How Supplied; Instructions For Use - NuMED BIB Instrucciones De Utilizacion

ENGLISH
I
NDICATIONS
Recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and
renal arteries. These catheters are not designed to be used in the coronary arteries.
The safety and effectiveness of this device for use as a stent delivery system
in the placement of intravascular stents has not been established.
D
ESCRIPTION
®
The NuMED BIB (Balloon in Balloon) Catheter is a triaxial design catheter. Two lumens
are used to inflate the balloons while one lumen is for tracking over a guidewire. The
radiopaque platinum marker(s) are placed beneath the 'working area' of the balloon. The
inner balloon is ½ of the outer balloon diameter and 1 cm shorter. Each balloon inflates to
the stated diameter and length at a specific pressure. The balloon size is ±10% at rated
burst pressure (RBP). The 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.
The purpose of the double balloon catheter is to apply an incremental inflation for the
purpose of opening an artery. The inner balloon provides initial expansion of the artery and
also acts as a tool to hold the catheter in the artery while the outer balloon is inflated. The
outer balloon is then inflated providing the remainder of the expansion.
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
ARNING
• 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.
• Confirm that the distal end of the introducing sheath is at least 2.5cm back from the
most proximal image markers before inflating the outer balloon. Failure to do so may
stretch the outer tubing and severely hinder balloon deflation.
• 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.
• Use two appropriate size inflation devices with pressure gauges for inflation.
• 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 except
when the procedure has been completed.
• 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.

Instructions for Use:

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