Zeiss CLARUS 500 User manual

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 States
and/or other countries.
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Mac OS, iMac, iPad, and QuickTime are either registered trade-
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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
CLARUS 500
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Table of Contents
1 Safety and Certifications .............................................................................. 7
1.1 Compliance...........................................................................................................................7
1.1.1 Laser Safety and Compliance.............................................................................................................7
1.1.2 Optical Safety....................................................................................................................................7
1.1.3 RoHS Compliance..............................................................................................................................7
1.1.4 Electrical Safety .................................................................................................................................8
1.2 Symbols and Labels ..............................................................................................................8
1.3 Warnings, Cautions, and Notes ..........................................................................................10
1.3.1 Definitions.......................................................................................................................................10
1.3.2 Warnings.........................................................................................................................................10
1.3.3 Cautions..........................................................................................................................................12
1.3.4 Notes ..............................................................................................................................................14
1.4 Report Serious Accidents....................................................................................................15
1.5 Essential Performance ........................................................................................................15
1.6 Electromagnetic Compatibility (EMC)..................................................................................15
1.6.1 Electromagnetic Emissions...............................................................................................................16
1.6.2 Electromagnetic Immunity...............................................................................................................17
1.6.3 Wireless Communications................................................................................................................17
2 Introduction ............................................................................................... 19
2.1 Scope..................................................................................................................................19
2.1.1 Intended Use / Indications for Use ...................................................................................................19
2.2 Usage .................................................................................................................................19
2.3 Intended Audience .............................................................................................................19
2.3.1 Patient Profile..................................................................................................................................19
2.3.2 Operator Profile...............................................................................................................................19
2.3.3 Data Analyst Profile .........................................................................................................................20
2.4 User Documentation...........................................................................................................20
2.4.1 Purpose...........................................................................................................................................20
2.4.2 Access.............................................................................................................................................20
2.4.3 Conventions Used in This Document................................................................................................20
2.5 Questions and Comments ...................................................................................................21
2.6 System Overview ................................................................................................................21
2.6.1 System Description ..........................................................................................................................21
2.6.2 Hardware Overview.........................................................................................................................22
2.6.3 Software Overview ..........................................................................................................................26
2.6.4 Networking Overview......................................................................................................................32
3 Installation ................................................................................................. 33
3.1 Hardware Installation .........................................................................................................33
3.1.1 Installation Requirements ................................................................................................................33
3.1.2 Installing the Instrument..................................................................................................................33
3.2 Software Installation ..........................................................................................................33

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3.2.1 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 Operation................................................................................................... 41
5.1 Safety During Operation.....................................................................................................41
5.2 Managing Data...................................................................................................................41
5.2.1 Manage Patient Records..................................................................................................................41
5.2.2 Manage Users .................................................................................................................................47
5.2.3 Manage Backups.............................................................................................................................50
5.2.4 Log Files ..........................................................................................................................................52
5.3 Preparing the Device ..........................................................................................................53
5.4 Preparing the Patient .........................................................................................................53
5.4.1 Dilating the Patient’s Eyes (Optional) ...............................................................................................53
5.4.2 Selecting the Patient........................................................................................................................53
5.4.3 Positioning the Patient ....................................................................................................................54
5.4.4 Aligning and Focusing on the Patient's Eye......................................................................................57
5.5 Acquire Images...................................................................................................................60
5.5.1 Acquisition Options .........................................................................................................................60
5.5.2 Blinking the Fixation Target .............................................................................................................66
5.5.3 Manually Positioning the Internal Fixation Target ............................................................................66
5.5.4 Capturing a Widefield Image ...........................................................................................................67
5.5.5 Capturing an Ultra Widefield Image (2-Image Montage)..................................................................69
5.5.6 Capturing an AutoMontage Image (4-Image Montage) ...................................................................71
5.5.7 Capturing a Montage Image (2-6 Image Custom Montage) .............................................................73
5.5.8 Capturing a Stereo Image................................................................................................................75
5.5.9 Capturing an External Eye Image .....................................................................................................77
5.5.10 Using the External Fixation Target ...................................................................................................77
5.5.11 Checking Scan Quality .....................................................................................................................78
5.5.12 Deleting or Replacing an Image.......................................................................................................78
5.6 Analyze Images ..................................................................................................................79
5.6.1 Proof...............................................................................................................................................80
5.6.2 Review ............................................................................................................................................80
5.6.3 Opening the Analyze Window .........................................................................................................80
5.6.4 Selecting and Sorting Images...........................................................................................................81
5.6.5 Editing Scanned Images...................................................................................................................82
5.6.6 Manually Creating a Montage .........................................................................................................94
5.6.7 Viewing Stereo Images....................................................................................................................94
5.6.8 Saving Edited Images.......................................................................................................................95
5.6.9 Creating a Report ............................................................................................................................95
5.7 Shutdown ...........................................................................................................................96
5.7.1 Logging Off.....................................................................................................................................96
5.7.2 Shutting Down ................................................................................................................................96
6 Configuration ............................................................................................. 99

Instructions for Use Table of Contents
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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....................................................................................................109
7.3.1 Removing Fluid Splashes................................................................................................................109
7.3.2 Removing Minor Dust Accumulation .............................................................................................109
7.3.3 Removing Severe Contamination ...................................................................................................110
7.3.4 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 .................................................................................................119
10.2.1 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 .....................................................................................................................125
12.1.1 U.S. Domestic Parts Ordering.........................................................................................................125
12.1.2 International Service Operations ....................................................................................................125
12.2 Accessory Kit Parts List ....................................................................................................126
12.3 Replaceable Parts .............................................................................................................127
12.3.1 Covers...........................................................................................................................................127
12.3.2 Cables ...........................................................................................................................................127
12.4 Returning Defective Parts.................................................................................................127
12.4.1 Equipment Return Authorization ...................................................................................................128
12.4.2 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 Certifications
CLARUS 500 1.1 Compliance
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1 Safety and Certifications
1.1 Compliance
CLARUS™ 500 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 stan-
dards:
• 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 Safety and Certifications Instructions for Use
CLARUS 5001.2 Symbols and Labels
8 / 144 2660021165005 Rev. A 2017-08
1.1.4 Electrical Safety
Electrical Safety Class I Equipment - Protection against electrical
shock (per IEC 60601-1).
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
Authorized European Community Representative

Instructions for Use 1 Safety and Certifications
CLARUS 500 1.2 Symbols and Labels
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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 dispose
via domestic waste disposal system or communal waste
disposal 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 to
1060 hPa)

1 Safety and Certifications Instructions for Use
CLARUS 5001.3 Warnings, Cautions, and Notes
10 / 144 2660021165005 Rev. A 2017-08
Symbol Meaning
Caution: Federal law (or United States) restricts this de-
vice 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.
uThese are actions that can be taken to prevent the hazard.
CAUTION! Indicates hazards that, if not avoided,
could cause minor or moderate injury.
uThese are actions that can be taken to prevent the hazard.
1.3.2 Warnings
WARNING! Opening the device covers
may result in injury.
uOnly ZEISS authorized service technicians may remove device
covers.
WARNING! Tipping the device
may result in injury.
uDo not allow the patient to lean on the table or use it as a sup-
port to stand up.
WARNING! Modifying this device
may increase risks and decrease the service life of the device.
uDo not use in the presence of flammable gasses.
uDo 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.
uDo not use this device in the presence of flammable anesthetics
or oxidizers such as pure oxygen or nitrous oxide.

Instructions for Use 1 Safety and Certifications
CLARUS 500 1.3 Warnings, Cautions, and Notes
2660021165005 Rev. A 2017-08 11 / 144
WARNING! Use of this equipment adjacent to or stacked with other
equipment
should be avoided because it could result in improper operation.
uIf 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 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.
uUse 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.
uYou are responsible for ensuring that the system meets the
safety requirements of IEC 60601-1.
uOnly 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).
uPlace any AC-powered, non-medical device peripherals at least
1.5 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 disconnecting
from the power supply.
Blocking access to the plug may result in an electrical hazard.
uSet 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.
uUse only accessories authorized by ZEISS.
uIn 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.
uAvoid exposure to beam.

1 Safety and Certifications Instructions for Use
CLARUS 5001.3 Warnings, Cautions, and Notes
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WARNING! Contact with the patient and a peripheral device
may cause an electric shock.
uDo 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 un-
proven.
uMedical professionals need to determine whether this device
should be used for patients who may be photosensitive, includ-
ing those with epilepsy.
WARNING! Unqualified personnel
may injure themselves or cause damage to the instrument.
uOnly trained, qualified personnel may use this device.
uThis device may be used only for its intended purpose.
uOnly ZEISS authorized personnel may perform maintenance or
repair procedures not described in this manual.
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 instru-
ment.
uRead the user documentation.
uFollow directions carefully.
uDo not make upgrades, or carry out repairs or modifications,
without specific guidance and instruction from ZEISS or an au-
thorized ZEISS represenative.
CAUTION! Improper cleaning
may result in inadequately disinfected equipment.
uRefer to the cleaning instructions in this Instructions for Use
and local and national disinfecting regulations.

Instructions for Use 1 Safety and Certifications
CLARUS 500 1.3 Warnings, Cautions, and Notes
2660021165005 Rev. A 2017-08 13 / 144
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.
uTransfer data through internal networks.
uEnsure that all firewalls and internet security applications are
up-to-date and running.
uConnecting the device to the internet or transferring data via
USB devices may result in compromised patient privacy and ex-
pose 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.
uThe CLARUS 500 has special EMC precaution requirements and
needs to be installed and put into service according to the EMC
information provided herein.
CAUTION! 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.
uDo not use extension cords with the instrument.
uDo not use power strips with the instrument.
uDo not plug in any other equipment into the same wall outlet
as the instrument.
uTo avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
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.
uNever attempt to decommission a ZEISS system or instrument.
Only ZEISS approved representatives are qualified to safely de-
commission your system.
uContact your ZEISS approved representatives to set up an ap-
pointment for system or instrument decommissioning.

1 Safety and Certifications Instructions for Use
CLARUS 5001.3 Warnings, Cautions, and Notes
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CAUTION! Packaging and transport by non-ZEISS personnel
could result in damage, loss, or non-compliance within the country
of transit.
uAllow only change to Zeiss approved representative to prepare
the instrument and associated components for transport.
uAllow 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.
uMake sure you support the instrument from the base whenever
you 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 the
device, including cables specified by the manufacturer.
uOtherwise, degradation of the performance of this equipment
could 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 Degradation
If image quality is degraded or image is absent from display, please
contact Zeiss customer service.
uThe 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.
uUse access controls to ensure that only authorized personnel
use the device.

Instructions for Use 1 Safety and Certifications
CLARUS 500 1.4 Report Serious Accidents
2660021165005 Rev. A 2017-08 15 / 144
NOTE Connecting the device to a network that includes other
equipment
may result in previously unidentified risks.
uYou are responsible for analyzing and controlling these risks.
uYou must reassess these risks when you make any changes to
the network, including connecting, disconnecting, or upgrading
equipment.
NOTE Unprotected devices
may be at risk from unauthorized individuals.
uSelect and set the Password strength setting in the User man-
agement 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 compentent 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, 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 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 Device warranty, result in damage to the instrument
and/or compromise safety for patients and operators.
uCLARUS 500 has special EMC precaution requirements and
needs to be installed and put into service according to the EMC
information provided herein.

1 Safety and Certifications Instructions for Use
CLARUS 5001.6 Electromagnetic Compatibility (EMC)
16 / 144 2660021165005 Rev. A 2017-08
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.
uUse only the accessories, transducers, and cables specified or
provided by ZEISS.
WARNING! Use of this equipment adjacent to or stacked with other
equipment
should be avoided because it could result in improper operation.
uIf 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 the
device, including cables specified by the manufacturer.
uOtherwise, degradation of the performance of this equipment
could result.
NOTE The emissions characteristics of this equipment
make it suitable for use in industrial areas and hospitals (CISPR 11
Class A).
uIf it is used in a residential environment, this equipment might
not offer adequate protection to radio-frequency communica-
tion services.
uThe user might need to take mitigation measures, such as relo-
cating or re-orienting the equipment.
1.6.1 Electromagnetic Emissions
The 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

Instructions for Use 1 Safety and Certifications
CLARUS 500 1.6 Electromagnetic Compatibility (EMC)
2660021165005 Rev. A 2017-08 17 / 144
1.6.2 Electromagnetic Immunity
The CLARUS 500 complies with the following immunity require-
ments:
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
[}17]
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 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 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
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 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

1 Safety and Certifications Instructions for Use
CLARUS 5001.6 Electromagnetic Compatibility (EMC)
18 / 144 2660021165005 Rev. A 2017-08
Test Fre-
quency (MHz)
Band (MHz) Service Modulation Maximum
power (W)
Distance (m) Immunity
Test Level (V/
m)
710
745
780
704 - 787 LTE Band 13,
17
Pulse 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
Table1: 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 ophthalmic camera is intended to capture, display,
measure, 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, infrared re-
flectance, and autofluorescence imaging modes for stereo, wide-
field, ultra-widefield, and montage fields of view.
2.2 Usage
The CLARUS 500 is designed for continuous use in a professional
healthcare facility environment.
Also see about this
2Safety and Certifications [}7]
2.3 Intended Audience
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, 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:

2 Introduction Instructions for Use
CLARUS 5002.4 User Documentation
20 / 144 2660021165005 Rev. A 2017-08
• 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 Data Analyst Profile
Operators who analyze the results of patient scans should have the
following additional qualifications.
2.3.3.1 Intended Demographic
Analysis should be done by an ophthalmologist, optometrist, or
other 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 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 de-
vice
• 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 de-
vice
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 [}20].
This is software code or program text.