En: Instructions For Use - St. Jude Medical RadiStop Instrucciones De Uso

RadiStop™ Compression Assist Device

en: Instructions for use

Content
Description
This combination of RadiStop™ Compression Assist Device consists of a support plate and a com-
pression pad with a strap. The whole set is sterile.
The left or right hand is placed into the support plate.The straps attached to the support plate are
placed over the palm and then tighten to secure the support plate around the hand and arm. The
compression pad is placed over the puncture site. The compression pad applies mechanical pres-
sure to the puncture site to induce hemostasis. The amount of pressure to the puncture site is ad-
justed by tightening or loosening the compression pad strap. The support plate provides support to
the hand and spreads pressure over the back of the hand, wrist and lower arm to ensure that the
venous flow is not obstructed.
Indication for Use
RadiStop Compression Assist Device is indicated in the compression of the radial artery after
catheterization.
Contraindications
RadiStop Compression Assist Device is contraindicated in patients who do not have two functional
arteries (ulnar and radial). RadiStop Compression Assist Device should not be used on patient hav-
ing an abnormal Allen's test.
Adverse Events
Potential complications which may be encountered during catheterization via the radial route in-
clude but are not limited to puncture of the posterior wall of the artery, artery occlusion, hematoma,
paresthesia and ischemia.
General Warnings
▪ For one time use only. Do not resterilize or reuse. Inspect the sealed sterile packaging prior to
use. Do not use if the original sterile package is not intact. Reuse after cleaning attempts, rest-
erilization and repackaging may result in patient/user infections.
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