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should be connected to different power
supply circuits.
29. Use of Lasers in surgery may result in Eye
Damage or damage to the endoscope from
reflected laser energy. Refer to the Laser
Device Instructions for proper and safe use.
•
When using a laser always wear
protective glasses designed for the
laser’s wavelength.
•
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.
30. 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.
31. This device should only be used by a trained
medical professional.
32. Biohazard waste, such as explanted devices,
needles and contaminated surgical
equipment, should be safely disposed of in
accordance with the institutions policy.
33. Serious incidents should be reported to
Arthrex, Inc., or an in-country representative,
and to the health authority where the incident
occurred.
1.3.2
PRECAUTIONS
1. Surgeons are advised to review the product-
specific surgical technique prior to
performing any surgery. Arthrex provides
detailed surgical techniques in print, video,
and electronic formats. The Arthrex website
also provides detailed surgical technique
information and demonstrations. Or, contact
your Arthrex representative for an onsite
demonstration.
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. 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.
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
