Warnings And Cautions; Warnings - Sunoptic Surgical LED-4500 Manual Del Usuario

2. WARNINGS AND CAUTIONS

Use of this equipment may present hazards to the user and/or patient. Before operating this
device, please read this operating manual thoroughly and follow all warnings, cautions, and
instructions for use. The words warning, caution, and note carry special meaning and should
be carefully reviewed:
WARNING: Indicates risks to the safety of the patient or user. Failure to follow warnings may
result in injury to the patient or user.
CAUTION: Indicates risks of improper use and/or damage to the equipment. Failure to follow
cautions may result in loss of function or product damage.
NOTE: Indicates special information to clarify instructions or present additional useful
information.
The appropriate "WARNING", "CAUTION" or "NOTE" symbol in this manual is intended to alert
the user to the presence of important operating and maintenance instructions in the manual.

2.1. Warnings

• The illuminator produces highly concentrated light. Avoid shining light beam into
eyes or looking directly into the light beams at the ends of connected instruments
and/or light guides.
• Qualified personnel must determine a safe working distance between the ends of
connected instruments and/or light guides and the patient for each application.
There is a risk of patient injury if a light guide or instrument connected to the light
source comes to close to the patient.
User is responsible for determining if interruption of light output will create an
•
unacceptable risk. Having a backup illuminator is advised.
User is responsible for providing backup lighting systems for your application
•
when using this device.
Not suitable for use in presence of flammable anesthetic mixture with air or with
•
oxygen or nitrous oxide.
For endoscopic procedures: the illuminator should only be used with type BF
•
endoscopic instruments which have been certified to IEC 60601-1 and IEC 60101-
2-18.
This symbol indicates type BF equipment.
All devices and/or instruments connecting to the illuminator must be classified as
•
medical equipment. It is the user's responsibility to ensure that all equipment used
with this device meets all applicable standards such as IEC 60601-1.
To prevent fire and/or electric shock, do not open or expose the illuminator to
•
liquids.
The illuminator-side light guide connection may become hot during use. Allow
•
adequate time to for end tip to cool before removal from illuminator.
Instruments and/or light guides connected to the illuminator must NON-
•
CONDUCTIVE. There should be no conductive shielding or any conductive
LIT-258 Sunoptic Surgical
Rev. A
®
Page 4 of 130
(English)