Abiomed Impella 5.0 Gebrauchsanweisung Seite 4

Cautions
Cautions indicate situations
in which equipment may
malfunction, be damaged, or
cease to operate. The yellow
symbol appears before caution
messages.
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CAUTIONS
Handle with care. The Impella
preparation, insertion, and removal. Do NOT bend, pull, or place excess pressure on the catheter or
mechanical components at any time.
Patients with aortic stenosis or other abnormal aortic valve performance may be compromised by
the use of the Impella
insufficiency.
Use only original accessories and replacement parts supplied by Abiomed.
Do NOT use damaged or contaminated connector cables.
To prevent device failure, do NOT start the Impella
been removed.
Do NOT remove the Impella
When replacing the purge cassette, the replacement process must be completed within 2 minutes. The
Impella ® 5.0 Catheter may be damaged if replacement takes longer than 2 minutes.
Do NOT kink or clamp any part of the Impella
Have a backup Automated Impella
Catheter available in the unlikely event of a device failure.
Do NOT use the bed mount as a handle.
INTENDED USE (EU)
INTENDED USE IN THE EUROPEAN UNION
The Impella 5.0 (intracardiac pump for supporting the left ventricle) is 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 5.0 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 ® 5.0 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
5.0 Catheter can be damaged during removal from packaging,
®
® 5.0 Catheter. Patients with aortic valve disease should be observed for aortic
5.0 Catheter until the placement guidewire has
®
5.0 Catheter over the length of the placement guidewire.
®
® 5.0 Catheter.
® Controller, purge cassette, connector cable, and Impella ® RP
User Manual