RETevalTM Visual Electrodiagnostic Device D This revolutionary utionary device measures the 30 Hz flicker implicit time, which has a strong correlation to retinal ischemic diseases such as diabetic retinopathy. Design Features • • • • Handheld Utilizes skin electrodes Mydriatic-free Ultra low-noise noise digital amplifier Easy to Use • • • • • • • • • • Instant results displayed on screen Test duration is less than 5 minutes per patient Built-in in pupillometry adjusts flash and backgro background intensity enabling testing without pupil dilation Single electrode array is placed on skin for each eye (Patent Pending) IR camera allows visualization of eye during test Simple joystick control Multi-lingual lingual user interface Fixation LED for the patient Blink and electrode-disconnected disconnected detection for more reliable results Small and lightweight – 2.8” W x 3.8” D x 9” H (7 cm x 10 cm x 23 cm), 88.2 .2 oz. (232 g) Clinical Capabilities • • Reports 30 Hz flicker implicit time Provides interpretation of implicit time for risk of vision-threatening threatening diabetic retinopathy TM RETeval is not yet FDA approved nor CE Marked Marked.. It is currently available for research use only under IRB approval and control. The RETeval eval device may be covered by one or more of the following US patents and their foreign counterparts: 7,540,613. Specifications Input Type Connector Type Noise CMRR Frequency Range Data Resolution Input Range Sampling rate Safety Power source Recharge time Size Weight Base station Custom 3 pin connector with positive, negative, and right leg drive signals. Male safety electrode connections < 0.1 µV at 30 Hz > 110 dB at 50-60 Hz DC-coupled 143 nV / bit ± 1.2 V Approximately 500 Hz – 2 kHz Battery-powered Li-Ion battery allows testing of 80 patients before recharging 4 hours – charger included 2.8” W x 3.8” D x 9” H (7 cm x 10 cm x 23 cm) 8.2 oz. (232 g) Convenient storage location, charging stand, and USB connectivity to your computer and network All specifications are subject to change. RETevalTM is not approved for sale by the FDA nor CE marked. LKC Technologies, Inc., established in 1975, is an ISO 13485:2003 certified, CE marked, and FDA-registered medical device manufacturer with quality products installed in fifty countries. LKC Technologies, Inc. 2 Professional Drive, Suite 222 Gaithersburg, MD 20879 USA t: 800.638.7055 (USA only) +1 301.840.1992 f: +1 301.330.2237 e: [email protected] www.lkc.com TM Please scan with your smartphone to access a demo video RETeval is not yet FDA approved nor CE Marked. It is currently available for research use only under IRB approval and control. The RETeval device may be covered by one or more of the following US patents and their foreign counterparts: 7,540,613.