Abiomed Impella 2.5 Manual Del Usuario página 5

INTENDED USE (EU)
The Impella (intracardiac pump for supporting the left ventricle) is intended
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for clinical use in cardiology and in cardiac surgery for up to 5 days for the
following indications, as well as others:
• The Impella is a circulatory support system for patients with reduced
left ventricular function, eg, post-cardiotomy, low output syndrome,
cardiogenic shock after acute myocardial infarction, or for myocardial
protection after acute myocardial infarction
• The Impella may also be used as a cardiovascular support system
during coronary bypass surgery on the beating heart, particularly in
patients with limited preoperative ejection fraction with a high risk of
postoperative low output syndrome
• Support during high-risk percutaneous coronary intervention (PCI)
• Post-PCI
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
• Bleeding
• Immune reaction
• Embolism, thrombosis
• Vascular injury through to angionecrotomy
• Positioning problems
• Infection and septicemia
• Dislocation of the pump
• 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
Impella 2.5 ® and Impella CP ® Circulatory Support Systems
OVERVIEW
The Impella Catheter is an intravascular microaxial blood pump that supports
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a patient's circulatory system. The Impella Catheter is inserted percutaneously
through the femoral artery and into the left ventricle.
When properly positioned, the Impella Catheter delivers blood from 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 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 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 System also includes the following single-use components:
• Impella Catheter
• Purge cassette
• Introducer kit
• 0.018 inch, 260 cm placement guidewire
• Connector cable
IMPELLA SET-UP AND INSERTION KIT
The components of the Impella System are packaged into a single box called
the Impella Set-up and Insertion kit.
The Impella 2.5 ® Set-up and Insertion kit contains:
• Impella 2.5 Catheter
• 0.018 inch, 260 cm placement guidewire
• Connector cable
• Purge cassette
• Introducer kit
»
13 Fr peel-away introducer
»
13 Fr dilator
»
18 G Seldinger needle
»
12 cc syringe
»
0.035 inch stiff access guidewire
The Impella CP Set-up and Insertion kit contains:
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• Impella CP Catheter
• 0.018 inch, 260 cm placement guidewire
• Connector cable
• Purge cassette
• Introducer kit
» 14 Fr x 13 cm Peel-away introducer
» Dilators - 8 Fr, 10 Fr, 12 Fr, and 14 Fr
» 0.035 inch stiff access guidewire
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