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State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
System Specifications
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
Imaging
Will compute the diameter of a lumen:
Will compute the length of a lumen:
Physiology
Pressure measurement and ratio display:
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.
© 2021 Abbott. All Rights Reserved.
44
OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
•
Accuracy of measurements presented must meet Product Requirements
specified in the Design History File (DHF).
•
The lumen must be displayed on the screen.
•
Accuracy of measurements presented must meet Product Requirements
specified in the DHF.
•
The lumen must be displayed on the screen.
•
Accuracy of measurements presented must meet Product Requirements
specified in the DHF.
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