LIT-239 SUNOPTIC SURGICAL®
Rev. A (English)
Page 6 of 21
mains circuit. Follow the instructions provided herein and always remove power
from the device prior to inspection or replacement of fuses.
10. Use only manufacturer’s specified compatible accessories and peripheral
equipment. Use of non-approved equipment may cause loss of function.
11. 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.
12. Avoid dropping the camera system or rough handling. The camera system contains
sensitive components prone to damage by mechanical shock.
13. 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 for conformance to IEC 60601-1 safety standards.
When used with other equipment, the leakage currents may be additive. The
person creating the ME system is responsible to comply with the applicable safety
regulations and safety standards for their location. Connect only IEC 60601-1
approved equipment to this device. Never touch peripheral equipment connections
on this device and the patient at the same time. This can create a risk of shock to
the patient.
14. Do not use the equipment in the prescence of flammable liquids, gases, or other
materials susceptible to ignition due to electrical sparking.
15. This equipment generates and radiates RF energy which may affect the normal
function of nearby installed equipment. Equipment that generates and radiates RF
energy may affect the normal function of the HD Camera System. When choosing
a location for the HD Camera System, consult the “Electromagnetic Compatibility”
section of this manual to ensure proper function with other installed equipment.
Cautions
To prevent improper use and/or damage to this device, please note the following cautions:
1. Carefully upack this unit and check if any damage occurred during shipment. If
damage is detected, refer to the Warranty and Return Policy section of this manual.
2. This equipment generates heat and uses cooling fans during normal use. To
reduce the risk of overheating and possible loss of function and/or damage to the
equipment, install the equipment in a well-ventilated space within the operating
conditions listed herein.
3. There is a risk of damage to the equipment if the equipment is subjected to
cleaning or sterilization methods not approved be the manufacturer. To reduce risk
of loss of funtion and/or damage to the equipment, only use the approved cleaning
and sterilization methods described herein.
4. High frequency surgical devices may cause interference with the video image
displayed on the surgical monitor. To reduce this risk, high frequency devices and
imaging equipment should be located on separate supply circuits.
5. There are no user serviceable parts inside the console or camera heads. There are
hazardous voltages present inside the console. Do not remove the cover. Return
the device to the manufacturer for service.
NOTE: The warranty is void if any of these warnings or cautions are disregarded.
