suction. During AUTO, the highest the p-level the Impella CP can run is P-9.
For the Impella 2.5 during AUTO, the highest p-level is P-8. After 3 hours of
operation, if you have not transferred to the standard configuration, the
controller automatically switches to P-level mode. Upon transfer from AUTO
mode to P-level mode, the controller displays the message shown below and
the AUTO setting is no longer an option.
BOOST
After transferring to Standard Configuration (or after 3 hours), if you select
BOOST, the Automated Impella Controller maximizes the Impella Catheter
flow for 5 minutes. At the end of 5 minutes, the controller returns to P-8.
P-LEVEL
In P-LEVEL mode you can select one of nine P-levels (P-0 to P-8) for the
Impella Catheter. Select the lowest P-level (P-2 or higher) that will enable you
to achieve the flow rate necessary for patient support.
P-level Flow Rates for the Impella 2.5 Catheter
P-level
Impella 2.5 Catheter
P-0
motor is stopped
P-1
P-2
P-3
Flow rate increases as
P-4
the P-level increases
P-5
P-6
P-7
Recommended
P-8
maximum P-level for
continuous use
Can be used to
provide maximum
flow for up to 5
minutes. After
BOOST
5 minutes, the
Automated Impella
Controller will
automatically default
to P-8.
*Flow rate can vary due to suction or incorrect positioning.
Impella 2.5
®
and Impella CP
®
*Flow Rate
Revolutions Per
(L/min)
Minute (rpm)
0.0
0
0.0 – 1.1
25,000
0.8 – 1.5
35,000
1.1 – 1.7
38,000
1.3 – 1.8
40,000
1.5 – 1.9
43,000
1.7 – 2.1
45,000
1.8 – 2.2
47,000
2.1 – 2.4
50,000
2.1 – 2.5
51,000
Circulatory Support Systems
P-level Flow Rates for the Impella CP Catheter
P-level
Impella CP Catheter
P-0
motor is stopped
P-1
P-2
P-3
Flow rate increases
P-4
as the P-level
increases
P-5
P-6
P-7
Recommended
P-8
maximum P-level for
continuous use
Boost can be
used to provide
maximum flow for
up to 5 minutes.
P-9** or
After 5 minutes, the
BOOST
Automated Impella
Controller will
automatically default
to P-8.
*Flow rate can vary due to suction or incorrect positioning.
** Peak flows at systole up to 4.3 L/min
USE OF THE REPOSITIONING SHEATH
AND THE PEEL-AWAY INTRODUCER
1.
Slide the repositioning sheath back to the red Impella plug.
2.
Remove the peel-away introducer completely from the
artery over the catheter shaft to prevent trauma and significant
bleeding and apply manual pressure above the puncture site.
3.
Grasp the two "wings" and bend back until the valve assembly
comes apart. Continue to peel the two wings until the introducer
is completely separated from the catheter shaft.
4.
Flush sidearm of the repositioning sheath prior to advancing the
sheath. Note: There is no sidearm on the Reaccess Sheath.
5.
Place a deadend cap on the sidearm of the repositioning sheath
to prevent further usage. The sideport should not be used to give
medication or draw blood because the blood could potentially
clot. Pressure bags should not be connected to the sideport of the
repositioning sheath. If a pressure bag is connected, the sideport
must have an infusion pump or flow limiting valve in place to
control the amount of fluid administered to the patient.
Note: There is no sidearm on the Reaccess Sheath.
6.
Slide the repositioning sheath over the catheter shaft and advance
it into the artery to the blue suture pads. Note: Do not insert the
blue tip of the suture pad into the artery.
7.
Secure the repositioning unit to the patient with the blue suture pads
or a StatLock
stabilization device. It is recommended to secure the
®
suture pads to the skin with light forward pressure and supported by
4x4 gauze before sterilization and dressing of the access site.
8.
Evaluate the catheter position in the aortic arch and remove
any excess slack. 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.
*Flow Rate
Revolutions Per
(L/min)
Minute (rpm)
0.0
0
0.0 - 0.9
23,000
1.1 - 2.1
31,000
1.6 - 2.3
33,000
2.0 - 2.5
35,000
2.3 - 2.7
37,000
2.5 - 2.9
39,000
2.9 - 3.3
42,000
3.1 - 3.4
44,000
3.3 - 3.7
46,000
9