Abiomed Impella LD Gebrauchsanweisung Seite 4

INTENDED USE (EU)
INTENDED USE IN THE EUROPEAN UNION
The Impella LD (intracardiac pump for supporting the left ventricle) is
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intended for clinical use in cardiology and in cardiac surgery for up to 10 days
for the following indications, as well as others:
• The Impella LD is a cardiovascular support system for patients with
reduced left ventricular function, eg, post-cardiotomy, low output
syndrome, cardiogenic shock after acute myocardial infarction
• The Impella LD 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
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
When properly positioned, the Impella LD
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 LD 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 LD 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
2 2
Catheter delivers blood from
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SINGLE-USE SYSTEM COMPONENTS
The Impella LD System also includes the following single-use components:
• Impella LD Catheter
• Purge cassette
• Incision template
• Connector cable
SYSTEM CONFIGURATION
Glucose
Solution
Automated Impella Controller
Connector Cable
Purge Cassette
IMPELLA LD CATHETER
®
The Impella LD 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.
Red
Impella
®
Plug
Check
Valve
Catheter Shaft
DIFFERENTIAL PRESSURE SENSOR
The Impella LD 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 LD 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.
Disconnect Y Connector from Purge Tubing
Impella LD Catheter
Connect Purge Tubing Directly
to Impella Catheter
Infusion Filter
Pressure
Reservoir
Inlet Area
Cannula
Differential
Pressure
Sensor
Outlet Area
Motor
Housing
Silicone
Plugs
User Manual