2 Introduction Instructions for Use
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• Able to work with elderly patients and those with disabilities
2.4.3 Job Requirements (Analysts)
• Accurately identify ocular anomalies
• Have a history of correct diagnoses of eye disease or work
solely within a research environment
• Be fully trained in the use of OCT equipment, and particularly,
in the analyses that comprise the Review portion of the
instrument software
2.5 User Documentation
2.5.1 Purpose
The user documentation that comes with your device is provided to
ensure that all users operate and maintain it safely and successfully.
• Read all user documentation before starting and using the
device
• Keep all user documentation where it is accessible at all times
for all users
• Pass the user documentation on to the next owner of the
device
2.5.2 Access
User documentation for your device is provided on the USB drive
that came with the device as part of the Instrument Accessory Kit.
2.5.3 Organization
This User Manual has been written to provide a comprehensive
overview of the Device and its software. It provides guidelines for
successful:
• Clinical setup and workflow
• Data acquisition and acceptance
• Review and Interpretation of PLEX® Elite 9000 data
In addition, instructions and information are provided to ensure
that data is safely managed and that the device is properly
maintained.
2.5.4 Other Applicable Documents
Document Title Optional (Y/N)
PLEX® Elite 9000 Release Notes N
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