Indications, Safety and Warnings

MC2X Three-Stage and Ultraflex Venous Cannulae

Contraindication: This device is not intended for use except as indicated. This cannula is contraindicated for use in procedures where the chambers of the heart will be opened or in cases with septal defects.

Indication: This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

Warning: The introduction of air into the right heart may result in the immediate total loss of venous drainage to the extracorporeal circulation.

Caution: Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

EOPA Cannula

Contraindication: This device is not intended for use except as indicated.

Indication: This product is intended for use with cardiopulmonary bypass as an arterial return cannula.

Warning: The introduction of air into the right heart may result in the immediate total loss of venous drainage to the extracorporeal circulation.

Caution: Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

EOPA^® Cannula with Dilator Tip Introducer and Guidewire

Contraindication: This device is not intended for use except as indicated.

Indication: This product is intended for use with cardiopulmonary bypass as an arterial return cannula.

Warning: For EOPA models with Dilator Tip Introducer, a guidewire must be used for proper placement of introducer tip while inserting cannula to avoid trauma to the back wall of the aorta.

Use imaging to ensure that guidewire is properly positioned in the descending arch of the aorta.

Caution: Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

EOPA 3D Cannula

Contraindication: This device is not intended for use except as indicated.

Indication: These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

Warning: 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.

Cannula tip must be inserted beyond side ports to minimum depth marks to avoid possibility of tissue dissection of the aorta.

Do not exceed maximum recommended flow rates.

Caution: Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

Bio-Medicus Multi Stage Femoral Venous Cannulae

Contraindication: Alone, the cannula and introducer are not medical treatment devices. There are no known contraindications for the use of the cannula, other than those generally contraindicated for cardiopulmonary bypass. The cannula introducer is only to be used with the appropriate sized Bio-Medicus^® Cannula. This device is not intended for use except as indicated.

Indication: These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The Cannula Introducer is intended to facilitate proper insertion and placement of the appropriate sized Cannula within the vessel for cardiopulmonary bypass. These products are intended for use up to six hours or less.

Caution: Care must be taken to avoid over-insertion of the cannula and possible impingement of the cannula tip against the vessel/ventricular/atrial walls. Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

Bio-Medicus Multi Stage Femoral Arterial Cannulae

Contraindication: Alone, this cannula is not a medical treatment device. Selection of patient as a candidate for such procedures is the physicians’ responsibility. The outcome is dependent on many variables including patient pathology, surgical procedure, and perfusion procedures. Do not use if the patient has severe peripheral atherosclerosis or severe arterial dissection. This device is not intended for use except as indicated.

Indication: This percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.

Caution: Care must be taken to avoid over-insertion of the cannula and possible impingement of the cannula tip against the vessel/ventricular/atrial walls.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

MiAR Cannula

Contraindication: This device is not intended for use except as indicated.

Indication: The MiAR^™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia Antegrade through the Aorta for up to six hours.

Caution: Additional care and caution may be necessary due to the unique adaptations required for minimally invasive techniques Care should be taken when inserting the needle to prevent perforation of the back wall of the aorta.

Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

DLP Dual Lumen Aortic Root Cannulae with Vent Line

Contraindication: This device is not intended for use except as indicated.

Indication: For use in cardiopulmonary bypass surgery for delivering cardioplegia solutions, venting the left heart through the aortic root and aspiration of air from the aorta.

Caution: Care should be taken when inserting the needle to prevent perforation of the back wall of the aorta.

Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

Gundry Silicone RCSP Cannula

Contraindication: This device is not intended for use except as indicated.

 

Indication: The cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrogradely through the coronary sinus.

Caution: Extreme caution should be exercised while introducing the cannula into the coronary sinus. Do not over inflate the balloon. Do not force the cannula into the coronary sinus as this may cause vessel damage.

Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

Cardioplegia Adaptors

Contraindication: This device is not intended for use except as indicated.

Indication: This adapter is intended for use in conjunction with cardiopulmonary bypass surgery.

Caution: Use the lowest possible pressure to reduce risk of hemolysis or risk of vessel damage.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

Gundry Silicone RCSP Cannula

Contraindication: This device is not intended for use except as indicated.

Indication: The cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrogradely through the coronary sinus.

Caution: Extreme caution should be exercised while introducing the cannula into the coronary sinus. Do not over inflate the balloon. Do not force the cannula into the coronary sinus as this may cause vessel damage.

Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

Cardioplegia Adaptors

Contraindication: This device is not intended for use except as indicated.

Indication: This adapter is intended for use in conjunction with cardiopulmonary bypass surgery.

Caution: Use the lowest possible pressure to reduce risk of hemolysis or risk of vessel damage.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

DLP Pericardial/Intracardiac Sumps

Contraindication: The Pericardial Sump (#12010, #12011) is not intended to be placed through a valve to drain a closed cardiac chamber. This device is not intended for use except as indicated.

Indication: These sumps are intended for draining the pericardial sac. The Intracardiac Sump can also be used to drain the cardiac chambers.

Caution: Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

DLP Cardio-Kits

Contraindication: This device is not intended for use except as indicated.

Warning: Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.