Berlin Heart EXCOR Adult, Instructions For Clinical Use

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General Information EXCOR Active
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3.4 Intended Use
3.4.1 Use
The EXCOR Active system is an electro-pneumatic driving system for the EXCOR
ventricular assist device. The EXCOR Active system may only be used for uni- or
biventricular circulatory support.
• LVAD- indicated for patients with sole left ventricular failure
• RVAD- indicated for patients with sole right ventricular failure
• BVAD- indicated for patients with identifiable failure of both the left and right ven-
tricles
All decisions regarding the selection of components as well as the care of the patient
are the sole responsibility of the treating physician. The recommendations made in
these instructions for use are based on the experiences of Berlin Heart. Before thera-
py with the EXCOR system, the treating physician must conduct a medical evaluation
of the mental and physical compliance of the patient.
EXCOR VAD in combination with EXCOR Active may only be used in combination
with EXCOR VAD system components, and only in accordance with the indications,
contraindications, and instructions for use.
Patient population
The EXCOR VAD ventricular assist device is designed for use on the hearts of pa-
tients ranging in age from newborn to adult.
Target cardiac output is based on patient size, weight, and body surface area. This
information is used in order to select a combination of blood pumps and cannulae that
will meet the patient’s medical needs.
The intended patient population may be restricted depending on country-specific ap-
provals.
Professional users
EXCOR VAD and EXCOR Active may only be implanted and configured by medical
personnel. Medical personnel are persons considered professional users who have
the necessary medical expertise, e.g., surgeons, VAD coordinators, cardiovascular
perfusionists, etc. EXCOR VAD and EXCOR Active training is a prerequisite.
Lay users
EXCOR Active can be used by patients or caregivers without medical knowledge. Pa-
tients and caregivers must receive training from the hospital. They must be able to
identify critical situations and react to them appropriately. Operation of the system by
the patient is contingent upon the patient’s mental and physical capability of doing so.
Intended conditions of use and usage environments
EXCOR VAD in combination with EXCOR Active is suitable for indoor and outdoor use
in professional healthcare facilities.
The device can be operated on mains power as well as using the included batteries.
The system can switch between power sources without operational downtime.
EXCOR VAD is used for continuous patient care. How long EXCOR VAD and
EXCOR Active are used depends on the patient’s particular indication.