Indwelling Voice Prostheses - inhealth technologies Blom-Singer Instrucciones De Uso

Blom-Singer

Indwelling Voice Prostheses

®
The device may be left in place in the TEP until it has persistent leakage or is not providing
adequate voice for speech, or requires resizing. Removal of the indwelling voice prosthesis
should only be done by grasping the tracheal flange of the device securely with a locking
hemostat.
COMPLICATIONS
Although rare, the following complications have been identified to occur with silicone
prostheses of the Blom-Singer type. They include: stoma (opening through neck into trachea or
wind pipe) contamination or sepsis, which may require removal of the voice prosthesis and/or
appropriate antibiotics; accidental aspiration of the voice prosthesis into the airway, which may
require removal by a physician; occasional extrusion of the prosthesis, requiring replacement
after dilation of the TEP and additional supervision of the stoma care regimen; puncture dilation
resulting in leakage of fluids around the voice prosthesis; inflammatory reaction around the
puncture site and formation of granulation tissue; dislodgment of the voice prosthesis and
subsequent closure of the TEP; intractable (uncontrollable) leakage around the voice prosthesis,
requiring surgical revision or closure of the puncture; dysphagia (difficulty swallowing); tearing
or other damage to the voice prosthesis from improper use; microbial growth deposits causing
voice prosthesis leakage or valve incompetence; accidental ingestion of the voice prosthesis
into the esophagus.
INSTRUCTIONS FOR USE
THIS DEVICE IS NOT INTENDED TO BE INSERTED OR REMOVED BY THE PATIENT.
All instructions related to device preparation, insertion, and removal are for the clinician only. If you
are a patient, refer to the section on "Device Cleaning and Care". Prior to device preparation for
placement, check the valve mechanism to be sure it is intact and working properly. The flap valve
should close flat against the seating surface inside the voice prosthesis.
Primary Voice Prosthesis Placement
The sterile option voice prosthesis may be placed by the physician at the time of total
laryngectomy (primary puncture, primary placement). Nonsterile product is not intended for
primary placement procedures.
Secondary (or Replacement) Device Placement
The following procedure is provided by Eric D. Blom, Ph.D. as recommended instructions for
secondary or replacement procedures.
Note: All secondary or replacement procedures must only be done with a bright light focused
directly on the stoma and TEP.
Use of gloves and protective eyewear is recommended. Measure the TEP tract before inserting a
voice prosthesis to confirm correct voice prosthesis sizing.
Dilate and Measure (Diagrams 1 and 2)
Please refer to the Blom-Singer Dilation/Sizing System Instructions for Use for complete product
details.
Voice Prosthesis Preparation
Prepare the voice prosthesis for insertion by utilizing the hand folding method of gel cap
insertion. Use only the appropriately sized gel caps provided with this product. Handle the
device with clean, gloved hands.
Remove the voice prosthesis and insertion components (gel cap, flange introducer, and inserter
tool) from the package. Be certain that your hands and the voice prosthesis are completely dry
before loading the gel cap. Failure to do so may cause premature dissolution of the gel cap.
1. Use only the short end of the gel cap. Discard the longer end of the gel cap (diagram 3).
2. Fold the esophageal flange tightly in half toward the center of the device (diagram 4).
3. Fold the two outer edges of the esophageal flange tightly against the folded flange (diagram 5)
and hold the prosthesis in this folded position.
8 I 37924-01B