inhealth Blom-Singer Indwelling TEP Occluder, Instructions For Use Manual

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Blom-Singer® Indwelling TEP Occluder
37720-03F | 9
stoma contamination or sepsis, which may require removal of the
device and/or appropriate antibiotics; accidental aspiration of the
device into the airway, which may require removal by a physician;
occasional extrusion of the device, requiring replacement after
dilation of the TE puncture and additional supervision of the
stoma care regimen; puncture dilation resulting in leakage of
fluids around the device; inflammatory reaction around the
puncture site and formation of granulation tissue; dislodgment of
the device and subsequent closure of the TE puncture; intractable
leakage around the device, requiring surgical revision or closure
of the puncture; difficulty swallowing; tearing or other damage to
the device from improper use; accidental ingestion of the device
into the esophagus and/or GI tract.
PRODUCT DESCRIPTION
The Blom-Singer Indwelling TEP Occluder is offered nonsterile.
Nonsterile product is not intended for primary placement
procedures.
The Blom-Singer Indwelling TEP Occluder is made of silicone,
a biocompatible material used in many medical products. This
device is latex-free.
The gel cap used for insertion of the device is made of a vegetable
base gelatin. Individual patient reactions to these materials may occur.
The Blom-Singer Indwelling Occluder, (diagram 1) consists of an
esophageal retention flange (diagram 1a), a tracheal retention
flange (diagram 1b), and a neck strap (diagram 1c).
Note: Since this is a non-speaking device, cleaning of the device
is not necessary. However, on the portion of the device that
shows out of the puncture, the patient may need to remove dried
mucus secretions using a tweezer.
In order to manage dryness and secretions of the airway, a heat
and moisture exchange system is recommended. If dry secretions
persist and require removal, it is recommended that the area of
crusting be humidified to prevent trauma to the tracheal tissue.
INSTRUCTIONS FOR USE
The following procedure is provided by Eric D. Blom, Ph.D. Please
refer to the diagrams located at the back of this instruction manual.