Abiomed Impella 2.5, Instructions For Use Manual

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7.26 Instructions for Use & Clinical Reference Manual (US)
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
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 Table 7.3.
Table 7.3 Troubleshooting When Operating the Impella
®
Catheter in the Presence of an
EAM System
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.
Examples of EAM
Systems
CARTO ® 3 System and
CARTO
®
XP Navigation
System (Biosense Webster,
Inc.)