Intended Use In The European Union - Abiomed Impella 5.0 Gebrauchsanweisung

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 5.0 Circulatory Support System.
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WARNINGS
Warnings alert you to situations that can cause death or serious injury. The
dark gray symbol appears before warning messages.
Use of the Impella System by trained and experienced practitioners has
been associated with improved outcomes. Consequently, the first use
of Impella should be preceded by the completion of a contemporary
Abiomed Impella training program and include on-site proctoring during
the first use by Abiomed clinical support personnel certified in the use of
Impella.
Fluoroscopy is required for the insertion of the Impella guidewire and
Impella 5.0 Catheter.
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 5.0 Catheter.
The sterile components of the Impella 5.0 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 5.0 Catheter. It is a disposable
device and is intended for 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 5.0
Catheter is set at P-level P-0.
Do NOT use saline in the purge system.
Do NOT use alcohol-based fluids for lubrication.
Do NOT use an Impella 5.0 System if any part of the system is damaged.
To prevent the risk of explosion, do NOT operate the Impella 5.0 System
near flammable anesthetics.
If at any time during the course of support with the Impella 5.0 Catheter,
the Automated Impella Controller alarms "Purge Pressure Low" or "Purge
System Open," follow the instructions presented in the Automated
Impella Controller manual.
Do NOT subject a patient who has been implanted with an
Impella 5.0 Catheter to magnetic resonance imaging (MRI).
The strong magnetic energy produced by an MRI machine may
cause the Impella 5.0 System components to stop working and
result in injuries to the patient. An MRI may also damage the
electronics of the Impella 5.0 System.
During defibrillation, do NOT touch the Impella 5.0 Catheter, cables, or
Automated Impella Controller.
Avoid overinserting the Impella 5.0 Catheter and possibly impinging the
catheter tip against the walls of the vasculature, atria, or ventricles.
Do NOT advance or withdraw the Impella 5.0 Catheter against resistance
without using fluoroscopy 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
CAUTIONS
Cautions indicate situations in which equipment may malfunction, be
damaged, or cease to operate. The light gray
caution messages.
Handle with care. The Impella 5.0
removal from packaging, preparation, insertion, and removal. Do NOT
bend, pull, or place excess pressure on the catheter or mechanical
components at any time.
Patients with aortic stenosis or other abnormal aortic valve performance
may be compromised by the use of the Impella 5.0 Catheter. Patients
with aortic valve disease should be observed for aortic insufficiency.
Use only original accessories and replacement parts supplied by
Abiomed.
Do NOT use damaged or contaminated connector cables.
To prevent device failure, do NOT start the Impella 5.0 Catheter until
the placement guidewire has been removed.
Do NOT remove the Impella 5.0 Catheter over the length of the
placement guidewire.
When replacing the purge cassette, the replacement process must be
completed within 90 seconds. The Impella 5.0 Catheter may be damaged
if replacement takes longer than 90 seconds.
Do NOT kink or clamp any part of the Impella 5.0 Catheter.
Have a backup Automated Impella Controller, purge cassette, connector
cable, and Impella 5.0 Catheter available in the unlikely event of a device
failure.
Do NOT insert the repositioning sheath into the peel-away sheath during
catheter insertion; slide the repositioning sheath towards the red pump
handle prior to inserting the device.
Never remove the guidewire when increased resistance is met.
Determine the cause of resistance using fluoroscopy and verify the
repositioning sheath is not inserted into the peal-away sheath.
In patients with transcatheter aortic valves position the Impella system
carefully to avoid interaction with the TAV prosthesis. In this situation,
avoid repositioning while the device is running; turn the device to
P-0 during repositioning or any movement that could bring the outlet
windows into proximity to the valve stent structures. If there is low
flow observed in a patient implanted with a transcatheter aortic valve
prosthesis, consider damage of the impeller and replace the Impella
pump as soon as possible.
INTENDED USE (EU)

INTENDED USE IN THE EUROPEAN UNION

The Impella 5.0 (intracardiac pump for supporting the left ventricle) is
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intended for clinical use in cardiology and in cardiac surgery for up to 10 days
for the following indications, as well as others:
• The Impella 5.0 is a cardiovascular support system for patients with
reduced left ventricular function, eg, post-cardiotomy, low output
syndrome, cardiogenic shock after acute myocardial infarction
• The Impella 5.0 may also be used as a cardiovascular support system
during coronary bypass surgery on the beating heart, particularly in
patients with limited preoperative ejection fraction with a high risk of
postoperative low output syndrome
symbol appears before
® Catheter can be damaged during
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