Abiomed Impella 5.0 Gebrauchsanweisung Seite 3

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
WARNINGS
Use of the Impella
improved outcomes. Consequently, the first use of Impella
a contemporary Abiomed Impella
by Abiomed clinical support personnel certified in the use of Impella
Fluoroscopy is required for the insertion of the Impella
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.
During insertion, avoid manual compression of the inlet, outlet, or sensor areas of the cannula
assembly on the Impella
The sterile components of the Impella
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
single use only. Reuse, reprocessing, 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 across the aortic valve if the Impella
Do NOT use saline in the purge system.
Do NOT use alcohol-based fluids for lubrication.
Do NOT use an Impella
To prevent the risk of explosion, do NOT operate the Impella
If at any time during the course of support with the Impella
Controller alarms "Purge Pressure Low" or "Purge System Open," follow the instructions presented in
this manual.
MR Unsafe - Do NOT subject a patient who has been implanted with an Impella
to magnetic resonance imaging (MRI). The strong magnetic energy produced by an MRI machine
may cause the Impella
patient. An MRI may also damage the electronics of the Impella
During defibrillation, do NOT touch the Impella
Controller.
Avoid overinserting the Impella
of the vasculature, atria, or ventricles.
Do NOT advance or withdraw the Impella
to determine the cause of the resistance. Doing so could result in separation of the catheter or
guidewire tip, damage to the catheter or vessel, or ventricular perforation.
Impella ® 5.0 Circulatory Support System
® 5.0 Circulatory Support System.
® System by trained and experienced practitioners has been associated with
training program and include on-site proctoring during the first use
®
guidewire and Impella
®
® 5.0 Catheter.
5.0 System can be used only if the sterilization indicators show
®
5.0 Catheter. It is a disposable device and is intended for
®
® 5.0 System if any part of the system is damaged.
5.0 System components to stop working, and result in injuries to the
®
® 5.0 Catheter, cables, or Automated Impella
5.0 Catheter and possibly impinging the catheter tip against the walls
®
5.0 Catheter against resistance without using fluoroscopy
®
should be preceded by the completion of
®
.
®
5.0 Catheter.
®
® 5.0 Catheter is set at P-level P-0.
5.0 System near flammable anesthetics.
®
5.0 Catheter, the Automated Impella
®
5.0 Catheter
®
® 5.0 System.
®
Warnings
Warnings alert you to situations
that can cause death or serious
injury. The red symbol
before warning messages.
®
appears
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