How Supplied - COOK Medical Advance Micro 14 Instrucciones De Uso

• Vessel dissection, perforation, rupture or injury
• Vessel spasm
INSTRUCTIONS FOR USE
Balloon Preparation
1. Choose a balloon appropriate to lesion length and vessel diameter.
2. Upon removal from package, inspect the catheter to ensure no damage
has occurred during shipping.
3. Remove protective balloon sleeve from balloon. Do not discard protective
sleeve after initial introduction of catheter into the vascular system; it may
be helpful in wrapping balloon prior to subsequent insertions.
4. Prepare balloon lumen with standard contrast-saline mixture as follows:
a. Fill a syringe of appropriate size with 1:1 mixture of contrast medium
and normal saline.
b. Attach the syringe to the hub of the catheter marked "BALLOON" and
pull back to apply negative pressure.
c. Release pressure, allowing negative pressure to draw mixture into
balloon lumen.
d. Detach syringe, leaving a meniscus of mixture on the hub of the
balloon lumen.
e. Prepare inflation device in standard manner and purge to remove all air
from syringe and tubing.
f. Attach inflation device to the balloon lumen, ensuring no air bubbles
remain at connection.
g. Pull negative pressure on the inflation device.
Balloon Introduction and Inflation
1. Flush the catheter lumen labeled "DISTAL" using heparinized saline
solution.
2. Apply negative pressure to lumen labeled "BALLOON" prior to
introduction. Advance the balloon dilatation catheter counter-clockwise
over a pre-positioned .014 inch (0.36 mm) wire guide.
3. Activate the hydrophilic coating by wiping the balloon with heparinized
saline solution.
4. Under fluoroscopy, advance the balloon to the lesion site. Carefully
position the balloon across the lesion using both the distal and proximal
radiopaque balloon markers.
NOTE: If resistance is met while advancing the balloon dilatation catheter,
determine the cause and proceed with caution.
5. Inflate balloon to desired pressure. Adhere to recommended balloon
inflation pressures. (See Compliance Card insert.)
6. If balloon pressure is lost and/or balloon rupture occurs, deflate balloon
and remove balloon and sheath as a unit.
Balloon Deflation and Withdrawal
1. Completely deflate the balloon using an inflation device or syringe. Allow
adequate time for the balloon to deflate.
NOTE: Balloons with large diameters and/or longer lengths may require
longer deflation times.
2. Deflate the balloon by pulling vacuum on the inflation syringe or inflation
device. Maintain vacuum on the balloon and withdraw the catheter. Upon
catheter withdrawal, a gentle counterclockwise rotation of the catheter
will assist balloon rewrap, minimizing trauma to the percutaneous entry
site.
3. If resistance is met during withdrawal, apply negative pressure with a
larger syringe before proceeding. If resistance continues, remove balloon
and sheath as a unit.

HOW SUPPLIED

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended
for one-time use. Sterile if package is unopened or undamaged. Do not use
the product if there is doubt as to whether the product is sterile. Store in a
dark, dry, cool place. Avoid extended exposure to light. Upon removal from
package, inspect the product to ensure no damage has occurred.
REFERENCES
These instructions for use are based on experience from physicians and (or)
their published literature. Refer to your local Cook sales representative for
information on available literature.
BALÓNKOVÝ KATETR S ULTRA NÍZKÝM PROFILEM
ADVANCE MICRO™ 14 PRO PTA
POZOR: Podle federálních zákonů USA smí tento prostředek být prodáván
pouze lékařem nebo na předpis lékaře (nebo kvalifikovaného zdravotníka
s licencí).
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ČESKY