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<h2>Indications, Safety, and Warnings</h2> <h3>Indications</h3> <p>This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means to improve visibility at the site.<br /> </p> <h3>Contraindications</h3> <ul> <li>This device is not intended for use except as indicated above.</li> <li>Do not use where the effects of an air stream or irrigation mist are contraindicated.<br /> </li> </ul> <h3>Warnings</h3> <ul> <li>Do not use oxygen with this device.</li> <li>Do not exceed inlet pressure of 60 psi (414 kPa).</li> <li>Use caution when moving the tip of the device closer than 3 cm (1.18 in) to the surgical site. Do not allow the tip to contact tissue.<br /> </li> </ul> <h3>Precautions</h3> <ul> <li>Proper surgical procedures are necessarily the responsibility of the medical profession. The described procedure is furnished for information purposes only. Each surgeon must, of course, evaluate the appropriateness of the procedure based on their own medical training and experience, and the type of surgical procedure.</li> <li>Use only PVC tubing to connect the airline to the device.</li> <li>Release compressed CO<sub>2</sub>/medical air in a controlled fashion, by pointing the tip of device away from the wound or surgical site before turning the device on.<br /> </li> <li>This device was designed for single-patient use only. Do not reuse, reprocess, or re-sterilize this product. Reuse, reprocessing, or re-sterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.</li> <li><b>Applicable where phthalates are identified on the product label.</b> Due to the presence of phthalates in the product, the clinician must weigh the medical benefits of product use against the drawbacks of phthalate exposure for male children and pregnant or nursing women.</li> </ul> <h3>Adverse effects</h3> <p>None known.</p> <h2>ClearView™ intracoronary shunt</h2> <h3>Indications</h3> <ul> <li>These shunts are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.</li> </ul> <h3>Contraindications</h3> <ul> <li>These shunts are not intended for use except as indicated above.</li> </ul> <h3>Warnings</h3> <ul> <li>Take care not to:<ul> <li>Damage or scratch the shunt prior to insertion into the coronary artery.</li> <li>Damage the intima of the coronary artery during product use.</li> <li>Attempt to force the shunt’s tips past any vessel obstructions.</li> </ul> </li> <li>In some cases, shunts may not be detectable by X-ray due to the variances in anatomical densities and X-ray techniques. Modifying the X-ray angle or distance may aid in detection.</li> </ul> <h3>Precautions</h3> <ul> <li>The shunt is not an implantable device and may only be used temporarily as described in the indications above.</li> <li>Check for any possible obstructions in the shunt’s internal lumen before placing the shunt in the artery.</li> <li>The shunt, tether, and tag should remain intact. Do not separate the components.</li> <li><b>Note: </b>Proper surgical procedures and techniques are necessarily the responsibility of the medical professional. The described procedure is furnished for informational purposes only. Surgeons must, of course, evaluate the appropriateness of the procedure based on their own medical training and experience and the type of surgical procedure.</li> <li>Take care not to damage the shunt or ensnare the tether with the cardiovascular needle or suture. Remove the shunt from the vessel prior to completion of the anastomosis.</li> <li>These shunts are designed and intended for single use only. Do not reuse.</li> </ul> <h3>Adverse effects</h3> <ul> <li>None known</li> </ul> <p><b>Important safety information</b></p> <p>Not all patients are candidates for beating heart procedures. Some patients would require cardiopulmonary support during surgery.</p> <p>UC202410583 EN</p>

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