The Provox® System
Contents
1. ATOS MEDICAL Leading the way in ENT www atosmedical us 1 800 217 0025 Contents Past experience continued innovations AA Provox 1 5 Provox2 6 Provox ActiValve 7 Provox Vega 8 Provox NID Voice Rehabilitation System 10 Provox NID Accessories 10 Professional Accessories 12 At Atos Medical we are always working with one foot in the past and one in the present focusing on the future We believe that our User Accessories 14 products need to be continuously tested and evaluated in order to know what to improve and what further demands the market might have Everything we do is based on Evidence and Experience and that is how we maintain our leading position The past is the key to our future actions We also act on present issues designing and testing new products that Provox Adhesives 20 fit with todays increasing demands for products that restore quality of life and technologies that address changing environmental condi tions As always our development leads to the launch of sophisticated products that are backed by documentation testing and adherence to Hands free Speech 24 high quality and performance standards Tracheostoma Support 28 Other Accessories 33 o E O Educational Material 35 Tommy Hedberg CEO of Atos Medical Starter Kits 38 Evidence amp Experience www atosmedical us 1 800 217 0025 4 Provox Voice Prostheses The original Pro2. Non sterile reusable For single patient use Includes one Provox Brush www atosmedical us 1 800 217 0025 Provox Brush The brush shaft may be slightly bent to reach the voice prosthesis better Provox Plug The Provox Plug can also be helpful to find out whether leakage occurs through or around the prosthesis i ii EN 4 e ma E y e ii i r a K 5 i ie iwi re nal s i J ie ISI MEAR IA Aa E E x p i id eta hy ASS NG i WAX iS hy ON Provox HME System A heat and moisture exchanger heats and moisturizes with coughing and mucus production This improves sleep inhaled air and restores breathing resistance to a great and the quality of life Provox HME is based on a simple extent It retains about 60 of the humidity in the airways mechanism that is documented as safe and hygienic that would otherwise be lost by breathing through an open tracheostoma Users experience fewer problems fe www atosmedical us 1 800 217 0025 Provox HME Cassettes The Provox HME cassette the 24 7 HME is the core of Atos Medical s product line for ef fective pulmonary rehabilitation following a total laryngectomy The provox family of HMEs continues to grow with the addition of the next generation of HME cassettes the Provox XtraHME Now with even better humidification from which many patients breathing
3. 998 108 257 260 Hilgers FJM Ackerstaff AH Ba alve Provox H Ackerstaff AH Hilgers FJM Aa gt Koopmans van Bein E Stomafilte ients Acta Otorinolaringol Esp 2001 Apr 52 3 221 5 um FJ Ackerstaff AH The influence of stoma occlusion h Acta Otolaryngol 1998 118 732 738 onson m AJM Tan IB Long term compliance of laryngectomized patients ehabilitation device Provox HME Stomafilter Laryngoscope m AJM Gregor RT A new heat and moisture exchanger with speech r Clin Otolaryngol 1996 21 414 418 K de Boer MF Meeuwis CA Knegt PPM Spoelstra HAA van Zandwijk N Balm AJM Heat and moisture exchangers as a preventative treatment option in the Ackerstaff AH Hilgers FJM Aa rehabilitation of laryngectomized patients Clin onson Otolaryngol 1995 20 504 509 K Balm AJM van Zandwijk N Improvements in respiratory and psychosocial functioning following total laryngectomy by the use of a heat and moisture inol Laryngol 1993 102 878 883 Hilgers FJM Aaronson NK Ackerstaff AH Schouwenburg PF van Zandwijk N The influence of a heat and moisture exchanger HME on the respiratory symptoms after total laryngectomy Clin Otolaryngol 1991 16 152 156 exchanger HME Ann Otol Rh The above references represent a selection For more information contact Atos Medical AB or your local representative More about the Provox System including
4. Ameye D Honraet K Loose D Vermeersch H Nelis H Remon JP Effec on the lifetime of a Provox silicone tracheoesophageal voice prosthesis Acta Otolaryngol 2005 ofa buccal bioadhesive nystatin Kummer P Chahoud M Schuster M Eysholdt U Rosanowski F Prosthetic voice rehabilitation after laryngectomy Failures and complications after previous radiation therapy HNO 2005 May 4 Epub loblek D Simunjak B lvkic M Hedjever M Speech and voice analysis after near total laryngectomy tracheoesophageal puncture with implantation of Provox 2 prosthesis Logoped Phoniatr s long term follow up retrospective study three to sixteen year follow up of 22 patients Rev Laryngol Otol Rhinol Bord Scheuermann K Delank KW Perforation ofthe esophagus with a mediastinal abscess HNO 2005 Jan 53 1 66 70 Article in German Makitie AA Niemensivu R Juvas A Aaltonen LM restoration using a voice prosthesis a single instit Laryngol 2003 Dec 112 12 1007 10 Hilgers FJ Ackerstaff AH Balm AJ Van den Brekel underpressure related replacements Provox Ac Free RH Van der Mei HC Elvi 2003 May 123 4 547 51 Op de Coul BMR Hilgers FJ Back L Lehtonen H Postlaryngectomy voice ution s ten year experience Ann Otol Rhinol W Bing Tan Persson JO A new problem solving indwelling voice prosthesis eliminating the need for frequent Candida and Valve Acta Otolaryngol 2003 Oct 123 8 972 9 ng
5. Muller SH de Jongh FH van Zandwijk N Hilgers FJ The physiological rationale of heat a 0 yClip adhesive to facilitate hands free a Otolaryngol Stockh in press nd moisture exchangers in post laryngectomy pulmonary rehabilitation a review Eur Arch torhinolaryngol 2006 Jan 263 1 1 8 Epub 2005 Jul 7 Tervonen H Back L Juvas A Rasanen P Makitie AA Sintonen H Roine RP Vilkman E Aaltonen LM Automatic speaking valve in speech rehabilitation for laryngectomized patients Eur Arch Otorhinolaryngol 2005 Oct 262 10 816 20 Epub 2005 Mar 1 Ackerstaff AH Fuller D Irvin M accracken E Gaziano J Stachowiak L Multicenter study assessing effects of heat and moisture exchanger use on respiratory symptoms and voice quality in laryngectomized individuals 0 olaryngol Head Neck Surg 2003 Dec 129 6 705 12 Hilgers FJ Ackerstaff AH Van As CJ Balm AJ Van den Brekel MW Tan IB Development and clinical assessment of a heat and moist ure exchanger with a multi magnet automatic tracheostoma valve Provox FreeHands HME for vocal and pulmonary rehabilitation after total laryngectomy Acta Otolaryngol 2003 Jan 123 1 9 1 9 Herranz Gonzalez Botas J Suarez T Garcia Carreira B Martinez Moran A Experience with the HME Provox Stomafilter in laryngectomized pat Spanish van As CJ Hilgers FJ on aspects of alaryngeal speec Ackerstaff AH Hilgers FJM Ba with a specialized pulmonary
6. a laryngologist and a speech therapist rated the long term tracheoesophageal speech of 78 74 95 of the patients as good or average The main causes for replacement of the device were obstruction leakage or inadequate size of the prosthesis and granulation or leakage around the fistula According to our 10 year experience use of the Provox prosthesis is an effective method of postlaryngectomy voice rehabilitation and it continues to be our preferred method of voice restoration in the majority of cases Makitie AA Niemensivu R Juvas A Aaltonen LM Back L Lehtonen H Postlaryn gectomy voice restoration using a voice prosthesis a single institution s ten year experience Ann Otol Rhinol Laryngol 2003 Dec 112 12 1007 10 www atosmedical us 1 800 217 0025 Provox 2 Voice Prosthesis Provox2 is a low resistance indwelling silicone voice prosthesis that can be inserted e immediately after TE puncture primary or secondary without the need for tem porary stenting This retrograde insertion method is to be performed by a physician using the Provox Guidewire e as a replacement prosthesis for the Provox 1 or other voice prosthesis e in an anterograde manner using the single use insertion tool This preferred method can be performed by any trained health care professional Features N e low airflow resistance e easy maintenance e safe placement e detectable in x ray The slightly concave shape of the trachea
7. is a liquid glue for skin application that cures on contact with the air Long term use may cause skin irritation and does not work for everybody The use of Skin Prep before application of silicone glue is normally recommended Order information Quantity REF Provox Silicone Glue 40 ml 7720 Bottle with brush cap non sterile For multiple application fo Bonin Kapi Gel Tracheostoma sizer Kapi Gel Tracheostoma Spacer is a 43 mm diameter 5 mm thick circular tacky laminated silicone gel spacer available in two center hole openings to accommodate different diameter tubes and Buttons 8 mm opening fits tubes or buttons with lt 14 mm OD 12 mm opening fits tubes or buttons with gt 12 mm OD Kapi Gel spacers are intended to help create a better seal around tracheostoma support devices and is suitable for uneven stoma anatomy Kapi Gel can improve tracheostoma device fitting act as a cushion behind tubes and buttons during digital occlusion and may help reduce air leakage Order information Size Quantity REF Kapi Gel Tracheostoma Spacer 8mm 10 pcs LATNG4008 Kapi Gel Tracheostoma Spacer 12 mm 10 pcs LATNG4012 www atosmedical us 1 800 217 0025 Hands free Speech The Provox FreeHands HME combines a Heat and The Provox FreeHands HME enables voice prosthesis Moisture Exchanger HME with an easy to operate users to have all benefits of an HME combined with automatic tracheostoma valve that allows speaking hands free s
8. through a tracheostoma will benefit Improved features Welcome two new family members XtraMoist HME comes even closer to mimicking normal nasal function Humidification is improved and good airflow is maintained for easy breathing XtraMoist is recommended for patients who have recently undergone a total laryngectomy and for those already accustomed to using an HME XtraFlow HME delivers superior airflow XtraFlow is great to use when exercising adapting to using an HME and for those that prefer lower resistance breathing Other Family members e HiFlow traditional lower resistance breathing for physical activity and acclimating to HME resistance initially e Normal traditional standard resistance breathing closer to normal upper airway resistance Features e heat and moisture exchanger HME e facilitates manual stoma occlusion thereby improving speech as well as hygiene 0 e beneficial side openings that enable airtight closure of the stoma even when the HME is covered by clothing which means that l Oa the HME can be discreetly hidden there will be less wet stains on the clothing The HME acts like a condenser and helps to protect the airways Order information Quantity Rx REF Provox XtraMoist HME 30 pcs 7290 Provox XtraFlow HME 30 pcs 7291 Provox HME Cassette Normal 30 pcs Rx 7242 Provox HME Cassette Normal ColorSplash Beige 30 pcs Rx 7247C Provox HME Cassette HiFlow 30 pcs Rx 7243 Provox HME Cas
9. trouble shooting www provoxweb info More about rehabilitation of olfaction after total laryngectomy www hoofdhals nki nl olfaction Start aspx Sales Office in the US Atos Medical Inc 11390 W Theodore Trecker Way West Allis WI 53214 1135 USA Tel 1 800 217 0025 Fax 1 414 227 9033 info us atosmedical com www atosmedical us e www atosdirect com Atos Medical AB 7974US 201001A 7974US 201001A
10. voice prosthesis Provox Vega Acta Otolaryngol 2009 Nov 7 Epub ahead of print Selected earlier publications Boscolo Rizzo P Marchiori C Gava A Da Mosto C The impact of radiotherapy and GERD on in situ lifetime of indwelling voice prostheses Eur Arch Otorhinolaryngol 2007 November 16 Epub ahead of print Schwandt LQ Van Weissenbruch R Van Der Mei HC Busscher HJ Albers FWJ Effect of dairy products on the lifetime of Provox2 voice prosthesis in vitro and in vivo Head amp Neck 2005 27 471 477 Lam PK Ho WK Ho AC Ng RW Yuen AP Wei WI Long term performance of indwelling tracheoesophageal speaking valves in Chinese patients undergoing laryngectomy Archives of Otolaryngology Head and Neck Surgery 2005 November 131 11 954 8 Stajner KatusicS Horga D Musura M Globlek D Voice and Speech after total laryngctomy Clinical Linguistics and Phonetics 2006 20 2 3 195 203 Schwandt LQ Tjong Ayong HJ van Weissenbruch R der Mei HC Albers FW Differences in aerodynamic characteristics of new and dysfunctional Provox 2 voice prostheses in vivo European Archives of Otorhinolaryngology 2006 June 263 6 518 23 Kummer P Chahoud M Schuster M Eysholdt U Rosanowski F Prosthetic voice rehabilitation after laryngectomy Failures and complications after previous radiation therapy HNO 2006 April 54 4 315 22 Bien S Okla S Analysis of complications afte surgical voice and speech rehabilitatio
11. 1 Lubrication with special medical grade fluoridated silicone oil is favorable in patients who experience possible adhesion of the valve to the valve seat Literature reference Hilgers FJM Ackerstaff AH Balm AJM Van Den Brekel MWM Tan IB Persson J 0 A New Problem solving Indwelling Voice Prosthesis Eliminating the Need for Frequent Candida and Underpressure related Replacements Provox ActiValve Acta Otolaryngol Stockh 2003 Oct 123 972 979 ce www atosmedical us 1 800 217 0025 Provox ActiValve is designed for those who experience short device lifetime of Provox 1 or Provox2 caused by e early leakage through the prosthesis due to excessive candida growth e inadvertent opening and thus leakage of the valve during swallowing or deep inhalation as the result of negative pressure building in the esophagus and or thorax To help prevent excessive candida overgrowth the valve flap and valve seat of the Provox ActiValve prosthesis are made of a candida resistant material To help prevent inadvert ent opening the valve and valve seat of the Provox ActiValve contain magnets which are available in three opening forces Light Strong and XtraStrong The Provox ActiValve should be considered after a patient has experienced approximately 5 consecutive short durations of use of Provox 1 or Provox2 prostheses shorter than 4 to 8 weeks Provox ActiValve is NOT intended for primary or secondary insertion at the time of s
12. 46 0 415 198 98 info atosmedical com www atosmedical com Z Zuu Hi laryngectomized individuals t Lorenz KJ Ackerstaff AH Hilge with a Provox voice prosthesi he Airway Clima s experience wi system European Archives of Otorhinolaryngo 192 FJM Hilgers AH Ackerstaff D and fixation system Provox La ap FJ Compliance quality of V tracheoesophageal speech Act p de Coul BM Ackerstaff AH van As Brooks CJ van den Hoogen FJ Meeuwis CA Manni JJ Hilgers ife and quantitative voice quality aspects of hands free speech Acta ur JK Muller SH Sinaasappel M Hart GA Van Zandwijk N Hilgers FJ Influence of heat and moisture exchanger respiratory load on transcu a randomized cross over study Head amp nec JK Muller SH De Jongh FH Vand Der Horst gers FJ A newly developed tool for intra tracheal temperature and humidity assessment in te Explorer ACE Medica amp Computing 2007 Aug 45 8 737 745 Epub 2007 Jul 13 taneou oxygenation in laryngectomized individuals k 2007 Dec 29 12 1102 1110 MJ Shehata M Van Leeuwen J Sinaasappel M amp Biological Engineering 5 FJM Maier H Hands free speech after surgical voice rehabilitation h the Provox Freehands HME tracheostoma valve ogy 2007 Feb 264 2 151 157 elopment and evaluation of a novel tracheostoma button yButton and La Otolaryngol 2005 Jun 125 6 629 37 Zuur JK
13. 5 7607 105 135 55 7641 10 5 135 55 7627 LaryTube 10 27 Rx 12 0 15 0 27 7609 LaryTube 10 36 Rx 120 15 0 36 7610 120 15 0 36 7643 12 0 15 0 36 7628 LaryTube 10 55 Rx 120 150 55 7611 12 00 15 0 55 7644 120 15 0 55 7629 LaryTube 12 27 Rx 13 5 17 0 27 7613 LaryTube 12 36 Rx 135 17 0 36 7614 13 5 17 0 36 7646 13 5 17 0 36 7630 LaryTube 12 55 Rx 135 17 0 55 7615 13 51 17 01 59 76047 135 017 Os 555 7031 Provox LaryTube Standard includes 5 HiFlow Provox LaryTube Fenestrated includes 5 HiFlow Provox LaryTube with Ring includes 5 HiFlow Cassettes 7241 Cassettes 7241 and 1 Provox Brush 7204 Cassettes 7241 1 FlexiDerm Oval 7254 ID inner diameter OD outer diameter L length in mm LaryTube Sizer Kit Rx REF 7648 www atosmedical us 1 800 217 0025 29 30 Provox LaryButton The Provox LaryButton is a short self retaining silicone tracheal cannula It maintains the opening of the tracheostoma and acts as a holder for other rehabilitation devices of the Provox System including the regular HME cassettes and the Provox FreeHands HME The main difference between the LaryButton and LaryTube is that the LaryButton is self retaining in the stoma Once inserted it remains in position taking advantage of the tissue elasticity of the tracheal opening which helps to hold it in place and provide an airtight seal Of course it also helps to prevent the tracheostoma from shrinking I
14. FreeHands HME Cassette 30 pcs Rx 7711 Provox FreeHands Speech Valve Membrane light white dot 1 pc Rx 7713 includes 1 pc 7719 Provox FreeHands Speech Valve Membrane medium blue dot 1 pc Rx 7714 includes 1 pc 7719 Provox FreeHands Speech Valve Membrane strong green dot 1 pc Rx 7715 includes 1 pc 7719 Provox FreeHands Cleaning and Storage Box 1 pc 7718 Provox FreeHands HME Adjustment Kit 7719 1 safety screwdriver and 1 membrane replacement forceps Provox FreeHands HME Replacement Device Rx 7722 Valve only Provox FreeHands HME Replacement Device Rx 7 16 Valve with light membrane Provox FreeHands HME Replacement Device Rx 7717 Valve with medium membrane Provox FreeHands HME Replacement Device Rx 7721 Valve with strong membrane www atosmedical us 1 800 217 0025 26 Provox FreeHands HME Starter Kit Provox FreeHands HME Starter Kit contains 1 valve unit housing with a medium blue dot membrane 5 FreeHands HME Cassettes 7712 2 Provox XtraBase 7265 1 Adjustment Kit 7719 1 Speech Valve Membrane light white dot 7713 1 Speech Valve Membrane strong green dot 7715 1 Cleaning and Storage Box 7718 5 Skin Prep tissues Order information Provox FreeHands HME Starter Kit Containing all above mentioned www atosmedical us 1 800 217 0025 The Provox HME Cap is a dome shape titanium ring that allows use of the special FreeHands HME cassettes without the Provox FreeHands
15. G Mehta AR Sar TEP for voice rehabilitation in laryngectomized patients Blom Singer vs Provox Our experience edical Journal of the Armed Forces India 2007 63 1 15 18 agarkar AN Gupta AK A comparative analysis of speech in postlaryngectomised cases Gazz Med eplacements The Laryngoscope 2008 Feb 1 2 252 257 kar S Tracheo esophageal puncture g RW Lam P Wong BY Insertion of Provox2 voice prosthesis using the anterograde technique immediately after the secondary tracheoesophageal puncture J Laryngol Otol 2005 arkowski J Gierek T Paluch J Wardas P The use of the vocal prosthesis Provox 2 for speech ehabilitation after total laryngectomy Otolaryngol Pol 2005 59 3 373 7 Article in Polish Hancock K Houghton B Van As Brooks CJ Coman W First clinical experience with a new non indwelling voice prosthesis Provox NID for voice rehabilitation after total laryngectomy Acta Otolaryngol 2005 Sep 125 9 981 90 Limited Warranty Atos Medical makes no warranty either expressed or implied as to the lifetime of the product delivered to the purchaser hereunder which may vary with individual use and biological conditions Further Atos Medical makes no warranty of merchantability or fitness of the product for any particular purpose Please Note The persons depicted in this document have agreed to be photographed for purposes of illustration only The Provox Catalog in French is available online at www atos
16. GJ Van Weissenbruch R Albers FW Busscher HJ Influence of the Provox Flush blowing and imitated coughing on voice prosthetic biofilms in vitro Acta Otolaryngol Balm AJM Tan IB van den Hoogen FJA van Tinteren H A decade of post laryngectomy vocal rehabilitation in 318 patients A single institution s experience with consistent application of Provox indwelling voice 2000 Nov 126 11 1320 8 BalleVH Rindsg L T prostheses Arch Otolaryngol Head Neck Surg homsen JC Primary speech restoration at laryngectomy by insertion of voice prosthesis 10 years experience Acta Otolaryngol 2000 Suppl 543 244 245 Ahmad Kumar BN Radford K O Connell J Batch surgery for laryngeal and hypopharyngeal carcino Ackerstaff AH Hilgers FJ Meeuwis CA van der Vel GC Manni JJ Multi institutional assessment of th Head Neck Surg 1999 Feb 125 2 167 73 AJG Surgical voice restoration following ablative ma J Laryng Otol Jul 2000 114 522 525 den LA van den Hoogen FJ Marres HA Vreeburg e Provox 2 voice prosthesis Arch Otolaryngol Laccourreye O Menard M Crevier Buchman L Couloigner V Brasnu D In situ lifetime causes n Apr 107 4 527 30 Aust MR Hilgers FJ Hilgers FJ 0 stance indwelling Provox voice prosthes Hilgers FJ esistance indwelling voice prosthesis Eur Archs W Tes gers FJM Schouwenburg PF A new low resista Provox HME and Provox Fr
17. HME valve unit This can be convenient e g for night use or if no regular Provox HME cassettes are available The HME Cap is snapped onto a FreeHands HME cassette and then used like a regular Provox HME cassette Although the HME Cap lacks the benefits of a lid spring valve mecha nism and side openings found in regular Provox HME cassettes it does allow the stoma to be closed manually for speech Note Do not use the FreeHands HME cassettes separately Order information Quantity Rx REF Provox HME Cap matt titanium 1 piece Rx 7730 Reusable non sterile Provox FreeHands HME Cassette 30 pcs Rx 7712 Non sterile for single use only www atosmedical us 1 800 217 0025 Provox HME Cap The Provox HME Cap is firmly attached to the FreeHands HME cassette and then inserted into the adhesive base plate holder After a maximum use time of 24 hours the cassette must be replaced 2 28 Tracheostoma Support The Provox LaryButton and Provox LaryTube allow Both products are made of soft flexible yet sufficiently for use of Provox HME Cassettes to help laryngectomees rigid silicone The conical anatomical shape helps to achieve pulmonary protection and rehabilitation ensure an optimal seal around the stoma without having to use adhesives Provox LaryTubes also allow immediate postoperative use of an HME www atosmedical us 1 800 217 0025 Provox LaryTube Available in three versions e The Fenestrat
18. Provox NID 17 6mm Rx 7101 Provox NID 20 6mm Rx 7111 A Provox NID 17 8 mm Rx 7102 Provox NID 20 8mm Rx 7112 Provox NID 17 10 mm Rx 7103 Provox NID 20 10 mm Rx 7113 Provox NID 17 12 mm Rx 7104 Provox NID 20 12 mm Rx 7114 Provox NID 17 14 mm Rx 7105 Provox NID 20 14 mm Rx 7115 Provox NID 17 18 mm Rx 7106 Provox NID 20 18 mm Rx 7116 Inserter of corresponding size included Non sterile ready for use For single patient use Provox NID Accessories Provox Dilator 17 20 PH The Provox Dilator is designed to facilitate replacement and insertion of the Provox NID prosthesis It serves to keep the fistula tract open after removal of and or prior to the insertion of the Provox NID Also a small circular ridge helps to keep the Provox Dilator in place and reduces the tendency of it sliding out Included in the Starter Kit and available separately Order information Rx REF Provox Dilator 17 Rx 7122 Provox Dilator 20 Rx 7123 Non sterile ready for use For single patient use www atosmedical us 1 800 217 0025 Provox Brush The Provox brush design is based on our long experience with indwelling Provox pros theses and is a valuable maintenance tool for in situ and ex situ cleaning Included in the Starter Kit and available separately Order information Quantity REF Provox Brush For use with Provox NID 20 6 10 mm set of 6 7204 Provox Brush XL Extra long version for use with Provox NID 20 12 18 mm set of 6 7225 Non ster
19. al overshooting E e Gentle smooth insertion not to be used in a freshly made not yet healed puncture fortabla SpD0pch a The valve is recessed and a totally encased by the prosthesis hood to minimize direct exposure of the valve to the esophagus A Inner diameter maximized to reduce airflow resistance during speech Angled valve opens flush with 9 SP valve interior to maximize airflow velocity through the Safety strap is TEF y p e Hd speech integrated into the face ess effortful of the tracheal flange www atosmedical us 1 800 217 0025 Provox NID Voice Rehabilitation System For nearly two decades clinicians from all over the world have known that our indwelling Provox voice prosthesis offers excellent function reliability and safety However many of you have asked for a convenient version that patients can insert remove and clean themselves while preserving key features and the proven quality of the Provox You asked and we listened Atos Medical is pleased to offer the Provox NID Provox NID Voice prosthesis e Patients may insert remove and clean the device themselves e The Provox NID is attached to a strong polypropylene cord with a safety medallion that is too wide to fall into the tracheostoma e Low airflow resistance e In situ cleaning possible with dedicated cleaning tools e Variety of sizes Provox NID 17 FR Size Rx REF Provox NID 20 FR Size RX REF
20. beBrush for LaryTube sizes 8 and 9 8mm 6 pcs 7660 Provox TubeBrush for LaryTube sizes 10 and 12 12mm 6 pcs 7661 Non sterile reusable The new Provox TubeHolder has been developed exclusively for use with the Provox LaryTube and Provox LaryButton The integrated clip connectors allow for optimal fit to the wings of the Provox LaryTube and LaryButton which reduces the physical stress on the soft silicone material Order information Quantity REF Provox TubeHolder 1 pc 7668 Non sterile reusable The plastic StomaMeasure is a ruler that can be used to estimate the diameter of the tracheostoma Order information Quantity REF StomaMeasure for LaryTube 1 pc 7807 Non sterile www atosmedical us 1 800 217 0025 Provox TubeBrush Provox TubeHolder StomaMeasure 33 34 Provox ShowerAid The Provox ShowerAid is used with Provox Adhesives FlexiDerm or Regular Used as a temporary replacement for a Provox HME Cassette while taking a shower Note Do not use with OptiDerm Order information Quantity REF Provox ShowerAid 1 pc 7260 Non sterile for single patient use boilable Includes 1 Provox FlexiDerm Oval Adhesive 7254 Provox BasePlate Adaptor The Provox BasePlate Adaptor allows the attachment of other devices with ISO 15 mm standard connectors to a Provox Adhesive base plate or Provox LaryTube cannula Order information Quantity REF Provox BasePlate Adaptor 1 pc 7263 Non st
21. dhesive Kit Pieces MAN N N UW N N N U N N N N UU N 10 10 10 Products Adhesive OptiDerm Round 7255 Adhesive OptiDerm Oval 7256 Remove 1 pc 72331 Skin Prep 77205 Provox Cleaning Towels 10 towels 7244 Provox HME Cassette HiFlow 72415 Adhesive FlexiDerm Oval 7254 Adhesive FlexiDerm Round 7253 Remove 1 pc 72331 Skin Prep 77205 Provox Cleaning Towels 10 towels 7244 Provox HME Cassette HiFlow 72415 Adhesive Regular Round 7251 Adhesive Regular Oval 7252 Remove 1 pc 72331 Skin Prep 77205 Provox Cleaning Towels 10 towels 7244 Provox HME Cassette HiFlow 72415 pieces of Adhesive FlexiDerm Oval 7254 and of Adhesive FlexiDerm Round 7253 pieces of Adhesive OptiDerm Round 7255 Adhesive OptiDerm Oval 7256 Adhesive Regular Round 7251 and of Adhesive Regular Oval 7252 XtraBase Adhesive Round 7265 Remove 1 pc 72331 Skin Prep 77205 Provox Cleaning Towels 10 towels 7244 Provox HME Cassette HiFlow 72415 www atosmedical us 1 800 217 0025 Rx Rx Rx Rx Rx REF 7292 7293 7295 7296 39 Prescription Devices Caution United States federal law restricts devices identified herein with the symbol Rx to sale distribution and use by or on order of a physician or licensed health care provider The availability of these devices without prescription outside the United States may vary from country to country Us
22. ed version designed for use in combination with a voice prosthesis Several small fenestrations are preferred over a single large one in order to prevent locking and ac cidental dislocation of the voice prosthesis The Provox Brush 7204 normally used for cleaning Provox voice prostheses is also suitable for cleaning the fenestrations of the Lary Tube e The Standard version made for use without voice prosthesis or when customized fen estration with the FenestrationPunch is preferred e The LaryTube with Ring version to be worn with an adhesive base plate Recommended if a cannula is only used during the night or with the Provox Free Hands HME to support the stoma seal To allow for proper selection and sizing the Provox LaryTube Sizer Kit contains sterilizable and reusable tubes of all lengths and sizes The Standard and Fenestrated LaryTube devices are secured by Provox TubeHolder or Provox LaryClip The LaryTube with Ring is held by an adhesive base plate LaryTube Rx Standard ID OD L REF Fenestrated ID OD L REF withRing ID OD L REF LaryTube 8 27 Rx _ 95 12 0 27 7601 a E a 2 l a E k i EN A LaryTube 8 36 Rx vo Dy 9 5 120 36 7602 a DS 295 120 36 7637 A E O oes y j LaryTube 8 55 Rx S 95 12 0 55 7603 Bo amp 93 120105517038 95 12 0 55 7625 LaryTube 9 27 Rx 10 5 13 5 27 7605 Ej lt 2 ee LaryTube 9 36 Rx 10 5 13 5 36 7606 10 5 13 5 36 7640 10 5 135 36 7626 LaryTube 9 55 Rx 10 5 135 5
23. eeHands HME Hamade R Hewlett N amp Scanlon E 2006 A q o Phon 20 187 193 Hilgers F J amp Ackerstaff A H Development and evaluation of a novel or replacement and complications of the Provox voice prosthesis Laryngoscope 1997 cCaffrey TV Early speech results with the Provox 1 prosthesis after laryngectomy Arch Otolaryngol Head Neck Surg 1997 Sep 123 9 966 8 _ Ackerstaff AH Balm AJM Tan IB Aaronson NK Persson JO Development and clinical evaluation of a second generation voice prosthesi etrograde insertion Acta Otolaryngol 1997 117 889 896 s Provox 2 designed for anterograde and Balm AJM Long term results of vocal rehabilitation after total laryngectomy with the is Clin Otolaryngol 1993 18 517 523 Cornelissen MW Balm AJM Aerodynamic characteristics of the Provox low ORL 1993 250 375 378 3 nce self retaining prosthesis Provox for voice ehabilitation after total laryngectomy Laryngoscope 1990 100 1202 1207 uantitative and qualitative evaluation of an utomatic occlusion device for tracheoesophageal speech the Provox FreeHands HME Clin Linguist tracheostoma button and fixation system Provox LaryButton and LaryClip adhesive to facilitate hands free tracheoesophageal speech Acta Otolaryngologica 2006 Dec 126 11 1218 1224 Head office Atos Medical AB P O Box 183 SE 242 22 H rby Sweden Tel 46 0 415 198 00 Fax
24. ent Non sterile reusable sterilizable Comes with 5 Provox Measure Flanges Provox Measure Flanges Non sterile for single use The Provox Dilator is used for up sizing the diameter of a TE fistula by stepwise dilation e when changing from a smaller to a larger diameter prosthesis e for temporary stenting of a TE fistula irrespective of type and diameter of the voice pros thesis used e in case of a shrunken fistula i e after the rare event of a lost voice prosthesis A retention collar at the end of each section prevents that section from sliding back to the preceding thinner section Diameter at tip 15 Fr increases to 24 Fr in one device Steps 18 20 22 24 Fr Order information Quantity Size REF Provox Dilator 1 pc One size 7211 Silicone non sterile reusable sterilizable www atosmedical us 1 800 217 0025 Provox Measure After reading the scale the Provox Measure is removed by tilting Provox Dilator User Accessories Once a Provox Voice Prosthesis is in place it usually requires little care However daily cleaning may help maintain device function and prolong its lifetime Provox Flush The Provox Flush is a cleaning device with several attractive features Use both hands when using the device to ensure a watertight fit between the tip and lumen of the prosthesis In experimental studies the regular use of the Provox Flush has shown a prolongation of device lifetime of voice prost
25. er Manual and Prescriber Information This catalog does not replace nor does it set forth the complete contents of the User Manual and or Prescriber Information for the products in this catalog and is not a substitute for reviewing and understanding that important information Therefore before prescribing and or using any of the products included in this catalog please review the entire contents of the respective User Manual and or Prescriber Information User Manuals and Prescriber Informations are available online at www atosmedical com In the United States you may also obtain a copies by calling 1 800 217 0025 sending a Fax to 1 414 227 9033 or an e mail to info us atosmedical com or writing to Atos Medical Inc 11390 W Theodore Trecker Way West Allis WI 53214 1135 USA Information in French is available online at www atosmedical com Reference list Provox Voice Prostheses New publications Hancock K Ward L Lawson N van As Brooks C An RCT of Two Indwelling Voice Prosthesis Patient Preferences ASHA Convention November 20th 2009 New Orleans USA Poster 330 Ward E Hancock K Lawson N van As Brooks C An RCT of 2 ndwelling Voice Prosthesis Perceptual voice characteristics ASHA Convention November 20th 2009 New Orleans USA Poster 325 Hilgers FJ Ackerstaff AH van Rossum _ Jacobi Balm AJ Bing Tan van den Brekel MW Clinical phase feasibility study of the next generation indwelling Provox
26. er boxes Outer tray can be cleaned in instrument washer OD outer diameter L length in mm www atosmedical us 1 800 217 0025 Barton Mayo Tracheostoma Button The Barton Mayo Tracheostoma Button Mayo Clinic was developed to provide leakproof tracheostoma valve retention for near total laryngectomy and total laryngectomy patients Some of the advantages of using a Barton Mayo Tracheostoma Valve include e Can be used with an HME Heat and Moisture Exchanger e Enhances speech with hands free stoma occlusion e Another option for positive stoma sealing e Reduces stoma contractions with a wide range of sizes available Please note Not for sale in Canada Diameter Length Order info Size Models Rx REF mm mm Short 15 ENBMB091 Bente a paaki 13 5 22 Rx ENBMBO092 Long 30 ENBMB093 Short 15 ENBMB101 ieee Ms Fy peak 15 0 22 Rx ENBMB102 Long 30 ENBMB103 Short 15 ENBMB121 cape Memes ay Reni 17 0 22 Rx ENBMB122 Long 30 ENBMB123 Short 15 ENBMB141 ad Macneostoma O Regular 19 0 22 Rx ENBMB142 Long 30 ENBMB143 Barton Mayo Sizing Kit ENBMBKIT Manufactured by Medical Innovations International Inc USA Conversion chart Barton Mayo Button Provox LaryButton REF Diameter Length REF Diameter Length Short 13 5 15 7671 12 8 9 Regular 13 5 22 7685 12 18 Long 13 5 30 Short 15 0 15 7672 14 8 10 Regular 15 0 22 7686 14 18 Long 15 0 30 Short 17 0 15 7673 16 12 Regular 17 0 22 7687 16 18 Long 17 0 30 S
27. erile for single patient use www atosmedical us 1 800 217 0025 Educational Material At Atos Medical we seek to increase awareness and knowledge regarding postlaryngectomy rehabilitation options The following material we offer as a courtesy to the dedicated professional www atosmedical us 1 800 217 0025 Provox 2 Training Kit Essential for practicing the Provox2 insertion replacement method ex vivo Contains 1 Inserter Pin 3 Loading Tubes 1 demo Provox2 8 mm 1 Instructions for Use Order information Includes REF Provox2 Training Kit 1 Inserter Pin 3 Loading Tubes 7222 1 demo Provox2 8 mm 1 Instructions for Use Artificial Fistula Model For practice and demonstration of the Provox Vega and Provox NID insertion and replacement methods Order information REF Artificial Fistula Model Provox 8201 Includes 1 SmartInserter loaded with Provox Vega 22 5Fr Artificial Fistula Model NID 7129 Includes 1 Provox NID prosthesis 8 mm 17 French and 1 inserter Model NID Model Provox Life as a Laryngectomee Brochure Introduction to post laryngectomy rehabilitation Explains the rationale behind products Available in several languages Order information REF Life as a laryngectomee 7962US PROVOX Vega Order information REF Provox Vega Poster MC0510 ThEN www atosmedical us 1 800 217 0025 Instructional CD s and DVD s Various instructional CD s and DVD s Order information REF A
28. erm base plate or a Provox LaryTube In these cases external humidifiers may no longer be needed Order information Pieces Products Rx REF Provox HME Sensitive Skin Starter Kit Adhesive OptiDerm Round 7255 Rx 7292 Adhesive OptiDerm Oval 7256 Remove 1 pc 72331 Skin Prep 77205 Provox Cleaning Towels 10 towels 7244 Provox HME Cassette HiFlow 72415 Adhesive FlexiDerm Oval 7254 Rx 7293 Adhesive FlexiDerm Round 7253 Remove 1 pc 72331 Skin Prep 77205 Provox HME Flexiderm Starter Kit Provox Cleaning Towels 10 towels 7244 Provox HME Cassette HiFlow 72415 Adhesive Regular Round 7251 Rx 7295 Adhesive Regular Oval 7252 Provox HME Regular Starter Kit Remove 1 pc 72331 Skin Prep 77205 Provox Cleaning Towels 10 towels 7244 Provox HME Cassette HiFlow 72415 N Un N N WN U NY NNUA NY NUN Provox HME Clinicians Adhesive Kit pieces of Adhesive FlexiDerm Oval 7254 and Rx 7296 of Adhesive FlexiDerm Round 7253 2 pieces of Adhesive OptiDerm Round 7255 Adhesive OptiDerm Oval 7256 Adhesive Regular Round 7251 and of Adhesive Regular Oval 7252 3 XtraBase Adhesive Round 7265 10 Remove 1 pc 72331 10 Skin Prep 77205 2 Provox Cleaning Towels 10 towels 7244 10 Provox HME Cassette HiFlow 72415 Provox HME Let s Start sample bag 1 of each Provox Adhesives 7251 7256 and 7265 Rx 7257 5 of each Provox HME Cassettes 7240 and 7241 1 unit of Provox Clea
29. f needed wings which are attached to the outer rim of the Provox LaryButton may be used to secure the button with a Provox LaryClip or Provox TubeHolder in order to avoid accidental dislodgement The Provox LaryButton is particularly well suited for patients with a circumferential skin fold around the tracheostoma so called lip however other users may also benefit To allow for proper selection and sizing the Provox LaryButton Sizer Kit contains sterilizable and reusable buttons of all lengths and sizes Key features e Effective The conical shape facilitates a tight fit as it allows the Provox LaryButton to be situated close to the stoma e Compatible The Provox LaryButton is intended to be worn in combination with the Provox HME System with optimal fit and stability e Soft The Provox LaryButton is constructed from soft silicon material and is atraumatically shaped to reduce negative side effects such as stoma irritation and bleeding Order information Rx OD L REF Provox LaryButton 12 8 Rx 12 8 7671 Provox LaryButton 14 8 Rx 14 8 7672 Provox LaryButton 16 8 Rx 16 8 7673 Provox LaryButton 18 8 Rx 18 8 7674 Provox LaryButton 12 18 Rx 12 18 7685 Provox LaryButton 14 18 Rx 14 18 7686 Provox LaryButton 16 18 Rx 16 18 7687 Provox LaryButton 18 18 Rx 18 18 7688 Non sterile for single patient use Maximum device lifetime 6 months Provox LaryButton Sizer Kit Rx 7690 Non sterile reusable sterilizable Sizer Buttons and inn
30. heses even if only used with air Features e comfortable use e allows flushing fresh water under slight pressure through the lumen of the prosthesis thereby helping to clean the prosthesis from debris and crusts flushing away mucus from the pharynx and esophagus The Provox Flush can be a valuable addition to the regular use of the Provox Brush Order information Quantity Size REF Provox Flush fits all Provox Voice Prostheses 1 pc one size 8109 Non sterile reusable Can be boiled For single patient use An in vitro study about the use of Provox Flush From the University of Groningen the Netherlands This study shows that use of the Provox Flush has a cleansing effect especially on Provox2 voice prostheses and furthermore suggests that daily airflow through voice prostheses as part of a daily maintenance scheme reduces biofilm formation and can be expected to prolong the life of these devices Free RH Van der Mei HC Elving GJ Van Weissenbruch R Albers FW Busscher HJ Influence of the Provox Flush blowing and imitated coughing on voice prosthetic biofilms in vitro Acta Otolaryngol 2003 May 123 4 547 51 14 www atosmedical us 1 800 217 0025 The Provox Brush is made for cleaning the inside of the Provox voice prosthesis without removing it from the TE fistula and works as follows e Insert the brush into the prosthesis and gently move it back and forth with a twisting motion e After rem
31. hoose what s right for your patient with eighteen 18 sizes that fulfill individual clinician preferences and treatment philosophies 3 diameters 17 Fr 20 Fr and 22 5 Fr 6 lengths 4 6 8 10 12 5 and 15 mm 3 g Product name 4 mm 6 mm 8 mm 10 mm 125 mm a ProvoxPlug Provox Flush Provox Vega 17 Fr 8110 8111 8112 8113 8114 8115 8119 Provox Vega 20 Fr 8120 8121 8122 8123 8124 8125 8129 5100 Provox Vega 8130 8131 8132 8133 8134 8135 8139 22 5 Fr Provox Brush 7204 XL 7225 Provox Dilator 7211 RX Note Provox Vega has a registration pending for Canada lts so easy Easy cleaning and maintenance Advanced design of the Provox Vega voice prosthesis assures effective and quick cleaning e Candida resistant blue ring e Newly designed Provox Flush fits all Provox voice prostheses with 4 nozzles that provide high tech turbulence for exceptional cleaning ability e Redesigned plugs in 3 sizes 17Fr 20Fr and 22 5Fr that further improve ease of use Effort needed fop om E www atosmedical us 1 800 217 0025 Innovative placement Easy airflow Innovative placement device the SmartInserter designed for added patient comfort and confident The Provox Vega voice prosthesis is clinician placement engineered to maximize airflow a i and minimize effort e Preloaded amp sterile e No assembling or loose parts Easy to control e Design prevents unintention
32. hort 19 0 15 7674 18 8 14 Regular 19 0 22 7688 18 18 Long 19 0 30 www atosmedical us 1 800 217 0025 32 Provox LaryClip The new patented Provox LaryClip is a two piece system that helps to optimize the airtight attachment of the Provox LaryButton and the Provox LaryTube to the stoma It consists of a square adhesive base and a hook and loop clip that allows for optimal fit to the wings of the Provox LaryButton and LaryTube When the adhesive Base is attached to the skin at both sides of the stoma and is even tually removed due to loss of its stickiness the Clip part can be removed and re attached as needed Key features e Increases the usability of the Provox LaryButton e Simple touch fasten unfasten solution Strong FlexiDerm adhesive properties e May be taped to the most optimal area to the skin around the stoma e An alternative to the use of neckbands Order information Quantity REF Provox LaryClip 1 set 7669 8 pcs LaryClip 40 pcs LaryClip Base Non sterile for single patient use www atosmedical us 1 800 217 0025 Other Accessories Provox FenestrationPunch The Provox Fenestration Punch is used for making small fenestrations in the LaryTube at the desired location Order information Quantity REF Provox FenestrationPunch 1 pc 7654 Non sterile reusable sterilizable New design for easier handling and improved hygiene Order information Size Quantity REF Provox Tu
33. ies of the popular FlexiDerm base plate and Provox XtraBase are alike But thanks to its special shape and controlled elasticity Provox XtraBase helps in many cases to achieve an optimized fit and even longer durability This may be most beneficial in case of e having a deep stoma e using an automatic tracheostoma valve Provox FreeHands HME Beyond that Provox XtraBase may improve stoma attachment in many other cases where firm skin contact is desired Order information Quantity REF Provox XtraBase 20 pcs 7265 Non sterile for single use www atosmedical us 1 800 217 0025 Accessories for tracheostoma attachment Proper skin preparation is essential for users of automatic tracheostoma valves Users of regular Provox HME also benefit from optimal cleaning around the tracheostoma Remove This product is used to remove medical tape and any residue left behind from the application of base plates from silicone glue It is recommended that Remove first be applied directly on top of a base plate where it penetrates the material best with Provox FlexiDerm After use the skin is oily and has to be cleaned water and non oily soap or Provox Cleaning Towel before using a new adhesive Order information Quantity REF Remove 50 pcs 403100 Non sterile for single use Provox Cleaning Towel Provox Cleaning Towels remove oil from the skin They are alcohol based and non perfumed Order information Quantity REF Pr
34. ile ready for use For single patient use 7126 and 7127 have been replaced by 7204 and 7225 Provox Flush The Provox Flush is a dedicated maintenance device for cleaning the inner lumen of the Provox NID prosthesis by using clean water or air Included in the Starter Kit and available separately Order information Rx REF on Provox Flush Rx 8109 Non sterile ready for use Suits all Provox voice prosthes For single patient use Provox NID Storage Box The Provox NID Storage Box helps to keep the Provox NID prosthesis and accessories clean and fits into a normal sized pocket for convenient storage and transport Included in the Starter Kit and available separately Order information REF Provox NID Storage Box 7128 Non sterile ready for use For single patient use www atosmedical us 1 800 217 0025 Professional Accessories Provox Trocar with Cannula This instrument is used for making primary or secondary TE punctures The Provox Trocar is preferred to a scalpel because it creates a round fistula and the surrounding tissue remains a intact After the trocar is withdrawn the Provox Guidewire is inserted through the cannula Order information Quantity REF Provox Trocar 1 pc 7203 Instrument steel non sterile reusable sterilizable Provox Pharynx Protector The Provox Pharynx Protector helps protect the pharyngeal walls from accidental piercing during primary TE puncture It can also red
35. l flange of i the Provox2 voice prosthesis helps ensure a proper eh 19 h success rate fit even if the fistula size changes slightly oS a A Order information Size Rx REF Provox 2 Starter Kit contains The stable flanges of the Provox2 voice prosthesis 1 each of Provox2 Voice Prostheses Provox2 4 5mm Rx 7216 facilitate immediate confirmation of whether the 721 6 7219 and 7221 Provox2 6mm Rx FIAT device is correctly in place 1 Provox Trocar 7203 Provox2 8 mm Rx 7218 1 Provox Pharynx Protector 7210 Provox2 10 mm Rx 7219 1 Provox Guidewire 7215 Provox2 12 5 mm Rx 7221 1 Provox Measure 7270 Provox2 15 mm Rx 7224 1 Set of Provox Brushes 6 pcs 7204 Provox2 Training Kit 7222 1 Provox Plug 7205 Provox2 Starter Kit see left Rx 7223 Provox2 is sterile for single use A Provox2 Training Kit is available to practice anterograde 1 Provox2 Training Kit 7222 insertion 1 Provox Flush 7206 From the long term prospective clinical trial of Provox ActiValve at the Netherlands Cancer Institute Amsterdam Prototype testing and the long term clinical trial confirmed that the new valve material remained free of Candida growth and that the use of magnets can prevent inadvertent opening of the valve during swallowing and or deep inhalation This resulted in a highly significant increase in device lifetime in the 18 laryngectomized patients in the prospective trial 14 fold increase on average range 3 39 fold p lt 0 00
36. medical com Patents and Trademarks Healthcare Ltd Provox Provox ActiValve Provox FreeHands HME Provox StomVent Provox XtraBase and Let s talk about life are registered trademarks owned by Atos Medical AB Sweden Provox Vega Provox XtraHME Provox HME Cap Provox LaryTube Provox LaryClip and Provox LaryButton are trademarks owned by Atos Medical AB Sweden Remove and Skin Prep are trademarks owned by Smith amp Nephew Inc U S A Kapi Gel is a registered trademark of Kapitex Provox Provox 2 Provox ActiValve Provox HME Provox FreeHands HME Provox HME Cap Provox XtraBase Provox StomVent TrachPhone and Provox NID are protected by patents US 5 314 470 US 5 976 151 US 5 738 095 US 6 422 235 US 5 042 468 JP 3 553 955 and other patents and patents and design registrations pending Morshed K Golabek W Szymanski M Olszanski W Speech rehabilitation using Provox voice prosthesis Otolaryngol Pol 2005 59 2 225 8 A Demi tablet Mar 125 3 304 6 ahead of print Article in German a G an Vocol 2004 29 2 84 6 7 ussart C Lawson G Remacle Voice prosthese 2003 124 5 299 304 rticle in Polish D Suoglu Y Emin H Guven M Kiyak E Factors that affect in situ lifetime of Provox voice prosthesis Kulak Burun Bogaz Ihtis Derg 2004 13 5 6 126 31 Article in Turkish
37. n in laryngectomized patients Problems related to implantation and change of voice prosthesis Otolaryngologia Polska 2006 60 2 129 34 Terada T Saeki N Toh K etal Voice rehabilitation with Provox2 voice prosthesis following total laryngectomy for laryngeal and hypopharyngea March 34 1 65 71 Gonzalez Poggioli N Gonzalez Botas JH Vazquez Bar fistulas today Acta Otorrinolaringol Esp 2007 March Bremke M Werner JA Lichtenberger G Folz BJ Chronic Succesful therapy with Provox voice prosthesis Laryngo o 3 h carcinoma Auris Nasus Larynx 2007 JC Novoa J V Martinez VJ Phonation 110 2 aspiration secondary to a Staffleri fistula inootologie 2007 Boscolo Rizzo P Zanetti F Carpen S Da Mosto MC Long term results with tracheoesophageal voice prosthesis Primary versus secondary TEP European Archives of Otorhinolaryngology 2008 Jan 265 1 73 77 Padhya TA Athavale SM Morgan JM McCaffrey TV An a tracheoesophageal puncture in the difficult laryngectomy 118 2 266 269 Soolsma J Van Den Brekel MW Ackerstaff AH Malm AJ Ta ternative approach for secondary neck The Laryngoscope 2008 Feb n B Hilgers FJ Long term results of Provox ActiValve solving the problem of frequent Candida and Underpressure related voice prosthesis tal Arch Sci Med 2005 164 3 191 194 Dec 119 12 988 90 18 Ramalingam WVBS Chikara D Rajagopal
38. ning Towels 7244 Non sterile for single use www atosmedical us 1 800 217 0025 Provox Adhesives Provox Adhesives FlexiDerm is very flexible and has the strongest adhesive properties It is especially suitable for patients with a deep and or irregular stoma or those who prefer a very soft and flexible adhesive Due to the type of glue used any residual glue should be removed with a suitable skin cleanser Average durability 48 hours esiverna val HenbermRound OptiDerm is intended for patients with sensitive skin or if the skin is not yet healed properly e g after surgery and or irradia tion OptiDerm absorbs moisture is gentle to the skin and needs less frequent replacement Average durability 36 hours Regular is a transparent adhesive It is less flexible and adhesive than FlexiDerm It leaves less residual glue is easier to handle and more comfortable to use This adhesive is recommended Gpiibermdval opib oina for persons with a regular normal stoma and skin Average durability 24 hours Order information Quantity REF FlexiDerm Oval 20 pcs 7254 FlexiDerm Round 20 pcs 7253 OptiDerm Oval 20 pcs 7256 OptiDerm Round 20 pcs 7255 Regular Oval Regular Round Regular Oval 20 pcs 7252 Regular Round 20 pcs 7251 Non sterile for single use Provox XtraBase Provox XtraBase is a unique convex self adhering base plate designed specifically for deep and or irregular stomas The adhesive propert
39. oval clean the brush with gauze e Repeat the procedure as often as necessary e After use clean the brush with water and store it dry for the next use Each brush may be used for a maximum period of 1 month Available in two lengths Designed for improved cleaning e Safety wings on the brush shaft that help prevent accidental aspiration of the Provox Brush e Blue shaft and ball tip for improved visibility e For improved hygiene the Provox Brush can be boiled max 5 min each time and disinfected in 70 ethanol or 2 hydrogen peroxide max 5 min each time e Hexagonal rear end for improved application of the Provox Plug e Reference number and size indication on the safety wings Order information Quantity Size REF Provox Brush 6 pcs 4 10mm 7204 Provox Brush XL 6 pcs 12 15mm 7225 Non sterile reusable Single patient use The Provox Plug is a first aid tool for temporarily stopping leakage through the prosthesis The plug is inserted into the opening of the Provox voice prosthesis with the help of the non bristled end of a Provox Brush The medallion end can be taped to the skin if desired Although speech is not possible while the Provox Plug is in place it is possible again after removal of the plug by pulling on the safety strap Order information Quantity Size REF Provox Vega Plug 17 Fr 1 pc 17 Fr 8119 Provox Vega Plug 20 Fr 1 pc 20 Fr 8129 Provox Vega Plug 22 5 Fr 1 pc 22 5 Fr 8139 Provox Plug for Provox2 1 pc One size 7205
40. ovox Cleaning Towel 200 pcs 7244 20 resealable pouches of 10 Non sterile for single use Skin Tac Skin Tac improves adhesion of appliances and tape to the skin Also works as a barrier be tween tape and skin to reduce irritation Convenient single use packets are ideal for travel and to maintain good hygiene Skin Tac is hypo allergenic and latex free Remove with rubbing alcohol For external use only Order information Quantity REF Skin Tac wipes 50 pcs MS407W www atosmedical us 1 800 217 0025 Skin Prep Skin Prep improves the stickiness of our adhesive baseplates by forming a thin protective bar rier on the skin Order information Quantity REF Skin Prep 50 pcs 420400 Non sterile for single use Preparing your skin 1 Clean the skin around the stoma 2 Improve the stickiness of the base plate by pre warming the base plate between your hands especially for OptiDerm 3 Protect the skin by applying Skin Prep or similar agent and let it dry 4 Apply the base plate to the skin Stretch the skin away from the stoma in order to improve the attachment evenly to wrinkled skin 5 Improve performance of the stoma seal by massaging the base plate carefully and gently for approximately one minute in order to improve skin attachment 6 Wait at least 30 minutes use manual occlusion if speaking is necessary www atosmedical us 1 800 217 0025 Provox Silicone Glue Provox Silicone Glue
41. peech without manual stoma closure It has many built in features that makes it easy to use and it requires only minimal handling and maintenance 24 www atosmedical us 1 800 217 0025 Provox FreeHands HME The Provox FreeHands HME is best used with a Provox XtraBase self adhering base plate but it can also be attached to any other Provox Adhesive base plate or a Provox LaryTube cannula with ring which itself is held by a base plate All features of the Provox FreeHands HME are designed for maximum discretion the small size the transparent color and the side openings which allow the device to be covered with clothing If needed by simply rotating the Provox FreeHands HME while in place a user can turn the automatic speech function on or off To match individual needs the Provox FreeHands HME is available with three easy to replace membranes each with different closing resistances The clinician should adjust the device for the user by choosing a suitable membrane and checking the proper function of the adjustable cough relief valve A dedicated cleaning container facilitates the maintenance of the reusable valve unit The FreeHands HME cassettes are specially designed to fit the FreeHands valve unit housing or the HME Cap and are different from the regular HME cassettes Note Do not use the FreeHands HME cassettes separately Order information Quantity Rx REF Provox FreeHands HME starter kit Rx 7710 Provox
42. practical guide to post laryngectomy rehabilitation including the Provox System CD ROM ISBN 90 75575 05 X Provox HME DVD 7969 N Picture CD ROM 7819 Olfaction CD ISBN 90 75575 07 6 Please contact us for further Secondary Puncture DVD Spanish English information Provox Instructional Movies NTSC 7861 N For Windows and Macintosh www atosmedical us 1 800 217 0025 Starter Kits Order information Provox FreeHands HME Provox2 Starter Kit Provox HME Let s Start sample bag Pieces 1 e ON WM Products Rx REF Valve unit housing with a medium blue dot Rx 7293 membrane FreeHands HME Cassettes 7712 Provox XtraBase 7265 Skin Prep Tissues Adjustment Kit Speech Valve Membrane light white dot 7713 Speech Valve Membrane strong green dot 7715 Cleaning and Storage Box 7718 of each Provox2 Voice Prostheses 7216 7219 Rx 7295 and 7221 Provox Trocar 7203 Provox Pharynx Protector 7210 Provox Guidewire 7215 Provox Measure 7270 Set of Provox Brushes 6 pcs 7204 Provox Plug 7205 Provox Flush 8109 Provox2 Training Kit 7222 of each Provox Adhesives 7251 7256 and 7265 Rx 7257 of each Provox HME Cassettes 7240 and 7241 unit of Provox Cleaning Towels 7244 38 gt www atosmedical us 1 800 217 0025 Order information Provox HME Sensitive Skin Starter Kit Provox HME FlexiDerm Starter Kit Provox HME Regular Starter Kit Provox HME Clinicians A
43. sette HiFlow ColorSplash Beige 30 pcs Rx 7243C Non sterile for single use max 24 hours www atosmedical us 1 800 217 0025 Provox Micron Order information Provox Micron HME Provox Micron HME A breakthrough in airway protection the world s first HME for laryngectomees that is com bined with an effective bacterial and viral filter Without compromising pulmonary rehabili tation and user friendliness we have combined our HME with a highly effective electrostatic filter which filters charged particles Provox Micron HME addresses the risk of infection by airborne pathogens and could be valuable for laryngectomees in need of improved health safety The Micron HME is designed to be worn in front of the tracheostoma and the integral filter helps to filter small airborne particles e g bacteria viruses dust and pollen The HME part of the Micron is clinically proven to improve the airway climate It is compatible with the Provox System and can be attached using Provox Adhesive Baseplates a Provox LaryTube or a Provox LaryButton Key features e Based on the original Provox HME cassette Provides the same HME capabilities as our Normal HME cassette Easy occlusion for voicing Sideway airflow for discrete use and optimal hygiene e Electrostatic filter material Bacterial Filtration Efhciency BFE gt 99 8 Virus Filtration Efficiency VFE gt 99 8 e Oval shaped and soft outer material e Fi
44. ts all the attachment devices in the Provox System Electrostatic filter Electrostatic air filters are intended to filter particles which are considered harmful for a patient These particles can be of different types like pollen which can cause asthma or allergenic re sponses street dust which can bear bacteria or virus or be allergenic and water droplets which can contain bacteria or viruses An HME is most effective when worn day and night It usually takes some weeks until the pulmonary symptoms improve During the first days of use there may be increased mucus production Quantity Rx REF 5 pcs Rx 7247 30 pcs Rx 7248 Non sterile for single use max 24 hours www atosmedical us 1 800 217 0025 Provox HME Starter kits Provox HME Starter kits allow users to test various base plates and cassettes for several days facilitating an informed choice for larger supplies The Provox HME Let s Start sample bag has one of each adhesive to try In addition to the mixed adhesive kit 4 adhesive specific kits allow you to use a specific adhesive over several days to ensure it is the best choice for you Talk to your clinician about which adhesive type you should try Our clinicians kit is a comprehensive tool kit to help determine the best adhesive for your patient The earlier the patient starts using an HME after surgery the easier it is to adapt HMEs are often introduced the day after surgery and attached by an OptiD
45. uce the risk of injury to the surgeon Order information Quantity REF Provox Pharynx Protector 1 pc 7210 Provox Pharynx Protector O Ring 1 pc 7209 Instrument steel non sterile reusable sterilizable Provox Guidewire The Provox Guidewire enables retrograde insertion of Provox 1 and Provox2 prostheses The tip contains a retainer slit into which the security string of the prosthesis is held There is also a stop on the guidewire shaft to allow extraction of the old prosthesis after the tracheal flange has been cut off The guidewire is not intended for pulling the prosthesis into the TE fistula a non toothed hemostatic forceps is recommended for this procedure Order information Quantity REF Provox Guidewire 1 pc 7215 Sterile for single use www atosmedical us 1 800 217 0025 The Provox Measure is used to check the length corresponding to prosthesis size of TE fis tulas The correct prosthesis size is important to minimize the risk of complications and should always be checked when replacing a prosthesis The single use flanges of Provox Measure can be attached to the instrument in two different ways facilitating measurement of fistulas made for different voice prosthesis diameters Note Do not use in 16 Fr fistulas without prior dilation to at least 20 Fr 21 24 FR 20 FR Order information Quantity Size REF Provox Measure 1 pc One size 7270 Provox Measure Flanges 5 pcs One size 7271 Provox Measure instrum
46. urgery In vitro air flow characteristics Provox ActiValve Provox2 ActiValve Light Order information Size Rx REF ActiValve Strong Provox ActiValve Light 4 5 mm Rx 7150 Provox ActiValve Light 6 mm Rx 7151 Provox ActiValve Light 8 mm Rx 7152 Provox ActiValve Light 10 mm Rx 7153 Provox ActiValve Light 12 5 mm Rx 7154 Provox ActiValve Strong 4 5 mm Rx 7160 Provox ActiValve Strong 6mm Rx 7161 a Provox ActiValve Strong 8 mm Rx 7162 0 05 1 25 10 128 15 175 20 min Provox ActiValve Strong 10 mm Rx 7163 da Provox ActiValve Strong 12 5 mm Rx 7164 Valve Strong in case of negative pressure in the PE segment Provox ActiValve XtraStrong 4 5 mm Rx 7165 Provox ActiValve XtraStrong 6 mm Rx 7166 Provox ActiValve XtraStrong 8 mm Rx 7167 Provox ActiValve XtraStrong 10 mm Rx 7168 Provox ActiValve XtraStrong 12 5 mm Rx 7169 Provox ActiValve Lubricant replacement 7149 Provox ActiValve is non sterile for single use Includes 1 Provox ActiValve Voice Prosthesis 1 single use insertion tool 2 Provox Brush 1 Provox ActiValve Lubricant 1 User Card www atosmedical us 1 800 217 0025 VAS m Vy Vega In 1990 the first Provox voice prosthesis was introduced followed by the second generation Provox2 in 1997 Provox has made a global impact Now we proudly pres ent the third generation Provox Vega voice prosthesis with SmartInserter The standard has been raised Easy choice Provox Vega makes it easy to c
47. vox voice prosthesis was developed in 1988 to provide for low airflow resistance and extended device lifetime The second generation Provox prosthesis Provox 2 was introduced in 1997 Based on the original Provox design Provox2 allows bi directional insertion i e either anterograde insertion through the stoma or retrograde insertion through the pharynx and mouth The Provox ActiValve is intended to help people who experience short prosthesis lifetime as the result of various biological conditions In 2009 the third generation Provox Vega with Smartinserter was introduced in three diameters www atosmedical us 1 800 217 0025 Provox Voice Prosthesis Provox 1 The original Provox voice prosthesis is supplied with a Provox Guidewire for retrograde insertion Order information Size Rx REF Provox 1 4 5mm Rx 7208 Provox 1 6mm Rx 7200 Provox 1 8mm Rx 7201 Provox 1 10 mm Rx 7202 Sterile for single use Includes 1 Provox Voice Prosthesis 1 Provox Guidewire 1 Scalpel 1 Provox Brush From the Department of Otolaryngology Head and Neck Surgery Helsinki University Central Hospital Helsinki Finland We performed a retrospective chart review of 95 patients 88 men and 7 women mean age 63 5 years who underwent insertion of a voice prosthesis in the period 1992 to 2002 Eighty one percent 77 95 of the patients underwent a primary prosthesis insertion at the time of laryngectomy A head and neck surgeon
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