LIT-168 Sunoptic Surgical
®
Rev. F (English)
Page 4 of 96
2. WARNINGS/CAUTIONS
Caution Federal law restricts this device to sale by or on the order of a licensed practitioner.
Caution To prevent fire or electric shock, do not open or expose the LED light source unit to rain
or moisture. Refer all servicing to qualified personnel only.
Caution Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen
or nitrous oxide.
Caution This equipment is suitable for use in hospital and clinical settings. Avoid placement near
other high RF equipment; user should determine proper placement and confirm normal operation of
equipment when stacked or used near or with other RF equipment.
Caution This product should be used only with type BF endoscopic instruments which have been
certified according to IEC 60601-1 for medical equipment and IEC 60601-2-18 for endoscopic
equipment.
This symbol indicates type BF equipment.
Caution User must not alter this device in any fashion. Doing so voids all warranties and
statements of suitability for any purpose.
Caution All devices connecting to the LED Light Source must be classified as medical equipment.
Additional information processing equipment connected to the LED Light Source, a Medical System
and the operator must determine that all equipment complies with the appropriate end-product
standards (such as IEC 60950 or IEC 60065 and the Standard for Medical System, IEC 60601-1-1).
Caution Always set the intensity control to the minimum level and insert the fiberoptic cable into
the unit before turning on the power. When light is not required at the surgical site, the intensity control
should be should be set to the fully dimmed position. If it becomes necessary to remove the fiber optic
cable without turning the unit off, turn the intensity control to the fully dimmed position.
Caution EQUIPMENT CONNECTION - The fiber optic cable must be a NON-CONDUCTIVE
CABLE. It should not have conductive shielding or any other conductive connection between the
patient and equipment. Such connection will impair safety of the equipment. It must be rinsed free of
soaking/disinfectant solution and dried before plugging into the LED light source receptacle. Ensure
the optical surface is clean before engaging into the light source.
Caution This equipment is intended to illuminate a surgical site; user is responsible for determining
if interruption of light output, including due to effects from electromagnetic disturbances, will create an
unacceptable risk. If such a determination is made, alternate arrangements (such as a standby
illuminator) should be made by the user to reduce the risk.
Caution The illuminator uses a highly concentrated light source (luminous power per area) and
this high energy density is retained through connected lightguides and instruments. The output of a
connected instrument left in close proximity or contact with tissue or flammable materials may present
a risk of injury or fire depending upon application. Qualified personnel must determine a safe working
distance and intensity setting for each application. The output should never be left on unattended.
Caution Use only approved manufacturer accessories and power cables. For more information,
contact your distributor.
Caution For grounding reliability, use only hospital grade marked power cord and receptacle.
