Abiomed ImpellaCP Manuel D'utilisation page 6

PRE-SUPPORT EVALUATION
Before initiating the procedure, evaluate the patient for factors that
may prevent successful placement of the Impella Catheter. Use imaging
technology to examine the patient's vasculature and femoral access site.
An echo assessment of the left ventricle is also recommended to rule
out left ventricular thrombus, mechanical aortic valves, or severe aortic
insufficiency. If the patient has a tortuous iliac artery, consider using the
provided 25cm sheath for insertion. The Impella Catheter can also be
inserted surgically.
STARTUP
SUPPLIES NEEDED
• Automated Impella Controller (Abiomed)
• Impella Set (Abiomed)
• Hospital provided:
• Diagnostic catheter (AL1 or MP without side holes or pigtail with
or without side holes)
• Standard 0.035" x 175 cm J-tip guidewire
• 500 cc bag of glucose solution for purge solution
(5% recommended; 5% to 20% acceptable) with 50 IU heparin/mL
Note: If the purge solution is supplied in bottles, open the vent on the
purge fluid spike and follow the same procedure as if supplied in bags.
CASE START
If you miss a step in the process of setting up the Impella Catheter, or if
you exceed the amount of time allowed to complete a step, the Automated
Impella Controller will display additional instruction screens for continuing
the setup process for some steps.
For the steps discussed below, All shaded steps require sterile technique.
Figure 1.4
CASE START
1. Press the START NEW CASE soft button from the startup screen
or plug in a new Impella Catheter. "Case Start" can also be selected
by pressing the MENU soft key.
2. The controller displays the screen shown above.
INSERT PURGE CASSETTE
1. Open the purge cassette package onto the sterile field.
2.
If included, remove and discard the Y-connector and secure the
yellow luer connector on the purge tubing to the sterile field.
4
3.
Pass the purge cassette and spike off the sterile field.
4.
Spike the glucose bag/bottle.
5. Press the NEXT soft button to continue.
6.
Open the purge cassette door by pressing the release on the
left side of the controller. Insert the purge cassette into the
Automated Impella Controller
7. Insert the purge cassette into the compartment on the front of
the controller. Follow the diagram on the inside of the purge
cassette door for proper placement.
8.
Slide the purge disc into the slot to the right of the purge
cassette until it snaps into place. The controller will automatically
begin priming the purge cassette. Note: The instructions for
inserting the purge disc appear if the disc is not snapped into place
within 3 seconds of inserting the purge disc.
9. Extend the purge tubing and close the purge cassette door.
There is sufficient room around the edges of the purge cassette
door so that it will not pinch the purge tubing as it exits.
10. The controller automatically begins priming the purge cassette
after it is inserted. The progress bar marks the progress of the
purge cassette priming.
CONNECT THE IMPELLA CATHETER
1.
Remove the Impella Catheter from its package using sterile
technique and inspect the catheter for damage.
2. Slide repositioning sheath towards the red pump handle.
3.
Inspect the cable for damage, including damage to the
connector pins at the controller end.
4. Pass the sterile connector cable from the Impella Catheter off
the sterile field.
Figure 1.5
5.
Open the cover on blue catheter plug by rotating clockwise.
Line up the notch on the connector cable with the notch in the
blue catheter plug on the front of the Automated Impella
Controller and plug the cable into the controller.
6.
Snap the purge clip (located on the pressure reservoir of the
clear sidearm) to the connector cable as shown in Figure 1.5.
Note: Snapping the plastic clip on the pressure reservoir to the
connector cable is important to prevent the tube from kinking.
7. Once the purge cassette is primed and the controller detects
that the connector cable is plugged in, it prompts you to
connect the yellow luer to the Impella Catheter.
User Manual