Provox® Essentials™

An introduction to the Provox® SystemThe globally leading system for vocal and pulmonary rehabilitation after total laryngectomy

The Provox2 low resistance, indwelling voice prosthesis has raised the standard in modern voice restoration.

The Provox® System has been a success from the begin-ning and it continues to be the world-wide golden standard of indwelling prostheses.

The combination of a simple atraumatic insertion tool, a comprehensive array of patient maintenance tools, extensive educational support for both the clinician and patient plus a long list of peer reviewed clinical publications make the Provox Voice Restoration System the logical choice.

Engineering a Provox®2

Provox®2 Starter Kit contains:• Provox®2VoiceProstheses -One of every length• Provox®Trocar - For making primary or secondary TE punctures• Provox®PharynxProtector - Helps protect the pharyngeal walls during primary TE puncture• Provox®Guidewire - Enables retrograde insertion• Provox®Measure - Determines the length of the TE fistula• SetofProvox®Brushes - For cleaning the inside of the Provox voice prosthesis without removing it from the TE-fistula• Provox®Plug - A first-aid tool for temporarily stopping leakage through the prosthesis• Provox®Flush - A cleaning device with several attractive features• Provox2®TrainingKit

Each item can also be ordered separately!

TheProvox®Systemalsocontainsothertypesofvoiceprostheses,educationalmaterial,courses,andmuchmore.

Provox®2 - a complete system

Hood • Preventsthevalvefromadhering totheposterioresophagealwall

• Protectsthevalve

Low airflow resistance• Alargeinnerlumencombinedwithanintegral pretensionedvalveleadstolowerairflowresistances

Sturdy valve, preloaded tension• Assuresatightclosurereducinginadvertent openingduetounderpressurewhenswallowing and/orinhaling

• Sealsthevalvetightlywhennotspeaking

• Increaseddurability

• ReducesdeformationduetoCandidagrowth

Wide flanges • Facilitatessaferandeasiercleaninginsitu

• IncreasesretentionintheTEpuncture

• SupportsTEpartywall

Valve rests on a firm seat• Strongdurablehinge

• Foranoptimizedseal

• Avoidsinversionoftheflapvalve duringcleaning

Firm fluoroplastic ring• Radio-opaque(visibleonx-ray)

• ResistsbiofilmformationorCandidagrowth

• Preventsdeformationoftheshaftbythesurrounding tissuepressure,whichcouldcausethevalvetoopen

Esophageal flange stronger than tracheal flange• Reducestheriskofaccidentaldislodgementintotrachea

Anterograde insertion• Providesimmediateconfirmationofproperplacement

• Enablesrapidchangeofprosthesis,noneedforusingadilator

• Guidewareavailableforretrogradeinsertion

Size information

Provox® LaryTube™

Provox® LaryButton™

Provox® LaryClip™

• Applicablefromthefirst postoperative hour (if no cuff is needed)• Evenduringradiotherapy• Evenincaseofskinirritations

• Self-retaining,softsiliconewith rounded edges• Mayhelppreventingstoma shrinkage• WingsforattachmentofProvox TubeHolder,Provox®LaryClip or special tapes

• Increasestheusabilityofthe Provox®LaryButton™and LaryTube™• Simpletouchfasten/unfasten solution • StrongFlexiDermadhesive properties • Maybetapedtotheskinatthe most optimal site around the stoma • Analternativetotheuseof neckbands

Provox® XtraBase®

• Aunique,convexself-adhering disposable base plate designed speciallyfordeepand/or irregular stomas • Sameadhesionpropertiesasthe popular FlexiDerm

Provox® FlexiDerm™ base plates

• Veryflexible&softwiththe strongest adhesion properties• Speciallysuitableforthose whopreferatransparent, soft and flexible adhesive

After total laryngectomy, breathing exclusively works through the stoma in the neck.

Important upper airway functions, e.g. filtering, humidifying and heating air, no longer exist for the lower airways; dry air enters the trachea directly.

It is very important to start using an HME directly postopera-tive in order to avoid deterioration of the pulmonary functions. The Provox® System offers a broad range of attachment devices for optimal fitting.

Provox®HME System

Foam treated with CaCl2• Forincreasedhumidityretention

• TheCaCl2hasantimicrobialproperties

• Tobeusedalldayandnight(max.24h)

Three Versions:• HiFlow- Lessbreathingresistance=forphysicalactivity andtogetusedtoHME-resistanceinitially

• Normal- Providesmoreresistance=closertonormalupperairwayresistance

• MicronHME- HighlyefficientfiltrationmaterialsaddedtotheHME=>heatand moistureexchangingcapabilitiescombinedwithafiltrationefficacy of≥99.8%(BFE/VFE)

Easy to operate valve• Justpressbuttonlightlyforvoicing - facilitatesmanualstomaocclusion - improvesspeech - improveshygiene - gentleontissuessurroundingvoiceprosthesis andstoma

Beneficial side openings• Stomaclosureevenifcoveredwithclothing

• Winddoesnotblowintostoma

• Nowetstainsonclothing

• Canbediscreetlyhidden

• Drawswarmairfromthebodyuponinhalation

Non-perforated adaptor interface- AssurestightfitbetweenHMEandholder- NomucuscollectionbetweenHMEcassetteandholder- Stableinterface

Flat bottom• Toavoidexcessivemucusaggregation

• Easytokeepclean

One piece lid• Improvedhygieneforpatientand surroundings

• Improvedappearance

• Protectsclothesfrommucusstains

The most extensively clinically tested HME for laryngectomees worldwide.

Subsidiaries

Distributors

Evidence and Experience•Extensiveeducationalsupportandscientificbackground

•Numerousindependentpeer-reviewedpublishedarticles

We are proud of our history and achievements. Our success is a result of our long term dedication and an on-going dia-logue with patients and clinicians.

Our products are clinically tested through vigorous research and/or original clinical trials. This testing has lead to the high lev-els of trust our patients and clinicians place in our products.

Atos Medical is a global company Atos Medical is certified according to• MedicalDeviceDirectiveMDD93/42/EEC

• SS-ENISO13485:2003Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes

• CanadianMedicalDevicesConformityAssessmentSystem(CMDCAS)

AtosMedicalhasacertifiedqualitysystemandourproceduresfollowallrelevantlaws,regulationsandapplicableguidelinesintheUSA,Canada,Asia-PacificaswellasinEuropeandallothermarketsinwhichwearerepresented.

Ear, Nose and Throat - Head and Neck • Laryngology Provox®System™• Otology TympoVent®eartubes MiddleEarImplants(AlliancewithHeinzKURZGmbH.)• Rhinology SinoJect®,NasalSplints,SeptalButton,Silatos,etc• MaxillaryandOrofacial Therabite®-Jawmotionrehabilitationsystem™ • Tracheostomy TrachPhone®etc

Located in more than 70 of the worlds major countries.

AtosMedicalwasfoundedwiththemissiontoimprovethelivesofpeople sufferingfromear,noseandthroatproblems.

Not a single product reaches the patients, before it is thoroughly tested to meet the highest quality standards.

© At

os M

edica

l AB,

2007

10D,

7994

.

Head Office:Atos Medical ABP.O. Box 183, SE-242 22 Hörby, SwedenTel: +46 (0)415 198 00 • Fax: +46 (0)415 198 98info@atosmedical.com • www.atosmedical.com

UserManualandPrescriberInformationThisbrochuredoesnotreplacenordoesitsetforththecompletecontentsoftheUserManualand/orPrescriberInformationandisnotasubstituteforreviewingandunderstandingthatimportantinformation.Therefore,beforeprescribingand/orusingtheproduct(s),pleasereviewtheentirecontentsoftheUserManualand/orPrescriberInformation.

UserManualandPrescriberInformation,includingWarningsandPrecautions,areavailableonlineatwww.atosmedical.com.

ThisbrochureisnottobedistributedintheU.S.A

LimitedWarrantyAtosMedicalmakesnowarranty,eitherexpressedorimplied,astothelifetimeoftheproductdeliveredtothepurchaserhereunder,whichmayvarywithindividualuseandbiologicalconditions.Further,AtosMedicalmakesnowarrantyofmerchantabilityorfitnessoftheproductforanyparticularpurpose.

Trademarks:Provox®,Provox®XtraBase®andLet’stalkaboutlife®areregisteredtrademarksownedbyAtosMedicalAB,Sweden.Provox®LaryClip™andProvox®LaryButton™aretrademarksownedbyAtosMedicalAB,Sweden.Remove™andSkin-Prep™aretrademarksownedbySmith&NephewInc.,U.S.A.

ReferencelistProvox®VoiceProsthesesNewpeer-reviewedpublications:Boscolo-RizzoP,MarchioriC,GavaA,DaMostoMC.TheimpactofradiotherapyandGERDoninsitulifetimeofindwellingvoiceprostheses.EurArchOtorhinolaryngol2007November16[Epubaheadofprint]SchwandtLQ,VanWeissenbruchR,VanDerMeiHC,BusscherHJ,AlbersFWJ.Effect of dairy products on the lifetime of Provox2 voice prosthesis in vitro and invivo.Head&Neck2005;27:471-477LamPK,HoWK,HoAC,NgRW,YuenAP,WeiWI.Long-termperformanceofindwellingtracheoesophagealspeakingvalvesinChinesepatientsundergoinglaryngectomy.ArchivesofOtolaryngology-HeadandNeckSurgery2005November;131(11):954-8.Štajner-KatušićS,HorgaD,MušuraM,GloblekD.VoiceandSpeechaftertotallaryngctomy.ClinicalLinguisticsandPhonetics2006;20(2/3):195-203.SchwandtLQ,Tjong-AyongHJ,vanWeissenbruchR,derMeiHC,AlbersFW.Differences in aerodynamic characteristics of new and dysfunctional Provox 2voiceprosthesesinvivo.EuropeanArchivesofOtorhinolaryngology2006June;263(6):518-23.KummerP,ChahoudM,SchusterM,EysholdtU,RosanowskiF.[Prostheticvoicerehabilitationafterlaryngectomy:Failuresandcomplicationsafterpreviousradiationtherapy.].HNO2006April;54(4):315-22BienS,OklaS.[Analysisofcomplicationsaftersurgicalvoiceandspeechrehabilitationinlaryngectomizedpatients.Problemsrelatedtoimplantationandchangeofvoiceprosthesis].OtolaryngologiaPolska2006;60(2):129-34.TeradaT,SaekiN,TohKetal.VoicerehabilitationwithProvox2voiceprosthesisfollowingtotallaryngectomyforlaryngealandhypopharyngealcarcinoma.AurisNasusLarynx2007March;34(1):65-71.GonzalezPoggioliN,Gonzalez-BotasJH,VazquezBarroJC,NovoaJ,V,MartinezVJ.[Phonationfistulastoday].ActaOtorrinolaringolEsp2007March;58(3):110-2.BremkeM,WernerJA,LichtenbergerG,FolzBJ.[ChronicaspirationsecondarytoaStaffierifistula:SuccesfultherapywithProvoxvoiceprosthesis.Laryngorhinootologie2007Boscolo-RizzoP,ZanettiF,CarpenéS,DaMostoMC.Long-termresultswithtracheoesophagealvoiceprosthesis:PrimaryversussecondaryTEP.EuropeanArchivesofOtorhinolaryngology2008Jan;265(1):73-77.PadhyaTA,AthavaleSM,MorganJM,McCaffreyTV.Analternativeapproachforsecondarytracheoesophagealpunctureinthedifficultlaryngectomyneck.TheLaryngoscope2008Feb;118(2):266-269.SoolsmaJ,VanDenBrekelMW,AckerstaffAH,MalmAJ,TanB,HilgersFJ.Long-termresultsofProvoxActiValve,solvingtheproblemoffrequentCandida-and“Underpressure”-relatedvoiceprosthesisreplacements.TheLaryngoscope2008Feb;118(2):252-257.RamalingamWVBS,ChikaraD,RajagopalG,MehtaAR,SarkarS.Tracheo-esophagealpuncture(TEP)forvoicerehabilitationinlaryngectomizedpatientsBlom-SingervsProvox:Ourexperience.MedicalJournaloftheArmedForcesIndia2007;63(1):15-18.

Selectedearlierpublications:NagarkarAN,GuptaAK:Acomparativeanalysisofspeechinpostlaryngectomisedcases.GazzMedItalArchSciMed.2005:164/3(191-194)NgRW,LamP,WongBY.InsertionofProvox2voiceprosthesisusingtheanterogradetechniqueimmediatelyafterthesecondarytracheoesophagealpuncture.JLaryngolOtol.2005Dec;119(12):988-90.HancockK,HoughtonB,VanAs-BrooksCJ,ComanW:Firstclinicalexperiencewithanewnon-indwellingvoiceprosthesis(ProvoxNID)forvoicerehabilitationaftertotallaryngectomy.ActaOtolaryngol.2005Sep;125(9):981-90.TrussartC,LawsonG,RemacleM:Voiceprostheses:long-termfollow-upretrospectivestudy(three-tosixteen-yearfollow-upof22patients).RevLaryngolOtolRhinol(Bord).2003;124(5):299-304.MakitieAA,NiemensivuR,JuvasA,AaltonenLM,BackL,LehtonenH:Postlaryngectomyvoicerestorationusingavoiceprosthesis:asingleinstitution’sten-yearexperience.AnnOtolRhinolLaryngol.2003Dec;112(12):1007-10.HilgersFJ,AckerstaffAH,BalmAJ,VandenBrekelMW,BingTanI,PerssonJO:Anewproblem-solvingindwellingvoiceprosthesis,eliminatingtheneedforfrequentCandida-and“underpressure”-relatedreplacements:ProvoxActiValve.ActaOtolaryngol2003Oct;123(8):972-9.FreeRH,VanderMeiHC,ElvingGJ,VanWeissenbruchR,AlbersFW,BusscherHJ:InfluenceoftheProvoxFlush,blowingandimitatedcoughingonvoiceprostheticbiofilmsinvitro.ActaOtolaryngol2003May;123(4):547-51.OpdeCoulBMR,HilgersFJM,BalmAJM,TanIB,vandenHoogenFJA,vanTinterenH:Adecadeofpost-laryngectomyvocalrehabilitationin318patients:Asingleinstitution’sexperiencewithconsistentapplicationofProvox ®indwellingvoiceprostheses.ArchOtolaryngolHeadNeckSurg2000Nov;126(11):1320-8.BalleVH,RindsøL,ThomsenJC.Primaryspeechrestorationatlaryngectomybyinsertionofvoiceprosthesis–10yearsexperience.ActaOtolaryngol2000;Suppl543:244-245.AhmadI,KumarBN,RadfordK,O’ConnellJ,BatchAJG:Surgicalvoicerestorationfollowingablativesurgeryforlaryngealandhypopharyngealcarcinoma.JLaryngOtol,Jul2000;114:522-525.AckerstaffAH,HilgersFJ,MeeuwisCA,vanderVeldenLA,vandenHoogenFJ,MarresHA,VreeburgGC,ManniJJ:Multi-institutionalassessmentof the Provox®2voiceprosthesis.ArchOtolaryngolHeadNeckSurg1999Feb;125(2):167-73.LaccourreyeO,MenardM,Crevier-BuchmanL,CouloignerV,BrasnuD:Insitulifetime,causesforreplacement,andcomplicationsoftheProvox® voice prosthesis.Laryngoscope1997Apr;107(4):527-30.HilgersFJM,AckerstaffAH,BalmAJM,TanIB,AaronsonNK,PerssonJO.Development and clinical evaluation of a second-generation voice prosthesis (Provox®2)designedforanterogradeandretrogradeinsertion.ActaOtolaryngol1997;117:889-896.

Provox®HMEandProvoxFreeHandsHMENewpeer-reviewedpublications:Hamade,R.,Hewlett,N.,&Scanlon,E.(2006).Aquantitativeandqualitativeevaluationofanautomaticocclusiondevicefortracheoesophagealspeech:theProvoxFreeHandsHME.ClinLinguistPhon.,20,187-193.Hilgers,F.J.&Ackerstaff,A.H.Developmentandevaluationofanovel

tracheostomabuttonandfixationsystem(ProvoxLaryButtonandLaryClipadhesive)tofacilitatehands-freetracheoesophagealspeech.ActaOtolaryngologica2006Dec;126(11):1218-1224ZuurJK,MullerSH,SinaasappelM.HartGA,VanZandwijkN,HilgersFJ.Influenceof heat and moisture exchanger respiratory load on transcutaneou oxygenation inlaryngectomizedindividuals:arandomizedcross-overstudy.Head&neck2007Dec;29(12):1102-1110ZuurJK,MullerSH,DeJonghFH,VandDerHorstMJ,ShehataM,VanLeeuwenJ,SinaasappelM,HilgersFJ.Anewlydevelopedtoolforintra-trachealtemperatureandhumidityassessmentinlaryngectomizedindividuals:theAirwayClimateExplorer(ACE).Medical&BiologicalEngineering&Computing2007Aug;45(8):737-745.Epub2007Jul13.LorenzKJ,AckerstaffAH,HilgersFJM,MaierH.Hands-freespeechaftersurgicalvoicerehabilitationwithaProvox®voiceprosthesis:experiencewiththeProvox®Freehands™HMEtracheostomavalvesystem.EuropeanArchivesofOtorhinolaryngology2007Feb;264(2):151-157.Selectedearlierpublications:FJMHilgers,AHAckerstaff.Developmentandevaluationofanoveltracheostomabuttonandfixationsystem(ProvoxLaryButtonandLaryClipadhesive)tofacilitatehandsfreetracheoesophagealspeech.ActaOtolaryngol(Stockh),inpress.OpdeCoulBM,AckerstaffAH,vanAs-BrooksCJ,vandenHoogenFJ,MeeuwisCA,ManniJJ,HilgersFJ.Compliance,qualityoflifeandquantitativevoicequalityaspectsofhands-freespeech.ActaOtolaryngol.2005Jun;125(6):629-37.ZuurJK,MullerSH,deJonghFH,vanZandwijkN,HilgersFJ:Thephysiologicalrationale of heat and moisture exchangers in post-laryngectomy pulmonary rehabilitation:areview.EurArchOtorhinolaryngol.2006Jan;263(1):1-8.Epub2005Jul7.TervonenH,BackL,JuvasA,RasanenP,MakitieAA,SintonenH,RoineRP,VilkmanE,AaltonenLM:Automaticspeakingvalveinspeechrehabilitationforlaryngectomizedpatients.EurArchOtorhinolaryngol.2005Oct;262(10):816-20.Epub2005Mar1AckerstaffAH,FullerD,IrvinM,MaccrackenE,GazianoJ,StachowiakL:Multicenterstudyassessingeffectsofheatandmoistureexchangeruseonrespiratorysymptomsandvoicequalityinlaryngectomizedindividuals.OtolaryngolHeadNeckSurg.2003Dec;129(6):705-12HilgersFJ,AckerstaffAH,VanAsCJ,BalmAJ,VandenBrekelMW,TanIB:Development and clinical assessment of a heat and moisture exchanger with a multi-magnetautomatictracheostomavalve(ProvoxFreeHandsHME)forvocalandpulmonaryrehabilitationaftertotallaryngectomy.ActaOtolaryngol2003Jan;123(1):91-9vanAsCJ,HilgersFJM,Koopmans-vanBeinumFJ,AckerstaffAH.Theinfluenceofstomaocclusiononaspectsofalaryngealspeech.ActaOtolaryngol1998;118:732-738.AckerstaffAH,HilgersFJM,BalmAJM,TanIB.Longtermcomplianceoflaryngectomizedpatientswithaspecializedpulmonaryrehabilitationdevice,Provox ®[HME]Stomafilter.Laryngoscope1998;108:257-260.HilgersFJM,AckerstaffAH,BalmAJM,GregorRT.Anewheatandmoistureexchanger with speech valve (Provox®[HME]Stomafilter).ClinOtolaryngol1996;21:414-418.The above references represent a selection. For more information contact Atos Medical AB or your local representative.

The complete catalog of the Provox System can be downloaded from www.atosmedical.com Other sources of information:MoreabouttheProvoxSystem,includingtroubleshooting:www.provoxweb.infoMoreaboutrehabilitationofolfactionaftertotallaryngectomy:www.hoofdhals.nki.nl/olfaction/Start.aspx