Instructions for use KaVoLUX 540 LED U / T
3 Product description | 3.1 Purpose – Proper use
▪ the unit was operated in accordance with the instructions for use, care and
installation.
▪ the IT components supplied by the operator meet the technical require-
ments in the present instruction for use for hardware and software, and are
installed and set up according to the descriptions of these components.
▪ in the case of repairs, the requirements of IEC 62353 "Recurrent tests and
tests before start-up of electrical items of medical electrical equipment and
systems - general regulations" are met in full.
It is a responsibility of the user:
▪ to only use equipment that is operating correctly,
▪ to protect him or herself, the patient and third parties from hazards, and
▪ to prevent contamination from the product
The applicable national legal regulations must be observed during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and startup of medical
devices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
Regular servicing and safety checks are essential for the permanent assurance
of the operating and functional safety of the KaVo product and for the preven-
tion of damage and hazards.
Testing and maintenance intervals: Maintenance must be performed once a
year, the safety checks at intervals of 2 years. Shorter intervals for the safety
checks may be specified by the tester if necessary.
The following persons are authorised to conduct repairs and servicing and the
safety check on the KaVo product:
▪ Technicians of KaVo branch offices after appropriate product training.
▪ Specifically KaVo-trained technicians of KaVo franchised dealers.
In Germany, operators, equipment managers and users are obliged to operate
their equipment in accordance with the MPG regulations.
The services encompass all the test tasks required in accordance with § 6 of the
medical devices operator ordinance (Medizinprodukte-Betreiberverordnung, MP-
BetreibV).
Note
The product must be cleaned and serviced according to instructions if it is not
to be used for an extended period of time.
Note
The treatment light may no longer be operated if the functional safety and
the faultless condition of the device cannot be guaranteed.
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Summary of Contents for LUX 540 LED T
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