Sunoptic Surgical Titan X300, Operator'S Manual

Page: 5 / 97

LIT-217 Sunoptic Surgical
®
Rev. F (English)
Page 5 of 97
cables are used, the device may have increased electromagnetic emissions and/or
decreased electromagnetic immunity which may result in improper operation.
•
This device meets CISPR 11 Class A limits and is suitable for use in a hospital and
industrial environments. If it is used in a residential environment (for which CISPR 11 class
B is normally required) this equipment might not offer adequate protection to radio-
frequency communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
•
Performance of this device may be affected in proximity of another device and/or
equipment capable of producing high levels of RF emissions. The device should be used
no closer than 12 inches (30 cm) to any part of RF equipment including cables. 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.
2.2 Cautions
•
Before each procedure, carefully check the illuminator for damage. DO NOT use a
damaged illuminator.
•
The user should verify the light guide end tip and the active illumination port are of the
same type before insertion. DO NOT attempt to force an end tip into an incorrect port.
•
All servicing and repair must be performed by the manufacturer or qualified service
technicians.
•
Ensure that the air vents located on the illuminator are not obstructed to allow the device
to receive the necessary cooling to prevent an overheating.
•
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or
patient is established.