LIT168 SUNOPTIC SURGICAL
®
Rev. D
(English) Date of Revision:05/26/17
Page 4 of 60
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 To prevent any potential electro-magnetic interference, do not use any kind of cellular
phone near the light source.
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 User is responsible for determining if interruption of light output will create an unacceptable
risk. If this determination is made arrangements should be taken 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 For grounding reliability, use only hospital grade marked power cord and receptacle.
