inhealth Blom-Singer Indwelling TEP Occluder, Инструкция по эксплуатации

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Blom-Singer® Indwelling TEP Occluder
37720-03F | 11
measurement is between two markers, select the longer one.
4. Fully insert the Dilator-Sizer and fasten the neck strap with
adhesive tape on to the patient’s neck. Leave the Dilator-Sizer in
the puncture to dilate 5 minutes, or longer if necessary, in order
to allow for easy insertion of the selected Indwelling Occluder.
Prior to insertion of the Blom-Singer Indwelling Occluder, remove
the tape from the neck strap, grasp the dilator securely, and
carefully withdraw it from the puncture. Immediately insert the
Indwelling Occluder.
Device Preparation
1. Prepare the device for easy, atraumatic insertion by utilizing the
Blom-Singer Gel Cap Insertion System. Use only the specially sized
gel caps provided with this product.
The Gel Cap Insertion System is designed for use with Blom-
Singer Prostheses only; do not use with any other type devices.
The following steps describe the hand folding method of gel cap
insertion.
a. Remove the device from the package. Always handle the
device with clean, gloved hands. Be certain that your gloves
and the device are completely dry before loading the gel cap.
Failure to do so may cause premature dissolving of the gel
cap.
b. Remove the Gel Cap Insertion System items from the package:
gel cap, flange introducer, and inserter tool.
c. Fold and load the device into the unprinted gel cap (discard
the printed end) according to the following steps.
d. Fold the esophageal retention flange tightly in half toward the
center of the device (diagram 4a).
e. Fold the two outer edges of the esophageal retention flange
tightly against the folded flange (diagram 4b) and hold the
device in this folded position.
f. Insert the folded portion of the esophageal retention flange
into the gel cap (diagram 4c). Gently tuck and push the folded
device as far as possible into the gel cap.
g. Use the flange introducer to gently tuck the remaining
portion of the folded esophageal retention flange completely