WARNINGS
The Impella
®
RP System is intended for use only by personnel trained in accordance
with the Abiomed Training Program.
Fluoroscopy is required to guide placement of the Impella
®
RP Catheter. The small
placement guidewire must be reliably observed at all times.
Be sure that the stopcock on the repositioning sheath is always kept in the closed
position. Significant bleed back can result if the stopcock is open.
Avoid manual compression of the inlet, outlet, or sensor areas of the cannula
assembly.
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.
Do NOT resterilize or reuse the Impella
®
RP Catheter. It is a disposable device
and is intended for single use only. Reuse, reprocessing, reinserting through the
introducer, or resterilization may compromise the structural integrity of the catheter
and/or lead to catheter failure which, in turn, may result in patient injury, illness, or
death.
Retrograde flow will occur from the pulmonary artery back into the inferior vena
cava if the Impella
®
RP Catheter is set at performance level P0.
Do NOT use saline in the purge system.
Do NOT use an Impella® RP System if any part of the system is damaged.
To prevent the risk of explosion, do NOT operate the Impella® RP System near
flammable anesthetics.
If at any time during the course of support with the Impella® RP Catheter, the
Automated Impella® Controller alarms “Purge Pressure Low” or “Purge System
Open,” follow the instructions presented in section 5 of this manual.
Do NOT subject a patient who has been implanted with an Impella
®
RP Catheter to
magnetic resonance imaging (MRI). The strong magnetic energy produced by an MRI
machine may cause the Impella
®
RP System components to stop working, and result
in injuries to the patient. An MRI may also damage the electronics of the Impella® RP
System.
Cardiopulmonary support (CPR) should be initiated immediately per hospital
protocol if indicated for any patient supported with the Impella® RP Catheter. When
initiating CPR, reduce the Impella® RP Catheter flow rate. When cardiac function
has been restored, return flow rate to the previous level and assess the placement
signal on the controller.
During defibrillation, do NOT touch the Impella® RP Catheter, cables, or
Automated Impella® Controller.
Impella
®
RP with the Automated Impella
®
Controller
Warnings
Warnings alert you to
situations that can cause
death or serious injury. The
red symbol appears
before warning messages.
2.1
