Warnings - Cuda surgical LED-4000 Manual De Uso

2. WARNINGS/ CAUTION
Caution Federal law restricts this device to sale by or on the order of a licensed practioner.
Caution To prevent fire or electric shock, do not open or expose the 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 60101-2-18 for endoscopic
equipment.
This symbol indicates type BF equipment.
Caution
This product is not provided as sterile.
WARNING
Do not modify this equipment without authorization of the manufacturer.
Caution All devices connecting to the LED light source must be classified as medical equipment.
When additional information processing equipment is connected to the LED Light Source, 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).
The LED 4000 is a highly concentrated light source (luminous power per area) and this
WARNING
high energy density is retained through connected lightguides and instruments.
connected instrument left in close proximity to tissue or flammable materials presents a risk of patient
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. Turn the light source off or place it in
standby if it will not be required for a period of time.
Caution The LED light source can cause permanent eye damage if viewed directly with
unprotected eye. To reduce the chance of eye damage, place the light source in standby mode when
light is not required.
Caution 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.
®
LIT-216 CUDA
SURGICAL
(English)
The output of a
Rev. B
Date of Revision:07/12/18
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