Contraindications - COOK Medical Advance Gebrauchsanweisung

ADVANCE® SALIVARY BALLOON CATHETER WITH WIRE GUIDE
CAUTION: U.S. federal law restricts this device to sale on or by the order of a physician (or a properly licensed
practitioner).
DEVICE DESCRIPTION
The Advance Salivary Balloon Catheter with Wire Guide consists of a balloon catheter and a wire guide.
The balloon catheter is a double-lumen catheter with a balloon near its distal tip. The catheter consists of two coaxial
lumens, which are labeled "DISTAL" and "BALLOON. " The distal lumen extends the length of the catheter and is used
to advance the catheter over the supplied wire guide. The balloon lumen is used to expand the balloon. The balloon
diameter (mm) and balloon length (mm) are inscribed on the tip of the manifold. Refer to product label for product
specifications.
The balloon is manufactured from an extra-thin wall, high-strength, minimally compliant material. Particular care
should be taken in handling the balloon to prevent damage. It will inflate to the indicated size parameters
when utilizing proper pressure recommendations. Adhere to balloon pressure parameters indicated. (See
Compliance Card Insert.) Use of a pressure gauge is recommended to monitor inflation pressures.
The wire guide is a stainless steel mandril with a stainless steel coil at the distal tip. The wire guide is 0.014 inch
(0.36 mm) in diameter and 50 cm in length.
INTENDED USE
The Advance Salivary Balloon Catheter is intended for the dilation of lesions and strictures in the submandibular and
parotid salivary ducts.

CONTRAINDICATIONS

• Acute glandular infection
• Acute purulent sialadenitis
WARNINGS
• This product is not intended for use in the vasculature.
• This product is not intended for use in the sublingual salivary duct or glands.
• This product is not intended for use through the working channel of a sialendoscope, as this could result in
shearing of the balloon.
• Do not exceed rated burst pressure.
parameters. (See Compliance Card Insert.) Overinflation may cause rupture of the balloon and may result in
damage to the duct wall. Use of a pressure gauge is recommended to monitor inflation pressures.
• Do not preinflate the balloon before inserting it into the salivary duct. Doing so may make balloon introduction
more difficult.
• Do not use a power injector for balloon inflation. Balloon rupture may occur.
• Do not use a power injector for injection of contrast medium through catheter lumen marked "DISTAL. " Catheter
rupture may occur.
1
The burst pressure data were analyzed using factors for a one-sided tolerance to determine with 95% confidence that 99.9% of these
balloons would not burst at or below calculated rated burst pressure.
PRECAUTIONS
• The product is intended for use by physicians trained and experienced in sialendoscopy.
• When inserting, manipulating or withdrawing the device, do not use excessive force.
• Flush the distal catheter lumen if resistance is felt when passing the catheter over the wire guide.
• The balloon is constructed of a heat-sensitive material. Do not heat or attempt to shape the catheter tip.
• Use only saline or sterile water as inflation medium. Never use air or any gaseous medium to inflate the
balloon.
Rupture of balloon may occur. Adhere to balloon inflation pressure
1
3
ENGLISH