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The voice prosthesis thereafter slides gently into position.

Provox 2 Voice Prosthesis:

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Voice Prosthesis with SmartInserter Clinician s Manual Region 1

3. Important patient information 3.1 General information Ensure that the patient understands to contact their clinician if: There is leakage through or around the prosthesis (coughing and/or change of mucus color). Speaking becomes difficult (higher effort and/or voice sounds more strained). There are any signs of inflammation or tissue changes at the puncture site or the stoma region (pain, redness, heat, swelling, traces of blood on the brush after brushing). Also inform the patient that: After a prosthesis replacement traces of blood may be found in the sputum. This may come from granulation tissue on the edges of the TE puncture. Occasionally, mild leakage through or around the prosthesis may occur in the first weeks after insertion of a new prosthesis. This often resolves spontaneously and does not require immediate replacement of the prosthesis. If leakage spontaneously occurs through the prosthesis a temporary blockage can be done with a Provox Vega Plug. Speech Training Sessions with a trained clinician are advised in order to acquire optimal voice sound, fluent speech, and optimal intelligibility. 3.2 Prosthesis maintenance Instruct the patient when and how to clean the Provox Vega XtraSeal voice prosthesis. Cleaning the prosthesis at least twice a day can help prolong the device life. CAUTION: Only use genuine Provox accessories that are intended for use with Provox Vega when cleaning the prosthesis. Brushing the prosthesis with the Provox Brush twice a day will help to remove mucus and food remnants from the prosthesis. Flushing the prosthesis with the Provox Flush also helps to clean debris and mucus from the prosthesis, which helps increase the life of the device. Note: The Provox Flush is intended for use only by patients who, as assessed by the clinician who prescribes the device, have demonstrated ability to understand and consistently follow the instructions for use without clinician supervision. Some dietary measures, like the daily intake of yogurt or butter milk containing lactobacilli, are considered to be helpful against excessive Candida growth. For detailed information on how to clean a Provox Vega, please see Instructions for each accessory. 3.3 Accessories CAUTION: Only use genuine Provox accessories that are intended for use with Provox Vega. Other accessories may cause patient harm or product malfunction. Accessories to facilitate insertion of the prosthesis (for clinician s use) Provox Dilator: Helps to convert from a prosthesis with a smaller shaft diameter to a Provox voice prostheses of larger diameter. Provox GuideWire: for placement of a Provox, Provox2 or a Provox Vega voice prosthesis in a freshly made TE puncture, or for retrograde replacement of a Provox indwelling voice prosthesis. Accessories to maintain the device function (for patient s use) Provox Brush / Provox Brush XL is used by the patient to clean the inside of the prosthesis. Provox Flush is an additional cleaning device that allows flushing of the prosthesis. Provox Vega Plug is a First Aid tool for patient s use that temporarily blocks leakage through the prosthesis. Other supplementary products that can be used with Provox voice prostheses Provox HME: Heat- and Moisture Exchanger partially restores lost nasal functions (heating, humidifying, breathing resistance). Provox FreeHands HME: A Heat and Moisture Exchanger combined with an automatic tracheostoma valve, designed to allow hands-free speech. Provox LaryTube: A silicone tracheal cannula intended to support shrinking stomas while retaining other rehabilitation devices of the Provox System. Provox LaryButton: A soft, self-retaining silicone tracheal cannula intended to support shrinking stomas while retaining other rehabilitation devices of the Provox System. 4. Adverse events/trouble shooting information The following are possible risks associated with prosthetic voice rehabilitation: Prosthesis related Leakage through the valve Leakage through the prosthesis may occur in association with Candida overgrowth of the valve flap or dislodgement of the radio opaque ring (valve seat). It may also occur if the esophageal flange of the prosthesis is not fully developed in the lumen of the esophagus or if the prosthesis is too short. Endoscopic examination should be performed to determine whether any of these phenomena has occurred. If the prosthesis is in the correct position and of the right length, and if cleaning of the prosthesis does not resolve leakage through the prosthesis, replacement of the prosthesis is indicated. Candida overgrowth Candida overgrowth of the prosthesis occurs in almost all patients. Radiotherapy, salivary content and dietary habits may influence how rapidly Candida can affect the silicone material. Treatment with antifungal agents may be considered as a preventive measure if Candida overgrowth causes leakage through the prosthesis or other incompetence of the valve. Compatibility with antifungal medicine An unknown variety of chemical substances may immediately influence the material properties of the device or may be absorbed by the material and subsequently released at a later time. Therefore, the introduction of antifungal medicines or drugs directly to or within close proximity of the voice prosthesis should be carefully assessed. Laboratory tests show only minor negative influence on the function of the Provox Vega voice prosthesis and components when using the following antifungal medications: Nystatin Fluconazole Mikonazol 12

free revascularized or pedicled flaps does not preclude surgical prosthetic voice restoration.

The ADVANTAGE indwelling voice prosthesis is the newest advancement in Blom-Singer voice restoration. Silver oxide has been incorporated into the prosthesis as a material preservative. The ADVANTAGE is placed by the clinician in the tracheoesophageal puncture so that routine changing of a voice prosthesis is unnecessary. It is ideal for laryngectomees who are unable or resistant to changing a removable voice prosthesis, such as the Duckbill or Low Pressure styles. The ADVANTAGE is inserted and replaced on an as needed basis by a speech pathologist or physician only.

Voice Prosthesis for Voice Rehabilitation Following …

A second generation, low-resistance, indwelling silicone voice prosthesis

Step 2. If the problem is with the prosthesis (voice is good open tract), the puncture should be dilated a sufficient length of time, and then the puncture tract length is carefully measured (not just a guess!). The prosthesis is inserted. Wait a few minutes if a gel cap insertion is used, so the capsule will completely dissolve. If the prosthesis is the correct length and properly inserted, it should rotate freely in the tract while it is still attached to the insertion tool. And if it is correctly inserted, you should feel resistance to gently trying to pull it back out while still attached to the inserter, because the esophageal flange is fully deployed in the esophagus. In many laryngectomees, you can see the esophageal flange of the prosthesis by passing a flexible endoscope through the nose and down into the upper esophagus. If the prosthesis is seen, you know that you have the correct size and that it is fully inserted into the puncture. It can be hard to see it sometimes because of secretions, the way healing occurs after surgery, and the absence of the usual landmarks that are there before surgery. Some tricks to get a good view: the scope is advanced slightly below the prosthesis. The examiner can tell where the scope is because the light of the scope will shine through the tissue allowing you to see it on the outside of the neck. You should occlude the stoma and try to voice on a long 'ahhhh' or 'eeeee' as the examiner very slowly removes the scope, and usually the prosthesis will be seen for a brief instant. It helps to record the exam and play it back because sometimes you think that you see the prosthesis but aren't sure. If the prosthesis isn't visualized with the scope, it may still be correctly inserted, just not easily visible. If the voice is worse with the prosthesis inserted in the puncture compared to open tract voicing, the prosthesis may be the wrong length or not correctly inserted, or you may need a prosthesis that has a lower resistance to the flow of air. The different types of prostheses have different levels of resistance.

Step 1. Determine whether the problem with getting voice is a problem with the prosthesis, or with the patient's anatomy & physiology. To do this, we usually remove the prosthesis from the puncture and have the pt try to voice "open tract" on a prolonged 'ahhhhhh'. Don't swallow when there is nothing in the puncture or you will get saliva leaking through the puncture into your trachea. If the voice is good, the problem is with the prosthesis and you go to Step 2. If the voice is not improved, the problem is with the pt. Skip Step 2, and Go to Step 3.

Blom-Singer ADVANTAGE Indwelling Voice Prosthesis - …

Step 4. The puncture needs to be fully open to a diameter that is slightly larger in diameter than the prosthesis (eg, 22 French for a 20 French prosthesis) to have an easy insertion. Start with a dilator/stent/catheter that is slightly smaller in diameter than the puncture - it should slide easily in and out of the puncture with a lubricant. Move to successively larger diameter stents/catheters until thedilator that is slightly larger than the diameter of the prosthesis (eg, 22 French for a 20 French prosthesis) slides easily in and out of the puncture tract. That can take hours sometimes, even overnight, but don't rush it. Once it is fully dilated, check that the open tract voicing is good. If it is, the puncture tract length is measured and the correct prosthesis is inserted. If the open tract voice is still not good after you know that the puncture is fully dilated, go to Step 5.

I have been using TEP speech for approximately 12 years and have never had occur what happened to me today. I exchanged my prosthesis this morning for one that was ready to be reinserted and shortly thereafter mucous started coming from the stoma in copious amounts. I thought that somehow I had caught a severe cold. After putting up with this stream of mucous for about 20-30 minutes, I decided to investigate. The suddenness and the constant output puzzled me. It turned out the mucous wasn't coming from the inner stoma, but leaking out of the middle of the prosthesis. After inserting a brand new prosthesis everything magically cleared up. Lesson: A prosthesis doesn't last forever - sometimes you should change to a new prosthesis and discard the old one! (Irwin Title)

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Placement of the voice prosthesis is included in the ..

Puncture related Aspiration of the prosthesis Accidental aspiration of the voice prosthesis or other components of the voice rehabilitation system may occur. Immediate symptoms may include gagging, coughing, choking or wheezing. As with any other foreign body, complications from aspiration of a component may cause obstruction or infection. Complications may include pneumonia, atelectasis, bronchitis, lung abscess, bronchopulmonary fistula and asthma. If the patient can breathe, coughing may remove the foreign body. Partial airway obstruction or complete airway obstruction requires immediate intervention for removal of the object. Ingestion of the prosthesis Accidental ingestion of the voice prosthesis, or other components of the voice rehabilitation system, may occur. As with any other foreign body, the symptoms caused by ingestion of the prosthesis or component of the voice rehabilitation system depends largely on size, location, degree of obstruction (if any) and the length of time it has been present. Ingested components that have remained in the lower esophagus may be removed by esophaguscopy or observed for a short period of time. The object may pass spontaneously into the stomach; foreign bodies that pass into the stomach usually pass through the intestinal tract. Surgical removal of foreign bodies in the intestinal tract must be considered when bowel obstruction occurs, bleeding is present, perforation occurs or the object fails to pass through the intestinal tract. Hemorrhage/Bleeding of the puncture Slight bleeding from the edges of the TE-puncture may occur during replacement of the prosthesis and generally resolves spontaneously. Patients on anti-coagulant therapy, however, should be carefully evaluated for the risk of hemorrhage prior to placement or replacement of the prosthesis. Infection and/or edema of the TE-puncture Infection, granulation formation and/or edema of the puncture (e.g during radio therapy) may increase the length of the puncture tract. This may cause the prosthesis to be drawn inward and under the tracheal or esophageal mucosa. Or, inflammation or overgrowth of the esophageal mucosa may cause the prosthesis to protrude from the puncture. Temporary replacement of the prosthesis by a prosthesis with a longer shaft is then advisable. Treatment with broad-spectrum antibiotics with or without corticosteroids may be considered for treatment of the infection. If the infection does not resolve with antibiotics and/or corticosteroid intervention in the presence of the prosthesis, the prosthesis should be removed. In some cases stenting the puncture with a catheter might be considered. If the puncture closes spontaneously secondary to removal of the prosthesis, repuncture for insertion of a new prosthesis may be required. Granulation around the puncture Formation of granulation tissue around the TE-puncture has been reported at an incidence of 5%. Electrical, chemical, or laser cauterization of the area of granulation may be considered. Hypertrophic scarring around the puncture Bulging of the tracheal mucosa over the tracheal flange may occur if the prosthesis is relatively short. This excess tissue may be removed by using a laser (CO2, or NdYAG). Alternatively, a prosthesis with a longer shaft can be used. Protrusion/extrusion of the prosthesis Protrusion of the prosthesis and subsequent spontaneous extrusion is sometimes observed during infection of the TE-puncture. Removal of the prosthesis is required to avoid dislodgement into the trachea. The puncture may close spontaneously secondary to the removal of the prosthesis. Repuncture may be necessary for insertion of a new prosthesis. Leakage around the prosthesis Transient leakage around the prosthesis may occur and may improve spontaneously. The most common reason is that the prosthesis is too long, which is solved by inserting a shorter prosthesis. A prosthesis of another diameter (upsizing) can also solve the leakage. It can also occur when the enlarged flange of the Provox Vega XtraSeal has not deployed fully into the esophageal lumen. No part of the enlarged esophageal flange should be visible alongside the shaft of the voice prosthesis and when rotated the voice prosthesis should move freely. Rotating the voice prosthesis while at the same time slightly pushing it towards the esophagus can help to unfold the enlarged flange completely. In case of uncertainty, use flexible endoscopy to confirm proper placement inside the esophagus. If leakage does not improve (which it often does spontaneously), a Provox XtraFlange can be used. Other methods to solve leakage around the voice prosthesis are temporary removal of the prosthesis and the insertion of a cuffed tracheal cannula and/or nasogastric feeding tube to permit shrinkage of the puncture. Alternatively, a purse string suture with 3x0 absorbable material could be submucosally applied around the TE-puncture after removal of the prosthesis. The new prosthesis should be inserted and the suture should be tightened gently, enclosing the puncture walls around the prosthesis. If leakage around the prosthesis is intractable, more conservative measures, surgical closure of the puncture and subsequent re-puncture may be necessary. Tissue damage If the prosthesis is too short, too long, or is pushed frequently against the esophageal wall by a tracheal cannula, stoma button, or the patients finger, damage of the puncture, tracheal and/or esophageal tissues may occur. In patients undergoing radiotherapy this may happen more easily. Inspect the conditions regularly to avoid severe damage. 5. Additional information 5.1 Compatibility with MRI, X-ray and radiation therapy Provox voice prostheses have been tested and found to be compatible, except Provox ActiValve, with Magnetic Resonance Imaging (tested up to 3.0 Tesla), x-ray and radiation therapy (tested up to 70 Gy). The prosthesis can be left in the TE-puncture during the examination/therapy session. Note that the radio-opaque valve seat is visible on x-ray. 5.2 Device lifetime Depending on individual biological circumstances the device life varies, and it is not possible to predict the integrity of the device over a longer period of time. The material of the device will be affected by e.g. bacteria and yeast, and the structural integrity of the device will eventually deteriorate. 5.3 User assistance information For additional help or information, please see back cover of the Instructions for Use for contact information. 13

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