COOK Medical Advance Gebrauchsanweisung Seite 6

Balloon Catheter Introduction and Inflation with Sialendoscopic Visualization and Ultrasound
Imaging
(For Use in the Submandibular or Parotid Salivary Ducts)
NOTE: If targeting the submandibular salivary duct, an appropriately sized introducer sheath may be used if desired.
(See Table 1)
1. Using a sialendoscope to visualize the desired treatment site, 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.
NOTE: If an introducer sheath is not utilized, the papilla may be dilated before introducing the balloon
catheter.
2. Advance the wire guide until it has passed through the desired treatment site.
3. Remove the sialendoscope, leaving the wire guide positioned through the desired treatment site.
4. Place the balloon catheter over the wire guide. While using ultrasound guidance, advance the balloon
catheter over the wire guide until the balloon is positioned across the desired treatment site.
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.
NOTE: If you meet with resistance while advancing the balloon catheter, do not force the balloon
catheter.
NOTE: If necessary to better visualize balloon placement with ultrasound guidance, you may preinflate
the balloon using low pressure (< 2 ATM) and deflate the balloon while it is in the duct. Ensure the
tip of the balloon is not positioned into the smaller branch of duct as undesired dilation of the
smaller branch may occur.
5. Prepare an inflation device with saline or sterile water and attach it to the balloon lumen.
6. Inflate the balloon to the desired pressure. Adhere to recommended balloon inflation pressures.
(See Compliance Card Insert)
7. If the balloon loses pressure and/or ruptures, pull negative pressure on the balloon inflation port and
remove the balloon catheter.
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 balloon.
3. Confirm adequate treatment with sialendoscope after balloon removal.
4. Remove sialendoscope and wire guide.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is
unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a
dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure
no damage has occurred.
REFERENCES
These instructions for use are based on experience from physicians. Refer to your local Cook sales representative for
more information.
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