Abiomed Impella 5.5 Manuel Utilisateur page 5

USER RESPONSIBILITY
The Impella System will perform in conformity with the description thereof
contained in this manual and accompanying labels and/or inserts, when
assembled, operated, and maintained in accordance with the instructions
provided. A defective system should not be used. When selecting the purge
fluid additive for a specific patient, the user should make an individualized
decision based on the patient status and consider any potential risks and side
effects the additives might have.
Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or patient is established.
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 Circulatory Support System.
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
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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 5.5 with SmartAssist Catheter.
During insertion, avoid manual compression of the inlet, outlet, or sensor
areas of the cannula assembly on the Impella 5.5 Catheter.
The sterile components of the Impella 5.5 System can be used only if the
packaging is not damaged, and the expiration date has not elapsed.
Do NOT resterilize or reuse the Impella 5.5 with SmartAssist 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 5.5 with
SmartAssist 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 5.5 with SmartAssist System if any part of the
system is damaged.
To prevent the risk of explosion, do NOT operate the Impella 5.5 with
SmartAssist System near flammable anesthetics.
If at any time during the course of support with the Impella 5.5 with
SmartAssist Catheter, the Automated Impella Controller alarms "Purge
Pressure Low" or "Purge System Open," follow the instructions presented
in the Automated Impella Controller manual.
MR Unsafe - Do NOT subject a patient who has been implanted
with an Impella 5.5 with SmartAssist Catheter to magnetic
resonance imaging (MRI). The strong magnetic energy produced
by an MRI machine may cause the Impella 5.5 System components
to stop working, and result in injuries to the patient. An MRI may also damage
the electronics of the Impella 5.5 System.
Impella 5.5 ® with SmartAssist ® Circulatory Support System
During defibrillation, do NOT touch the Impella 5.5 with SmartAssist
Catheter, cables, or Automated Impella Controller.
Avoid overinserting the Impella 5.5 Catheter and possibly impinging the
catheter tip against the walls of the vasculature or ventricles.
Do NOT advance or withdraw the Impella 5.5 with SmartAssist 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.
In patients with transcatheter aortic valves position the Impella system
carefully to avoid interaction with the transcatheter aortic valve
prosthesis. Unintentional interaction of the Impella motor housing
with the TAVR device may result in destruction of the impeller blades.
This can lead to systemic embolization, serious injury, or death. In this
situation, avoid repositioning while the device is running; turn the device
to P0 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 as
soon as possible.
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 5.5 with SmartAssist Catheter can be
damaged during 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 5.5 with SmartAssist
Catheter. Patients with aortic valve disease should be observed for aortic
insufficiency.
Use only original accessories and replacement parts supplied by Abiomed.
To prevent device failure, do NOT start the Impella 5.5 with SmartAssist
Catheter until the placement guidewire has been removed.
Do NOT remove the Impella 5.5 with SmartAssist Catheter over the
length of the placement guidewire.
When replacing the purge cassette, the replacement process must be
completed within 90 seconds. The Impella 5.5 with SmartAssist Catheter
may be damaged if replacement takes longer than 90 seconds.
Do NOT kink or clamp any part of the Impella 5.5 with SmartAssist
Catheter.
Have a backup Automated Impella Controller, purge cassette, and
Impella 5.5 with SmartAssist Catheter available in the unlikely event of a
device failure.
Heparin (25 or 50 IU per mL) or sodium hydrogen carbonate (25 or 50
mEq/L) should be added to the purge solution. The Impella Catheter has
not been tested with any other anticoagulants, such as direct thrombin
inhibitors, in the purge solution. Use of other anticoagulants may reduce
the longevity or performance of the Impella catheter.
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