Warnings/ Cautions - Sunoptic Surgical Titan x350 Gebrauchsanleitung

2. WARNINGS/ CAUTIONS

WARNING The illuminator produces a highly concentrated (luminous energy per unit area) light beam
and this high energy density is retained through any 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 illuminator should never be left on unattended.
Caution Rx only. Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner.
Caution To prevent fire or electric shock, do not open or expose the illuminator 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 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 controlto 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 fiberoptic cable without
turning the unit off, turn the intensity control to the fully dimmed position.
Caution The fiberoptic cable used with this illuminator must be electrically NON-
CONDUCTIVE. 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 illuminator receptacle. Ensure the optical
surface is clean before connecting the cable to the illuminator.
Caution When using high intensity illuminators 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 reduced.
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-218 Sunoptic Surgical
Rev. C
This symbol indicates type BF equipment.
®
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