Abiomed Impella 5.5, Руководство пользователя

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User Manual
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.
Observation Actions
Unable to start
Impella
or
Impella stops
running
1. Place the MNS magnets in the “Reduced” position and
attempt to start the Impella Catheter.
2. If the Impella Catheter does NOT start with the magnets
in the “Reduced” position, place the magnets in the
“Stowed” position and start the Impella Catheter.
3. Increase the Impella 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 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.
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)
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.
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
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