Fcc Statement; Essential Performance - Abbott Ultiri 1015082 Operation Manual

Reference Abbott website for patent markings: www.abbott.com/patents
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its respective owner.
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
© 2023 Abbott. All Rights Reserved.

FCC Statement

This equipment has been tested and found to comply with the limits for a Class A
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful interference when the
equipment is operated in a commercial environment. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instruction manual, may cause harmful interference to radio
communications. Operation of this equipment in a residential area is likely to
cause harmful interference in which case the user will be required to correct the
interference at his own expense.
Operation is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by Abbott Medical could void
the user's authority to operate the equipment.

Essential Performance

Abilities
1. Acquire wireless signals from pressure transducers for display on the
primary monitor.
Accurately compute and display physiology parameters on the primary
2.
monitor.
Description of Performance Monitoring During Testing
During testing, two pressure transducer signals that simulate cardiac rhythm are
wirelessly received, displayed as a graph and as numeric values of aortic (Pa)
and distal (Pd) blood pressures, and viewed on the primary monitor.
•
The graph may show a very short duration dropout or pulse during
external electromagnetic compatibility (EMC) immunity influence. This is
acceptable if the average readings are stable within the acceptable
limits.
• The acceptable limit of the deviation for each average numeric pressure
caused by any external EMC immunity influence is ≤ 2 mmHg.
•
The acceptable limit of the difference between the two average numeric
pressures caused by an external EMC immunity influence is ≤ 3 mmHg.
•
The display may freeze, flicker, or go blank during an external EMC
immunity influence, provided there is no permanent effect to its essential
performance. If necessary, power down and start again to continue
testing.
Ultiri™ Measurement System Operation Manual – 600327583 Rev. A
Specifications
37