Keeler Jazz Ultra, Инструкция по эксплуатации

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Jazz Ultra Instruments 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
Keeler Jazz Ultra Otoscopes are indicated for the examination of the health of the external
auditory canal, the tympanic membrane, and the middle ear. Otoscopy can aid in the detection
of ear conditions, including but not limited to earache, ear infection, hearing loss, ringing in the
ears, infl ammation, and foreign bodies.
Keeler Jazz Ultra Ophthalmoscopes are indicated for examining the posterior segment of
the eye referred to as the fundus, to aid in the screening and diagnosis of retinal pathology
including, but not limited to, diseases such as cataracts, papilloedema, glaucomatous disc
cupping, diabetic retinopathy, hypertensive retinopathy and retinal detachments. When set to
a high power and magnifi cation, it can also be used to examine the anterior segment of the
eye, which includes the eyelids, cornea, sclera, conjunctiva, iris, aqueous, crystalline lens and
anterior vitreous.
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 21 minutes.
While no acute optical radiation hazards have been identifi ed for
Diagnostic Instruments, 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.