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PreludeSYNC
Radial Compression Device
PRODUCT DESCRIPTION
The PreludeSYNC DISTAL™ Radial Compression Device is a sterile, single use disposable device used to assist in gaining
and maintaining hemostasis of the radial artery following catheterization procedures. It has a soft wristband and thumb
saddle strap with secure hook and loop fasteners. The band delivers adjustable compression of the puncture site with an
inflatable balloon, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal
visualization of the puncture site and ease of placement.
INDICATIONS FOR USE
The PreludeSYNC 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.
• Not indicated for femoral artery compression.
• Patients with an abnormal Allens test, radial pulse, or insufficient dual artery supply.
WARNINGS
• Prior to inflation of balloon, confirm that air is being injected into the PreludeSYNC DISTAL and NOT the side port of the
sheath or other device.
• Ensure the band is fastened tightly around the wrist and hand without slack.
• Prolonged over-inflation of balloon may cause pain, numbness, artery occlusion, nerve damage or damage to the device.
• Under-inflation of balloon, or failure to secure band without slack around the wrist and hand, may compromise the ability
of the device to assist hemostasis of the artery, resulting in bleeding, and/or hematoma.
• 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 DISTAL is in use.
• Do not leave the PreludeSYNC DISTAL on for an inappropriately long period of time as tissue damage, or arterial occlusion
may occur.
• Do not expose the PreludeSYNC DISTAL 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.
REUSE PRECAUTION STATEMENT
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse,
reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-
infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of
the device may lead to injury, illness or death of the patient.
POTENTIAL COMPLICATIONS
Possible complications that may result from use of this device include, but are not limited to: hematoma, recurrent bleeding,
local venous thrombosis, nerve damage, pain or numbness, complex regional pain syndrome, allergic reaction, and artery
occlusion.
I N S T R U C T I O N S F O R U S E
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