Abiomed Impella 5.5 Manuel Utilisateur page 14

POSITIONING AND STARTING THE
IMPELLA 5.5 WITH SMARTASSIST
®
CATHETER
When the Impella 5.5 with SmartAssist Catheter is not correctly placed, there
is no effective unloading of the ventricle (hydraulic short circuit). The patient
may not be benefiting from the flow rate shown on the controller.
Retrograde flow will occur across the aortic valve if the flow rate of
the Impella Catheter is less than 0.5 L/min.
1.
Reconfirm that the placement guidewire has been removed and
Confirm that the controller displays a pulsatile waveform and the
cannula bend at the aortic valve annulus, placing inlet approximately
5 cm deep into ventricle. (See step 6 if the controller displays a
ventricular waveform.)
2. Press START IMPELLA soft button to open the P-level menu. Turn
the selector knob to increase the P-level from P-0 to P-2.
3.
Press the selector knob to select the new P-level. Increase the P-level
to P-9 to confirm correct and stable placement.
4.
Evaluate the catheter position in the aortic arch. If there is slack in the
catheter, press and hold the anchor button, remove the excess slack, and
release the anchor button. The catheter should align against the lesser
curvature of the aorta rather than the greater curvature. Verify placement
with fluoroscopy and with the placement signal screen. Note: When
repositioning the catheter ensure there is enough slack in the anti-
contamination sleeve to allow for easy movement of the catheter.
5.
Reposition the catheter as necessary.
6.
If the Impella Catheter advances too far into the left ventricle and the
controller displays a ventricular waveform (shown above) rather than an
aortic waveform, follow these steps to reposition the catheter.
a) Press and hold the anchor button, pull the catheter back until an aortic
waveform is present on the placement screen.
b) When the aortic waveform is present, pull the catheter back an
additional 3 cm for Impella 5.5 with SmartAssist. (The distance
between adjacent markings on the catheter is 1 cm.)
c) Release anchor button.
d) The catheter should now be positioned correctly.
10
USE OF THE REPOSITIONING UNIT
®
1.
Slide the blue suture hub and advance the ribs into the graft.
2.
Secure the repositioning unit to the patient with the blue suture pads or
a catheter stabilization device.
3.
Evaluate the catheter position in the aortic arch. If there is excess slack,
press and hold the anchor button, remove the excess slack, and release
the anchor button. The catheter should align against the lesser curvature
of the aorta rather than the greater curvature. Verify placement with
fluoroscopy and with the placement signal.
4.
Carefully extend the anticontamination sleeve to maximum length
and secure the end closest to the red Impella plug by tightening the
anchoring ring.
5.
Select the lowest P-level that will enable you to achieve the highest
flow rate necessary for patient support. You can select one of ten
P-levels (P-0 to P-9) for the Impella 5.5 Catheter.
P-LEVEL
In P-LEVEL mode you can select one of ten P-levels (P-0 to P-9) for the
Impella 5.5 with SmartAssist Catheter (see table below). Select the lowest
P-level (P-2 or higher) that will enable you to achieve the highest flow rate
necessary for patient support.
P-level
P-0
P-1
P-2
P-3
P-4
P-5
P-6
P-7
P-8
P-9
*Flow rate can vary due to suction or incorrect positioning
To operate the Impella Catheter in P-level mode:
1.
Press the FLOW CONTROL soft button to open the FLOW
CONTROL menu.
2.
Turn the selector knob to increase or decrease the flow rate.
3.
Press the selector knob to select the new flow rate
ADJUSTING THE LV PLACEMENT SIGNAL
The LV placement signal and LV estimates are not displayed when pumps
are running at P-3 or lower. Increase pump speed to P-4 or higher to
re-enable signal
Alarm conditions and low pump speeds may affect the LV placement
signal and estimates
Disruption of the outlet pressure placement signal, including alarms
related to the Ao placement signal, will prevent calculation and display of
an LV estimate. An operational Ao placement signal is required for the LV
estimate
LV placement signal calibration is not available if the P-level is less than P-4
or if Suction, Placement Signal Not Reliable, or positioning alarms are active
Abnormal conditions, including cardiac arrhythmia, Ao-LV uncoupling, or
aortic stenosis may limit the utility of the LV adjustment tool
Mean Flow (L/min) Revolutions Per
30 - 60 mmHg Minute (rpm)
0 0
0 12,000
0.0 - 1.9 17,000
1.1 - 2.7 20,000
1.9 - 3.3 22,000
2.8 - 3.7 24,000
3.4 - 4.1 26,000
3.9 - 4.5 28,000
4.3 - 4.9 30,000
5.0 - 5.5 33,000
User Manual