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OPERATING THE IMPELLA 5.5
WITH SMARTASSIST CATHETER IN
ELECTROMAGNETIC FIELDS
The Impella Catheter contains a permanent magnet motor that emits an
electromagnetic field. This field may produce electromagnetic interference
with other equipment. In addition, other equipment that emits a strong
electromagnetic field may affect the operation of the Impella Catheter motor.
ELECTROANATOMIC MAPPING (EAM) SYSTEMS
The electromagnetic field emitted by the Impella Catheter may produce
interference with the magnetic location detection component of the
electroanatomic mapping (EAM) system, particularly when the mapping
catheter is close to the Impella Catheter motor. For example, mapping in the
right or left ventricular outflow tracts places the mapping catheter in close
proximity to the Impella Catheter motor in the ascending aorta.
Electromagnetic interference may appear as:
• Instability in the displayed location of the mapping catheter
• Magnetic interference errors generated by the electroanatomic
mapping system
When operating the Impella
®
Catheter in the presence of an EAM system, use
P-level mode. Operate the Impella Catheter at P-1–P-5 or P-7. The motor
speeds at these P-levels cause the least interference. Best performance is
observed when the Impella Catheter motor is at least 3 cm from the sensors
in the mapping catheter. If you suspect interference, follow the
troubleshooting steps below.
Observation
Actions
Interference with
1. Check for and address other sources of interference.
the magnetic
2. Reposition the Impella Catheter to ensure that the
location detection
Impella motor is at least 3 cm from the sensors in
component of the
the mapping catheter; however do NOT pull the inlet
EAM system
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)
When initiating Impella Catheter support in the presence of a magnetic
navigation system (MNS), follow the steps below:
1.
Insert the Impella Catheter following the steps outlined in this manual.
2.
Place the MNS magnets in the "Reduced" or "Stowed" position.
3.
Start the Impella 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 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 Catheter may stop running.
To resume operation, follow the steps below.
During magnetic navigation of the mapping catheter, the motor current of the
Impella Catheter may temporarily increase to the point that the catheter stops
running. The table below explains how to resume operation.
When the MNS magnets are in the "Navigate" position, the displayed Impella
Catheter flow may be artificially elevated. To accurately assess the flow rate,
note the displayed flow when the magnets are in the "Stowed" position.
Impella 5.5
®
with SmartAssist
®
Circulatory Support System
Observation
Actions
1. Place the MNS magnets in the "Reduced" position and
attempt to start the Impella Catheter.
Unable to start
2. If the Impella Catheter does NOT start with the magnets
Impella
in the "Reduced" position, place the magnets in the
or
"Stowed" position and start the Impella Catheter.
Impella stops
3. Increase the Impella Catheter P-level to P-5 or higher.
running
4. Place the MNS magnets in the "Navigate" position and
proceed with magnetic navigation.
MNS magnets:
"Navigate"
Displayed flow
The Impella Catheter displayed flow will be artificially
seems too high
elevated when the MNS magnets are in the "Navigate"
position.
or
The displayed flow will be accurate when the MNS magnets
MNS magnets:
are in the "Stowed" position.
"Stowed"
Displayed flow
drops
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.
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*
Advisory
Notification
1 beep every 5 minutes
Abnormal
situation.
3 beeps every
Serious
Prompt action
15 seconds
needed.
High priority.
10 beeps every
Critical
Immediate
6.7 seconds
action needed.
* 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.
Visual Indicator
Alarm header on
white background
Alarm header on
yellow background
Alarm header on red
background
15
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