Voice Prosthesis for rehabilitation after total laryngectomy. Clinician s manual. Unregistered copy. Region 4

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1 Voice Prosthesis for rehabilitation after total laryngectomy Clinician s manual Region 4

2 1 2 A B

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4 Figures Fig. 1 4

5 Fig. 2 Fig. 3 Fig. 4 Fig. 5 5

6 Fig. 6 Fig. 7 Fig. 8 Fig. 9 & 10 Fig. 11

7 Fig. 12 Fig. 13 Fig. 14 Fig. 15 Fig. 16

8 Prescription information CAUTION: United States Federal law restricts this device to sale, distribution and use by or on order of a physician or a licensed practitioner. The availability of this product without prescription outside the United States may vary from country to country. Disclaimer Atos Medical offers no warranty - neither expressed nor implied - to the purchaser hereunder as to the lifetime of the product delivered, which may vary with individual use and biological conditions. Furthermore, Atos Medical offers no warranty of merchantability or fitness of the product for any particular purpose. Patents and trademarks Provox is a registered trademark of Atos Medical AB. Provox2 is protected by US patent no , JP and other patents.

9 Contents ENGLISH Ελληνικά Türkçe ORDERING INFORMATION... 99

10 The manual, which accompanies this product, may be revised from time to time and must therefore be reviewed prior to each procedure in which the product is used. Contents Intended use / Indications...10 Contraindications...11 WARNINGS...11 PRECAUTIONS...12 Adverse events...12 Directions for use...20 Trouble shooting...23 Device description Figure 1: Provox2 Voice Prosthesis 1. Valve. Molded in one part with the body of the prosthesis. 2. Esophageal flange. 3. Tracheal flange. 4. Radio-opaque, candida resistant valve seat. 5. Safety strap. Serves also as introduction string for retrograde insertion. 6. Direction identification knobs. When pulling the prosthesis through the fistula in case of retrograde insertion or overshooting, they must face the open lumen of the trachea and not the mucosa. 7. Size information (length between flanges). Available: 4.5, 6, 8, 10, 12.5, 15 mm. 8. Outer Diameter: 7.5 mm (22.5 F). Figure 2: Loading Tube Figure 3: Inserter Materials: Medical grade silicone rubber and plastic. Intended use / Indications The Provox2 Voice Rehabilitation System is intended for use in surgical, prosthetic voice restoration after total laryngectomy. The prosthesis may be inserted by the physician at the time of the total laryngectomy (primary puncture), or at a later date (secondary puncture), or may be used to replace the present prosthesis. 10 English

11 THIS MANUAL DESCRIBES ONLY THE REPLACEMENT PROCEDURE. Primary and secondary puncture and placement is performed by the physician. Replacement of the device is carried out by a physician or licensed practitioner who may, in his or her independent medical judgment and in accordance with the law of the state in which he or she practices, consider delegating the replacement of the prosthesis to a clinician trained in the procedure. The Provox2 prosthesis is not intended for use in primary or secondary tracheoesophageal (TE) - puncture procedures unless it is used with the Provox GuideWire, the Provox Trocar and Cannula, and the Provox Pharynx Protector (for primary TE-puncture only) components of the Provox Voice Rehabilitation System. Instructions for use of the prosthesis in primary and secondary TE puncture procedures are set forth in the Physician s manual which accompanies the Provox GuideWire. Review the Provox GuideWire Physicians manual before using the Provox prosthesis in conjunction with primary or secondary TE puncture procedures. Contraindications There are no known contraindications for use or replacement of the Provox2 prosthesis among patients already using prosthetic voice rehabilitation. Contraindications for primary and secondary TE puncture are set forth in the Physician s manual accompanying the Provox GuideWire. WARNINGS Dislodgement / extrusion of the Provox2 voice prosthesis from the TE fistula and subsequent ingestion, aspiration or tissue damage may occur. For further information about these events, see Adverse events below. To reduce the risk if dislodgment/extrusion and its potential sequelae: Select the proper prosthesis size. A tight fit may cause tissue necrosis and extrusion. Instruct the patient to consult a physician immediately if there are any signs of tissue edema and/or inflammation/infection. Treatment may require antibiotic therapy, temporary insertion of a prosthesis with a longer shaft, removal of the prosthesis, surgical closure of the fistula tract, and/or repuncture. 11

12 Instruct the patient to use only the original Provox accessories (Brush, Flush, Plug) for cleaning of the prosthesis or temporary occlusion and to avoid all other kinds of manipulation. If tracheal cannula or stoma studs are used, choose a shape that does not push on the prosthesis or hook the tracheal flange of the prosthesis during insertion and removal of the cannula. For example a perforated cannula (for speech) should have several small perforations instead of one large opening. Re-use and re-processing may cause crosscontamination and damage to the device, which could cause patient harm. PRECAUTIONS Load the prosthesis with the esophageal flange bent forward - into the insertion tool device before placement. Incorrect loading can cause immediate valve failure and fluid aspiration. Carefully assess any patient undergoing anticoagulant treatment for the risk of bleeding or hemorrhage prior to placement or replacement of the prosthesis. Aseptic technique should be employed in the management of the voice prosthesis to avoid introducing contaminants into the stoma, TE-fistula or esophagus. Adverse events Leakage through the prosthesis Leakage through the prosthesis may occur in association with candida overgrowth or dislodgement of the radiopaque 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. Dislodgement of the radio-opaque ring is an indication for replacement of the prosthesis and for thorough examination of the patient to determine that the ring has not been aspirated. If the radiopaque ring has not been dislodged, 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. 12

13 Candida overgrowth Candida overgrowth of the prosthesis occurs in almost all patients. Radiotherapy, salivary content and dietary habit may influence how rapidly candida can affect the silicone material. Treatment with antifungal agents may be considered if candida overgrowth causes leakage through the prosthesis or other incompetence of the valve. Possible treatments include: Nystatin oral solution: 2-3 times daily 5-10 ml ( B E) orally with simultaneous brushing of the prosthesis with the Provox Brush dipped in the Nystatin oral solution to coat the inside of the prosthesis; Diflucan suspension: once daily 5 ml (50 mg) orally with simultaneous brushing of the voice prosthesis with the Provox Brush dipped in Diflucan suspension to coat the inside of the prosthesis. Leakage around the prosthesis Transient leakage around the prosthesis may occur and may improve spontaneously. If leakage does not improve spontaneously, temporary removal of the prosthesis and the insertion of a cuffed tracheal cannula and/or nasogastric feeding tube to permit shrinkage of the fistula may be considered. Alternatively, a purse string suture with 3x0 absorbable material could be submucosally applied around the TE-fistula after removal of the prosthesis. The new prosthesis should be inserted and the suture should be tightened gently, enclosing the fistula wall around the prosthesis. If leakage around the prosthesis is intractable to more conservative measures, surgical closure of the fistula and subsequent repuncture may be necessary. Hemorrhage Slight bleeding from the edges of the TE-fistula may occur during replacement of the prosthesis and generally resolves spontaneously. Patients on anticoagulant therapy, however, should be carefully evaluated for the risk of hemorrhage prior to placement or replacement of the prosthesis. Granulation around the fistula Formation of granulation tissue around the TE-fistula has been reported at an incidence of approximately 5%. Electrical, chemical, or laser cauterization of the area of granulation may be considered. 13

14 Hypertrophic scarring around the TE-fistula 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. Infection and/or edema of the TEfistula around the prosthesis In the presence of infection, granulation formation and/or edema around the prosthesis, the fistula tract may become longer, causing the prosthesis to be drawn inward and under the tracheal mucosa. Conversely, inflammation or overgrowth of the esophageal mucosa may cause the prosthesis to protrude from the fistula tract. Temporary replacement of the prosthesis by a prosthesis with a longer shaft is then advisable. Treatment with broad-spectrum antibiotics with or without corticosteroid 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. If the fistula tract closes spontaneously secondary to removal of the prosthesis, repuncture for insertion of a new prosthesis may be required. Ingestion of the prosthesis Accidental ingestion of the Provox2 voice prosthesis, or other components of the Provox Voice Rehabilitation, may occur. As with any other foreign body, the symptoms caused by ingestion of the prosthesis or component of the Provox2 voice rehabilitation system depends largely on the size, location, degree and obstruction (if any) and the length of time it has been present. The ingested component 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. 14

15 Aspiration of the prosthesis Accidental aspiration of the Provox2 voice prosthesis or other components of the Provox 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 be caused by obstruction or infection. Complications may include pneumonia, atelectasis, bronchitis, lung abscess, bronchopulmonary fistula and asthma. If the patient can speak or breathe, coughing may dislodge the foreign body. Partial airway obstruction or complete airway obstruction requires immediate intervention for removal of the object. Protrusion / extrusion of the prosthesis Protrusion of the prosthesis and subsequent spontaneous extrusion is sometimes observed during infection of the TE-fistula. Removal of the prosthesis is required to avoid dislodgement into the trachea. The fistula tract may close spontaneously secondary to the removal of the prosthesis. Repuncture may be necessary for insertion of a new prosthesis. Tissue damage If the prosthesis is too short, too long or is pushed frequently against the esophageal wall by a tracheal cannula, stoma stud or a finger of the patient, damage of the fistula, tracheal and esophageal tissues may occur. In patients undergoing radiotherapy this may happen more easily. Inspect the conditions regularly to avoid severe damage. Individualization of treatment Anterograde vs. retrograde insertion If the Provox2 prosthesis cannot be inserted in an anterograde manner, retrograde insertion by use of the Provox GuideWire REF 7215 may be performed. This method should be used for placements directly after TE puncture procedure (primary or secondary), and in cases where it is difficult to reach and probe the fistula tract with the Provox2 inserter from the stoma. In cases of a thinned/atrophic fistula wall (very short fistula tract, often combined with leakage around the prosthesis), mucosal folds 15

16 overlapping the posterior part of the prosthesis or if the esophageal flange is difficult to develop within the esophagus, retrograde insertion can help to protect the fistula tract and to completely develop the esophageal flange of the prosthesis. Retrograde insertion should only be performed by the physician. Read the instructions accompanying the Provox GuideWire. Patient counseling information After a prosthesis replacement traces of blood may be found in the sputum. This most probably comes from granulation tissue on the edges of the TE fistula. Occasionally, mild leakage through or around the prosthesis may occur in the first weeks after introduction of a new prosthesis. This often resolves spontaneously and does not require immediate replacement of the prosthesis. Cleaning the prosthesis at least twice a day and after each meal with the Provox Brush can help prolonging the device life. Forced expectoration with the stoma closed also helps to clean the prosthesis. The oval shape of the tracheal flange is helpful in determining the ideal position of the prosthesis (by pointing downwards). Some dietary measures, like the daily intake of yogurt or skim milk containing lactobacilli, are considered to be helpful against excessive candida growth. In case of spontaneous leakage a temporary blockage can be achieved with the Provox Plug. The patient must see their clinician if: - there is leakage through or around the prosthesis (coughing) - speaking becomes difficult (higher effort) - there are any signs of inflammation or tissue changes at the fistula tract or the stoma region (pain, redness, heat, swelling) Speech Therapy with a trained clinician is advised in order to acquire fluent speech. How supplied The Provox2 voice prosthesis (Figure 1) is available in one diameter and several lengths (distance between flanges). It is supplied sterile for single use. It comes with a single use Insertion Tool (Figure 2 and 3) for anterograde insertion and 16

17 a reusable Provox Brush (Figure 4) for cleaning of the inside of the prosthesis. The brush should be given to the patient for daily maintenance. Accessories to maintain the device function (for patient s use) Caution: Only use genuine Provox accessories that are intended for use with Provox2 for the handling and cleaning of your prosthesis. Instruct your patient on how to clean the device and to avoid all other kinds of manipulation of the prosthesis than the cleaning and maintenance described below. The Provox Brush / Provox Brush XL (Figure 4). The patient should clean the prosthesis at least twice a day and after each meal with the Provox Brush by inserting the brush into the prosthesis and moving it gently back and forth with a twisting movement. After the brush is removed it should be wiped with a gauze. The procedure can be repeated as often as necessary. The brush can be used as long as it appears clean and shows no defects (maximum one month). One Provox Brush / Provox Brush XL comes with the prosthesis. For details and how to clean the brush see Instructions for Use that come with the Provox Brush. The Provox Flush (Figure 5) ; In addition to using the Provox Brush, the patient may also clean the Provox voice prosthesis with the Provox Flush. The Provox Flush can be used to flush drinking water or air through the lumen of the prosthesis. For details and how to clean the Provox Flush see Instructions for Use that come with the Provox Flush. Provox Plug (Figure 6): A tool for patient use that temporarily blocks leakage through the prosthesis. The Plug is inserted into the opening of the Provox prosthesis with the smooth end of a Provox Brush. The Provox Plug can be kept in place during drinking, and can be removed by pulling on the safety strap. While the Provox Plug is in place, speaking is not possible Cleaning and disinfection of the accessories The accessories should be cleaned after each use and disinfected at least once a day according to their Instructions for use. Inform the patient if the accessories are visibly soiled or have air dried when there is someone in the home with a respiratory infection, 17

18 or have been otherwise contaminated by contact with a pet, dropping on the floor or other gross contamination, the accessories should be cleaned and disinfected just prior to use. During hospitalization there is an increased risk of device contamination and patient infection. Therefore it is important to clean and disinfect the accessories immediately after use and again just before use during hospitalization, and rinse using sterile water, rather than drinking water. Accessories to facilitate insertion of the prosthesis and to create a TEP fistula (for clinician s use) Provox Measure: (Figure 7) Measures the length (corresponding to prosthesis size) of the existing TE fistula. Note: Before using the Provox Measure, make sure the fistula diameter has at least a diameter of 6.6 mm (20 F). Smaller fistulas should be dilated first, because, if the fistula is too small, it may be difficult to remove the instrument. Order size: 1 Provox Measure, non-sterile, sterilizable, reusable, and 5 Provox Measure Flanges, non-sterile, sterilizable, single use. Read instructions. Provox Dilator: (Figure 8) Helps to convert from a prosthesis with a smaller shaft diameter to a Provox voice prostheses. The Provox Dilator is a silicone rubber instrument for stepwise dilation of the TEP fistula, beginning from 15 F at the tip and ending at 24 F. Each step section (e.g. 18, 20, 22 F) has a small retention collar to help reduce the risk of the instrument slipping out of the fistula. The Provox Dilator can also be used to temporarily block the fistula when the prosthesis has been removed, or to upsize a fistula that has shrunk after removal or loss of a Provox voice prosthesis. Order size: 1 Provox Dilator, non-sterile, sterilizable, reusable. Read instructions. Provox Trocar and Cannula: (Figures 9 and 10) Stainless steel instruments for performing a primary or secondary TE puncture. The Provox Trocar creates a small, rounded puncture. After puncturing, the inner Trocar is removed and the Provox GuideWire is then pushed through the outer sleeve (Cannula) into the pharyngeal opening, which remains after removal of the larynx, to allow the Provox or Provox2 prosthesis to be attached and pulled into the fistula. Order size: 1 Provox Trocar and 1 Provox Cannula, reusable, sterilizable. Read instructions. 18

19 Provox Pharynx Protector: (Figure 11) For protection of the pharyngeal wall during primary TE only. Stainless steel instrument. Interchangeable for left- or right-handed use. Order size: 1 Provox Pharynx Protector, reusable, sterilizable. Read instructions. Provox2 Training Kit: (Figure 12) For hands-on training of the Provox2 loading and insertion procedure. Allows new staff to improve performance. Contains 1 Provox2 voice prosthesis for demonstration use, 3 loading tubes, 1 inserter and 1 Instructions for use manual. Reusable, some water-soluble lubricant needed after 3 loading attempts. Other supplementary products that can be used with Provox voice prostheses Provox HME: (Figure 13) Heat- and Moisture Exchanger can partially restore lost nasal functions (heating, humidifying, breathing resistance) in cases where the upper airway is short circuited by a tracheostoma. Provox HME is especially designed for use after total laryngectomy. Depending on skin type, it can be attached to the stoma by means of Provox Adhesive base plates or Provox LaryTubes (see below). The actual HME cassettes facilitate stoma occlusion for speech. Besides better lung function, Provox HME may improve speech by increasing dynamic range and/or maximum phonation time. For more information see specific product descriptions. Provox FreeHands HME: (Figures 14 & 15, including Provox HME Cap) A Heat- and Moisture Exchanger combined with an automatic tracheostoma valve, designed to allow handsfree speech. May not be optimal for all patients. For more information see specific product descriptions. Provox LaryTube: (Figure 16) Soft, yet sufficiently rigid silicone tracheal cannula. Intended to support shrinking stomas while retaining Provox HME cassettes or the Provox FreeHands HME automatic speaking valve. Available in different versions and several sizes. For use with voice prostheses, the Fenestrated Provox LaryTube version must be chosen. Other versions must be fenestrated individually at the level of the TEP fistula. For more information see specific product descriptions. Please find all ORDERING CODES at the end of this manual. 19

20 Instructions for the clinician Maintaining device effectiveness Do not use the product if the package is damaged or opened. Directions for use Indications for replacement The prosthesis is not a permanent implant and needs periodic replacement. The primary indication for replacement of the Provox2 voice prosthesis is incompetence of the valve, causing leakage of fluids through the prosthesis. In the event of total blockage of the prosthesis and/or excessive pressure to obtain adequate speech, cleaning of the prosthesis by suction, preferably under endoscopic control, should be tried before replacement is undertaken. Inspection of the prosthesis can then be carried out with a rigid 30 nasopharyngoscope or a flexible laryngoscope. In this way, inspection of the valve and cleaning of the prosthesis is feasible. Incompetence of the valve, blockage of the prosthesis and/or excessive pressure to obtain adequate speech may resolve with cleaning and inspection. Anterograde replacement procedure Choosing the right length of the prosthesis Use a Provox2 voice prosthesis of the proper length. To determine the right length, you may use the Provox Measure (see Accessories) or use the prosthesis as its own measuring device. If there is too much (i.e. 3 mm / ~0.12 inches, or more) space between the tracheal flange of the old prosthesis and the mucosal wall, a shorter prosthesis should be used. This can be observed sometime postoperatively, when the tracheo-esophageal party wall shows less induration due to the resolution of the surgical edema and inflammation. However, it should be kept in mind that a slightly long prosthesis (unless there is a pistoning effect, squeezing fluids around the device) may not be a problem, whereas a prosthesis that is too short is always problematic. Deformation of the tracheal flange may indicate that the prosthesis is too short, and a longer prosthesis should be used. Use of a prosthesis with a longer shaft should also be considered if the tracheal mucosal shows a tendency to become hypertrophic and to bulge over the tracheal flange. 20

21 Loading the voice prosthesis into the insertion tool: The method is described for right-handed use; if used left-handed, right should read left, and left should read right. See illustration (1) The insertion tool consists of an inserter (A) and a loading tube (B). The loading tube has a split opening for securing the prosthesis, and a tapered end for anterograde insertion into the TE-fistula. The loading tube has been pre-lubricated internally to facilitate passage of the voice prosthesis through the tube. Insert the safety strap of the prosthesis into the slit (2) of the inserter, fixate it by pulling firmly in the direction of the arrow (3) and place the prosthesis with its tracheal opening on top of the inserter (4). (5) Squeeze the esophageal flange of the voice prosthesis forward between thumb and index finger of your right hand. Hold the loading tube with your left hand. Insert ( hook ) the squeezed flange of the prosthesis with an angle of about 45 into the slit of the loading tube. (6) Push the inserter forward for about 1 cm (~0.4 inches). This holds the voice prosthesis with the esophageal flange folded forward. (7) Press the protruding part of the prosthesis down with your left thumb. The esophageal flange should now be completely folded forward. Push the inserter forward until mark line 1 is level with the rim of the loading tube (see also illustration 8). CAUTION: If the esophageal flange is not folded forward and too much force is needed to press the prosthesis forward, pull it back and follow the instructions from illlustration 5. Additional water-soluble lubrication may be needed. The Provox2 prosthesis is now prepared for placement. Replacement of the prosthesis The Provox, Provox2 or any other prosthesis is removed from the TE-fistula by pulling out the device with a non-toothed hemostat (unless greater force has to be used, as may be the case with the first generation Provox prosthesis) or by means of the Provox GuideWire in a transoral manner, as described in the manual accompanying the Provox GuideWire. At the clinician s discretion, the tracheal flange of 21

22 the prosthesis may be grasped with forceps and cut off, and the rest of the prosthesis can then be pushed into the esophagus for passage through the intestinal tract. The patient s clinical history of abdominal diseases should be taken into account. See illustration (8): Insert the tapered side of the loading tube into the TE-fistula, and probe the fistula pushing forward, until the tip of the loading tube is completely inside the lumen of the esophagus and the posterior esophageal wall is reached. (9) Hold the loading tube with your left hand in this position. Hold the inserter with your right hand, using your thumb as a natural stop at mark line 2. Push the inserter (right hand) forward until mark line 2 is level with the rim of the loading tube. CAUTION: Do not inject the prosthesis using the inserter like a syringe. Do not hold the inserter like a pen. Both methods will lead to incorrect placement. (10) The forward folded esophageal flange should now unfold in the lumen of the esophagus. Check this by gently pulling the insertion tool (loading tube and inserter together) backwards until the anterior esophageal wall is reached, anchoring the esophageal flange against the anterior esophageal wall. Hold the inserter in this position, using the front esophageal wall as a stop. (11) Draw the loading tube backwards while keeping the inserter in the same position and remove it over the inserter. As a result, the tracheal flange should unfold. If the tracheal flange does not unfold automatically, pull and turn the inserter with the prosthesis lightly around its axis several times, or use a nontoothed hemostat to pull gently on the tracheal flange and rotate this in position. The knobs on the prolonged tracheal flange indicate in which direction the safety strap should be pulled. The smooth side of the tracheal flange should face the tracheal mucosa and the knobs should face toward the lumen. (12) Check to see if the prosthesis is in the proper position by rotating and exerting slight traction on the tracheal flange. If the prosthesis 22

23 is safely in place, cut off the safety strap on the outer edge of the tracheal flange. (13) The Provox2 voice prosthesis is ready for use. The end of the tracheal flange should point downwards into the trachea. Remarks - If you have little experience with the Provox2 replacement procedure, read the Trouble shooting section below and practice with the Provox2 Training Kit (REF 7222) and Artificial Fistula Model (REF 8201). - If the insertion is not successful, it can be repeated with the same tools and devices. If, however, the procedure has to be repeated more than twice, additional water-soluble lubrication of the loading tube is advisable. - If replacement of the voice prosthesis by anterograde method is not successful, the retrograde replacement method with the Provox GuideWire may be used, using the safety strap as introduction string. See Individualization of treatment section above. Trouble shooting Safety strap forgotten If you do not attach the safety strap of the prosthesis, it may be lost during insertion, either in esophagus, fistula or trachea. There is a risk of aspiration or ingestion. If this happens, interrupt insertion if appropriate, secure the prosthesis with a nontoothed hemostat and pull it out by using another hemostat. Reload the prosthesis into the insertion tool and repeat the procedure. If the prosthesis is already lost, see Adverse events section for more information. The esophageal flange is not completely folded forward into the loading tube. (1) If this happens and it is hard to push the prosthesis forward within the tube, interrupt the insertion and pull the prosthesis backwards out of the loading tube. Reload and repeat the procedure. 23

24 The esophageal flange is not completely folded forward into the loading tube. (2) If this happens and the valve is damaged (i.e. dislodging the blue valve seat or tearing off the valve flap), there is a risk of aspiration. Always check the integrity of the valve after replacement by letting the patient swallow some water. If the prosthesis leaks, check the function endoscopically. Replace the prosthesis if the valve is damaged. Inserting the prosthesis completely into the esophagus (overshooting). In case of overshooting (the whole prosthesis is developed in the esophagus) results, leave the safety strap attached to the inserter; use a non-toothed hemostat to pull the prosthesis into position. The identification knobs on the prolonged tracheal flange must always face the open lumen of the trachea, never the mucosal membrane. Slight rotation might be helpful to fully position the prosthesis. Cut the safety strap only after the correct fit is obtained. In some cases it might be easier to overshoot the prosthesis and position it as described above. Conditions which may favor this approach include: Use of very short prostheses (4.5 mm), very thin fistula walls, mucosal fold in the esophageal front wall which may otherwise entrap the esophageal flange of the prosthesis. Inserter is not placed far enough into the fistula. If this happens and undershooting (the esophageal flange is released and unfolds still in the fistula tract) results, the prosthesis may be immediately pulled out again with the inserter, still attached by the safety strap. Alternatively, if undershooting is not recognized, it may lead to immediate leakage through the prosthesis and / or difficult voicing and / or early extrusion towards the trachea. Confirm the correct position by pulling and rotating the prosthesis while it is still attached to the inserter. This reduces the risk of leaving the prosthesis partially inserted in the fistula tract. Always fully probe the fistula tract with the inserter and reach the free lumen of the esophagus before releasing the prosthesis. You may carefully touch the esophageal back wall for confirmation. The tip of the loading tube 24

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