Sunoptic Surgical Titan 300 Manual Del Operador página 4

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.
Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen
Caution
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 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.
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.
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 Use of this illuminator with accessories or attachments requires that the end-user follow
all accessory or attachment instructions which could affect illuminator setup, usage and/ or settings.
Caution For grounding reliability, use only hospital grade marked power cord and receptacle.
LIT125
SUNOPTIC SURGICAL
(English)
This symbol indicates type BF equipment.
®
It should not have
Rev. H
Date of Revision: 03/28/17
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