Cuda surgical ELITE 180 Manual De Uso página 4

2. WARNINGS/ CAUTION
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 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.
To prevent any potential electro-magnetic interference, do not use any kind of cellular
Caution
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 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. 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 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 light source receptacle. Ensure the optical surface is clean before
engaging into the light source.
Caution When using high intensity lightsources at full output, the recommended distance from
the headlight module to the patient is not less than 12 inches (30.5 cm). If using less than 12 inches
from the patient, the light intensity must be turned down.
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.
LIT034 ®
CUDA SURGICAL ELITE 180
(English)
This symbol indicates type BF equipment.
Rev. P
Date of Revision: 02/09/17
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