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Warnings, Precautions, and Limitations
16
Ultiri™ Measurement System Operation Manual – 600327583 Rev. A
•
To protect the privacy and security of sensitive information, including
electronic protected health information (EPHI), and to protect the integrity
of the system itself, the system should be located in a physically secure,
access-controlled environment. Do not use the Ultiri Measurement
System if there is reason to believe the system's security has been
compromised or if the system was unaccounted for during a period of
time (i.e., misappropriated, modified, or tampered with).
Precautions
•
Patients with potential microvascular dysfunction and borderline index
values should be interpreted with caution, and management strategies
should be guided not only by pressure measurement, but also by
possible supplementary clinical risk stratification and other tests.
•
Before performing a physiological parameter procedure or creating a
physiological parameter recording, review the installed software User
Manual for additional warnings and cautions.
•
To connect to the correct Wi-Box AO Transmitter, you must select the
room where the system is being used. The first time you connect to a
room, you must enter the room's information into the system. Refer to
the installed software User Manual for more information.
•
Do not unplug from AC power or turn off main power until the shutdown
is complete and the screen turns black. Disconnecting from AC power
before the shutdown is complete may damage the system.
•
The power switch shuts down the Ultiri Measurement System, but power
remains in the mains cable and power supply unit. To fully disconnect
from mains power, remove the mains power plug from the wall socket.
•
Output sensitivity changes should be performed by a qualified
technician. Incorrect settings may result in discrepancies between
monitor system and Ultiri Measurement System values.
•
Direct connection to a non-secure network (e.g., the internet) may
interfere with correct operation and / or result in inappropriate access to
patient information. Furthermore, it should be noted that reconfiguring a
used network may lead to inability to import or export patient
examination data, ultimately leading to a risk of loss of patient and
examination data. To avoid this problem, Abbott Technical Service
recommends verifying network settings in the system setup after each
change.
•
No connections to other systems or components are to be made to the
Ultiri Measurement System except through the Connector Panel. No
connections are to be made through the Connector Panel except as
described in this manual. In addition, all such combinations of systems
shall comply with the standard IEC 60601-1, Medical electrical
equipment - Part 1: General requirements for basic safety and essential
performance. Any person who connects external equipment to the Ultiri
Measurement System has formed a medical system and is therefore
responsible for compliance of the system with the requirements of
IEC 60601-1. If in doubt contact a qualified technician. Only the
PressureWire X Guidewire and the Wi-Box AO Transmitter are intended
to be used with the Ultiri Measurement System.
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