Instructions For Use; Preparation; Operating Instruction - Atos Medical Provox Vega Instrucciones De Uso

the lower esophagus may be removed by esophagoscopy 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
from 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.
Spontaneous passage of the device may be awaited for 4-6 days. The patient should
be instructed to observe the stools for the ingested device. If the device does not pass
spontaneously, or if there are signs of obstruction (fever, vomiting, abdominal pain) a
gastroenterologist should be consulted. The silicone housing of the Vega voice prosthesis
can be located and retrieved endoscopically. The device may be retrieved by using a non
toothed grasping forceps. During endoscopy, the device may appear as a oval shape with
an opening in the middle with an outer diameter of about 10-17 mm (the fl anges of the
device), or as a cuffl ink shape with a shaft length of 8, 10, 12.5 or 15 mm, depending on
the size of the device. Refl ections from the light source on the clear silicone rubber may
be seen. In prostheses that have been in situ for some time, white or yellow appearing
Candida deposits may be visible on the device.
Infection and/or edema of the TE-puncture – Infection, granulation formation and/or
edema of the puncture may increase the length of the puncture tract. This may cause the
prosthesis to be drawn inward and under the tracheal or esophageal mucosa. Infl ammation
or overgrowth of the esophageal mucosa may also cause the prosthesis to protrude from
the puncture. Temporary replacement of the prosthesis by a prosthesis with a longer
shaft is then advisable. If standard medical treatment does not resolve the infection, the
prosthesis should be removed. In some cases stenting the puncture with a catheter might
be considered. If the puncture closes spontaneously re-puncture 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 about 5%. Electrical, chemical, or
laser cauterization of the area of granulation may be considered.
Granulation/Hypertrophic scarring around the puncture – Bulging of the tracheal
mucosa over the tracheal fl ange may occur if the prosthesis is relatively short. This
excess tissue may be removed by using a laser. 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. Re-puncture 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 laryngectomy tube, stoma button, or the patients' fi nger, damage
of the puncture, tracheal and/or esophageal tissues may occur. Inspect the conditions
regularly to avoid severe damage.
Leakage through the valve – Leakage through the prosthesis may occur because:
• Candida overgrowth near the valve seat and valve fl ap may lead to incomplete closure
of the valve fl ap, which causes leakage through the device. This is a normal event in
prosthetic voice rehabilitation and an indication to replace the voice prosthesis.
• Stronger negative pressure in the PE-segment occurs during swallowing. To investigate
this, transstomal inspection of the valve fl ap of the prosthesis should be performed
during swallowing.
Leakage around the prosthesis – Transient leakage around the prosthesis may occur and
may resolve spontaneously. The most common reason is that the prosthesis is too long,
which is solved by inserting a shorter prosthesis. If the problem is not solved by inserting
the correct length prosthesis, other factors that may affect tissue integrity in the area
of the TE puncture (for example gastroesophageal refl ux or thyroid function) should be
considered, evaluated, and treated. In enlarged punctures with reduced retention strength
other conventional treatment methods such as the injection of fi llers (e.g., collagen) or
temporary removal of the voice prosthesis, should be considered. If the leakage around
the voice prosthesis is intractable, more conservative measures, such as surgical closure
of the puncture may be necessary.

2. Instructions for use

Please see accompanying Illustration manual for illustrations referenced in this
Instructions for Use.
For a visual overview of the different procedures you can fi nd links to video animations
under the section headings below.
Caution: The videos do not replace nor do they set forth the complete contents of the
Instructions for Use and /or Prescriber Information, and are not a substitute for reviewing
the entire contents of the Instructions for Use. The videos are only intended to further
enhance the understanding of the procedure after review of the Instructions for Use.

2.1 Preparation

Prior to the puncture always determine what size and diameter of voice prosthesis to use.
The appropriate size and diameter depends on the anatomy of the patient, local medical
practice and preference of the surgeon.

2.2 Operating instruction

Check the integrity of the sterile package. Do not use the product if the package is damaged
or opened. Unsterile product may cause infection.
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