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

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37720-03F
This device should not be placed in a small tracheostomal airway if
its presence obstructs breathing. This device is not a valved voice
prosthesis and does not function like one. Tracheoesophageal
speech is not possible with an Indwelling TEP Occluder.
Placement of the Indwelling prosthesis is contraindicated in a TE
puncture that has dilated substantially beyond the diameter of
a conventional 16 French or 20 French Blom-Singer Indwelling
prosthesis.
HOW SUPPLIED
The Indwelling TEP Occluder is available by special order in 16
French or 20 French diameters. It is supplied nonsterile; do not
sterilize or place in an autoclave as damage to the device may
occur. Provided in each package is the appropriately sized gel
caps and inserters.
WARNINGS AND PRECAUTIONS
The Blom-Singer Indwelling TEP Occluder is a medically
prescribed device. Initial sizing and instructions for use must be
provided by a qualified medical professional trained in the use of
this particular device.
InHealth relies on the qualified, trained medical professional to
instruct patients on the use and care of this device and to provide
patients with the Blom-Singer instructions for use supplied with
the product.
If the device is not functioning properly, the patient should have
it evaluated by a qualified, trained medical professional soon as
possible.
If there are tears, cracks, or structural damage to the device or
accessories, discontinue use. Signs of a defective device include,
but are not limited to,
• occluder degradation due to patient chemistry caused by
microbial growth colonization on device;
• improper sizing caused by a compromised tracheoesophageal
wall status;
• device pushed through TEP caused by improper use of inserter
tool, improper sizing, or a compromised tracheoesophageal
wall status;