Cuda surgical LLS-LLX, Operation Manual, Page: 4 / 80

LIT-246 CUDA
®
Surgical
Rev. E (English)
Page 4 of 80
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 headlight produces highly concentrated light. Avoid looking directly into the light
source.
•
Qualified personnel must determine a safe distance between the headlight module and
patient for each application.
•
User is responsible for determining if interruption of light output will create an
unacceptable risk. Having a backup headlight or other 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.
•
To prevent fire and/or electric shock, do not open or expose the headlight system to
liquids.
•
The headlight system should only be used with manufacturer-approved battery packs.
•
This device meets CISPR 11 Class A limits and is suitable for use in a hospital
environment. Performance of this device may be affected in proximity of another device
and/or equipment capable of producing high levels of RF emissions. In the event
performance of this device is affected due to high levels of RF emissions, relocation of
the suspected device and/or equipment producing high levels of RF emissions or the
headlight system may reduce or eliminate the problem.
•
Any serious incident that has occurred in relation to this device should be reported to the
manufacturer and the competent authority of the Member State and/or Country in which the user
and/or patient is established.
2.2. Cautions
•
Before each procedure, carefully check the battery state-of-charge and charge battery
as necessary to ensure the headlight has enough duration for the procedure.
•
All servicing and repair must be performed by the manufacturer or qualified service
technicians.
•
Ensure that the air vents located on the headlight module are not obstructed to allow
the headlight to receive the necessary cooling to prevent an overheating.