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

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37720-03F
into the gel cap (diagram 4d). Do not use any sharp or serrated
instruments to avoid damaging the device.
h. The esophageal retention flange should be folded toward the
center of the device and completely enclosed inside the gel
cap (diagram 4e).
Device Insertion
Warning: Caution should be exercised to avoid accidental
displacement of the device which could result in aspiration of
the device into the trachea. Should aspiration occur, the patient
should attempt to cough the device out of the trachea. Further
medical attention may be necessary if coughing the device out
is unsuccessful.
1. Place the device on the inserter and lock the neck strap onto
the safety peg (diagram 3).
2. Caution the patient not to swallow as you remove the
previously inserted Dilator-Sizer to avoid aspiration of saliva into
the trachea prior to inserting the device.
3. Apply a light coating of water-soluble lubricant (oil-free) to
the tip of the gel-capped end of the device and immediately
insert the device completely into the TE puncture by aligning
the tip of the device partially in the puncture with the neck strap
oriented upwards (diagram 5). Note: Do not use petroleum-
based products such as Vaseline® to lubricate the device as these
products can damage silicone.
4. Hold the device in this position of complete insertion for at
least three minutes. This allows ample time for the gel cap to
dissolve and release the esophageal retention flange (diagram
1a) within the esophagus. Patients should be instructed to swallow
their saliva or warm water to facilitate dissolving the gel cap.
Caution: If the device does not insert easily on the first attempt,
do not continue to try to insert it. Instead, insert a clean puncture
dilator, of the appropriate diameter, for a few minutes to dilate the
TE tract, and then try again.
5. Detach the device neck strap (diagram 1c) from the safety
peg on the inserter. Place a finger against the neck strap and
carefully withdraw the inserter from the device with a twisting
motion. Warning: Caution should be exercised when removing