NuMED MOUNTED CP STENT Gebrauchsanweisung Seite 4

3. Measure the diameter of the reference stricture and vessel proximal and distal to the target lesion to
determine the appropriate size stent and delivery system.
Preparation Of Stent Delivery System
• Visually inspect the balloon/stent assembly to assure proper placement of the stent and to assure that the
stent is evenly crimped. Uneven crimping could cause the stent to deploy in a non-symmetrical manner (MAY
BE CONFIRMED BY FLUOROSCOPY).
Stent Deployment
1. Use of the tools supplied with the stent is necessary to defeat the hemostasis valve without
damaging the stent. Once the stent is past the hemostasis valve, the tool must be pulled out of the
valve.
2. The assembly is advanced through the long delivery sheath and over the stiff guidewire into the desired
location for implant.
3. After correct positioning of the stent, pull back on the sheath to expose the stent. Confirm proper stent
position by a small injection of contrast through the sidearm of sheath or through a second catheter.
4. Expand the stent initially by inflating the inner balloon until it is fully expanded. One may "reposition" the
stent at this point by moving the BIB
hold the stent tightly against the BIB
outer balloon. This could cause the stent to slip off the balloon catheter.
5. Confirm positioning and inflate the outer balloon to rated diameter. Do not exceed the manufacturer's balloon
rated burst pressure.
Delivery System Withdrawal
1. Once the stent is expanded, deflate both balloons completely and rotate to ensure the stent is free and
properly deployed. If there is a residual waist in the stent, expand only the outer balloon again, making sure
not to exceed the rated burst pressure.
2. Remove the balloon catheter and confirm the result with angiography.
NOTE: Diameter of the stent may be increased after placement by expanding with a larger diameter balloon. Do
not exceed the maximum recommended expanded stent diameter of 24mm for the 8 zig stents, and 30mm for
the 10 zig stents.
RETURN OF EXPLANTED DEVICE
NuMED, Inc. is interested in obtaining recovered CP Stents. Place the explanted device in a container or vial
immediately after excision. For further instructions on the return of an explanted device, contact RA Manager,
NuMED, Inc. 2880 Main Street, Hopkinton, New York, 12965. Phone number: 315-328-4491.
WARNING: NuMED stents are placed in the extremely hostile environment of the human body. Stents may fail to
function for a variety of causes including, but not limited to, medical complications or failure of stent by fracture
and embolization. In addition, despite the exercise of all due care in design, component selection, manufacture,
and testing prior to sale, stents may be easily damaged before, during, or after insertion by improper handling,
crimping or other intervening acts. Metal stents placed where there are extrinsic forces of compression, i.e. right
ventricular outflow tract, are especially prone to fatigue fracture and embolization and should be avoided.
Stents and accessories are sold in an 'as is' condition. The entire risk as to the quality and performance of the
stent is with the buyer. NuMED disclaims all warranties, expressed or implied, with respect to catheters and
accessories, including but not limited to, any implied warranty of merchantability or fitness for a particular
purpose. NuMED shall not be liable to any person for any medical expenses or any direct or consequential
damages resulting from the use of any catheter or accessory or caused by any defect, failure, or malfunction of
any catheter or accessory, whether a claim for such damages is based upon warranty, contract, tort, or
otherwise. No person has any authority to bind NuMED to any representation or warranty with respect to
catheters and accessories.
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catheter. The unexpanded outer balloon and expanded inner balloon
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catheter. DO NOT deflate the inner balloon before expansion of the
Warranty and Limitations
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