Atos Medical PROVOX Vega User manual

Voice Prosthesis
Patient’s Manual
Region 1
Unregistered copy

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 uoroplastic Valve Seat
e) Esophageal Flange
f) Valve Flap
A
A
Unregistered copy

3. Provox Brush
5. Provox Vega Plug
4. Provox Flush
Unregistered copy

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
Atos Medical offers no warranty - neither expressed nor implied - to the purchaser
hereunder as to the lifetime of the product delivered, which may vary with individual use
and biological conditions. Furthermore, Atos Medical offers no warranty of merchantability
or tness of the product for any particular purpose.
Patents and trademarks
Provox
®
is a registered trademark owned by Atos Medical AB, Sweden. Provox
®
Vega™
is protected by US patent no 8.332.999 as well as other patents, patents pending and
design patents pending.
Unregistered copy

Contents
ENGLISH.....................................................................................6
DEUTSCH ...................................................................................9
NEDERLANDS........................................................................ 12
FRANÇAIS ............................................................................... 15
ITALIANO................................................................................. 18
ESPAÑOL................................................................................. 21
PORTUGUÊS........................................................................... 24
SVENSKA ................................................................................. 27
ORDERING INFORMATION............................................... 31
Unregistered copy

6
The Instructions for Use, which accompanies this product, may be revised from time
to time and must therefore be reviewed prior to each procedure in which the product
is used.
Contents
1. Glossary ..................................................................................................................................................6
2. Descriptive information.....................................................................................................................6
2.1 Indications for use.........................................................................................................................6
2.2 Description of the device ...........................................................................................................6
2.3 CONTRAINDICATIONS..................................................................................................................7
2.4 WARNINGS .......................................................................................................................................7
2.5 PRECAUTIONS.................................................................................................................................7
3. Instructions for use..............................................................................................................................7
3.1 Using the Provox Vega to speak...............................................................................................7
3.2 Cleaning the Provox Vega ..........................................................................................................7
3.3 Accessories.......................................................................................................................................7
3.4 Additional devices.........................................................................................................................8
4. Adverse events/ Trouble shooting by symptom ......................................................................8
5. Additional information......................................................................................................................8
5.1 Compatibility with MRI, X-ray and radiation therapy.......................................................8
5.2 Device lifetime................................................................................................................................8
5.3 User assistance information .....................................................................................................8
Stomal airway management
Emergency situations
It is important that emergency personnel knows that you are a neck breather. This will
help them determining that oxygen and rescue breathing need to be administered to your
stoma and not to your mouth or nose.
We recommend that you and your clinician download the guidelines for rescue breathing
from www.atosmedical.com/rescuebreathing
Elective situations
If you need to undergo a procedure that requires intubation (putting a breathing tube
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 using
a voice prosthesis. It is important for them to understand that the voice prosthesis should
stay in place. If it is removed, uids from your mouth, food pipe, or stomach may get
into your windpipe.
It is very important that the intubation tube is inserted and removed carefully so 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.
HME Heat and Moisture Exchanger (Articial Nose). Device that
retains the heat and moisture in the exhaled air, which otherwise is
lost when breathing through a tracheostoma.
PE-Segment Pharyngo-esophageal segment. The part of the esophagus (food
pipe)wheresoundiscreatedbyvibrationoftissuewhenusinga
voice prosthesis.
Silicone A material often used in medical devices.
TE-puncture Smallarticialopeningcreatedbetweenthetrachea(windpipe)
andtheesophagus(foodpipe).
Tracheostoma Breathing opening in the front of the neck, where the windpipe is
connectedtotheskin(alsocalled‘stoma’).
Voiceprosthesis Aone-wayvalvewithretainingangesinsertedintoaTE-puncture
toallowspeechbyredirectingairtotheesophagus(food pipe)
while reducing the risk of food and liquids entering the trachea
(windpipe).
2. Descriptive information
2.1 Indications for use
The Provox Vega Voice Prosthesis is a sterile single use indwelling voice prosthesis
intendedforvoicerehabilitationaftersurgicalremovalofthelarynx(laryngectomy).
Cleaning of the voice prosthesis is performed by the patient while it remains in situ.
2.2 Description of the device
Provox Vega is a single-use medical device with a one-way valve that keeps a TE-puncture
open for speech, and reduces the risk of liquid and food entering the trachea. It is made
ofmedicalgradesiliconeanduoroplastic.
ENGLISH
Unregistered copy

7
For illustration see Fig. 1.
a)ProsthesisHood
b)ProsthesisShaft
c)TrachealFlange
d)Radio-opaqueuoroplasticValveSeat
e)EsophagealFlange
f)ValveFlap
Provox Vega package
The Provox Vega package contains the following user accessories:
• 1ProvoxBrushofasizecorrespondingtothevoiceprosthesis,non-sterile
• 1ProvoxBrushInstructionsforUse
• 1ProvoxVegaPatient’smanual
2.3 CONTRAINDICATIONS
There are no known contraindications for use or replacement of the Provox Vega voice
prosthesis among patients already using prosthetic voice rehabilitation.
2.4 WARNINGS
Accidental aspiration (entering the windpipe) of the Provox Vega voice prosthesis or other
components of the Provox voice rehabilitation system may occur. Immediate symptoms
may include gagging, coughing, choking or wheezing. If this occurs 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 clinician.
Accidental swallowing of the Provox Vega voice prosthesis may occur. If this occurs,
contact your physician who will advise you further.
Re-use and re-processing may cause cross-contamination and damage to the device,
which could cause patient harm.
2.5 PRECAUTIONS
Consult your clinician if
• Thereisleakagethroughoraroundtheprosthesis(coughing;and/orchangeofmucus
color)
• Speakingbecomesdifcult(highereffortand/orvoicesoundsmorestrained)
• Thereareanysignsofinammationortissuechangesatthepunctureregion(pain,
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:
Only use genuine Provox accessories that are intended for use with Provox Vega for the
handling and cleaning of your prosthesis.
3. Instructions for use
3.1 Using the Provox Vega to speak
When you close off your tracheostoma, you can direct the air from your lungs through
theprosthesisintoyouresophagus(Fig.2).
That air stream causes vibration of the tissues in your esophagus, which produces
the sound of your voice. You can speak by using a Heat and Moisture Exchanger like the
Provox HME, using a handsfree speaking device like Provox Freehands HME or simply
byclosingyourstomadirectlywithanger.
An HME may improve pulmonary function and also facilitates stoma occlusion and
speaking. A handsfree device enables speech without the need to close the tracheostoma
by a nger.
3.2 Cleaning the Provox Vega
In order for you to speak with your voice prosthesis, the prosthesis needs to be clean so that
air can pass through it. Regular cleaning of the prosthesis also helps to prolong device life.
• BrushingtheprostheseswiththeProvoxBrushtwiceadayremovesmucusandfood
remnants from the prosthesis.
• FlushingtheprosthesiswiththeProvoxFlushalsohelpstocleandebrisandmucus
from the prosthesis, which helps increase the life of the device.
Note: The Provox Flush is intended for use only by patients who have been assessed 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
lactobacilli, are considered to be helpful against excessive Candida growth.
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 is an additional cleaning device that allows ushing of the prosthesis (Fig.4).
The Provox Vega Plug is a First Aid tool for patient’s use that temporarily blocks leakage
through the prosthesis (Fig.5).
Unregistered copy

8
3.4 Additional devices
Provox HME: Heat- and Moisture Exchanger partially restores lost nasal functions (heating,
humidifying, breathing resistance).
Provox FreeHands HME: A Heat and Moisture Exchanger combined with an automatic
tracheostoma valve, designed to allow hands-free speech.
Provox LaryTube: A silicone tracheal cannula intended to support shrinking stomas
while retaining other rehabilitation devices of the Provox System.
Provox LaryButton: A soft, self-retaining silicone tracheal cannula intended to support
shrinking stomas while retaining other rehabilitation devices of the Provox System.
4. Adverse events/ Trouble shooting by symptom
Itistheresponsibilityofyourcliniciantoinformyouaboutrisksandbenetsofprosthetic
voice rehabilitation and to instruct you what to do in case you may encounter adverse
events. If you are not sure that you have completely understood all instructions, ask your
clinician for further explanation.
Symptom: Coughing (triggered by drinking or eating) while the prosthesis is in place.
Most common reasons: Leakage through or around the prosthesis.
Measures:
1. Clean the prosthesis with the Provox Brush and/or Flush. There may be food remnants
preventing the valve from proper closure.
If leakage continues:
2. Observe the prosthesis while drinking. Try to identify if it leaks through the center
or around the prosthesis.
 a.)IfyouthinkitleaksthroughthecenteryoucanusetheProvoxVegaPlugwhile
youareeatinganddrinkingtopreventleakage.Notifyyourclinicianthatyouneed
a new prosthesis.
 b.)Ifyouthinkitleaksaround,orifthePlugdoesnotstoptheleakage.Notifyyour
clinician that you may have leakage around your prosthesis.
Symptom: Speakingbecomesmoreandmoredifcult.
Most common reasons: Valve obstruction, tissue swelling in the throat (e.g. during
radiotherapy).
Measures:
1. Clean the prosthesis with the Provox Brush and/or Flush. There may be food remnants
increasingtheairowresistance.
2. If that does not help: Contact your clinician immediately.
Symptoms: Pain,heat,swelling,andrash(togetheroralone)intheareaoftheprosthesis
or stoma.
Most common reasons: Tissue inammation and infections.
Measures: Contact your clinician immediately.
Symptoms: Traces of blood are seen on the Brush after brushing.
Most common reasons: Tissue inammation and infections at the esophageal side.
Measures: Contact your clinician immediately.
5. Additional information
5.1 Compatibility with MRI, X-ray and radiation therapy
The Provox VegavoiceprosthesiscanbeleftintheTE-punctureduringtheMRI,X-ray
and radiation examination/therapy session. The Provox Vega voice prosthesis is compatible
withMagneticResonanceImagingupto3.0Tesla,X-rayandradiationtherapyupto70
Gy.Notethattheradio-opaquevalveseatisvisibleonx-ray.
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
of the device will be affected by e.g. bacteria and yeast, and the structural integrity of
the device will eventually deteriorate.
5.3 User assistance information
For additional help or information please see back cover of the Instructions for Use for
contact information.
Unregistered copy

9
DEUTSCH
DieseHinweise,diedemProduktbeiliegen,werdenregelmäßigüberarbeitetund
sollten vor jedem Prothesenwechsel durchgelesen werden.
Inhalt
1. Glossar .....................................................................................................................................................9
2. Beschreibung ........................................................................................................................................9
2.1 Anwendungshinweise.................................................................................................................9
2.2 Produktbeschreibung..................................................................................................................9
2.3 GEGENANZEIGEN ....................................................................................................................... 10
2.4 WARNUNGEN ............................................................................................................................... 10
2.5 VORSICHTSMASSNAHMEN...................................................................................................... 10
3. Bedienungsanleitung...................................................................................................................... 10
3.1 Sprechen mit der Provox Vega Stimmprothese .............................................................. 10
3.2 Reinigen der Provox Vega Stimmprothese ....................................................................... 10
3.3 Zubehör ......................................................................................................................................... 11
3.4 Zusätzliche Produkte................................................................................................................. 11
4. Nebenwirkungen/Problemlösung nach Symptomen geordnet..................................... 11
5. Zusätzliche Informationen ............................................................................................................ 11
5.1 Kompatibilität mit MRI, Röntgen und Strahlentherapie .............................................. 11
5.2 Lebensdauer des Produkts...................................................................................................... 11
5.3 Weitere Informationen ............................................................................................................. 11
Wichtige Informationen für Patienten mit Tracheostoma
Notfallsituationen
Esistwichtig,dassimNotfallErsthelfererkennen,dassSieübereinTracheostomaatmen.
DiesistdieVoraussetzungfürdieEntscheidung,dasseineSauerstoffzufuhrundkünstliche
BeatmungnichtüberMundundNase,sondernüberIhrTracheostomaerfolgenmuss.
WirempfehlenIhnenundIhremArzt,sichdenLeitfadenfürdieNotfallbeatmung
unter www.atosmedical.com/rescuebreathing herunterzuladen.
Besondere Situationen
WennSiesicheinerOperationunterziehenmüssen,beidereineIntubation(Einführen
einesBeatmungstubusinIhreLuftröhre)erforderlichist,müssenderAnästhesistundder
operierendeArztwissen,dassSieübereinTracheostomaatmenundeineStimmprothese
tragen. Es ist wichtig, dass ihnen bewusst ist, dass die Stimmprothese in situ verbleiben
sollte.WenndieStimmprotheseentferntwird,könnenFlüssigkeitenausIhremMund,
IhrerSpeiseröhreoderIhremMagenindieLuftröhregelangen.
Esistsehrwichtig,dassderIntubationstubusvorsichtigeingeführtundentferntwird,
damit die Stimmprothese nicht verschoben wird oder herausrutscht.
1. Glossar
Mediziner Arzt.
HME Wärme-undFeuchtigkeitstauscher(künstlicheNase)EinProdukt,
das Wärme und Feuchtigkeit speichert, die ansonsten beim
AusatmendurcheinTracheostomaverlorengehenwürde.
PE-Segment Pharyngo-ösophageales Segment. Der Teil der Speiseröhre, in
dembeiderBenutzungeinerStimmprothesedurchVibrationdes
Gewebes Ton entsteht.
Silikon EinMaterial,dashäugfürMedizinprodukteverwendetwird.
TE-Punktion KleinekünstlicheÖffnungzwischenLuftröhreundSpeiseröhre.
Tracheostoma AtemöffnunginderLuftröhreanderVorderseitedesHalses,auch
Stoma genannt.
Stimmprothese EinwegventilmitHalteansch,dasineineTE-Punktioneingesetzt
wird.ErmöglichtdasSprechendurchUmleitenderAtemluftindie
SpeiseröhreundverringertgleichzeitigdasRisiko,dassSpeisen
oderFlüssigkeitenindieAtemwegegelangenkönnen.
2. Beschreibung
2.1 Anwendungshinweise
DieProvoxVegaStimmprotheseisteinesterileVerweilprothesezumeinmaligen
GebrauchwährendderStimmrehabilitationnacheinerchirurgischenEntfernungdes
Larynx(Laryngektomie).DerPatientkanndieStimmprotheseineingesetztemZustand
selbst reinigen.
2.2 Produktbeschreibung
ProvoxVegaisteinMedizinproduktzureinmaligenVerwendung.DasEinweg-Ventil
hältdieTE-PunktionzumSprechenoffenundverringertdasRisiko,dassSpeisen
oderFlüssigkeitenindieAtemwegegelangenkönnen.AusmedizinischemSilikonund
Fluorplastik hergestellt.
Unregistered copy

10
ZurVeranschaulichungsieheAbbildung1.
a)Prothesenkappe
b)Prothesenschaft
c)TrachealerFlansch
d)StrahlenundurchlässigerVentilsitzausFluorplastik
e)ÖsophagealerFlansch
f)Ventilklappe
Provox Vega Lieferumfang
DieProvoxVegaPackungenthältfolgendesZubehör:
• 1ProvoxBrushinderpassendenGröße,nichtsteril
• 1BedienungsanleitungfürdieProvoxBrush
• 1ProvoxVegaBedienungsanleitungfürdenPatienten
2.3 GEGENANZEIGEN
FürdenGebrauchoderdenAustauschderProvoxVegaStimmprothesesindunterPatienten,
diebereitseineprothetischeStimmrehabilitationnutzen,keineGegenanzeigenbekannt.
2.4 WARNUNGEN
DieProvoxVegaStimmprotheseoderandereKomponentendesProvox
Stimmrehabilitationssystems können versehentlich aspiriert werden(indieLuftröhre
gelangen).UnmittelbareSymptomekönnenHusten,WürgenoderKeuchensein.Wenden
Sie sich unverzüglich an Ihren Arzt,falls diese Symptome auftreten sollten. Ein
FremdkörperindenAtemwegenkannzuernsthaftenKomplikationenwiez.B.akuter
Atemnotund/oderAtemstillstandführenundmussvoneinemArztentferntwerden.
DieProvoxVegaStimmprothesekannversehentlichverschlucktwerden.Wenden Sie
sich an Ihren Arzt, falls dies geschieht.
WiederverwendungundWiederaufbereitungkönneneineKreuzkontaminationund
eineBeschädigungdesProduktesverursachen,wasfürdenPatientennegativeFolgen
habenkönnte.
2.5 VORSICHTSMASSNAHMEN
Wenden Sie sich an Ihren Arzt, falls
• Eine Leckage um oder durch die Stimmprothese auftritt (Husten und/oder eine
VeränderungderSekretfarbedeutethieraufhin).
• DasSprechenschwierigwird(Siemüssensichmehranstrengenund/oderIhreStimme
klingtunnatürlich).
• Sie Anzeichen einer Entzündung oder von Veränderungen des Gewebes an der
Punktionbemerken(Schmerzen,Wärmegefühl,Schwellungen,Blutspurennachdem
ReinigenaufderBürste).
So verringern Sie Infektionsrisiken:
ReinigenSieIhreHändegründlich,bevorSiedenBereichumIhrTracheostomaberühren
undbevorSieIhreProtheseund/oderZubehörreinigen.
Halten Sie alle Produkte sauber, die in Kontakt mit Ihrem Tracheostoma oder der
Stimmprothese kommen.
So können Sie das Risiko von Beschädigungen am Produkt verringern:
VerwendenSienuroriginalProvoxZubehör,dasfürVerwendungundReinigungder
Provox Vega Stimmprothese gedacht ist.
3. Bedienungsanleitung
3.1 Sprechen mit der Provox Vega Stimmprothese
SiekönnenLuftausderLungeüberdieStimmprothesedirektinIhreSpeiseröhreleiten,
indemSieIhrTracheostomaschließen(Abbildung2).
DerLuftstromerzeugtVibrationenimGewebederSpeiseröhreunderzeugtsoIhre
Stimme.ZumSprechenbenutzenSieentwedereinenWärme-undFeuchtigkeitsaustauscher
(z.B.ProvoxHME),einFreeHandsHMEzumfreihändigenSprechenoderSieverschließen
das Stoma einfach mit Ihrem Finger.
Ein HME kann die pulmonalen Funktionen verbessern und den Verschluss des Stomas,
undsomitdasSprechen,erleichtern.BeieinemProduktzumfreihändigenSprechen
müssenSiedasTracheostomanichtmiteinemFingerschließen.
3.2 Reinigen der Provox Vega Stimmprothese
UmmitIhrerStimmprotheseeineStimmeerzeugenzukönnen,mussdieProthesesauber
sein,damitLufthindurchströmenkann.EineregelmäßigeReinigungderStimmprothese
verlängertihreLebenszeit.
• DieProthesesolltezweiMaltäglichmitderProvoxBrushgereinigtwerden,umSekret
undSpeiserestevonderProthesezuentfernen.
• Durch Spülen der Prothese mit Provox Flush wird das Entfernen von Sekret und
Speiseresten erleichtert.
Achtung:ProvoxFlushdarfnurvonPatientenbenutztwerden,dievonIhremArztin
derenVerwendungeingewiesenwurdenunddieinderLagesind,diesenohneAufsicht
einesMedizinerszubenutzen.
• Bestimmte Nahrungsmittel, wie etwa der tägliche Konsum von Yoghurt oder
Buttermilch mit Milchsäurebakterien, können hilfreich gegen exzessives Wachstum
von Candida sein.
BITTE BEACHTEN SIE: Verwenden Sie nur original Provox Zubehör, das für
Verwendung und Reinigung der Provox Vega Stimmprothese gedacht ist. Andere
Produkte können zu Verletzungen oder Beschädigungen an der Stimmprothese führen.
Unregistered copy