inhealth Blom-Singer Indwelling TEP Occluder, Инструкция по эксплуатации

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dissolved and incorrectly deployed the esophageal retention
flange inside the puncture tract rather than inside the lumen of
the esophagus, considerable resistance to device rotation will
be felt.
A second method for confirming esophageal retention flange
deployment is to utilize direct flexible endoscopy confirmation
of deployment.
If the assessment methods described above fail to provide
satisfactory verification of correct esophageal retention flange
deployment, remove the device, dilate and remeasure the
puncture tract, and repeat the device insertion and confirmation
process.
Once deployment of the esophageal retention flange has been
confirmed, detach the neck strap from the tracheal retention
flange (diagram 1b) at the area of reduced neck strap width,
where it meets the tracheal flange, by cutting carefully with
scissors (diagram 6).
Note: if you are uncertain that the esophageal retention flange
has properly unfolded, and the device is in place inside the
esophageal lumen, after using the steps described above, do
not detach the neck strap from the device. Securely tape the
neck strap to the neck and observe the patient for a few days for
retention ability.
Removal of 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withdrawn.
Insert a Dilator-Sizer of the appropriate diameter, and tape it in
position for five minutes prior to inserting a new Indwelling Occluder.