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PRODUCT DESCRIPTION
The PreludeSYNC EVO™ Radial Compression Device is a sterile, single use disposable device used to assist
in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures.
It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of
the puncture site with a large inflatable balloon, and a check valve for easy inflation and deflation with a
specialized connection syringe. A clear curved backer plate provides optimal visualization of the puncture
site and ease of placement.
INDICATIONS FOR USE
The PreludeSYNC EVO is a compression device used to assist in gaining hemostasis of arterial percutaneous
access sites.
CONTRAINDICATIONS
•
Patients hypersensitive to the materials of the compression device.
•
Patients with infection or other serious skin diseases at the site of puncture.
•
Pertaining to radial artery catheterization only: patients with an abnormal Allens test, radial pulse, or
insufficient dual artery supply.
•
Not indicated for femoral artery compression.
CLINICAL BENEFITS
•
The PreludeSYNC EVO assists in gaining hemostasis of arterial percutaneous access sites.
WARNINGS
•
Prior to inflation of balloon, confirm that air is being injected into the PreludeSYNC EVO and NOT the
side port of the sheath or other device.
•
Ensure the band is fastened securely around the wrist without slack.
•
Over-inflation of balloon (above 30mL of air) may cause pain, numbness, artery occlusion, or damage
to the device.
•
Under-inflation of balloon, or failure to secure band without slack around the wrist, may compromise
the ability of the device to assist hemostasis of the artery.
•
Arterial pulse distal to the compression device should be monitored to ensure the artery is not
completely occluded as arterial damage or thrombosis may occur.
•
Patients should not be left unattended while the PreludeSYNC EVO is in use.
•
Do not leave the PreludeSYNC EVO on for an inappropriately long period of time as tissue damage
may occur.
•
Do not expose the PreludeSYNC EVO to organic solvents, as they may cause damage to the device.
CAUTIONS
•
Maintain sterile field during application.
•
This device should be used by clinicians with adequate training in the use of the device.
•
Sterile if package is unopened and undamaged.
I N S T R U C T I O N S F O R U S E
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