Indications, Safety, and Warnings
AAR1000 Controller
Contraindication
This device used for any other purposes than for the indicated use is the responsibility of the user. Indication: The AAR1000 Controller is intended for use only in conjunction with the Medtronic VARD or Medtronic Resting HeartTM Module during cardiac surgery or extracorporeal support procedures. This device is not designed, sold or intended for use except as indicated.
Indication
The AAR1000 Controller is intended for use only in conjunction with the Medtronic VARD or Medtronic Resting Heart™ Module during cardiac surgery or extracorporeal support procedures. This device is not designed, sold or intended for use except as indicated.
Warning
The possibility of electrical failure or mechanical failure exists with all blood circulatory support devices. The possible adverse effects of failures include, but are not limited to infection, blood loss, hemolysis, air embolism, circulatory compromise and thromboembolic phenomena A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures. The benefits of extracorporeal support must be weighed against the risk of systematic anticoagulation and must be assessed by the prescribing physician.
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 which accompany each product.
Affinity VARD
Contraindication
This device not indicated for patients with a body weight less than 10 kilograms and is not indicated for use with a roller pump. The VARD® is not designed, sold, or intended for use except as indicated.
Indication
The VARD is a single-use, disposable medical device. It is intended to be used in an extracorporeal perfusion circuit to separate and remove macro-air entering the venous line during surgical procedures requiring extracorporeal circulatory support. The device is indicated for use in procedures requiring a blood flow rate of 1-6 L/min and lasting up to 6 hours. The VARD is indicated for placement in the venous line of an extracorporeal circuit proximal to a centrifugal pump. The VARD is indicated for use only with a Medtronic controller. The VARD is indicated for use only with the AAR1000. The Bio-Pump+ Blood Pump in the Medtronic Resting Heart Module is indicated for use only with the Bio-Console. The Carmeda Affinity NT Oxygenator and Carmeda Affinity Arterial Filter in the Medtronic Resting Heart Module have the same indications for use as a Carmeda Affinity NT Oxygenator and Carmeda Affinity Arterial Filter used in other extracorporeal circuits.
Warning
Excessive air removal through the VARD may result in undesirable levels of blood removal from the arterial-venous circuit.
A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures. The benefits of extracorporeal support must be weighed against the risk of systematic anticoagulation and must be assessed by the prescribing physician.
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 which accompany each product.
Medtronic Resting Heart System
This product is coated with Carmeda® BioActive Surface under license from Carmeda AB and is licensed for use only as part of an extracorporeal blood circulation system or circuit which includes an oxygenator or blood pump. Carmeda® is a registered trademark of Carmeda AB
Contraindication
The Medtronic Resting Heart Module is not intended for procedures in which high rates of pericardial or cardiotomy suction are necessary to manage acute disruptions in hemostasis. The addition of a venous reservoir system may be considered under those conditions.
The device is not indicated for patients with a body weight less than 10 kilograms.
The device is not designed, sold or intended for use except as indicated.
Indication: The Medtronic Resting Heart® Module is indicated for use in surgical procedures requiring extracorporeal circulatory support, gas exchange, and thermal regulation. The device is indicated for use in procedures requiring blood flow rate of 1-6 lpm and lasting up to six hours.
The system is indicated for use only with the Bio-Console.
The VARD is indicated for use only with the AAR1000. The Bio-Pump+ Blood Pump in the Medtronic Resting Heart Module is indicated for use only with the Bio-Console. The Carmeda Affinity NT Oxygenator and Carmeda Affinity Arterial Filter in the Medtronic Resting Heart Module have the same indications for use as a Carmeda Affinity NT Oxygenator and Carmeda Affinity Arterial Filter used in other extracorporeal circuits.
Warning
Because the Resting Heart Module is a closed-loop circuit considerations must be made in the methodology for sequestering and re-infusing left ventricular vent and pericardial suction blood. A cell salvaging and washing system may be utilized. Depending on the volume of blood being salvages, it may be necessary to incorporate a Carmeda-coated cardiotomy reservoir into the circuit.
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 which accompany each product.