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CAUTIONS
Cautions indicate situations in which equipment may malfunction, be
damaged, or cease to operate. The light gray
caution messages.
Handle with care. The Impella 5.5 with SmartAssist Catheter can be
damaged during removal from packaging, 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 5.5 with SmartAssist
Catheter. Patients with aortic valve disease should be observed for aortic
insufficiency.
Use only original accessories and replacement parts supplied by Abiomed.
To prevent device failure, do NOT start the Impella 5.5 with SmartAssist
Catheter until the placement guidewire has been removed.
Do NOT remove the Impella 5.5 with SmartAssist Catheter over the
length of the placement guidewire.
When replacing the purge cassette, the replacement process must be
completed within 90 seconds. The Impella 5.5 with SmartAssist Catheter
may be damaged if replacement takes longer than 90 seconds.
Do NOT kink or clamp any part of the Impella 5.5 with SmartAssist
Catheter.
Have a backup Automated Impella Controller, purge cassette, and
Impella 5.5 with SmartAssist Catheter available in the unlikely event of a
device failure.
Heparin (25 or 50 IU per mL) or sodium hydrogen carbonate (25 or 50
mEq/L) should be added to the purge solution. The Impella Catheter has
not been tested with any other anticoagulants, such as direct thrombin
inhibitors, in the purge solution. Use of other anticoagulants may reduce
the longevity or performance of the Impella catheter.
2
INTENDED USE
The Impella 5.5
symbol appears before
supporting the left ventricle. It is intended for clinical use in cardiology and
in cardiac surgery for up to 29 days for the following indications, as well as
others:
• The Impella 5.5 with SmartAssist heart pump is a cardiovascular support
• The Impella 5.5 with SmartAssist heart pump is also a temporary support
• The Impella 5.5 with SmartAssist heart pump may also be used as a
CONTRAINDICATIONS
The Impella 5.5
following situations:
• Mechanical aortic valves, severe aortic valvular stenosis
• 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
• Mural thrombus in the left ventricle
• Ventricular septal defect (VSD) after myocardial infarction
• Anatomic conditions precluding insertion of the pump
POSSIBLE COMPLICATIONS
There are risks of complications with every procedure using a blood pump.
These include among others:
• Acute renal dysfunction
• Aortic valve injury
• Cardiogenic shock
• Cerebral Vascular Accident/Stroke
• Myocardial infarction
• Renal failure
• Thrombocytopenia
• Hemolysis
• Bleeding
• Limb Ischemia
• Immune reaction
• Embolism, thrombosis
• Cardiac or vascular injury (including ventricular perforation)
• Positioning problems causing haemolysis or reduced
• Infection and septicemia
• Dislocation of the pump
• Cardiovalvular injuries due to extreme movement of the suction cannula
• 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
with SmartAssist
®
heart pump is an intracardiac pump for
®
system for patients with acutely reduced left ventricular function, e.g. low
output syndrome, cardiogenic shock after acute myocardial infarction.
system for patients in need of circulatory support due to chronically
reduced left ventricular function, e.g. for bridging patients with chronic
heart failure to implantable assist device, heart transplantation, or
myocardial recovery / stabilization.
cardiovascular support system during cardiological interventions or
heart surgery (e.g. coronary bypass surgery), particularly in patients with
limited preoperative ejection fraction with a high risk of postoperative
low output syndrome, or in cases of difficulties to wean from heart-lung
machine support.
with SmartAssist
®
heart pump is contraindicated for the
®
the aortic arch
haemodynamic support
in relation to the cardiac valve or as a result of attachment by suction of
the pump to the valve system following incorrect positioning
User Manual
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