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Informations for the Re-use of VISIO 22+
Product description:
Stationary opto-electronic CCTV magnifying device for magnifying texts and
images. The reading materials are being viewed and magnified by the camera
and directly shown on the integrated monitor.
Specific purpose:
CCTV magnifiers are medical devices used to assist reading blackprint
material. Visually impaired people use these devices to compensate their
partial loss of vision or eye-illnesses.
Product life time:
Seven years from manufacturing date, provided that the recommended
service and maintenance intervals have been complied with.
Re-use / Installation and Maintenance:
The device may only be repaired, technically refurbished and reconditioned
by BAUM service personnel or by service technicians authorized by BAUM
Retec AG.
Further use or re-use is only allowed after a thorough technical cleaning and
disinfection in combination with a safety check.
Safety checks (§6 MP-BetreibV):
The carry out of safety checks must explicitly only be done by BAUM Retec AG
or by an organization authorized by BAUM Retec AG!
BAUM Retec AG does not stipulate certain intervals or deadlines for safety
checks. The statements made in §6 Medizinprodukte-Betreiberverordnung
regarding intervals and deadlines are however recommended (at least every
two years).
An assessment of the safety condition of a device is made during a safety
check according to German standard VDE 0751.
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