Limitations - Abbott Ultiri 1015082 Operation Manual

•
PressureWire X Guidewire readings may be affected by defibrillation.
After defibrillation, restart the procedure. Re-zero and re-equalize the
PressureWire X Guidewire.
•
Radio transmitting equipment, cellular phones, and strong emission
sources such as high frequency surgical equipment shall not be used in
close proximity to the Ultiri Measurement System since this could
influence the performance of the device.
Note: The device should be used in a hospital environment
except for near active high frequency (HF) surgical equipment
and the radio frequency (RF) shielded room of a medical
equipment system for magnetic resonance imaging, where the
intensity of electromagnetic (EM) disturbances is high.
• Check that the monitor cables and aortic pressure transducer (AO)
adapter used with the Ultiri Measurement System interface are
compatible with the catheterization laboratory system to be used. The
AO should be in accordance with ANSI / AAMI BP22-1994. After the
laboratory monitor system has been zeroed, use only the Ultiri
Measurement System to calibrate the AO and PressureWire X
Guidewire.
•
After use, the PressureWire X Guidewire may be a potential biohazard.
Handle and dispose of in accordance with accepted medical practice
and applicable laws and regulations.
•
Do not immerse in liquid: Do not use the Ultiri Measurement System if it
has been immersed in liquid.

Limitations

•
The system has no patient alarm functions. Do not use it for cardiac
monitoring.
• Only a qualified service representative can perform maintenance or
service components of the system. Any attempt to open the system
components by anyone other than a qualified Abbott Technical Service
representative will void the warranty.
Ultiri™ Measurement System Operation Manual – 600327583 Rev. A
Warnings, Precautions, and Limitations
17