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viicomply with the system requirements in standard IEC 60601–1. This standard requires theusage of an Isolation Transformer to power the non–medical peripheral device(s) if locatedwithin 1.5 m from the patient. If the peripheral device is located outside the patientenvironment (beyond 1.5 m) and is connected to the instrument, a separation device mustbe used if there shall be electrical connection between the non–medical peripheral deviceand the instrument.WARNING: The person or the responsible organization connecting additional devices orreconfiguring the system must evaluate the complete system to ensure compliance to theapplicable IEC 60601–1 requirements.CAUTION: The instrument operator must not attempt to touch the patient and theperipheral device simultaneously.WARNING: This instrument may cause ignition of flammable gases or vapors. Do NOT usein the presence of flammable anesthetics such as nitrous oxide, or in the presence of pureoxygen.WARNING: The instrument itself is transportable and may be moved from one location toanother. However, if the instrument is placed on a power table provided by CZMI, do notmove the table to another location while the instrument and any other peripherals areplaced on it. Doing so may cause the system components to tip over and cause harm to thepatient, the operator, or others in the vicinity.WARNING: Do not scan patients who have been injected with photo–dynamic therapy(PDT) treatment drugs, such as Visudyne , in the previous 48 hours. Failure to observe thiswarning could result in unintended exposure and uncontrolled treatment of neovascularvessels.CAUTION: Avoid tipping. Do not use the instrument on an uneven or sloped surface.Also, do not roll the table in deep pile carpet or over objects on the floor such as powercords. Failure to observe these precautions could result in tipping of the instrument and/ortable and resulting injury to operator or patient and damage to the instrument.CAUTION: When you complete scan acquisition and before you click Finish or ID Patientin the Acquire Screen, always prompt the patient to sit back and move the head away fromthe chinrest. Clicking either of these buttons in the Acquire screen causes the chinrest toreposition itself beyond the point where the patient’s eye would contact the lens if thehead remained in the chinrest. Failure to observe this warning could result in injury to thepatient.CAUTION: The operator should check that the patient is not holding on to the instrumentbefore or during tests. Although movement of the motorized chinrest is slow, giving plentyof warning for patients to remove their fingers, there is potential for fingers to be squeezedand possibly injured.CAUTION: (United States) Federal law restricts this device to sale by or on the order of alicensed healthcare practitioner.CIRRUS HD-OCT User Manual2660021159751 Rev. A 2015-08

viiiCAUTION: Do not reconfigure system components on the table, nor add non–systemdevices or components to the table, nor replace original system components withsubstitutes not approved by Zeiss. Such actions could result in failure of the table heightadjustment mechanism, instability of the table, tipping and damage to the instrument, andinjury to operator and patient.CAUTION: Do not use the printer, the instrument, or the optional power table with anextension cord or a power strip (multiple portable socket outlet).NOTE: The optional CIRRUS HD-OCT Power Table is safe to use within the patientenvironment when the instrument is powered through it, as instructed herein.Optical Safety IEC 60825–1 EN ISO 15004–2 Classification: Group 1 Instrument – Per EN ISO 15004–2. Group 1 instruments areophthalmic instruments for which no potential light hazard exists.WARNING: This device contains visual stimuli, including flickering light and flashingpatterns, between 5 and 65 Hz. Medical professionals need to determine whether thisdevice should be used for patients who may be photosensitive, including those withepilepsy.CAUTION: 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.2660021159751 Rev. A 2015-08CIRRUS HD-OCT User Manual

ixNetworking 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.CAUTION: Do not use the NAS device or the instrument with an extension cord or apower strip (multiple portable socket outlet). For additional safety, do not plug the NASdevice and the instrument into the same wall outlet. Failure to observe this instructioncould result in electrical shock to the patient and/or examiner.Printer SafetyWARNING: Except when powering the printer through an isolation transformer in the USBconfiguration, peripheral devices such as printers must be placed at least 1.5 meters (4.9feet) away from the patient, such that the patient cannot touch a peripheral device withany part of his or her body while being examined. In addition, the instrument operatormust not attempt to touch the patient and a peripheral device at the same time whileexamining the patient. Failure to observe this warning could result in electrical shock to thepatient and/or examiner. Use of a printer in a wireless configuration enables you to observethis warning more easily.WARNING: When using the printer in the USB configuration, you must power the printerthrough an isolation transformer. Failure to observe this warning could result in electricalshock to the patient and/or examiner. To do so, you must use a special power cable. InNorth America, the required cable has an IEC–320–14 connector on one end and a NEMAS–15R connector on the other end. This cable is included in the accessory kit shipped withthe instrument.WARNING: To directly connect a printer to the CIRRUS HD-OCT using a network patch cord(UTP cable), only use an unshielded RJ–45 connector. Use of a shielded network patchcord will ground the printer through the CIRRUS HD-OCT, which could result in electricalCIRRUS HD-OCT User Manual2660021159751 Rev. A 2015-08

xshock to the patient and/or examiner. It could also invalidate the system safety approval. Inthis configuration, the printer must be placed at least 1.5 m away from the patient.CAUTION: If you use a non–approved device or if you connect it incorrectly—forexample, by plugging the printer into the wall while using a USB connection, or by using ashielded network (UTP) cable—you could invalidate the system safety approval.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.CAUTION: Do not use the printer or the instrument with an extension cord or a powerstrip (multiple portable socket outlet). For additional safety, do not plug the printer and theinstrument into the same wall outlet. Failure to observe this instruction could result inelectrical shock to the patient and/or examiner.Record and Data SafetyPatient Record DeletionCAUTION: Deletion is permanent in Native Archive mode; you cannot recover a patientrecord nor retrieve its archived exams, because deleting a patient record includes deletingthat patient’s index data. The deleted index data includes where the archived exam datacan be found.Patient Records MergeCAUTION: Be certain that you select the correct patient records to merge. Once youmerge patient records, you must use the Move Scan feature to separate the merged file.Data Archive and RetrieveCAUTION: We strongly recommend that you archive daily to a network archive location (anetwork file server or network attached storage device). If you do not archive at all, paperrecords are the only way to retain patient information in case of system hard drivemalfunction.2660021159751 Rev. A 2015-08CIRRUS HD-OCT User Manual

xiRisks of Internet ConnectivityCAUTION: When connected to the Internet, the CIRRUS HD-OCT may be vulnerable toserious security risks, including viruses and worms that could disable your system oradversely affect its performance. Internet connectivity enables third party software,software drivers and updates to be downloaded to your system, either automatically orintentionally. Installation of any unapproved software, including drivers, could degrade theperformance of the instrument and/or lead to corrupted diagnostic or therapeuticinformation and may void the instrument warranty.Windows Automatic UpdateCAUTION: All non–high–priority updates (driver, hardware or optional updates, etc.)should not be installed.Prohibited ActivitiesThe following activities are prohibited using the CIRRUS HD-OCT instrument.CAUTION: Attempting to perform these prohibited activities may void your CIRRUSHD-OCT warranty and may result in damage to your CIRRUS HD-OCT system. Zeiss is notresponsible for software upgrades or repairs necessitated by the attempted performance ofthe following prohibited activities. Do not relocate the CIRRUS HD-OCT database to a network file server. Do not share CIRRUS HD-OCT folders with other computer systems via the network. Do not share the CIRRUS HD-OCT system printer on the network if the printer isconnected to the USB port.Networking GuidelinesCIRRUS HD-OCT provides IT–Network capabilities in order to allow for data archiving aswell as information sharing within the clinical environment and across medical facilities.NOTE: Users are responsible for network setup and maintenance, including installation andconfiguration of all necessary hardware and software. Zeiss Technical Support is limited totesting network connectivity of the CIRRUS HD-OCT. Technical Support cannot troubleshootor repair problems with network connectivity. Please observe the following guidelinesregarding networking of the CIRRUS HD-OCT instrument.Refer to the CIRRUS OCT Installation Guide for all additional information on networkconnectivity.CIRRUS HD-OCT User Manual2660021159751 Rev. A 2015-08

xiiElectromagnetic Compatibility (EMC)WARNING: The use of accessories, transducers and cables other than those specified mayresult in increased emissions or decreased immunity of the equipment.WARNING: The CIRRUS HD-OCT should not be used adjacent to or stacked with otherequipment. If adjacent or stacked use is necessary, the equipment or system should beobserved to verify normal operation in the configuration in which it will be used.CAUTION: The CIRRUS HD-OCT has special EMC precaution requirements and needs tobe installed and put into service according to the EMC information provided herein.CAUTION: Portable and mobile RF communications equipment can affect medicalelectrical equipment.Guidance and manufacturer’s declaration – electromagnetic emissionsThe CIRRUS HD-OCT is intended for use in the electromagnetic environment specified below. The customer or user of the CIRRUS HD-OCTshould assure that it is used in such an environment.Emissions TestComplianceRF emissionsCISPR 11Group 1RF emissionsCISPR 11Class AHarmonic emissionsIEC 61000–3–2Class AVoltage fluctuations/flicker emissionsIEC 61000–3–3Complies2660021159751 Rev. A 2015-08Electromagnetic environment – guidanceThe CIRRUS HD-OCT uses RF energy only forits internal function. Therefore, its RFemissions are very low and are not likely tocause any interference in nearby electronicequipment.The CIRRUS HD-OCT CIRRUS are suitable foruse in all establishments other than domesticestablishments and those connected to a lowvoltage power supply network which suppliesbuildings used for domestic purposes.CIRRUS HD-OCT User Manual

xiiiGuidance and manufacturer’s declaration – electromagnetic immunityThe CIRRUS HD-OCT is intended for use in the electromagnetic environment specified below. The customer or user of the CIRRUS HD-OCTshould assure that it is used in such an environment.Immunity TestIEC 60601 test levelCompliance levelElectromagnetic environment – guidanceElectrostatic Discharge(ESD) IEC 61000–4–2 6 kV contact 8 kV air 6 kV contact 8 kV airFloors should be wood, concrete, or ceramic tile. Iffloors are covered with synthetic material, therelative humidity should be at least 30%.Electrical fasttransient/burst IEC 61000–4–4 2 kV for power supplylines 1 kV for input/outputlines 2 kV for power supplylines 1 kV for input/outputlinesMains power quality should be that of a typicalcommercial or hospital environment.Surge IEC 61000–4–5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common modeMains power quality should be that of a typicalcommercial or hospital environment.Voltage dips, shortinterruptions, and voltagevariations on power supplyinput lines. IEC 61000–4–11 5% UT ( 95% dip in UT)for 0,5 cycle40% UT (60% dip in UT) for5 cycles70% UT (30% dip in UT) for25 cycles 5% UT (95% dip in UT)for 5 sec 5% UT ( 95% dip in UT)for 0,5 cycle40% UT (60% dip in UT) for5 cycles70% UT (30% dip in UT) for25 cycles 5% UT (95% dip in UT)for 5 secMains power quality should be that of a typicalcommercial or hospital environment. If the user ofthe CIRRUS HD-OCT requires continued operationduring power mains interruptions, it isrecommended that the CIRRUS HD-OCT be poweredfrom an uninterruptible source.3 A/mPower frequency magnetic fields should be at levelscharacteristic of a typical location in a typicalcommercial or hospital environment.Power frequency (50/60 Hz) 3 A/mmagnetic fieldIEC 61000–4–8UT is the a.c. mains voltage prior to application of the test level.CIRRUS HD-OCT User Manual2660021159751 Rev. A 2015-08

xivGuidance and manufacturer’s declaration – electromagnetic immunityThe CIRRUS HD-OCT is intended for use in the electromagnetic environment specified below. The customer or user of the CIRRUS HD-OCTshould assure that it is used in such an environment.Immunity TestIEC 60601 test levelCompliance levelElectromagnetic environment – guidancePortable and mobile RF communications equipmentshould be used no closer to any part of the CIRRUSHD-OCT, including cables, than the recommendedseparation distance calculated from the equationapplicable to the frequency of the transmitter.Recommended separation distanced 1.17 P 80 MHz to 800 MHzConducted RF IEC 61000–4–63 Vrms150 kHz to 80 MHz3VRadiated RFIEC 61000–4–33 V/m80 MHz to 2,5 GHz3 V/md 2.33 P 800 MHz to 2,5 GHzwhere P is the maximum output power rating of thetransmitter in watts (W) according to the transmittermanufacturer and d is the recommended separationdistance in meters (m).Field strengths from fixed RF transmitters, asdetermined by an electromagnetic site survey,ashould be less than the compliance level in eachfrequency range.b Interference may occur in thevicinity of equipment marked with the followingsymbol:Note 1: At 80 MHz and 800 MHz, the higher frequency applies.Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,objects and people.a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,AM and FM broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RFtransmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CIRRUS HD-OCT isused exceeds the applicable RF compliance level above, the CIRRUS HD-OCT should be observed to verify normal operation. If abnormalperformance is observed, additional measures may be necessary, such as reorienting or relocating the CIRRUS HD-OCT.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.2660021159751 Rev. A 2015-08CIRRUS HD-OCT User Manual

xvContentsSafety and Certifications1 IntroductionIntended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Operator Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1Data Analyst Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . .Subject Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Installation and Setup. . . . . . . . . . . . . . . . . . . . . . . . . . .User Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-31-11-11-2Intended Demographic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Expected Occupational Skills. . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Suggested Job Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 1-21-31-31-4Accessing PDF Versions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Instruction Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-52 System OverviewHardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1Power Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Power Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Power Down Through Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Power Down Through Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Licensed Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Basic Screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Toolbar Options. . . . . . . . . . . . . . . . . . . . . . .

CIRRUS HD-OCT User Manual 2660021159751 Rev. A 2015-08 iii Safety and Certifications Before using the CIRRUS HD-OCT, you must fully understand potential safety hazards. Read the following safety warnings and cautions in their entirety before using the HD-OCT instrument. Additional warnings an