Intended Use; System Configurations - Abiomed Automated Impella Controller Manual Del Usuario

Do not insert the repositioning sheath into the peel-away sheath during
catheter insertion; slide the repositioning sheath towards the red pump
handle prior to inserting the device.
Never remove the guidewire when increased resistance is met. Determine
the cause of resistance using fluoroscopy and verify the repositioning
sheath is not inserted into the peal-away sheath.
In patients with transcatheter aortic valves position the Impella
system carefully to avoid interaction with the TAV prosthesis. In
this situation, avoid repositioning while the device is running;
turn the device to P0 during repositioning or any movement that
could bring the outlet windows into proximity to the valve stent
structures. If there is low flow observed in a patient implanted with a
transcatheter aortic valve prosthesis, consider damage of the impeller
and replace the Impella pump as soon as possible.

INTENDED USE

The Impella (intracardiac pump for supporting the left ventricle) is
intended 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
• 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
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
2
OVERVIEW
The Impella Catheter is an intravascular microaxial blood pump that
supports 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
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 CP ® with SmartAssist ®
• Impella CP with SmartAssist
® ®
• 0.018 inch, 260 cm placement guidewire
• Purge cassette
• Introducer kit
» Peel-away introducers - two 14 Fr introducers (13 cm and 25 cm)
»
Dilators - 8 Fr, 10 Fr, 12 Fr, and 14 Fr
» 0.035 inch stiff access guidewire

SYSTEM CONFIGURATIONS

The Automated Impella Controller connects to the Impella Catheter and
accessory components in the initial set-up configuration as illustrated.
If included, disconnect Y Connector from Purge Tubing
Glucose
Solution
Automated Impella Controller
Purge Cassette
Figure 1.1
Set-up and Insertion kit contains:
Catheter
Impella ® Catheter
Connector
Cable
Connect Purge Tubing Directly
to Impella Catheter
User Manual