2.2
Power the Automated Impella® Controller using its internal battery if the integrity
of the protective earth conductor is questionable.
Medical electrical equipment needs special precautions regarding EMC and needs
to be installed and put into service according to the electromagnetic compatibility (EMC)
information provided in section 7 of this manual.
During transport, the Automated Impella® Controller may be exposed to stronger
electromagnetic disturbance than during in-hospital use. Strong electromagnetic
disturbance may cause the Automated Impella® Controller to display soft button
menu selections that were not selected by the user. Operators should be aware that,
under these conditions, the operating parameters are not affected. No user intervention
is required. Monitor Impella® RP Catheter flow and patient hemodynamics to confirm
normal operation. The condition will resolve itself once the Automated Impella® Controller
is no longer exposed to the disturbance.
Portable and mobile RF communications equipment can affect medical electrical
equipment.
The equipment or system should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the equipment or system should
be observed to verify normal operation in the configuration in which it will be used.
Use of cables, other than those sold by Abiomed, may result in increased emissions
or decreased immunity of the Automated Impella® Controller.
The Automated Impella® Controller uses RFID (radio frequency identification) to
identify and communicate with the purge cassette. Other equipment may interfere with
the Automated Impella® Controller even if that other equipment complies with CISPR
emission requirements.
Avoid overinserting the Impella® RP Catheter and possibly impinging the catheter
tip against the walls of the vasculature, atrium, or ventricle.
Torquing the catheter should be monitored carefully using fluoroscopy.
Do NOT advance or withdraw the Impella® RP Catheter against resistance without
using fluoroscopy to determine the cause of the resistance. Doing so could result
in separation of the catheter or guidewire tip, damage to the catheter or vessel, or
perforation.
Instructions for Use & Clinical Reference Manual (US)
