Precautions; Instructions For Use; Voice Prosthesis Replacement - Atos Provox ActiValve Manual Del Usuario

1.5 PRECAUTIONS

• During loading of the prosthesis make sure that the esophageal flange is completely folded forward in the loading tube (Fig. 7).
Incorrect loading can cause device damage with immediate valve failure and fluid aspiration.
• Carefully assess any patient on anticoagulant treatment or with bleeding disorders for the risk of bleeding prior to prosthesis
placement or replacement.
• Aseptic technique should be employed in the management of the voice prosthesis to avoid introducing contaminants into
the stoma, TE-puncture or esophagus.
• For internal lubrication of the Provox ActiValve, only use Provox ActiValve Lubricant. Other lubricants may damage the
prosthesis irreparably, leading to material destruction and valve malfunction.
• In patients with excessive biofilm formation (micro- organisms and yeasts) the prosthesis, and especially the silicone parts of
the prosthesis, may develop heavy biofilm formation. Therefore it is important to instruct the patient to review the Adverse
Events section in the manual and to contact their clinician if they experience any of the described events.

2. Instructions for use

Caution: Do not use the product if the package is damaged or opened.

2.1 Voice prosthesis replacement

Preparation
Determine the required length of the voice prosthesis by using the current (old) prosthesis as measuring device. If there is
more than 3 mm / ~0.12 inches space between the tracheal flange and the mucosal wall, a shorter prosthesis should be used.
If the prosthesis fit is too tight, a longer prosthesis should be used. Alternatively, the Provox Measure (see Accessories) can
be used to determine the length.
Determine the required strength. If the short device life on standard voice prostheses is caused by biofilm, select Provox
ActiValve Light. If the shorter device life is caused by biofilm and/or inadvertent valve opening, i.e. the valve flap is opened
during swallowing or heavier breathing, select Provox ActiValve Strong.
If an early leakage problem persists, replace the prosthesis with the Provox ActiValve that has the next higher opening force.
If a higher opening force is perceived to negatively impact the patient's speech, the patient may return to the use of a device
with a lower opening pressure, taking shorter device life into account.
Loading the voice prosthesis into the insertion tool:
1. Secure the Safety Strap of the prosthesis by threading it into the slit (Fig. 2) of the Inserter Pin. Fixate the safety strap by
pulling it into the narrower part of the slit (Fig. 3). CAUTION: Always attach the safety strap of the prosthesis to the Inserter Pin.
It could otherwise be lost during insertion causing aspiration or ingestion.
2. Place the prosthesis on top of the Inserter with the tracheal side down (Fig.4).
3. Fold the esophageal flange forward by pinching it together between thumb and index finger. Hold the loading tube with your
other hand. Insert the folded esophageal flange of the prosthesis into the slit of the loading tube (Fig. 5).
4. Push the Inserter Pin forward about 1 cm (~0.4 inches) (Fig.6).
5. Press the protruding part of the flange forward with your thumb into the loading tube. The esophageal flange should now be
completely folded forward (Figure 7).
6. Push the inserter into the Loading Tube until mark line 1 is level with the edge of the loading tube (Fig.8). The Provox
ActiValve voice prosthesis is now prepared for placement.
CAUTION: If the esophageal flange is not completely folded forward, too much force will be needed to press the prosthesis
forward which could cause device damage.
Inserting the new prosthesis into the puncture (Anterograde replacement).
Caution: Do not "inject" the prosthesis using the inserter like a syringe.
1. Pull out the current prosthesis with a non-toothed hemostat.
2. Gently insert the Loading Tube in the TE-puncture until the tip is completely inside the puncture.
3. Insert the prosthesis by holding the loading tube stable with one hand and push the inserter forward with your other hand
until mark line 2 is level with the rim of the loading tube (Fig. 9).
4. Check the prosthesis placement by holding the loading tube and inserter together and pulling them back through the puncture
until the esophageal flange reaches the anterior esophageal wall (Fig. 10).
5. Release the prosthesis by removing the loading tube (the inserter remains in position) (Fig. 11). If the tracheal flange does
not unfold automatically, rotate and pull the inserter pin, or use a non-toothed hemostat to pull the tracheal flange and rotate
this in position.
6. Check proper position by rotating and lightly pulling the tracheal flange. Thereafter place the voice prosthesis so that the
safety strap is pointing downwards.
7. Check valve function by asking the patient to speak (Fig. 12) and by observing the prosthesis while the patient drinks water
(Fig. 13).
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