LIT-255
CUDA
®
SURGICAL
Rev. D
Page 5 of 128
(English)
2.
GENERAL WARNINGS
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.
Warnings
To avoid potential serious injury to the user, patient, and/or damage to this device, please note the
following warnings:
•
Failure to follow instructions in this manual may lead to serious injury or damage to the
equipment. Read this operating manual thoroughly, especially the warnings, and be familiar
with its contents before using this equipment.
•
This equipment is designed to be used by a qualified physician, having complete knowledge
of the use of this equipment and the procedure to be performed.
•
This equipment should be installed and tested prior to use. A pre-operative check should be
performed prior to administration of patient anesthesia to ensure all desired functions are
operational, that a viable surgical image is being displayed on the monitor, and there are no
signs of damage to the equipment.
•
It is recommended to have a back-up system ready for use in the event of primary equipment
failure.
•
This equipment must not share the same electrical outlet with life support or life sustaining
equipment. In the case of equipment failure, this equipment may draw excessive power from
the supply circuit and interrupt service to other equipment powered by the same circuit.
•
An uninteruptable power supply is recommended.
•
Always set up the console in a location that allows adequate ventilation (airflow) to the
console. Insufficient ventilation may cause the console to overheat and shut down and create
risk of fire. Always set up the equipment so that the power inlet is readily accessible.
•
Use only manufacturer’s specified compatible accessories and peripheral equipment. Use of
non-approved equipment may cause loss of function.
•
Before each use, check the outer surface of this equipment to be used to ensure that there
are no rough surfaces, sharp edges, or protrusions that can cause injury.
•
Avoid dropping the camera system or rough handling. The camera system contains sensitive
components prone to damage by mechanical shock.
•
This device complies with the IEC 60601-1 safety standard. When peripherals are connected
to this device, a Medical Electrical (ME) System is formed and the system should be evaluated
