Intended Audience - Abiomed Impella RP Manual Del Usuario

INTENDED AUDIENCE

This manual is intended for use by cardiologists, surgeons, nurses, perfusionists, and cardiac
catheterization lab technicians who have been trained in the use of the Impella
Support System.
WARNINGS
The Impella RP ®
with the Abiomed Training Program.
Fluoroscopy is required to guide placement of the Impella RP
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
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
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
Do NOT use saline in the purge system.
Do NOT use an Impella RP
To prevent the risk of explosion, do NOT operate the Impella RP
flammable anesthetics.
If at any time during the course of support with the Impella RP
Automated Impella
Open," follow the instructions presented in this manual.
MRI Unsafe - Do NOT subject a patient who has been implanted with
an Impella RP
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
Impella RP ® with the Automated Impella
System is intended for use only by personnel trained in accordance
System can be used only if the
®
® Catheter. It is a disposable device
Catheter is set at P-level P-0.
®
® System if any part of the system is damaged.
Controller alarms "Purge Pressure Low" or "Purge System
®
Catheter to magnetic resonance imaging (MRI). The strong
®
® Controller
Circulatory
®
Catheter. The small
®
® System near
Catheter, the
®
®
System.
®
Warnings
Warnings alert you to
situations that can cause
death or serious injury. The
red symbol appears before
warning messages.
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