Second Opinion®- User Manual

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Warnings

The following warnings apply to the use of all Second Opinion® software:

● CAUTION: SECOND OPINION®  IS NOT INTENDED TO OFFER A DIAGNOSTIC ASSESSMENT. Further clinical investigation of any detected potential pathologic and non-pathologic features that may appear in radiographs is always required.

 

● Second Opinion® is to be used with visual and tactile oral examination and patient risk assessment.

 

● Users should regularly confirm that the computer on which the Second Opinion® Client software is operating is free of viruses or malware.

 

● Users should regularly confirm that the Second Opinion®Client software has been updated with the latest security patches.

 

● Do not use Second Opinion® software without proper training. Operator training and review of the Second Opinion® user manuals required prior to using the system.

 

● The Second Opinion® system may make a detection and highlight a region where no pathologic or non-pathologic feature exists. Users must always exercise their professional interpretative skills when reviewing the regions that have been detected by  SecondOpinion®.

 

Second Opinion® may not detect or mark all regions that are indicative of a pathology. Users must always exercise their professional interpretative skills to determine whether any pathologic and non-pathologic features warranting clinical attention are present in radiographs processed by Second Opinion®.

 

● Effectiveness and safety have been established only for detections in bitewing and periapical radiographic image types. Any features detected and highlighted on radiographs types other than bitewing and periapical cannot be used by the clinician to assist in radiographic evaluations. As an added safety provision, prior to detection processing, Second Opinion® deploys a CV Model that classifies submitted radiographs into types: Bitewing, Periapical, and Other. If an image is categorized as Other, the Second Opinion®Client will display a message to the user indicating that the image type is not supported.

 

● All images submitted for SecondOpinion® processing must be JPEG, RVG, DCM, TIFF, PNG, and DIC. SecondOpinion® may not function properly if an image in an unsupported format is submitted.