Evaheart Medical USA, Inc.

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Helpful Definitions

AC/DC Adapter: A component of the EVAHEART LVAS that supplies power to the EVAHEART LVAS. The Adapter provides power to the Controller from a grounded AC outlet. The other major power source is the External Battery.

Aorta: The main artery that supplies blood to your body.

Battery Charger: A component of the EVAHEART LVAS that is used to recharge the External Batteries.

Blood Pump: The main component of the EVAHERT Left Ventricular Assist System. The pump helps the heart by producing blood flow needed by the body, relieving some of the work that would be done by the heart.

Carrying Bag: A bag to hold the EVAHEART LVAS components.

Controller: A component of the EVAHEART LVAS that operates and controls the Blood Pump.

Controller Display Panel: The portion of the Controller that shows status information about the Controller and the batteries. The display panel also shows Alarm indicators and Event codes.

CS System: An internal system of the EVAHEART LVAS that circulates sterile water from the Controller to the Blood Pump.

CSU: A component which pumps sterile water to lubricate the Blood Pump.

Driveline: The special cable that connects that EVAHEART blood pump to the Controller.

Emergency Controller: A component of the EVAHEART LVAS designed to be used in an emergency situation if the full size Controller fails.

EVAHEART: Name for this company’s left ventricular assist system.

EVAHEART LVAS: Shortened name for the EVAHEART Left Ventricular Assist System. Name for this company’s blood pump and all components required for proper functioning of the blood pump.

Exit Site: The location on a person’s body where the Driveline leaves the body through the skin.

External Battery: A component of the EVAHEART LVAS that serves as one of the two ways to supply power to the EVAHEART LVAS. The other power source is the AC/DC Adapter.

Investigational Device: Official title given to a device going through the approval process of the Food and Drug Administration (FDA) prior to commercialization of the device.

LVAD: Stands for Left Ventricular Assist Device, sometimes the term is shortened to ‘VAD’. Term used to describe a blood pump connected to a person’s heart to assist with blood flow.

LVAS: Stands for Left Ventricular Assist System. Term used to describe a blood pump and all of its components necessary for proper functioning of the blood pump.

Left Ventricle: One of the four chambers or sections of a human heart. This chamber is responsible for pumping the blood out to the rest of the body. If there is a weakness in the left ventricle, the heart cannot pump enough blood to all the parts of the body.

Outer Belt: A belt worn by patients after the EVAHEART LVAS is implanted. The Outer Belt keeps the Driveline close to a patient’s body and helps to keep it stable in case of accidental pulling on the Driveline.

Power Source: Device that supplies power to the EVAHEART LVAS. There are two major power sources – External Batteries and AC/DC Adapter.

System Components: Consists of EVAHEART Blood Pump, Controller, External Battery, Battery Charger, AC/DC Adapter, and Emergency Controller.

VAD: Stands for Ventricular Assist Device, shortened term from LVAD. Term used to describe a blood pump implanted in a person’s heart to assist with blood flow.