Abiomed Impella LD, Руководство пользователя

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User Manual
If you suspect interference, follow the troubleshooting steps below.
Observation Actions
Interference with the
magnetic location
detection component
of the EAM system
1. Check for and address other sources of interference.
2. Reposition the Impella
® Catheter to ensure that the
Impella
®
motor is at least 3 cm from the sensors in the
mapping catheter; however do NOT pull the inlet area
out of the left ventricle.
3. Ensure that the Impella
®
Catheter is operating at
P-1–P-5 or P-7, as these P-levels cause the least
interference.
MAGNETIC NAVIGATION SYSTEMS (MNS)
Example of MNS
• Stereotaxis Niobe ® Magnetic Navigation System (Stereotaxis)
When initiating Impella LD Catheter support in the presence of a magnetic
navigation system (MNS), follow the steps below:
1.
Insert the Impella LD Catheter following the steps outlined in this
manual.
2.
Place the MNS magnets in the “Reduced” or “Stowed” position.
3.
Start the Impella LD Catheter in the manner described in this manual.
Increase P-level to at least P-5.
4.
Place the MNS magnets in the “Navigate” position and proceed with
magnetic navigation.
Keep operating the Impella LD Catheter at a P-level of at least P-5 when the
MNS magnets are in the “Navigate” position. If the P-level falls below P-5,
the Impella LD Catheter may stop running. To resume operation, follow the
steps in the table below.
During magnetic navigation of the mapping catheter, the motor current
of the Impella LD Catheter may temporarily increase to the point that the
catheter stops running.
When the MNS magnets are in the “Navigate” position, the displayed
Impella LD Catheter flow may be artificially elevated. To accurately assess the
flow rate, note the displayed flow when the magnets are in the “Stowed”
position.
Observation Actions
Unable to start
Impella LD ®
or
Impella LD stops
running
1. Place the MNS magnets in the “Reduced” position and
attempt to start the Impella LD ® Catheter.
2. If the Impella LD Catheter does NOT start with the
magnets in the “Reduced” position, place the magnets in
the “Stowed” position and start the Impella LD Catheter.
3. Increase the Impella LD Catheter P-level to P-5 or higher.
4. Place the MNS magnets in the “Navigate” position and
proceed with magnetic navigation.
MNS magnets:
“Navigate”
Displayed flow
seems too high
or
MNS magnets:
“Stowed”
Displayed flow
drops
The Impella LD Catheter displayed flow will be artificially
elevated when the MNS magnets are in the “Navigate”
position.
The displayed flow will be accurate when the MNS magnets
are in the “Stowed” position.
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 controller sounds an
alarm tone and displays 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 only be heard
and displayed if it’s a higher priority alarm that the one that was muted.
For a full list of all Impella alarms, refer to the Automated Impella Controller
Instructions for Use document.
ALARM LEVELS
Alarms are divided into three levels of severity:
• Advisory (white)
• Serious (yellow)
• Critical (red)
Category Description Audible Indicator* Visual Indicator
Advisory Notification 1 beep every 5
minutes
Alarm header on white
background
Serious Abnormal
situation.
Prompt action
needed.
3 beeps every 15
seconds
Alarm header on yellow
background
Critical High priority.
Immediate
action needed.
10 beeps every 6.7
seconds
Alarm header on red
background
* Sound pressure of audible alarm indicators is >80 dBA
MUTE ALARM FUNCTION
Pressing the
MUTE ALARM
button on the upper right of the Automated
Impella Controller 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. 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.
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