Warnings/ Cautions - Sunoptic Surgical Titan x450 Manual De Usuario

2. WARNINGS/ CAUTIONS

The illuminator produces a highly concentrated (luminous energy per unit
WARNING
area) light beamand 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
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 To prevent any potential electro-magnetic interference, do not use any kind
of cellular phone near the illuminator.
Caution
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
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 minimumlevel 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.
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 illuminatormust 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.
LIT-219 SUNOPTIC SURGICAL
(English)
Rx only. Federal law restricts this device to sale by or on the order of a
This product should be used only with type BF endoscopic instruments
This symbol indicates type BF equipment.
All devices connecting to the Illuminator must be classified as medical
®
If it becomes
Rev. -
Date of Revision: 06/21/16
Page 4 of 104