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•Cover the patient’s eyes, or use
protective glasses designed for the
laser’s wavelength.
•To prevent damage to the
Endoscope, the Laser should be
activated only after the tip of the laser
can be seen through the endoscope.
28. To ensure FCC RF Exposure limits for base
station transmissions devices are met, a
distance of 20 cm or more shall be
maintained between the Camera Control Unit
(which contains the antennas), and persons
during operation. To ensure compliance, an
operator closer than 20 cm to Camera
Control Unit is not recommended.
1.3.2 PRECAUTIONS
1. United States Federal law restricts sale of
this device to or on the order of a physician.
2. Only use the device with Arthrex compatible
equipment listed in Section 2.2.
3. Inserting an incompatible Camera Head into
the camera receptacle (see Figure 1) can
result in damage to the CCU.
4. The warranty becomes void and the
manufacturer is not liable for direct or
resulting damage if:
•The device or the accessories are
improperly used, prepared or
maintained;
•The instructions in the manual are not
adhered to;
•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.
5. This device should only be used in
compliance with its intended use.
6. Prior to each use, the CCU and all
associated equipment must be inspected for
proper operation. Visually inspect lenses to
ensure there are no scratches, chips or
cracks.
7. 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.
8. 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.
9. 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.
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