inhealth Blom-Singer Indwelling TEP Occluder, Инструкция по эксплуатации

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Blom-Singer® Indwelling TEP Occluder
37720-03F | 13
the inserter to avoid accidental displacement of the device which
could result in aspiration of the device. Secure the device with
adhesive tape across the neck strap. It is recommended to orient
the device with the neck strap up.
NECK STRAP DETACHMENT
The Indwelling Occluder is designed to include the optional
detachment of the neck strap following confirmation that the
device esophageal retention flange is securely positioned within
the esophageal lumen against the anterior wall of the esophagus.
Removal of the neck strap is an optional procedure.
The neck strap should not be detached from the Indwelling
Occluder if:
• use of a laryngectomy tube may potentially dislodge the
device;
• a patient has previously been wearing a device that is larger
in diameter than the Indwelling Occluder currently being
inserted;
• the diameter of the TE puncture is dilated significantly larger
than the device diameter;
• the health of the stoma tissue or physical condition of the
patient is in question; or,
• direct flexible endoscopy is not utilized for confirmation of
esophageal flange deployment.
Note: It is important not to detach the neck strap from the
device in the instances cited above. Tape the neck strap to the
peristomal skin and observe security of device retention for an
extended period of time.
The following procedure for confirming deployment of the
esophageal retention flange is recommended by Eric D. Blom, Ph.D.
After insertion of the device in the puncture tract and completion
of the 3-minute waiting period for gel cap dissolution and
esophageal retention flange deployment, repeatedly rotate the
device on the inserter while it is in the puncture. If the esophageal
retention flange has deployed and has properly seated against
the mucosa of the anterior esophageal wall, the device on the
inserter will rotate easily in the puncture tract. If the gel cap has