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

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Blom-Singer® Indwelling TEP Occluder
37720-03F | 7
• leakage around the device;
• tissue reaction or infection of puncture tract.
Handle the device and the gel cap loading tool carefully to avoid
damaging the products.
Use only the specially sized gel caps provided by InHealth
Technologies. The Gel Cap Insertion System is designed for use
with Blom-Singer devices only.
Do not use petroleum-based products such as Vaseline® to
lubricate the device as these products can damage silicone.
Changes in the anatomy or medical status of the patient may
lead to improper fitting and/or function of the device. It is
recommended that the device and TEP be evaluated by the
clinician at regular intervals.
Device Dislodgement
Care must be exercised during device insertion or removal to
avoid injury to the TEP or 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.
Confirm gel cap dissolution and deployment of the esophageal
retention flange per procedures provided to ensure that the
device is securely retained in the TEP.
If the device is accidentally dislodged from the puncture, the
patient should immediately place a Blom-Singer puncture dilator,
of the appropriate diameter, in the puncture to keep it from
closing and leaking fluids. The device should be reinserted within
24 hours.
Foreign objects should never be inserted into the device by the
patient.
Management of Indwelling TEP Occluder During Planned or
Unplanned Airway Events
During a planned (e.g., elective) or unplanned (e.g., emergency)
airway event that involves stomal manipulation, the device
should not be removed.