Instructions for use: Ikus - Berlin Heart

Safety information
1 Important safety information
Changes:
• The safety information has been supplemented.
WARNING
The EXCOR system and its components may be used only by
prescription of the attending physician.
Only system components may be used with the EXCOR system. No
components other than those supplied by Berlin Heart may be used.
The warranty shall otherwise be voided.
The long-term storage conditions for all sterile products must be
observed: temperature +15°C to 25°C, relative humidity 35% to 50%.
Store in a dry place! Otherwise there is a risk that the products may no
longer be sterile.
Do not resterilize or reuse EXCOR sterile components! Otherwise
there is a risk of infection or damage to materials. EXCOR sterile components
are: blood pumps, cannulae, drivelines, accessory set (de-airing
set, tube connecting set, membrane set, pressure gauge set).
Do not resterilize or reuse EXCOR sterile components after the use-by
date. Otherwise there is a risk of infection or damage to materials. The
use-by date is printed on the labels of the inner and outer packaging.
Only remove the de-airing needle if the blood pump is running and the
parameters have been adjusted.
During implantation: ensure that the blood pumps are completely free
of air at the start. Do this by first triggering a single step, then if
necessary expelling any air bubbles using the de-airing needle. See
section 6.2.6 of the instructions for use.
Do not reintroduce de-airing needles that have been once removed.
Otherwise the membrane may be damaged. See section 6.2.5 of the
instructions for use.
Do not touch the pumps or cannulae under any circumstances with
pointed or sharp objects (e.g. surgical instruments). See chapter 8 of
the instructions for use.
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