Abiomed Automated Impella Controller Manual Del Usuario página 29

SUCTION DETECTION DURING SENSOR DRIFT OR
SENSOR FAILURE
If sensor drift occurs or the pressure sensor fails, the controller can no
longer detect suction. (For more information about suction, refer to the
Suction discussion earlier in this manual.)
Note: The effectiveness of Impella 5.0 or Impella LD Catheter
support can only be assessed by monitoring patient hemodynamics,
cardiac imaging, and the Impella 5.0 Catheter motor current.
Signs of suction Include the following:
• A drop in the patient's arterial pressure
• Decreased output, if a cardiac monitor is in place
• Dampened or flat motor current waveforms
If imaging reveals that the suction is caused by the catheter inlet area
in close proximity to the intraventricular wall, reposition the catheter as
described in Table Guide for Managing Hemolysis in Various Circumstances.
If hemodynamic parameters, such as low aortic pressure or high pulmonary
artery pressure, indicate suction caused by inadequate filling volume, reduce
P-level and follow the management strategies described in the Table Guide
for Managing Hemolysis in Various Circumstances.
ENABLING PURGE FLOW NOTIFICATIONS
The purge flow notification white alarms Purge Flow Increased and
Purge Flow Decreased ) are disabled by default.
To Enable these alarms:
1. Press MENU and scroll to Settings/Services. Press the selector
knob.
2. Scroll to Enable Purge Flow Change Notifications and
press the selector knob to enable these alarms.
DISABLING AUDIO ALARMS
The audio for the following alarms can be disabled:
• Placement Signal Not Reliable
• Placement Signal Lumen Blocked
• Suction
• Purge System Blocked / Purge Pressure High
To disable the audio:
1. Press MENU and scroll to "Settings/Services."
Press the selector knob.
2. Highlight alarm and press the selector knob to disable the audio
for the selected alarm.
SURGICAL MODE
Surgical Mode can be enabled to silence the Impella Stopped alarm
that occurs when P-level is reduced to P-0. A white banner notification
displays throughout the duration of Surgical Mode support.
To Enable Surgical Mode:
1. Press > MENU and scroll to > Settings/Services.
Press the Selector knob.
2. Scroll to > Enable Surgical Mode,
Press the Selector knob to enable it.
You can Disable Surgical Mode in one of two ways:
1.
Increase P-level above P-0, or
2.
Press MENU, select > Settings/Services,
then select > Disable Surgical Mode.
Automated Impella Controller
TIMED DATA RECORDING
The Automated Impella Controller can hold up to 24 hours of real-time
data. Once memory is full, the controller starts overwriting the old data.
The timed data recording feature allows you to permanently save real-time
operating data for later analysis. Timed data recording is automatically
turned on during certain alarm conditions to capture data for analysis. You
can also manually turn on the feature at any time to capture data for later
analysis.
To manually access the timed data recording feature:
1. Press MENU and scroll to "Start Data Snapshot." Press the selector
knob.
2. The controller records data for a predefined period of 10 minutes.
OPERATING THE IMPELLA 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
Examples of EAM Systems
• CARTO 3 System and
®
• CARTO XP Navigation System (Biosense Webster, Inc.)
®
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 in Troubleshooting When Operating the
Impella Catheter in the Presence of an EAM System table.
Troubleshooting When Operating the Impella Catheter in the
Presence of an EAM System
Observation Actions
Interference with the 1. Check for and address other sources of
magnetic location interference.
detection component of 2. Reposition the Impella Catheter to ensure that
the EAM system 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.
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