Electromagnetic Compatibility - HEINE SIGMA 250 (M2) Manual Del Usuario

Light exposure hazard
Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination
should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to
provide clear visualization of the target structures. This device should be used with filters that eliminate
UV radiation (< 400 nm) and, whenever possible, filters that eliminate short-wavelength blue light (<420 nm).
The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time.
If the value of radiance were reduced in half, twice the time would be needed to reach the maximum
exposure limit.
While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is
recommended that the intensity of light directed into the patient's eye be limited to the minimum level which
is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The
risk may also be increased if the person being examined has had any exposure with the same instrument
or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply
particularly if the eye has been exposed to retinal photography.
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 should not exceed 150 minutes (with the use of HEINE
Disposal
The product must be recycled as separated electrical and electronic devices. Please observe the relevant
state-specific disposal regulations.

Electromagnetic Compatibility

Medical electric devices are subject to special precautionary measures with regard to electromagnetic compati-
bility (EMC). Portable and mobile high frequency communication equipment can affect medical electric devices.
This device is intended for use by medical professionals in the electromagnetic environment specified below.
The user of this device should assure that it is used in such an environment.
The use of accessories, converters or cables other than the ones specified by HEINE might lead to
increased emission reduced electrical immunity of the medical equipment.
The device may not be stacked directly near or used directly beside other devices. If the device is to be
operated in a stack or with other devices, the device should be watched to ensure it operates properly in
this location.
The appendix contains the tables „Guidance and Manufacturer's declaration –
Electromagnetic immunity" , technical data and an explanation of the used symbols.
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MED 113379 2017-04-13
A.R. 16D/Ø54mm A.R. lens).
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