Welch Allyn RETeval-DR, Directions For Use Manual

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Appendices
Approved accessories
Part number Item
RETeval-001 Welch AllynRETeval-DR Visual Electrodiagnostic Device, including Disposable Sensor Strips (2
packages—50 Pairs per package), Charging Dock, and USB Cable; 100-240 V, 50-60 Hz, Lithium-Ion
Battery (#RETeval-ACC-02); IEC Plug Types A, G, E/F, and I (RETeval-ACC-05); English Directions for
use
RETeval-SS-50 Disposable Sensor Strips for Welch Allyn RETeval-DR Visual Electrodiagnostic Device; Quantity 50
Pairs
RETeval-ACC-04 Eyecup Accessory for Welch Allyn RETeval-DR Visual Electrodiagnostic Device
RETeval-ACC-01 Lead-Wire Accessory for Welch Allyn RETevall-DR Visual Electrodiagnostic Device
RETeval-ACC-05 Power Transformer Accessory Kit for Welch Allyn RETeval-DR Visual Electrodiagnostic Device;
100-240 V, 50-60 Hz IEC Plug Types A, G, E/F, I and C
RETeval-ACC-03 Dust Cover Accessory for Welch Allyn RETeval-DR Visual Electrodiagnostic Device
RETeval-ACC-02 3.6 V Battery for Welch Allyn RETeval-DR Visual Electrodiagnostic Device; Lithium-Ion
For information about any Welch Allyn product, contact Welch Allyn at
www.welchallyn.com/about/company/locations .
DR assessment protocol
The DR Assessment Protocol is designed to aid in the detection of vision threatening
diabetic retinopathy (DR), which is defined as severe non-proliferative DR (ETDRS level
53), proliferative DR (ETDRS levels 61+), or clinically significant macular edema (CSME).
This definition of vision-threatening DR (VTDR) is the same as used in the NHANES
2005-2008 epidemiology study (Zhang et al. 2010) sponsored by the United States
National Center for Health Statistics (NCHS) and the Centers for Disease Control and
Prevention (2011).
The DR assessment protocol was developed using measurements of 467 people with
diabetes aged 23 – 88 (Maa et al. 2016). The gold standard, 7-field, color, stereo, ETDRS-
compliant fundus photography with non-physician expert grading (double-read with
adjudication), classified each subject into a severity group (Table 1) based on the
subject’s worst eye. The study had a planned oversampling of low-prevalence
retinopathy levels, and the subject population included 106 diabetics with VTDR in at
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