System Components Overview; Heartware ® Ventricular Assist System; Heartware ® Controller; Heartware ® Monitor - HeartWare Ventricular Assist System Instructions For Use Manual

HeartWare

6.0 SYSTEM COMPONENTS OVERVIEW

6.1 HeartWare Ventricular Assist System
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The HeartWare System consists of a blood pump with integrated inflow cannula; a 10mm diameter gel impregnated
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polyester outflow graft with strain relief, and a percutaneous driveline. A strain relief is used on the outflow graft to
prevent kinking. The driveline cable is wrapped with woven polyester fabric to encourage tissue in-growth at the skin
exit site. The small, wearless pump has a displaced volume of 50cc and weighs 160 grams. The pump has one moving
part, an impeller which spins blood to generate up to 10 L/min of flow. There are two motors in the pump housing with
one motor providing redundancy. A short integrated inflow cannula, which may be smooth or partially sintered, is
inserted into the left ventricle and the outflow graft connects the HVAD
the myocardium and allows for pump orientation adjustments intraoperatively. The device size and short inflow cannula
allow for pericardial placement, which eliminates the need for abdominal surgery and device pockets (Figure 2).
6.2 HeartWare Controller
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The controller (Figure 3) is a microprocessor unit that controls and manages HeartWare
sends power and operating signals to the blood pump and collects information from the pump. The percutaneous
driveline is connected to the controller, which must always be connected to two power sources using an AC
adapter or DC adapter and/or rechargeable batteries. The internal, non-replaceable rechargeable battery inside
the controller is used to power an audible "No Power" alarm when both power sources are disconnected. The
controller interfaces with the monitor through a data port.
CaUTiOn:
The HeartWare ® Controller is designed for single patient use. DO NOT use the controller on
more than one patient.
6.3 HeartWare Monitor
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The monitor (Figure 4) is a touch screen tablet PC computer that uses proprietary software to display system
performance information and permits adjustment of selected controller parameters. When connected to a controller,
the monitor receives continuous blood pump information from the controller and displays real-time and historical pump
information. The monitor also displays alarm conditions.
6.4 HeartWare Controller Power Sources
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The controller requires two power sources for safe operation: either two batteries, or one battery (Figure 5) and an AC
adapter (Figure 6) or DC adapter (Figure 7). While active, patients will typically use two batteries. While relaxing or
sleeping, patients should use power from an electrical outlet (AC adapter) because it provides power for an unlimited
period of time. The batteries should be exchanged when their charge falls below 25% capacity. Spare, fully charged
batteries should always be available.
warning: Disconnecting both power sources (batteries and AC or DC adapter) at the same time will stop
the pump. At least one power source must be connected at all times.
6.5 HeartWare ® Battery Charger
The battery charger (Figure 8) is used to simultaneously recharge up to four batteries.
I
4 HeartWare Ventricular Assist System
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Pump to the aorta. A sewing ring attaches to
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System operation. It
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Figure 2: HVAD Pump and left ventricular (LV)
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cannulation
Figure 3: Controller
1. Monitor Connector 3. Driveline Connector
2. Power Connector 4. Power Connector
Figure 4: Monitor
1. Monitor/Controller Connection
Figure 5: Battery
Figure 6: AC adapter Figure 7: DC adapter
Figure 8: Battery charger