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Automated Impella Controller

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Instruction Manual from ABIOMED Inc

The Automated Impella Controller and Impella Catheters have been cleared by the FDA for hospital-to-hospital transport via ambulance, helicopter, or fixed-wing aircraft. The Automated Impella Controller is qualified for safe use by healthcare professionals to facilitate the transport of patients supported by the Impella Systems from one medical facility to another. The Impella System performs lifesustaining functions. To use the system during transport you must understand and follow the Impella instructions for use. The transport team should include one person fully trained in the use of the Automated Impella Controller and Impella Catheter.