System Components
System Overview
Blood Pump
The Hydraulically levitated impeller uses an ultra-thin layer of circulating sterile water which lubricates the mechanical seal interface and cools the area around the shaft to minimize the risk of clot formation.
The Open-vane impeller with large flow gaps allow for excellent blood washout and operation at lower speeds to reduce blood sheer.
Pump Speed Modulation allows for customizable speed reduction at set intervals to facilitate aortic valve opening.
Inflow Cannula
The Novel Double Cuff Tipless (DCT) Inflow Cannula is designed to enhance tissue in-growth and may contribute to a decrease in post-LVAD stroke.
The Inflow Cannula also sits flush with the endocardium and is forgiving against malposition.
Controller
The fully integrated controller is the external wearable component that controls pump speed and CSU (Cool Seal Unit) water pressure. The controller features 2 external battery slots for continuous support and an emergency battery installed as a backup power source.
The controller features 2 screens: a display panel and controller screen. The display panel features LED indicators for charge indicators and a status indicator. The controller screen is a touch screen with 4 different tabs for instantaneous pump speed information, CSU parameters, battery indicators, and device settings.
CSU
The CSU (Cool Seal Unit) provides a reservoir and filter for continuous circulation of sterile water into the pump to levitate the impeller. This feature paired with the impeller’s wide flow gaps allow the device to operate at low speeds while maintaining high blood flow.
Emergency Controller
The emergency controller is a backup circuitry for the main controller. Requiring only two connections, an external battery and the blood pump cable, the blood pump automatically powers the controller at a fixed speed.
Battery Charger
Robust battery charger charges two external batteries simultaneously.
External Batteries
External batteries provide up to 12 hours of support. Batteries can be charged in the dedicated battery charger or the main controller when connected to AC/DC power.
EVAHEART®2 External Monitor System
The EVAHEART®2 External Monitor System is a user-friendly and easily adaptable interface for display of device-related parameters for clinician use.
Real-time waveforms for blood pump parameters and flow estimation.
User-friendly and intuitive troubleshooting functionality provides fast access to alarm resolutions.
Pump Speed Modulation functionality allows for a fully customizable settings to accommodate for patient’s physiological differences and facilitate aortic valve opening.