Device Description; Intended Use - COOK Medical UPJ Gebrauchsanweisung

UPJ OCCLUSION BALLOON CATHETER SET
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly
licensed practitioner).

DEVICE DESCRIPTION

• Set Contains (set components may vary)
• Radiopaque balloon catheter
• Appropriate diameter PTFE coated stainless steel wire guide 80 cm long
• Removable inflation/injection adapter
• Syringe

INTENDED USE

Used to temporarily occlude the ureteropelvic junction to prevent stone fragments from entering the ureter
during percutaneous lithotripsy, and for injection of contrast medium. The removable inflation/injection
adapter allows the cystoscope to be removed after the catheter is in place.
CONTRAINDICATIONS
There are no known contraindications.
WARNINGS
• Always inflate the balloon with a sterile liquid. Never inflate with air, carbon dioxide or any other gas.
PRECAUTIONS
• Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture. Inflation
of the balloon 2 or 3 times with an appropriate inflation medium prior to use will allow easier inflation of
the balloon.
• Only water soluble lubricants are recommended for use with the occlusion balloon catheter. Use of other
than water soluble lubricants may cause the inflated balloon to burst.
• Do not overinflate the balloon.
• Refer to product label or the inflation check valve on the balloon device for appropriate balloon volume.
• To prevent the balloon from rupturing, avoid excessive pressure. The amount of inflation may be
determined fluoroscopically.
• This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to
device failure and/or transmission of disease
INSTRUCTIONS FOR USING UPJ OCCLUSION BALLOON CATHETER SET
1. Remove the TFE sheath which protects the balloon section of the UPJ Occlusion Balloon Catheter; discard
the sheath.
2. Secure the wire guide to the catheter by tightening the Tuohy-Borst adapter. (Figure A) The wire should
protrude approximately 1 cm to 2 cm from the occlusion balloon catheter tip to act as a filiform during
placement.
3. Under x-ray or fluoroscopic control, cystoscopically pass the UPJ Occlusion Balloon Catheter with wire
guide into the ureter and up to the UPJ.
4. After positioning and before inflating the balloon, remove the wire guide and then remove the
cystoscope.
5. Slide the inflation/injection adapter onto the distal end of the occlusion balloon catheter until the tip
meets the Luer lock adapter. Tighten the caps on both ends of the adapter. (Figure B)
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ENGLISH