950-0073-00 B SM, English, Arthrex Synergy UHD4 System
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10. This equipment should not share an
electrical outlet or grounding with life
supporting or life sustaining equipment.
11. If one or more mains powered units are
connected simultaneously to one socket
by the means of a distribution box, the
sum of the individual leakage currents
may exceed the tolerated limits.
12. Before each use, the outer surface of
the portions of the Endoscope and any
Endoscopically Used Accessory, which
are intended to be inserted into the
patient, should be checked to ensure
there are no unintended rough edges,
sharp edges or protrusions which may
cause a safety hazard.
13. Safety hazards to patients may result
from gas embolism caused by, for
example, over-insufflation of air or inert
gas prior to high frequency surgery or
laser assist gas.
14. The leakage current through the patient
could increase using endoscopes with
powered accessories.
15. When Endoscopes are used with
Energized
Endoscopically
Used
Accessories,
the
Patient
Leakage
Currents may be additive. This is
particularly true if a CF Applied Part is
used, in which case a Type CF
Endoscopically Used Accessory should
be used to minimize total Patient
Leakage Current.
16. Explosive gas concentrations inside the
patient can cause hazards while using
High-Frequency Endoscopically Used
Accessories.
17. For the protection of service personnel,
and for safety during transportation, all
devices and accessories that are
returned for repair must be prepared for
shipment as described in “
Returning
the Device”
of this manual. The
manufacturer has the right to refuse to
carry out repairs if the product is
contaminated.
18. This equipment/system is intended for
use by healthcare professionals only.
This equipment/system may cause radio
interference
or
may
disrupt
the
operation of nearby equipment. It may
be
necessary
to
take
mitigation
measures, such as re-orienting or
relocating
the
Synergy
UHD4
Video
System or shielding the location.
19. NOT for use in an Oxygen Rich
Environment.
20. Applied Parts of other ME Equipment
used
within
the
configuration
for
Endoscopic Application shall be type BF
or CF Applied Parts.
21. NO Modifications of this equipment is
allowed.
22. Connecting any equipment that has not
been supplied as part of this ME System
to Multiple Socket Outlets may result in
increased leakage currents. Use an IEC
Approved
Isolation
Transformer
to
isolate any such interconnections from
the ME System.
23. Before each use or after changing
viewing modes/settings the Operator
should check to ensure that the view
observed
through
the
Endoscope
provides a live image (rather than a
stored one) and has the correct image
orientation.
24. Risk of burns!
Light sources emit large amounts of light
energy and thermal energy. As a result:
The scope light guide tip can get
extremely hot as result of high intensity
light, giving rise to high temperatures in
front of the light emission window which
may cause severe burns. Always keep
the light source in the STANDBY mode
when not in use.
Surface temperatures of the insertion
portion of the endoscope as well as light
guide connectors on the Camera
Control Unit (CCU) and the endoscope
rise during use. This can cause the
temperature of the body tissue to rise to
106 °F (41°C).
Potential
Thermal injury to the patient’s
tissue (e.g. from prolonged exposure to
the intense illumination in small cavities,
or if the endoscope’s distal end is
placed in close proximity with the tissue)
