3
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ALL PUPIL II by KEELER
1. INDICATIONS FOR USE
These devices are intended to be used only by suitably trained and authorised healthcare
professionals.
CAUTION: Federal Law restricts this device to sale by or on the order of a
physician or practitioner.
Intended use / purpose of instrument
Indirect ophthalmoscope is an AC or battery-powered device containing illumination and
viewing optics; and it is intended to be used to examine the cornea, aqueous, lens, vitreous
and retina of the eye. The device is intended for use by a trained healthcare professional and is
mounted on the user’s head.
2. SAFETY
2.1 PHOTOTOXICITY
CAUTION: The light emitted from this instrument 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 safety guideline after 35 minutes.
Testing was completed with a 20D, 55mm diameter Volk lens.
While no acute optical radiation hazards have been identifi ed for Indirect
Ophthalmoscopes, we recommend keeping the intensity of the light
reaching the patient’s retina to the minimum possible for the respective
diagnosis. Children, people with aphakia and people suffering from
eye conditions are most at risk. An increased risk may also occur if the
retina is exposed to the same or a similar device with a visible light
source within 24 hours. This applies, in particular, if the retina has been
photographed with a fl ashbulb in advance.
Keeler Ltd shall on request, provide the user with a graph showing the
relative spectral output of the instrument.
2.2 WARNINGS AND CAUTIONS
Please note that the proper and safe functioning of our instruments is only guaranteed if
both the instruments and their accessories are exclusively from Keeler Ltd. The use of other
accessories may result in increased electromagnetic emissions or reduced electromagnetic
immunity of the device and may lead to incorrect operation.
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