Instructions for use: Ikus - Berlin Heart

2 General product information
2.1 Use in accordance with the intended applications
2.2 Indications
Use in accordance with the intended applications
EXCOR is a ventricular assist device designed for human use. It can be used for
univentricular (LVAD or RVAD) or biventricular support. Atrial or ventricular cannulation
is possible.
EXCOR must only be operated with EXCOR components (see page 88) and with
observance of the indications, contraindications and instruction manual.
EXCOR with Ikus is designed exclusively for stationary use in a clinic. In patients who
show stable hemodynamic parameters and are supported by blood pumps of the sizes
60 ml and/or 80 ml, Ikus can be replaced by EXCOR mobile driving system Excor.
In doing so, the indications, contraindications and intended applications of EXCOR
mobile driving system Excor must be observed.
The EXCOR blood pumps and EXCOR cannulas are disposable products.
Acute or chronic, conservatively uncontrollable cardiac insufficiency of different genesis
in stages III or IV according to NYHA with an expected short-term to long-term support
requirement.
2.3 Contraindications
• Signs of infection which do not correspond to a sepsis-like syndrome
• Sepsis
• Advanced multiorgan failure
2.4 Possible objectives of the therapy
Bridge-to-Transplant (BTT)
In patients who are already listed for a transplant and for whom a conservative
medication-based treatment is no longer possible, the system can bridge the waiting
time until the transplant.
Bridge-to-Recovery (BTR)
By means of relief, the myocardium should be able to recover to the extent that the
EXCOR VAD can be explanted after the individual treatment duration.
Destination therapy (DT)
In patients for whom a contraindication to transplant exists, a long-term, open-end
mechanical circulatory support should be achieved.
2.5 Manufacturer’s warranty
• EXCOR blood pumps: Max. duration of use: 500 days; recommended duration of use:
one year
• EXCOR cannulas: With appropriate treatment, no time restriction
• Batteries: six months
• Ikus, with exception of the batteries: If the prescribed maintenance cycles are observed,
two years
The warranty is valid only when it is stored as prescribed and used as directed, and when
the packaging is intact. This applies in particular to all sterile packages as well as the
aluminum-coated outer packaging of the blood pump.
If an ambient temperature of 30 °C is exceeded in running operation, the maintenance
interval is reduced to 3 months.
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