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State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
Safety Information
Electromagnetic Interference
The system produces images by using digital signal processing techniques that
operate in the radio frequency (RF) energy range. The system is therefore
susceptible to interference generated by other RF energy sources such as
medical devices, information technology products, or radio / television
transmission towers. Tracing the source of radiated interference can be difficult.
The user must determine if an artifact caused by radiated interference will
negatively impact image quality and the subsequent study results.
To help identify the source of electromagnetic interference, ask the following
questions:
Please answer these questions before contacting Abbott Service. The answers
will help determine if the problem is in the system or in the imaging environment.
Safety Functions Built Into the OPTIS Integrated Next
The following safety functions have been built into the system:
12
OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
•
Is the interference intermittent or constant?
•
Does the interference occur with one catheter only, or with other
imaging catheters?
•
Is the interference present if the system is moved to a different location
in the facility? Examples: Placing the system close to an ECG cable can
increase electromagnetic interference. Moving the cable or other
medical equipment away from the system can reduce electromagnetic
interference.
•
The system disables light output and disables all motors in these
situations:
– The optical fiber stops rotating due to mechanical failure.
– Communication is lost between the imaging engine and the drive
motor and optical controller (DOC).
– Communication is lost between the computer and the imaging engine.
•
Pressing the Stop button on the DOC disables power to the DOC and
laser output. Refer to "Drive Motor and Optical Controller (DOC)" on
page 23.
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