CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12Safety 1- 7CAUTION: Applicable Phototoxicity Statements (FDA CDRH Ophthalmoscope Guidance#71): Because prolonged intense light exposure can damage the retina, the use of thedevice for ocular examination should not be unnecessarily prolonged. While no acuteoptical radiation hazards have been identified for direct or indirect ophthalmoscopes, it isrecommended that the exposure time for the patient’s eye be limited to the minimum timethat is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be atgreater risk. The risk may also be increased if the person being examined has had anyexposure with the same instrument or any other ophthalmic instrument using a visible lightsource during the previous 24 hours. This will apply particularly if the eye has beenexposed to retinal photography. This medical device has no user adjustable intensitysettings for light incident on the retina, nor does it produce UV radiation or short–wavelength blue light.CAUTION: The appliance coupler is the main disconnect device of the instrument.Position the instrument in such a way to have easy access to disconnect the appliancecoupler in case of an emergency.CAUTION: In case of an emergency, disconnect the appliance coupler from the back ofthe instrument.When the power cord is connected to the instrument, the green light on the power switchwill start flashing. When the power switch is pressed, the light will change to solid greenand the entire instrument will be powered.Networking SafetyWARNING: When networking the CIRRUS HD-OCT, use only network cables with anunshielded RJ–45 connector. Use of a shielded network cable in the CIRRUS HD-OCT couldresult in electrical shock to the patient and/or examiner.Network Attached Storage Device SafetyWARNING: To directly connect the NAS device to the CIRRUS HD-OCT, use a network patchcord only with an unshielded RJ–45 connector. Use of a shielded network patch cord willground the NAS device through the CIRRUS HD-OCT, which could result in electrical shockto the patient and/or examiner.CAUTION: We strongly recommend you use peripheral devices supplied or approved byZeiss, when available, because they will have been tested to work with the instrument. Ifyou do use a peripheral device that conforms with the requirements in this section but isnot supplied by Zeiss, do not install any unapproved third party software on the instrument.Installation of any unapproved software, including drivers, could degrade the performanceof the instrument and/or lead to corrupted diagnostic or therapeutic information and mayvoid the instrument warranty.
