English; Intended Audience - Abiomed Automated Impella Controller Manual De Usuario

ENGLISH

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.
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WARNINGS
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.
During defibrillation, do NOT touch the Impella Catheter, cables,
or Automated Impella Controller.
Power the Automated Impella Controller using its internal battery
if the integrity of the protective earth conductor is questionable.
Lithium-ion battery replacement by inadequately trained personnel
could result in excessive temperatures, fire, or explosion. Only
technicians authorized by Abiomed should remove or change the
battery.
To avoid risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
No modification of this equipment is allowed.
Medical electrical equipment needs special precautions regarding
EMC and needs to be installed and put into service according to
the electromagnetic compatibility (EMC) information provided in
this manual.
During transport, the Automated Impella Controller may be
exposed to stronger electromagnetic disturbance than during
in-hospital use. Strong electromagnetic disturbance may cause
the Automated Impella Controller to display soft button menu
selections that were not selected by the user. Operators should
be aware that, under these conditions, the operating parameters
are not affected. No user intervention is required. Monitor Impella
Catheter flow and patient hemodynamics to confirm normal
operation. The condition will resolve itself once the Automated
Impella Controller is no longer exposed to the disturbance.
Portable and mobile RF communications equipment can affect
medical electrical equipment.
The equipment or system should not be used adjacent to or
stacked with other equipment. If adjacent or stacked use is
necessary, the equipment or system should be observed to verify
normal operation in the configuration in which it will be used.
Use of cables, other than those sold by Abiomed, may result in
increased emissions or decreased immunity of the Automated
Impella Controller.
The Automated Impella Controller uses RFID (radio frequency
identification) to identify and communicate with the purge
cassette. Other equipment may interfere with the Automated
Impella Controller even if that other equipment complies with
CISPR emission requirements.
To prevent the risk of explosion, do NOT operate the Impella
System near flammable anesthetics.
Do NOT use damaged or contaminated connector cables.
Automated Impella Controller with SmartAssist
CAUTIONS
To prevent malfunction of the Automated Impella Controller,
avoid long-term exposure to direct sunlight and excessive heat
(40 °C).
To prevent overheating and improper operation, do NOT block
the cooling vents of the Automated Impella Controller while it is
operating.
The Li-Ion batteries must be charged for 5 hours prior to
system operation in order to meet the runtime requirement of
1 hour. Failure to do so will yield a shorter runtime. After being
unplugged, the Automated Impella Controller will operate for at
least 60 minutes after the batteries have been fully charged.
Minimize exposure of Impella System components to sources of
electromagnetic interference (EMI). Exposure to sources of EMI,
such as cell phones and two-way radios, may cause operational
interference. To clear interference, either increase the distance
between system components and the EMI source or turn off the
EMI source.
Operation of Impella System components may interfere with the
operation of other devices. If interference occurs, increase the
distance between the device and system components.
Have a backup Automated Impella Controller, purge cassette,
connector cable, and Impella Catheter available in the unlikely
event of a device failure.
Do NOT use the bed mount as a handle.
INTENDED USE (EU)
The Automated Impella Controller is intended for exclusive use of Impella
catheters and accessories. The controller may only be connected with
devices which are listed in these instructions.
CONTRAINDICATIONS (EU)
There are no contraindications for use of the Automated Impella
Controller, which operates the Impella pumps. Please see the respective
catheter user manuals for indications, contraindications and possible
complications.
OVERVIEW
REUSABLE SYSTEM COMPONENTS
The Impella System consists of the following reusable components:
• Automated Impella Controller (AIC)—The AIC provides an interface
for monitoring and controlling the function of the Impella Catheters.
The controller provides a fluid purge to the Impella Catheters.
The controller provides backup power when the Impella System is
operated away from AC power. The controller weighs 26 lbs (11.8
kg) and can operate on its internal battery for at least 60 minutes
when fully charged.
• AIC cart—holds the controller. The cart has wheels for easy
transport of the controller and a storage basket.
SINGLE-USE SYSTEM COMPONENTS
The Impella System also includes the following single-use components:
• Impella Catheter—The Impella Catheter is a microaxial blood pump
that is operated by the AIC. There are different types of Impella
Catheters, each of which has a programmable memory chip in
the red (or blue) Impella plug. The AIC reads the memory chip to
determine which type of Impella Catheter is connected and operate
it as intended.
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