Berlin Heart EXCOR Pediatric VAD, Manual, Page: 31 / 250

Chapter 2 General Information
2 General Information
2.1 Device description
EXCOR is an extracorporeal, pneumatically driven ventricular assist device. It is
designed to support the right and/or left ventricle when the native heart is unable to
maintain normal blood flows and pressures even with help of drug therapy and intra­
aortic balloon counterpulsation. The device is designed for mid to long term
mechanical support.
The EXCOR consists of 1 or 2 extracorporeal, pneumatically driven blood pumps and
cannulae which connect the blood pump(s) to the atrium or ventricle and to the great
arteries. The Ikus provides alternating air pressure to the blood pumps through driving
tubes.
The blood pump is divided into an air chamber and a blood chamber by a multi-layer
flexible polyurethane membrane. The alternating air pressure provided by the
Ikus
moves the membrane, thus filling and emptying the blood pump. Both the blood
chamber and the polyurethane connectors are transparent to allow for visual detection
of deposits and for monitoring the filling and emptying of the blood pump.
Valves (three-leaflet polyurethane valves) are located at the inlet and outlet positions
of the blood pump connector stubs, thus ensuring the unidirectional blood flow.
Pulse rate, systolic drive pressure, diastolic suction pressure and the relative systolic
duration can all be monitored and adjusted on the driving unit.
2.2 Indications for use
The EXCOR is intended to provide mechanical support as a bridge to cardiac
transplantation for pediatric patients. Pediatric patients with severe isolated left
ventricular or biventricular dysfunction who are candidates for cardiac transplant and
require circulatory support may be treated using the EXCOR.
2.3 IDE Clinical Study Summary
See chapter 3: Summary of Clinical Studies, page 25.
2.4 Intended operation environment
Ikus is intended for use in a clinical setting. It can be used in any kind of hospital unit,
e.g. OR, ICU, intermediate care unit or general care unit. It may be moved between
clinical units using the built-in wheels, however in this case the patient must always be
accompanied by a person trained in the use of the manual pump and emergency
procedures. Thus, the patient shall be guaranteed care in case of an emergency.
Transporting the device during operation by any vehicles (e.g. ambulance, aircraft,
etc.) is not allowed.
During movement of the device in operation within the clinic all electromagnetic
compatibility precautions (EMC precautions) must be observed. See chapter 17: EMC
tables, page 231. Otherwise there is a risk of electromagnetic disturbances and the
fault-free operation of Ikus could not be guaranteed.
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