Zeiss opmi lumera 700, Инструкция по эксплуатации

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Instructions for Use 2 Safety notes
OPMI LUMERA 700 2.3 Responsibilities and duties of the operator
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Carry out checks according to the extent specified.
The safety inspections of the device should at least comprise the
following points:
• Availability of the Instructions for Use
• Visual inspection of the device and accessories for damage, as
well as legibility of the labels
• Leakage current test
• Test of protective ground conductor
• Function and wear test of the brakes
• Function test of all switches, buttons, sockets and indicator
lamps of the device
Maintenance and inspection
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To ensure safe operation of the device and reach the expected
service life: Comply with the maintenance and inspection
intervals specified in these Instructions for Use.
Modifications to the product
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WARNING: This device must not be modified without the
manufacturer’s approval. If the device is modified, suitable
inspections and testing must be completed to ensure that it can
still be used safely.
Accessories and additional equipment
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If you want to connect accessories or additional equipment to
the device: Contact your ZEISS contact partner [
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11].
Any additional equipment connected to medical electrical devices
must demonstrably comply with the applicable IEC or ISO standards
(e.g. IEC 60950 for data processing equipment).
In addition, all configurations must meet the normative require-
ments for medical systems (see IEC 60601-1-1 or Clause 16 of the
3rd edition of IEC 60601-1 respectively).
Anyone connecting additional equipment to medical electrical
systems is a system configurer and as such responsible for
compliance of the system with the standards for systems.
Local legislation has priority over the above normative require-
ments.
2.3.1 Messages to manufacturer and authorities
If a serious incident occurs in connection with this medical device
affecting the operator or another person, the operator (or person
responsible) must report this serious incidence to the manufacturer
or seller of the medical product. In the European Union, the
operator must report this serious incident to the responsible
authorities in the applicable country.