Warnings/ Caution - Cuda surgical Elite 1000 Mode D'emploi

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2. WARNINGS/ CAUTION

WARNING
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 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
licensed healthcare practitioner.
Caution
unit to rain or moisture. Refer all servicing to qualified personnel only.
Caution
or with oxygen or nitrous oxide.
Caution
kind of cellular phone near the lightsource.
Caution
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
warranties and statements of suitability for any purpose.
Caution
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
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 fiberoptic cable without turning the unit off, turn the intensity
control to the fully dimmed position.
Caution
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
®
LIT-217 CUDA
SURGICAL
(English)
The illuminator uses a highly concentrated light source (luminous power
Rx only. Federal law restricts this device to sale by or on the order of a
To prevent fire or electric shock, do not open or expose the lightsource
Not suitable for use in presence of flammable anesthetic mixture with air
To prevent any potential electro-magnetic interference, do not use any
This product should be used only with type BF endoscopic instruments
User must not alter this device in any fashion. Doing so voids all
All devices connecting to the Illuminator must be classified as medical
Always set the intensity control to the minimum level and insert the
The fiberoptic cable must be electrically NON-CONDUCTIVE. It
Rev. A
Date of Revision:
Page 4 of 66

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Tx350a

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