Product Description; Warnings And Precautions - inhealth technologies Blom-Singer Instrucciones De Uso

Blom-Singer Indwelling Voice Prostheses
®
ENGLISH
BLOM‑SINGER® INDWELLING VOICE PROSTHESES
for Primary, Secondary, Replacement Tracheoesophageal Puncture (TEP) Procedures

PRODUCT DESCRIPTION

Please refer to the diagrams located at the front of this instruction manual.
The Blom-Singer Indwelling Voice Prosthesis is provided in sterile or non-sterile options for
primary, secondary, or replacement tracheoesophageal puncture (TEP: opening made by a
surgeon between trachea or "windpipe" and esophagus for placement of a voice prosthesis)
procedures. The device is packaged with one (1) flange introducer, one (1) inserter stick, two (2)
appropriately-sized gel caps (made of vegetable-based gelatin), and a Voice Prosthesis Cleaning
System. The device is made of medical-grade silicone and consists of a one-way silicone flap
valve, an esophageal flange, a body that holds the valve assembly, a tracheal flange, and a safety
strap. Devices are available in 16 Fr or 20 Fr diameter. Some devices may include silver oxide
treatment to valve (Advantage and Dual Valve); a second one-way flap valve (Dual Valve); a
titanium body ring (Advantage Hard Valve Assembly); large tracheal and/or esophageal flanges;
or a valve with higher resistance (Increased Resistance). Sterile option voice prostheses are
sterilized by ethylene oxide.
INDICATIONS (Reasons to prescribe the device or procedure)
The Blom-Singer Indwelling Voice Prosthesis is indicated for tracheoesophageal voice
restoration following total laryngectomy, when placement or replacement of an indwelling
voice prosthesis is performed by a qualified, trained clinician.
CONTRAINDICATIONS (Reasons that make it inadvisable to prescribe the particular device or
procedure)
The Blom-Singer indwelling voice prosthesis is a medical product that should be used only by a
qualified clinician with experience and training in its use and care.

WARNINGS AND PRECAUTIONS

Sizing of length and diameter for voice prosthesis selection must be determined by a qualified
clinician trained in the use of this particular device. The clinician must carefully determine the
device size and model to address the clinical needs of the individual patient and their TEP.
The clinician is to instruct patients on the use and care of this device and to provide patients
with these instructions for use supplied with the product. This medical device is for single use
only. It may not be reused. Reuse of this device could result in infection. If the device is not
functioning properly, the patient should have it evaluated by a clinician as soon as possible. The
voice prosthesis and accessories must be carefully removed from its packaging and handled in
a manner to prevent contamination of the device. Handle the device and accessories carefully
to avoid damage. If there are tears, cracks, or structural damage to the prosthesis, cleaning
device, or accessories, discontinue use and contact InHealth Technologies Product Complaints.
Do not use the device in the event of the packaging or sterile packaging being damaged or
unintentionally opened prior to use; discard and replace it with a new prosthesis. When using
a sterile device, aseptic handling technique must be used. Use only the appropriately sized gel
caps. Do not use petroleum-based products such as Vaseline® to lubricate the voice prosthesis
as these products can damage the device. Changes in the anatomy or medical status of the
patient may lead to improper fitting and/or function of the device. Dislodgement or extrusion
of the device from the TEP may occur and result in ingestion, aspiration (inhalation) or tissue
damage. A foreign body such as a voice prosthesis in the airway may cause complications
such as acute respiratory (breathing) distress and/or respiratory arrest (stop breathing). Always
measure the TEP when changing the device to select the proper device size. If the device is
improperly sized, it may cause tissue necrosis (tissue death) and/or device dislodgement.
If converting a patient from a large diameter voice prosthesis to a smaller diameter voice
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