekanülen oder Tracheostoma-Buttons
Verschlucken der Prothese die Folge sein.
• Weisen Sie den Patienten darauf hin, ausschließlich Original-Provox-Zubehör
• Wiederverwendung und Wiederaufbereitung
Folgen haben könnte.
1.5VORSICHTSMASSNAHMEN
Austauschen der Prothese sorgfältig beurteilt werden.
• Achten Sie beim Umgang mit der Prothese auf ein aseptisches Vorgehen, um das
2. Gebrauchsanweisung
2.1 Auswahl der richtigen Stimmprothesengröße
Kombinationen aus Länge und Durchmesser erhältlich.
• Auswahl des Schaftdurchmessers
Prothese ermitteln.
Durchmesser einschrumpft.
• Auswahl der Schaftlänge
verwendet werden.
Prothese verwendet werden.
Hinweis:
2.2 Vorbereitung
(Abb. 3–6)
Stimmprothese platzieren
Ösophagealen Flansch falten
muss im Faltinstrument eingerastet sein).
und drehen Sie den Ladetubus so lange, bis er in seiner Position einrastet (Abb. 5).
Laden
Ring am Ladetubus ausgerichtet ist (Abb. 6).
18
Alte Stimmprothese entfernen
gefasst und abgeschnitten werden. Der Rest der Prothese kann anschließend in den
Ösophagus geschoben werden, sodass er durch den Darmtrakt transportiert und
Punktion vorbereiten (optional)
vereinfachen.
2.3 Einsetzen – anterograder Prothesenwechsel
(Abb. 7–10)
VORSICHT:
1. Faltinstrument entfernen (optional)
Faltinstrument, indem Sie es entsichern und vom Ladetubus trennen (Abb. 7).
2. Sondieren der tracheo-ösophagealen Punktion
3. Stimmprothese einsetzen
Halten Sie den Ladetubus mit einer Hand stabil in Position und schieben Sie
Stimmprothese wird nun vollständig im Ösophagus entfaltet (Abb. 9).
Die Stimmprothese wird nun vollständig im Ösophagus entfaltet (Abb. 9).
4. Stimmprothese lösen
Stimmprothese in die korrekte Position.
5.
2.4 Zusammenbau und erneutes Laden des ProvoxInsertion
System
System geladen werden.
Stimmprothese platzieren
2. Bringen Sie den Sicherheitsfaden an, indem Sie ihn von beiden Seiten durch den
Vorbereitung wie in Abschnitt 2.2 beschrieben fort.
VORSICHT:
2.5 Abschluss des Eingries
Nach dem Einsetzen:
Auf korrekten Sitz kontrollieren
1. Kontrollieren Sie die korrekte Position der Stimmprothese, indem Sie sachte
VORSICHT: Vergewissern Sie sich, dass beide ösophagealen Flansche sich
Stimmprothese darf kein Teil des vergrößerten ösophagealen Flansches sichtbar
in Richtung Ösophagus geschoben wird, kann dabei helfen, den vergrößerten
19
Ordnungsgemäße Funktionsweise prüfen
ein und wieder heraus. Die ordnungsgemäße Funktionsweise der Prothese kann
Sicherheitsfaden abschneiden
2.6 Entsorgung
3. Wichtige Patienteninformationen
3.1 Allgemeine Informationen
Stellen Sie sicher, dass der Patient weiß, dass er sich in den folgenden Fällen an
seinen Arzt wenden muss:
Stimme).
Informieren Sie den Patienten ferner über die folgenden Punkte:
stammen.
3.2 Pege der Prothese
VORSICHT: Verwenden Sie bei der Reinigung der Prothese ausschließlich
originales Provox-Zubehör, das für die Verwendung mit Provox Vega vorgesehen ist.
Hinweis:
4. Zusätzliche Informationen
4.1 Die Vereinbarkeit des Produktes mit MRT- und
Röntgenuntersuchungen sowie Strahlentherapien
4.2 Nutzungsdauer des Produkts
lassen.
20
4.3 Vereinbarkeit mit Antimykotika
4.4Anwenderunterstützung
5. Meldung
mit dem Produkt ereignet haben, dem Hersteller sowie den nationalen Behörden des
NEDERLANDS
Provox® Vega™ XtraSeal™
1. Algemene informatie
1.1 Indicaties voor gebruik
eenmalig gebruik bedoeld voor stemrevalidatie na chirurgische verwijdering van de
wordt uitgevoerd door een arts of specialist verpleegkundige.
Het Provox Insertion System is niet bedoeld voor gebruik voor het inbrengen van een
stemprothese in een zojuist uitgevoerde punctie.
1.2 Productbeschrijving
Algemeen
punctie openhoudt voor spraak en tegelijk de kans verkleint dat vloeistof of voedsel
dient periodiek te worden vervangen. De prothese (afbeelding 1) is verkrijgbaar in
verschillende diameters en diverse lengtes.
problemen met lekkage rondom de stemprothese verholpen.
voor eenmalig gebruik, steriel (afbeelding 2)
1.3 CONTRA-INDICATIES
met een prothese.
1.4 WAARSCHUWINGEN
• De Provox Vega stemprothese kan losraken of uit de tracheo-oesofageale punctie
worden gedreven,
ademhalingsproblemen en/of ademstilstand.
• Selecteer de juiste maat voor de prothese.
• De patient moet onmiddelijk een arts raadplegen bij tekenen van weefseloedeem
en/of ontsteking/infectie.
• Instrueer de patiënt om een arts te raadplegen als sprake is van lekkage door of
• Kies, indien deze worden gebruikt, laryngectomiecanules of stomabuttons
met een geschikte vorm die geen druk uitoefenen op de prothese en tijdens het
inbrengen en verwijderen van de laryngectomie canule of stomabutton niet achter de
onbedoelde ingestie van de prothese.
Other manuals for Provox Vega XtraSeal
2
Table of contents
Languages:
Other Atos Medical Medical Equipment manuals
Atos Medical
Atos Medical Provox FreeHands FlexiVoice User manual
Atos Medical
Atos Medical PROVOX NiD User manual
Atos Medical
Atos Medical PROVOX Vega User manual
Atos Medical
Atos Medical Provox Dilator 17 User manual
Atos Medical
Atos Medical PROVOX HME Cap User manual
Atos Medical
Atos Medical PROVOX ActiValve User manual
Atos Medical
Atos Medical Provox Vega XtraSeal User manual
Atos Medical
Atos Medical THERABITE ActiveBand User manual
Atos Medical
Atos Medical PROVOX Measure User manual
Atos Medical
Atos Medical PROVOX Micron HME User manual
Atos Medical
Atos Medical PROVOX Brush Assembly instructions
Atos Medical
Atos Medical PROVOX Vega User manual
Atos Medical
Atos Medical PROVOX FreeHands HME Series User manual
Atos Medical
Atos Medical Provox Vega XtraSeal User manual
Atos Medical
Atos Medical PROVOX Liberty Electrolarynx User manual
Atos Medical
Atos Medical TheraBite User manual
Atos Medical
Atos Medical TheraBite JAW MOTION REHABILITATION SYSTEM User manual
Atos Medical
Atos Medical ProTrach DualCare User manual
Atos Medical
Atos Medical PROVOX Vega User manual
Atos Medical
Atos Medical PROVOX Vega User manual
