2009 US Provox Catalog
Contents
1. 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 Ameye D Honraet K Loose D Vermeersch H Nelis H Remon JP Effect of a buccal bioadhesive nystatin tablet on the lifetime of a Provox silicone tracheoesophageal voice prosthesis Acta Otolaryngol 2005 Mar 125 3 304 6 Kummer P Chahoud M Schuster M Eysholdt U RosanowskiF Prosthetic voice rehabilitation after laryngectomy Failures and complications after previous radiation therapy HNO 2005 May 4 Epub ahead of print Article in German Globlek D Simunjak B lvkic M Hedjever M Speech and voice analysis after near total laryngectomy and tracheoesophageal puncture with implantation of Provox 2 prosthesis Logoped Phoniatr Vocol 2004 29 2 84 6 Trussart C Lawson G Remacle M Voice prostheses long term follow up retrospective study three to sixteen year follow up of 22 patients Rev Laryngol Otol Rhinol Bord 2003 124 5 299 304 Scheuermann K Delank KW Perforation of the esophagus with a mediastinal abscess HNO 2005 Jan 53 1 66 70 Article in German Makitie AA Niemensivu R Juvas A Aaltonen LM Back L Lehtonen H Postlaryngectomy voice restoration using a voice prosthesis a single institution s ten year experience Ann Otol Rhinol Laryngol 2003 Dec 112 12 1007 10 Hilgers FJ Ackerstaff AH Balm AJ Van den Brekel MW Bing2. User 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 fitness of the product for any particular purpose 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 atosmedical com Patents and Trademarks 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 peer reviewed publications Boscolo Rizzo P Marchiori C Gava A Da Mosto MC 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
3. Order information Quantity REF StomaMeasure for LaryTube 1 pc 7807 Non sterile Provox TubeBrush Provox TubeHolder StomaMeasure 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 sterile for single patient use 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 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 P
4. 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 racheoesophageal speaking valves in Chinese patients undergoing laryngectomy Archives of tolaryngology Head and Neck Surgery 2005 November 131 11 954 8 cS GS us tajner Katusi S 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 after surgical voice and speech rehabilitation 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 et al Voice rehabilitation with Provox2 voice prosthesis following total laryngectomy for laryngeal and hypopharyngeal carcinoma Auris Nasus Larynx 2007 March 34 1 65 71 Gonzalez Poggioli N Gonzalez Botas JH Vazquez B
5. Blue shaft and ball tip for improved visibility For improved hygiene the Provox Brush can be boiled max 5 min each time and disin fected in 70 ethanol or 2 hydrogen peroxide max 5 min each time Hexagonal rear end for improved application of the Provox Plug Reference number and size indication on the safety wings Order information Quantity Size REF Provox Brush 6 pcs 4 5 10 7204 mm Provox Brush XL 6 pcs 12 15mm 7225 Non sterile reusable 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 Plug 1 pc One size 7205 Non sterile reusable For single patient use Includes one Provox Brush 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 Provox HME System A heat and moisture exchanger heats and moisturizes experience fewer problems with coughing and mucus inhaled air and restores breathing resistance toa production This improves
6. Kit and available separately Provox NID 17 Starter Kit 12 18 mm Rx 7132 Containing Dilator 17 Brush XL set of 6 Flush 17 Storage Box Provox NID 20 Starter Kit 6 10 mm Rx 7133 Order information Rx REF Containing Dilator 20 Brush set of 6 Flush 20 Storage Box Provox Dilator 17 Rx 7122 Provox NID 20 Starter Kit 12 18 mm Rx 7134 pee aan 7123 Containing Dilator 20 Brush XL set of 6 Flush 20 Storage Box Non sterile ready for use For single patient use Nai em O Sling U We 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 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 reduce 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
7. 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 REF 7208 7200 7201 7202 7220 Provox 1 Starter Kit 1 Provox Voice Prosthesis Provox 1 each of Provox Voice Prosthesis 6 8 10 mm 7200 7201 7202 Provox Trocar 7203 Provox Pharynx Protector 7210 Set of Provox Brushes 6 pcs 7204 Provox Plug 7205 Provox 2 Voice Prosthesis using the Provox Guidewire _ can be performed by any trained health care professional Features low airflow resistance asa replacement prosthesis for the Provox 1 or other voice prosthesis Provox2 is a low resistance indwelling silicone voice prosthesis that can be inserted 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 in an anterograde manner using
8. 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 Provox Measure 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 After reading the scale the Provox Measure is Order information Quantity Size REF FEIGNED Y MIRING Provox Measure 1 pc One size 7270 Provox Measure Flanges 5 pcs One size 7271 Provox Measure instrument Non sterile reusable sterilizable Comes with 5 Provox Measure Flanges Provox Measure Flanges Non sterile for single use Provox Dilator The Provox Dilator is used for up sizing the diameter of a TE fistula by stepwise dilation when changing from a
9. sleep and the quality of great extent It retains about 60 of the humidity life Provox HME is based ona simple mechanism that in the airways that would otherwise be lost by is documented as safe and hygienic breathing through an open tracheostoma Users Provox HME Cassette The Provox HME cassette is the core of Atos Medical s product line for effective pulmonary rehabilitation following a total laryngectomy It features multiple functions Provox HME Cassettes are available in two versions Normal intended for all day use HiFlow for lower airflow resistance e g for physical activity or when adapting to one s first HME The Provox HME Cassette fits both the Provox Adhesive base plates and the Provox LaryTubes The HiFlow version is recommended for the latter 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 Features heat and moisture exchanger HME facilitates manual stoma occlusion with the help of a simple lid spring valve mechanism thereby improving speech as well as hygiene beneficial side openings that enable airtight closure of the stoma even when the HME is covered by clothing which means that by the HME can be discreetly hidden there will be no wet stains on the clothing The HME acts like a condenser and helps to protect the airway
10. smaller to a larger diameter prosthesis for temporary stenting of a TE fistula irrespective of type and diameter of the voice pros thesis used 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 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 prostheses even if only used with air Features comfortable use allows flushing fresh water under slight pressure through the lumen of the prosthesis thereby helping to clean the prosthesis from debris and crusts The Provox Flush can be a valuable addition to the regular use of the Provox Brush flushing away mucus from the pharynx and esophagus Order
11. the single use insertion tool This preferred method Provox ActiValve is designed for those who experience short device lifetime of Provox 1 or Provox2 caused by early leakage through the prosthesis due to excessive candida growth 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 Provox ActiValve e easy maintenance safe placement detectable in x ray The slightly concave shape of the tracheal flange of the Provox2 voice prosthesis helps ensure a proper fit even if the fistula size changes slightly oS high success rate Provox 2 Starter Kit contains The stable flanges of the Provox2 voice prosthesis 1 each of Provox2 Voice Prostheses facilitate immediate confirmation of whether the 7216 7219 and 7221 device is correctly in place 1 Provox Trocar 7203 1 Provox Pharynx Protector 721
12. total laryngectomy www hoofdhals nki nl olfaction Start aspx Insurance coverage payment co payments deductibles and other restrictions vary depending on patient s policy and medical need 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 e www atosmedical com www atosdirect com oisture exchanger respiratory load on transcutaneou oxygenation in laryngectomized individuals 7974US 200803B Atos Medical AB 7974US 200803B Head office Atos Medical AB P O Box 183 SE 242 22 H rby Sweden Tel 46 0 415 198 00 Fax 46 0 415 198 98 info atosmedical com e www atosmedical com
13. whole these results although obvious to the study participants were viewed together as an improvement in the postoperative quality of life Provox HME Let s start sample bag allows the user to test all different base plates and cas settes for some days facilitating to make an informed choice for larger supplies Order information Pieces Products Rx REF 1 of each Provox Adhesives 7251 7256 and Rx 7257 7265 5 of each Provox HME Cassettes 7240 and 7241 1 unit of Provox Cleaning Towels 7244 Non sterile for single use max 24 hours With an improved quality of life participants indicated they were more willing to communicate slept better and generally felt better about themselves and that the number of attempts to speak increased Although not a part of the study spouses and friends volunteered observations similar to those of the study participants The majority of patients were very positive about this pulmonary protection and rehabilitation system to the point they have continued to use the HME beyond the conclusion of the study As one patient observed If you can replace the voice with an artificial voice prosthesis it makes sense to replace the nose with an artificial moistening and heating device Ackerstaff AH Fuller D Irvin M Maccracken E Gaziano J Stachowiak L Multicenter study assessing effects of heat and moisture exchanger use on respiratory symptoms and voice quality in laryngectomized ind
14. with light membrane without manual stoma closure It has many built in Provox FreeHands HME Replacement Device Rx 7717 features that makes it easy to use and it requires e w nie Mat Aoa only minimal handling and maintenance Provox FreeHands HME Replacement Device Rx 7721 Valve with strong membrane 20 21 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 The Provox HME Cap is a dome shape titanium ring that allows use of the special FreeHands HME cassettes without the Provox FreeHands 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
15. 0 1 Provox Guidewire 7215 1 Provox Measure 7270 1 Set of Provox Brushes 6 pcs 7204 1 Provox Plug 7205 1 Provox Flush 7206 1 Provox2 Training Kit 7222 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 0 001 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 Order information Size Rx REF Provox2 4 5mm Rx 7216 Provox2 6mm Rx 7217 Provox2 8mm Rx 7218 Provox2 10mm Rx 7219 Provox2 12 5 mm Rx 7221 Provox2 15mm Rx 7224 Provox2 Training Kit 7222 Provox2 Starter Kit see left Rx 7223 Sterile for single use Includes 1 Provox2 Voice Prosthes
16. 00 pcs 7244 20 resealable pouches of 10 Non sterile for single use 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 Provox Silicone Glue Provox Silicone Glue 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 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 de
17. 1 piece Rx 7730 Reusable non sterile Provox FreeHands HME Cassette 20 pcs Rx 7712 Non sterile for single use only 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 24 Tracheostoma Support The Provox LaryTube allows the use of Provox HME Cassettes and helps laryngectomees with an unstable or deep stoma to achieve pulmonary protection and rehabilitation Provox LaryTubes also allow immediate post operative use of an HME Patients with highly sensitive skin e g during the radiotherapy period can use Provox Larylube when no adhesive can be used Provox LaryTubes are made of soft flexible yet sufficiently rigid silicone The conical anatomical shape helps to assure an optimal seal around the stoma Provox LaryTube Available in three versions The Fenestrated 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 The Standard version made for use without voice prosthesis or when customized fen estration with the Fenestrati
18. Mayo Tracheostoma Button Barton Mayo Tracheostoma Button Barton Mayo Tracheostoma Button Barton Mayo Tracheostoma Button Barton Mayo Sizing Kit Size 10 12 14 Models Short Regular Long Short Regular Long Short Regular Long Short Regular Long Manufactured by Medical Innovations International Inc USA Conversion chart Barton Mayo Button REF Short 9 Regular Long Short 10 Regular Long Short 12 Regular Long Short 14 Regular Long Diameter 13 5 13 5 13 5 15 0 15 0 15 0 17 0 17 0 17 0 19 0 19 0 19 0 Length 15 22 30 15 22 30 15 22 30 15 22 30 Diameter mm 125 17 0 19 0 Length mm 15 22 30 15 22 30 15 22 30 15 22 30 Rx Rx Rx Rx REF ENBMB091 ENBMB092 ENBMB093 ENBMB101 ENBMB102 ENBMB103 ENBMB121 ENBMB122 ENBMB123 ENBMB141 ENBMB142 ENBMB143 ENBMBKIT Provox LaryButton REF 7671 7685 7672 7686 7673 7687 7674 7688 Diameter Length 12 8 12 18 14 8 14 18 16 16 18 18 18 18 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 Lary Tube 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
19. Provox XtraBase 7265 strong green dot 7715 1 Adjustment Kit 7719 1 Cleaning and Storage Box 7718 5 Skin Prep tissues Order information Rx REF Provox FreeHands HME Rx 7710 Provox 2 Starter Kit 1 each of Provox2 Voice Prostheses 1 Provox Measure 7270 7216 7219 and 7221 1 Set of Provox Brushes 6 pcs 7204 1 Provox Trocar 7203 1 Provox Plug 7205 1 Provox Pharynx Protector 7210 1 Provox Flush 7206 1 Provox Guidewire 7215 1 Provox2 Training Kit 7222 Order information Rx REF Provox2 Starter Kit Rx 7225 Provox 1 Starter Kit each of Provox Voice Prosthesis 6 8 10 mm 7200 7201 7202 Provox Trocar 7203 Provox Pharynx Protector 7210 Set of Provox Brushes 6 pcs 7204 Provox Plug 7205 mai _ _ f el Order information Rx REF Provox Starter Kit Rx 7220 35 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 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 Please Note The availability of these devices without prescription outside the United States may vary from country to country
20. Tan Persson JO Anew problem solving indwelling voice prosthesis eliminating the need for frequent Candida and underpressure related replacements Provox ActiValve Acta Otolaryngol 2003 Oct 123 8 972 9 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 Op de Coul BMR Hilgers FJM 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 prostheses Arch Otolaryngol Head Neck Surg 2000 Nov 126 11 1320 8 BalleVH Rinds L Thomsen JC Primary speech restoration at laryngectomy by insertion of voic prosthesis 10 years experience Acta Otolaryngol 2000 Suppl 543 244 245 w om Ahmad Kumar BN Radford K O Connell J Batch AJG Surgical voice restoration following ablative surgery for laryngeal and hypopharyngeal carcinoma J Laryng Otol Jul 2000 114 522 525 Ackerstaff AH Hilgers FJ Meeuwis CA van der Velden LA van den Hoogen FJ Marres HA Vreeburg GC Manni JJ Multi institutional assessment of the Provox 2 voice prosthesis Arch Otolaryngol Head Neck Surg 1999 Feb 125 2 167 73 Laccourreye 0 Menard M Crevier Buchman L Couloigner V Brasnu D In situ lifetime
21. Wa nf in a eae L A uk aa rf FF m wa Wed wis alk hs Past experience continued innovations 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 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 fit with today s 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 high quality and performance standards lt Aa i os Ji j Tommy Hedberg CEO of Atos Medical Contents Provox Voice Prostheses Provox NID Voice Rehabilitation System Provox NID Accessories Professional Accessories User Accessories Provox HME System Heat and Moisture Exchanger Provox Adhesives Hands free Speech Tracheostoma Support Other Accessories Educational Material Starter Kits 10 12 17 20 24 29 31 34 Provox Voice Prostheses Theoriginal Provox voice prosthesis was dev
22. a tolaryngol 2005 Jun 125 6 629 37 0 Zuur JK Muller SH de Jongh FH van Zandwijk N Hilgers FJ The physiological rationale of heat a 0 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 Maccracken E Gaziano J Stachowiak L Multicenter study assessing effects of heat and moisture exchanger use on respiratory symptoms and voice quality in laryngectomized individuals Otolaryngol 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 moisture 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 91 9 Herranz Gonzalez Botas J Suarez T Garcia Carreira B Martinez Moran A Experience with the HME Provox Stomafilter in laryngectomized patients Acta Otorinolaringol Esp 2001 Apr 52 3 221 5 Spanish van As CJ Hilgers FJM Koopmans van Beinum FJ Ackerstaff AH The influence of stoma occlusion on as
23. arro JC Novoa J V Martinez VJ Phonation fistulas today Acta Otorinolaringol Esp 2007 March 58 3 110 2 Bremke M Werner JA Lichtenberger G Folz BJ Chronic aspiration secondary to a Staffleri fistula Succesful therapy with Provox voice prosthesis Laryngorhinootologie 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 alternative approach for secondary tracheoesophageal puncture in the difficult laryngectomy neck The Laryngoscope 2008 Feb 118 2 266 269 Soolsma J Van Den Brekel MW Ackerstaff AH Malm AJ Tan B Hilgers FJ Long term results of Provox ActiValve solving the problem of frequent Candida and Underpressure related voice prosthesis replacements The Laryngoscope 2008 Feb 118 2 252 257 Ramalingam WVBS Chikara D Rajagopal G Mehta AR Sarkar S Tracheo esophageal puncture 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 Selected earlier publications agarkar AN Gupta AK A comparative analysis of speech in postlaryngectomised cases Gazz Med tal Arch Sci Med 2005 164 3 191 194 g RW Lam P Wong BY Insertion of Provox2 voice prosthesis using the anterogra
24. 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 The Provox Fenestration Punch is used for making small fenestrations in the LaryTube at the desired location Other Accessories Provox FenestrationPunch Order information Quantity REF Provox FenestrationPunch 1 pc 7654 Key features s Non sterile reusable sterilizable Increases the usability of the Provox LaryButton e Simple touch fasten unfasten solution e Strong FlexiDerm adhesive properties e May be taped to the most optimal area to the skin around the stoma AMANA tothe USE OT NE Kangi New design for easier handling and improved hygiene Order information Size Quantity REF Order information Quantity REF Provox TubeBrush 9mm 6 pcs 7660 Provox LaryClip 1 set 7669 Provox TubeBrush 13 mm 6 pcs 7661 8 pcs LaryClip 40 pcs LaryClip Base Non sterile for single patient use Non sterile reusable The new Provox TubeHolder has been developed exclusively for use with the Provox Lary Tube and Provox LaryButton The integrated clip connectors allow for optimal fit to the wings of the Provox Lary Tube 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
25. causes for replacement and complications of the Provox voice prosthesis Laryngoscope 1997 Apr 107 4 527 30 Aust MR McCaffrey TV Early speech results with the Provox 1 prosthesis after laryngectomy Arch Otolaryngol Head Neck Surg 1997 Sep 123 9 966 8 Hilgers JM Ackerstaff AH Balm AJM Tan IB Aaronson NK Persson JO Development and clinical evaluation of a second generation voice prosthesis Provox 2 designed for anterograde and etrograde insertion Acta Otolaryngol 1997 117 889 896 ilgers FJM Balm AJM Long term results of vocal rehabilitation after total laryngectomy with the w resistance indwelling Provox voice prosthesis Clin Otolaryngol 1993 18 517 523 sistance indwelling voice prosthesis Eur Archs ORL 1993 250 375 378 3 ilgers FIM Schouwenburg PF A new low resistance self retaining prosthesis Provox for voice habilitation after total laryngectomy Laryngoscope 1990 100 1202 1207 H 0 Hilgers FJM Cornelissen MW Balm AJM Aerodynamic characteristics of the Provox low e H e Provox HMEand Provox FreeHands HME New peer reviewed publications Hamade R Hewlett N amp Scanlon E 2006 A quantitative and qualitative evaluation of an automatic occlusion device for tracheoesophageal speech the Provox FreeHands HME Clin Linguist Phon 20 187 193 Hilgers F J amp Ackerstaff A H Development and evaluation of a novel tracheostoma but
26. de technique immediately after the secondary tracheoesophageal puncture J Laryngol Otol 2005 Dec 119 12 988 90 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 orshed K Golabek W Szymanski M Olszanski W Speech rehabilitation using Provox voice prosthesis Otolaryngol Pol 2005 59 2 225 8 Article in Polish Demir 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 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 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 Provox Provox 2 Provox ActiValve Provox HME Provox FreeHands HME Provox HME Cap Provox XtraBase Provox StomVent TrachPhone
27. elling Provox voice prosthesis The Provox brush design is based on our long experience with indwelling Provox pros offers excellent function reliability and safety However many of you have asked for a convenient version that theses and is a valuable maintenance tool for in situ and ex situ cleaning Included in patients can insert remove and clean themselves while preserving key features and the proven quality of the the Starter Kit and available separately Provox You asked and we listened Atos Medical is pleased to offer the Provox NID 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 sterile ready for use For single patient use 7126 and 7127 have been replaced by 7204 and 7225 Provox NID Voice prosthesis e Patients may insert remove and clean the device themselves Provox Flush 17 20 e The Provox NID is attached to a strong polypropylene cord with a safety wee medallion that is too wide to fall into the tracheostoma The Provox Flush is a dedicated maintenance device for cleaning the inner lumen of L e Low airflow resistance the Provox NID prosthesis by using clean water or air Included in the Starter Kit and I available separately In situ cleaning possible with dedicated cleaning tools P M e Variety of sizes Order information Rx REF ProvoxNID17FR Size Rx REF Prov
28. eloped in 1988 to provide for low airflow resistance and extended device lifetime The second generation Provoxprosthesis Provox 2 wasintroducedin 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 Similarly to the Provox2 the Provox ActiValve allows for bi directional replacement The original Provox voice prosthesis is supplied with a Provox Guidewire for retrograde insertion Order information Size Rx Provox 1 4 5 mm Rx Provox 1 6 mm Rx Provox 1 8 mm Rx Provox 1 10 mm Rx Provox 1 Starter Kit see right Rx 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 a laryngologist and a speech therapist rated the long term tracheoesophageal speech of 78 74 95 of the
29. information Quantity Size REF Provox Flush 1 pc 20 Fr 7206 Non sterile reusable Can be boiled For single patient use Anin 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 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 Insert the brush into the prosthesis and gently move it back and forth with a twisting motion After removal clean the brush with gauze 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 The design of the Provox Brush has recently been updated to allow for even easier handling New features include Safety wings on the brush shaft that help prevent accidental aspiration of the Provox Brush
30. is 1 single use insertion tool 1 Provox Brush A Provox2 Training Kit is available to practice anterograde insertion to 8 weeks Provox ActiValve is NOT intended for primary or secondary insertion at the time of surgery Order information Size Rx REF Provox ActiValve Light 4 5mm Rx 7150 Provox ActiValve Light 6mm Rx 7151 Provox ActiValve Light 8mm 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 6 mm Rx 7161 Provox ActiValve Strong 8 mm Rx 7162 Provox ActiValve Strong 10 mm Rx 7163 Provox ActiValve Strong 12 5 mm Rx 7164 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 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 Provox2 ActiValve Light ActiValve Strong In vitro air flow characteristics I min Provox ActiValve Light in case of early candida overgrowth Provox Acti Valve Strong in case of negative pressure in the PE segment Provox NID Voice Rehabilitation System Provox Brush For nearly two decades clinicians from all over the world have known that our indw
31. ividuals Otolaryngol Head Neck Surg 2003 129 705 712 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 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 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 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 20 pcs 7252 Regular Round 20 pcs 7251 Non sterile for single use Provox Adhesives Provox Adhesives OptiDerm Oval OptiDerm Round FlexiDerm Oval FlexiDerm Round Regular Oval Regular Round Provox XtraBase Provox XtraBase is a unique convex self adhering base plate designed specifically for deep and or irregular stomas The adhesive pr
32. onPunch is preferred 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 FreeHands HME to support the stoma seal 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 with Ring LaryTube 8 27 Rx 95 12 0 27 7601 5 LaryTube 8 36 Rx F 95 12 0 36 7602 ON 95 120 36 7637 lt LaryTube 8 55 Rx 95 12 0 55 7603 5 95 120 55 7638 LaryTube 9 27 Rx 10 5 135 27 7605 gt LaryTube 9 36 Rx 10 5 13 5 36 7606 105 135 36 7640 LaryTube 9 55 Rx 10 5 13 5 55 7607 10 5 13 5 55 7641 LaryTube 10 27 Rx 120 150 27 7609 Larylube 10 36 Rx 120 150 36 7610 120 150 36 7643 LaryTube 10 55 Rx 12 0 150 55 7611 12 0 15 0 55 7644 LaryTube 12 27 Rx Bs 170271127613 LaryTube 12 36 Rx 135 17 0 36 7614 13 5 17 0 36 7646 LaryTube 12 55 Rx 1511706555 7615 135 1701 55 7647 Provox LaryTube Standard includes 5 HiFlow Provox LaryTube Fenestrated includes 5 HiFlow Provox LaryTube with Ring includes 5 HiFlow ID 9 5 9 5 10 5 10 5 12 0 12 0 13 5 13 5 OD 12 0 12 0 13 5 13 5 15 0 15 0 17 0 17 0 L 36 55 36 55 36 55 36 55 REF 7624 7625 7626 7627 7628 7629 7630 7631 Cassettes 7241 Cassettes 7241 and 1 Provox Bru
33. operties 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 having a deep stoma 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 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 per fumed Order information Quantity REF Provox Cleaning Towel 2
34. oxNID20FR Size RX REF O E uey mes Provox NID 17 6 mm Rx 7101 Provox NID 20 6 mm Rx 7111 Wa ja is Non sterile ready for use For single patient use Provox NID 17 8mm Rx 7102 Provox NID 20 8mm Rx 7112 Provox NID 17 10mm Rx 7103 Provox NID 20 10 mm Rx 7113 TM Provox NID 17 12mm Rx 7104 ProvoxNID 20 12mm Rx 7114 Provox NID Storage Box Provox NID 17 14mm Rx 7105 Provox NID 20 14mm Rx 7115 The Provox NID Storage Box helps to keep the Provox NID prosthesis and accessories aor S Ie s s ne a eee clean and fits into a normal sized pocket for convenient storage and transport Included Inserter of corresponding size included Non sterile ready for use For single patient use in the Starter Kit and available separately Order information REF Provox NID Storage Box 7128 Non sterile ready for use For single patient use TM Provox Dilator 17 20 For greater convenience and economy all accessories are provided in a handy starter kit The Provox Dilator is designed to facilitate replacement and insertion of the Provox I Order information Rx REF i 7 NID prosthesis It serves to keep the fistula tract open after removal of and or prior to i the insertion of the Provox NID Also a small circular ridee helps to keep the Provox Provox NID 17 Starter Kit 6 10 mm Rx 7131 i pa js Containing Dilator 17 Brush set of 6 Flush 17 Storage Box Dilator in place and reduces the tendency of it sliding out Included in the Starter
35. pects of alaryngeal speech Acta Otolaryngol 1998 118 732 738 Ackerstaff AH Hilgers FJM Balm AJM Tan IB Long term compliance of laryngectomized patients with a specialized pulmonary rehabilitation device Provox HME Stomafilter Laryngoscope 1998 108 257 260 Hilgers FJM Ackerstaff AH Balm AJM Gregor RT A new heat and moisture exchanger with speech valve Provox HME Stomafilter Clin Otolaryngol 1996 21 414 418 Ackerstaff AH Hilgers FJM Aaronson NK 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 rehabilitation of laryngectomized patients Clin Otolaryngol 1995 20 504 509 Ackerstaff AH Hilgers FJM Aaronson NK Balm AJM van Zandwijk N Improvements in respiratory and psychosocial functioning following total laryngectomy by the use of a heat and moisture exchanger HME Ann Otol Rhinol 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 wo z The above references represent a selection For more information contact Atos Medical AB or your local representative More about the Provox System including trouble shooting www provoxweb info More about rehabilitation of olfaction after
36. rovox Provox2 and Provox NID insertion and replacement methods Order information REF Artificial Fistula Model Provox2 7286 Includes 1 Provox2 prosthesis 8 mm and 1 inserter Artificial Fistula Model NID 7129 Model Provox2 Model NID Includes 1 Provox NID prosthesis 8 mm 17 French and 1 inserter 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 Various instructional CD s and DVD s Order information A practical guide to post laryngectomy rehabilitation including the Provox System CD ROM Provox HME DVD Picture CD ROM Olfaction CD Secondary Puncture DVD Spanish English Provox Instructional Movies NTSC For Windows and Macintosh REF ISBN 90 75575 05 X 7969 N 7819 ISBN 90 75575 07 6 Please contact us for further information 7861 N Instructional CD s and DVD s Starter Kits Provox HME Let s Start sample bag 1 ofeach Provox Adhesives 7251 7256 and 7265 5 ofeach Provox HME Cassettes 7240 and 7241 1 unitofProvox Cleaning Towels 7244 Order information Rx REF Provox HME Let s Start sample bag Rx 7257 Provox FreeHands HME 1 valve unit housing with a medium 1 Speech Valve Membrane blue dot membrane light white dot 7713 FreeHands HME Cassettes 7712 1 Speech Valve Membrane
37. s Order information Quantity Rx REF Provox HME Cassette Normal 20 pcs Rx 7240 Provox HME Cassette HiFlow 20 pcs Rx 7241 Non sterile for single use max 24 hours Provox HME Let s Start sample bag g w 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 OptiDerm base plate or a Provox LaryTube In these cases external humidifiers may no longer be needed Provox HME Let s Start sample bag F From a USA based multi center study about heat and moisture exchangers RESULTS Compliance was 73 n 59 decrease in coughing 68 sputum production 73 forced expectoration 60 and need for stoma cleaning 52 of these 59 patients Regarding daily cough expectoration frequency a statistically significant decrease P lt 0 0001 was found between the first and last trial weeks Regarding influence on voice quality 46 of regular users reported improvement in intelligibility 30 in loudness 37 in fluency and 40 in telephone intelligibility Fourteen patients 19 reported skin irritation with discontinuation of 7 patients In conclusion the most obvious results of this study the decrease in pulmonary symptoms and the improvement in voice quality are a carbon copy of the results found in the several studies from the Netherlands Cancer Institute and more recently in the United Kingdom and Spain As a
38. sh 7204 Cassettes 7241 1 FlexiDerm Oval 7254 ID inner diameter OD outer diameter L length in mm 25 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 If 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 Effective The conical shape facilitates a tight fit as it allows the Provox LaryButton to be situ ated close to the stoma Compatible The Provox Lar
39. ton and fixation system Provox LaryButton and LaryClip adhesive to facilitate hands f tracheoesophageal speech Acta Otolaryngologica 2006 Dec 126 11 1218 1224 ree Zuur JK Muller SH Sinaasappel M Hart GA Van Zandwijk N Hilgers FJ Influence of heat and a randomized cross over study Head amp neck 2007 Dec 29 12 1102 1110 Zuur JK Muller SH De Jongh FH Vand Der Horst MJ Shehata M Van Leeuwen J Sinaasappel M Hilgers FJ A newly developed tool for intra tracheal temperature and humidity assessment in laryngectomized individuals the Airway Climate Explorer ACE Medical amp Biological Engineering amp Computing 2007 Aug 45 8 737 745 Epub 2007 Jul 13 Lorenz KJ Ackerstaff AH Hilgers FJM Maier H Hands free speech after surgical voice rehabilitation with a Provox voice prosthesis experience with the Provox Freehands HME tracheostoma valve system European Archives of Otorhinolaryngology 2007 Feb 264 2 151 157 Selected earlier publications FJM Hilgers AH Ackerstaff Development and evaluation of a novel tracheostoma button and fixation system Provox LaryButton and LaryClip adhesive to facilitate hands free racheoesophageal speech Acta Otolaryngol Stockh in press Op de Coul BM Ackerstaff AH van As Brooks CJ van den Hoogen FJ Meeuwis CA Manni JJ Hilgers FJ Compliance quality of life and quantitative voice quality aspects of hands free speech Act
40. vice 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 FreeHands Kit Includes 25 pcs HME cassettes 1 pc Rx 7710 01 Provox FreeHands HME Cassette 20 pcs Rx 7712 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 Fi a n d S free S eec h Provox FreeHands Cleaning and Storage Box 1 pc 7718 maa D Provox FreeHands HME Adjustment Kit 7719 1 safety screwdriver and 1 membrane replacement forceps Provox FreeHands HME Replacement Device Rx 7722 The Provox FreeHands HME combinesa Heatand TheProvoxFreeHands HME enables voice prosthesis Valve only Moisture Exchanger HME with an easy to operate users to have all benefits of an HME combined with Provox FreeHands HME Replacement Device Rx 7716 automatic tracheostoma valve that allows speaking hands free speech Valve
41. yButton is intended to be worn in combination with the Provox HME System with optimal fit and stability 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 inner boxes Outer tray can be cleaned in instrument washer OD outer diameter L length in mm 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 Features Barton Mayo Tracheostoma Button 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 Order info Barton
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