Sunoptic Surgical Titan X300 Manual Del Operador página 4

2. WARNINGS/ CAUTION
WARNING The illuminator uses a highly concentrated light source (luminous power per
area) and this high energy density is retained through connected light guides and instruments.
The output of a connected instrument left in close proximity or contact with tissue or flammable
materials presents a risk of injury or fire. Qualified personnel must determine a safe working
distance and intensity setting for each application. The output should never be left on
unattended.
Caution Rx only. Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner.
Caution To prevent fire or electric shock, do not open or expose the lightsource 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.
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 Illuminator must be classified as medical equipment.
Additional information processing equipment connected to the Illuminator, 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.
necessary to remove the fiberoptic cable without turning the unit off, turn the intensity control to
the fully dimmed position.
Caution The fiberoptic cable must be electrically NON-CONDUCTIVE. 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 lightsource receptacle. Ensure
the optical surface is clean before connecting the cable to the lightsource.
LIT-217 Sunoptic Surgical
Rev. D
This symbol indicates type BF equipment.
®
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