Welch Allyn RETeval-DR, Directions For Use Manual

Page: 48 / 60

Safety Battery-powered. Complies with optical, electrical, and biocompatibility safety standards.
Power source Li-Ion battery allows testing of approximately 70 patients before recharging, depending on the
protocol used
Recharge time 4 hours – charger included
Size 2.8” W x 3.8” D x 9” H (7 cm x 10 cm x 23 cm)
Docking station Convenient storage location, charging stand, and USB connectivity to your computer or laptop and
network
Protocol DR Assessment
All specifications are subject to change.
1
For Troland-based flicker protocols having a retinal illuminance energy
≥
4 Td
∙
s.
Operating environment
Temperature 10 °C – 35 °C (50 °F – 95 °F)
Humidity 10% – 90% non-condensing
Air pressure 62 kPa – 106 kPa (-80 m / -260 feet – 4000 m / 13,000 feet)
Product performance
The RETeval-DR device’s normal operation includes measuring flicker implicit time with a
single-patient, single-day standard deviation that is typically less than or equal to 1.0 ms;
therefore, the RETeval-DR device must operate with no unintended deviations in
settings and with typical operation.
Contact Welch Allyn Technical Support: www.welchallyn.com/service if changes in
performance are noted.
Essential performance
The RETeval-DR device is neither life supporting nor life sustaining nor is it a primary
diagnostic device, its function is to aid a physician in making a diagnosis in combination
with other data and in light of the physician’s knowledge and experience, as such the
RETeval-DR device has no Essential Performance as pertains to risk.
Device lifetime
The lifetime of the device is five (5) years or 10,000 test protocols performed, whichever
comes first. The manufacture date of the device can be found on the device labels.
Welch Allyn will service RETeval-DR devices that are within their lifetime. Support may
require an annual subscription service after the initial one (1) year warranty period. The
expected battery life is at least one (1) year. If the RETeval-DR device fails to hold a
charge, a new battery can be ordered.
44 Specifications Welch Allyn
®
RETeval-DR
™