Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment

Ocular Images

The purpose of the evaluation is to confirm operability and usability of the SL-D301 Slit Lamp and the DC-4 digital camera attachment by conducting a usability evaluation and subsequently submitting a questionnaire and hold an interview with the operator. Of special interest for the study is to confirm whether the illumination level of SL-D301 is enough to perform an eye exam since the maximum illumination level on the SL-D301 is lower than other existing Topcon digital ready slit lamps due to regulations that limit the maximum light intensity on the human eye. The SL-D301 will be compared against the predicate device SL-3G.

An eye care professional familiar with the use of slit lamps and experienced with other Topcon and other manufacturer's slit lamps will evaluate operability and usability of SL-D301 and DC-4 digital camera attachment instrument performing routine eye examinations and image capture on volunteer subjects using above mentioned instruments. Similar evaluations will be performed with the SL-3G Slit Lamp and a comparative evaluation will be drawn between the two instruments. At the end of the evaluation, the evaluator will be presented with a questionnaire on specific points regarding the performance and features of the instruments and interviewed. The responses will then be evaluated by Topcon.

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