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

10. With the catheter/lead in tension and under fluoroscopic guidance advance the inner and outer
Evolution® Shortie RL Controlled-Rotation Dilator Sheaths along the catheter/lead activating the device as
necessary until vessel entry is obtained.
To activate the inner Evolution® Shortie RL Controlled-Rotation Dilator Sheath, slowly squeeze and release
the trigger activation handle (one squeeze every one to two seconds max):
For Bi-Rotational motion
Squeeze trigger to activate sheath rotation. A return of the trigger to it's 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 it's forward
most position. Repeat as appropriate.
11. Immediately end the use of the device when the first of either, minimal entry into the vessel has been
achieved or fluoroscopic monitoring confirms that a mid-clavicular location along the cardiac lead has been
reached. Exchange the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set for the appropriately
sized Evolution® RL Controlled-Rotation Dilator Sheath Set.
WARNING: The Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set should be used only to
minimally enter the vessel.
NOTE: If using Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set when minimal entry into the
vessel has been verified, exchange the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set for the
Evolution® RL Controlled-Rotation Dilator Sheath Set as described in the "Suggested Instructions for Use".

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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