COOK Medical Advance Gebrauchsanweisung Seite 5

2. Remove the balloon catheter from the package. Inspect the balloon catheter to ensure that no damage
has occurred during shipping.
3. Remove the yellow-tipped shipping stylet from the distal tip of the balloon catheter.
4. Remove the protective orange balloon sleeve from the balloon catheter.
5. Apply negative pressure to the lumen labeled "BALLOON" before introducing it into the salivary duct.
Balloon Catheter Introduction and Inflation with Introducer Sheath and Sialendoscopic
Visualization
(For Use in the Submandibular Salivary Duct)
1. Use an appropriately sized introducer sheath to access the desired salivary duct. (See Table 1.)
2. Use the sialendoscope to view the desired treatment site, and then pre-position the wire guide, floppy
end first. If using a sialendoscope with an instrument channel, the wire guide may be inserted through
the instrument channel. If there is no instrument channel, insert the wire guide through the introducer
sheath into the salivary duct alongside the sialendoscope.
3. Advance the wire guide until it has passed through the desired treatment site.
4. While maintaining position of the wire guide within the salivary duct, remove the sialendoscope from
the salivary duct and from the wire guide.
5. Place the balloon catheter over the wire guide. Advance the balloon catheter over the wire guide until
the proximal end of the balloon catheter enters the introducer sheath.
NOTE: In order to prevent trauma to the duct, be sure to maintain the position of the wire guide when
you advance and manipulate the balloon catheter.
6. Insert the sialendoscope into the introducer sheath behind the balloon catheter and advance the
sialendoscope through the introducer lumen.
7. Advance the balloon catheter and sialendoscope together until the treatment site is visualized.
8. Advance the balloon catheter independently until the balloon is positioned across the desired
treatment site. Do not advance the balloon into the smaller branch of duct as undesired dilation of
the smaller branch may occur.
NOTE: If you meet with resistance while advancing the balloon catheter, do not force the balloon
catheter.
9. To ensure that the sialendoscope is not alongside the balloon during inflation, maintain position of the
balloon catheter while withdrawing the sialendoscope until the balloon catheter shaft is visible.
10. Prepare an inflation device with saline or sterile water and attach it to the balloon lumen.
11. Inflate the balloon to the desired pressure. Adhere to recommended balloon inflation pressures.
(See Compliance Card Insert)
12. If the balloon loses pressure and/or ruptures, pull negative pressure on the balloon inflation port and
remove the balloon and sialendoscope as a unit.
Balloon Deflation and Withdrawal
1. Use an inflation device or syringe to completely deflate the balloon. Allow adequate time for the
balloon to deflate.
2. Maintain vacuum on the balloon and withdraw the balloon catheter.
NOTE: Do not use excessive force when removing the balloon.
NOTE: If you meet with resistance while using a sialendoscope, remove the sialendoscope first, and
then the balloon catheter.
3. Confirm adequate treatment with sialendoscope after balloon removal.
4. Remove sialendoscope and wire guide.
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