Warnings
Do not exceed the rated burst pressure. Pressure in excess of the rated burst
pressure can cause balloon rupture, embolization of balloon fragments, and potential
inability to withdraw the catheter.
If excessive resistance is felt upon removal, or the balloon bursts during inflation, the
balloon and sheath should be removed together as a unit over the guidewire,
maintaining vascular access. Continued guidewire access permits reintroduction of a
new introducer sheath to preserve hemostasis.
Multiple inflations of the balloon in excess of the rated burst pressure can cause
irreversible enlargement of the waist diameter as a function of pressure.
Use only appropriate balloon contrast inflation medium, in a 1:8 or higher dilution of
contrast medium to saline. Do not use air or gaseous medium to inflate the balloon.
This catheter is not intended for pressure measurement or fluid injection.
The catheter should be used prior to the 'Use Before' date noted on the package label.
During the procedure, an external defibrillator should always be on hand and ready to
use.
Temporary pacing, or rarely permanent pacing, may be required due to intra-cardiac
catheter or guidewire manipulation, or balloon inflation induced heart block.
Prolonged inflation of the balloon can cause prolonged hypotension and
hypoperfusion of critical vascular beds resulting in loss of conscious and acute
cardiopulmonary arrest. Duration should be limited to a brisk inflation/deflation
cycle. Limit the number of inflations and correctly size the balloon per Page 8.
Do not reuse the V8 product as it compromises the intended function or performance
or encourages the spread of infection. The V8 product should be used on one
patient for a single procedure then discarded. It should not be reprocessed and used
again, even on the same patient.
Precautions
Avoid extended exposure to light and store at room temperature.
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. Do not use product if contents of package are broken or
loose.
Dilatation procedure should be conducted under fluoroscopic guidance with
appropriate x-ray equipment.
Careful attention must be paid to the maintenance of tight catheter connections
before proceeding to avoid air introduction into the system.
Under no circumstances should any portion of the catheter system be advanced
against significant resistance. The cause of the resistance should be identified with
fluoroscopy and action taken to remedy the problem.
1204-001 Revision D.1
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