How Supplied; Popis Prostředku - COOK Medical Advance 35LP Instrucciones De Uso

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 .035 inch (0.89 mm) wire guide.
3. 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.
4. Inflate balloon to desired pressure. Adhere to recommended balloon
inflation pressures.
5. 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.
ČESKY
BALÓNKOVÝ DILATAČNÍ KATETR S NÍZKÝM
PROFILEM ADVANCE® 35LP PRO PTA
POZOR: Podle federálních zákonů USA smí tento prostředek být prodáván
pouze lékařem nebo na předpis lékaře (nebo kvalifikovaného zdravotníka
s licencí).
POPIS PROSTŘEDKU
Balónkový dilatační katetr s nízkým profilem Advance 35LP pro PTA je
dvoulumenný katetr s balónkem v blízkosti distálního hrotu. Katetr se skládá
ze dvou samostatných lumen s označením „DISTAL" (distální) a „BALLOON"
(balónkový). Distální lumen prodlužuje délku katetru a používá se k umístění
vodicích drátů. Balónkový lumen se používá k expanzi balónku. Na hrotu
rozdělovacího dílu jsou uvedeny průměr balónku (mm) a délka balónku (cm).
Balónek je vyroben z velmi tenkého, velmi pevného a minimálně poddajného
materiálu. Manipulaci s balónkem je třeba věnovat zvláštní pozornost,
aby se zabránilo jeho poškození. Při použití doporučených hodnot tlaku
se naplní na indikovanou velikost. Dodržujte tlakové parametry pro plnění
balónku uvedené v příbalové kartě obsahující informace o poddajnosti.
Další informace viz štítek výrobku. Doporučujeme použít tlakoměr ke kontrole
tlaku plnění.
(See Compliance Card insert.)
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