Abiomed Impella 5.0 Gebrauchsanweisung Seite 5

POSSIBLE COMPLICATIONS (EU)
There are risks of complications with every procedure using a blood pump. These include among others:
• Hemolysis
• Bleeding
• Immune reaction
• Embolism, thrombosis
• Vascular injury through to angionecrotomy
• Positioning problems
• Infection and septicemia
• Dislocation of the pump
OVERVIEW
The Impella 5.0 Catheter is an intravascular microaxial blood pump that supports a patient's circulatory system.
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The Impella 5.0 Catheter is inserted via femoral or axillary artery cut-down through the artery and into the left
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ventricle
When properly positioned, the Impella
ventricle, through the cannula, to the outlet opening in the ascending aorta. Physicians and device operators
monitor the correct positioning and functioning of the Impella
Impella ® Controller.
This section describes the components of the Impella
the accessory components.
REUSABLE SYSTEM COMPONENTS
The Impella ® 5.0 System consists of the following reusable components:
• Automated Impella Controller—provides the user interface, alarm indications, and portable battery
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• Automated Impella ® Controller cart—for easy transport of the Automated Impella
SINGLE-USE SYSTEM COMPONENTS
The Impella 5.0 System also includes the following single-use components:
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• Impella ® 5.0 Catheter
• Purge cassette
• 0.018 inch, 260 cm placement guidewire
• Connector cable
• Impella Axillary Insertion kit
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Impella ® 5.0 Circulatory Support System
• Cardiovalvular injuries due to extreme movement of
the suction cannula in relation to the cardiac valve or
as a result of attachment by suction of the pump to
the valve system following incorrect positioning
• Endocardiac injuries as a result of attachment of the
pump due to suction
• Pump failure, loss of pump components following a
defect
• Patient dependency on the pump after use for
support
5.0 Catheter delivers blood from the inlet area, which sits inside the left
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5.0 Catheter on the display screen of the Automated
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® Catheter and the Automated Impella ® Controller, as well as
® Controller
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