Instructions for use: Ikus - Berlin Heart

Operator obligations
General product information
The warranty claim is invalidated if the Ikus is opened by anyone other than the service
personnel of Berlin Heart GmbH or people authorized by Berlin Heart GmbH service.
The general business conditions of Berlin Heart GmbH apply.
2.6 Operator obligations
Only qualified, technical medical personnel who have received product-specific training
may work with EXCOR. Training sessions by appointment.
The operator is responsible for informing and caring for the patient.
The operator is entrusted with ensuring the observance of the prescribed maintenance
intervals (see “Maintenance” on page 7).
If damage arises in a component, Berlin Heart GmbH service must be informed
immediately.
The patient must be informed about the safety risks and precautionary measures
(relating to humidity, temperature, electromagnetic fields, etc.).
The Ikus must only be operated with the components mentioned in this document. The
Ikus must not be operated with multi-outlet power strips or extension cords.
2.7 Packaging and sterility
EXCOR blood pumps and cannulas are disposable products and are not intended
for reuse.
The sterile parts are sterilized with ETO and packaged in a double sterile package. Before
opening the sterile package, its intactness must be checked. Sterile parts with damaged
sterile packaging must not be used. This also applies to sterile parts which have
exceeded the imprinted expiration date.
An aluminum-coated outer packaging protects the Carmeda ® coating (CBASTM ) of the
sterile-packaged blood pump against fluctuations in air humidity. Blood pumps with
damaged outer packaging must not be used.
The following articles are delivered in a sterile state: Blood pumps, cannulas, pressure
gauge set, de-airing set, de-airing hammer, tube attachment set.
The outer packaging and the external sterile package are nonsterile and must be
removed before handing over to a sterile person.
2.8 Transportation and storage
Transportation
To transport the Ikus, only the supplied original transport crate must be used. Ensure
that the Ikus is placed firmly and securely inside the transport crate and that the case is
correctly closed.
The case may only be transported as shown. Do not tilt or overturn the Ikus when it is
packed inside the transport crate.
Caution!
• Always observe a resting period of six hours after each transportation before switching
on the Ikus!
Note
• See also Chapter 5.8 “Packaging and transport” on page 29.
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