Equipment Connection - Cuda surgical LLS-2000 Manual De Uso

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.
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.

EQUIPMENT CONNECTION

Caution
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.
User is responsible for determining if interruption of light output will create an
Caution
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.
®
LIT168 CUDA SURGICAL
(English)
This symbol indicates type BF equipment.
-
The fiber optic cable must be
Date of Revision:06/29/17
a NON-
Rev. D
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