Mobile Operation - Abiomed Automated Impella Controller Manual De Usuario

Use the DISPLAY soft button to navigate to the trend screen.
Once in the trend screen, use the DISPLAY soft button to change the
timescale and y-scale. The timescale can be updated to view trends of 15
minutes, 1 hour, 8 hours, or 12 hours.
LVEDP will not be available and will display dashes when there is suction or
if the position is in the Aorta. The Cardiac Output, Native Cardiac Output
and Cardiac Power Output will not be available and will display dashes
when the Placement Signal Low condition is detected or the position is in
the Aorta or Ventricle.
The LVEDP Trend Screen is only available with Impella CP with SmartAssist
catheters and Impella 5.5 with SmartAssist catheters.
TO USE THE METRICS TRENDS FOR WEANING
When using the trend screen for weaning, enter a new cardiac output every
time the P-level is changed. The cardiac output should be entered once
the new P-level is stable. This will re-calculate the CPO with the new mean
arterial pressure and cardiac output entry.

MOBILE OPERATION

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.
The Automated Impella Controller (AIC) can be operated on internal battery
power when it is not connected to AC power.
1.
Disconnect the AIC from AC power.
2. The controller beeps once every 5 minutes to alert you that it is
running on battery power and a white advisory notification appears
in the alarms area on the screen. The AC power icon displays a red
X through it.
3. When the controller is connected back to AC power, the white
advisory notification turns gray and the battery power icon turns
green.
TRANSPORT WITHIN THE HOSPITAL
Patients supported with the Impella System may require transport within
the hospital for various reasons. Transport can be safe and simple for
patients supported with Impella Catheters.
Considerations for transport within the hospital:
• The AIC and Impella Catheters are designed to operate on battery
power for at least 1 hour.
• Confirm that the battery capacity displayed on the controller is 100%.
• If transport time might be longer than 1 hour, bring an extension cord
or confirm that you will be able to connect the controller to AC power
once you arrive at your destination.
• When rolling the AIC cart across a threshold, firmly grasp the cart
handle and pull it over the threshold.
• Pay close attention to all system components and connections when
rolling the AIC cart over thresholds and through elevator doors.
• Do not stress the connector cable from the controller to the Impella
Catheter.
Automated Impella Controller with SmartAssist
TRANSPORT BETWEEN HOSPITALS
During transport, the Automated Impella Controller (AIC) may
be exposed to stronger electromagnetic disturbance than during
in-hospital use. Strong electromagnetic disturbance may cause the
AIC 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
AIC is no longer exposed to the disturbance.
Guidelines for Patient Transport
The AIC is qualified for safe use by healthcare professionals to facilitate
the transport of patients supported by the Impella System from one
medical facility to another. To use the system during transport you must
understand and follow the instructions in this manual. The transport team
should include person(s) fully trained in the use of the AIC and the Impella
Catheter.
Patients are placed on the AIC for circulatory support for periods compliant
with the intended use duration of the Impella Catheter. If, during this time,
a patient requires additional resources and specialized teams at another
location (e.g., a larger facility such as a transplant center), the patient may
be transferred safely to such a location using the AIC.
Maintaining optimal patient hemodynamic status and correct Impella
Catheter position are two key factors in managing patients supported with
the Impella System during transport. Steps should be taken to eliminate
or minimize any aspect of the transport that might adversely affect these
factors.
The AIC is designed to operate for 60 minutes on battery power. Transport
teams should take this into consideration when planning the transport. If
the total transport time is expected to include more than 60 minutes during
which the system will be disconnected from AC power, arrangements
should be made to use a vehicle with a built-in DC to AC power inverter.
Important Transport Considerations
1.
Planning is critical to success. Abiomed representatives can help
with planning for transport. They can be contacted 24 hours a day
at the Abiomed 24hr hotline (see back cover).
2. The Automated Impella Controller should be fully charged prior to
transport. Keep the Automated Impella Controller connected to AC
power (or an AC inverter) whenever possible.
3.
Do not stress the connector cable from the controller to the Impella
Catheter. Such tension could move the catheter out of correct
position and compromise patient circulatory support.
4.
Carefully monitor purge pressures during changes in altitude.
5.
The controller should be positioned to allow easy access to the
display screen and soft buttons to view alarms and make any
necessary changes.
6.
Maintain ACTs between 160 and 180 seconds or at the level
recommended by the physician responsible for the patient.
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