How Supplied; Storage Conditions - COOK Medical Evolution RL Instructions For Use Manual

Controlled-rotation dilator sheath set
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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.

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.

STORAGE CONDITIONS

Keep dry
Keep away from sunlight
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