Warnings - Cuda surgical ELITE 300 Manual De Uso

2. WARNINGS

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.
Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen or nitrate oxide.
To prevent any potential electro-magnetic interference, do not use any kind of cellular phone near the light
source.
This product should be used only with type BF endoscopic instruments which have been certified
according to IEC 601-1 for medical equipment and IEC 601-2-18 for endoscopic equipment.
Caution
This product is not provided as sterile.
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
Light source can cause permanent eye damage if viewed directly with unprotected eye.
To reduce the chance of eye damage, set the intensity control always to the minimum level and insert the
fiber optic cable into the unit before turning on the power.
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.
LIT037 CUDA ® SURGICAL ELITE 300
(English)
This symbol indicates type BF equipment.
Rev. L
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