Instructions for Use - ZEISS...Installing Review Software 34 3.2.2 Upgrading Instrument and Review Software 37 4 Daily Startup 39 4.1 Turn on the Instrument 39 4.2 Logging In 40 5

CLARUS 500

Instructions for Use

Copyright

© 2017, Carl Zeiss Meditec, Dublin, CA

Trademarks

All Zeiss products mentioned herein are either registered trade-marks or trademarks of Carl Zeiss Meditec, Inc. in the United Statesand/or other countries.

Windows, Windows Media, Windows Server, and Microsoft are ei-ther registered trademarks or trademarks of Microsoft Corporationin the United States and/or other countries.

Mac OS, iMac, iPad, and QuickTime are either registered trade-marks or trademarks of Apple Inc. in the United States and/or othercountries.

All other trademarks used in this document are the property oftheir respective owners.

Patents

http://www.zeiss.com/meditec/en_us/imprint/patents

Instructions for Use Table of ContentsCLARUS 500

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Table of Contents

1 Safety and Certifications .............................................................................. 7

1.1 Compliance........................................................................................................................... 71.1.1 Laser Safety and Compliance ............................................................................................................. 71.1.2 Optical Safety .................................................................................................................................... 71.1.3 RoHS Compliance.............................................................................................................................. 71.1.4 Electrical Safety ................................................................................................................................. 8

1.2 Symbols and Labels .............................................................................................................. 8

1.3 Warnings, Cautions, and Notes .......................................................................................... 101.3.1 Definitions....................................................................................................................................... 101.3.2 Warnings......................................................................................................................................... 101.3.3 Cautions.......................................................................................................................................... 121.3.4 Notes .............................................................................................................................................. 14

1.4 Report Serious Accidents.................................................................................................... 15

1.5 Essential Performance ........................................................................................................ 15

1.6 Electromagnetic Compatibility (EMC).................................................................................. 151.6.1 Electromagnetic Emissions............................................................................................................... 161.6.2 Electromagnetic Immunity ............................................................................................................... 171.6.3 Wireless Communications................................................................................................................ 17

2 Introduction ............................................................................................... 19

2.1 Scope.................................................................................................................................. 192.1.1 Intended Use / Indications for Use ................................................................................................... 19

2.2 Usage ................................................................................................................................. 19

2.3 Intended Audience ............................................................................................................. 192.3.1 Patient Profile.................................................................................................................................. 192.3.2 Operator Profile............................................................................................................................... 192.3.3 Data Analyst Profile ......................................................................................................................... 20

2.4 User Documentation........................................................................................................... 202.4.1 Purpose........................................................................................................................................... 202.4.2 Access ............................................................................................................................................. 202.4.3 Conventions Used in This Document................................................................................................ 20

2.5 Questions and Comments ................................................................................................... 21

2.6 System Overview ................................................................................................................ 212.6.1 System Description .......................................................................................................................... 212.6.2 Hardware Overview......................................................................................................................... 222.6.3 Software Overview.......................................................................................................................... 262.6.4 Networking Overview...................................................................................................................... 32

3 Installation ................................................................................................. 33

3.1 Hardware Installation ......................................................................................................... 333.1.1 Installation Requirements ................................................................................................................ 333.1.2 Installing the Instrument.................................................................................................................. 33

3.2 Software Installation .......................................................................................................... 33

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3.2.1 Installing Review Software............................................................................................................... 343.2.2 Upgrading Instrument and Review Software.................................................................................... 37

4 Daily Startup .............................................................................................. 39

4.1 Turn on the Instrument ...................................................................................................... 39

4.2 Logging In .......................................................................................................................... 40

5 Operation................................................................................................... 41

5.1 Safety During Operation..................................................................................................... 41

5.2 Managing Data................................................................................................................... 415.2.1 Manage Patient Records.................................................................................................................. 415.2.2 Manage Users ................................................................................................................................. 475.2.3 Manage Backups............................................................................................................................. 505.2.4 Log Files .......................................................................................................................................... 52

5.3 Preparing the Device .......................................................................................................... 53

5.4 Preparing the Patient ......................................................................................................... 535.4.1 Dilating the Patient’s Eyes (Optional) ............................................................................................... 535.4.2 Selecting the Patient........................................................................................................................ 535.4.3 Positioning the Patient .................................................................................................................... 545.4.4 Aligning and Focusing on the Patient's Eye...................................................................................... 57

5.5 Acquire Images................................................................................................................... 605.5.1 Acquisition Options ......................................................................................................................... 605.5.2 Blinking the Fixation Target ............................................................................................................. 665.5.3 Manually Positioning the Internal Fixation Target ............................................................................ 665.5.4 Capturing a Widefield Image ........................................................................................................... 675.5.5 Capturing an Ultra Widefield Image (2-Image Montage).................................................................. 695.5.6 Capturing an AutoMontage Image (4-Image Montage) ................................................................... 715.5.7 Capturing a Montage Image (2-6 Image Custom Montage) ............................................................. 735.5.8 Capturing a Stereo Image................................................................................................................ 755.5.9 Capturing an External Eye Image ..................................................................................................... 775.5.10 Using the External Fixation Target ................................................................................................... 775.5.11 Checking Scan Quality ..................................................................................................................... 785.5.12 Deleting or Replacing an Image....................................................................................................... 78

5.6 Analyze Images .................................................................................................................. 795.6.1 Proof............................................................................................................................................... 805.6.2 Review ............................................................................................................................................ 805.6.3 Opening the Analyze Window......................................................................................................... 805.6.4 Selecting and Sorting Images........................................................................................................... 815.6.5 Editing Scanned Images................................................................................................................... 825.6.6 Manually Creating a Montage ......................................................................................................... 945.6.7 Viewing Stereo Images.................................................................................................................... 945.6.8 Saving Edited Images....................................................................................................................... 955.6.9 Creating a Report ............................................................................................................................ 95

5.7 Shutdown........................................................................................................................... 965.7.1 Logging Off..................................................................................................................................... 965.7.2 Shutting Down................................................................................................................................ 96

6 Configuration ............................................................................................. 99

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6.1 Configuring Local Settings.................................................................................................. 99

6.2 Setting All Options ........................................................................................................... 100

6.3 Configuring Report Settings ............................................................................................. 100

6.4 Configuring Printers ......................................................................................................... 101

6.5 Configuring Acquisition Settings ...................................................................................... 102

6.6 Configuring Security Settings ........................................................................................... 103

6.7 Configure Capture Settings............................................................................................... 104

6.8 Configuring Import and Export......................................................................................... 104

6.9 Configure a Stand-Alone Instrument ................................................................................ 105

6.10 Clearing Alert History ....................................................................................................... 105

6.11 Configuring Patient Record Settings................................................................................. 105

6.12 Connecting to a Wireless Printer ...................................................................................... 106

6.13 Connecting to a LAN ........................................................................................................ 107

6.14 Data Storage .................................................................................................................... 108

7 Cleaning and Disinfection......................................................................... 109

7.1 Safety During Cleaning ..................................................................................................... 109

7.2 Cleaning Agents ............................................................................................................... 109

7.3 Cleaning the Front Lens.................................................................................................... 1097.3.1 Removing Fluid Splashes................................................................................................................ 1097.3.2 Removing Minor Dust Accumulation ............................................................................................. 1097.3.3 Removing Severe Contamination ................................................................................................... 1107.3.4 Cleaning the Front Window Lens................................................................................................... 111

7.4 Cleaning the Chinrest and Forehead Support ................................................................... 112

7.5 Peripherals and Table ....................................................................................................... 112

7.6 Cleaning the PC Screen..................................................................................................... 112

8 Maintenance ............................................................................................ 113

8.1 Safety During Maintenance .............................................................................................. 113

8.2 Maintenance Schedule...................................................................................................... 113

8.3 Offline Teleservice ............................................................................................................ 113

8.4 Data Storage - Backup...................................................................................................... 114

8.5 Replacing the External Fixation Diode .............................................................................. 114

9 Troubleshooting....................................................................................... 115

9.1 Safety During Troubleshooting......................................................................................... 115

9.2 Error Messages................................................................................................................. 116

9.3 Information Messages ...................................................................................................... 117

10 Specifications ........................................................................................... 119

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10.1 Electrical Specifications .................................................................................................... 119

10.2 Instrument Specifications ................................................................................................. 11910.2.1 At-Instrument Computer Specifications ......................................................................................... 119

10.3 Dimensions and Weight.................................................................................................... 120

10.4 Ambient Requirements for Operation............................................................................... 120

10.5 Ambient Requirements for Storage .................................................................................. 120

10.6 Ambient Requirements for Transport ............................................................................... 120

10.7 Fundus Camera Specifications .......................................................................................... 120

10.8 Laser Classification ........................................................................................................... 121

11 Legal Notices ........................................................................................... 123

11.1 Software Copyright .......................................................................................................... 123

11.2 End User Software License Agreement............................................................................. 123

11.3 Acknowledgment ............................................................................................................. 123

12 Accessories and User Replaceable Spare Parts ......................................... 125

12.1 Parts Orders ..................................................................................................................... 12512.1.1 U.S. Domestic Parts Ordering......................................................................................................... 12512.1.2 International Service Operations .................................................................................................... 125

12.2 Accessory Kit Parts List .................................................................................................... 126

12.3 Replaceable Parts ............................................................................................................. 12712.3.1 Covers ........................................................................................................................................... 12712.3.2 Cables ........................................................................................................................................... 127

12.4 Returning Defective Parts ................................................................................................. 12712.4.1 Equipment Return Authorization ................................................................................................... 12812.4.2 Packing for Shipment .................................................................................................................... 128

13 Decommissioning ..................................................................................... 129

13.1 Safety During Decommissioning ....................................................................................... 129

14 Packaging and Transport ......................................................................... 131

14.1 Safety During Transport ................................................................................................... 131

15 Disposal ................................................................................................... 133

15.1 Packaging Disposal........................................................................................................... 133

15.2 Instrument Disposal.......................................................................................................... 133

Glossary ................................................................................................... 135

Index........................................................................................................ 137

Instructions for Use 1 Safety and CertificationsCLARUS 500 1.1 Compliance

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1 Safety and Certifications

1.1 ComplianceCLARUS™ 500 is compliant with ISO 10940:2009 and ISO15004-1:2006.

1.1.1 Laser Safety and Compliance

1.1.2 Optical SafetyCLARUS 500 is compliant with the following optical safety stan-dards:

• IEC 60825-1

• ANSI Z80.36

• ISO 15004-2

• Classification: Group 1 Instrument - Per ANSI Z80.36 and ISO15004-2

Group 1 instruments are ophthalmic instruments for which nopotential light hazard exists.

• Class 1 Laser Product – Per IEC 60825-1.

1.1.3 RoHS ComplianceThe product is RoHS-compliant according to Directive 2011/65/EU.

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1.1.4 Electrical SafetyElectrical Safety Class I Equipment - Protection against electricalshock (per IEC 60601-1).

1.2 Symbols and LabelsSymbol Meaning

Warning

Caution

Note

Electricity

Must follow Instructions for Use

Power On (computer)

Power Off (computer)

Protective Earth

Fuse

Direct Current

Type B Applied Parts

Manufacturer

Authorized European Community Representative

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Symbol Meaning

Serial Number

Catalog Number/Part Number

Model Number

Certification mark of CSA – Nationally Recognized Test-ing Laboratory for US and Canada

Disposal of the Product within the E.U. Do not disposevia domestic waste disposal system or communal wastedisposal facility.

Fragile

Keep Dry

This End Up

Transport conditions: humidity (10% to 95%)

Transport conditions: temperature (-40°C to 70°C)

Transport conditions: atmospheric pressure (500 hPa to1060 hPa)

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Symbol Meaning

Caution: Federal law (or United States) restricts this de-vice to sale by or on the order of a licensed healthcarepractitioner

1.3 Warnings, Cautions, and Notes

1.3.1 DefinitionsWarnings and cautions are defined as follows:

WARNING! Indicates hazards that, if not avoided,could cause severe injury or death.

u These are actions that can be taken to prevent the hazard.

CAUTION! Indicates hazards that, if not avoided,could cause minor or moderate injury.

u These are actions that can be taken to prevent the hazard.

1.3.2 Warnings

WARNING! Opening the device coversmay result in injury.

u Only ZEISS authorized service technicians may remove devicecovers.

WARNING! Tipping the devicemay result in injury.

u Do not allow the patient to lean on the table or use it as a sup-port to stand up.

WARNING! Modifying this devicemay increase risks and decrease the service life of the device.

u Do not use in the presence of flammable gasses.

u Do not use in oxygen rich environments.

WARNING! Using this device in the presence of flammable gasesmay cause ignition and result in a fire hazard.

u Do not use this device in the presence of flammable anestheticsor oxidizers such as pure oxygen or nitrous oxide.

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WARNING! Use of this equipment adjacent to or stacked with otherequipmentshould be avoided because it could result in improper operation.

u If such use is necessary, this equipment and the other equip-ment should be observed to verify that they are operating nor-mally.

WARNING! Use of accessories, transducers, and cables other than thosespecified or provided by the manufacturer of this equipmentcould result in increased electromagnetic emissions or decreasedelectromagnetic immunity of this equipment and result in improperoperation.

u Use only the accessories, transducers, and cables specified orprovided by ZEISS.

WARNING! Adding peripheral equipment or replacing partsmay result in noncompliance with the safety requirements of IEC60601-1.

u You are responsible for ensuring that the system meets thesafety requirements of IEC 60601-1.

u Only approved equipment to their respective IEC/ISO standardssuch as IEC 60601-1 or IEC 60950 are allowed to be connectedto the Signal Input/Output parts (SIP/SOPs).

u Place any AC-powered, non-medical device peripherals at least1.5 m away from the instrument and connect them to a sepa-ration device, unless an isolation transformer is used.

WARNING! Unplugging the power cord is the means of disconnectingfrom the power supply.Blocking access to the plug may result in an electrical hazard.

u Set up the instrument so that it can be unplugged easily.

WARNING! Using parts that are not authorized by ZEISSmay compromise device safety during operation.

u Use only accessories authorized by ZEISS.

u In the U.S., call 800–341–6968. Outside the U.S., contact yourlocal Zeiss distributor. You can find the ZEISS contact partnerfor your country on our website: www.zeiss.com.

WARNING! Class 3B laser radiationwhen open.

u Avoid exposure to beam.


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WARNING! Contact with the patient and a peripheral devicemay cause an electric shock.

u Do not touch the patient and a peripheral device at the sametime.

WARNING! Device produces visual stimuli, including flickering light andflashing patterns, between 5 and 65 Hzmay adversely affect certain patients, although this effect is yet un-proven.

u Medical professionals need to determine whether this deviceshould be used for patients who may be photosensitive, includ-ing those with epilepsy.

WARNING! Unqualified personnelmay injure themselves or cause damage to the instrument.

u Only trained, qualified personnel may use this device.

u This device may be used only for its intended purpose.

u Only ZEISS authorized personnel may perform maintenance orrepair procedures not described in this manual.

1.3.3 Cautions

CAUTION! Use of controls or adjustments or performance of proceduresother than those specified hereinmay result in hazardous optical radiation exposure.

CAUTION! Attempting to carry out activities not specifically endorsedby ZEISSmay void your warranty and could result in damage to the instru-ment.

u Read the user documentation.

u Follow directions carefully.

u Do not make upgrades, or carry out repairs or modifications,without specific guidance and instruction from ZEISS or an au-thorized ZEISS represenative.

CAUTION! Improper cleaningmay result in inadequately disinfected equipment.

u Refer to the cleaning instructions in this Instructions for Useand local and national disinfecting regulations.

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CAUTION! Internet connection of the CLARUS 500increases its vulnerability to serious security risks, including virusesand worms that could disable your system or adversely affect itsperformance and may void the instrument warranty.

u Transfer data through internal networks.

u Ensure that all firewalls and internet security applications areup-to-date and running.

u Connecting the device to the internet or transferring data viaUSB devices may result in compromised patient privacy and ex-pose the network to malware.

CAUTION! Installing or putting the device into service without regard toEMC information providedmay void your Device warranty, result in damage to the instrumentand/or compromise safety for patients and operators.

u The CLARUS 500 has special EMC precaution requirements andneeds to be installed and put into service according to the EMCinformation provided herein.

CAUTION! Use of the acquisition device, a printer, or the power tablewith an extension cord or a power strip (multiple portablesocket outlet)

could cause electrical shock to the patient or operator.

u Do not use extension cords with the instrument.

u Do not use power strips with the instrument.

u Do not plug in any other equipment into the same wall outletas the instrument.

u To avoid the risk of electric shock, this equipment must only beconnected to a supply mains with protective earth.

CAUTION! Using this instrument with patients who are light-sensitive,including epilepticsmay cause nausea or harm to the patient.

CAUTION! Attempting to decommission your systemmay result in damaged equipment and danger to personnel.

u Never attempt to decommission a ZEISS system or instrument.Only ZEISS approved representatives are qualified to safely de-commission your system.

u Contact your ZEISS approved representatives to set up an ap-pointment for system or instrument decommissioning.


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CAUTION! Packaging and transport by non-ZEISS personnelcould result in damage, loss, or non-compliance within the countryof transit.

u Allow only change to Zeiss approved representative to preparethe instrument and associated components for transport.

u Allow only ZEISS-approved personnel to transport the instru-ment and associated components.

CAUTION! Do not lift or carry the instrument using the patient support.The patient support could break if used as a carrying handle.

u Make sure you support the instrument from the base wheneveryou carry the instrument.

CAUTION! Portable RF communications equipment (including peripher-als such as antenna cables and external antennas)should be used no closer than 30 cm (12 inches) to any part of thedevice, including cables specified by the manufacturer.

u Otherwise, degradation of the performance of this equipmentcould result.

CAUTION! The CLARUS 500 is intended for use in a professional health-care facility environment.Using the instrument in any other environment may void the war-ranty and compromises the safety of the patient and/or operator.

CAUTION! Image DegradationIf image quality is degraded or image is absent from display, pleasecontact Zeiss customer service.

u The physician must decide whether the image is appropriate fordiagnosis

1.3.4 Notes

NOTE Transferring data via USB devicesmay result in compromised patient privacy and expose the networkto malware.

u Use access controls to ensure that only authorized personneluse the device.

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NOTE Connecting the device to a network that includes otherequipmentmay result in previously unidentified risks.

u You are responsible for analyzing and controlling these risks.

u You must reassess these risks when you make any changes tothe network, including connecting, disconnecting, or upgradingequipment.

NOTE Unprotected devicesmay be at risk from unauthorized individuals.

u Select and set the Password strength setting in the User man-agement screen.

1.4 Report Serious AccidentsReport any serious incident related to this instrument, the operator,patient, or anyone else:

• To the instrument manufacturer or distributor.

• (European Union only) To the compentent authority in the statewhere the instrument operator is established.

1.5 Essential PerformanceThe main clinical performance of the CLARUS 500 is to capture, dis-play and store images to aid in the diagnosis and monitoring of dis-eases and disorders occurring in the retina, ocular surface and visi-ble adnexa. Since there is are no surgical or treatment decisionsmade solely on data obtained by the instrument, it was determinedthat the CLARUS 500 has no “essential performance” as defined inIEC 60601-1 standard.

1.6 Electromagnetic Compatibility (EMC)

WARNING! Installing or putting the device into service without regard toEMC information providedmay void your Device warranty, result in damage to the instrumentand/or compromise safety for patients and operators.

u CLARUS 500 has special EMC precaution requirements andneeds to be installed and put into service according to the EMCinformation provided herein.

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WARNING! Use of accessories, transducers, and cables other than thosespecified or provided by the manufacturer of this equipmentcould result in increased electromagnetic emissions or decreasedelectromagnetic immunity of this equipment and result in improperoperation.

u Use only the accessories, transducers, and cables specified orprovided by ZEISS.

WARNING! Use of this equipment adjacent to or stacked with otherequipmentshould be avoided because it could result in improper operation.

u If such use is necessary, this equipment and the other equip-ment should be observed to verify that they are operating nor-mally.

WARNING! Portable RF communications equipment (including peripher-als such as antenna cables and external antennas)should be used no closer than 30 cm (12 inches) to any part of thedevice, including cables specified by the manufacturer.

u Otherwise, degradation of the performance of this equipmentcould result.

NOTE The emissions characteristics of this equipmentmake it suitable for use in industrial areas and hospitals (CISPR 11Class A).

u If it is used in a residential environment, this equipment mightnot offer adequate protection to radio-frequency communica-tion services.

u The user might need to take mitigation measures, such as relo-cating or re-orienting the equipment.

1.6.1 Electromagnetic EmissionsThe CLARUS 500 complies with the following emission require-ments:

Phenomenon Standard

Conducted and radiated RF emis-sions

Group 1 CISPR 11 Class A

Harmonic distortion IEC 61000-3-2

Voltage fluctuations and flicker IEC 61000-3-3 Class A

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1.6.2 Electromagnetic ImmunityThe CLARUS 500 complies with the following immunity require-ments:

Phenomenon Basic EMC standard or testmethod

Immunity test levels

Electrostatic Discharge IEC 61000-4-2 ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Radiated RF EM fields IEC 61000-4-3 3 V/m 80 MHz – 2,7 GHz80 % AM at 1 kHz

Proximity fields from RF wirelesscommunications equipment

IEC 61000-4-3 See Wireless Communications[} 17]

Rated power frequency magneticfields

IEC 61000-4-8 30 A/m50 Hz or 60 Hz

Electrical fast transients / bursts IEC 61000-4-4 ± 2 kV 100 kHz repetition fre-quency

Surges line-to-line IEC 61000-4-5 ± 0,5 kV, ± 1 kV

Surges line-to-ground IEC 61000-4-5 ± 0,5 kV,± 1 kV, ± 2 kV

Conducted disturbances inducedby RF fields

IEC 61000-4-6 3 V 0,15 MHz – 80 MHz 6 V in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz

Voltage dips, short interruptions,and voltage variations on powersupply input lines.

IEC 61000-4-11 0 % UT1; 0,5 cycle At 0°, 45°, 90°, 135°, 180°, 225°,270° and 315°

0 % UT1; 1 cycleand 70 % UT1; 25/30 cycles Single phase: at 0°

Voltage Interruptions IEC 61000-4-11 0 % UT1; 250/300 cycle

1UT is the a.c. mains voltage prior to application of the test level.

1.6.3 Wireless Communications

Test Fre-quency (MHz)

Band (MHz) Service Modulation Maximumpower (W)

Distance (m) ImmunityTest Level (V/m)

385 380 - 390 TERTRA 400 Pulse 18 Hz 1.8 0.3 27

450 430 - 470 GMRS 460,FRS 460

FM ± 5 kHzdeviation 1 kHz sine

2 0.3 28

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Test Fre-quency (MHz)

Band (MHz) Service Modulation Maximumpower (W)

Distance (m) ImmunityTest Level (V/m)

710745780

704 - 787 LTE Band 13,17

Pulse 217 Hz 0.2 0.3 9

810870930

800 - 960 GSM800/900,TETRA 800,iDEN 820,CDMA 850,LTE Band 5

Pulse 18 Hz 2 0.3 28

1720 1845 1970

1700 - 1990 GSM 1800;CDMA 1900;GSM 1900;DECT; LTEBand1,3,4,25;UMTS

Pulse 217 Hz 2 0.3 28

2450 2400 - 2570 Bluetooth,WLAN,802.11 b/g/n,RFID 2450,LTE Band 7

Pulse 217 Hz 2 0.3 28

5240 55005785

5100 - 5800 WLAN802.11 a/n

Pulse 217 Hz 0.2 0.3 9

Table 1: Test specifications for enclosure port immunity to RF wireless communications equipment.

Instructions for Use 2 IntroductionCLARUS 500 2.1 Scope

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2 Introduction

2.1 Scope

2.1.1 Intended Use / Indications for UseThe CLARUS ophthalmic camera is intended to capture, display,measure, annotate, and store images to aid in the diagnosis andmonitoring of diseases and disorders occurring in the retina, ocularsurface and visible adnexa. It provides true color, infrared re-flectance, and autofluorescence imaging modes for stereo, wide-field, ultra-widefield, and montage fields of view.

2.2 UsageThe CLARUS 500 is designed for continuous use in a professionalhealthcare facility environment.

Also see about this

2 Safety and Certifications [} 7]

2.3 Intended Audience

2.3.1 Patient ProfileThis device may be used on any patient who is able to sit uprightwith his or her face in the instrument's chin and forehead rest, in-dependently or with assistance.

2.3.2 Operator Profile

2.3.2.1 Intended Demographic

This device is intended for use by the following trained profession-als:

• Opticians

• Ophthalmic Photographers

• Optometrists

• Ophthalmologists

• Medical Assistants

• Clinical Researchers

2.3.2.2 Required Occupational Skills

Operators are expected to have the following skills:

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• Knowledge of how to capture fundus images

• Experience managing patients

• Experience with the Microsoft Windows operating system andapplications based on it

2.3.3 Data Analyst ProfileOperators who analyze the results of patient scans should have thefollowing additional qualifications.

2.3.3.1 Intended Demographic

Analysis should be done by an ophthalmologist, optometrist, orother heath care professional with training in interpretation of fun-dus images.

2.3.3.2 Required Occupational Skills

Data analysts are expected to know how to evaluate fundus im-ages.

2.4 User Documentation

2.4.1 PurposeThe user documentation that comes with your device is provided toensure that all users operate and maintain it safely and successfully.

• Read all user documentation before starting and using the de-vice

• Keep all user documentation where it is accessible at all timesfor all users

• Pass the user documentation on to the next owner of the de-vice

2.4.2 AccessUser documentation for your device is provided on the USB drivethat came with the device as part of the Instrument Accessory Kit.

2.4.3 Conventions Used in This DocumentCertain types of information are specially marked in this documentfor better recognition.

• This is a list.

– This is a second level list.

This is a cross-reference: Questions and comments [} 20].

This is software code or program text.

Instructions for Use 2 IntroductionCLARUS 500 2.5 Questions and Comments

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The name of software windows are Capitalized. For example: "Pa-tient Screen"

Names of menus, and buttons or other selectable items, are shownin Bold.

• View menu.

• File > Save as

• My documents > Documents

2.5 Questions and CommentsIf you have questions or comments about this user documentationor the device, contact your ZEISS representative.

2.6 System Overview

2.6.1 System DescriptionCLARUS 500 is a non-contact, high-resolution imaging device for invivo imaging of the human retina. Imaging modes include:

• True color reflectance imaging

• Infrared reflectance imaging (IR)

• Fundus autofluorescence with green or blue excitation (FAF-Gand FAF-B)

• Stereo imaging

• External eye imaging

2.6.1.1 Principles of Operation

Using a monochromatic camera, a broad line of illumination scansacross and detects the retina.

Red, green and blue LEDs (light emitting diodes) sequentially illumi-nate to generate true color images. The broad bandwidth of LEDsgives a true color rendering. Blue and green LED illumination forFAF (fundus auto-fluorescence) enables fluorescence imaging.

By illuminating only a narrow strip of the retina at a time, the illu-mination stays out of the viewing path, keeping haze and fluores-cence of the anterior segment out of the retinal image and allow-ing a clear view of much more of the retina than the annular-ring il-lumination used in traditional fundus cameras. The design allows asingle exposure to image an area of the retina previously coveredby the 7-fields in the early treatment of diabetic retinopathy study(ETDRS).

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2.6.1.2 Key Features

Key Features

• Scan Type Options:

– True color

– Infrared reflectance (IR)

– Fundus autofluorescence with green excitation

– Fundus autofluorescence with blue excitation

– Stereo imaging

– External eye imaging

• Field of View Options:

– Widefield: A single image captures a field of view (FOV) of133° when measured from the center of the eye.

(FOV of 90° when measured as described in ISO 10940).

– Ultra-widefield: Two images stitched together into a mon-tage with a 200° FOV when measured from the center ofthe eye (135° when measured as described in ISO 10940).

– AutoMontage: a 4-scan montage using preset fixation tar-gets.

– Montaged images: 2-6 widefield images stitched into asingle, combined retina image.

2.6.2 Hardware OverviewThe CLARUS 500 is connected to the All-in-One PC using cablesmounted under the table. The operator controls the instrument andsoftware using the instrument joystick, the All-in-One PC touch-screen, wireless keyboard and touchpad.

Instructions for Use 2 IntroductionCLARUS 500 2.6 System Overview

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2.6.2.1 System Hardware

1

2

3

4

5

6

Figure 1: System Hardware

1 CLARUS 500 Acquisition De-vice

2 All-in-One PC

3 Pivoting Rack 4 Touchpad

5 Keyboard 6 Joystick


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2.6.2.2 Patient View

1

2

3

4

Figure 2: Patient View

1 Forehead rest Helps keep the patient's head steady and inplace

2 Front lens Aperture for image acquisition

3 Chin rest Positions the patient's head at the correctheight

4 Chin rest ad-juster

Manually raises and lowers the chin rest


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2.6.2.3 Operator Controls

3

4

1

2

Figure 3: Operator Controls

1 Focus knob Manually adjusts the focus

2 Friction knob Tightens or loosens the swivel movement of theacquisition head

3 Cross-table lock Locks the cross-table so that the acquisitionhead cannot move

4 Joystick Moves the acquisition head side-to-side and for-ward and back

The joystick button triggers image capture


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2.6.2.4 External Fixation Target

2

1

3

Figure 4: Installing the External Fixation Target

The External Fixation Target (1) attaches to the mount (2) onthe top of the Patient Support (3). The External Fixation Targetdirects the patient's gaze when:

• A patient has difficulty fixating on internal fixation target.

• The operator needs to direct a patient's gaze to a position thatcannot be obtained using internal fixation.

2.6.3 Software OverviewThe CLARUS 500 software includes three distinct areas: Patient,Acquire, and Analyze windows. All windows use the same toptoolbar.

2.6.3.1 Main Toolbar

Figure 5: Main Toolbar

Pos. Symbol Explanation

1 Indicates your current screen:

• Patient

• Patient > Acquire

• Patient > Analyze

2 Opens online help


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Pos. Symbol Explanation

3 Quickly hides the screen for patient privacy

4 Opens notification volume control

5 Opens the Settings to configure the instrument and set yourpreferences

6 Minimizes the application on the computer's desktop.

7 Allows you to select whether to log off or shut down

2.6.3.2 Patient Window

Use the Patient window to find, edit, and add patient records.

1 2 3 4

56789

Figure 6: Patient Window

Pos. Name Explanation

1 Search field Searches for a patient record by patient name, ID, or date of birth

2 Advanced Opens the Advanced search, which allows a more detailed search

3 Add Allows you to create a new patient record

4 Patient data Displays data about the selected patient


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5 Acquire Opens the Acquire window allowing you to acquire new scans forthe selected patient

6 Analyze Opens the Analyze window allowing you to analyze scans and pre-pare reports

7 History Lists the selected patient's scans from prior visits

8 All Lists patient records available on the local database

9 Today Lists patient records for the patients scheduled today

2.6.3.3 Acquire Window

Use the Acquire window to set image capture options and captureimages.

1 2 3 4 5 6

789101113 12

Figure 7: Acquire Window


1 Patient data Information about the currently selected patient

2 Laterality Indicates which eye is being captured


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3 Alignment preview A visual aid for aligning the instrument with the patient's pupil

4 Live IR preview Displays a real-time preview image prior to capture and a qualitycheck image following capture

5 Thumbnail filters Filters the Capture bin by laterality or scan type

6 Capture bin Displays thumbnails of images that have already been captured, alongwith the capture settings

7 Analyze Opens the Analyze window

8 Focus Displays the current focus and allows for manual focus adjustments.

9 Blink internal fixation tar-get

Blinks the internal fixation target for a configurable amount of time

10 Capture Captures the image

11 Pupil Size Toggles between mydriatic and non-mydriatic acquisition mode

12 Fixation Type Toggles between internal fixation and external fixation targets

13 Patients Returns to the Patients window

2.6.3.4 Analyze Window - Proof

The Analyze window has two modes:

• Proof to view and select images

• Review screen to compare and edit images


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1 2 3 4 5 6 7 8

9101112

Figure 8: Analyze Window - Proof


1 Patient data Displays information about the currently selected patient

2 Favorites Flags selected image(s) with a yellow start for easy identifiication

3 Laterality filter Allows you to filter the images to show one or both eyes

4 Date filters Allows you to filter the images to show only those taken between thestart date and end date you set

5 Scan type filter Allows you to select which type(s) of scans to show

6 View Allows you to select what size to display the images in preview

7 Sort Allows you to group the images by scan type or laterality or show im-ages in the order they were taken (Date/Time)

8 Clear Remove all thumbnails from the Selection bin

9 Review Opens the Review screen for viewing and editing the images in theSelection bin

10 Selection bin Displays thumbnails of selected images

11 Viewport Displays available images as filtered

12 Patients Returns to the Patient window


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2.6.3.5 Analyze Window - Review

1 2 3 4 5 6 7 8 9 10 11

121314

Figure 9: Analyze Window - Review


1 Number of viewports Controls how many viewports are in the main display area

2 Zoom Opens the zoom slider

3 Annotate Opens the annotation tool panel

4 Adjust image Opens the brightness, contrast, saturation, and sharpness sliders

5 Adjust Color Opens the color adjustment tool

6 Rotate Rotates the image 180° clockwise

7 Save Saves the edited image

8 Print Report Opens a preview of the report to print.

9 Montage Allows you to select scans and create a montage image from them.

10 Stereo Provides a stereo view of the image

11 Sort Selection Allows you to select the way to sort the selected scans.

12 Proof Returns to the Proofsheet

13 Viewport Allows you to see the selected images.

14 Patients Returns to the Patient window


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2.6.4 Networking OverviewCLARUS 500 can run as a standalone instrument storing patientand exam data locally, or it can be connected to a network serveror EMR system to share data and worklists in a central location.

WARNING! Adding peripheral equipmentmay result in noncompliance with the safety requirements of IEC60601-1.

u You are responsible for ensuring that the system meets thesafety requirements of IEC60601-1.

u Place any AC-powered, non-medical device peripherals at least1.5 m away from the device and connect them to a separationdevice, or else use an isolation transformer.

WARNING! Connection to It-Networks including other equipmentcould result in previously unidentified risks related to patients, oper-ators or third parties.

Changes to the IT networks could introduce new risks that requireadditional analysis.

Changes to the IT networks include:

u Changes to network configurations

u Connections of additional items

u Disconnection of items

u Update of equipment

u Upgrade of equipment

ü The Responsible Organization should identify, analyze, evaluateand control these risks.

Instructions for Use 3 InstallationCLARUS 500 3.1 Hardware Installation

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3 Installation

WARNING! Powering peripherals directly through a wall socketcould result in electrical shock to the patient and/or examiner.

u When using a printer in the USB configuration, always powerthe printer through an isolation transformer. Some ZEISS equip-ment comes with an isolation transformer that may be used byplugging into a special power strip provided with the equip-ment. Talk to your ZEISS Service Representative to determine ifthis is true for your equipment.

u If you are not sure, plug all peripherals (such as a printer), intoan isolation transformer. This requires a special power cable. InNorth America, the required cable has an IEC–320–14 connec-tor on one end and a NEMA S–15R connector on the otherend. This cable is included in the accessory kit shipped with theinstrument.

3.1 Hardware Installation

3.1.1 Installation RequirementsInstall the CLARUS 500 instrument in an environment that meetsthe following requirements:

• no direct sunlight

• properly grounded, dedicated 15 A power source that meets alllocal electrical codes

• not connected to a power strip

• the device's ventilation openings are not blocked

• the device is not exposed to water or other liquids

Do not modify the instrument or use cables not provided by ZEISS.

3.1.2 Installing the InstrumentRefer to the Installation Instructions for complete installation in-structions.

3.2 Software InstallationA CLARUS 500 system ships with software installed on your instru-ment. From time to time you will be notified to upgrade systemsoftware (Upgrading Instrument and Review Software [} 37]).

You can install review software on any compatible laptop or com-puter that clinicians use to review scanned images (Installing Re-view Software [} 34]).

3 Installation Instructions for UseCLARUS 5003.2 Software Installation

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3.2.1 Installing Review SoftwareYou can install review software on (up to 20) computers that clini-cians use to compare, analyze, annotate and save scans acquiredon CLARUS 500.

NOTE If you need to uninstall review software, use the Windowscontrol panel for adding and removing programs.

The computer must meet the following minimum requirements:

• Runs on:

– Windows 7

– Windows 8

– Windows 10.

– Windows 2008 Server R2

– Windows 2012 Server R2

• Has an Intel processor with a Passmark benchmark score of atleast 5675.

• Has at least 8 GB of memory.

• Has at least 100 GB of disk space available.

• Has a monitor with resolution set to at least 1920 x 1080.

Review software does not support the following functions:

• Adding, Editing, or Deleting the equipment data.

• Deleting a Scan.

• Adding users or user accounts.

Prerequisite þ The computer and monitor meet the minimum requirementslisted above.

þ You know the User Name and Organization Name to use forthis installation.

þ You know whether this installation will use Remote DesktopServices.

Action 1. Insert the software media into the review station computer'sUSB drive.

2. In the CLARUS 500 software folder, double-click onsetup.exe.

ð A confirmation opens.

3. Click Next.

4. Accept the license agreement, then click Next.

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5. Type the user name and organization name and click Next.

6. Select Review Software, then click Next.

7. If you want to choose a different destination folder for the re-view software, click Change... and browse to the desiredfolder.


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8. Click Next.

9. If this review software will use Remote Destop Services, checkRemote Desktop services will be used.

10. Click Next.

Instructions for Use 3 InstallationCLARUS 500 3.2 Software Installation

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11. Click Install.

12. If your system prompts you to confirm changes on the com-puter, click Yes.

ð Review software installation begins. Installation takes sev-eral mintues to complete.

13. When installation is complete, click Finish.

3.2.2 Upgrading Instrument and Review SoftwareAction 1. Select the Maintenance tab on the Settings screen. Under

Update, click Start Update....


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2. Confirm that you would like to continue.

Result ü The software installs and the system reboots.

When you upgrade instrument or review software,CLARUS 500 re-tains stored information including:

• Logins and Passwords

• Patient Data

• Exam Data

Instructions for Use 4 Daily StartupCLARUS 500 4.1 Turn on the Instrument

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4 Daily Startup

4.1 Turn on the Instrument

CAUTION! Do not unplug the instrument during startupor instrument damage may occur.

u Make sure the instrument has completed its system checks be-fore you unplug or remove power.

Each time you turn on the CLARUS 500, system diagnostics checksthat the system initialzed correctly and is running properly. If the di-agnosic check detects any problems, an error or alert message dis-plays. For more information about startup errors and alerts, referto: Troubleshooting [} 115].

NOTE If a critical system test failstake the device out of service.

u Contact your ZEISS representative.

u If a non-critical test fails or a warning appears, the device canstill be used. Contact your ZEISS representative. (See Mainte-nance [} 113].)

NOTE! A System Administrator must assign an account foreach system operator.

1

2

Action 1. Turn on the instrument (green switch).

2. When the system test sequence completes, click Continue.(See Adding a New User [} 48].)

3. Log in.

ð The Patient window displays.

4 Daily Startup Instructions for UseCLARUS 5004.2 Logging In

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4.2 Logging InAfter the system boots up and the passes the system check uponstartup and when a user logs off, the login screen opens.

NOTE An Administrator must add a user's name and password be-fore that user can log in. (Adding a New User [} 48])

NOTE Passwords are case-sensitive.

Action1. Double-click on the Ziess application icon.

ð The login screen opens.

2. Select your user name.

3. Type your password.

Instructions for Use 5 OperationCLARUS 500 5.1 Safety During Operation

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5 Operation

5.1 Safety During Operation

CAUTION! Improper operator trainingcould lead to poor scan quality, damage to system components, orinadvertent patient safety compromise.

u Train all operators fully.

u Ensure all personnel are familiar with the information containedin Safety and Certifications [} 7].

u Ensure that routine maintenance has been properly carried outin conformance with the Maintenance Schedules described inthe chapter Maintenance [} 113].

5.2 Managing Data

5.2.1 Manage Patient RecordsWhen patient records are imported from an EMR, they are recon-ciled with local records as follows:

• Same ID and Issuer of ID, different name, date of birth, or gen-der: The local record is updated to match the EMR record.

• Different ID or Issuer of ID: A new patient record is generated.

Some EMR systems allow records that are missing key identifyinginformation. The CLARUS 500 automatically adds the default "Un-known" if the name is missing, but rejects records that do not havea Patient ID or date of birth.

5.2.1.1 Adding a Patient

Addition the patient's name and date of birth is required.

Prerequisite þ The Patient window is open.

Action 1. Click Add.

5 Operation Instructions for UseCLARUS 5005.2 Managing Data

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2. Type the patient's name, gender and date of birth.

3. Type the patient's Refractive Error information (optional).

4. Select the patient's Eye Color (optional).

5. To acquire a scan, click Acquire.

5.2.1.2 Merging Patient Records

If two records are inadvertently created for the same patient, theycan be merged to store all the patient data in one record.

Action 1. In the Patient window, select the patient name and click onthe down arrow.

2. Select Merge.

3. Type the name or ID for the duplicate patient record in thesearch field and click Search.

4. Select the duplicate patient record(s). You can merge up to 20patient records.

5. To see the details of selected patient records side by side withthe original record, select Compare.

6. Select Merge.

Instructions for Use 5 OperationCLARUS 500 5.2 Managing Data

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7. Enter a reason for the merge, then select Merge again.

ð The exam data from the duplicate patient record is addedto the original patient record.

5.2.1.3 Reassigning Test Data

If you inadvertently select the wrong patient record at the begin-ning of an exam, you can reassign the data to the correct patientrecord.

Prerequisite þ The FORUM test database must be disabled in the Report Out-put settings. Refer to Configure Automatic End of Test Reports.

Action 1. In the Patient window, search for the patient record that wasincorrectly associated with the data. See Search for a PatientRecord.

2. Select the patient record, then open the drop-down menu byclicking on the down arrow. Select Exam.

3. Select the data to reassign, then select Reassign.

4. In the search field, type a few letters of the name, ID number,or DOB of the patient record the data should be assigned to,then click the Search button.

5. Select the patient record, then select Next.

6. Enter a reason for moving the data and select Reassign Test.

5.2.1.4 Deleting a Patient Record

NOTE Only Administrators can complete this task.

Patients deleted on the instrument are not deleted from the EMRsystem.

Prerequisite þ The instrument is not connected to FORUM or any other EMRsystem.


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Action 1. In the Patient window, select the patient name and click onthe down arrow and select Delete.

ð A confirmation opens.

2. Click Delete.

5.2.1.5 Manually Correcting Laterality

You can change the laterality of an image after it is saved using theAcquire, Review, or Proof Sheet screen.

Laterality change feature does not work under the following condi-tions:

• After the data is exported

• In connected mode (FORUM)

• On imported data

Prerequisite þ Acquire, Review, or Proof Sheet is open.

Action 1. Select the image you want to change.

2. Click the existing laterality indicator (OD or OS).

3. Click the desired laterality (OD or OS).

ð The laterality indicator changes for the image.

4. Click Save.

5.2.1.6 Importing Data

You can import data in the following individual exams or multipleexams (bulk import).

You can import the following file formats:

• JPG

• TIFF

• PNG

• JPEG2000

• DICOM

• ZIP (compressed)


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Action

1. Insert the removable media into the USB port.

2. Click Settings > Specific Settings.

ð The Specific Settings window opens.

3. Click Import.

4. Click Import... and navigate to the file stored on the externalremovable media device.

5. Click Select.

ð A confirmation informs you when the import completes.

6. Click OK.

5.2.1.6.1 Data Integrity of Imported Records

For all imported patient records, it is possible to import new scandata and update patient data, including obscured patient records. Ifduring import the device encounters information associated with apatient that was already imported, the device does the following:

• imports all scan data (exams) not previously imported, but neverdeletes nor overwrites any scan data already imported

• updates patient data only if it was created on a later date thanthe data already imported. This prevents overwriting of newerpatient data with older

5.2.1.7 Exporting Data

You can export data in the following ways:


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• In the Proofsheet or Review screen, select an image andright-click.

• In the Proofsheet screen, select multiple images and right-click.

• Export all of a patient's data; select Settings > Specific Set-tings > Export.

• Set automatic export (Configuring Import and Export [} 104])

Action

1. If you are exporting to removable media, insert the media intothe USB port.

2. Click Settings > Specific Settings.

ð The Specific Settings window opens.

3. Click Export.

ð A list of all patients opens.

4. Check the patients you want to export and click Export.


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5. Navigate to the folder you want to use for export and click Se-lect.

ð A progress bar appears until export is complete.

6. Click OK.

ð The data exports and a confirmation opens.

7. Click OK.

5.2.2 Manage Users

CAUTION! Do not use Bitlocker Passkeys with this instrument or reviewsoftware.

NOTE Unsecured Loginsmay result in unauthorized access or inaccurate record-keeping.

u Create individual user accounts for each staff member.

u Staff members should log out after every use.

5.2.2.1 About User Access

Not all users have access to all features. The table below list someof the key differences for different types of users.

Operator Doctor Administrator

Acquire Scans X X

Review Scans X X

Edit and Anno-tate Scans

X X

Use review soft-ware installedon a separatecomputer

X X

Reset your ownpassword

X X X


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Delete a localpatient record

X X X

Change Settings X X

Reset otheruser's pass-words

X

Add or deleteOperators orDoctors

X

Export log files X

Add or deleteAdministrators

X

Table 2: Permissions Levels

5.2.2.2 Adding a New User


Action

1. Click Settings > User Management.

2. Click Add User.

3. Type the information for the new user and select the user'srole.

4. Click Add User.

Result ü The new user can now log in.


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5.2.2.3 Deleting a User


Action


2. Select the Login name for the user you want to delete.

3. Click Delete User.

Result ü The user's Login is now disabled.

5.2.2.4 Changing a User's Password


Prerequisite þ Settings are open.

Action 1. Select User Management.

2. Select the Login name for the user who needs a new pass-word and click Change Password ....

ð The password reset panel opens.


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3. For New password, type a new password for the user.

4. For Repeat new password, retype the new password.

Result ü The new password for the user is now active.

5.2.2.5 Changing Your Own Password

Action


2. Click Change Password ....

3. For Old password, type your existing password.

4. For New password, type a new password.

5. For Repeat new password, retype the new password.

Result ü Your password is now changed to the new password.

5.2.3 Manage BackupsOn the CLARUS 500, you can enable data backup each time thesystem shuts down (Configuring Automatic Backups [} 51]). Youcan also back up data manually at any time (Backing Up Data Man-ually [} 51]).


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5.2.3.1 Configuring Automatic Backups

You can save a backup copy of selected data at any time. You cansave this data on removable media for import into other applica-tions.

Action


2. Click Settings > Maintenance.

ð The Maintenance window opens.

3. Slide Data backup on Shutdown to Backup Enabled.

4. Click Browse.

5. Navigate to the folder where you want to store the backupsand click Select.

Result ü Each time the system shuts down a backup will be saved inthe selected folder.

5.2.3.2 Backing Up Data Manually

Action


2. Click Settings > Maintenance.


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ð The Maintenancewindow opens.

3. Click Backup Now.

ð A progress bar opens.

ð When the backup completes, a confirmation opens.

4. Click OK.

Result ü A new data backup is stored in the folder you configured tostore automatic backups. (See Configuring Automatic Back-ups [} 51].)

5.2.3.3 Restoring Data from a Backup


If the CLARUS 500 has automatic backups enabled or if there is asaved manual backup, you can restore the system with the datafrom the backup file.

Action 1.

5.2.4 Log FilesCLARUS 500 records the following events and identifies them bydate, time, and User ID:

• Log on/log off

• Create, modify, delete data

• Import/export data from removable media

• Receipt/transmit data from/to the network

• Remote service activity

Instructions for Use 5 OperationCLARUS 500 5.3 Preparing the Device

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Events are automatically recorded in 1-5 audit files of 5 Mb each.When file size limit is reached, the device overwrites existing files.

The default folder for the audit log files is C:\ProgramData\CarlZeiss Meditec\...\Logs.

NOTE Save (export) audit log files regularlyto ensure events of consequence can be tracked should you en-counter a data error.

u Log on as Administrator.

u Click Tools > Export Audit Log File.

u In the Browse folder, browse to the export location.

u Click Save.

ð The log is exported as a .zip file with the format: Audit-Log_dd_mm_yyyy_hh_mm.

5.3 Preparing the DeviceAction 1. Wipe the chinrest and forehead rest with an alcohol pad, and

allow the assembly to dry. (See Cleaning the Chinrest and Fore-head Support [} 112].)

2. Carefully read and understand any instructions provided by theofficiating physician or researcher.

5.4 Preparing the Patient

NOTE Keep the front of the lens clean.The quality of image capture is greatly affected by the cleanlinessof the front lens.

u Avoid touching the lens with anything but approved cleaningequipment.

u Use the protective cover to keep dust off the lens when the de-vice is not in use.

For complete instructions on cleaning the lens, refer to: Cleaningand Disinfection [} 109]

5.4.1 Dilating the Patient’s Eyes (Optional)The minimum pupil size for the CLARUS 500 is 2.5 mm, which istypically achieved without dilation.

5.4.2 Selecting the PatientFinding a patient's name can vary depending on the systems youuse.

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• If you use an EMR system:

– The patient's name might be listed under Today

– If the patient is not listed under Today, click All to scrollthrough the list or Search for their name or ID (See Findinga Patient [} 54]).

– If the patient is not in the database, add the patient's infor-mation. (See Adding a Patient [} 41]).

• If you do not use an EMR system:

– Click All to scroll through the list or use Search (See Findinga Patient [} 54]).

– If the patient is not in the database, add the patient's infor-mation. (See Adding a Patient [} 41]).

Action 1. Find the patient's name using the list or search and select thepatient's name.

2. Click Acquire.

5.4.2.1 Finding a Patient

Action 1. To find a patient using Search, type the first name, last name,patient ID, or a scan date of the person you want to find.

2. Click the Search icon.

3. To refine your search criteria, use Advanced Search.

5.4.3 Positioning the Patient

CAUTION! Pinch hazard for hands and fingers. Keep operator and pa-tient hands and fingers away from crosstable during align-ment and image capture.

Action 1. Adjust the table (and patient chair, if needed) until the patientcan comfortably reach the headrest and chinrest.

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2. Ask the patient to:Sit comfortably with feet flat on the ground.Lean forward slightly, grasping the table handles if needed forstability.Rest their chin in the chinrest.Rest their forehead against the forehead rest.

3. Adjust the chin rest up or down as needed until align the pa-tient's canthus to the canthus marker on the patient support.


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4. Swing the acquisition head left to align with the patient's righteye or right to align with the patient's left eye.


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5.4.4 Aligning and Focusing on the Patient's EyeIn addition to the preview image, two images of the iris help toalign the eye.

The top iris image is used for vertical alignment. The height of theband is the minimum pupil size required. If the pupil is smaller thanthe transparent band, you can change the pupil setting to Non-Myd, or dilate the patient's pupils.

Action u Push the acquisition head closer to the patient.

u Twist the joystick to move the acquisition head up or down un-til the patient's pupil is aligned with the transparent band.

u If the patient's pupil is smaller than the transparent band,change the setting to Non-Myd or dilate the patient's pupil(Dilating the Patient’s Eyes (Optional) [} 53]).

u Slide the instrument front to back and side-to-side until the pa-tient's pupil is centered on the yellow cross hairs on the bottomiris image.


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ð When the pupil is aligned, a live view of the fundus appearsin the live IR preview window.

u Ensure that the image is in focus. If needed, manually focus theimage (Manually Focusing the Image [} 59]).

u Make fine adjustments as needed to eliminiate any shadowsshowing in the IR preview window.

u If either alignment is not centered, repeat these steps until theyare centered.


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5.4.4.1 Manually Focusing the Image

Prerequisite þ You reached the focus step in a Scan Acquisition task.

þ You want to manually focus the image.

Action u Uncheck Autofocus.

u Turn the focus knob on the acquisition head (1) or use (+ and- ) (2) or the focus slider (3) on the screen to manually adjust fo-cus.

1

2 3 4

u Use the focusing guides (4) in the upper left corner of the IRPreview panel, to aid in focus.

5 Operation Instructions for UseCLARUS 5005.5 Acquire Images

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5.5 Acquire Images

5.5.1 Acquisition Options

5.5.1.1 Field of View Options

3 41 2

Pos. Description Example

1 Widefield (WF)

Single image, 133° wide by 133° high

Instructions for Use 5 OperationCLARUS 500 5.5 Acquire Images

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2 Ultra-Widefield (UWF)

Two image montage, 200° wide by 133°high

3 Auto Montage

Four image montage, 200° wide by 200°high


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4 Montage

Up to six images montaged in an opera-tor-selected configuration


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5.5.1.2 Scan Types

NOTE! Example images shown below are taken from scansacquired from multiple subjects.

1 2 3 4

Pos. Description Explanation Example

1 Color Color

High resolution, colorimages of the fundusappear similar in colorto direct observation(ophthalmoscopy).

You can also view amonochrome image ofeach composite color(red, green, and blue).


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Blue Channel

Red Channel

Green Channel


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2 IR Infrared reflectance

Infrared light is used tocapture these images,with the unique prop-erty of increased pene-tration through tissue,providing improved vi-sualization of choroidalstructures. A mono-chrome image is gener-ated.

3 FAF-Green Fundus autofluores-cence with green exci-tation. The eye is illu-minated with light at awavelength that stimu-lates the natural fluo-rescence of lipofuscin.A monochrome imageis generated.

4 FAF-Blue Fundus autofluores-cence with blue excita-tion. The eye is illumi-nated with light at awavelength that stimu-lates the natural fluo-rescence of lipofuscin.A monochrome imageis generated.

5.5.1.3 Internal Fixation Targets

The internal fixation target set positions include 9 fixed points tosteer a patient's gaze:

Figure 10: Fixed Targets

• Central

• Temporal

• Nasal


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• Superior

• Inferior

• Superotemporal

• Superonasal

• Inferonasal

• Inferotemporal

You can override the preset fixation targets and choose any loca-tion within the patient's field of view (See Manually Positioning theInternal Fixation Target [} 66].)

If the patient is unable to see the fixation target, you can blink thefixation target to help the patient to see it. (See Blinking the Fixa-tion Target [} 66].)

Internal fixation targets adjust to any point within the 90 degreecircular FOV.

5.5.2 Blinking the Fixation TargetIf the patient is having trouble seeing the internal fixation target,you can blink the target to make it easier for them to see. To canchange the blink settings, refer to: Configure Capture Settings[} 104].

Prerequisite þ A patient is being prepared for Scan Acquisition and cannotsee the fixation target.

1

Action 1. Click the blink buttion (1).

Result ü The internal fixation target blinks several times.

5.5.3 Manually Positioning the Internal Fixation TargetYou can place the internal fixation target anywhere on the screenusing the touchscreen or the mouse.

Prerequisite þ A patient is being prepared for Scan Acquisition and youwant to change or set the internal fixation target.


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1

Action 1. In the IR Preview panel, double-click (or press the touchscreenand hold) to select a position for the internal fixation target (1).

Result ü The internal fixation target moves to your selected locationin both the Preview panel and the patient's FOV.

5.5.4 Capturing a Widefield Image

Figure 11: Widefield Fixation Tar-get

Figure 12: WF Image Example

When you capture a widefield (WF) image, CLARUS 500 takes oneimage and with a fixation target preset near the center.

If the patient cannot see the fixation target, you can:

• Blink the fixation target: Blinking the Fixation Target [} 66]

• Change the fixation target: Manually Positioning the InternalFixation Target [} 66]

• Use the external fixation target: Using the External Fixation Tar-get [} 77]


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Prerequisite þ The device is prepared. (See Preparing the Device [} 53].)

þ The patient is prepared. (See Preparing the Patient [} 53].)

Action u Under Scans, select WF.

u Select the Scan Type (Color, IR, FAF-Green, or FAF-Blue). Formore information about Scan Types, refer to: Scan Types[} 63].

u Under Settings, select Myd if the patient's pupil is dilated andNon Myd if the patient's pupil is not dilated.

u Instruct the patient to look inside the imaging aperture, focuson the green fixation target and blink naturally.

u The instrument automatically focuses the image. To manuallyadjust focus, refer to: Manually Focusing the Image [} 59].

u Instruct the patient to blink and then open their eyes wide.

u Click the joystick button or click Capture.

ð A preview of the captured image appears for several sec-onds and is added to the selection bin.

u Repeat adjustments and scans as needed until all scans are ac-quired.


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5.5.5 Capturing an Ultra Widefield Image (2-Image Montage)

Figure 13: UWF Fixation Targets

Figure 14: UWF Image Example

When you capture an Ultra Widefield (UWF) image, CLARUS 500takes two widefield images and stiches them together for a widerview of the retina. The fixation targets for these images are presetat temoral and nasal.

If the patient cannot see the fixation target, you can:

• Blink the fixation target: Blinking the Fixation Target [} 66]

• Change the fixation target: Manually Positioning the InternalFixation Target [} 66]

• Use the external fixation target: Using the External Fixation Tar-get [} 77]

Prerequisite þ The device is prepared. (See Preparing the Device [} 53].)

þ The patient is prepared. (See Preparing the Patient [} 53].)

Action u Under Scans, select UWF.

u Select the Scan Type (Color, IR, FAF-Green, or FAF-Blue). Formore information about Scan Types, refer to: Scan Types[} 63].

u For Pupil Size, select Myd if the patient's pupil is dilated andNon-Myd if the patient's pupil is not dilated.

u Instruct the patient to look inside the imaging aperture, focuson the green fixation target and blink naturally. If the patientcannot see the fixation target, have the patient focus on theexternal fixation target (Using the External Fixation Target[} 77]).

u The instrument automatically focuses the image. To manuallyadjust focus, refer to: Manually Focusing the Image [} 59].


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u Instruct the patient to blink and then open their eyes wide.

u Click the joystick button or click Capture.

ð A preview of the captured image appears for several sec-onds and is added to the selection bin.

ð If the image can be included in a montage, it will have agreen checkmark.

u If the image in the selection bin has a yellow exclamation point,delete and retake the image. (See Deleting or Replacing an Im-age [} 78])

ð The internal fixation target advances to the next position inthe sequece.

u Recheck adjustments and focus for the second scan in the se-rie