Abiomed Impella 5.0 Manual Del Usuario página 4

CONTRAINDICATIONS (EU)
CONTRAINDICATIONS IN THE EUROPEAN UNION
• Mechanical aortic valves, severe aortic valvular stenosis or valvular
regurgitation
• Hematological disorder causing fragility of the blood cells or hemolysis
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Aneurysm or necrotomy or severe anomaly of the ascending aorta
and/or the aortic arch
• Mural thrombus in the left ventricle
• Ventricular septal defect (VSD) after myocardial infarction
• Anatomic conditions precluding insertion of the pump
• Other illnesses or therapy requirements precluding use of the pump
• Severe peripheral arterial occlusion disease (PAOD) is a relative
contraindication
POSSIBLE COMPLICATIONS (EU)
There are risks of complications with every procedure using a blood pump.
These include among others:
• Hemolysis • Cardiovalvular injuries due to extreme
• Bleeding movement of the suction cannula in
• Immune reaction relation to the cardiac valve or as a result of
• Embolism, thrombosis attachment by suction of the pump to the
• Vascular injury through valve system following incorrect positioning
to angionecrotomy • Endocardiac injuries as a result of
• Positioning problems attachment of the pump due to suction
• Infection and septicemia • Pump failure, loss of pump components
• Dislocation of the pump following a defect
• Patient dependency on the pump after use
for support
OVERVIEW
The Impella 5.0 Catheter is an intravascular microaxial blood pump that
supports a patient's circulatory system. The Impella 5.0 Catheter is inserted
via femoral or axillary artery cut-down through the artery and into the left
ventricle.
When properly positioned, the Impella 5.0
the inlet area, which sits inside the left 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 5.0 Catheter
on the display screen of the Automated Impella Controller. This section
describes the components of the Impella Catheter and the Automated Impella
Controller, as well as 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
• Automated Impella Controller cart—for easy transport of the
Automated Impella Controller
SINGLE-USE SYSTEM COMPONENTS
The Impella 5.0 System also includes the following single-use components:
• Impella 5.0 Catheter
• Purge cassette
• 0.018 inch, 260 cm placement guidewire
• Connector cable
• Impella Axillary Insertion kit
2 2
Catheter delivers blood from
®
SYSTEM CONFIGURATION
IMPELLA 5.0 CATHETER
®
The Impella 5.0 Catheter is an intravascular microaxial blood pump that
delivers up to 5.0 liters of blood per minute from the left ventricle into the
aorta.
DIFFERENTIAL PRESSURE SENSOR
The Impella 5.0 Catheter has an electronic differential pressure sensor
located at the proximal end of the 21 Fr cannula. The purpose of the pressure
sensor is to generate the placement signal, which is used by operators and
the controller to monitor the position of the Impella 5.0 cannula relative to
the aortic valve.
The pressure sensor is a flexible membrane integrated into the cannula. One side
of the sensor is exposed to the blood pressure on the outside of the cannula and
the other side is exposed to the pressure of the blood inside of the cannula. The
sensor generates an electrical signal proportional to the difference between the
pressure outside the cannula and the pressure inside. This signal is displayed on
the Automated Impella Controller as the placement signal.
User Manual