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Do not use device if package, catheter or components show any signs of
damage (crimped, crushed, cut, opened etc.).
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Do not use device if labeling is damaged or has been defaced or made
partially illegible.
•
Do not use sharp instruments near the extension tubing or catheter
body. Catheter failure may result from contact with sharp objects. Do not
use scissors to remove the dressing as this could possibly cut or damage
the device.
•
Do not suture through any part of the catheter. There is a danger of
tearing the catheter tubing or damaging the suture wing from the
bifurcate if excessive force is applied to the catheter.
•
Avoid sharp or acute angles that could compromise the opening of the
catheter lumens.
•
Repeated over tightening of the bloodlines, syringes and caps will reduce
connector life, shorten the life of this catheter and could lead to potential
connector failure. Use only Luer Lock (threaded) Connectors with this
catheter. Catheter should be inspected for damage before and after each
treatment.
•
Ensure all caps and bloodline connections are secured prior to and
between treatments.
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Clamping near the luers and/or hub of the catheter should be avoided.
Repeated clamping of the tubing in the same location may cause the
tubing to weaken.
•
Do not clamp the shaft of the catheter. Use only the line extension
clamps which have been provided with the catheter.
•
To help avoid air embolism, fill (prime) the device with sterile,
heparinized saline or normal saline solution prior to catheter insertion.
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Do not use excessive force to flush obstructed lumen.
•
Do not advance the guidewire or catheter if you meet with unusual
resistance.
•
Do not use force to insert or withdraw the guidewire from any component
as this could cause the wire to break or unravel. In the event the
guidewire should become compromised for any reason, remove the
introducer needle or sheath introducer and guidewire together as a unit.
•
To avoid vessel perforation and damage, do not insert or withdraw the
guidewire, dilators, or valved pull-apart sheath/introducer forcibly.
•
Do not insert the valved pull-apart sheath/introducer further than
necessary. Depending upon patient size and access site, it may not be
necessary to insert the entire length of the introducer into the vessel.
•
The valved pull-apart sheath/introducer is designed to reduce blood loss
and the risk of air intake.
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The valved pull-apart sheath/introducer is not intended for arterial use.
•
Dilators and catheters should be removed slowly from the sheath/
introducer. Rapid removal may damage the valve members resulting in
blood flow through the valve.
CHEMICAL EXPOSURE WARNINGS
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Do not use acetone on any part of the catheter tubing. Chlorhexidine is
the preferred alternative.
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See SITE CARE Section for full list of recomended antiseptic agents.
POSSIBLE COMPLICATIONS
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Air Embolus
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Arterial Puncture
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Bacteremia
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Bleeding
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Brachial Plexus Injury
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Cardiac Arrhythmia
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Cardiac Tamponade
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Death
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Deep Vein Thrombosis of the lower extremity
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Dissection or Occulusion of the Carotid Artery
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Endocarditis
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Exit Site Infection
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Exit Site Necrosis
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Fermoral Artery Damage
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Fermoral Artery Dissection
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Femoral Vein Occlusion
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Femoral Nerve Damage
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Fibrin Sheath
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Hematoma
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Hemomediastinum
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Hemorrhage
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Hemothorax
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Inflammation, Necrosis, or Scarring of skin over implant area
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Laceration of the Vessel or Viscus
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Lower Extremity Ischemia
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Lumen Thrombosis
Formation
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