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Medical device
This camera 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 camera reading system is a medical device to assist with the
reading and magnifying of printed text and images. Visually impaired people can
compensate for their loss of visual acuity by using this device.
Life span of product
Seven years from the date of invoice (ex Reinecker). According to EEC the
supplier of medical devices is obliged to define the life span of a product.
Note: The mentioned life span does not reflect the complete life span of the
topolino smart. It is rather an indication on when the product might be obsolete
and substitution might be recommended due to new product developments.
Safety advice
topolino smart has to be installed in closed and dry rooms only. Do not plug
topolino smart 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. It is a device of protection class II. The openings in the casing ensure
optimum cooling and must not be covered.
Combination with other products
Warning: This camera reading system must not be located directly beside, next
or on top of another medical device. 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.
Precautions by alteration of the performance of the system
Stop using the reading device if technical features or performances should change.
Switch the device off and disconnect the power supply from the mains wall socket.
Refer directly to your dealer or to Reinecker Vision GmbH Service Center.
Reinstatement and installation
This device may be technically maintained and reconditioned by Reinecker Vision
GmbH only or by an authorized technician. Reinstatement may only take place after
the system has been cleaned and safety checked.
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