Zeiss CLARUS 500 Instructions For Use Manual
CLARUS® 500
Instructions for Use
Copyright
©2019 , Carl Zeiss Meditec, Dublin, CA
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All Zeiss products mentioned herein are either registered trademarks or trademarks of Carl Zeiss Meditec, Inc. in the United States
and/or other countries.
Windows, Windows Media, Windows Server, and Microsoft are
either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries.
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All other trademarks used in this document are the property of
their respective owners.
Patents
http://www.zeiss.com/meditec/en_us/imprint/patents
Instructions for Use Table of Contents
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Table of Contents
1 Safety and Certifications .............................................................................. 9
1.1 Compliance...........................................................................................................................9
1.1.1 Laser Safety and Compliance.............................................................................................................9
1.1.2 Optical Safety....................................................................................................................................9
1.1.3 RoHS Compliance..............................................................................................................................9
1.1.4 Electrical Safety .................................................................................................................................9
1.2 Symbols and Labels ............................................................................................................10
1.3 Warnings, Cautions, and Notes ..........................................................................................12
1.3.1 Definitions.......................................................................................................................................12
1.3.2 Warnings.........................................................................................................................................12
1.3.3 Cautions..........................................................................................................................................15
1.3.4 Notes ..............................................................................................................................................17
1.4 Report Serious Accidents....................................................................................................18
1.5 Essential Performance ........................................................................................................18
1.6 Electromagnetic Compatibility (EMC)..................................................................................18
1.6.1 Electromagnetic Emissions...............................................................................................................19
1.6.2 Electromagnetic Immunity...............................................................................................................19
1.7 Wireless Communications...................................................................................................20
2 Introduction ............................................................................................... 21
2.1 Scope..................................................................................................................................21
2.1.1 Intended Use / Indications for Use ...................................................................................................21
2.2 Usage .................................................................................................................................21
2.3 Intended Audience .............................................................................................................21
2.3.1 Patient Profile..................................................................................................................................21
2.3.2 Operator Profile...............................................................................................................................21
2.3.3 Doctor Profile..................................................................................................................................22
2.3.4 Administrator Profile .......................................................................................................................22
2.4 User Documentation...........................................................................................................23
2.4.1 Purpose...........................................................................................................................................23
2.4.2 Access.............................................................................................................................................23
2.4.3 Conventions Used in This Document................................................................................................23
2.5 Questions and Comments ...................................................................................................23
2.6 System Overview ................................................................................................................23
2.6.1 System Description ..........................................................................................................................23
2.6.2 Hardware Overview.........................................................................................................................25
2.6.3 Software Overview ..........................................................................................................................29
2.6.4 Networking Overview......................................................................................................................35
3 Installation ................................................................................................. 37
3.1 Hardware Installation .........................................................................................................37
3.1.1 Preparing to Install ..........................................................................................................................37
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3.2 Software Installation ..........................................................................................................38
3.2.1 Installing Review Software...............................................................................................................38
3.2.2 Upgrading Instrument and Review Software....................................................................................42
3.3 Installation Troubleshooting...............................................................................................43
4 Daily Startup .............................................................................................. 45
4.1 Turn on the Instrument ......................................................................................................45
4.2 Logging In ..........................................................................................................................46
5 Configuration ............................................................................................. 47
5.1 About User Roles................................................................................................................47
5.2 Opening Settings ................................................................................................................47
5.3 Setting All Options .............................................................................................................48
5.4 Managing Data...................................................................................................................49
5.4.1 Manage Patient Records..................................................................................................................49
5.4.2 Manage Users .................................................................................................................................61
5.4.3 Manage Backups.............................................................................................................................66
5.4.4 Log Files..........................................................................................................................................68
5.4.5 Data Storage ...................................................................................................................................69
5.5 Managing Connections .......................................................................................................69
5.5.1 Connecting to a Wireless Printer......................................................................................................69
5.5.2 Mapping Networked Drives.............................................................................................................70
5.5.3 Connecting to a LAN .......................................................................................................................71
5.6 Managing Licenses .............................................................................................................72
5.6.1 Activating Licenses Online ...............................................................................................................73
5.6.2 Activating Licenses Offline...............................................................................................................73
5.6.3 Returning Product Licenses..............................................................................................................75
5.6.4 Repairing Product Licenses ..............................................................................................................77
5.7 Configuring Local Settings..................................................................................................78
5.8 Configuring Report Settings ...............................................................................................79
5.9 Configuring Acquisition Settings ........................................................................................80
5.10 Clearing Alert History .........................................................................................................80
5.11 System Administration .......................................................................................................81
5.11.1 Windows Patches and Updates .......................................................................................................81
5.11.2 Data Safety......................................................................................................................................81
5.11.3 Networking .....................................................................................................................................82
5.11.4 Configuring Enhanced Security........................................................................................................83
6 About User Roles ....................................................................................... 97
7 Operation................................................................................................... 99
7.1 Safety During Operation.....................................................................................................99
7.2 Preparing the Device ..........................................................................................................99
7.2.1 Finding a Patient .............................................................................................................................99
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7.2.2 Selecting the Patient......................................................................................................................100
7.3 Preparing the Patient .......................................................................................................100
7.3.1 Dilating the Patient’s Eyes (Optional) .............................................................................................101
7.3.2 Lifting the Patient's Eyelid (Optional) .............................................................................................101
7.3.3 Positioning the Patient ..................................................................................................................102
7.3.4 Aligning and Focusing on the Patient's Eye....................................................................................104
7.4 Acquire Images.................................................................................................................107
7.4.1 About Acquisition Options.............................................................................................................107
7.4.2 Capturing a Widefield Image .........................................................................................................113
7.4.3 Capturing an Ultra-widefield Image (2-Image Montage) ................................................................114
7.4.4 Capturing an AutoMontage Image (4-Image Montage) .................................................................115
7.4.5 Capturing a Montage Image (2-6 Image Custom Montage) ...........................................................117
7.4.6 Capturing a Stereo Image..............................................................................................................118
7.4.7 Capturing an External Eye Image ...................................................................................................120
7.4.8 Blinking the Fixation Target ...........................................................................................................121
7.4.9 Manually Focusing the Image ........................................................................................................122
7.4.10 Manually Positioning the Internal Fixation Target ..........................................................................122
7.4.11 Using the External Fixation Target .................................................................................................123
7.4.12 Checking Scan Quality...................................................................................................................124
7.4.13 Deleting or Replacing an Image.....................................................................................................124
7.5 Analyze Images ................................................................................................................125
7.5.1 Proof.............................................................................................................................................125
7.5.2 Review ..........................................................................................................................................126
7.5.3 Opening the Analyze Window.......................................................................................................126
7.5.4 Sorting and Selecting Images.........................................................................................................126
7.5.5 Editing Scanned Images.................................................................................................................128
7.5.6 Manually Creating a Montage .......................................................................................................144
7.5.7 Viewing Stereo Images..................................................................................................................145
7.5.8 Saving Edited Images.....................................................................................................................145
7.5.9 Creating a Report ..........................................................................................................................146
7.6 Shutdown .........................................................................................................................146
7.6.1 Logging Off...................................................................................................................................147
7.6.2 Shutting Down..............................................................................................................................147
8 Cleaning and Disinfection......................................................................... 149
8.1 Safety During Cleaning .....................................................................................................149
8.2 Cleaning Agents ...............................................................................................................149
8.3 Cleaning the Front Lens....................................................................................................149
8.3.1 Removing Fluid Splashes................................................................................................................149
8.3.2 Removing Minor Dust Accumulation .............................................................................................149
8.3.3 Removing Severe Contamination ...................................................................................................150
8.4 Cleaning the Front Window Lens......................................................................................151
8.4.1 Cleaning Heavy Contamination......................................................................................................151
8.4.2 Brush Cleaning Method.................................................................................................................151
8.4.3 Wipe Cleaning Method..................................................................................................................152
8.4.4 Dust Cleaning................................................................................................................................152
8.5 Cleaning the Chinrest and Forehead Support ...................................................................153
8.6 Peripherals and Table .......................................................................................................153
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8.7 Cleaning the PC Screen.....................................................................................................153
9 Troubleshooting....................................................................................... 155
9.1 Safety During Troubleshooting.........................................................................................155
9.2 System Startup Errors.......................................................................................................156
9.3 Error Messages.................................................................................................................156
9.4 Information Messages ......................................................................................................158
9.5 Image Quality Troubleshooting ........................................................................................160
10 Specifications ........................................................................................... 163
10.1 Electrical Specifications ....................................................................................................163
10.2 Instrument Specifications .................................................................................................163
10.2.1 At-Instrument Computer Specifications .........................................................................................163
10.3 Dimensions and Weight....................................................................................................164
10.4 Ambient Requirements .....................................................................................................164
10.5 Fundus Camera Specifications ..........................................................................................164
10.6 Laser Classification ...........................................................................................................165
11 Legal Notices ........................................................................................... 167
12 Accessories and User Replaceable Spare Parts ......................................... 169
12.1 Parts Orders .....................................................................................................................169
12.1.1 U.S. Domestic Parts Ordering.........................................................................................................169
12.1.2 International Service Operations ....................................................................................................169
12.2 Accessory Kit Parts List (Replaceable Parts)......................................................................170
12.3 Additional Replaceable Parts............................................................................................171
12.4 Returning Defective Parts.................................................................................................172
12.4.1 Equipment Return Authorization ...................................................................................................172
12.4.2 Packing for Shipment ....................................................................................................................172
13 Decommissioning ..................................................................................... 173
13.1 Safety During Decommissioning .......................................................................................173
14 Packaging and Transport ......................................................................... 175
14.1 Safety During Transport ...................................................................................................175
14.2 Instrument Disposal..........................................................................................................175
15 Disposal ................................................................................................... 177
15.1 Packaging Disposal...........................................................................................................177
15.2 Device Disposal.................................................................................................................177
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Glossary ...................................................................................................179
Index ........................................................................................................ 181
Empty page, for your notes
Instructions for Use 1 Safety and Certifications
CLARUS® 500 1.1 Compliance
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1 Safety and Certifications
1.1 Compliance
CLARUS® 500 from ZEISS is compliant with ISO 10940:2009 and
ISO 15004-1:2006.
1.1.1 Laser Safety and Compliance
1.1.2 Optical Safety
CLARUS® 500 is compliant with the following optical safety
standards:
• IEC 60825-1
• ANSI Z80.36
• ISO 15004-2
• Classification: Group 1 Instrument - Per ANSI Z80.36 and ISO
15004-2
Group 1 instruments are ophthalmic instruments for which no
potential light hazard exists.
• Class 1 Laser Product – Per IEC 60825-1.
1.1.3 RoHS Compliance
The product is RoHS-compliant according to Directive 2011/65/EU.
1.1.4 Electrical Safety
Electrical Safety Class I Equipment - Protection against electrical
shock (per IEC 60601-1).
1 Safety and Certifications Instructions for Use
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1.2 Symbols and Labels
Symbol 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
Instructions for Use 1 Safety and Certifications
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Symbol Meaning
Authorized European Community Representative
Serial Number
Catalog Number/Part Number
Model Number
Certification mark of CSA – Nationally Recognized
Testing Laboratory for US and Canada
Disposal of the Product within the E.U. Do not dispose
via domestic waste disposal system or communal waste
disposal facility.
Fragile
Keep Dry
This End Up
Transport conditions: humidity (10% to 95%)
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Symbol Meaning
Transport conditions: temperature (-40°C to 70°C)
Transport conditions: atmospheric pressure (500 hPa to
1060 hPa)
Caution: Federal law (or United States) restricts this
device to sale by or on the order of a licensed healthcare
practitioner
1.3 Warnings, Cautions, and Notes
1.3.1 Definitions
Warnings 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 covers
may result in injury.
u Only ZEISS authorized service technicians may remove device
covers.
WARNING!
Tipping the device
may result in injury.
u Do not allow the patient to lean on the table or use it as a
support to stand up.
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WARNING!
Modifying this device
may 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 gases
may cause ignition and result in a fire hazard.
u Do not use this device in the presence of flammable anesthetics
or oxidizers such as pure oxygen or nitrous oxide.
WARNING!
Use of this equipment adjacent to or stacked with other
equipment
should be avoided because it could result in improper operation.
u If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating
normally.
WARNING!
Use of accessories, transducers, and cables other than those
specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.
u Use only the accessories, transducers, and cables specified or
provided by ZEISS.
WARNING!
Adding peripheral equipment or replacing parts
may result in noncompliance with the safety requirements of IEC
60601-1.
u You are responsible for ensuring that the system meets the
safety requirements of IEC 60601-1.
u Only approved equipment to their respective IEC/ISO standards
such as IEC 60601-1 or IEC 60950 are allowed to be connected
to the Signal Input/Output parts (SIP/SOPs).
u Place any AC-powered, non-medical device peripherals at least
1.5 m away from the instrument and connect them to a
separation device, unless an isolation transformer is used.
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WARNING!
Unplugging the power cord is the means of disconnecting
from 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 ZEISS
may 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 your
local Zeiss distributor. You can find the ZEISS contact partner
for your country on our website: www.zeiss.com.
WARNING!
Class 3B laser radiation
when open.
u Avoid exposure to beam.
WARNING!
Contact with the patient and a peripheral device
may cause an electric shock.
u Do not touch the patient and a peripheral device at the same
time.
WARNING!
Device produces visual stimuli, including flickering light and
flashing patterns, between 5 and 65 Hz
may adversely affect certain patients, although this effect is yet
unproven.
u Medical professionals need to determine whether this device
should be used for patients who may be photosensitive,
including those with epilepsy.
WARNING!
Unqualified personnel
may 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 or
repair procedures not described in this manual.
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WARNING!
Use of the acquisition device, a printer, or the power table
with an extension cord or a power strip (multiple portable
socket 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 outlet
as the instrument.
u To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
1.3.3 Cautions
CAUTION!
Use of controls or adjustments or performance of procedures
other than those specified herein
may result in hazardous optical radiation exposure.
CAUTION!
Attempting to carry out activities not specifically endorsed
by ZEISS
may void your warranty and could result in damage to the
instrument.
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
authorized ZEISS represenative.
CAUTION!
Improper cleaning
may result in inadequately disinfected equipment.
u Refer to the cleaning instructions in this Instructions for Use
and local and national disinfecting regulations.
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CLARUS® 5001.3 Warnings, Cautions, and Notes
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CAUTION!
Internet connection of the CLARUS® 500
increases its vulnerability to serious security risks, including viruses
and worms that could disable your system or adversely affect its
performance and may void the instrument warranty.
u Transfer data through internal networks.
u Ensure that all firewalls and internet security applications are
up-to-date and running.
u Connecting the device to the internet or transferring data via
USB devices may result in compromised patient privacy and
expose the network to malware.
CAUTION!
Installing or putting the device into service without regard to
EMC information provided
may void your Device warranty, result in damage to the instrument
and/or compromise safety for patients and operators.
u The CLARUS® 500 has special EMC precaution requirements
and needs to be installed and put into service according to the
EMC information provided herein.
CAUTION!
Using this instrument with patients who are light-sensitive,
including epileptics
may cause nausea or harm to the patient.
CAUTION!
Attempting to decommission your system
may 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
decommission your system.
u Contact your ZEISS approved representatives to set up an
appointment for system or instrument decommissioning.
CAUTION!
Packaging and transport by non-ZEISS personnel
could result in damage, loss, or non-compliance within the country
of transit.
u Allow only change to Zeiss approved representative to prepare
the instrument and associated components for transport.
u Allow only ZEISS-approved personnel to transport the
instrument and associated components.
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CLARUS® 500 1.3 Warnings, Cautions, and Notes
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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 whenever
you carry the instrument.
CAUTION!
Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the
device, including cables specified by the manufacturer.
u Otherwise, degradation of the performance of this equipment
could result.
CAUTION!
The Zeiss Instrument is intended for use in a professional
healthcare facility environment.
Using the instrument in any other environment may void the
warranty and compromises the safety of the patient and/or
operator.
CAUTION!
Image Degradation
If image quality is degraded or image is absent from display, please
contact Zeiss customer service.
u The physician must decide whether the image is appropriate for
diagnosis
1.3.4 Notes
NOTE
Transferring data via USB devices
may result in compromised patient privacy and expose the network
to malware.
u Use access controls to ensure that only authorized personnel
use the device.
NOTE
Connecting the device to a network that includes other
equipment
may 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 to
the network, including connecting, disconnecting, or upgrading
equipment.
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NOTE
Unprotected devices
may be at risk from unauthorized individuals.
u Select and set the Password strength setting in the User
management screen.
1.4 Report Serious Accidents
Report any serious incident related to this instrument, the operator,
patient, or anyone else:
• To the instrument manufacturer or distributor.
• (European Union only) To the competent authority in the state
where the instrument operator is established.
1.5 Essential Performance
The main clinical performance of the CLARUS® 500 is to capture,
display and store images to aid in the diagnosis and monitoring of
diseases and disorders occurring in the retina, ocular surface and
visible adnexa. Since there is are no surgical or treatment decisions
made solely on data obtained by the instrument, it was determined
that the CLARUS® 500 has no “essential performance” as defined
in IEC 60601-1 standard.
1.6 Electromagnetic Compatibility (EMC)
WARNING!
Installing or putting the device into service without regard to
EMC information provided
may void your ZEISS instrument warranty, result in damage to the
instrument and/or compromise safety for patients and operators.
u This instrument has special EMC precaution requirements and
needs to be installed and put into service according to the EMC
information provided herein.
NOTE
The emissions characteristics of this equipment
make it suitable for use in industrial areas and hospitals (CISPR 11
Class A).
u If it is used in a residential environment, this equipment might
not offer adequate protection to radio-frequency communication services.
u The user might need to take mitigation measures, such as
relocating or re-orienting the equipment.
Electromagnetic Emissions [}19] and Electromagnetic Immunity
[}19] are required per IEC 60601-1-2:2014.
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1.6.1 Electromagnetic Emissions
The Zeiss Instrument complies with the following emission requirements:
Phenomenon Standard
Conducted and radiated RF
emissions
Group 1
CISPR 11 Class A
Harmonic distortion IEC 61000-3-2
Voltage fluctuations and flicker IEC 61000-3-3 Class A
Table1: Electromagnetic Emissions
1.6.2 Electromagnetic Immunity
The CLARUS® 500 complies with the following immunity requirements:
Phenomenon Basic EMC standard or test
method
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 GHz
80 % AM at 1 kHz
Proximity fields from RF wireless
communications equipment
IEC 61000-4-3 See Wireless Communications
[}20]
Rated power frequency magnetic
fields
IEC 61000-4-8 30 A/m
50 Hz or 60 Hz
Electrical fast transients / bursts IEC 61000-4-4 ± 2 kV 100 kHz repetition
frequency
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 induced
by 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 power
supply input lines
IEC 61000-4-11 0 % UT1; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % UT1; 1 cycle
and
70 % UT1; 25/30 cycles
Single phase: at 0°
Voltage Interruptions IEC 61000-4-11 0 % UT1; 250/300 cycle
Table2: Electomagnetic Immunity
1 Safety and Certifications Instructions for Use
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1
UT is the a.c. mains voltage prior to application of the test level.
1.7 Wireless Communications
Test
Frequency
(MHz)
Band (MHz) Service Modulation Maximum
Power (W)
Distance (m) Immunity
Test 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 kHz
deviation
1 kHz sine
2 0.3 28
710
745
780
704 - 787 LTE Band 13,17Pulse 217 Hz 0.2 0.3 9
810
870
930
800 - 960 GSM
800/900,
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; LTE
Band
1,3,4,25;
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
5500
5785
5100 - 5800 WLAN
802.11 a/n
Pulse 217 Hz 0.2 0.3 9
Table3: Test specifications for enclosure port immunity to RF wireless communications equipment.
Instructions for Use 2 Introduction
CLARUS® 500 2.1 Scope
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2 Introduction
2.1 Scope
2.1.1 Intended Use / Indications for Use
The CLARUS® 500 ophthalmic camera is indicated to capture,
display, annotate and store images to aid in the diagnosis and
monitoring of diseases and disorders occurring in the retina, ocular
surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and
montage fields of view.
2.2 Usage
The CLARUS® 500 is designed for continuous use in a professional
healthcare facility environment.
The mode of operation for the table is 2 minutes on and 20
minutes off.
2.3 Intended Audience
CLARUS® 500 users have a role, which is assigned when an
Administrator creates their username and password. These roles
are:
• Operator
• Doctor
• Administrator
For more information, refer to: About User Roles [}62].
2.3.1 Patient Profile
This device may be used on any patient who is able to sit upright
with his or her face in the instrument's chin and forehead rest,
independently or with assistance.
2.3.2 Operator Profile
2.3.2.1 Intended Demographic
This device is intended for use by the following trained professionals:
• Opticians
• Ophthalmic Photographers
• Optometrists
• Ophthalmologists
2 Introduction Instructions for Use
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• Medical Assistants
• Clinical Researchers
2.3.2.2 Required Skills
Operators are expected to have the following skills:
• Knowledge of how to capture fundus images
• Experience managing patients
• Experience with the Microsoft Windows operating system and
applications based on it
2.3.3 Doctor Profile
2.3.3.1 Intended Demographic
Doctors are ophthalmologisst, optometrists, or other heath care
professionals with training in interpretation of fundus images.
2.3.3.2 Required Skills
Doctors are expected to know how to evaluate fundus images.
2.3.4 Administrator Profile
2.3.4.1 Intended Demographic
Administrators maintain the facility's computers, instruments, and
networks.
2.3.4.2 Required Skills
Administrators are expected to know:
• Windows administration principles
• Networking principles
• Data management principles
• Permissions and user assignment principles
• The site or facility systems, including:
– Network(s)
– Computers and connections
– Medical record system connections
– Instrument connections
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2.4 User Documentation
2.4.1 Purpose
The user documentation that comes with your device is provided to
ensure that all users operate and maintain it safely and successfully.
• Read all user documentation before starting and using the
device
• Keep all user documentation where it is accessible at all times
for all users
• Pass the user documentation on to the next owner of the
device
2.4.2 Access
User documentation for your device is provided on the USB drive
that came with the device as part of the Instrument Accessory Kit.
2.4.3 Conventions Used in This Document
Certain types of information are specially marked in this document
for better recognition.
• This is a list.
– This is a second level list.
This is a cross-reference: Questions and comments [}23].
This is software code or program text.
The name of software windows are Capitalized. For example:
"Patient Screen"
Names of menus, and buttons or other selectable items, are shown
in Bold.
• View menu.
• File > Save as
• My documents > Documents
2.5 Questions and Comments
If you have questions or comments about this user documentation
or the device, contact your ZEISS representative.
2.6 System Overview
2.6.1 System Description
CLARUS® 500 is a non-contact, high-resolution imaging device for
in vivo imaging of the human eye. Imaging modes include:
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• True color reflectance imaging
• Fundus autofluorescence with green or blue excitation (FAF-G
and FAF-B)
• Stereo imaging
• External eye imaging
2.6.1.1 Principles of Operation
Using a monochromatic camera, a broad line of illumination scans
across the retina.
Red, green and blue Light Emitting Diodes (LEDs) sequentially
illuminate to generate true color images. The broad bandwidth of
LEDs gives a true color rendering. Blue and green LED illumination
enables Fundus AutoFlourescence (FAF) imaging.
By illuminating only a narrow strip of the retina at a time, the
illumination stays out of the viewing path, keeping haze and
fluorescence of the anterior segment out of the retinal image and
allowing a clear view of much more of the retina than the annularring illumination used in traditional fundus cameras. The design
allows a single exposure to image an area of the retina previously
covered by the 7-fields in the Early Rreatment of Diabetic
Retinopathy Study (ETDRS).
2.6.1.2 Key Features
Scan Type Options:
• True color
• Fundus autofluorescence with green excitation
• Fundus autofluorescence with blue excitation
• Stereo imaging
• External eye imaging
Field of View Options:
• Widefield: A single image with a 133° FOV when measured
from the center of the eye.
(90° when measured as described in ISO 10940).
• Ultra-widefield: Two images stitched together into a montage
with a 200° FOV when measured from the center of the eye.
(135° when measured as described in ISO 10940).
• AutoMontage: a 4-scan montage using preset fixation targets.
• Montage: 2-6 widefield images stitched into a single,
combined retina image.
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2.6.2 Hardware Overview
The CLARUS® 500 is connected to the All-in-One PC using cables
mounted under the table. The operator controls the instrument and
software using the instrument joystick, the All-in-One PC touchscreen, wireless keyboard and touchpad.
2.6.2.1 System Hardware
1
2
3
4
5
6
Figure1: System Hardware
1 CLARUS® 500 Acquisition
Head
2 All-in-One PC
3 Keyboard Tray 4 Touchpad
5 Keyboard 6 Joystick
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2.6.2.1.1 USB Locations
1
2
Figure2: USB Port Locations (6 total)
Number Type Quantity Location
1 USB 2.0 2 Side
2 USB 3.0 4 Bottom
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2.6.2.2 Patient View
1
2
3
4
Figure3: Patient View
1 Forehead rest Helps keep the patient's head steady and in
place
2 Front lens Aperture for image acquisition
3 Chin rest Positions the patient's head at the correct
height
4 Chin rest
adjuster
Manually raises and lowers the chin rest
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2.6.2.3 Operator Controls
3
4
1
2
Figure4: Operator Controls
1 Focus knob Manually adjusts the focus
2 Friction knob Tightens or loosens the swivel movement of the
acquisition head
3 Joystick Moves the acquisition head side-to-side and
forward and back
(The joystick button triggers image capture)
4 Cross-table lock Locks the lateral movement of the acquisition
head
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2.6.2.4 External Fixation Target
2
1
3
Figure5: Installing the External Fixation Target
1 External Fixation
Target
Used when patient cannot see the internal
fixation target
2 External Fixation
Target Mount
Mount for the external fixation target
3 Patient Support Support for the headrest and chinrest
2.6.3 Software Overview
The instrument software includes three distinct areas: Patient,
Acquire, and Analyze windows. All windows use the same top
toolbar.
2.6.3.1 Main Toolbar
1
2
3
4
5 6
Figure6: Main Toolbar
Pos. Symbol Explanation
1 Indicates your current screen:
• Patient
• Patient > Acquire
• Patient > Analyze
2 Quickly hides the screen for patient privacy
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Pos. Symbol Explanation
3 Opens notification volume control
4 Opens the Settings to configure the instrument and set your
preferences
5 Minimizes the application on the computer's desktop
6 Allows you 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
Figure7: 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
5 Acquire Opens the Acquire window allowing you to acquire new scans for
the selected patient
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