Merit Medical PreludeSYNC DISTAL Instrucciones De Uso página 2

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 in atable balloon, and a check valve for easy in ation
and de ation with a syringe. A clear curved backer plate provides optimal visualization of the puncture
site and ease of placement.
INDICATIONS FOR USE
The PreludeSYNC DISTAL™ 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 insu cient dual artery supply.
WARNINGS
• Prior to in ation of balloon, con rm 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-in ation of balloon may cause pain, numbness, artery occlusion, nerve damage or
damage to the device.
• Under-in ation 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 eld 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
English