Abiomed Automated Impella Controller Manual De Usuario página 10

PREPARING FOR USE IN FLIGHT−ENABLE FLIGHT
MODE
Flight Mode is available in the software for air transport. When active,
Flight Mode disables the purge cassette RFID transmitter so the controller
cannot detect the purge cassette. If any purge system alarms are triggered
during transport, the transport team should inform the managing hospital
upon arrival.
When preparing to use the system in-flight, select > Enable Flight Mode.
When Flight Mode is active, a white alarm appears on screen (see Figure
below). During air transport, a grounding cable is needed to connect the
controller to ground. The grounding cable is provided by the hospital.
Once transport is complete, select > Disable Flight Mode.
TO ENABLE FLIGHT MODE
Select: > Menu > Settings/Service > Enable Flight Mode.
A white alarm appears at the top of the screen:
Figure 4. Flight Mode Enabled alarm
Connect the controller to a ground and, if equipped, put the Impella
Connect in Flight mode. Upon arrival, you are instructed to disable Flight
Mode.
Note: the AIC cannot detect the purge cassette while in Flight mode.
Therefore, there are special purge system alarms that direct you to inform
the team receiving the patient. You are advised to have the team address
operations when Flight mode is disabled.
TO DISABLE FLIGHT MODE
Select: > Menu > Disable Flight Mode.
The updated software permits the user to switch off the Purge Cassette
Detection (RF-ID) to enable safe air transport.
DEFIBRILLATION
During defibrillation, do NOT touch the Impella Catheter,
cables, or Automated Impella Controller.
If emergency defibrillation is required during support with the Impella
System, universal safety precautions should be followed. To avoid the risk
of electrical shock, caregivers should use caution during defibrillation to
ensure they do not touch the Impella Catheter, cables, or controller.
ECG INTERFERENCE
Operating the Automated Impella Controller may cause interference with
electrocardiogram (ECG) signals. Please check the electrode pads and
leads for good fixation and contact. If interference persists, activate the
50/100 Hz band-elimination filter or the 60/120 Hz band-elimination filter
(also known as notch filter) on your ECG device. The filter frequency will
be based on the AC power frequency for the country in which you are
operating the equipment. If your ECG device does not have the appropriate
filters, disconnect the Automated Impella Controller temporarily from AC
power to obtain an undisturbed signal. Please observe the battery status
while running the Automated Impella Controller on battery power.
10
LATEX
The AIC was not made with natural rubber latex or synthetic derivatives of
natural rubber latex.
Battery Power Note
If the Automated Impella Controller is allowed to discharge completely
and the system shuts down due to low battery, the controller will need to
charge for an extended period of time before it will turn on again.
ALARMS OVERVIEW
The Automated Impella Controller monitors various functions to determine
whether specific operational parameters are within expected limits. When
a parameter goes outside of its specified limits, the Automated Impella
Controller sounds an alarm message that can be viewed on the display
screen on the front of the controller. The alarm tone indicates the severity
of the alarm. The alarm message on the display screen is color-coded
for severity and provides details on the cause of the alarm and how to
resolve the alarm. After muting an alarm, if another alarm occurs it will be
displayed but only heard if it is a higher priority alarm than the one that
was muted.
ALARM LEVELS
Alarms are divided into three levels of severity:
• Critical ( red ) • Serious ( yellow ) • Advisory ( white )
Category Description
Advisory Notification
Serious Abnormal situation.
Prompt action
needed.
Critical High priority.
Immediate action
needed.
* Sound pressure of audible alarm indicators is >67 dBA
Audible Visual Indicator
Indicator*
1 beep every 5 Alarm header on white
minutes background
3 beeps every Alarm header on yellow
15 seconds background
10 beeps every Alarm header on
6.7 seconds red background
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