Intended Use Welch Allyn® PanOptic™ Plus Ophthalmoscope:
The Welch Allyn PanOptic ophthalmoscopes are intended to be used by clinicians and medically qualified personnel for examination of the retina, cornea, aqueous, lens and vitreous of the eye under illumination and magnification on pediatric and adult patients.
The intended use environments for the Welch Allyn PanOptic ophthalmoscopes are professional healthcare facility environments such as general physician's offices, hospitals, specialist, urgent care, clinics, and clinical environment training.
WARNING: Patient injury risk. The light emitted from the ophthalmoscope is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the recommended maximum exposure (RME) of 2.2 J/cm2, unless additional action is taken by the user to minimize exposure, after 30 min. The risk of retinal injury at an exposure of 2.2 J/cm2 is not high, but because some patients may be more susceptible than others, caution is advised if this radiant exposure value is exceeded. However, because of a significant risk of injury at exposures exceeding 10 J/cm2, the user should avoid exposures longer than 30 min.