9.
Attach the anticontamination sleeve to the blue section of the
repositioning sheath. Lock the anchoring ring in place by turning
it clockwise. Secure the catheter shaft in place by tightening the
connected anchoring ring.
10. Carefully extend the anticontamination sleeve to maximum length
and secure the end closest to the red Impella plug by tightening
the anchoring ring.
TRANSFER TO STANDARD
CONFIGURATION
Abiomed recommends transitioning from the initial set-up configuration to
the standard configuration as soon as practical. The standard configuration
ensures that purge solution is delivered through the catheter to prevent blood
from entering the motor. After 2 hours of operation, if the system is still in the
set-up configuration, a white, advisory alarm notifies the operator to transfer
to the standard configuration. Press MUTE ALARM to silence the alarm for
30 minutes.
When you transfer to the standard configuration, the purge pressure is no
longer regulated at 600 mmHg. In the standard configuration, purge flow can
range from 2 to 30 mL/hr and purge pressure can range from 300 to 1100
mmHg.
When disconnecting the red luer on the Y connector, do NOT grasp the white
flush valve or apply force. Grasp the luer on both sides beneath the white
flush valve while connecting or disconnecting lines from the red pressure
sidearm.
To transfer to the standard configuration, follow these steps:
1.
Press PURGE MENU and select "Transfer to Standard
Configuration" from the menu. Press START to continue.
2.
Set up a standard sodium chloride solution with pressure bag
(pressurized to 300–350 mmHg) using straight tubing without
injection ports. Press NEXT to continue.
3.
Clamp the red luer on the Y connector from the red pressure
sidearm. Disconnect and end cap the red luer.
4.
Create a slow drip from the NaCl pressure bag to flood the
luer connector of the red pressure sidearm and make a wet-to-wet
connection. Fully open the roller clamp. Press NEXT to continue.
5.
Remove and discard the Y-connector and connect the yellow luer
of the purge cassette directly to the Impella Catheter. Press NEXT
to continue.
6.
Press DONE to complete the transfer to standard configuration
process.
Glucose
Solution
Automated Impella
®
Controller
Connector Cable
Purge Cassette
Y Connector
Upon transfer to the standard configuration, the controller will switch
to P-level mode and operate at P-8 if previously running in AUTO. If the
controller was already in P-level mode at the time of the transfer, it will
continue operating at the P-level at which it was operating at the time of the
transfer. Once the controller is operating in the standard configuration, AUTO
is no longer an option on the flow menu.
10
PATIENT WEANING
Weaning the patient from the Impella Catheter is at the discretion of the
physician.
The following weaning instructions are provided as guidance only.
REMOVING THE IMPELLA
The Impella Catheter can be removed after weaning when the introducer is
still in place or when the catheter is secured with the repositioning sheath.
Removal of the Impella Catheter must be completed with care to avoid
damage to the catheter assembly. Do NOT attempt to remove the Impella
Catheter through the repositioning sheath. The Impella Catheter will not pass
through the repositioning sheath.
REMOVING THE IMPELLA CATHETER WITH THE
INTRODUCER IN PLACE
REMOVING THE IMPELLA CATHETER SECURED WITH THE
REPOSITIONING SHEATH
REMOVING THE IMPELLA CP CATHETER WHILE
Sodium Chloride (NaCl)
MAINTAINING GUIDEWIRE ACCESS
Solution in Pressure Bag
(FOR IMPELLA CP CATHETERS)
Impella
Catheter
®
1.
To initiate weaning, press FLOW CONTROL and reduce P-level by
2 level increments over time intervals as cardiac function allows.
2.
Keep Impella Catheter P-level at P-2 or above until the catheter is
ready to be explanted from the left ventricle.
3.
When the patient's hemodynamics are stable, reduce the P-level to
P-1 and pull the Impella Catheter back across the aortic valve into
the aorta.
4.
If the patient's hemodynamics remain stable, follow instructions in
the next section for removing the Impella Catheter.
1.
Reduce the P-level to P-0.
2.
Remove the Impella Catheter through the introducer.
3.
Wait until ACT drops below 150 seconds.
4.
When ACT is below 150 seconds, remove the introducer.
5.
Disconnect the connector cable from the Automated Impella
Controller and turn the controller off by pressing the power switch
on the side of the controller for 3 seconds.
6.
Apply manual compression for 40 minutes or per hospital protocol.
1.
When ACT is below 150 seconds, press FLOW CONTROL and
reduce the P-level to P-0.
2.
Remove the Impella Catheter and repositioning sheath together
(the catheter will not come through the repositioning sheath).
3.
Disconnect the connector cable from the Automated Impella
Controller and turn the controller off by pressing the power switch
on the side of the controller for 3 seconds.
4.
Apply manual compression for 40 minutes or per hospital protocol.
1.
Remove the stylet from the guidewire port.
CATHETER
®
User Manual