950-0027-01B 7 of 55
Non-authorized persons perform
repairs, adjustments or alterations to the
device
Non-authorized persons open the
device.
NOTE: Receipt of technical documentation
from the manufacturer does not authorize
individuals to perform repairs, adjustments,
or alterations to the device or accessories.
Only authorized service personnel may
perform repairs, adjustments or alterations
on the device and accessories. Any violation
will void the manufacturer’s warranty.
Authorized service technicians are trained
and certified only by the manufacturer. The
Manufacturer will make available on request
circuit diagrams, component part lists,
descriptions, calibration instructions and
other information required for service to any
Arthrex Authorized Service Center.
4. This device should only be used in
compliance with its intended use.
5. Prior to each use, the CCU and all
associated equipment must be inspected for
proper operation. Visually inspect lenses to
assure there are no scratches, chips or
cracks.
6. To carry out safe operation, it is absolutely
necessary to carry out proper care and
maintenance of the device and accessories.
See “Maintenance” section of this manual.
7. Ensure that the available mains voltage
matches the mains voltage data on the rear
of the device which is located near the
appliance inlet module.
8. This device may only be connected to
endoscopes which, in their intended use and
technical specifications, are appropriate for
use with the device for the intended medical
procedure. The endoscopes must comply
with the latest version of DIN EN 60601-2-18
and ISO 8600.
9. This equipment has been tested and found
to comply with Class A limits of IEC 60601-
1-2:. These limits are designed to provide
reasonable protection against harmful
interference in a typical medical installation.
However, if interference does occur with
other equipment, it may be corrected by one
or more of the following measures;
Reorient or relocate this
equipment, the other
equipment, or both;
Increase the distance between
the different pieces of
equipment;
Consult a biomedical engineer.
10. Do not expose the Camera Control Unit
[CCU] to moisture, or operate it in a wet
area, or store liquids above the CCU.
11. Do not excessively bend or kink instrument
power cord or camera head cable.
12. Handle all equipment carefully. If the CCU or
camera head is dropped or damaged in any
way, return it immediately for service.
13. If the camera head or camera head cable
are damaged in any way, or cable or
connector jacket are cut, do not autoclave
camera head, or immerse camera head in
liquid (water, chemical disinfectants or
sterilants, etc.). Notify your Arthrex Sales
Representative. If it is necessary to return
the camera head to Arthrex for service,
disinfect the camera head before shipping
and reference “Returning the Device”.
14. Store camera head and all accessories in a
protective container to prevent damage
during storage. Do not store CCU where it
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.
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