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will be exposed to temperatures in excess of
140°F (+ 60°C).
15. Additional equipment connected to medical
electrical equipment must comply with the
respective IEC or ISO standards (e.g. 60950
for data processing equipment).
Furthermore all configurations shall comply
with the requirements for medical electrical
systems (see IEC 60601-1 ). Anybody
connecting additional equipment to medical
electrical equipment configures a medical
system and is therefore responsible that the
system complies with the requirements for
medical electrical systems. Attention is
drawn to the fact that local laws take priority
over the above mentioned requirements. If
in doubt, consult your local representative,
or the technical department.
16. Any person who connects external
equipment to signal input and signal output
ports or other connectors has formed a
system and is therefore responsible for the
system to comply with the requirements of
IEC 60601-1. If in doubt, contact a qualified
Biomedical technician or your local
representative.
17. This equipment has been tested and found
to comply with the Class A limits for medical
devices to IEC 60601-1-2:. These limits are
designed to provide reasonable protection
against harmful interference in a typical
medical installation. This equipment
generates and can radiate radio frequency
energy and, if not installed and used in
accordance with the instructions, may cause
harmful interference to other device(s) in the
vicinity. However, there is no guarantee that
interference will not occur in a particular
installation. If this equipment does cause
harmful interference to other devices, which
can be determined by turning the equipment
off and on, the user is encouraged to try to
correct the interference by one or more of
the following measures:
(a) Reorient or relocate the receiving
device.
(b) Increase the separation between the
equipment.
(c) Connect the equipment into an outlet on
a circuit different from that to which the
other devices are connected.
(d) Consult the manufacturer or field service
technician for help.
This unit was not evaluated for use with
electrosurgical devices which access the
site via the same endoscope as the light
engine and camera. The unit must be re-
evaluated prior to use with electrosurgical
devices when they will operate through the
same endoscope as the light source and
camera.
18. After each use, thoroughly clean unit and
accessories (See
“Cleaning and
Sterilizing”
).
NOTES:
1. Observe all national waste management
regulations.
2. Do not dispose of WEEE as unsorted
municipal waste.
