Zeiss VISULAS green, Руководство пользователя

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Documentation set 2 Safety notes
VISULAS green 2.3 Responsibilities and duties of the responsible organization
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• Check the ventilation slits of the system. They should not be
covered or obstructed.
• Functional check of all switches, buttons, connectors and
control lamps on the system
Service life
The development, production and maintenance of this system, and
also the associated risks, are based on an expected service life of
12,000 power-on hours, assuming that the system is operated and
maintained as prescribed by the manufacturer.
Maintenance and inspection
u
To ensure safe operation of the system and to reach the
expected service life: Observe the maintenance and inspection
intervals that are specified in these instructions for use.
Changes to the product
Modifications to the product or failure to follow the manufacturer’s
instructions may substantially reduce the expected service life and
significantly increase the risks associated with the use of this system
and are thus not permitted.
Accessories and additional equipment
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If you want to connect accessories or additional equipment to
the system: Contact ZEISS [
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7].
Additional equipment connected to medical electrical systems must
comply with the corresponding IEC or ISO standards (e.g.
IEC 60950 for data processing equipment).
Furthermore all configurations must comply with the normative
requirements for medical electrical systems (see IEC 60601-1-1).
If you connect additional devices to medical electrical systems, you
are responsible for ensuring that the system complies with the legal
and normative requirements for systems.
2.3.1 Notification to manufacturers and authorities
If an incident occurs in connection with this medical device wich
affects the responsible organization or another person, the respon-
sible organization (or person responsible) must report this incident
to the manufacturer or seller of the medical product. In some
countries (e.g. the European Union) the responsible organization
must report this incident to the responsible authorities in the appli-
cable country.