Placement Signal - Abiomed Impella 2.5 Instructions For Use Manual

3.10
When the Impella 5.0 or LD Catheter is correctly positioned across the aortic valve, the changes
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in pressure associated with the cardiac cycle result in a pulsatile placement signal (see Figure
3.7). During diastole (time zero in Figure 3.6), the large pressure difference between the aorta
and the left ventricle creates a large electrical signal. Then at the peak of systole, when the
aortic valve opens, the pressure difference between the aorta and the left ventricle—and thus
the electrical signal—is zero. Thus, the continual pressure changes associated with the cardiac
cycle produce the pulsatile (up and down) waveform seen on the Automated Impella
display.
Impella 5.0 S/N: 123456
60
-20
1000
0
Impella Flow Purge System
5.0
5.2 Max
Purge Flow:
________________________
4.8 Min L/min
Purge Pressure: 600 mmHg
Figure 3.7 Correct Impella
When the Impella 5.0 or LD Catheter is not properly placed across the aortic valve, or when
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it is fully in the aorta or fully in the ventricle, the pressures outside and inside the cannula are
the same throughout the cardiac cycle. As a result, the pressure on either side of the sensor
membrane is the same, resulting in a flat placement signal (see Figure 3.8).
21 - 12 - 2010 05:30
Impella 5.0 S/N: 123456 Impella S/N 123456 30 - 06 - 2011 05:30
1 . R ed uce t h e P - lev el t o P - 2 un t i l i m a g i n g i s a v a i la b le.
Impella Position Wrong
2 . R ep osi t i on w i t h i m a g i n g .
3 . R et ur n t o p r ef er r ed P - lev el a n d con f i r m p osi t i on i n g w i t h i m a g i n g .
Impella Position
Wrong
Impella Flow Purge System System Power
Impella Flow Purge System System Power
5.0
5.0
5.2 Max Purge Flow: 20.0 ml/hr
Purge Flow: 20.0 ml/hr
________________________ L/min -.-
4.8 Min L/min Time Remaining: 021:52 Purge Pressure: 600 mmHg
100% 100%
Figure 3.8 Incorrect Impella
30 - 06 - 2011 05:30
Placement
Signal
( mmHg)
35/2
( 17 )
10 sec.
Motor
Current
( mA)
8 00/690
( 7 45)
10 sec.
System Power
20.0 ml/hr
100%
5.0/LD Catheter Positioning and Pulsatile Placement Signal
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Impella 5.0 S/N: 123456 Impella S/N 123456
Impella Position Wrong
MUTE MUTE
ALARM ALARM
60
FLOW
P-LEV EL
CONTROL
P - 8
0 . 0 5 . 0
P - 8 0 . 0
DISPLAY DISPLAY
-20
1000
PURGE
PURGE
SYSTEM
SYSTEM
0
Impella Flow Impella Flow
MENU
MENU
5.0
5.0
5.2 Max
________________________
4.8 Min
5.0/LD Catheter Positioning and Flat Placement Signal
®
Instructions for Use & Clinical Reference Manual (US)
® Controller
MUTE
ALARM
FLOW
CONTROL
0 . 0
P - 8 0 . 0
DISPLAY
PURGE
SYSTEM
MENU
21 - 12 - 2010 05:30
30 - 06 - 2011 05:30
1 . R ed uce t h e P - lev el t o P - 2 un t i l i m a g i n g i s a v a i la b le.
2 . R ep osi t i on w i t h i m a g i n g .
3 . R et ur n t o p r ef er r ed P - lev el a n d con f i r m p osi t i on i n g w i t h i m a g i n g .
Placement
CONTROL
Signal
( mmHg)
6/2
( 2)
DISPLAY
10 sec.
Motor
Current
( mA)
8 01/8 00 SYSTEM
( 8 00)
10 sec.
Purge System Purge System System Power System Power
Purge Flow: 20.0 ml/hr
Purge Flow: 20.0 ml/hr
L/min Time Remaining: 021:52 Purge Pressure: 600 mmHg
100% 100%
MUTE MUTE
ALARM ALARM
FLOW
P-LEV EL
P - 8
0 . 0 0 . 0
P - 8 0 . 0
DISPLAY
PURGE
PURGE
SYSTEM
MENU
MENU