The EVAHEART Left Ventricular Assist System is composed of implantable and external components.

The implantable components are a Blood Pump, an Inflow Cannula, and an Outflow Graft. A pump cable or driveline passes percutaneously through the patient’s skin and connects the Blood Pump to the Controller.

The external components are the Controller with CS System, power sources, Emergency Controller, Outer Belt, External Monitor, and Battery Charger.

External Components

Controller

The Controller contains the electronic components and power to control the Blood Pump and the CS System that maintains the bearing and seals. The Controller is connected directly to the implanted Blood Pump by a driveline. A Controller is placed in a Carrying Bag during normal usage. The Controller, with its displays and alarms, is the user interface to the Blood Pump.

The Controller displays pump speed (rpm) and pump power (watts), as well as battery status and alarms for the Controller, Pump, and CS System Unit (CSU).

CS System

The CSU is the primary component of the CS System, and it consists of a reservoir, a diaphragm pump, a filter and two pressure sensors.

The CS System circulates sterile water to the pump seal/bearing and back through the Controller. In the event that blood gets past the seal, the CS fluid will carry it away. The fluid is then filtered to continuously supply clean sterile water to the seal and bearing. Changes in the CS Lines' pressures can indicate abnormalities in the CS System.

Overview of Blood Pump and CS System

Power Sources and AC/DC Adapter

To power the EVAHEART LVAS safely, power sources (external batteries and an internal emergency battery) and an AC/DC Adapter are provided.

The EVAHEART LVAS uses rechargeable lithium ion batteries; two batteries can power the system for 8 to 10 hours. A separate dedicated Battery Charger is used to charge the batteries. The batteries are used when the patient has no access to an AC power supply. It is recommended to keep the two batteries connected to the Controller at all times. The remaining power left in the batteries is shown on the Controller.

The AC/DC adapter can be plugged into any conventional grounded home outlet (100 to 125 VAC, 50/60 Hz). When voltage from the AC/DC Adapter is detected, it is used preferentially.

The emergency battery supplies power to the system in emergency situations, such as when there are no outside power sources. The emergency battery is automatically charged when connected to an AC/DC power source.

Emergency Controller

The Emergency Controller is designed to be used - in very rare situations - as a back-up to the Controller if it fails.

The Emergency Controller, with batteries attached, can provide power to the Blood Pump until medical personnel can replace or repair the Controller.