Indication for use
The ZEPHYR® Vascular Compression Band (VCB) is indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient’s arm or leg, including: radial, brachial, dorsalis pedis, or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in anticoagulation therapy.
- The ZEPHYR VCB must be applied by a physician, nurse or technician experienced with vascular procedures. The patient must be checked regularly for arterial patency, bleeding, hematoma or thrombosis while the ZEPHYR VCB is in use.
- The ZEPHYR VCB should be used only for hemostasis of a puncture site on a patient’s limb. Sterile or aseptic technique should be used.
- Sterility of package contents is not guaranteed if the individual packages are previously damaged or opened. Only new, sterile ZEPHYR VCBs taken from factory-sealed pouches, should be used.
- The ZEPHYR VCB is a single-use, sterile device. Attempts to re-use or re-sterilize may result in device breakage or malfunction resulting in patient injury or infection. Do not use if the package has been opened or damaged.
- Do not use alcohol, disinfectants, or any other liquids with the ZEPHYR VCB or on the patient while the ZEPHYR VCB is being applied. The ZEPHYR VCB must be deployed onto a dry site.
- Federal (USA) law restricts this device to sale by or on the order of a physician.
- The ZEPHYR VCB deployment should be performed by physicians or physician-directed allied health care professionals with adequate training in the use of the device.
- Use caution when applying compression with the ZEPHYR VCB, taking care not to overtighten it.
- Do not over-inflate the balloon. Over-inflation can result in balloon damage that compromises the performance of the ZEPHYR VCB.
- Only insert the nozzle of the syringe into the valve on the ZEPHYR VCB.
- Do not insert the nozzle of the syringe into a Luer connector or valve on a sheath or any other device.
- Do not inject any liquids into the ZEPHYR VCB balloon.
- Use caution if deploying the ZEPHYR VCB onto a patient with uncontrolled hypertension or systolic pressure of more than 180mmHg.
- When operating the syringe, control the plunger by pressing on the end at all times. Ensure correct placement, alignment and securement of the ZEPHYR VCB.
- Patients should not be left unattended while the ZEPHYR VCB is in use.
- Do not leave the ZEPHYR VCB on for inappropriately long periods of time as tissue damage may occur.
- Do not apply if the circumference of the wrist at the puncture site is too large or small, exceeding the size range of the ZEPHYR VCB.
- Instruct the patient not to touch or bump the ZEPHYR VCB or move their hand or wrist during compression.
- Monitor the patient during the compression period for bleeding, hematoma or thrombosis, and to ensure proper deployment and patent distal blood flow through the ulnar and radial arteries.
- Patients with infection or other serious skin diseases at the site of puncture.
- Patients with an abnormal Allen test or radial pulse, or insufficient blood supply in the ulnar or radial arteries.
Please refer to the Instructions For Use for complete information, including indications, precautions, warnings, and potential adverse events.