The Safeguard Radial adds to Merit Medical’s growing portfolio of products designed to support hemostasis following radial approach procedures.

Patent Hemostasis

• Focuses compression only on the radial artery where you want it
• Puncture site clearly visible for visual assessment
• Stable positioning of bulb for optimal compression, not occlusion

Comfort

• Non-woven textile band for patient comfort
• No rigid plastic edges
• Low profile design

Convenient and Easy

• One size fits all, easily adjusted to any wrist size
• Uses standard Luer lock syringe, no need for special syringe
• Easy to monitor distal and proximal pulses to ensure patent hemostasis is achieved
• Easy inflation and deflation

CONTRAINDICATIONS

The adhesive portion of SAFEGUARD Radial should not be used over excori - ated skin.

WARNINGS

• Prior to inflation of bulb, confirm that you are ONLY injecting air into SAFEGUARD Radial compression device and NOT to side port of sheath or other device.

• Over-inflation of bulb (above 7 mL of air) could cause bulb to excessively expand and cause pain, numbness, or radial artery occlusion.

• Under-inflation of bulb could compromise ability of device to assist hemo - stasis of radial artery.

• Maintain sterile field during application.

CAUTIONS

• Read instructions prior to use.

• RX Only: Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

• This device is intended for single use only. Do not reuse or resterilize.

• Do not use if package is damaged

• This device should be used by clinicians with adequate training in the use of the device.

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; bleeding; pain or numbness; radial artery occlusion.