Abiomed Impella 2.5, Instructions For Use Manual

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5.40 Instructions for Use & Clinical Reference Manual (US)
Impella Flow
5.0
System Power
MUTE
ALARM
0 . 0
DISPLAY
0 . 0
MENU
PURGE
SYSTEM
Impella 5.0 S/N: 123456
30 - 06 - 2011 05:30
100%
CONTROL
FLOW
P - 9
L/min
5.2 Max
________________________
4.8 Min
Purge System
Purge Pressure: 600 mmHg
Purge Flow: 20.0 ml/hr
Motor
Current
8 00/690
( 7 45)
( mA)
10 sec.
Placement
Signal
( mmHg)
35/2
( 17 )
10 sec.
60
-20
1000
0
Figure 5.46 Confirming Placement on the Placement Signal Screen
9.
Make sure there is no bleeding at the transition from the repositioning sheath to the
artery. Close and dress the wound. Secure the repositioning sheath to the patient with
the blue suture pads or a StatLock
®
device.
10.
Attach the anticontamination sleeve to the sheath. Lock it in place by turning clockwise.
Secure the catheter by tightening the connected anchoring ring.
11. Carefully extend the anticontamination sleeve to maximum length and secure the end
closest to the red Impella
®
plug by tightening the anchoring ring.
12.
Reposition the catheter as necessary.
13.
Select the lowest P-level that will enable you to achieve the flow rate necessary for
patient support. You can select one of ten P-levels (P-0 to P-9) for the Impella
®
5.0
Catheter (see Table 5.5).
Table 5.5 P-Level Flow Rates for the Impella
®
5.0 Catheter
P-Level
*Flow Rate
(L/min)
Revolutions Per Minute
(rpm)
P-0 0.0 0
P-1 0.0 – 1.4 10,000
P-2 0.5 – 2.6 17,000
P-3 0.5 – 3.1 20,000
P-4 0.9 – 3.4 22,000
P-5 1.4 – 3.7 24,000
P-6 1.8 – 4.0 26,000
P-7 2.6 – 4.4 28,000
P-8 3.4 – 4.7 30,000
P-9 4.2 – 5.3 33,000
*Flow rate can vary due to suction or incorrect positioning.
Vascular Closure
When securing the
repositioning sheath, vascular
closure may be difficult in
obese patients with extensive
adipose tissue.
9. 9.
Make sure there is no bleeding at the transition from the repositioning sheath to the
artery. Close and dress the wound. Secure the repositioning sheath to the patient with
the blue suture pads or a StatLock
®
device.
10. 10.
Attach the anticontamination sleeve to the sheath. Lock it in place by turning clockwise.
Secure the catheter by tightening the connected anchoring ring.
11. 11. Carefully extend the anticontamination sleeve to maximum length and secure the end
closest to the red Impella
®
plug by tightening the anchoring ring.
12. 12.
Reposition the catheter as necessary.
Retrograde Flow
A setting of P-0 will result
in retrograde flow when
the Impella
® 5.0 Catheter is
placed across the aortic valve.
Retrograde flow may also
occur at P-1.
Placement Monitoring
Suspended
When the Impella
®
Catheter is
operating in a low flow range,
placement monitoring may be
suspended and the flow rate
in the lower left corner of the
controller display screen will
turn yellow to indicate that
Impella
® position is unknown.
Addition of Heparin to
the Purge Solution
As soon as practical after
placement, change the purge
fluid to include heparin.
The recommended heparin
concentration is 50 IU/mL
in 20% dextrose solution.
(Follow the Change Purge
Fluid procedure described
later in this section to change
the purge fluid.)