Instructions For Use - NuMED MULLINS-X Gebrauchsanweisung

ENGLISH
I
NDICATIONS:Recommended for Percutaneous Transluminal Angioplasty (PTA) of the
femoral, iliac and renal arteries. This catheter is not indicated for use in the
coronary arteries, stent placement or stent redilation.
D
ESCRIPTION
The NuMED PTA Ultra High Pressure Dilatation Catheter is a coaxial design catheter with a
balloon mounted on its distal tip. The lumen labeled with the balloon size is for balloon
inflation while the through lumen allows the catheter to track over a guidewire. Four
radiopaque bands define the center of the dilatation balloon - two on each side of the balloon
center spaced 10mm apart, and two under the balloon shoulders. Each balloon inflates to
the stated diameter and length at a specific pressure. The balloon size is ± 10% at the
Rated Burst Pressure (RBP). The RBP is different for each size. Please check the package
label for the RBP. It is important that the balloon not be inflated beyond the RBP.
H S
OW UPPLIED
Supplied sterilized by ethylene oxide gas. Sterile and non-pyrogenic if package is unopened
or undamaged. Do not use the product if there is doubt as to whether the product is sterile.
Avoid extended exposure to light. Upon removal from package, inspect the product to
ensure no damage has occurred.
W
ARNINGS
• CAUTION: Do not exceed the RBP. An inflation device with pressure gauge is
recommended to monitor pressure. Pressure in excess of the RBP can cause balloon
rupture and potential inability to withdraw the catheter through the introducer sheath.
• In PTA, the dilated balloon should not markedly exceed the diameter of the artery lying
just proximal to the stenosis.
• Use only appropriate balloon inflation medium. Do not use air or gaseous medium to
inflate the balloon.
• Do not advance the guidewire, balloon dilatation catheter, or any other component if
resistance is met, without first determining the cause and taking remedial action.
• This catheter is not recommended for pressure measurement or fluid injection.
• Do not remove the guidewire from the catheter at any time during the procedure.
• This device is intended for single use only. Do not resterilize and/or reuse it, as this
can potentially result in compromised device performance and increased risk of cross-
contamination.
P
RECAUTIONS
• Dilatation procedures should be conducted under fluoroscopic guidance with
appropriate x-ray equipment.
• Guidewires are delicate instruments. Care should be exercised while handling to help
prevent the possibility of breakage.
• Careful attention must be paid to the maintenance of tight catheter connections and
aspiration before proceeding to avoid air introduction into the system.
• Under no circumstances should any portion of the catheter system be advanced
against resistance. The cause of the resistance should be identified with fluoroscopy
and action taken to remedy the problem.
• If resistance is felt upon removal, then the balloon, guidewire, and the sheath should be
removed together as a unit, particularly if balloon rupture or leakage is known or
suspected. This may be accomplished by firmly grasping the balloon catheter and
sheath as a unit and withdrawing both together, using a gentle twisting motion
combined with traction.

Instructions for Use:

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