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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.
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.
Mean Flow (L/min)
P-level
30 - 60 mmHg
P-0
0
P-1
0
P-2
0.0 - 1.9
P-3
1.1 - 2.7
P-4
1.9 - 3.3
P-5
2.8 - 3.7
P-6
3.4 - 4.1
P-7
3.9 - 4.5
P-8
4.3 - 4.9
P-9
5.0 - 5.5
*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
Impella 5.5
®
with SmartAssist
Revolutions Per
Minute (rpm)
0
12,000
17,000
20,000
22,000
24,000
26,000
28,000
30,000
33,000
®
Circulatory Support System
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
ADJUST LV PLACEMENT SIGNAL
Adjust the LV placement signal to reduce potential measurement
variability. Adjust the LV Placement Signal when the white
notification appears on the screen. The notification appears
first when a suggested adjustment is calculated. If a suggested
adjustment is calculated, then a second notification will appear
after 24 hours of pump use.
To adjust LV Placement Signal:
Press the MENU soft buttons.
1.
2.
Select "Adjust LV Signal" option with rotary knob
3.
Adjust the waveform using toggle arrows or rotary knob. The LV
Adjustment defaults to the suggested adjustment value.
Press DONE to confirm suggested adjustment.
4.
LV waveform adjustments occur in increments of 1 mmHg from -60 to
60 mmHg.
Recommended: Do not adjust to a value other than the suggested value.
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