Instructions for Use
8 Operation
2660021169042 Rev. A 2018-03
8.6 Check Scan Quality
2660021169042 Rev. A 2018-03
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8.6.4.1 RPE Acceptance Criteria
Test
Pass
Fail
Explanation
Retina
Position
Retina is in an
appropriate position
in the scan
Retina is too low in the scan
Example of retina position too low: .
If the retinal tissue is captured too
low in the axial FOV of the scan,
there will not be enough contrast to
detect sub-RPE illumination.
Table 13:
RPE Acceptance
8.6.4.2 Signal Quality Acceptance Criteria
PLEX® Elite 9000 OCT Angiography (AngioPLEX
TM
) is more sensitive
to signal quality than structural OCT imaging.
Test
Pass
Fail
Explanation
Signal
Strength
6 or higher
Less than 5
Low signal strength causes poor
scan quality and can affect interpre-
tation of the images.
Shadows Shadows exhibit floaters or disease
•
Floater
: dark area appears in
different locations in multiple
scans (compare the flow en face
and structural en face image).
•
Possible disease
: Angiography
image is dark, but the B-scan
and the structural en face image
are normal.
Dark spots, dark or
blurry scans
OCT Angiography sensitivity
sometimes show dark spots resulting
from poor local signal, not capillary
dropout.
Poor signal quality appears
throughout the image; the B-scan
also looks dark or blurry.
Table 14:
Signal Quality Acceptance
Enface Flow Image
Enface Structural Image B-Scan
Explanation
• Blue arrow shows a
floater
• Red arrow shows
possible impaired
capillary flow:
– Good signal in
the structural en
face and the B-
scan
– B-scan and en
face images
show a
decreased signal
in the same area
Table 15:
Example: Signal Criteria Example: Angio 6mmx6mm
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