Effective

• The PreludeSYNC™ assists in achieving vascular hemostasis.
• Access site visibility – Large area with clear, unobstructed site visibility.

Comfortable 

• The PreludeSYNC™ is constructed from a soft material that lies against the patient’s skin while providing an outer layer that is easy to clean.
• The balloon was designed to comfortably achieve patent hemostasis.

Secure 

• Band attachment was designed with a material that provides adjustable, secure placement of the device.

Options

• Available in two sizes, 24 cm and 29 cm
• Available with the safety and convenience of a specialized connection device and syringe
• Also available with a standard luer device and standard syringe

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. 

WARNINGS

• Prior to inflation of bulb, confirm that air is being injected into the Prelude Sync 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 bulb (above 20mL of air) may cause pain, numbness, artery occlusion, or damage to the device.

• Under-inflation of bulb, 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 Prelude Sync is in use.

• Do not leave the Prelude Sync on for an inappropriately long period of time as tissue damage may occur.

• Do not expose the Prelude Sync 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.

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.