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Indications, Safety, and WarningsSelect 3D™ II Arterial CannulaIndications for UseThese cannulas are intended for use in perfusion of the ascending aorta during short-term cardiopulmonary bypass. This product is intended for use up to six hours or less.ContraindicationsThis device is not intended for use except as indicated above.Warnings

In cannulation, extreme caution should be exercised if there is a possibility of tissue dissection of the aorta. Avoid pointing the cannula tip directly toward the branch arteries of the aortic arch to minimize the possibility of directing any dislodged emboli into the arteries or causing increased blood pressure in the brain.

Avoid directing the tip at the aortic valve.

Avoid bending or kinking the cannula. Patient and procedure selection is totally a medical responsibility and the outcome is dependent on many variables, including patient anatomy, pathology, surgical and perfusion procedures and techniques.

This cannula is for short-term, temporary use only.

PrecautionsNote: Proper surgical procedures and techniques are the responsibility of the medical professional. The described procedure is furnished for information purposes only. Surgeons must evaluate the appropriateness of the procedure based on their own medical training and experience and the type of surgical procedure. Exercise care during the connection of the cannula and the perfusion line to insure that no air is trapped in the perfusion line. Placement location and orientation of the sutures in the aorta is critical to proper positioning of the cannula. Once the cannula is firmly secured with the sutures, it is difficult to change the position of the cannula. Do not exceed recommended flow. Please tighten luer caps before using.This cannula is designed and intended for single use only. DO NOT REUSE.Do not exceed maximum recommended flow rates listed below for Select 3D® and Select 3D® II Models:

Up to 4 LPM (liters per minute) for an 18 Fr cannula;

Up to 5 LPM for a 20 Fr cannula;

Up to 6 LPM for a 22 Fr cannula;

Up to 6 LPM for a 24 Fr cannula.

Adverse EffectsThis device, as do all extracorporeal blood system devices, has possible side effects which include, but are not limited to, infections, blood loss, thrombus formation, embolic events, and dislocation. Vessel damage and complications at the puncture site may occur if the Instructions for Use are not followed.Important Safety InformationCare and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgery procedures. For a listing of indications, contraindications, precautions, and potential adverse events, please refer to the instructions for use.Caution: Federal law (USA) restricts this device to sale by or on the order of the physician. US-CV-2500095 v1.0

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