How Supplied; Beskrivelse Af Produktet - Cook Medical Coda Instrucciones De Uso

Balloon Preparation
NOTE: Balloon and balloon lumen of the Coda and Coda LP Balloon
Catheters contain air. The air must be removed from balloon and balloon
catheter prior to insertion using standard technique.
1. Remove protective balloon sleeve.
2. Prepare balloon lumen with standard 3:1 saline and contrast mixture as
follows:
a. Attach syringe, with appropriate amount of 3:1 saline and contrast
mixture, to stopcock on balloon lumen.
b. Purge all air from balloon in standard fashion.
c. Completely deflate balloon and close stopcock.
3. To increase ease of insertion, balloon may be lubricated with a thin layer
of sterile, biocompatible lubricant.
Balloon Introduction and Inflation
1. Flush the Distal lumen using heparinized saline solution.
2. Advance the balloon catheter over a pre-positioned .035 inch wire guide,
utilizing a minimum 14.0 French introducer sheath for the 10.0 French
Coda Balloon Catheter or a minimum 12.0 French introducer sheath for
the 9.0 French Coda LP Balloon Catheter.
NOTE: If resistance is met while advancing the wire guide or balloon
catheter, determine the cause and proceed with caution.
CAUTION: Prior to introduction, determine the amount of standard
3:1 saline and contrast mixture needed to inflate the balloon to the
desired inflation diameter. Refer to the Balloon Inflation Parameters
chart in Figs. 1 and 2. Over-inflation of the balloon may result in
damage to vessel wall and/or vessel rupture.
3. Under fluoroscopy, advance the balloon to the desired position using
radiopaque markers.
CAUTION: If the Coda or Coda LP Balloon Catheter is being utilized to
expand a vascular prosthesis, use the radiopaque markers to ensure
that the entire balloon is positioned within the prosthesis.
4. Inflate balloon with standard 3:1 saline and contrast mixture using a 20 cc
or larger syringe. Adhere to recommended balloon inflation volumes.
5. If balloon pressure is lost and/or balloon rupture occurs, deflate the
balloon and remove balloon and sheath as a unit.
NOTE: Care should be taken to monitor balloon manipulations and
inflation using fluoroscopy at all times.
Balloon Deflation and Withdrawal
1. Completely deflate the balloon using an appropriately sized syringe.
Allow adequate time for the balloon to deflate.
2. Deflate the balloon by pulling vacuum on the inflation syringe.
3. Maintain vacuum on the balloon and withdraw the catheter. 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.
DANSK
CODA® OG CODA® LP BALLONKATETRE
FORSIGTIG: I henhold til amerikansk lovgivning må dette produkt kun
sælges til en læge (eller en autoriseret behandler) eller efter dennes
anvisning.

BESKRIVELSE AF PRODUKTET

Coda ballonkatetrene og Coda LP ballonkatetrene består hver især af to
uafhængige lumen. Den distale lumen ("Distal") forlænger katetrets længde
og bruges til placering over kateterledere. Ballonlumenen ("Balloon") bruges
til at inflatere og deflatere ballonen.
Ballonen er fremstillet af et bøjeligt polyurethanmateriale. Der skal udvises
særlig forsigtighed ved håndtering af ballonen for at forhindre beskadigelse.
Ballonen inflateres til de angivne størrelsesparametre, når de korrekte
volumenanbefalinger anvendes.
Røntgenfaste bånd sidder på ballonkatetret som en hjælp til placering af
produktet under gennemlysning.
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