Indications, Safety, and Warnings

DLP Metal Tip Single Stage Venous Cannulae and DLP Malleable Single Stage Venous Cannulae

Contraindication: This device is not intended for use except as indicated. Indication: These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

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 Pediatric One-Piece Arterial Cannulae

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 cardiopulmonary bypass, up to six hours or less.

Warning: Avoid directing the cannula tip toward the branch arteries of the aortic arch to minimize inadvertent embolization into the arteries or causing increased intracranial blood pressure.

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 Straight Tip Arterial Cannulae

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 cardiopulmonary bypass. This product is intended for use up to six hours or less.

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 One-Piece Pediatric Arterial Cannulae and Bio-Medicus One-Piece Pediatric Venous Cannulae

Contraindication: Alone, the cannula and obturator 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 obturator is to be used only 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 Obturator 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 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 Aortic Root Cannulae

Contraindication: This device is not intended for use except as indicated. Indication: This cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

The Model 23009 cannula may also be used to monitor pressure in 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. 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 Cardioplegia Needles

Contraindication: This device is not intended for use except as indicated. Indication: These cannulae are intended for use in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solution. Only model 10313 may be used to aspirate air from the aorta during the de-airing procedure.

Caution: Care should be taken when inserting the needle to prevent aortic dissection or 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 Cardioplegia Adapter with Pressure Port

Contraindication: This device is not intended for use except as indicated. Indication: These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring.

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.