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

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If the device becomes dislodged, it should be replaced as soon as
possible with an all-purpose catheter of a compatible diameter
to prevent aspiration of esophageal contents, and to maintain
the opening between the trachea and the esophagus so that an
Indwelling occluder can be inserted at a later time.
Standard resuscitation procedures for neck breathers should be
utilized in a medical emergency.
Please instruct your patient to consider obtaining a medical alert
bracelet or card to identify them as a neck breather. This should
be kept in a clearly visible location.
Device Removal
The attached neck strap on an Indwelling occluder should only
be removed after the esophageal retention flange position within
the esophagus has been verified. Never attempt to insert or
reinsert an Indwelling occluder that has the neck strap removed.
Never remove one Indwelling occluder and insert another
occluder without first dilating the TE puncture and remeasuring
the tract to confirm correct device length.
The patient should never attempt to remove the device or allow
anyone other than a qualified, trained medical professional to
remove the device.
The Indwelling occluder is not a permanent device and requires
replacement periodically. Many clinicians recommend routine
follow-up evaluations not longer than 6 months. InHealth
Technologies makes no warranty, either expressed or implied, as
to the lifetime of the Indwelling TEP Occluder. The device lifetime
may vary with individual use and biological conditions.
Removal of the Indwelling occluder should only be done by
grasping the outer tracheal flange of the device securely with a
locking hemostat. Pull gently and firmly until the device is fully
withdrawn.
Caution: Federal (USA) law restricts this device to sale by or on
the order of a physician or a licensed speech pathologist.
COMPLICATIONS
Although rare, the following complications have been identified to
occur with silicone devices of the Blom-Singer type. They include: