Zeiss OPMI Lumera i, Instructions For Use Manual

Page: 11 / 184

Version 8.0
G-30-1720-en
Page 11
OPMI Lumera i Safety measures
Controlling the surgical
microscope via CALLISTO eye
Any change in the focus and zoom setting via CALLISTO eye may lead to
unwanted movement at the surgical microscope during application (e.g.,
in the OP mode). Only personnel who have been specifically trained are
allowed to control the surgical microscope via CALLISTO eye (option).
Transport & Service • The system may be transported over long distances (e.g., during relocation,
return for repair, etc.) only in its original packaging or in special return
packaging. Please contact your dealer or ZEISS Service for this purpose.
• If there is a failure and you cannot resolve the issue using information in
the chapter “What to do in the event of malfunctions”, attach an “Out of
order” sign to the system and contact ZEISS Service.
Safety inspection • To prevent any impairment of the system’s safety as a result of aging, wear,
etc., the organization operating the system must ensure, in accordance with
the applicable national regulations, that the regular technical safety checks
defined for this system are performed on schedule and to the stipulated
extent. The technical safety checks must only be performed by the
manufacturer ZEISS or persons authorized by ZEISS. The safety inspections
for the system 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
– Function test of the manual mode without the patient, at least semi-
annually.
Medical electrical
systems
Any additional equipment you connect to medical electrical devices must
demonstrably comply with the applicable standards and directives (e.g.,
IEC 60950-1 for data processing equipment).
In addition, all configurations must meet the standard requirements for
medical electrical systems (see IEC 60601-1).
Anyone connecting additional equipment to medical electrical devices is a
system configurer and as such is responsible for compliance of the system
with the normative requirements for medical electrical systems.