Sensitive Medical
Device
The Impella RP
Catheter
®
is a sensitive medical
device with extremely fine
tolerances. In particular, the
inlet and outlet areas of the
catheter assembly may be
damaged if subjected to
strong external forces.
Shaded Steps
All shaded steps require
sterile technique.
Discard the Y
Connector
After opening the
purge cassette package,
disconnect and discard
the Y connector. The Y
connector is only used with
the Impella
2.5 Catheter.
®
Purge Solution Bottles
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.
Close Purge Cassette
Door
Once the purge cassette is
installed, be sure to close
the purge cassette door to
prevent the purge cassette
from being dislodged
accidentally.
Connect Purge Disc
Within 3 Seconds
The instructions for
inserting the purge disc
appear if it is not snapped
into place within 3 seconds
of inserting the purge
cassette.
12
CASE START
Fluoroscopy is required to guide placement of the Impella RP
placement guidewire must be reliably observed at all times.
The sterile components of the Impella RP
sterilization indicators show that the contents have been sterilized, the packaging is
not damaged, and the expiration date has not elapsed.
Avoid manual compression of the inlet, outlet, or sensor areas of the cannula
assembly.
Do NOT remove the Impella RP
guidewire.
Handle with care. The Impella RP
packaging, preparation, insertion, and removal. Do NOT bend, pull, or place excess
pressure on the catheter or mechanical components at any time.
Do NOT kink or clamp any part of the Impella RP
CASE START
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.
INSERT PURGE CASSETTE
1. Open the purge cassette package. Disconnect and discard the Y connector. Secure the
YELLOW luer to the sterile field.
2. Pass the purge cassette and spike off the sterile field.
3. Spike the fluid bag/bottle.
4. Press the NEXT soft button.
5. Open the purge cassette door by pressing the release on the left side of the controller.
Insert the purge cassette into the Automated Impella
that follow).
6. The purge cassette snaps into a molded compartment on the front of the controller.
Follow the diagram on the inside of the purge cassette door for proper placement.
7. 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.
8. 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.
®
Catheter. The small
System can be used only if the
®
®
Catheter over the length of the placement
Catheter can be damaged during removal from
®
Catheter.
®
Controller (described in the steps
®
User Manual