3.4
Component
Inlet area
Motor housing
Catheter shaft
Repositioning unit
Blue Impella® plug
Clear sidearm
Infusion filter
Pressure reservoir
Check valve
Description
The proximal end of the cannula is attached to the inlet area where
blood enters the cannula.
The 21 Fr motor housing consists of an encapsulated motor.
An 11 Fr catheter shaft is located between the motor housing and
the blue Impella® plug. The lumen of the catheter shaft contains
a purge lumen, an electrical cable, and a differential pressure
measurement cable.
The catheter shaft has transversal marks:
• The transversal marks at 1 cm intervals aid in proper positioning.
The repositioning unit consists of a sheath and an anticontamination
sleeve with an anchoring ring.
• The 11 Fr sheath (14 Fr outer diameter) with hemostatic valve
is located on the catheter shaft and allows repositioning of the
catheter.
• The anchoring ring of the anticontamination sleeve secures the
sheath to the catheter; turning in the counterclockwise direction
enables movement of the catheter and turning in the clockwise
direction disables movement.
The blue Impella® plug has a clear sidearm and contains memory
that retains operating parameters in case the patient needs to be
transferred to another controller. The plug connects the Impella® RP
Catheter to the Automated Impella® Controller through a connector
cable.
The clear sidearm is attached to the purge cassette tubing. It leads to
the infusion filter, the pressure reservoir, and the check valve.
The infusion filter prevents bacterial contamination and prevents air
from entering the purge lumen.
The pressure reservoir includes a flexible rubber diaphragm that
provides additional filling volume by means of an expansion chamber
during purge solution change.
The yellow check valve ensures that purge fluid does not flow in the
reverse direction when the purge solution is exchanged.
Instructions for Use & Clinical Reference Manual (US)
Table 3.1 Impella
®
RP Catheter Components (continued)
DIFFERENTIAL PRESSURE SENSOR
The Impella® RP Catheter has an electronic differential pressure sensor located at the proximal
end of the cannula. The purpose of the pressure sensor is to generate the placement signal used
to calculate the low generated by the Impella® RP Catheter.
The pressure sensor is a flexible membrane integrated into the cannula. One side of the sensor
is exposed to the blood pressure on the outside of the inlet area and the other side is exposed
to the pressure of the blood inside of the cannula. The sensor generates an electrical signal
proportional to the difference between the pressure outside the inlet area and the pressure
inside the cannula. This signal is displayed on the Automated Impella® Controller as the
placement signal.
