7
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Adjustable monitor for comfortable reading position, easy positioning and
effortless assembly/disassembly
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compact folding function
Medical device
This reading system is classified as a medical device, class I according to 93/42/EEC,
Annexe IX, standard 12. For the distribution to countries outside the EU the respective
country-specific guidelines have to be regarded.
Purpose
This opto-electronic reading system is a medical device to assist with the reading
and magnifying of printed text and pictures. Visually impaired people can compen-
sate for their loss of visual acuity by using this device.
Evolution and lifetime of products
The Medical Device Directive regulates by law that manufacturers of medical
devices shall determine a period of safety operation of a product. We fulfill hereby
legal requirements and determine - for formal reasons - a period of three years after
date of first purchase.
Note:
The mentioned life span does not reflect the complete life span of the mezzo EDU.
It is rather an indication on when the product might be obsolete and substitution
might be recommended due to new product developments.
Safety advice
The device has to be installed in closed and dry rooms only. Do not plug it into an
electrical circuit that is also being used for any life sustaining or support systems.
The device may not be used in the patients environment.
This device should not be operated in explosion-endangered environments. This
opto-electronic device should only be installed in conjunction with modern electrical
circuitry.
Combination with other medical products
If the device is used near another electrical device, monitor the other device to
ensure that it is working properly. In case of doubt please contact Reinecker Vision
GmbH or any licensed distribution partner.
