LIT-218
NICO
Corporation
Rev. C
(English)
Page 4 of 22
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.
This symbol indicates type BF 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 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. Ensure the optical surface is clean before
connecting the cable to the illuminator.
Caution
When using high intensity illuminators at full output, the recommended from working
distance 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.
