Electromagnetic Compatibility - HEINE mini 3000 Manual Del Usario

General Notes and Warnings
The HEINE mini 3000
®
according to ISO 15004-1:2006.
The HEINE mini 3000
®
Check the correct operation of the device before use! Do not use the device if there are visible signs of
damage or a flickering of the illumination.
Do not use the device in hyperbaric chambers, in explosive or oxygen loaded environments!
Do not use the device near strong magnetic fields like MRI scanners.
Do not look into bright light sources by means of loupes. Hazard of glare!
The performance and safety of the device can only be guaranteed when fitted with original
HEINE accessories and HEINE spare parts. Otherwise the warranty is terminated.
Don't modify the device! If the device is modified despite that, take care that use of the device is safe by
performing investigations and tests.
For the examination please use as little light as possible. To do so, you can use the fixation star as it is
combined with a neutral grey filter which reduces the brightness to 30%. Please ensure to switch off the
light after each examination.
Your HEINE mini 3000
with care and clean it at regular intervals.
Store and use the device in dry and dust-free environments only! If you don't use the device for a longer
period of time, please remove the batteries in advance.
Phototoxicity
Because prolonged intense light exposure can damage the retina, the use of the device for ocular examina-
tion 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.
The emitted light of this instrument might be dangerous. The risk for injuries of the eye will increase with
prolonged exposition times and will depend on the distance between instrument and eye. Without using
additional filters an exposition time longer than 192 seconds at full intensity in a distance of 100 mm will
excess the limits of the guideline for eye hazards.

Electromagnetic Compatibility

Medical electric devices are subject to special precautionary measures with regard to electromagnetic
compatibility (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.
LED Ophthalmoscope in its original packaging meets the requirements for transport
LED Ophthalmoscopes meet the requirements according to ISO 10942:2006.
LED Ophthalmoscope is a precise optical instrument. Please handle the device
®
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