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Affinity

Venous Air Removal Device (VARD)

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 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 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.

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.