5.4
Instructions for Use & Clinical Reference Manual (US)
CASE START
Fluoroscopy is required to guide placement of the Impella
®
RP Catheter. The small
placement guidewire must be reliably observed at all times.
The sterile components of the Impella
®
RP System can be used only if the
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 Catheter over the length of the placement
guidewire.
Handle with care. The Impella
®
RP Catheter can be damaged during removal from
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 Catheter.
CASE START
1.
Press the
MENU
soft button from the startup screen. “Case Start” is the default
selection on the pop-up menu that appears on the screen.
2.
Press the selector knob to select “Case Start.” The controller displays the screen shown
in Figure 5.3.
Impella Flow
5.0
Purge System
Purge Flow: 20.0 ml/hr
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
5.0
L/min
5.2 Max
________________________
4.8 Min
Prime Impella Purge Cassette
Priming Purge Cassette
1. Insert purge cassette.
2. Plug in Impella catheter cable.
Figure 5.3 Initial Case Start Screen
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.
Two Ways to Start the
Setup Procedure
You can start the setup
procedure from the
MENU
on the startup screen (as
described on this page) or
when a new Impella
®
RP
Catheter is plugged into the
controller.
