COOK Medical Evolution RL Gebrauchsanweisung Seite 5

advanced at least to the innominate vein, are often necessary to
extract the lead tip through the scar tissue at the site of venous
entry, and to avoid a venotomy.
7. If the catheter/lead is not removed from the vessel with gentle
pulling then using dilator sheaths, including the Evolution or Evolution
RL Controlled-Rotation Dilator Sheath Set may help separate the
catheter/lead from tissue encapsulation.
8. With the inner Evolution RL Controlled-Rotation Dilator Sheath
placed inside the appropriate outer sheath for telescopic action, insert
the proximal free end of the catheter/lead with Locking Stylet in
place, into the distal end of the inner Evolution RL Controlled-Rotation
Dilator Sheath. Advance the catheter/lead with Locking Stylet, until it
completely exits the opposite (proximal) end of the sheath set.
9. Apply adequate retracting pressure or tension on the catheter/lead
via its Locking Stylet. This is critical to safe passage of the sheath set
over the catheter/lead. If tension is inadequate, the catheter/lead
may buckle, precluding the sheath set from advancement along
the appropriate path.
10. With the catheter/lead in tension, and under fluoroscopic guidance,
advance the inner sheath along the length of the catheter/lead and into
the blood vessel. Rotate the inner Evolution® RL Controlled-Rotation
Dilator Sheath, by squeezing and releasing the trigger activation
handle.
For Bi-Rotational motion
Squeeze trigger to activate sheath rotation. A return of the trigger
to its forward most position will mechanically change the rotational
direction of the sheath to the direction opposite of the last rotation.
Repeat as appropriate.
For Uni-Rotational motion
Squeeze trigger to activate sheath rotation and repeat without
allowing trigger to return to its forward most position. Repeat as
appropriate.
Advance the outer sheath over the inner sheath, keeping it within the
vessel.
11. In a telescopic manner, alternately advance the inner, and then
outer, sheaths while maintaining adequate tension on the catheter/lead
and/or its wire guide or Locking Stylet, until the catheter/lead is free of
tissue restriction. In general, the inner sheath should not be advanced
more than 4 cm beyond the outer sheath.
NOTE: Always monitor fluoroscopically while advancing the
sheaths to avoid shearing the catheter/lead or rupturing the vessel.
Continue to maintain adequate tension on the catheter/lead
and Locking Stylet. Adjust the angle of entry to keep the sheaths
aligned with the catheter/lead in the vessel and to minimize sheath
curvature during advancement. Rotating the inner Evolution RL
Controlled-Rotation Dilator Sheath Set using the trigger activation
handle and its outer sheath during advancement may facilitate
progress through exuberant scar tissue.
NOTE: When the sheath set is tracking around a bend along the
targeted lead/catheter, keep the outer sheath's beveled tip (if
applicable) to the inside radius of the bend.
12. For cardiac leads, if the lead has not been freed by the time the
sheaths near the myocardium, position the outer sheath so that the
blunt end is directed toward the myocardium. Pull the inner sheath
back several centimeters.
13. Apply countertraction with the outer sheath as follows:
Firmly hold the outer sheath one centimeter from the heart wall and
steadily pull the Locking Stylet back; the pacing tip will be pulled into
the sheath.
14. When the catheter/lead has become unentangled and freed from
tissue attachment, carefully remove from the patient, the catheter/
lead, Locking Stylet and Evolution or Evolution RL Controlled-Rotation
Dilator Sheath Set.
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