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

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ENGLISH
37720-03F | 5
BLOM-SINGER® INDWELLING TEP OCCLUDER
The Blom-Singer Indwelling TEP (Tracheoesophageal Puncture)
Occluder is a non-valved silicone device designed for placement
in and maintenance of the TE (tracheoesophageal) puncture
following total laryngectomy.
The Indwelling TEP Occluder is intended to:
1. Maintain the TEP fistula by keeping the puncture tract open.
2. Prevent leakage of esophageal contents into the trachea
during swallowing.
This Blom-Singer medical device may be used only once by
one patient. It may not be reused. See Warnings, Precautions
and Complications.
Do not use the device if it becomes contaminated; discard and
replace it with a newly packaged device.
This device is for anterograde placement only. Not intended for
retrograde placement.
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.
INDICATIONS
The Blom-Singer Indwelling TEP Occluder is indicated for
anterograde placement in and maintenance of the TE puncture
following total laryngectomy when placement, or replacement,
of the indwelling silicone prosthesis is performed by a qualified,
trained medical professional. This device is for use with healed,
intact tracheoesophageal puncture fistulas only.
CONTRAINDICATIONS
The Blom-Singer Indwelling TEP Occluder is a medical product
that should be used only by a qualified, medical professional with
experience and training in its use and care.