Alarm Levels - Abiomed Impella Manuel D'utilisation

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.
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
10
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
Alarm Delay
For some AIC alarms, there is a short delay between the triggered event
and the audible annunciation and visual display of the alarm—and the
display of the warning on-screen. See Alarm Delay Information table,
directly below.
Alarm Delay Information
Impella Defective
Impella Position Wrong
Controller Error
Emergency Shutdown Imminent
Battery Failure
Controller Failure
Battery Comm. Failure
Purge System Blocked
Alarm Display
The alarm window is located in the upper left region of the display screen
on the front of the AIC. Alarms are listed in order of priority, with the
highest priority alarm at the top. Up to three alarms may be displayed at
one time. The colored background behind the highest priority alarm will
alternate between two shades of that color. The white panel displayed to
the right of the alarm header contains instructions for resolving the alarm
condition. The instructions should be followed in the order given.
Mute Alarm Function
Pressing the MUTE ALARM button on the upper right of the AIC display
screen will silence the audible alarm indicator for 2 minutes (for red or
yellow alarms) or 5 minutes (for white advisory alarms). When an alarm is
silenced, the words MUTE ALARM next to the button are replaced by the
mute alarm indicator, a crossed-out bell icon.
Alarm History Screen
The alarm history may be accessed through the MENU. This screen
contains a log of the alarms that occurred during the case.
The AIC maintains a long-term log that is saved after the AIC is powered
down or after a power failure, and this information may be downloaded by
Abiomed personnel.
Alarms That Resolve On Their Own
The audible indicator will shut off if an alarm condition is resolved before
you press MUTE ALARM. The visual message, however, will continue to
be displayed, with the alarm header on a gray background, for 20 minutes
or until you press MUTE ALARM. This allows you to identify the alarm
that occurred.
8 second delay
11±5 second delay
12±3 second delay
15±1 second delay
28±8 second delay
38±8 second delay
40±10 second delay
75±45 second delay
User Manual