How Supplied; Instructions For Use - NuMED Z-MED II Instrucciones De Utilizacion

ENGLISH
INDICATIONS: Recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
• A patient with isolated pulmonary stenosis.
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require
surgical intervention.
DESCRIPTION
The NuMED PTV 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. A
radiopaque band[s] defines the center [or shoulders, if two] of the dilatation balloon.
Each balloon inflates to the stated diameter and length at a specific pressure. The balloon size is ± 10% at the
nominal pressure. The Rated Burst Pressure (RBP) is different for each size. Check the package label for the RBP. It
is important that the balloon not be inflated beyond the RBP.

HOW SUPPLIED

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.
CONTRAINDICATIONS
Other than standard risks associated with insertion of a cardiovascular catheter, there are no known
contraindications for valvuloplasty. The patient's medical condition could affect successful use of this catheter.
• Patients with mild valvular stenosis.
• A patient with valvular stenosis with major congenital heart defects that require open heart surgery.
WARNINGS
• 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.
• Catheter balloon inflation diameter must be carefully considered in selecting a particular size for any patient.
The inflated balloon diameter should not be significantly greater than valvular diameter. The choice of the
balloon size to be used for valve stenosis has been established by the VACA Registry to be approximately
1.2 to 1.4 times the valve annulus. It is important to perform an angiogram prior to valvuloplasty to measure
the size of the valve in the lateral projection.
• Balloons ≥ 4cm in length may impinge upon the tricuspid valve mechanism and may injure it. Balloons
longer than 4cm are not recommended for children ≤ 10 years old.
• Use only appropriate balloon inflation medium. Do not use air or gaseous medium to inflate the balloon.
• 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.
• The catheter should be used prior to the 'Use Before' date noted on the package label.
• Right ventricular outflow tract damage has occurred with balloons larger than 1.5 times the size of valve
annulus.
• The catheter is intended for valvuloplasty applications only, and is not intended for angioplasty.
• THE CATHETER IS NOT INTENDED FOR USE WITH STENTS.
PRECAUTIONS
• Dilatation procedure 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.
• Before removing the catheter from the sheath it is very important that the balloon is completely deflated.
• Proper functioning of the catheter depends upon its integrity. Care should be used when handling the
catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter.

INSTRUCTIONS FOR USE

Prior to valvuloplasty, carefully examine all equipment to be used during the procedure, including the catheter, to
verify proper function and that the catheter size is suitable for the specific procedure for which it is intended. Also,
inflate the dilatation catheter to the appropriate RBP and deflate to verify proper function.
Remove balloon protector. Inspect the catheter for damage prior to insertion.
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Check that all connections are tight. Fill and purge the dilatation balloon. Prime and flush the distal lumen.
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Instructions for Use
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