Optical Coherence Tomography

Model: PRIMUS 200

User Manual
ii

This PRIMUS User Manual1 contains the instructions for use for the PRIMUS instrument,
including safety information.

Copyright
© 2017 Carl Zeiss Meditec, Inc. All rights reserved in the events of granting of patents or
registration as a utility patent.

Trademarks
FORUM, Selective Pixel Profiling, AutoConnect, Auto Fovea Finder and AutoCenter are
registered trademarks of Carl Zeiss Meditec, Inc. in the United States and/or other
countries.
Windows and Microsoft are either registered trademarks or trademarks of Microsoft
Corporation in the United States and/or other countries. Carl Zeiss Meditec accepts no
liability for the performance or use of such products.
All other trademarks used in this document are the property of their respective owners.
Third party products are cited for information purposes only. This does not represent
approval or recommendation of these products. Other brand names, software and
hardware names used in this manual are generally subject to trademark or patent
protection. The quoting of products is for informational purposes only and does not
represent a trademark misuse.

Patents
www.meditec.zeiss.com/patents

Reproduction
This manual is protected by copyright. Unless expressly authorized in writing,
dissemination, duplication or other commercial exploitation of this document or
communication of its contents or parts of it is not permitted. In case of infringement, the
violator may be liable to pay compensation for damages.

Change Notice
Specifications due to technical developments are subject to change. This manual is not
subject to the revision service. Please contact the manufacturer or authorized dealer to
request the latest edition of the manual.

Usability
The usability of the PRIMUS instrument is reviewed by cross-functional product team and is
sufficiently represented by the User Manual, Quick Instructions and Release Notes.

1. At present, the user manual is offered only in English language and will be translated later in certain
localized languages and released by a certified translation agency, which will provide a Notarized
Translation Certificate of Authenticity (TCOA).

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 Contents iii

Contents

(1) Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Purpose of This User Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
PRIMUS Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
PRIMUS System Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
User Changes to Software or Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Instrument Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Precautions and Tips to Avoid Damage . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Protection of Patient Health Information . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
Symbols and Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
Protective Packing Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
USB Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Product Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Instrument Disposition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Abbreviations and Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
(2) Operational Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Chapter Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Startup - System and PRIMUS Application . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Initial System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Operational Sequence and Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Key Screens and its Zones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Function Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Performance Verification Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Power Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
(3) Acquire Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Chapter Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Acquisition Screen - Macular Thickness . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Acquisition Screen - HD 5 Line Raster . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Identify the Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Prepare the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Initiate a Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Guidelines for Obtaining Good Quality Scans . . . . . . . . . . . . . . . . . . . . 3-29
(4) Analyze Reports: Retina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

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Chapter Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Access Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Retinal Layers Automatically Detected and Displayed . . . . . . . . . . . . . . . 4-2
Macular Thickness Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Macular Thickness Analysis (MTA) Follow-up . . . . . . . . . . . . . . . . . . . . . 4-13
Eye Health Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
5-line HD Raster Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
1-line HD Raster Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Reports and Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
(5) Analyze Reports: Glaucoma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Chapter Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Access Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
ONH & RNFL Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
RNFL Thickness Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Reports and Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
(6) Anterior Segment Scan Acquisition and Analysis . . . . . . . . . . . 6-1
Acquiring Anterior Segment Scan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Auto Central Corneal Thickness (CCT). . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Scan Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Anterior Segment - Scan Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
(7) Data Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Chapter Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
The Administrator User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Create Institution Name and Logo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
System Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
User Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Patient Record Search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Add, Edit, Delete, Exam and Merge Patient Records . . . . . . . . . . . . . . . . 7-9
Usage Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13
Edit or Print Analysis Report(s). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14
Export to Optical Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14
Export PDF Analysis to USB Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-16
Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18
(8) Backup and Restore . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Chapter Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Data Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Backup Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
PRIMUS Hard Disk Drive(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

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Backup Data Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Restore Data Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Export Log files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
(9) Routine Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Chapter Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Fuse Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Handling Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Routine Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
(10) Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
OCT Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Fundus Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Electrical, Physical and Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Measurement Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
(11) Legal Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Software Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Software License Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

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 Introduction 1-1

(1) Introduction

Intended Use
PRIMUS 200 OCT with Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH) and
Macular Normative Databases is indicated for in-vivo viewing, axial cross sectional
imaging and measurement of anterior and posterior ocular structures.

Indications for Use

PRIMUS 200 OCT is a non-contact, high resolution tomographic and biomicroscopic
imaging device. It is indicated for in-vivo viewing, axial cross-sectional imaging and
measurement of anterior and posterior ocular structures, including cornea, retina, retinal
nerve fiber layer, macula, and optic nerve head. The PRIMUS normative databases are
quantitative tools for the comparison of retinal nerve fiber layer (RNFL) thickness, macular
thickness and optic nerve head (ONH) measurements to a database of normal subjects. It is
intended for use as a diagnostic device to aid in the detection and management of ocular
diseases including, but not limited to, macular holes, cystoid macular edema, diabetic
retinopathy, age-related macular degeneration and glaucoma.
Note: The PRIMUS instrument is not intended to be used as the sole diagnostic method for
any disease.
PRIMUS instrument is a stand-alone comprehensive Spectral Domain Optical Coherence
Tomography (SD-OCT) device which offers:
• an affordable and reliable OCT clinical tool with basic functions to aid in the diagnosis
and management of retinal diseases and glaucoma.
• quality imaging combined with capable glaucoma/retina visualization for improved
diagnostic confidence, a simple work-flow experience, and patient-oriented educational
reports to enhance patient satisfaction and practice loyalty.

Patient Population
The PRIMUS instrument may be used on all adults in need of diagnostic evaluation of the
eye. This includes (but is not limited to) patients with the following disabilities or
challenges:
• Wheelchair user
• Very low or not measurable visual acuity
• Fixation problems
• Postural problems
• Deafness
• Large body, but not those above 99th percentile based on anthropomorphic data.
There is a general requirement that the patient be able to sit upright and be able to place
their face in the chin and forehead rest of the instrument (with or without supplemental
human or mechanical support).

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Application
The PRIMUS instrument is designed for continuous use, although it is expected that most
sites operate the instrument for 10 hours or less per day, indoors (not in direct sunlight),
within a medical office or hospital setting. This setting shall have clean air free of soot,
vapors from adhesives, grease, or volatile organic chemicals. Other Operating Environment
specifications are given in Chapter 10. Application related warnings are given in this
chapter and elsewhere.
PRIMUS instrument is not a portable device. It is intended for placement in one location.
However, there is no permanently installed infrastructure associated with the instrument,
and it can be moved between locations following the applicable guidelines and warnings
in this chapter.

Operator Profile
We assume that users are clinicians or technicians with professional training or experience
in the use of ophthalmic imaging equipment, proper patient handling and in diagnostic
interpretation of the images generated. Specific assumptions regarding the profiles of
individuals performing instrument operation or data visualization are given below. This
manual contains information that will aid in the proper instrument operation and
visualization of the resultant data.

CAUTION: Carl Zeiss Suzhou is not responsible for diagnostic interpretation. It is the
clinician’s responsibility to make diagnostic interpretations of OCT scans.

Instrument Operation
Demographic
An adult with one of the following qualifications:
• Ophthalmologist or other Medical Doctor
• Optometrist or equivalent
• Nurse
• Certified Medical Technician
• Ophthalmic Photographer
• Non-certified Assistant.

Occupational Skills
Must possess all of the following skills:
• Computer literate
• Basic knowledge of the eye
• Ability to work with elderly patients and those with disabilities.

Job Requirements
Must be able to perform all of the following operations:
• Power on the unit and log on
• Enter, find and modify patient identifying data

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 Introduction 1-3

• Clean surfaces that contact patient

• Position patient with the device, aligning the device, the table height and the patient's
chair
• Select and acquire scan
• Review and save scan or try again
• Visualize report(s)
• Review the analysis report for completeness
• Output analysis report
• Backup data using USB devices like flash drive or external hard disk
• Turn off the unit

Data Visualization
Demographic
• Ophthalmologist or other Medical Doctor
• Optometrist or equivalent

Occupational Skills
• Computer literate
• Ability to work with elderly patients and those with disabilities

Job Requirements
Training and certification as required by governing bodies to visualize the analysis in the
treatment of ophthalmic diseases or other eye-related medical issues.

Purpose of This User Manual

ZEISS designed this User Manual to serve as a training, usage, and reference guide for
proper scanning and operation of the instrument. While we offer training in the use of the
PRIMUS instrument, we do not offer instruction in diagnostic interpretation of the data and
analyses. This manual does not attempt to do so either.
Below are explanations of three symbols used throughout the manual that require special
attention:

WARNING: Failure to follow instructions may result in a hazard that can

lead to serious injury to person and property. Instructions may also
describe potential serious adverse reactions and safety hazards.

CAUTION: Failure to follow instructions may result in a hazard that may lead to
moderate injury or damage to the equipment or other property.

Note: Important information which should be given special attention.

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Organization of this Manual

This introductory chapter provides a system description, installation and safety information.
Chapter 2 provides an overview of how to operate the PRIMUS instrument. Chapter 3
explains in detail how to acquire scans. Chapter 4, 5 and 6 covers the analysis
functionality along with reports. Chapter 7 explains about user’s data management.
Chapter 8 explains the Backup and Restore functionality. Chapters 9, 10 and 11 cover
Routine Maintenance, Instrument Specifications, and Legal Notices respectively.
Note: Your instrument may exhibit minor differences in appearance on individual screens,
depending upon serial number of the instrument.

Electronic User Manual Access

The electronic PRIMUS User Manual is provided with the instrument via CD or USB flash
drive which are included in the software kit “FLASH DRIVE SW PRIMUS 200”. You need to
view the User Manual PDF using a separate computer.

Navigating within a PDF Version of the User Manual

In the PDF version of the User Manual, when the mouse cursor is over a blue
cross-reference link, the mouse cursor changes to a finger pointer ( ). Clicking a
+ cross-reference link takes you to the referenced section in the manual.
• To return to the page where you clicked the cross-reference link, press Alt+left arrow on
the keyboard, as shown on the left.
+ • Press Alt+right arrow to return to the cross-referenced page, as shown on the left.

Text Conventions
• “Click” means “left mouse button click”.
• Chain of menu items are indicated with the use of the “>” symbol between items. For
example, “ > ” directs you to select Shut down in the Logoff / Shutdown
menu.

Access the Menu

PRIMUS offers Help , Settings and Logoff / Shutdown menus. To access the
options offered through each menu, click the menu headings.
To go back to the Patient screen;
• Click outside the Logoff / Shutdown ( ) option to make the option disappear.
• Click Close on the help screen or Back on the SETTINGS screen.
Grayed-out menu icons show that they are not available in that context.

On-line Help Access

Click Help menu to access the information related to the PRIMUS application through
the PRIMUS software. Help opens a brief HTML version of the PRIMUS - User Manual.

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 Introduction 1-5

Once opened, you can click on each topic on the left side of the help page to read the
particular topic. Hit the Backspace button on your keyboard to view the previous topics
read. Click Close to quit the help screen.
Note: Use the PDF or hard copy manual for full instructions.

PRIMUS Technology
The PRIMUS is a computerized instrument that acquires and allows visualization of
cross-sectional tomograms of the eye using Spectral Domain Optical Coherence
Tomography (SD-OCT). SD-OCT is a form of non-invasive, low-coherence interferometry
that produces high-resolution tomograms without contacting the eye.
In low-coherence interferometry, light is sent along two optical paths, one being the
sample path (into the eye) and the other the reference path of the interferometer. The light
source is an 840 nm Superluminescent Light emitting Diode (SLD). Light beams returning
from the sample and reference paths are combined and introduced to the detector, which
is a spectrometer in SD-OCT. The spectrometer resolves the interference signals throughout
the depth of each A-scan immediately by means of a Fourier transformation. This is
possible because the spectrometer resolves the relative amplitudes and phases of the
spectral components scattered back from all depths of each A-scan tissue sample, without
varying the length of the reference path.
PRIMUS instrument employs various technologies to provide an image of the retinal area
addressed by the scan. PRIMUS instrument includes a confocal Scanning Laser
Ophthalmoscope (cSLO) and uses the OCT beam to create the retinal image.

Software
ZEISS pre-installs all software necessary to operate the PRIMUS instrument. Software
updates with installation instructions may be provided on a DVD or USB flash drive.
Note: Only ZEISS service personnel can install software updates. The required Windows
environment can be reached only through Service login.

Data Storage
The system computer stores data locally. We strongly recommend backup of PRIMUS exam
data to a USB flash drive or an External hard disk. For more information, please refer to
Chapter 8.
Archival storage of analysis ePDF(s) is designed to occur in a network environment. We
recommend archiving analysis PDF(s) to DICOM archive device, which operates as a
network file server. For more information, see Chapter 7, Data Management.

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PRIMUS System Hardware

The major components of PRIMUS instrument are OCT Engine, Optical head, Power supply
module, Patient support (Forehead/Chin rest), Video Monitor, Keyboard, Mouse, motorized
adjustable instrument table (optional) and Printer (optional). The PRIMUS instrument’s OCT
Engine integrates the scan acquisition optics, the interferometer, spectrometer and
computer. ZEISS offers a wheelchair accessible motorized power table (optional)
(Figure 1-1), which accommodates elevation adjustment to each patient's height. On the
backside of the OCT Engine, there are four USB ports (Figure 1-2). System specifications
are provided in Chapter 10.
For Anterior Segment OCT imaging, an external optics is provided in addition to the
posterior segment optics, which must be mounted by the user when Anterior Segment
reports are selected.

18
17
16
1
15
2
14
13 3
12 4
11

10 5
6
9
7

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1 Optical Head 8 Caster(s) 15 Chin Rest

2 Video Monitor 9 Table Up and Down Switch 16 Forehead Rest
3 Keyboard 10 Motorized Height Adjustable instrument table 17 Forehead / Chin Rest
4 Mouse 11 Joy Stick with Trigger 18 External Fixation Arm
5 Power Supply Module 12 Swivel Knob - Anterior Segment External Optics
(not illustrated)
6 System Power Switch 13 Knob - Forehead / Chin Rest Height Adjustment
7 OCT Engine 14 Refractive Error Knob

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 Introduction 1-7

Note: Carl Zeiss Suzhou provide two kinds of motorized tables as optional component.
a. K2-110C/230C table with 1-tabletop (110V or 230V version)
b. YT2Z/YT2Z1 table with 2-tabletop (230V or 110V version)
Please read the specified table user manual for the detailed instructions. The table's user
manual is included in the package of the table.
Note: The optional K2 Power Table is safe to use within the patient environment when the
instrument is powered through it, as instructed herein.
Note: When PRIMUS is connected to K2 tables, the rating power is 240VA.

User Changes to Software or Hardware

The PRIMUS instrument is a medical device. The software and hardware have been
designed in accordance with U.S., European and other international medical device
standards designed to protect clinicians, users and patients from potential harm caused by
mechanical, diagnostic or therapeutic failures.

WARNING: Do not modify or add to the software found on the PRIMUS

instrument except as authorized by ZEISS. Unauthorized modification of
PRIMUS software or hardware (including peripherals) can jeopardize the
safety of operators and patients, the performance of the instrument, and
the integrity of patient data. Unauthorized modification also voids the
instrument warranty.

Instrument Installation
Only a ZEISS authorized representative should install the PRIMUS instrument, who will
verify proper operation of the instrument.
Note: Only trained ZEISS Service personnel may perform calibration (see Performance
Verification Check, page 2-20).
Once the instrument is installed, make sure that you do not move the Optical Head and
OCT Engine. This will cause the cables between the Optical Head and OCT Engine to break.
Note: Leaning or placing many items (other than the PRIMUS equipment) on the table may
cause table breakdown.

Care in Handling
Use extreme care when handling and transporting the PRIMUS instrument shipping boxes.
The instrument contains fragile optics that require highly precise alignment.

Installation Requirements
• The instrument with the optional height adjustable table requires a floor area of at least
6' x 8' (1.80 m by 2.4 m) for installation and patient comfort during use.
• You must install it in a ventilated room and must not block the ventilated instrument
covers that allow heat to dissipate from the device. For more information on acceptable

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operating conditions (electrical, physical and environmental), see Specifications,

page 10-1.

CAUTION: Failure to provide proper ventilation could potentially lead to heat

build-up, which could cause component failure and/or fire.

CAUTION: Do not bundle the device cables, as this may lead to heat build-up
causing instrument shutdown.

• The PRIMUS must operate on a dedicated power outlet. PRIMUS is pre-configured at

factory to work on 100-240VAC line voltage.

Precautions and Tips to Avoid Damage

CAUTION: Users are not authorized to dismantle or modify the PRIMUS instrument
hardware. To transport the instrument outside the office, you must consult with a
ZEISS service technician. Failure to do so voids all warranties offered with the
PRIMUS instrument.

• Only ZEISS authorized technicians should disassemble or service this

instrument. In the case of malfunction, error messages or operational problems,
contact ZEISS customer service or your local CZM distributor.
• This instrument has no special measures to protect against harmful ingress of
water or other liquids (classified IPX0—ordinary equipment). Do not place
containers of liquid on or near the instrument, and do not use aerosols on or
near it.
• Do not place containers of liquid on or near the table where spillage onto the
instrument or table could occur, resulting in a safety hazard and/or damage to the
instrument or the table.
• In case of a non-medical emergency related to the instrument, unplug the power
cord from the wall outlet and call for service immediately.
• Do not place the OCT engine very near to the wall. To prevent heat buildup that
may damage the instrument, you must install it in a ventilated room and must
not block the ventilated instrument covers that allow heat to dissipate from the
device. For more information on acceptable operating conditions, see
Specifications on page 10-1.
• If the temperature of instrument covers is more than 48 degree Celsius during
working conditions
• the user and patient must not touch the Optical Head for more than 1 minute.
• the user must not touch the OCT engine for more than 10 seconds.
• the user must not touch the power supply for more than 1 second.
• With the exception of the main power fuse(s) in power supply module, there are
no user-replaceable parts in the instrument. For the replacement of any
component, accessory, or peripheral, except the fuse(s), contact ZEISS customer
service or your local CZM distributor.

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• The instrument must be turned off when not in use for an extended period.
• The instrument cannot be used with a flammable liquid (reagent, etc).
• The instrument cannot be used in an oxygen-rich environment.
• See Routine Cleaning, page 9-3 for instructions on cleaning the imaging
aperture.

Protection of Patient Health Information

Note: Health care providers have responsibility for the protection of patient health
information (PHI), both hard-copy and electronic. To protect patient confidentiality of your
exported electronic data, the use of encryption is recommended and is the responsibility of
the user.

Safety
Note: If a serious incident has occurred in relation to this medical device, to the user, or to
another person, then the user (or responsible person) must report the serious incident to
the medical device manufacturer or the distributor.

Product Safety
The PRIMUS instrument is classified as follows:
• Class I Equipment – Protection against electrical shock.
• Type B – Degree of protection against electric shock of applied part (chin and forehead
rests).
• Ordinary Equipment (IPX0) – Degree of protection against ingress of liquids (none).
• Continuous Operation – Mode of operation.
• Safety Standards – IEC 60601-1 and IEC 60601-1-2.
• The product complies with U.S. medical electrical safety requirements.

WARNING: To prevent electric shock, the instrument must be plugged into

an earth grounded outlet. Do not remove or disable the ground pin. Only
an authorized ZEISS service representative is allowed to install the
instrument.

WARNING: To prevent electrical circuit shock and maintain system safety

integrity, you must connect the power cord of the monitor to the insulated
outlet of the power supply module.

WARNING: Do not open the instrument covers. Opening the instrument

covers could expose you to electrical and optical hazards.

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WARNING: To maintain patient safety, if the instrument is externally

connected to non-medical peripheral devices (i.e., printer, storage devices,
etc.), the complete system must comply with the system requirements in
standard IEC 60601-1. This standard requires the usage of an Isolation
Transformer to power the non-medical peripheral device(s) if located
within 1.5 m from the patient. If the peripheral device is located outside
the patient environment (beyond 1.5 m) and is connected to the
instrument, a separation device or Isolation Transformer must be used if
there shall be electrical connection between the non-medical peripheral
device and the instrument in case any system leakage current is out of
limit.

The person or the responsible organization connecting additional devices

or reconfiguring the system must evaluate the complete system to ensure
compliance to the applicable IEC 60601-1 requirements.

The instrument operator must not attempt to touch the patient and the
peripheral device simultaneously.

WARNING: The Superluminescent Light emitting Diode (SLD) exposure

time limit must not be more than 10 minutes.

WARNING: This instrument may cause ignition of flammable gases or

vapors. Do NOT use in the presence of flammable anesthetics such as
nitrous oxide, or in the presence of pure oxygen.

WARNING: The instrument itself is transportable and may be moved from

one location to another. However, if the instrument is placed on a table
provided by third party suppliers, do not move the table to another
location while the instrument and any other peripherals are placed on it.
If the instrument is placed on a table provided by ZEISS, remove the
monitor while device is moved. Otherwise it may cause the system
components to tip over and cause harm to the patient, the operator, or
others in the vicinity.

WARNING: When you lower the table, make sure that there is no
component under the table to avoid obstruction.

WARNING: Do not scan patients who have been injected with

photo-dynamic therapy (PDT) treatment drugs, such as Visudyne®, in the
previous 48 hours. Failure to observe this warning could result in
unintended exposure and uncontrolled treatment of neovascular vessels.

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WARNING: Avoid tipping. Do not use the instrument on an uneven or

sloped surface. Also, do not roll the table in deep pile carpet or over
objects on the floor such as power cords. Failure to observe these
precautions may result in tipping of the instrument and/or table and
resulting injury to operator or patient and damage to the instrument.

WARNING: The operator should check that the patient is not holding the
chin rest and the instrument metal base before or during tests. Ask
patients to remove their fingers from the instrument metal base as there
is a potential for fingers to be squeezed and possibly injured. In case of
entrapment of hair or fingers in metal base, the operator must move the
optical head in such a way so as to free the entrapment.

CAUTION: Country specific laws may restrict the sale of this device by or on the order
of a licensed healthcare practitioner.

CAUTION: Federal law (United States) restricts this device to sale by or on the order
of a Physician or Practitioner.

WARNING: Do not use the printer, the instrument and the height
adjustable table with an extension cord or a power strip (multiple
portable socket outlet).

Optical Safety

• IEC 60825-1:2014
• ISO 15004-2:2007
• IEC 62471:2006
• Classification: Group 1 Instrument - Per EN ISO 15004-2. Group 1 instruments are
ophthalmic instruments for which no potential light hazard exists.

WARNING: This device contains visual stimuli, including flickering light

and flashing patterns, between 5 and 65 Hz, which may cause possible
seizures in epileptic patients. Medical professionals need to determine
whether this device should be used for patients who may be
photosensitive, including those with epilepsy.

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CAUTION: Applicable Phototoxicity Statements (FDA CDRH Ophthalmoscope

Guidance #71): Because prolonged intense light exposure can damage the retina,
the use of the device for ocular examination should not be unnecessarily prolonged.
While no acute optical radiation hazards have been identified for direct or indirect
ophthalmoscopes, it is recommended that the exposure time for the patient’s eye be
limited to the minimum time that is necessary for diagnosis. Aphakes and persons
with diseased eyes will be at greater risk. The risk may also be increased if the
person being examined has had any exposure with the same instrument or any
other ophthalmic instrument using a visible light source during the previous 24
hours. This will apply particularly if the eye has been exposed to retinal
photography.

Note: This medical device has no user adjustable intensity settings for light incident on the
retina, nor does it produce UV radiation or short-wavelength blue light.

CAUTION: The power supply module is the main disconnect device of the
instrument. Position the power supply module in such a way to have easy access to
disconnect the power supply module from power supply in case of an emergency.
Pull the cord from the power supply module which connects to the wall socket. You
can also switch off the power supply from the wall socket.

After the power cord is connected and when the power switch is pressed, the green light
on the power switch glows and the entire instrument will be powered.

Check and Replace Instrument Fuse(s)

WARNING: When replacing the fuse(s), carefully follow the instructions in
Chapter 9 to safely check and replace fuse(s). Always power down the
instrument and unplug the power cord before proceeding. At all times, use
the minimum force necessary to accomplish each step so as to prevent
damage or injury.

WARNING: Always replace fuse(s) with the same type and rating. Failure to
do so may create a risk of fire.

WARNING: Powering the instrument with the incorrect setting could result
in electrical shock to users and patients and severe damage to the
instrument.

CAUTION: We strongly recommend you use peripheral devices supplied or approved

by ZEISS, when available, because they will have been tested to work with the
instrument.

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Printers
WARNING: To maintain patient safety, if the instrument is externally
connected to printer, the complete system must comply with the system
requirements in standard IEC 60601-1 and IEC 60950 for printers. This
standard requires the usage of a separate power supply or isolation
transformer to power the printer.

WARNING: The peripheral devices such as printers must be placed at least

1.5 meters (4.9 feet) away from the patient, such that the patient cannot
touch a peripheral device with any part of his or her body while being
examined. In addition, the instrument operator must not attempt to touch
the patient and a peripheral device at the same time while examining the
patient. Failure to observe this warning could result in electrical shock to
the patient and/or examiner.

WARNING: You must power the printer through a separate wall outlet or
an isolation transformer. Failure to observe this warning could result in
electrical shock to the patient and/or examiner.

WARNING: If you use a non-approved device or if you connect it

incorrectly—for example, using the printer with a USB connection and
plugging the printer directly into the same wall socket used by the
PRIMUS instrument —you could invalidate the system safety approval.

WARNING: Do not use the printer or the instrument with an extension cord
or a power strip (multiple portable socket outlet). For additional safety, do
not plug the printer and the instrument into the same wall outlet. Failure
to observe this instruction could result in electrical shock to the patient
and/or examiner.

Patient Record Deletion

CAUTION: Deletion of patient record is permanent in local drive. Deleting a patient
record includes deleting that patient’s exam data. You cannot recover a patient
record unless you have created a backup (see Data Storage, page 1-5).

Data Backup - External Storage Device

CAUTION: We strongly recommend that you backup daily to a external storage
device—USB Flash/Pen Drive. If you do not backup at all, paper records and/or
CD/DVDs are the only way to retain patient information in case of system hard drive
malfunction (see Backup Data Process, page 8-2).

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CAUTION: Backup created in External Storage Device from PRIMUS instrument must
not be tampered/altered by the user which will cause failure in restore attempt.
Prohibited actions include the renaming of folders or relocating the backup content
to another location.

Risks of Internet Connectivity

CAUTION: When connected to the Internet, the PRIMUS instrument may be
vulnerable to serious security risks, including viruses and worms that could disable
your system or adversely affect its performance. Internet connectivity enables third
party software, software drivers and updates to be downloaded to your system,
either automatically or intentionally. Do not install any unapproved third party
software on the instrument. Installation of any unapproved software, including
drivers, could degrade the performance of the instrument and/or lead to corrupted
diagnostic or therapeutic information and may void the instrument warranty.

Windows Update
CAUTION: Only a ZEISS authorized service representative must perform the Windows
update.

Anti-Virus Software
Note: Do not perform virus scanning while acquiring exam data. We also recommend
routinely scanning for virus.

Prohibited Activities
CAUTION: Attempting to perform the prohibited activities may void your PRIMUS
instrument warranty and may result in damage to your PRIMUS system. ZEISS is not
responsible for software upgrades or repairs necessitated by the attempted
performance of the prohibited activities.

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Electromagnetic Compatibility (EMC)

WARNING: The use of accessories other than those specified may result in
increased emissions or decreased immunity of the equipment.

WARNING: The PRIMUS instrument should not be used adjacent to or

stacked with other equipment.

CAUTION: The PRIMUS instrument has special EMC precaution requirements and
needs to be installed and put into service according to the EMC information
provided herein.

CAUTION: Portable and mobile RF communications equipment can affect medical

electrical equipment.

Cables Information for EMC Reference

Cable Maximum Cable Length Shielded/Unshielded Number Cable
Classification
AC power cable 2.5m for OCT power input cable without K2 table; Unshielded 3 Set AC Power
1.32m for monitor power cable;
2m for K2 table power cable;
0.75m for OCT power cable when connected to K2 table
USB cable 1.75m for mouse and keyboard USB cable; Shielded 3 Set DC Power
1.84m for monitor USB cable
DVI cable 1.9m Shielded 1 Set DC Power
DC Power cable 1.29m for 2 set; Shielded 3 Set DC Power
1.79m for 1 set

Important Information about Electro Magnetic Compatibility (EMC)

Optical Coherence Tomography (OCT) needs special precautions regarding EMC and put
into service according to the EMC information provided in the user manual and other
documents; Optical Coherence Tomography conforms to this EN
60601-1-2:2007+AC:2010/IEC 60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• The use of accessories and cable other than those specified, with the exception of
accessories and cables sold by Carl Zeiss of Optical Coherence Tomography as
replacement parts for internal components, may result in increased EMISSIONS or
decreased IMMUNITY or decreased LIFESPAN of the Optical Coherence Tomography.
• Optical Coherence Tomography should not be used adjacent to or stacked with other
equipment. In case adjacent or stacked use is necessary, the Optical Coherence
Tomography should be observed to verify normal operation in the configuration in
which it will be used.

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Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The PRIMUS 200 instrument is intended for use in the electromagnetic environment specified below. The customer or user of the PRIMUS 200
instrument should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
The PRIMUS 200 instrument uses RF energy
RF emissions Group 1 only for its internal function. Therefore, its RF
CISPR 11 emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions Class B The PRIMUS 200 instrument is suitable for
CISPR 11 use in all establishments, including domestic
establishments and those directly connected
Harmonic emissions Class A
to the public low-voltage power supply
IEC 61000-3-2
network that supplies buildings used for
Voltage fluctuations/flicker emissions Compliance domestic purposes.
IEC 61000-3-3

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The PRIMUS 200 instrument is intended for use in the electromagnetic environment specified below. The customer or user of the PRIMUS 200
instrument should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
Electrostatic Discharge ± 6 kV contact ± 6 kV contact Floors should be wood, concrete, or ceramic tile. If
(ESD) IEC 61000-4-2 ± 8 kV air ± 8 kV air floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast ± 2 kV for power supply ± 2 kV for power supply Mains power quality should be that of a typical
transient/burst lines lines commercial or hospital environment.
IEC 61000-4-4 ± 1 kV for input/output ± 1 kV for input/output
lines lines
Surge IEC 61000-4-5 ± 1 kV lines to lines ± 1 kV lines to lines Mains power quality should be that of a typical
± 2 kV lines to earth ± 2 kV lines to earth commercial or hospital environment.
Voltage dips, short <5% UT (>95% dip in UT) <5% UT (>95% dip in UT) Mains power quality should be that of a typical
interruptions, and voltage for 0,5 cycle for 0,5 cycle commercial or hospital environment. If the user of
variations on power supply 40% UT (60% dip in UT) for 40% UT (60% dip in UT) for the PRIMUS 200 instrument requires continued
input lines. IEC 61000-4-11 5 cycles 5 cycles operation during power mains interruptions, it is
70% UT (30% dip in UT) for 70% UT (30% dip in UT) for recommended that the PRIMUS 200 instrument be
25 cycles 25 cycles powered from an uninterruptible power supply or a
<5% UT (95% dip in UT) <5% UT (95% dip in UT) battery.
for 5 cycles for 5 cycles
Power frequency (50/60 Hz) 3 A/m 3 A/m Power frequency magnetic fields should be at levels
magnetic field characteristic of a typical location in a typical
IEC 61000-4-8 commercial or hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.

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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The PRIMUS 200 instrument is intended for use in the electromagnetic environment specified below. The customer or user of the PRIMUS 200
instrument should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the SYSTEM,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.

Recommended separation distance

3 .5
d [ ] P
V1
Conducted RF 3 Vrms 3V
3 .5
IEC 61000-4-6 150 kHz to 80 MHz d [ ] P 80 MHz to 800 MHz
E1
Radiated RF 3 V/m 3 V/m
7 800 MHz to 2,5 GHz
IEC 61000-4-3 80 MHz to 2,5 GHz d [ ] P
E1
where ‘P’ is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and ‘d’ is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b Interference may occur in the
vicinity of equipment marked with the following
symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,

AM and FM broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PRIMUS 200
instrument is used exceeds the applicable RF compliance level above, the PRIMUS 200 instrument should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PRIMUS 200
instrument.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Recommended separation distances between portable and mobile RF communications equipment and the
PRIMUS 200 instrument
The PRIMUS 200 instrument is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the PRIMUS 200 instrument can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the PRIMUS 200 instrument as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output power of Separation distance according to frequency of transmitter
transmitter ‘m’
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W
3 .5 3 .5 7
d [ ] P d [ ] P d [ ] P
V1 E1 E1
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance ‘d’ in metres (m) can be estimated
using the equation applicable to the frequency of the transmitter, where ‘P’ is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the higher frequency applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.

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 Introduction 1-19

Symbols and Labels

Warning

Caution

Note

Must Follow Instructions for Use

On / Off

100-240V~ power supply

ONLY for monitor of device

Fuse

Direct Current

Type B applied parts

Manufacturer

Authorized European Community Representative

Serial number

Model number

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

Year of manufacture

IPx0 No special protection

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Protective Packing Symbols

The protective packing symbols specify the handling requirements and the transport and
storage conditions.
Handling Requirements Transport and Storage Conditions

Relative Humidity (10% to 90%, including

Fragile, Handle with Care
condensation)

Keep Dry Temperature (-40 to +70 deg. C)

This End Up Atmospheric Pressure Limits (500 hPa to 1060 hPa)

Note: The instrument is not intended to be transported outside of its original package.

Unpacking Instructions Symbol Sheet

The following symbol sheet serves as instructions to safely unpack the instrument from its
shipping box.

CAUTION: The Optical head and the OCT Engine are factory connected with optical
fiber cord (OFC). Place the shipping box near the table before opening the box.
Carefully lift the Optical head from the shipping box and fix it properly on the table
and then lift the OCT Engine. To prevent injury or damage to the instrument, two
people—not one—must lift the instrument out of the box, bending the knees and
keeping the back straight.

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 Introduction 1-21

Note: When the PRIMUS instrument is being unpacked, save the original shipping
materials for possible future use. To prevent damage, the instrument must be transported
in its original shipping package.

Product Labels and Serial Number Location

The product label is located on the Cross table.
The product label displays the serial number, input power requirement and the month of
manufacture in MMYYYY format (for example, 012017).

USB Connectors
USB connectors are on the side of the monitor, as shown in Figure 1-2 below.

cáÖìêÉ=NJOW=l`q=jçåáíçêJ=rp_=`çååÉÅíçêë

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1-22 Introduction

Product Service Life

The service life of the PRIMUS instrument is 8 years.

Instrument Disposition
When it comes time to upgrade the PRIMUS instrument, contact ZEISS customer service or
your local CZM distributor to inquire about trade-in or upgrade values we may offer. If you
do not wish to trade in the instrument, please dispose of it in accordance with local and
national requirements.

Disposal of the Product

Packaging materials should be retained for future relocation or repair.
If you wish to dispose of the packaging material, contact a recognized collection system for
recycling.
The device contains electronic components. At the end of its lifetime, the product and its
integrated batteries should be disposed of in accordance with the relevant national
regulations.
In accordance with applicable national regulations at the time at which the product was
brought onto the market, the product specified on the consignment note is not to be
disposed of via the domestic waste disposal system or communal waste disposal facilities.
For further information on disposal of this product, please contact your local dealer or the
manufacturer or its legal successor company.
Where the product or its components are resold, the seller must inform the buyer that the
product is to be disposed of in accordance with the currently applicable national
regulations.

Abbreviations and Acronyms

Abbreviation / Full Word / Phrase
Acronym
A Ampere
A/m Ampere Per Meter
AC Alternating Current
AG Incorporated (stock company)
AS Anterior Segment
B Brightness
.com Commercial Organization
C Contrast
CCT Central Corneal Thickness
CD Compact disc

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 Introduction 1-23

Abbreviation / Full Word / Phrase

Acronym
CDRH Center for Devices and Radiological Health
CISPR Comité International Spécial des Perturbations Radioélectriques (French)
Special International Committee on Radio Interference
cm Centimeter
Co. Company
cSLO confocal Scanning Laser Ophthalmoscope
CZM Carl Zeiss Meditec
CZSZ Carl Zeiss Suzhou Co., Ltd
DC Direct Current
deg. C Degree Celsius
DHCP Dynamic Host Configuration Protocol
DICOM Digital Imaging and Communications in Medicine
DNS Domain Name System
DoB Date of Birth
DVD Digital Versatile Disc
DVI Digital Visual Interface
E.U. European Union
EC European Community
EEC European Economic Community
EMC Electro Magnetic Compatibility
EN European Standards
ESD Electro Static Discharge
etc. et cetera (and other things)
FDA Food and Drug Administration
FWHM Full Width at Half Maximum
GB Gigabyte
GHz Gigahertz (thousands of MHz)
H Height
HD High Definition
HDD Hard Disk Drive
hPa Hecto Pascals
Hz Hertz
ID Identification
IEC International Electrotechnical Commission
Inc. Incorporation
IP Ingress Protection

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Abbreviation / Full Word / Phrase

Acronym
IP Internet Protocol
ISO International Organization of Standardization
JPEG Joint Photographic Experts Group
kg Kilogram
kHz Kilohertz (1000 Hertz)
kV Kilo Volt
L Length
LAN Local Area Network
lbs Pounds
LED Light-Emitting Diode
Ltd. Limited
m Meter
MAC Media Access Control
Max. Maximum
MHz Megahertz (million Hertz)
mm Millimeter
MPR Multi-Planar Reformat
MWL Modality Work List
μm Micro Meter
μW Micro Watt
NEMA National Electrical Manufacturers Association
nm Nanometer
no. Number
NDB Normative Database
OCT Optical Coherence Tomography
OD Oculus Dexter (right eye)
OFC Optical Fiber Cord
ONH Optic Nerve Head
OS Oculus Sinister (left eye)
OU Oculus Uterque (both eyes)
PACS Picture Archiving and Communication System
PCIE Peripheral Component Interconnect Express
epdf Encapsulated Portable Document Format
pdf Portable Document Format
PDT Photo-Dynamic Therapy
PHI Patient Health Information

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Abbreviation / Full Word / Phrase

Acronym
PN Part Number
Rep. Representative
RF Radio Frequency
RJ Registered Jack
RNFL Retinal Nerve Fiber Layer
SD-OCT Spectral Domain Optical Coherence Tomography
sec Second
SI International System of Units
SLD Superluminescent Light emitting Diode
SN Serial Number
TCOA Notarized Translation Certificate of Authenticity
U.S. United States
USB Universal Serial Bus
UTP Unshielded Twisted Pair
UV Ultra Violet
V Volt
Vrms Volts Root Mean Square
W Watts
W Width
www World Wide Web

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 Operational Overview 2-1

(2) Operational Overview

Chapter Overview
This chapter provides an overview of how to operate the PRIMUS instrument. It explains
basic operations like startup and shutdown, and initial system setup tasks. It provides an
overview of the typical work flow, introduces the screens and their respective zones you will
use. Topics include:
• Startup - System and PRIMUS Application, page 2-1
• Initial System Setup, page 2-7
• Operational Sequence and Screens, page 2-13
• Key Screens and its Zones, page 2-13
• Function Descriptions, page 2-18
• Performance Verification Check, page 2-20
• Power Down the System, page 2-20

Startup - System and PRIMUS Application

To activate power, press the system power switch, found in the power supply module (see
PRIMUS System Hardware on page 1-6).
Upon startup, the instrument is configured to automatically log on to the PRIMUS
application without the need to use the Windows environment.

CAUTION: After a fail safe / accidental hardware shutdown attempt, PRIMUS

instrument must not be restarted in Windows "Safe mode", it must be restarted in
Windows "Normal mode" only.

System Check During Start

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2-2 Operational Overview

During system start, PRIMUS instrument checks the following items displayed on screen:
• Database: Checks accessibility and integrity of the database. If this check fails, you will
not be able to log in and use the instrument.
• Installation Files: Checks that critical system software files are present and have not
been altered. If this check fails, you will not be able to log in and use the instrument.
• Instrument: Checks the connectivity of the instrument hardware with the system
computer. If this check fails, you will not be able to log in and use the instrument.
• Instrument Storage Space: Checks for adequate free space on the hard drive to acquire
new scans. If free space is critically low, you need to back-up exams and clear them
before you acquire new scans.

Log on to Windows and PRIMUS Application

The PRIMUS 200 device is configured to automatically log on to Windows and start the
PRIMUS application. Automatic log on is performed using the “Primus” user account.
Following are the default password information for the various Windows users:
Username Password
Primus Jun2014$Zeiss
ITAdministrator Carlzeiss2014
Following are the default password information for the PRIMUS application depending on
the software versions:
Username Version Password
v1.0 Admin#100*
Administrator
v2.0, v2.2, v3.0 2010

Status Area
The status area in the middle of the screen presents current status information using a
single Orange/Red indicator.

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Note: If Startup check detected warning(s), the system check will remain on screen and
inform you of the results. Click on Details button for an explanation of the current status in
terms of the status components and the system gives you an option to shut down only. If
problem occurs again and repeats, call contact ZEISS customer service or your local CZM
distributor.
Note: Upon successful system startup check, a continue button is active for you to
go/navigate to the LOG IN screen. Click Continue and LOG IN screen appears.

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 Operational Overview 2-3

Status Colors
The overall instrument status is communicated by the color. The colors have the following
meanings:
• Orange means warning: The instrument is operational but a problem or set of problems
exist.
• Red means critical: One or more serious problems exists that restricts use of the
instrument.
• Blue means information: Conveys additional information about a particular task or
procedure. For e.g exporting a report, transferring of data and so on.

Status Components
The following components contribute to the overall status.

Instrument Status
Indicates whether or not the instrument hardware is in communication with the system
computer, and therefore capable of acquiring new scans. It can report status as either
ready to acquire scans (orange) or unable to acquire new scans (red).
• Red: If instrument status is red, PRIMUS instrument only allows you to power-off the
instrument. Use the Shutdown icon on the bottom left corner of the screen. If the
problem persists after power-off and restart, contact ZEISS customer service or your
local CZM distributor.
Note: Although, you can power-off the instrument through hardware, we suggest you to
power-off the instrument through software first and then power-off the hardware (also see
CAUTION(s) on page 2-1 and 2-20).

Hard Disk Status

Indicates available hard disk space status. It reports two statuses:
• Orange: Low hard disk space. When free hard disk space is low at startup, you must
click Continue at system start before continuing to the login screen. Also, the system
alerts you to clear exam data.
• Red: Critically low hard disk space. When hard disk space is critically low, the Capture
button is disabled. You must clear a sufficient amount of hard disk space by backing-up
exam data and then clearing the backed-up exams to continue.
Once you have created space on your hard drive, you must shut down, then restart the
PRIMUS application for the Capture button to be enabled.
Overall Pass or Fail: Below is list of items, the overall system check reports as Pass or Fail.
• If the system passes all checks, the system check will remain on screen and the Continue
button will be available to advance to user login.
• If it reports Startup check complete, detected warning(s), the system check will remain
on screen and inform you of the results. You may click Details for more information. Click
Continue to advance to user login.

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2-4 Operational Overview

• If it reports Startup check complete, detected serious error(s), the device must be shut
down, the system check will remain on screen and the Continue button will NOT be
available. You may click Details button for more information and later click Shut down
icon. If this occurs, contact ZEISS customer service or your local CZM distributor. Be
prepared to communicate the system check details, which are accessible by clicking the
Details button.

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 Operational Overview 2-5

User Login
After the instrument is assembled, the first time login is done as Service user.
The Service login opens up CONFIGURATION WIZARD for the service personnel to configure
your device for Local settings (system Date and Time), Institution Information, Patient
Management, Login Settings, Administrator password and Printer setup. Also, see Initial
System Setup on page 2-7 for details.
Note: Any change to language settings requires a device restart for the setting to become
active.
Note: The CONFIGURATION WIZARD can also be edited when you login as Administrator. See
Initial System Setup on page 2-7 for details.
Note: The first time you log in to a new PRIMUS system as Administrator, you must
create/edit an institution name and create at least one PRIMUS user account. See Initial
System Setup on page 2-7 for details.
Note: You cannot edit nor delete the Service account, which is used only by ZEISS technical
support personnel. These accounts helps CZM technical support to restore access to your
system, in case you lose the password for the Administrator account.
You must log in to access the PRIMUS functions. The USER LOGIN dialog appears when the
instrument passes the system check upon startup, and each time a user logs out of the
system software.

Select the User Name

Enter Password (case sensitive)

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Select a user name from the drop-down list and enter the corresponding password to
access the system software. Note that passwords are case-sensitive.
• No user names appear in the drop-down list until user accounts are created (see Initial
System Setup on page 2-7).
Note: We strongly recommend that you create individual user accounts for each staff
member who acquires or visualizes scans, and that staff members routinely logout to
secure the instrument. (To create user accounts, see Initial System Setup on page 2-7.)
If you enter an invalid user name or password, a message will prompt you to try again.
If you enter an invalid password for three consecutive times as Administrator, a message
will prompt you to reset password, as shown in Figure 2-5. Click to

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2-6 Operational Overview

generate a User key. Contact the ZEISS service desk and if required send the user key to
ZEISS service via an e-mail and obtain a Service key. Enter the Service key and
click . Enter the new password and click .
When you log in successfully, the PATIENT screen appears. See Identify the Patient on
page 3-10 to use the PATIENT screen.

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Log off the System

To log off your account (and also to prevent unauthorized access when you are not using
the instrument), you need to click the icon at upper right of the screen and then select
Log off. When you log off the PRIMUS instrument, it reverts to the USER LOGIN dialog,
enabling login again for you and other users. Upon successful login, the system always
returns to the PATIENT screen.
Note: The Log off button is not available on the ACQUISITION or REVIEW or ANALYSIS
screens. To log off the application from ACQUISITION or ANALYSIS screen, you must click
CANCEL to return to the PATIENT screen. To log off the application from REVIEW screen, you
must click Re Scan and then click CANCEL to return to the PATIENT screen.

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 Operational Overview 2-7

Initial System Setup

Upon initial system start, before you can use the PRIMUS application for scan acquisition,
you must create an institution name and create at least one PRIMUS user account. Several
other initial setup items are optional but are also worthy of consideration. This sections
below explain how to perform the required initial setup tasks:
• Administrator User Account, page 2-7
• Institution Information, page 2-7
• System Date and Time format, page 2-8
• Add User Accounts, page 2-9
• DICOM Network, page 2-10
• Data Backup, page 2-11

Administrator User Account

To manage administrative functions, PRIMUS instrument dedicates a special user account
with the user name Administrator. Only the Administrator user can create and edit
the institution name, user accounts and staff records. (See Chapter 7, for details.)
The Administrator account appears in the drop-down list of user names on the login
screen. The Administrator user can also acquire or visualize scans.

Institution Information
Before you can use the PRIMUS application, you must create/edit an institution name for
your system. The institution name is required as part of the information by which data is
uniquely associated with the system where it is acquired. To access the INSTITUTION
INFORMATION section, click the Settings icon on the right top side of the screen and then
click General Settings tab.

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Type the name of your institution and other required details as shown in Figure 2-6. The
Institution name, Department and e-mail fields accept up to 64 characters only, including
spaces.

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2-8 Operational Overview

The logo graphic is optional. To add a logo graphic, browse to the external storage device
and select the logo in JPEG format (.jpg) (see Chapter 7). Once you have supplied the
name and logo, they will appear on all analysis printouts.

System Date and Time format

You must set the date and time format for your system as shown in Figure 2-7. The date
and time are required as part of the information associated with the system when a scan is
acquired. To access the LOCALE SETTINGS section, click the Settings icon on the right top side
of the screen and then click GENERAL SETTINGS tab.

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Patient Management
Patient ID Issuer field is found in Patient Management section of GENERAL SETTINGS tab
as shown in Figure 2-8.

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Note: Upon software updates: If the Patient ID Issuer already exists (for example, the same
one used in the previous software version), the value appears in the Patient ID Issuer
field, where it can be edited, if desired. If it does not exist, a new Patient ID Issuer can be

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 Operational Overview 2-9

added. Any change made only applies to patients going forward; the change does not
appear on patient information already in the database.
Note: The Patient ID Issuer field denotes assigning authority of patient IDs entered at a
particular site or practice. As a recommendation, it should be set to the same value on
every instrument in the practice and to the same value as in the leading patient
information system, if applicable.

Display of Patient Name

Patient names can be entered in three different ways, i.e., either by Phonetic, Alphabetic
and Ideographic. Set the slider to Enabled position (Figure 2-8) to add patient names
with multi component(s). You can also set the component’s order of display that you wish
to see on the PATIENT screen by moving the order using the arrows next to the component
list.
Set the slider to Disabled position, if you require only the alphabetic names to be entered
on the PATIENT screen.

Add User Accounts

No user names are available to log in with until user accounts are created. This section
explains how to create user accounts.
Note: We strongly recommend that you create individual user accounts for each staff
member who acquires or visualizes scans, and that staff members routinely log out to
secure the instrument. Following these procedures helps prevent unauthorized access to
PRIMUS data and functions, and enables accurate record-keeping. For record-keeping,
PRIMUS records the user name under which each scan is acquired.

Register (Create) Staff Records

To access the Users dialog, you must be logged in as the Administrator user.
1. Click Settings > User Management > Users.... The (Users) dialog appears.

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2-10 Operational Overview

2. In the Users dialog, click Add User. The Add User dialog opens.

Orange bordered fields

are mandatory,

E-mail field is optional.

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3. Edit the User fields as desired. A User must have a last name and first name; other
fields are also mandatory, E-mail field is optional. To log in with this user name and
acquire scans, the User Group field must be selected as Operator. When finished with
your changes, click Add User button.
• To discard the changes before saving, click Cancel.
Note: Once logged in, any user can change his or her own password by selecting Settings
> User Management > Users Details and completing the CHANGE PASSWORD dialog. The
administrator user may take advantage of this feature by creating new user accounts with a
temporary password, providing it to the user, and asking the user to change the password.

DICOM Network
Select Settings > Network > Connection Configuration. Set the DICOM network to Enabled
(also see DICOM Network, page 7-20).
In the DICOM Archive mode, you will be able to export encapsulated PDF(s) (ePDF) of the
analysis reports from the analysis screen only; for viewing on a remote station with an
DICOM viewer.
When you export ePDF to the DICOM Archive, a popup text appears about the archival
success or a warning message if archival has failed.

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 Operational Overview 2-11

DICOM Network Recommendations

CAUTION: Prior to DICOM configuration, Contact your ZEISS representative to verify
the DICOM conformance statements between the two systems (PRIMUS and PACS).
Failure to do so may lead to connectivity (interoperability) problems between the
two systems.

Today’s Patient List

In the connected mode, Today’s patient list shows all Modality Work List (MWL) patients.
If Automatic MWL refresh is enabled in network settings (Figure 7-20), this list updates
automatically in specific time interval set by user (Figure 7-20). Otherwise user can
manually refresh the patient list by clicking the refresh button .
User can always do a patient search from the search bar that shows search results from
local patients and patients from the configured PACS.

Data Backup
CAUTION: If you have selected the Enabled button for data backup at shutdown,
make sure that during shutdown, you do not try to hard reset the device or unplug
the power or backup drive. This will cause device failure and will lead to an
unusable (corrupted) backup.

If you do not select the backup Enabled button, the system will not backup at all. However,
when the hard disk status turns orange, you may have to backup exams in order to clear
enough exams that were not backed-up. At that time, backing-up may take several hours.
You can backup manually at any time by selecting Settings > Maintenance > Data backup
> Start data backup now (See Chapter 8, for details).
Click Back to save your changes and to exit Settings window.
Note: Be sure before you make any changes to the settings as the changes are saved
automatically. There is no option to discard changes.

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2-12 Operational Overview

Normative Data Settings

PRIMUS gives you a way to select the default normative database for both Native and
DICOM Archive modes. Click the icon on the patient management screen and then
select the appropriate option from the Normative Data drop-down box.

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Figure 2-10 displays the default Normative Data Settings. From the Normative Data
drop-down box, you can select Global, Chinese or Indian.
This system defaults to Global Normative data which is the only one supported in this
version.

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 Operational Overview 2-13

Operational Sequence and Screens

Sequence of Operation
The flow chart below illustrates the sequence of operation and the relationship of the
operational modes.

System Start

User Login

Patient

Acquire Analyze
Re scan

Review

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Patient screen is the default screen when you log in to PRIMUS. It is the launch point for
the clinical functions of PRIMUS: scan acquisition and analysis. You must identify a patient
before you can either acquire or analyze exam data.
For every scan acquisition made, a review screen appears for the user to decide whether to
re-scan or move to next scan acquisition or view analysis or add new scans if required.
This manual will introduce each screen in relevant sections that explain its use.

Key Screens and its Zones

This section describes PRIMUS screens (Patient, Acquisition, Analysis) and the key elements:
• Patient Screen, page 2-14
• Acquisition Screen, page 2-15
• Acquisition (Review) Screen, page 2-16
• Analysis Screen, page 2-17
These elements are illustrated in the sample screen(s) below.

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2-14 Operational Overview

Patient Screen

(Other Screens: Acquisition & Analysis)

1 2

3 4

6
5

9 8

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The major zones of Patient screen are:

1. Current Screen Name & User Action/Information zone displays the screen on which
you are working. Alerts to the operator by the PRIMUS instrument are displayed in this
area with icon . This zone appears on all the three screens.
2. Menu Icons zone appears at upper right and contains the Help, Settings, and Exit
menus. This zone appears on all the three screens. Click to select menus and menu
items.
Settings

Help Exit
(Log off /
(Shut down)

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Note: Disabled menu icons appear in gray. These items are not available in the current
screen.
3. Patient search zone allows you to search saved patients using name, ID and Date of
Birth.
4. Patient information (name, ID, gender, date of birth, Age) zone is on to upper right of
the screen.

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 Operational Overview 2-15

5. All & Today’s patient list zone displays list of patients of the present day upon selecting
TODAY and all patient list upon selecting ALL.
6. Scan protocol zone offers scan and various scan reports for Glaucoma, Retina and
Anterior segment.
7. Saved Reports zone displays all previously saved reports for the selected patient.
8. New Procedure button does not appear in the stand alone mode. In the connected
mode (i.e when connected to FORUM), all scheduled work-list items present in DICOM
MWL, required to undergo an eye examination of a particular patient is displayed in
this drop down button. For more information about scheduling a patient refer the
DICOM Workflow for Modality Worklist on page 7-7.
9. Eye Health Report option allows you to generate a consolidated report of Macular
Thickness and ONH&RNFL options.

Acquisition Screen

(Other Screens: Patient & Analysis)

1
2
4
3
5

7 8

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The major zones of Acquisition screen are:

1. Patient information (name, ID, gender, date of birth, Age) zone in the upper left of the
screen.
2. Previous/Current/Next scan zone displays the scan report / eye you are acquiring,
scans that were acquired and scans required to acquire.

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2-16 Operational Overview

3. Fundus video zone displays the patient’s fundus when the optical unit is brought near
the eye. This zone also displays the overlay for all scans, which are centered by default
and can be moved within the zone.
4. Primary B-scan view-port zone is displayed in the center of screen.
5. Thumbnail view-port zone is displayed on the upper right of screen.
Note: The Thumbnail view-port zone does not appear for Single line HD Raster.
6. Orientation zone displays options to rotate the overlay lines of Single and 5 line HD
scan.
Note: The Orientation zone does not appear for Macular Thickness and ONH & RNFL.
7. Fixation target zone allows the patient to fixate on the green LED so that the gaze
remains straight. You can select the target in one of the 9 appropriate fixed positions.
You can turn-off or turn-on the internal fixation from alignment screen. By default, the
internal fixation is turned-on (to its default position) on the alignment screen.
8. Optimize and Signal Strength zone displays sliders to Enhance & Center the scan
image and signal strength indicator.
9. Navigation bar zone allows you to navigate to other screens.
Note: This Navigation bar zone does not appear in Patient screen.

Acquisition (Review) Screen

(Other Screens: Patient & Analysis)

2 4

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 Operational Overview 2-17

The major zones of Acquisition (Review) screen are:

1. Scan Capture Information zone displays the scan signal strength, date and time.
2. Frozen Fundus Image zone displays the image of the fundus.
3. Primary B-scan image zone is displayed in the middle of the screen. The horizontal
cyan line in the overlay of all scan patterns corresponds to this view-port. The selected
cyan line 5 line scan corresponds to this view-port.
You can double click the primary B-scan image to view in full screen size.
Note: For Macular Thickness, the default image is 16th of 32.
Note: For Optic Disc, the default image is 64th of 128.
Note: For 5 line HD Raster, the default image is 3rd of 5.
4. Preview zone when clicked opens a separate screen with thumbnail of 32 B-scans for
Macular Thickness and 128 B-scans for ONH & RNFL. You can double click each image
to view in full screen size.
Note: For 5 line scan, all 5 images are displayed in this preview zone.
Note: For Single line scan, there is no preview displayed.

Analysis Screen

(Other Screens: Acquisition & Patient)

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The zones of ANALYSIS screen are:

1. Previous / Current / Next Analysis zone displays the list of reports for which scan
acquisition was saved. The current report analysis will always be shown bigger for
your reference.
2. Comments zone allows you to add comments for the current analysis. It also consists
of standard description for you to select.

CAUTION: The comments entered in the Add Comments text box are printed on the
final report. Carl Zeiss Suzhou is not responsible for diagnostic interpretation based
on the comments. It is the clinician's responsibility to make diagnostic
interpretations based on the OCT scans and not rely on the comments.

3. Navigation Bar zone allows you to navigate to other screens. In the Analysis screen,
you have the option of saving images after you draw linear dimensions. Print button in
the navigation bar allows you to save the analysis either to a hard copy or CD/DVD as
pdf and also export the epdf to DICOM server in the connected mode.
Note: If only one report for one eye was saved, the navigation bar displays only Cancel
and Print buttons, the Next Analysis button remains inactive.

Function Descriptions
The table below identifies and describes the Functions available in various screens:
Functions and its Description Enabled in Screen
• Today’s Patient list: Today’s patient list is displayed on the Patient Screen
Today’s Patients tab.
• Today’s / Previous Reports: Opens the PATIENT REPORTS for Patient Screen with a
the selected patient, to view and/or edit the record. patient selected
• Delete (Patient): Generates a confirmation prompt, asking Patient Screen with a
user if you wish to delete the selected or opened patient patient selected
record from the database.
• Merge (Patient): Allows merging of two patient records in Patient and Merge Patient
the database. Data Screen with the
patients selected
• Add: Opens fields, where you can enter new patient Patient Screen
information.
• Advanced...: Opens a MODALITY WORKLIST dialog, Patient Screen
allowing you to set parameters for patient search through
the DICOM server.
• New Procedure: Allows user to select and perform the Patient Screen
procedures scheduled in DICOM MWL.
• Back: Opens the previous screen and saves the changes Settings Screen
you made.

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 Operational Overview 2-19

Functions and its Description Enabled in Screen

• Teleservice Off line: Packages the collection of logs and Settings > General Settings
configuration from device which can be stored in a Screen
removal storage device (by Administrator user) for sending
it by email to the ZEISS Service personnel for off-line
analysis.
(When logged in as Administrator)
• Teleservice Online: Enables remote access and controlling Settings > General Settings
of the device when connected to the Internet for ZEISS Screen
Service Personnel to troubleshoot and fix application
problems remotely.
(When logged in as Administrator)
• Browse...: Opens dialog window to select path. Settings > General
(When logged in as Administrator) Settings, Maintenance
Screen
• Manage Printers...: Opens the PRINTER SETUP/Manager Settings > General Settings
dialog for managing the network/locally connected printer. Screen
(When logged in as Administrator)
• Run Wizard: Opens Configuration Wizard to set the Settings > Maintenance
Application Language, Date and Time Format, System Screen
Date and Time, Institution Information, Patient
Management, User Management and Printer Set up.
(When logged in as Administrator)
• Next: Opens up next window to complete that one Settings > Maintenance
particular function. Screen
• Previous: Opens up previous window to complete that Settings > Maintenance
one particular function. Screen
• Finish: Complete that one particular function. Settings > Maintenance
Screen
• Backup Now: Backs up the patient records to the selected Settings > Maintenance
target path. Screen
(When logged in as Administrator)
• Export: Exports all log files to USB flash drive or hard disc. Settings > Maintenance
(When logged in as Administrator) Screen
• Add User: Enables you to create or edit staff as users and Settings > User
designate their user privileges. Management Screen
(When logged in as Administrator)
• Delete User: Allows you to disable the user account from Settings > User
usage (user account is not deleted for audit purposes) Management Screen
(When logged in as Administrator)
• Change Password...: Enables you to change the password Settings > User
for the current user. Management Screen

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Functions and its Description Enabled in Screen

• Brightness/Contrast: Adjusts Brightness and Contrast Acquisition and Analysis
Screens
• Colored OCT: Toggles the display of OCT images between Acquisition and Analysis
color or grayscale. Screens
• DICOM export: Allows archival of patient reports (pdfs Analysis Screen
generated at the end of analysis) through the DICOM
server.
• Help: Opens On-line help for the current screen in HTML. Always
• Licenses: Opens the LICENSES dialog, where you can view Settings > Licenses
the licensing status of optional features and can perform
Off-line and On-line activation using an Activation ID.

Performance Verification Check

You are not authorized to do Performance Verification Check. Only service personnel from
CZM can perform the performance verification check. Contact ZEISS customer service or
your local CZM distributor.

Power Down the System

You need to power down the system through software first and then the hardware (power
supply module) (see the PRIMUS System Hardware drawing on page 1-6).
CAUTION: We strongly recommend that you power down through software first for
the instrument to initiate any action that is configured to be performed during
shutdown such as "Auto Backup" and to avoid abrupt shutdowns that could result
in loss of patient data.

Power Down Through Software

1. Click on the upper right on the PATIENT screen and select Shut down. Do not
switch off the power supply until the screen glows off. Power down through software
allows you to close the application only. See Power Down Through Hardware,
page 2-20 to power down the OCT Engine (also see CAUTION on page 2-1).
Note: You can also shut down the application from LOGIN SCREEN or from SETTINGS SCREEN.

Power Down Through Hardware

CAUTION: We strongly recommend that you power down through software first for
the instrument to initiate any action that is configured to be performed during
shutdown such as "Auto Backup" and to avoid abrupt shutdowns that could result
in loss of patient data.

To power down through hardware, press the power switch located on the power supply
module (see the PRIMUS System Hardware drawing on page 1-6) under the table
(also see CAUTION on page 2-1).

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 Acquire Scans 3-1

(3) Acquire Scans

Chapter Overview
This chapter explains in detail how to acquire scans. It covers the following steps:
• Acquisition Screen - Macular Thickness, page 3-1
• Acquisition Screen - HD 5 Line Raster, page 3-8
• Identify the Patient, page 3-10
• Prepare the Patient, page 3-16
• Initiate a Scan, page 3-18
• Guidelines for Obtaining Good Quality Scans, page 3-29
The PRIMUS instrument offers scan acquisition protocols to acquire retinal, ONH & RNFL
and Angle View & Cornea (Anterior Segment) scans. Their characteristics and applications
are covered in Posterior Segment Scans – Protocols / Reports, page 3-14 and
Anterior Segment Scans – Protocols / Reports, page 3-15.

Acquisition Screen - Macular Thickness

When you select any scan report and click Acquire, the ACQUISITION screen appears.
Note: The example below shows a Macular Thickness scan report.

View-Ports
(Annotations 5, 9 and 11 of Figure 3-1)
The ACQUISITION screen has primarily three view-ports for the user to look to achieve a good
scan image.
• The Fundus view-port is at upper left of the screen, where you see a confocal Scanning
Laser Ophthalmoscope (cSLO) image of the Fundus when the optical unit is brought
near the eye. You use this view-port to center the scan beam through the pupil. The
joystick helps you to reach the proper working distance by bringing the white dot into
focus. The white dot must be in focus for the Fundus view-port to work properly.
Note: There is no fundus image for anterior segment scans. For AS scans, the iris view-port
is overlaid with a scan pattern which is centered by default and can be moved within the
zone. Click and drag the scan pattern to adjust scan placement.
Note: The fundus view is overlaid with a box indicating the location of the scan pattern on
the fundus for all scan report(s) which are centered by default and can be moved within the
zone. You can adjust the overlay placement on the desired retinal feature by moving the
scan pattern overlay (for details, see Adjust Scan Placement on page 3-21). Click and
drag the box / line(s) to adjust scan placement.
Note: For Macular Thickness scan report, the overlay has two lines normal to each other
and one dotted circle placed within the dotted square (Figure 3-14).
Note: For ONH & RNFL scan report, the overlay has two lines normal to each other and two
concentric circles placed within the dotted square (Figure 3-14).

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Note: For 5 line scan, the overlay has 5 lines and for Single line scan, the overlay has one
line and has one dotted circle placed at the center of both 5 and Single line
(Figure 3-14).

1 2 3

13 15 16
4
14

11 12
6

10 9 7
8

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1 Patient information 7 Signal Strength Indicator 13 Brightness Control for Fundus

2 Current Screen in work-flow 8 Navigation Bar 14 Primary B-Scan Direction
3 Current Scan Report, Total no. of Scans 9 Primary Scan image view-port 15 Brightness Control for B-scan
selected, Current Eye Indicator
4 Secondary B-Scan Direction 10 Fixation Target 16 Gray-scale / Color toggle button
5 Secondary B-Scan Image - Preview 11 Fundus view-port with scan overlay
6 Image Optimize (Enhance and Center) 12 Click to drag Scan Pattern Overlay

• The primary B-scan display view-port is in the center of screen. This view-port includes a
color-coded scan marker at upper left, to identify scan line and direction of scan. The
color and orientation of the marker correspond to the color and orientation of the lines
that make up the scan pattern overlay from the Fundus view-port for posterior segment
scans. The Enhance (polarization) and Center (Z-offset) (posterior segment scans only)
sliders within Optimize button helps you improve the scan image quality and center it
vertically.

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 Acquire Scans 3-3

Note: For Macular Thickness scan report, the horizontal cyan line in the overlay
corresponds to this view-port and is a fast B-scan image port.
Note: For 5 line scan, the 3rd line corresponds to this view-port.
Note: For Single line scan, only Fast B-scan view-port is displayed.
• The Secondary B-scan display view-port is on the upper right of the screen. This
view-port includes a color-coded scan marker (or number at upper left for 5 Line HD to
identify the scan line). The color and orientation of the marker correspond to the color
Macular
Five line HD Thickness and orientation of the lines that make up the scan pattern overlay from the Fundus
view-port (for posterior segment scans) or the Iris Viewport (for anterior segment scans).
Note: For Macular cube scan, the vertical magenta line in the overlay corresponds to this
view-port and is a slow B-scan image port.
Note: For 5 line scan, there are five view-ports which correspond to 1, 2, 3, 4 and 5 lines
(one cyan and four magenta).
Note: For Single line scan, there is no secondary view-port displayed.

Fixation
PRIMUS instrument provides an internal fixation as the default patient fixation method.
This method is preferred for its reproducibility and ease of use. However, if the patient’s
visual acuity in the subject eye precludes internal fixation, you have the option of attaching
and using the external fixation device, which is a light-emitting diode on the end of an
adjustable arm. The patient must be asked to fixate on the tip with the other eye in a way
that the gaze remains straight. Attach the device to the port on the top of the instrument,
and bend the flexible arm to place it manually in the desired position without contacting
the patient’s eye.

What the Patient Sees

Before scan acquisition, the patient looks into the imaging aperture and sees one of 9
circular fixation target(s) (see Figure 3-2). The default fixation location is either the center
or lateral offset (ONH & RNFL), depending on the scan protocol.

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3-4 Acquire Scans

For all anterior segment scans, the patient sees a blurry red flashing target against a green
background.

Patients sees only one of 9 fixation target(s) as selected by the operator.

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Instruct the patient to look at the green LED in the target, and not at the moving red lights
(the scan beam).

Moving the Fixation Target

(Annotation 10 of Figure 3-1)
You can manually change the target on any of 9 dots in all scan types. If the cursor hovers
over the fixation target icon, the cursor turns into a hand with a pointing finger. You can
turn-off or turn-on the internal fixation from alignment screen. By default, the internal
fixation is turned-on (to its default position) on the alignment screen.

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The patient sees the green fixation target against a black background with a thin
horizontal red line repeatedly scrolling from the top of the screen to the bottom, which is
the scan beam moving across the field of view. When the scan beam reaches the bottom of
the screen, thin red lines briefly flash, showing the scan pattern of the selected scan type.
For the ONH & RNFL scan report, the fixation target is offset to one side to allow the center
of the optic nerve to move to the center of the scan pattern. However, you can manually
change the target to any of 9 dots.
When scan acquisition starts, the patient may notice the red lines scrolling, and in some
cases at a different angle, depending on the selected scan type.

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 Acquire Scans 3-5

Optimize the Scan Display

(Annotation 6 of Figure 3-1)
The goal of optimizing the scan image is to yield the strongest scan signal, and thus the
best scan image. Better images are more defined, and have more red and yellow color.
For posterior segment scans, click Optimize, just above the Capture button. This
automatically optimizes first the scan image centering (Z-offset), and then optimizes the
scan image quality (polarization). Instruct the patient not to blink during optimization.
Note: The Center and Enhance buttons attempt to automatically find the optimal positions
for Z-offset and polarization, respectively.
You can use the Center slider (adjusts Z-offset) and Enhance slider (optimizes polarization)
within the Optimize drop-down to optimize each aspect independently. The associated
slider enables you to adjust each manually. Use Center first, since you must see the scan
image before you can enhance it.
Z Align
Scroll up to move You can also optimize the scan image by manually making slight adjustments to the focus
eye closer, or and/or to the positioning of the optical head.

Adjust Z-offset
The cSLO image of the eye is clearest when the axial position (Z-alignment) is correct.
In the usual course of a scan, the first thing you do after positioning is adjust the Z-offset
(axial position) of the scan. The axial length of the PRIMUS scan image is 2 mm while the
eye length is 10-fold larger. So, if the axial range is not correct, the retina is not scanned,
Scroll down to move and you see nothing but noise in the live scan image. The 2 mm axial “window” must be
eye away
positioned to bracket the retina, making it visible in the scan image.
• Once you bring the retina into range for the first scan, it is likely to be visible. Still, you
are likely to adjust Z-offset from scan to scan to center the retinal scan image. If the
retinal image is already visible on the monitor, you can skip step 1 below.
To bring the scan image into view along the Z-axis, follow these steps:
1. Click the Optimize button (pictured left). OR
2. Click the Center (Z-offset) button (within Optimize button) to bring the entire retinal
scan image into view or manually move the slider using mouse or click on the Center
button and then scroll the mouse wheel on the scan image display.
• It is not necessary for the retinal scan image to be centered. The important issue is
that none of the image be cut off.

Grayscale / Colored Toggle Button

(Annotation 17 of Figure 3-1)
You can toggle between color and gray-scale globally, in the primary b-scan view-port(s),
by clicking Colored OCT button on the Acquisition (or) Review (or) Analysis
screen(s). You can toggle between color and gray-scale in the fundus view port on Analysis
screen.

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3-6 Acquire Scans

Note: Switching between Gray-scale and Color mode automatically adjusts the Brightness
and Contrast values suitable to the selected mode. PRIMUS adjusts the Brightness and
Contrast values such that the brightness value is always more than the contrast.

Brightness / Contrast Icon

(Annotation 15 of Figure 3-1)
The FUNDUS AND PRIMARY B-SCAN DISPLAY view-port area has a brightness/Contrast
icon which allow adjustment of the brightness (vertical) and contrast (Horizontal).
When selected, brightness (B) and contrast (C) values appear numerically on the image.
Click on the icon and hold-down the left mouse button, drag the cursor over the
view-port vertically (brightness) or horizontally (contrast). They also work in combination
when you click and drag the mouse diagonally. Click again the icon to exit the
settings.
Note: Ask the patient to hold their gaze and head steady during Focus, as the Optical head
moves during this procedure. During Focus, check the FUNDUS view-port to ensure that the
white dot (reflection from fundus) is still centered. If the FUNDUS view-port turns dark, click
the B/C icon and change the brightness and contrast.
Note: For ONH & RNFL scan report, it is sufficient to keep the optic disc within the outer
dashed circle, but it is best to center the scan on the optic disc as well as possible.
Note: For the HD 5 Line Raster and HD Single Line scans, toggle to black and white to
assist in showing the additional resolution gained by using the HD scans. Adjustments to
brightness and contrast as well as switching the scans to black and white images are
available on the ACQUISITION, REVIEW and ANALYSIS screen.

Scan Direction
(Annotation 4 and 15 of Figure 3-1)
Scan Display Left to Right Orientation
Left to Right Scan Display
Summarized PRIMUS instrument always displays left to right scan images as follows:
For horizontal scans, left represents • For horizontal scans, left of scan represents left of scan display and right of scan
left and right represents right. For represents right of scan display.
vertical scans, left to right • For vertical scans, bottom of scan represents left of scan display and top of scan
represents bottom to top. For
represents right of scan display.
diagonal scans, left takes
precedence over bottom. • For diagonal scans in 5 Line and Single Line HD Raster, left takes precedence over
bottom, so that left of scan represents left of scan display and right of scan represents
right of scan display.

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 Acquire Scans 3-7

Navigation Bar
(Annotation 8 of Figure 3-1)
The navigation bar appears at the bottom of the screen, consisting of a series of buttons by
which you access functions and/or other screens.

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• Cancel: Returns you to the PATIENT screen.

• Skip to Next Scan: Takes you to the next scan type you selected in scan protocol.
• Capture: Initiates scan acquisition.

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3-8 Acquire Scans

Acquisition Screen - HD 5 Line Raster

From the PATIENT screen, select scan type HD 5 Line Raster, as shown in Figure 3-5.
2
1 3

16 17 4
14 15
5

12 13
11 6

10 9 7
8

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1 Patient information 7 Signal Strength Indicator 13 Click to drag Scan Pattern Overlay
2 Current Screen in work flow 8 Navigation Bar 14 Brightness Control for Fundus

3 Current Scan report and Total no. of Scan 9 Primary Scan image View-port 15 B-Scan Direction
report(s) selected, Current Eye Indicator
4 Scan Line Number 10 Fixation Target. 16 Brightness Control for B-scan
5 Magenta Lines Image - Preview 11 Scan Orientation 17 Gray-scale / Color Toggle button
6 Image Optimize (Enhance and Center) 12 Fundus view-port with scan overlay

In 5 Line mode, the scan creates 5 parallel scans of equal length, and the line rotation is
adjustable (see Changing Scan Pattern Orientation on page 3-9). By default, the
lines are horizontal and each line is 6 mm long and separated by 250 μm (0.25 mm) from
the next, so that the 5 lines together cover 1 mm width.

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 Acquire Scans 3-9

Changing Scan Pattern Orientation

(Annotation 11 of Figure 3-5)
PRIMUS instrument allows only rotation adjustment to the scan pattern using the
orientation port, found at the bottom of the fundus view-port (see Figure 3-6). Rotation
adjustments apply to all 5 lines uniformly.
• Default orientation of 0 degrees is horizontal. Click the vertical lines icon to orient the
scan pattern lines vertically or click the counterclockwise/clockwise rotation arrows.
Enter a value to adjust the angle in the ranges of 0 to 360 degrees when using rotation
arrows. Values entered from 91 to 269 are automatically changed to the corresponding
value 180 degrees opposite.
• You can also hold and rotate (clockwise/counter clockwise) the symbol (next to the
single or 5 line overlay) to change the orientation, as shown on left.

Rotate the scan lines

Vertical / 90 degree orientation counter-clockwise Enter Value

Horizontal / 0 degree orientation Rotate the scan lines

clockwise

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Signal Strength
The Signal Strength indicator appears on top of the Navigation bar. It ranges from 0 to 10,
with 10 being maximum signal strength. Center slider (in Optimize) allows you to change
the acquisition settings for the HD 5 Line Raster so that the best signal to noise ratio is
obtained at the bottom of the B-scan. For additional information on how to optimize a
scan image, refer Optimize the Scan Display procedure on page 3-5.

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3-10 Acquire Scans

Identify the Patient

Acquire button is disabled until you identify a patient and select at least one protocol. Use
the PATIENT screen to identify (select or add) a patient. After system start and login, the
PATIENT screen appears by default (From other modes, click Cancel to return to the PATIENT
screen). You can identify a patient in three ways from patient information area on the left
side of PATIENT screen - All patient list, Today patient list and Advanced... search. For
details to identify a patient, see the indicated sections.
• Find Existing Patient, page 3-10
• Add New Patient, page 3-12
• Procedure Selection Dialog, page 3-11
• Select Reports for the Patient, page 3-14
• Posterior Segment Scans – Protocols / Reports, page 3-14
• Anterior Segment Scans – Protocols / Reports, page 3-15
From the patient information area, once you identify the patient, select the report(s) from
new scan protocol and click Acquire to initiate a new exam for that patient. The
ACQUISITION screen appears.

Find Existing Patient

There is no ALL patient list in connected mode (see Figure 3-7). A refresh button is
present in connected mode for MWL refresh.
You can select a patient from either the All or Today patient list displayed in patient
information area on the left side of PATIENT screen (as shown on left). You can select only
Patient Screen – All / Today Patient List one patient at a time. When you select a patient, the New Scan Protocol and select eye
Patient List as displayed in the buttons becomes active. If the patient has saved exams, the View Reports button becomes
Stand Alone mode. active.
To populate or filter the patient list, search by clicking the or .
• When you search with , you need to give either patient’s first or last name / Patient
ID / date of birth / partial information like any letter from the name. After you enter
required details, click or press ENTER on the keyboard.
Note: When using DoB, use MM/DD/YYYY format with forward slash (/) as separators.
Note: When using partial information like any letter from the name, searches in local
databases that contain large numbers of records may exceed configured limits. When this
occurs, the user is notified via a Status Bar message that the list of displayed patients has
been truncated. In this case, narrow your search parameters. Click Advanced... if you want
to search using additional parameters—see Chapter 7.
Note: The search returns all patients that match all defined parameters, sorted
alphabetically with last name.
• When you search with , you need to give either of the details as shown in
Figure 7-4 (stand alone mode) and Figure 7-5 (connected mode).

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 Acquire Scans 3-11

View Today’s Patients Tab

To select a patient from the list of today’s patients, select the Today’s Patients (Figure
3-7) tab.
There is no ALL patient list in Connected mode. Also, a refresh button (as shown below) is
present in Connected mode for MWL refresh.

Active when DICOM is Enabled

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How Today’s Patients List Is Populated

Today’s patients list is populated automatically with the following:
• New patients added today on local PRIMUS instrument.
• Patients scheduled for this PRIMUS instrument (DICOM Archive mode only) (see
Today’s Patient List, page 2-11).
The list is sorted alphabetically by last name.
Note: If the selected patient is retrieved from the DICOM server and has more than one visit
scheduled, a drop-down button lists all the available work-lists for that patient (Figure
3-8) and the user is allowed to select any one desired procedure from the list before
proceeding for a particular scan.

The user can see the scheduled worklist items (procedure steps) for the scheduled patient.
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3-12 Acquire Scans

Add New Patient

To add a new patient, click the (Figure 3-9) and fill in the required fields,
which are indicated with brown borders and then click anywhere on the screen to save the
entry.

Patient ID

Click this down arrow to enter patient’s Refractive error and referring Doctor,
and select the consulting Doctor
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• A Patient ID is required for all patient files. No patient data can be saved without a
patient ID, hence the system creates a unique ID automatically for this patient. All
Patient IDs generated by PRIMUS instrument have 10 numeric characters. However you
can expand the ID to maximum 64 characters (alpha, numeric and keyboard symbols).
Patient ID field does not accept characters \ * ?. Patient name fields doe not accept \ ^
= * ?.
• When you click , the new patient information is saved to the database and
to the list of All / Today patients. If data is missing from required fields,
the button will be enabled but will not save the patient details unless all
required fields are entered.

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• Click the to enter the referring doctor’s name and to select the consulting doctor
(see Advanced Settings, page 3-13). Refer to Figure 3-9. After you select the
doctor’s name(s), click .
CAUTION: Ensure that you select or enter the patient’s age and gender correctly
because choosing an incorrect age or gender may lead to an erroneous
representation in the Normative Database (NDB) related analysis results of the
patient.

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 Acquire Scans 3-13

Optional Patient Information

On the patient screen, click the to view the refraction error fields and after you
enter the values click . Refer to Figure 3-9.

Refractive Error
Entering Patient Refractive Error—You may enter the refractive error in spherical
equivalents (Diopters) for each eye on the patient demographic entry screen if desired.
These values are for reference only. Refer to Figure 3-9.
In the REFRACTIVE ERROR zone, enter minus (-) power to compensate for myopic corrections
and plus (+) power to compensate for hyperopic corrections (as shown below). These
values are for record purpose only.

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Note: PRIMUS instrument does not compensate for the patient’s refractive error by
automatically changing the focus adjustment.
During acquisition, ask the patient if the fixation target is clearly visible while adjusting
focus manually, using the refractive error knob.

Advanced Settings
On the patient screen, click > Advanced Settings to select default B-scan color,
B/C value and to add the consulting Doctor name.
• Set the default B-scan display to either color or gray-scale. However you can switch
between color and gray-scale globally in Acquisition/Review/Analysis screen(s), by
selecting or de-selecting the icon . Refer to Brightness / Contrast Icon, page
3-6.
• Set the default Brightness/Contrast value for B-scan and/or Fundus/Iris view-port.
However you can change the B/C values in Acquisition/Review/Analysis screen(s), by
clicking the icon . Refer to Brightness / Contrast Icon, page 3-6.

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3-14 Acquire Scans

• Add/update the consulting doctor name that can be assigned to individual patient (see
Add New Patient, page 3-12). Click Add Doctor, enter the name and click OK to
save changes or Cancel to discard changes. You can also mark a particular Doctor as
default consulting Doctor.

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Eye Health Report: You can add Central Corneal Thickness value in the Eye Health report.
For more details refer Eye Health Report section on page 4-17.
Usage Report: Generate a Usage report that displays the complete details of scans
generated for one month. For more details refer Usage Report section on page 7-13.

Select Reports for the Patient

After you identify a patient, a list of scans at the right of the screen appears. You can select
any report to be generated by clicking the check box.
Before the patient puts his or her head in the chinrest, click to select the desired eye. The
default selection is OU and OD is scanned first as per PRIMUS workflow.
Note: The instrument also automatically detects which eye is being scanned.
Note: The first scan acquisition of the day will run slightly slower than all later scans.
The selected scan reports for each eye will be listed near the right top of the ACQUISITION
screen. PRIMUS instrument provides the following scan types for posterior and anterior
scans.

Posterior Segment Scans – Protocols / Reports

Retina Protocol
• Macular Thickness Report: Generates a cube of data through a 6 mm square grid by
acquiring a series of 32 horizontal scan lines each composed of 512 A-scans. In
addition, a high-definition crosshair scan (1024 x 2) is acquired first. Each
high-definition scan is composed of 1024 A-scans.

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• 5 Line HD Raster Report: Generates 5 parallel scans of 6mm equal length, with
adjustable orientation. Each line is always composed of 1024 A-scans (highest
resolution over 6 mm length).
• 1 Line HD Raster Report: Generates 1 scan of 6mm length, with adjustable orientation.
The line is always composed of 1024 A-scans (highest resolution over 6 mm length).

Glaucoma Protocol
• ONH & RNFL Report: Generates a cube of data through a 5 mm square grid by
acquiring a series of 128 horizontal scan lines each composed of 128 A-scans. In
addition, a high-definition crosshair scan is acquired first. The high-definition scan is
composed of 1024 A-scans.

Anterior Segment Scans1 – Protocols / Reports

• Angle View and Cornea: Generates 1 scan of 8mm length, with adjustable orientation.
The line is always composed of 1024 A-scans (highest resolution over 8 mm length).
• Auto CCT: Generates a cube of data through a 4 mm square grid by acquiring a series of
32 horizontal scan lines each composed of 512 A-scans.

Add New Scans to the Current Scan List

During acquiring particular scans, if you require to add new scans, click Add New Scans in
any of the review screen. Select the reports and the desired eye and click Done to save
changes or Cancel to discard the changes.

Select eye(s)

Select Report(s)

1. Anterior Segment Scan Acquisition and Analysis is an optional feature that may not be available in all markets and, when available in
a market, may not be on all instruments. If you do not have this feature and want to purchase it, contact your local ZEISS distributor.

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Prepare the Patient

Patient preparation includes:
• Precautions, below
• Adjust the Height, page 3-16
• Preparing the Patient for the Exam Experience, page 3-18
• Optional Eyelid Elevation, page 3-18
• Optional Dilation of Patient’s Eye(s), page 3-18
Note: The forehead and chin-rests should be cleaned between each examination with an
alcohol prep wipe.

Precautions
CAUTION: The operator should check that the patient is not touching the instrument
with hands before or during tests. Although movement of the instrument is slow
during alignment and focus, instruct the patients to remove their fingers from the
metal base of the instrument, as there is potential for fingers to be squeezed and
possibly injured if left in the area shown below:

Keep fingers away

from the metal base

Adjust the Height

Once you have entered or selected a patient record (see Find Existing Patient, page
3-10), the next step is to adjust the instrument height for patient comfort. Seat the patient
on the patient side of the PRIMUS instrument, facing the operator.
It is important to optimize patient comfort by properly adjusting the height of the table
and/or chin cup. This permits lengthy examination with a clear, consistent view of the
fundus, resulting in high quality OCT images.

How to Adjust the Height

There are three ways to adjust the height:

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 Acquire Scans 3-17

• You can raise or lower the entire PRIMUS table using the table height switch. This switch
is underneath the center of the table on the operator side (see the PRIMUS System
Hardware drawing on page 1-6).
• You can also raise or lower the chin cup using the knob below the chin cup on one side
(see Figure 3-13).
• For finer adjustments, rotate the knob on the joy stick to raise or lower the optical head
(see Figure 3-13).

Rotate to adjust height

Rotate to adjust height

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With the patient seated, follow these steps to adjust the height:
Note: You must observe the patient when you are adjusting the height to make sure that
the patient is comfortable with the height adjustments and the ocular lens is not touching
or impacting the patient's eye.
1. Raise or lower the tabletop to bring the forehead rest approximately level with the
patient's forehead.
2. Before asking the patient to place his or her chin on the chin cup, move the Optical
head safely away from the patient's face. Use the black joystick located on the
operator side of the Optical head.
Note: If Optical head is locked, unlock by pulling the brake which is near the joystick
towards you to release the Optical head.
3. Now ask the patient to place his or her chin on the chin cup. The patient's forehead
should press firmly against the forehead rest without any neck or back strain. You may
need to readjust the height of the tabletop or the patient's chair position.
4. Adjust the height of the chin cup so that the eyes align with the alignment / canthus
markers (red lines) on the forehead/chin rest. The adjustment knob is below the chin
cup on one side of the forehead/chin rest (see Figure 3-13).

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3-18 Acquire Scans

Preparing the Patient for the Exam Experience

The patient’s exam experience with the PRIMUS instrument is normally brief and
comfortable. An experienced operator can acquire several scans from each eye in the space
of 5-7 minutes. An exam usually requires the patient to look inside the imaging aperture
for 1-3 minutes at a time for each eye, depending on the number of scans desired. The
instrument acquires most scans in less than 3–3.5 seconds. The additional time is required
to align the patient before scanning and to optimize scan quality. The patient may sit back
between scans as needed. Note that the PRIMUS instrument is never to contact the
patient’s eye.
Note: It is not necessary for the patient to put their head on the chin-rest until after the
desired scan is selected.

Optional Eyelid Elevation

To get a scan unobstructed by the eyelids, especially for vertical scans, you may find it
necessary to tape the eyelids of either eye or manually elevate the eyelid during scan
acquisition in accordance with standard medical practice. For many patients, it is sufficient
to ask them to open their eyes wide during scan acquisition.

Optional Dilation of Patient’s Eye(s)

WARNING: If the eye is dilated, do not attempt to acquire images of angle
view, as you may not get correct angle between cornea and iris due to the
iris enlargement in the limbus.

The minimum pupil size required for PRIMUS instrument is 2 mm. This can usually be
achieved without dilation. If dilation is performed on a subject for an exam, we
recommend that dilation be used on subsequent visits if quantitative comparisons will be
made. Dilation should not directly affect the quantitative measurements, but it may affect
them indirectly by allowing more variability in how the OCT beam enters the eye. Although
such an effect should be small, optimal repeatability will be achieved by imaging the
patient in the same way at every visit.

Initiate a Scan

Patient Setup
CAUTION: Though the chinrest is designed strong enough to support patient’s head,
the patient must place his/her head on the chinrest and must not press intentionally
to avoid damage and injury.

Ensure that the patient’s chin and forehead rest comfortably on the chin-rest and against
the forehead fixture. Adjust table height (if available) for patient comfort.

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 Acquire Scans 3-19

Position The Optical head

Once the SCAN ACQUISITION SCREEN is active, you can begin to position the Optical head
for scanning.
Note: The optimal position of the Optical head ocular lens is ~26 mm or ~1” from the
patient’s eye.

Tools to Position the Optical head

Note: When you move the Optical head towards the patient, make sure that the Optical
head approach direction is towards the center of forehead rest. The forehead rest shape
and smooth contours reduce the risk of injury.
Use the following tools to position the Optical head for scanning:
• The joystick to make gross and fine adjustments of the Optical head in the horizontal
plane—side to side, forward and back. The joystick is located on the rear (operator
side) of the Optical head.
• The joystick knob makes fine vertical adjustments. The joystick spins in either direction
to move the Optical head up or down slowly and smoothly. Turn the joystick clockwise
to raise the Optical head, counter-clockwise to lower it.
• The refractive error knob retracts and extends the ocular lens. Refractive error knobs are
located on both sides of the Optical head at the patient's eye level (see PRIMUS
System Hardware on page 1-6). From the operator side, turn the knob toward the
“-” marking to extend the lens toward the patient. Turn it towards “+” marking to
retract it. This adjusts the focus of the cSLO black and white image you see on the
monitor (Fundus view-port).

Position the Optical Head to Align Eye using Fundus View-port

The immediate goal of positioning is to acquire a cSLO image and a scan image of the
desired retinal feature. The black and white cSLO image aids you in accurately positioning
the instrument and placing the scan, but the final goal is to acquire a high quality scan
image.
You must position the Optical head manually, using the joystick to make adjustments in
three dimensions for the region of the white dot (reflection from fundus) visible in the
Fundus view-port. It is a reiterative process of positioning with the joystick, focusing the
ocular lens and positioning further until the white dot is visible.
1. Focus on the patient’s eye from a distance before moving the Optical head. Instruct
the patient to look straight ahead. Then move the Optical head toward the patient’s
eye. Place it so that the ocular lens is approximately 26 mm (1.02 inch) from the
patient’s eye.

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3-20 Acquire Scans

2. Manipulate the joystick—move for lateral adjustments and twist for vertical
adjustments—to center the white dot (reflection from fundus through pupil) in the
fundus view-port. Then, using the joystick, gently push the optical head towards the
scanning eye and observe that the white dot “grow” until a fundus image becomes
fully visible.

Posterior Segment Cube 512x32 scan pattern Anterior Segment & Posterior Segment
1 Line HD Raster scan pattern

Posterior Segment Cube 128x128 scan pattern Posterior Segment 5 Line HD Raster scan pattern

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A scan pattern overlays the cSLO image for posterior segment scans (Figure 3-14). It
remains in the center of the image as default (can be moved) and illustrates the path of the
scan beam.
3. Instruct the patient to look at the center of the green LED (fixation target). With the
joystick, carefully continue to push the Optical head toward the eye and make vertical
adjustments until you get a good fundus image and a visible band of contrasting
colors (green, yellow, red) against the background noise in the primary view port.
4. Instruct the patient to continue to fixate on the green LED (fixation target). If
necessary, further adjust the Optical head position from side to side, up and down,
until the retinal image fills the screen and is evenly illuminated. Push the brake near
the joystick to lock the Optical head in place.
While the Optical head is locked, you can still adjust the focus and twist the joystick to
adjust height. With experience, you may find that you have condensed steps 2 through 4
into one continuous step.
Note: It is not necessary to spend a long time trying to get the best possible view of the
fundus. It is more important to have a strong scan image signal than an excellent fundus
cSLO image.
If necessary, remind the patient not to move in any direction.
You will begin to see a white dot once the patient is positioned in the chin-rest (although
the image may be poorly resolved until properly focused). Alignment progresses through a
series of steps, although the order in which many of the steps are performed (and whether
they are repeated) will vary depending on the co-operativeness of the patient (e.g.,
whether patients can fixate steadily at a requested location, opacity of their eye, etc.).

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 Acquire Scans 3-21

Adjust Scan Placement

Accurate scan placement on the desired retinal feature is nearly automatic with the
PRIMUS instrument, because:
• The instrument detects which eye is being scanned and,
• It automatically places the fixation target in the correct location for the eye and scan
acquisition protocol you have selected.
Still, the SCAN ACQUISITION SCREEN offers two intuitive and easy methods to precisely
adjust scan placement, so you can scan the exact part of the retina you want.

When you place mouse over the (Optional) – Adjust scan pattern placement: To do this, move the mouse so the cursor
scan pattern, the cursor becomes hovers within the space of the scan pattern. The cursor will turn into a move symbol .
a move symbol , indicating Hold-down the left mouse button and drag the mouse to control the position of the scan
that you can click and drag to pattern box (Figure 3-15). Release the mouse button to set the scan pattern in its new
move it. position.
(Optional) – Adjust region of view: You can change the patient’s fixation by selecting any
When you place mouse over the
of the nine dots (Figure 3-15) to bring that selected point into the center of view and for
fixation target, the cursor
becomes a finger pointer ( ), the fundus image visible within the FUNDUS view-port.
indicating that you can click it to • Why move the fixation target? Aside from changing between fovea and disc locations, it
select. may not be clear why one would want to adjust the fixation target location. The usual
reason is to bring another portion of the retina into view or into the center of view so
that the scan pattern may be applied to it. For example, there may be a particular area
of pathology away from the macula or the optic disc.
• When freezing the cSLO image of the macula, you may observe better contrast when
you move the fixation LED to bring part of the optic disc into view on the edge of
the cSLO image. It may also help in orienting your observations.

Scan Pattern

Fixation
target

Click and drag scan pattern and/or

change fixation target to adjust their placement.
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To change positions, click the desired fixation target. The fixation target that allows
imaging of that part of the retina will be selected. You may need to adjust the scan pattern
position to capture the exact location of interest.
In either case, instruct the patient to follow the fixation target, which has the effect of
changing the region of view. It is desirable to center the area of interest in the field of view
so that you always are scanning the deepest part of the bowl of the retina, which helps
maintain the scan image in the vertical center of the display.
Note: If you adjust the scan pattern placement, check the OCT scan display at right to
make sure that the retinal images are not too high in the view-port. When the edges of
scan images are near the upper boundary, they tend to “fold over,” reflecting a “mirror
image” back into the view-port. If this occurs, or if the scan image is completely inverted,
you must adjust the image using the Center slider in Optimize drop-down. See Capture
the Image on page 3-22.
Note: For Optic Disc Cube 128x128 scans, it is sufficient to keep the optic disc within the
outer dashed circle, but it is best to center the scan on the optic disc as well as possible.

Capture the Image

Instruct the patient to blink once and then open eyes wide during scan acquisition. Click
Capture on the screen or ‘press’ the firing button on the joy stick to capture the images.
After the completion of acquisition, the system beeps.
Note: The blue bordered button on the screen is mapped to the trigger of the joystick.
Note: Avoid a blink when clicking Capture. The patient may blink before and after the scan,
but the scan initiation can be impacted if the blink is right at the moment the operator
clicks Capture. Once the scan has been initiated and is in progress, allowing the patient to
blink freely can help maintain a good tear film and may improve the quality of the OCT
image.
The system processes the images and automatically presents them on the REVIEW screen,
where you can then go to the ANALYSIS screen and decide to either save the scan or try
again. To proceed, see Review Scan - Re Scan (or) Skip to Analysis (or) Go to
Next Scan on page 3-22.

Scan in Progress Indicator

During acquisition, after the user clicks Capture, a busy cursor is shown when a scan is in
progress. The review screen appears within 5 sec of image capture. If the scan is not of
good quality, PRIMUS instrument gives you the choice to either Re Scan or Skip to Analysis
or Go to Next Scan.

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 Acquire Scans 3-23

Acquire an HD 5 Line Raster Scan

1. Select the HD 5 Line Raster from the scan selections.
2. Align the white dot (reflection from fundus) and focus the fundus (see Initiate a
Scan, page 3-18).
3. Choose the angle of the scan desired using the ORIENTATION buttons below the FUNDUS
view-port (see Figure 3-6).
4. Center and enhance the OCT image until you have an acceptable scan fundus and
scan quality (see Adjust Scan Placement, page 3-21).
Click the Capture button and review.

Review Scan - Re Scan (or) Skip to Analysis (or) Go to Next Scan

After you acquire a scan, the REVIEW screen appears. The REVIEW screen format depends on
which scan protocol you have acquired.
Review the captured data to ensure it is of acceptable quality. See Guidelines for
Obtaining Good Quality Scans on page 3-29 for more information.
• Signal Strength Indicator: This appears in the center near the top. Besides the observed
image quality, an important element of acceptable quality is the Signal Strength
indicator, which should be 6 or higher. It ranges from 0 to 10, with 10 being maximum
signal strength. Image quality score 6 or higher is acceptable.
Note: The Signal Strength indicator applies to the scan as a whole.

WARNING: You must make sure that the eye from the work-flow and eye
being scanned match.

Note: Signal strength and image quality can be significantly reduced when the imaging
aperture (the lens) is dirty or smudged. If you suspect this problem, follow the instructions
to clean the Imaging Aperture (page 9-3).
Note: By default the overlay transparency is 100% fully transparent.
If the captured scan is of good quality, click Skip to Analysis or Go to Next Scan (or Add
New Scans (see Add New Scans to the Current Scan List, page 3-15)) and
continue.
• If you click Skip to Analysis, you will see ANALYSIS screen with options either to Print or
Save the image data, if desired.
• If you click Go to Next Scan, you will see ACQUISITION screen to acquire new scan.
If the captured scan is not of good quality, click Re Scan to return to the ACQUISITION screen.
Note: When you click Re Scan, you will notice that the scan pattern overlay will remain in
the same location on the fundus image view-port.
Note: When you are finished analyzing scans, click Cancel in the ANALYSIS screen. You will
return to the PATIENT screen. (see Chapters 4 and/or 5).

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3-24 Acquire Scans

Review Screen for Macular Thickness

1
3 4
10 2 5

6
9

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1 Scan Information 6 Image slice slider

2 Scan Direction 7 Navigation bar
3 Brightness/Contrast button for B-scan 8 Current X slice through front (Primary B scan)
4 Color/Gray Scale toggle button 9 Image slice slider with scan cube overlay
5 X slices through front (Primary B scans) - Thumbnail Preview 10 Brightness/Contrast button for Fundus

For cube scans (Macular Thickness and ONH & RNFL), the REVIEW screen presents the
captured Fundus image, along with an interactive multi-planar reformat (MPR), which
enables you to view image cross-sections through two dimensions (see Reviewing
Image Data using Multi-Planar Reformat (MPR), page 3-25). The example above
is for a Macular Thickness scan report which displays 32 images.
Note: For ONH & RNFL scans, 128 images are displayed (See Acquisition (Review)
Screen, page 2-16).

View-Ports
(Annotation 6 and 9 of Figure 3-16)
Primary B-scan image view-port is displayed in the middle of the screen. The horizontal
cyan line in the fundus image overlay of all scan report(s) corresponds to this view-port.

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 Acquire Scans 3-25

Note: You can view one of the 32 B-scans for Macular Thickness (Retina) and 128 B-scans
for ONH & RNFL (Glaucoma) in this view-port by moving the slider on the right of the
view-port (or) by placing the cursor on the view-port and scrolling the mouse wheel. You
will see that the horizontal line in the Fundus view-port responds to this scrolling of the
mouse wheel.

Signal Strength Indicator

(Annotation 1 of Figure 3-16)
Signal Strength zone displays strength of signal during acquisition.
Note: Though the signal strength is more than 6, you must also check the quality for
localized weak signal due to eye blink, eye occlusions, poor alignment of eye, etc., and for
vertical placement of image (i.e., image either too low or too high) in the view-port(s).

Navigation Bar
(Annotation 7 of Figure 3-16)
The navigation bar, consisting of a series of buttons by which you access functions or other
operational modes, appears at the bottom of the screen.

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• Re Scan: Allow you to rescan by returning you to the ACQUISITION screen of the same
scan type.
Note: When you click Re Scan, you will notice that the scan pattern overlay will remain in
the same location on the fundus image view-port.
• Skip to Analysis: Takes you to the Analysis screen bypassing all other scans you selected
in scan protocol.
• Go to Next Scan: Takes you to the next scan type selected in scan protocol.
Note: When only one scan report for one eye is captured, then only Re Scan and
Skip to Analysis buttons are active on navigation bar.
Note: The blue bordered button on the screen is mapped to the trigger of the joystick.

Reviewing Image Data using Multi-Planar Reformat (MPR)

The view-port is interactive: Click and drag the triangle of the cyan line (Fast B-scan) in the
fundus view-port or click the fundus / OCT scan view-ports and use the mouse scroll wheel
to “move through” the active plane of the view-port; you will see the resulting
cross-sections update simultaneously in the other view-ports. This functionality enables you
to quickly search through the data cube and stop when you see an area of interest.

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3-26 Acquire Scans

Note: The view-ports are not interactive for vertical B-scan (magenta line in overlay).

Drag triangle on slice

navigator to change
currently slices

Data Cube Orientation

Top of cube
en face imag=e Z Cyan line and slice number
indicate current fast B-scan
X (X slice) seen in
Side of cube = middle scan view-port
Front of cube = slow B-scan plane
fast B-scan plane magenta line
right upper view-port
cyan line
middle view-port Y

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The upper left view-port in the Review screen shows the frozen fundus image with the scan
pattern overlay. The overlay has one line that is centered by default, called the slice
navigator. This line indicates the currently selected cross-section (slice) seen in the middle
view-port of the screen. The horizontal cyan line in the overlay corresponds to the middle
scan view-port, which presents the fast B-scan. You can drag this slice navigator by the
triangle on the edge to change the currently selected slice.
To better understand the perspective, think of the data as a cube. The middle (larger)
view-port show the data in planes parallel to the front of the cube. The X slice parallel to
the front of the cube (middle view-port) is also known as the fast B-scan because this is the
direction in which each line of A-scans is acquired extremely quickly (in milliseconds).

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 Acquire Scans 3-27

Review Screen for HD 5 Line Raster Scan

1
10 3 4
2

5
9
7
8

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1 Scan Information 6 Navigation bar

2 Scan Direction 7 Center view-port enlarged (third line)
3 Brightness/Contrast button 8 Orientation angle for 5 Lines
4 Color/Gray Scale toggle button 9 5 line overlay
5 View-port - All five lines 10 Brightness/Contrast button

View-Ports
(Annotation 5, 7 and 9 of Figure 3-19)
All the three view-ports act in synchrony to the change in selection of the lines.
For the HD 5 Line Raster scan, the REVIEW screen (Figure 3-19) presents the OCT scan
image, along with all five lines of the scan. The upper left view-port shows the frozen
fundus image with a overlay that shows the placement of the 5 line scans. The five
view-ports on the right show each of the line scans from top to bottom. In the center
view-port, by default, the image of third line (cyan line) is seen in larger view.
You can view one of the 5 B-scans in the center view-port (larger view) by clicking the 5
small view-ports in preview zone on to the right of the review screen (or) by clicking the

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3-28 Acquire Scans

overlay lines in the Fundus view-port (or) by scrolling the mouse wheel in either Fundus
view-port or Primary B-scan image view-port.
The chosen line (cyan) in the overlay of 5 line scan corresponds to this view-port. The cyan
line of single line scan corresponds to this view-port.
Note: Default image is 3rd of 5.
Note: Each line or view-port when selected changes to cyan in color.
Note: For Single line scan, there is no preview displayed.

Image Display Options During Review

• Full screen: For Macular Cube scans, you can double-click any image in the preview to
open it in full screen. Click the icon on the full screen image to return to normal
view.
For Line scans, you can click the thumbnail images to see larger view in the center
view-port. Also, you can double-click the center view-port to open it in full screen.
• Adjust brightness/contrast: Refer to Brightness / Contrast Icon, page 3-6. Any
user-initiated changes made on any screen become the new instrument default settings,
which are persistent for other scans in the work-flow till you go back to the patient
screen again.
• Color: Clicking the Color button toggles the display area between color and
grayscale modes (b-scan display only).
Note: Brightness/Contrast and Color adjustments apply simultaneously to all OCT scan
view-ports.
Note: Between the Fundus image and its scan image, Brightness/Contrast operate
independently. Select one or the other to apply such changes.
Note: You can switch between color and grayscale globally, for all view-ports using Colored
OCT icon .

Criteria for Reviewing Good Quality Scans

During scan review, use the following criteria to ensure that an image you have captured is
suitable.
1. The fundus image:
• The focus should be sharp and clear, preferably with good visibility of the
branching blood vessels.
• The scan overlay should be centered on the fovea or optic nerve head.
• The fundus image should have uniform illumination without dark corners.
• There should be few, if any, artifacts that may cast shadows on the OCT scan.
2. The OCT scan image:
• OCT scan should be complete in all windows without missing data.
• Color density should be the same from end to end.
• Signal strength should be 6 or greater.

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Guidelines for Obtaining Good Quality Scans

Before capturing an image, follow these guidelines to optimize image quality.
1. Fundus image:
• The focus should be sharp and clear, preferably with good visibility of the
branching blood vessels. Adjust manually with the joystick and the refractive error
knob.
• Center the scan overlay on the fovea for macular scans and on the optic nerve
head for optic disc scans.
• Ensure uniform illumination without dark corners.
• Eliminate or reduce artifacts that may cast shadows on the OCT scan (if possible).
• Floaters may often be moved by asking the subject to shift eyes around prior to
image capture.
• Corneal opacities may be minimized by realignment of the pupil.
2. OCT scan image: To optimize signal strength for the best possible OCT images, follow
these guidelines:
• Center the OCT scan in the mid to upper part of the scan acquisition screen.
Click Optimize or move Center slide to aid in placement.
• The OCT B-scan should be complete in both windows without missing data.
• A tilted retina may be corrected for by moving the pupil alignment off-center to
allow for a more level OCT scan.
• Media opacities may be minimized by searching different pupil positions for the
brightest OCT image.
• Adjust the enhancement setting to achieve the brightest and clearest scan.
• Ask the patient to blink once before obtaining the scan. Patients with severe dry
eye should use artificial tears prior to scanning.

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Troubleshooting when you get Unsatisfactory Scan Image

Indicator Potential Problem What you should do

OCT image The OCT image is not centered Use the Center slider (or mouse
centered properly and the scan is too high wheel) to center the scan.
or too low in the window.
For patients with certain Re scan. On the ACQUISITION SCAN
pathologies or anatomical screen, click Optimize
features, it may be difficult to
ensure centering across all B-scans
in a cube.
Other factors Fundus image – scan may not be Adjust the scan pattern position in
aimed through the pupil. the Fundus view-port.
Fundus image – focus has drifted Manually adjust using the
away from patient’s refraction. Alignment controls.
Patient fixation issues. Communicate with the patient to
ensure they are fixating in the
same position as at the start of the
scan.
Excessive blinking or moving. Communicate with the patient to
reduce blinking and movement.
Figure 3-20 illustrates the case of poor scan quality. Given below are the reasons along
with the corrective action:
• Fundus image is not clear - Correct the refractive error of the patient.
• B-Scan is not centered - Use the Center slider in the Optimization option to align the
B-scan image.
• Low signal strength - Use the Enhance slider in the Optimization option to enhance the
signal strength.

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 Analyze Reports: Retina 4-1

(4) Analyze Reports: Retina

Chapter Overview
This chapter explains how to use the analysis portion of PRIMUS software. This chapter is
common to reports: Macular Thickness, 5 Line HD Raster and Single Line HD. Topics
covered in this chapter include:
• Access Analysis, (below)
• Retinal Layers Automatically Detected and Displayed, page 4-2
• Macular Thickness Analysis, page 4-2
• Macular Thickness Analysis (MTA) Follow-up, page 4-13
• Eye Health Report, page 4-17
• 5-line HD Raster Analysis, page 4-20
• 1-line HD Raster Analysis, page 4-21
• Reports and Printing, page 4-22

Access Analysis
The ANALYSIS screen enables you to view and measure anatomical structures depicted in the
scan images. To access analysis, click the View Reports button when it is active. It is active
when a patient record with saved report(s) is selected from the PATIENT screen.
Note: You can also start the analysis by double-clicking the selected report.
• Click to select the patient from the patient list—You can select only one patient at a
time (see Identify the Patient on page 3-10).
• Click the corresponding date on to the right—It is organized by scan Date and each
date with the reports and eye details (OD/OS).
• Select report(s) of one or more dates to view—Hold down the Ctrl (Control) key and
click to select multiple report(s) from different dates. To deselect the selected reports,
hold down the Ctrl key and click the selected reports.
When you click the View Reports button, the ANALYSIS screen appears (see Figure 4-1).
The image(s) will appear as shown in Figure 4-1, after a few seconds. Analysis screen for
Macular Thickness report is discussed here as an example.

You can select multiple reports

You can select reports

from multiple dates

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4-2 Analyze Reports: Retina

Retinal Layers Automatically Detected and Displayed

Cube scan analyses incorporate an algorithm to automatically find and display the inner
limiting membrane (ILM) and the retinal pigment epithelium (RPE).
In the scan images, which are cross-sections (slices), the layers appear as colored lines that
trace the anatomical feature on which they are based. The ILM is represented by a white
line, the RPE by a black line. These lines are also known as segmentation lines. These layers
serve as the basis for the macular thickness and volume measurements in the Macular
Thickness Analysis, page 4-2.
• View Segmentation results: Click to hide or show the colored lines indicating the
ILM and RPE layers (Annotation 6 of Figure 4-1).
No Segmentation lines are shown for ILM and RPE

Segmentation lines are shown for ILM and RPE

— Inner Limiting Membrane (ILM)

— Retinal Pigment Epithelium (RPE)

Macular Thickness Analysis

The Macular Thickness Analysis (MTA) provides interactive scan images as well as the
fundus image with scan cube overlay(s). The default screen, shown in Figure 4-1,
displays:
• the identified fovea location.
• the fundus image with scanned cube overlay or colored thickness map.
• the ETDRS grid map.
• a table containing average thickness and volume measurements.

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 Analyze Reports: Retina 4-3

You may also manipulate the fovea location on this screen, which will update the data
table and the ETDRS grid thickness measurements.

1 2

3 5 6 24 7
4
8
9
10
14

13 15
11 21 12

17
16

23 22

18
19
20

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1 Patient Information 13 Scan Pattern

2 Analysis list (with OD and OS details) 14 Anterior Layer (ILM)
3 Scan Information (Exam Date/Time and Signal Strength) 15 Posterior Layer (RPE)
4 Brightness/Contrast & Gray/Color Toggle for B-Scan image 16 ETDRS Grid Map with Normative Data colors
5 Ruler (Add/Delete Line Measurement) 17 Comments Area
6 View Segmentation Results 18 Average thickness and volume measurements (Data Table) with
Normative Data colors
7 Snap slice navigator to ETDRS Grid center position 19 Slice through Cube Front
8 Brightness/Contrast Toggle for Fundus image 20 Navigation Bar
9 Fundus Image with Scan Cube Overlay 21 Slice Navigator
10 Click and drag the triangle 22 Orientation Markers
11 Color code for thickness overlays 23 Details on Normative data
12 Slice through Cube Side 24 Edit Segmentation Results

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4-4 Analyze Reports: Retina

The screen displays:

• Patient Details—Name, Age, Gender, DoB and Patient ID
• the current and selected analyses with eye details
• the patient’s exam by date, with the signal strength of the scan
• Viewport(s)—Fundus, Primary & Vertical B-scan
• ETDRS Grid (with average thickness and volume measurements)
• Navigation Bar
• Comments area

Macula Normative Database

The Macular Thickness Analysis supports the clinician in identifying areas of the macula
that may be of clinical concern by comparing the measured macular thickness to
age-matched data in the Macula Reference Normative Database. Normative data that is
age-matched to the patient appears when you perform a Macular Thickness analysis on
patients at least 18 years old. Data was not collected from subjects less than 18 years old.
The Reference Normative Database uses a color code, to indicate the normal distribution
percentiles. The color code applies to the ETDRS grid average thickness values and the data
table (see Figure 4-4 on page 4-12).
Among same-age individuals in the normal population, the percentiles apply to each
particular retinal thickness measurement as follows:
• The thickest 1% of measurements fall in the light red area. Measurements in light red are
considered outside normal limits (light red > 99%).
• The thickest 5% of measurements fall in the light yellow area or above (95% < light
yellow99%, suspect above normal).
• 90% of measurements fall in the green area (5%  green  95%).
• The thinnest 5% of measurements fall in the yellow area or below (1%yellow < 5%,
suspect below normal).
• The thinnest 1% of measurements fall in the red area. Measurements in red are
considered outside normal limits (red < 1%).
Note: Clinicians must exercise judgment in the interpretation of the normative macula
data. For any particular measurement, note that 2 out of 20 normal eyes (10%) will fall
either above or below green.
Interpretation of the 1st Percentile: Values color-coded as “1st percentile” are lower than
99% of the database sample, but may not extrapolate well to the general population with
fewer than 300 subjects in the reference database. Results falling in this region should be
interpreted with caution.
Interpretation of the 5th Percentile: Values color-coded as “5th percentile” are lower than
95% of the database sample. The 95% Confidence Interval on the 5th Percentile extends
from the 2.5th percentile to the 7.7th percentile of the normative database. Information
icons on the ANALYSIS screen offer additional information about the normative database

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 Analyze Reports: Retina 4-5

limits. If the green zone is transgressed the symbol changes into a triangle with an
exclamation mark. Hovering over the icon will display a tool-tip, and clicking the icon will
create a printout of the additional information presented. See Normative Data Details
Report on page 4-23 for more information.

Analysis Screen Functionalities

The following information applies to the ANALYSIS screen in general, independent of the
type of report you are viewing.

View Ports
(Annotation 19 & 12 of Figure 4-1)
The Macular Thickness Analysis (MTA) provides interactive scan images as well as the
fundus image with scan cube overlay, as shown in Figure 4-1, on page 4-3.
The viewports are interactive: Click and drag the triangle of scan pattern on the frozen
fundus image (or) click the primary b-scan viewport or frozen fundus image and use the
mouse scroll wheel to “move through”; you will see the resulting cross-sections update
simultaneously in the other viewports. This functionality enables you to quickly search
through the data cube and stop when you see an area of interest.

Image Quality Information

(Annotation 3 of Figure 4-1)
Signal Strength Value—This appears just above the B/C and color/gray scale icons in
primary view port. It ranges from 0-10, with 10 being maximum signal strength. When
values are less than 6, the value is below the acceptable threshold; when 6 or higher, the
value is acceptable.
Note: The Signal Strength value applies to the entire cube scan.

Navigation Bar
(Annotation 20 of Figure 4-1)
• Cancel button: Click the Cancel button to return to the PATIENT screen.
• Save button: Click Save to save the current analysis with the line measurement changes
(added or deleted) applied, comments added or deleted, and B/C and Grayscale/Color
toggle changes. Your changes are not saved as part of the analysis until you click the
Save button. If you make line measurement changes to the image(s) and proceed to
another analysis without saving, the system insists you either save or discard the
changes, as shown below.

• Next Analysis button: Click Next Analysis to navigate to other report selected.
• Print button: Click Print to initiate printing. You can print to paper, create a PDF that can
be exported to USB device or to CD/DVD and/or export to DICOM. See Reports and
Printing on page 4-22 for details.

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4-6 Analyze Reports: Retina

Line Measurement
(Annotation 5 of Figure 4-1)
These buttons appear to the top right in the Primary B-scan image viewport of the analysis
screen. If you keep mouse cursor over the buttons, their function appears in the form of a
tooltip. The following paragraphs describe the additional features available on the
MACULAR THICKNESS ANALYSIS screen.
• Ruler button: Click Ruler and then click and drag on a scan image to draw a
straight line that measures the distance between the start and stop points. The resulting
measurement appears next to the line in micrometers.
• You can create several additional measurement lines when the cursor remain as .
• The changes appear on the analysis reports (printout).
Note: You may use the ruler tool with the high definition images too, and separate
measurements can be added / deleted to different b-scan slices i.e., either of slices (32
slices of Macular Thickness and 5 slices of 5 Line HD Raster). Clicking Save once saves all
the changes made on the individual slice(s) before you move out of the analysis screen.
• Delete Measurements button: Click Delete and then keep the cursor on the line.
When the cursor changes to cross-hair, click to delete the currently selected
measurement line. To de-select a line, move cursor anywhere on the image, off the line.

Brightness/Contrast
(Annotation 4 & 8 of Figure 4-1)
(See also Brightness / Contrast Icon on page 3-6).
When this feature is used, values appear on the image that reflect
the numerical parameter values you select. Click and drag the mouse up and down to
change brightness; left or right to change contrast. They also work in combination when
you move the mouse diagonally.
Note: The feature is present in both saved fundus and primary view port(s).

Color
(Annotation 4 of Figure 4-1)
You can switch between color and grayscale for the primary viewport, by selecting or
deselecting .
Note: This feature is present in primary and fundus view port.
Fundus B-Scan Marker
This icon appears when you mouse hover on the fundus image. When the fundus B-scan
marker is turned on, you can associate a particular region between the acquired fundus
image and the corresponding B-scan image and vice-versa. You can click anywhere on the
6mmx 6mm scan pattern zone and view the corresponding region on the B-scan. Based on
where you have clicked on the fundus image, a region of interest is created both on fundus
image and B-scan image.

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 Analyze Reports: Retina 4-7

Fundus B-Scan Marker

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A rectangular amber colored indicator will appear on the fundus image as shown below.
This indicator will be applicable to a maximum of two B-scan slides above and below the
originally identified B-scan slide. For example, if you are selecting B-scan slide number 4
then this indicator will cover up to slide 2 on the top and slide 6 on the bottom.

Fundus B-Scan Slider

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4-8 Analyze Reports: Retina

Full Screen View

(Annotation 19 of Figure 4-1)
You can double-click the primary OCT image to open the current image in full screen. Click
the button on the full-screen image or Esc on the keyboard to return to normal view.
Note: The Brightness/Contrast, Color/Grayscale and Ruler buttons do not appear on the full
screen image.

Add Comments
(Annotation 17 of Figure 4-1)
This Analysis window permits you to enter individual scan
comments. It also provides comments with standard
description to assist clinicians in saving time.
CAUTION: The comments entered in the Add Comments text box are printed on the
final report. Carl Zeiss Suzhou is not responsible for diagnostic interpretation based
on the comments. It is the clinician's responsibility to make diagnostic
interpretations based on the OCT scans and not rely on the comments.
Edit Segmentation Results
(Annotation 24 of Figure 4-1)
Click Edit Segmentation Results to open the EDIT SEGMENTATION screen, as shown in
Figure 4-3. Here you can edit the currently selected X and Y slice placement on the ILM
and RPE layers—PRIMUS calculates thickness between these layers.

ILM Layer

RPE Layer

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 Analyze Reports: Retina 4-9

This feature is especially useful in cases where the retina has structural anomalies or
pathology that may cause the algorithms to incorrectly trace the actual boundaries. Click
and drag the ILM line or the RPE line, shaping and placing it in the desired location by your
mouse movement. You can draw and redraw the line or any portion of it repeatedly,
selecting any point on a line to start each successive drawing action.
Note that when you mouse hover a line, it “pops,” or becomes thicker. The boundary lines
you trace will never break. However, they will not cross each other.
Your changes are not saved as part of the Macular Thickness analysis until you click the
Save button on the ANALYSIS screen. Then they will persist with the analysis until you
re-edit the same layers and click Save again, or click Cancel when viewing the edited
analysis.

Fundus Image Overlay Options

On the fundus image, the ILM-RPE overlay displays by default, which shows a
corresponding (in terms of color) thickness representation from above (en face). The
tabbed menu below the fundus image gives you the following overlay options: ILM-RPE,
ETDRS and None (as shown to the left and in Figure 4-1, on page 4-3).
The overlay option buttons are found below the fundus image.
Note: The ILM-RPE overlay is not transparent.

Numerical Average Thickness and Volume Measurements

The area at lower left presents average thickness and volume numerically.

ETDRS Thickness Grid with

Normative Data colors

Details on Normative Data

Average Thickness and

Volume Measurements with
Normative Data colors
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It includes a table with central subfield thickness for the central circle of the circular map
known as the ETDRS Grid, and total volume and overall average thickness for the ILM-RPE
tissue layer over the entire 6 x 6 mm square scanned area. The ETDRS Grid shows overall
average thickness in nine sectors. This circular map is composed of three concentric circles
with diameters of 1 mm, 3 mm and 6 mm, and except for the central circle, is divided into
superior, nasal, inferior and temporal quadrants. The central circle has a radius of 500

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4-10 Analyze Reports: Retina

micrometers (1 mm diameter). In the OCT fundus image (top left of screen), the fundus
area within the overlay is the area over which the individual thickness measurements are
made, and that contribute to the subfield averages.

Auto Fovea Finder™: Automatic Fovea Identification

PRIMUS identifies the fovea location automatically by looking for the reduced reflectivity
under the retina. When the ANALYSIS screen first comes up, the fovea location has been
determined and is indicated by the overlay position and the position of the slice navigator
in the cube.
The ETDRS grid in Figure 4-4 shows the values, in micrometers (μm), of the ILM-RPE
thickness, calculated as described above. You can change the position of the ETDRS grid. If
you change it, the reported values also change. The position of the fovea and the center of
the ETDRS grid appears below the grid. In the example above (Figure 4-4), the fovea is
located at the intersection of slice 255 and 16.
If PRIMUS cannot identify a fovea in the scan, it reports: “Centre of Fovea not found.
Centre of scan pattern used as fovea center”. In this case, the center of the scan is used for
the initial placement (position 256 and 16 for 512x32 scans). It is also possible for the
algorithm to find a depression in the reflectivity around the ILM that is not related to the
fovea—in this case, the reported fovea will be wrong. In either case, the user can set the
fovea manually by moving the ETDRS grid overlay on the fundus image.
The most common conditions that cause failure of the fovea-finding algorithm are those
that cause the greatest disturbance of the foveal architecture, such as AMD, other causes
of macular edema, and proliferative diabetic retinopathy. Epiretinal membranes and other
vitreoretinal interface disorders where the vitreoretinal interface becomes distorted can
also cause the algorithm to fail.
If the fovea is very far from the center, the algorithm may fail to find it. Hence, re-scan and
use the optimize button to get the fovea within the reasonable distance off the center.

Working with Scan Cube Overlays

In the ILM-RPE overlay, the colors on the overlay correspond to the color-coded side bar
scale on the right. The colors denote retinal thickness in micrometers (μm) (as shown to the
left).
When ETDRS position is selected from the overlay menu, a small yellow circle appears
centered around the PRIMUS-calculated fovea position (as shown on the left). This
calculated ETDRS Grid position can be repositioned by clicking and dragging the circle
using the mouse.

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 Analyze Reports: Retina 4-11

The thickness grid also moves in conjunction with the repositioning of the ETDRS Grid
position on the overlay, as shown in Figure 4-5.

ETDRS Grid position moved

Note that in the fundus image,

as the green circle moves in the
yellow square, the thickness grid
also moves accordingly.
The fovea location also changes.

ETDRS Thickness Grid moves

in conjunction with ETDRS Grid

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As you adjust the ETDRS Grid position, the thickness grid and fovea location also reflects
the new values associated with the new setting.
Interactive function button for ETDRS include the Snap slice navigator to ETDRS Grid center
position (Annotation 7 of Figure 4-1). Click this icon to move the slice navigator
(cyan horizontal line) to the ETDRS Grid center position. For example, manually drag the
ETDRS Grid to a new position on the overlay, then:
• Select to center the slice navigator over the new ETDRS Grid position, as shown on the
left. Note that the thickness grid does not change location.
• Click Reset to bring the ETDRS Grid position to the original PRIMUS-calculated position.
The slice navigator also move back to their original positions over the ETDRS Grid
position.

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4-12 Analyze Reports: Retina

Now move the slice navigator to a new position, as shown in Figure 4-6. The ETDRS Grid
position does not change, nor does the thickness grid position.

Slice Navigator(s)

See that the ETDRS Grid

position did not change
with slice navigator position.

ETDRS Thickness Grid(s)

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Scan Display Left to Right Orientation

See Scan Direction on page 3-6.

Data Cube Orientation Data Cube Orientation

Top of cu
The ANALYSIS screen presents an interactive multi-planar reformat En Face Explained
en face sc bepl= Z (MPR), which enables you to view image cross-sections through
yellow scanan
line
ane En face, from the
two dimensions. For example, in a Macular Thickness scan, the French, means
X
Side of cube =
upper left view-port shows the saved fundus image with an en face literally, “on the
Vertical B-scan plane scan overlay. The other two view-ports show cross-sectional scan face”; that is,
magenta scan line
Front of cube = Right top viewport images in two planes. Thinking of the data as a cube, the looking directly into
fast B-scan plane the eye, which is
blue scan line view-ports show the data in planes parallel to the side of the cube
Primary viewport Y the same
(Y plane, right top view-port) and the front of the cube (X plane,
perspective as the
primary (center) view-port), as shown in Figure 4-1 and to the fundus image.
left.

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 Analyze Reports: Retina 4-13

Macular Thickness Analysis (MTA) Follow-up

Selecting the Macular Thickness Analysis (MTA) Follow-up option allows you to compare
two Macular Cube 512x32 scans side by side, as shown in Figure 4-7 on page 4-14. The
default function is to compare the two most recent scans of a particular patient. PRIMUS
lets you to compare exams from two dates so that the exams can be synchronized to show
the equivalent location of the retina in each image. In addition, the thickness maps for the
two images, the Normative color coded ETDRS grid and Normative details like average
thickness, volume measurements are displayed.
By default, the Synchronize option is turned on, it allows you to view the reference and
follow-up B-scans simultaneously by moving the image slice navigator present on each of
image. Otherwise, you will be able to individually scroll through the B-scans using the
respective image slice navigator.
You can change the follow-up or reference exam as per your requirement by selecting the
required scan from the 'Reference' or 'Follow-up' drop downs.
Note the following points while changing the follow-up or reference exam:
• You cannot select the same scan for both reference and follow-up
• The follow-up scan date must be recent or later than the reference image's scan
date
The additional comment can be entered for the Macular Thickness Analysis Follow-up
report. The comments entered for reference Macular Thickness Analysis will not be
displayed in this report.

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4-14 Analyze Reports: Retina

1
2

4
9
5
10
6

7
11
3
3
12

13 14

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1 Patient Information 8 Comments Area

2 Scan Information (Exam Date/Time and Signal Strength) 9 Fundus Image with Scan Cube overlay
3 Image slice Navigator 10 ETDRS Grid with Normative Data colors
4 Fundus Image Overlay options 11 Average thickness and volume measurements (Data Table) with
Normative Data colors
5 Synchronize Option 12 B-scans View port
6 Reference Image drop-down 13 Reference screen
7 Follow-up Image drop-down 14 Follow-up screen

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 Analyze Reports: Retina 4-15

Working with MTA Follow-up Feature

By default, for a new patient the MTAFollow-up option would be disabled. To create an
MTA Follow-up report there must be an existing Macular Analysis report for a particular
patient. So, locate the patient through the search functionality. Once the patient details are
located, follow the below given steps to create an MTA Follow-up report:
1. From the PATIENT screen, select MTAFollow-up.

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2. Click Acquire. Move to the analysis screen.

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4-16 Analyze Reports: Retina

3. By default, the currently acquired image appears in the Follow-up pane. The recently
acquired image as per the image time-stamp appears in the Reference pane as shown
below.

Follow-up pane
Reference pane

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4. If you want to compare the current image with an older image then you can do that by
choosing the required image from the “Reference” drop down as shown below.

Reference drop-down

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5. Click Save to commit the changes.

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 Analyze Reports: Retina 4-17

6. The Analysis dialog appears. Click New Report to save the current changes as new
report, or if you want to overwrite the existing report click Overwrite report button.

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Eye Health Report

The Eye Health Report feature of PRIMUS allows patients to know the present condition of
their retina. It combines both Glaucoma and Macular Thickness Analysis scans into a single
report. The reason is Glaucoma is a disease that has no symptoms when untreated
eventually can lead to blindness. It will never show up any signs during its early, and into
its late stages. While, Macular Thickness Analysis can reveal various retinal diseases like
Age-related Macular Degeneration (AMD), Macular hole, diabetic retinopathy and so on.
That's the reason examinations for glaucoma and macular thickness need to be performed.
Both of these reports are displayed in a side-by-side manner for a particular eye. Follow the
below given procedure to access the Eye Health Report:
1. From the PATIENT screen, enter the patient details. Upon selecting the eye/s click Eye
Health Report option.

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On clicking the Eye Health Report option, you will notice that both ONH & RNFL and
Macular Thickness options will also be selected.
2. Click Acquire.

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4-18 Analyze Reports: Retina

3. The Macular Thickness acquisition screen appears. Perform the acquisition procedure
for the right eye i.e OD. This will be followed by the OHN&RNFL acquisition for OD. If
you have selected both eyes which is OU in step 1. Then, the left eye acquisition
procedure needs to be completed for both Macular Thickness and ONH&RNFL.
4. Complete the analysis procedure.
5. From the “Print” drop-down, click the Print Eye Health Report option. You can also
print the Eye Health Report from the Patient Management screen. To print the Eye
Health Report, click the View Reports button and select the Print Eye Health Report
option.
The Eye Health Report will be printed and you can check the required parameters through
this report.
By default, the Eye Health Report displays the Glaucoma and Macular Thickness analysis
information. But there is an option inside the ADVANCED SETTINGS which allows you to
print the Cornea analysis report as part of the Eye Health Report.
For this you have to enable the “Include Central Corneal Thickness” option present under
the Eye Health Report pane as shown below.

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 Analyze Reports: Retina 4-19

The Eye Health Report is a licensed feature. Check with the ZEISS support team for
enabling the license. If you have not obtained the license, this option will appear grayed
out as shown in the figure.

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4-20 Analyze Reports: Retina

5-line HD Raster Analysis

The ANALYSIS screen for HD 5 Line Raster scan operates in the same manner as described in
Macular Thickness Analysis on page 4-2, with the following exception: a total of five
images are acquired and are seen as thumbnails in which one of the five images is
displayed in primary view port as shown in Figure 4-15.

1
2

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1 Fundus image with 5 lines overlay 2 Large image of selected line 3 5 thumbnail images
(with scan pattern orientation angle) (corresponds to cyan line) (corresponds to 4 magenta lines
and one cyan line)

There are four B-scan images as thumbnails which correspond to magenta lines and one
B-scan image as thumbnail which correspond to cyan line. The view of the line selected
(cyan) in the overlay is displayed in center. The scan angle is indicated below the fundus
image.
You can view 1 of 5 B-scans in the primary view port by clicking the 5 thumbnails on the
upper right of the screen (or) by clicking the horizontal lines in the Fundus view port (or) by
scrolling the mouse wheel in either Fundus view port or primary B-scan image view port.
All the three view ports (fundus, primary and thumbnails) act in synchrony to the change in
selection of the lines.
Note: All screens associated with the HD 5 Line Raster and HD Single Line scans will
display the scans in either in color or Black & White. Switching to black & white may
improve the perceived image quality of the HD scans. Adjustments to brightness and

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 Analyze Reports: Retina 4-21

contrast as well as switching the scans to black and white images are available using the
Brightness/Contrast and Color/Grayscale icons.

Scan Display Left to Right Orientation

Left to Right Scan Display PRIMUS always displays left to right scan images as follows:
Summarized • For horizontal scans, left of scan equals left of scan display and right of scan equals
For horizontal scans, left equals right of scan display.
left and right equals right. For all • For vertical scans, bottom of scan equals left of scan display and top of scan equals
diagonal scans in 5 Line and
right of scan display.
Single Line Raster, left takes
precedence over bottom. For • For diagonal scans in 5 Line and Single Line Raster, left takes precedence over bottom,
vertical scans, left to right equals so that left of scan equals left of scan display and right of scan equals right of scan
bottom to top. display.

1-line HD Raster Analysis

The ANALYSIS screen for 1 Line HD Raster scan operates in the same manner as described in
5-line HD Raster Analysis on page 4-20, with the following exception: only one image
appears, as shown in Figure 4-16.

1
2

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1 Fundus image with 1 line overlay (with scan pattern orientation angle) 2 Single B-scan image (cyan line)

The view of the line (cyan) in the overlay is displayed in center. The scan angle is indicated
below the fundus image.

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4-22 Analyze Reports: Retina

Reports and Printing

PRIMUS enables you to generate analysis reports in color, which you can then either print
on paper or export in an electronic format, such as PDF. PRIMUS provides a standard
(stock1) print mode only. This section describes prints of various Macular thickness reports.
The report page has a header with fields for patient details (Name, DoB, ID, Gender),
Doctor, Technician, and Institution details (name with logo, Telephone number and Email).
See Institution Information on page 2-7). The layout of these fields limit the number of
characters that can be displayed on the report, even though you can enter additional
characters on the instrument when creating the Name, ID, etc. Specifically, reports can
display 64 characters for ID; 40 for Institution name; and 25 characters for Name (first and
last name combined). These character limits include spaces. If you create patient names,
IDs, etc., longer than can be displayed on the report, be aware that the information you
see on screen may not be complete ( ..... suffixed to the patient names, IDs, etc., on the
report shows that some text is missing and you may have to find the same on patient
screen).
The body of all reports consists of fundus and B-scan image(s) with the scan information
such as date and time, signal strength, overlay orientation (for 1 and 5 Line HD raster
scans), comments (if any added during analysis), signature of the report analyst and Zeiss
logo.
• The current slice number at which the fundus and primary B-scan images were
visualized and line measurements of that slice, if any, are displayed on the print. You
have to take separate prints for each slice of a particular report. PRIMUS does not offer
customizing of report printing.
The footer of all reports consists of the time at which the report was printed, the user’s
name and the PRIMUS equipment with the software version.
Note: If an analysis is edited and not saved, printing a report does not save the edited
analysis, but will display the editions on the report only.
Note: The date/time of printing an analysis is printed in the footer of the page.

1. As seen on the screen. You cannot customize your printouts.

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 Analyze Reports: Retina 4-23

Normative Data Details Report

There is measurement variability for the macula parameters which may impact the
normative data colors. If the true value is near the limit of what the software uses to
determine the normative database color code, then it is possible that the color code could
vary from exam to exam. When at least one parameter is close to a normative limit, a blue
icon button is displayed. When the cursor hovers over this icon button, the tooltip
appears as shown below.

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If you click the blue icon button a PRINT PREVIEW screen displays the Normative Data Details
Report as shown below. The report can be printed from the PRINT PREVIEW screen.

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4-24 Analyze Reports: Retina

The Normative Data Details Report displays the parameters of the analysis in the units
measured and as a percentile from the normative database. In addition, the report displays
the result minus the reproducibility limit, as well as the result plus the reproducibility limit,
and their corresponding percentiles. Each of these measurements are presented with the
appropriate normative database color code.
This report provides the ability to see how close a particular measurement comes to a
normative limit cutoff by checking the actual percentile. In addition, the plus measurement
variability and the minus measurement variability values are also color-coded so the user
can determine if the original normative database designation would cross over to a
different color level when considering the measurement variability. Due to measurement
variability, it is possible that the normative data colors may change on subsequent visits
without representing a change in the condition of the patient.
You may generate a Normative Data Details Report from the following analyses:
• Macula Thickness Analysis
• ONH and RNFL OU Analysis
Note: ONH and RNFL OU Analysis report will print two pages of the Normative Data
Details Report as these reports are OU printouts (two eyes).

Stock or Standard Print

The stock print mode provides a standard print layout for each kind of analysis report.
Stock printout examples include:
• Macular Thickness (with ETDRS overlay) Stock Printout, Figure 4-20
• Macular Thickness (with ILM-RPE overlay) Stock Printout, Figure 4-21
• Macular Thickness (with no ETDRS or ILM-RPE overlay) Stock Printout, Figure 4-22
• MTA Follow-up Stock Printout, Figure 4-23
• Eye Health Stock Printout, Figure 4-24
• High Definition Image HD 5 Line Raster Stock Printout, Figure 4-25
• High Definition Image HD Single Line Raster Stock Printout, Figure 4-26
Selecting Printer icon presents a dialog like any other print dialog of Windows, as
described below.

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 Analyze Reports: Retina 4-25

The print (whether a hard copy or pdf) generated is a report based on what is currently on
screen (The current cross-sections will appear in the report). The system presents a print
preview, as shown in Figure 4-19, of the current analysis report.

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Hardcopy When you click the Print button, three options (as shown to the left), are available. If you
want to print to an attached printer without using other options, simply click the Printer
icon.
Note: To save the toner, on the analysis screen before you click Print button, change the
b-scans to gray-scale. Then on the print preview, click to switch from gray-scale to
Eco/Normal mode which will effect b-scan images to appear dim than the gray-scale.
This screen also gives you the options to export in .pdf (Portable Document Format) format.
PDF Formats Click the to export to USB device and to burn to CD/DVD. See Export PDF
Analysis to USB Device, on page 7-16 and Export to Optical Media, on page
7-14.
Export to USB Burn to CD/DVD

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4-26 Analyze Reports: Retina

Click the appropriate button(s) to generate a printout or to export the file to the .pdf
format. After completion of the printing or export, click the in the upper right corner
of the screen to close the REPORTS PREVIEW screen and return to the ANALYSIS screen.
On the ANALYSIS screen, when you click the drop-down in Print button, you get the option of
Export To DICOM. If configured, you may select Export To DICOM to send the file to the
DICOM Archive (See Export to DICOM Server, on page 4-34).

Macular Thickness Printout

The printout for Macular Thickness (Figure 4-20, Figure 4-21 and Figure 4-22)
includes three images—one fundus image and two B-scan images. The printout also
include one ETDRS thickness grid with thickness and volume measurements.
The upper left fundus image has an overlay showing the area addressed by the cube scan
(with currently selected slice for Horizontal B-scan). The largest, bottom scan image shows
the currently selected fast B-scan, corresponding to the cyan (horizontal) scan line in the
fundus image overlay. The middle right scan image shows the vertical B-scan,
corresponding to the magenta (vertical) scan line in the fundus image overlay.
The upper right ETDRS thickness grid with thickness and volume measurements,
corresponding to the ETDRS Grid (green and yellow circles) in the fundus image overlay.

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 Analyze Reports: Retina 4-27

Sample printout of Macular Thickness with ETDRS overlay.

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4-28 Analyze Reports: Retina

Sample printout of Macular Thickness with ILM-RPE overlay.

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 Analyze Reports: Retina 4-29

Sample printout of Macular Thickness with no ETDRS and ILM-RPE overlay.

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4-30 Analyze Reports: Retina

MTA Followup Report Printout

Sample of the MTA Follow-up printout.

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 Analyze Reports: Retina 4-31

Eye Health Report Printout

Sample of the Eye Health Report printout.

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4-32 Analyze Reports: Retina

5 Line HD Raster Printout

The printout for the High Definition Image HD 5 Line Raster scans, Figure 4-25, includes
a fundus image showing the placement of the overlay and all five b-scan images.
• The largest, bottom b-scan image shows the currently selected line B-scan,
corresponding to the cyan colored scan line in the fundus image overlay. The top right
scan images shows the remaining four B-scans, corresponding to the magenta lines in
the fundus image overlay.

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 Analyze Reports: Retina 4-33

Single Line HD Raster Printout

The printout for the High Definition Image HD Single Line Raster scan, Figure 4-26,
includes a fundus image showing the placement of the overlay and only one b-scan image
that corresponds to the cyan colored scan line in the fundus image.

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Export to DICOM Server

Once analysis is performed, any report that would normally be printed can be manually
added to the patient's electronic medical record as an encapsulated PDF document for
easy viewing when the DICOM Network is Enabled.
From any ANALYSIS screen, click the Print icon and select Export to DICOM from the list.
You will see a dialog showing the DICOM archive being accessed ((a) in Figure 4-27) and
if the export of analysis report to server is failed, an alert as seen on ((b) in Figure 4-27) is
displayed.

(a)

(b)
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You can view the encapsulated PDF document only using a DICOM Viewer such as
(Forum®).

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 Analyze Reports: Retina 4-35

Data Export
Once analysis is performed, fundus image both normal and HD version along with B-scan
images and can be manually added to the patient's electronic medical record through the
Data Export feature.
The files being exported varies with each scan. For example, if you have selected ONH
&RNFL scan, then on selecting Data Export you would get B-scan images. Similarly, if you
have selected MTA-Followup scan on exporting the data you would get B-scan images,
normal and HD versions of the fundus image.
From any ANALYSIS screen, click the Print icon and select Data Export from the list. You will
see a dialog showing the export process ((a) in Figure 4-28) and if the export of analysis
report to server is successful, a message as seen on ((b) in Figure 4-28) is displayed.

(a)

(b)
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The Data Export option can be also accessed from the PATIENT screen by clicking View
Reports button.

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 Analyze Reports: Glaucoma 5-1

(5) Analyze Reports: Glaucoma

Chapter Overview
This chapter explains how to use the optic nerve head (ONH) and retinal nerve fiber layer
(RNFL) analysis portion of PRIMUS software. Topics covered in this chapter include:
• Access Analysis, (below)
• ONH & RNFL Analysis, page 5-2
• Reports and Printing, page 5-14
• Export to DICOM Server, page 5-16

Access Analysis
The ANALYSIS screen enables you to view and measure anatomical structures depicted in the
scan images. To access analysis, click the View Reports button when it is active; it is active
when a patient record with saved report(s) is selected from the PATIENT screen.
• Click to select the patient from the patient list—You can select only one patient at a
time (see Find Existing Patient on page 3-10).
• Click the corresponding date on the right—It is organized by scan Date and each date
with the reports and eye details (OD/OS).
• Select report(s) of one or more dates to view—Hold down the Ctrl (Control) key and
click to select multiple report(s) from different dates. To deselect the selected reports,
hold down the Ctrl key and click the selected reports. To get an OU analysis, select an
OD and an OS report(s) from the same date.
Note: You can also start the analysis by double-clicking the selected report if you do not
need an OU analysis.

You can select multiple reports

You can select reports

from multiple dates

When you click the View Reports button, the ANALYSIS screen appears (see Figure 5-1 on
page 5-3). The image(s) will appear in the image screen below, after a few seconds.

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5-2 Analyze Reports: Glaucoma

ONH & RNFL Analysis

The ONH & RNFL Analysis provides interactive scan images as well as the fundus image
with optic disc and cup outlines. The default screen, shown in Figure 5-1, on page 5-3
displays:
• Patient Details—Name, Age, Gender, DoB and Patient ID
• the current and selected analyses with eye details
• the patient’s exams by date, with the signal strength of the scan for both eyes
• the identified ONH location
• the fundus image with optic disc and cup outlines and ONH Spoke
• RNFL thickness map with optic disc and cup masks
• B-scan extracted from RNFL Calculation Circle
• Average RNFL thickness along Calculation Circle for quadrants
• Left and right eye RNFL thickness graph
• Left and right eye neuro-retinal rim thickness
• a table with Average RNFL Thickness, five optic disc parameters for both eyes
• Comments area
• Navigation Bar
PRIMUS displays the analysis results for either right (OD) or left (OS) or both eyes (OU) for
RNFL and ONH scan on the Analysis screen. For OU analysis, make sure that you select two
reports of different eyes—an OD (right) and an OS (left) of the same date.
Note: When only either OD or OS is selected, the other section will be blank in analysis
screen and in the print reports. Hence, you will fail to get the OU analysis.
You can also manipulate the RNFL Calculation Circle location and ONH Spoke angle on this
screen, which will update the data table.

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 Analyze Reports: Glaucoma 5-3

1 2

3
13
4 14
5
6 21
7
8 15
9
10 20
16
17
11

12 18

19

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1 Patient Information 12 Average RNFL thickness and Calculation Circle for quadrants along
with Superior and Inferior Normative data colors
2 Analysis list (with OD, OS or OU details) 13 Left and right eye RNFL thickness graph
3 Scan Information (Exam Date/Time and Signal Strength) 14 Drag to select current A-scan sample
4 OCT fundus with ONH radial spoke, optic disc and cup outlines. Control to 15 Average RNFL Thickness, five optic disc parameters table with
choose angle of ONH spoke. Normative data colors
5 RNFL thickness map with optic disc & cup masks and a color scale 16 Left and right eye neuro-retinal rim thickness
6 ONH radial spoke 17 Drag to select an angular sample
7 Optic disc outline 18 Comments Area
8 Optic cup outline 19 Navigation Bar
9 Move purple circle to select a different center 20 Reset Button (returns the Calculation Circle to original PRIMUS
identified Optic disc)
10 Calculation Circle Offset (horizontal, vertical) in mm relative to the OCT 21 Details on Normative data
center
11 4 mm B-scan extracted from ONH radial spoke /
B-scan extracted from RNFL Calculation Circle (not shown)

Analysis Screen Functionalities

The following information applies to the ONH and RNFL ANALYSIS screen only. PRIMUS
offers OD, OS and OU (combined OD and OS) analysis.

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5-4 Analyze Reports: Glaucoma

View Ports
The ONH & RNFL analysis provides fundus image with RNFL Calculation Circle and Optic
Disc and Cup outlines, RNFL thickness map and B-scan image(s) (tabs for ONH and RNFL),
as shown in Figure 5-1, on page 5-3.
The viewports are interactive—Click and drag the calculation circle (purple) on the frozen
fundus image, you will see that the RNFL thickness map and B-scan image(s) update
simultaneously. Also, the Quadrant, thickness graphs (RNFL and Neuro-retinal rim) and
parameters table update to the movement of calculation circle.
When you move the calculation circle, the ONH spoke and Optic disc (black outline) & cup
(red outline) also move along the calculation circle. The spoke does not change the angle
Counterclockwise but the optic disc and cup outlines change their shape.
rotation of
spoke The angle of the spoke can be changed by clicking the arrows—up (counterclockwise
rotation of spoke) and down (clockwise rotation of spoke), as shown on left.
Clockwise
rotation of When you click , the calculation circle and optic disc & cup outlines return back to
spoke
the PRIMUS calculated location, along with the spoke—spoke angle does not change.
Spoke
Image Quality Information
Signal Strength Value—This appears just above the fundus image. It ranges from 0-10,
with 10 being maximum signal strength. When values are less than 6, the value is below
the acceptable threshold; when 6 or higher, the value is acceptable.

Note: The Signal Strength value applies to the entire cube scan.
Disc Center
The disc center values indicate the location of the Calculation Circle in mm relative to the
center of the scanned area (horizontal offset and vertical offset). If you move the
Calculation Circle, the disc center values will update.

Navigation Bar
• Cancel button: Click the Cancel button to return to the Patient screen.
• Save button: Click Save to save the current analysis with the changes applied to the
spoke angle, drag lines in thickness graphs, location of the calculation circle, etc.,. Your
changes are not saved as part of the analysis until you click the Save button. If you make
changes to the image(s) and proceed to other analysis without saving, the system insists
you to either save or discard the changes, as shown below.

• Next Analysis button: Click Next Analysis to navigate to other report selected.
• Print button: Click Print to initiate printing. You can print to paper, create a PDF that can
be exported to USB device or to CD/DVD and/or export to DICOM. See Reports and
Printing, on page 5-14 for details.

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 Analyze Reports: Glaucoma 5-5

Brightness/Contrast:
The B/C icon appears when you hover the mouse on the b-scan image.
When this feature is used, values appear on the image that reflect
the numerical parameter values you select. Click and drag the mouse up and down to
change brightness; left or right to change contrast. They also work in combination when
you move the mouse diagonally.
Note: The feature is present in B-scan image view port only.

Color
The Color/Grayscale icon appear when you hover the mouse on the b-scan and fundus
image.
You can switch between color and grayscale for the B-scan and fundus image viewport, by
selecting or deselecting .
Note: This feature is present in B-scan and fundus image view ports.

Full Screen View

You can double-click the OCT B-scan image to open the current image in full screen. Click
a button on the full-screen image or Esc on the keyboard to return to normal view.
Note: The Brightness/Contrast and Color/Grayscale buttons do not appear on the full
screen image.

Add Comments
This Analysis window permits you to enter individual scan comments. It also provides
comments with standard description to assist clinicians in saving time.

CAUTION: The comments entered in the Add Comments text box are printed on the
final report. Carl Zeiss Suzhou is not responsible for diagnostic interpretation based
on the comments. It is the clinician's responsibility to make diagnostic
interpretations based on the OCT scans and not rely on the comments.

Optic Nerve Head Parameters

This section describes how the optic nerve head calculations are performed and how the
data is displayed and summarized on the ONH AND RNFL OU ANALYSIS screen. This section
makes some reference to elements that include RNFL Thickness Measurements, but
those measurements are described more fully starting on page 5-8.

Performing the Optic Nerve Head Calculations

The disc edge is determined by the termination of Bruch’s membrane. This is validated1 in
the literature. The rim width around the circumference of the optic disc is then determined

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5-6 Analyze Reports: Glaucoma

by measuring the amount of neuro-retinal tissue in the optic nerve. This differs from other
methods that determine the cup margin based on its intersection with a plane at a fixed
distance above the disc1,2.
In this method, the disc and rim area measurements correspond to the anatomy in the
same plane as the optic disc, while the 2D drawing is in the plane of the OCT en face
image, as would be seen by the clinician. In tilted discs, when the nerve exit is oblique, the
disc is viewed at an angle by the clinician, foreshortening the image. Therefore areas
visualized in the ophthalmoscopic examination, photographs, or other images will be
reduced. Measuring the area in the same plane as the optic disc addresses this
foreshortening and better ties the results to the anatomy.

Illustrations of the Optic Nerve Head Calculations

The borders of the optic disc and the cup are illustrated in multiple places on the ONH AND
RNFL OU ANALYSIS screen. The first place is on top of the OCT fundus image, as shown on
the left. Shown in purple is the Calculation Circle used for RNFL thickness measurements
(see RNFL Calculation Circle and Peripapillary RNFL Thickness on page 5-8). The
optic disc outline is shown as a black line. The border of the cup is shown as a red line. The
area between these two (optic disc outline and cup border) is the neuro-retinal rim area.
• The base of this image is a sum of the reflectivity in each A-scan, in order to illustrate
the anatomy scanned.
The second place the cup and disc boundaries are illustrated is on
top of the RNFL thickness map (shown on the right). The interior
of the cup is shown in light gray. The neuro-retinal rim is shown in
dark gray. The outer boundary of the neuro-retinal rim
corresponds to the disc boundary.
The third place the cup and disc boundaries are illustrated is on
the extracted ONH OCT B-scan, as shown on the left. The B-scan
data is extracted from a 4 mm radial cross-section that cuts through the center of the disc.
The segmented RPE layer is shown on the B-scan as a black line, and the disc boundaries
are shown in this 2D picture as black marker (small circles in the RPE layer). The segmented
ILM is shown as a red line, and the cup boundaries are shown in this 2D picture as red
marker (small circles in the ILM layer). The location of the radial cross-section is shown as a
turquoise line on top of the OCT fundus. The radial line can be chosen in 5º increments by
clicking the arrows (to the right of the fundus image) up or down.

1. Strouthidis NG, Yang H, Fortune B, Downs JC, Burgoyne CF. “Comparison of Clinical and Three-Dimensional Histomorphometric
Optic Disc Margin Anatomy,” Invest Ophthalmol Vis Sci. 2009; 50: 2165.
Strouthidis NG, Yang H, Fortune B, Downs JC, Burgoyne CF. “Detection of the optic nerve head neural canal opening within
three-dimensional histomorphometric and spectral domain optical coherence tomography data sets.” Invest Ophthalmol Vis Sci.
2009; 50:214.
1. Strouthidis NG, White EG, Owen VMF, Ho TA, Garway-Heath DF. “Improving the repeatability of Heidelberg retina tomograph and
Heidelberg retina tomograph II rim area measurements.” Br J Ophthalmol 2005; 89:1433.
2. Tan JC, White E, Poinoosawmy D, Hitchings RA.”Validity of rim area measurements by different reference planes.” J Glaucoma.
2004;13:245.

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 Analyze Reports: Glaucoma 5-7

Neuro-retinal Rim Thickness

The neuro-retinal rim thickness is also plotted for the left eye and right eye together for an
OU analysis, in units of micrometers, as shown below.
Neuro-retinal Rim Thickness
for the selected sample

Drag this blue line to

select the sample of interest

You can use the blue line to select the sample of interest. There are 360 samples available.
The text in the upper right corner shows the measurement of Neuro-retinal thickness in
micrometers for each eye at the given sample location.

Optic Nerve Head Summary Parameters

The information illustrated as described above in neuro-retinal rim thickness graph is
summarized into 5 parameters that characterize the optic nerve head. These parameters
are shown in the data table, as the bottom 5 lines of information.

ONH
summary
data

The neuro-retinal rim area (mm2) is the darker gray neuro-retinal rim region shown on top
of the RNFL thickness map. The lighter gray region on that same map is the area of the cup
(mm2); the total area of the disc is the area of the rim plus the area of the cup (mm2). The
Average C/D Ratio is given by the square-root of the ratio of the area of the cup to the area
of the disc. The Vertical C/D Ratio is the ratio of the cup diameter to the disc diameter in
the vertical meridian; VC/(VC+Vr1+Vr2). Cup volume (mm3) is a 3D measurement defined
as the volume between a plane created by the cup outline at the vitreous interface and the
posterior surface of the ONH (see Figure 5-2).

Illustration of PRIMUS HD-OCT ONH Parameters

The illustration below (Figure 5-2 (a)) shows a sketch of a disc, as presented in the 2D en
face view. Illustration (Figure 5-2 (b)) shows how this appears on the screen. The shaded
region represents the neuro-retinal rim area (mm2), the patterned region is the area of the
cup (mm2); the total area of the disc is the area of the rim plus the area of the cup (mm2).
The C/D (cup-to-disc ratio) is given by the square-root of the ratio of the area of the cup to
the area of the disc. The Vertical C/D is the ratio of the cup diameter to the disc diameter in

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5-8 Analyze Reports: Glaucoma

the vertical meridian; VC/(VC+Vr1+Vr2). Cup volume (mm3) is a 3D measurement defined

as the volume between a plane created by the cup outline at the vitreous interface and the
posterior surface of the ONH.

(a) (b)

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RNFL Thickness Measurements

RNFL Calculation Circle and Peripapillary RNFL Thickness

Based on the location of the optic disc, PRIMUS HD-OCT automatically places a purple
Calculation Circle of 3.46 mm diameter evenly around its center, which is automatically
identified by AutoCenter™ algorithm.
If you feel that the Calculation Circle is not optimally placed, you can click and drag the
Calculation Circle to adjust its placement. The optic disc parameters are recalculated under
the assumption that the user-selected center is the true center of the disc. You can click
the button (for either eye) to return it to the automatically defined position.

255 individual A-scans (pixel)

arranged in a circular form
a RNFL Calculation circle.

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Note: For circular scans (as extracted in the ONH and RNFL OU Analysis and for the
neuro-retinal thickness graph), left of scan starts at the most temporal point of the 3.46
mm circle, and travels around the circle starting in the superior direction, then nasal, then
inferior, then back to temporal (TSNIT). This is clockwise for the right eye and
counterclockwise for the left eye.

Thickness Calculations
Layer-seeking algorithms find the RNFL inner (anterior) boundary and RNFL outer
(posterior) boundary for the entire cube, excepting the optic disc. The system extracts from
the data cube 255 A-scan samples along the path of the Calculation Circle that together
comprise the RNFL scan image displayed (seen in Figure 5-3). Based on the RNFL layer
boundaries in the extracted circle scan image, the system calculates the RNFL thickness at

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 Analyze Reports: Glaucoma 5-9

each point along the Calculation Circle. The thickness data is plotted in the right and left
eye thickness graphs.
The ONH and RNFL OU Analysis also derives the rest of its elements along the Calculation
Circle. The rest of the RNFL Thickness-Derived Analysis Elements are:
• RNFL Thickness Maps, page 5-9
• TSNIT Thickness Profiles, page 5-10
• RNFL Data Table, page 5-10

RNFL Average Thickness Values

These values report average thickness along the RNFL Calculation Circle by quadrants (as
shown on left) with normative data colors.

RNFL Thickness-Derived Analysis Elements

PRIMUS uses the RNFL thickness measurements and ONH measurements to construct and
display the following elements.

RNFL Thickness Maps

These maps are based on all calculated thickness data for the cube. Each is further
described below. These maps also show optic disc measurements, as described above.
• RNFL THICKNESS MAPS (as shown on left) derive from pixel average thickness
measurements and report thickness using a color pattern, where cool colors (blues,
greens) represent thinner areas and warm colors (yellows, reds) represent thicker
areas. The maps exclude the optic disc, which appears solid gray. The color code
expresses thickness ranging from zero (blue) to 350 micrometers (white).
Note: Changing the placement of the RNFL Calculation Circle on the fundus image
changes the thickness calculation on the RNFL thickness map, RNFL thickness graph,
Neuro-retinal Rim thickness graph and RNFL quadrants.
Note: Changing placement of calculation circle also changes the optic disc parameter
calculations and the ONH and RNFL b-scans.
Note: When the temporal RNFL is very thin or entirely absent, the RNFL algorithm may
show an artificial thickening of the RNFL in this area. If the temporal RNFL appears thicker
than normal, examine the algorithm lines as displayed on the extracted circular B-scan to
determine if the algorithm has correctly identified the RNFL.
Note: There are several reasons why a particular region might differ from normal. The
deviation map shows when a particular region of an eye is thinner than the same region in
a population of normal subjects, but such deviation is not always due to pathological loss
of RNFL, for any of the following reasons:
1. For each superpixel, 5% of normals will in generally be highlighted yellow, and 1% of
normals will in general be highlighted red. Since each map consists of 2500
superpixels, 125 pixels on average might be expected to be highlighted on each
normal.

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5-10 Analyze Reports: Glaucoma

2. The normative database consisted of a population with a limited range of spherical

error (-12 D to +6 D) and axial length (22 to 28 mm). Subjects with strongly myopic or
hyperopic eyes may have a different distribution of measured RNFL thickness values,
and may tend to flag more often than subjects who fall within the range of the
population used to create the normative database.
There is a wide variation in RNFL bundle anatomical distribution among the normal
population. A person with split-bundle anatomy or a person with a very tilted RNFL bundle
pattern may show a deviation from normal anatomy without indicating that this person
has lost RNFL.
TSNIT Thickness Profiles
RNFL Thickness for the selected sample

Drag this blue line to

select the sample of interest

The TSNIT Thickness Profiles (TSNIT stands for Temporal, Superior, Nasal, Inferior, Temporal)
display thickness at each A-scan location along the Calculation Circle. The profile shows
left and right eye RNFL thickness together, to enable comparison of symmetry in specific
regions. Drag the blue vertical line in the OU profile to select the current A-scan sample
from among the 256 samples.
RNFL Data Table

RNFL
Summary
Data

The data table reports average thickness around the RNFL calculation circle.
The data table also reports optic disc parameters as described previously (see Optic
Nerve Head Summary Parameters, on page 5-7).
For completeness, it is necessary to introduce and explain the application of the RNFL
Normative Database in these elements.

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 Analyze Reports: Glaucoma 5-11

Normative Database for the Retinal Nerve Fiber Layer

The ONH and RNFL OU Analysis supports the clinician in identifying areas of the RNFL that
may be of clinical concern by comparing the measured RNFL thickness to age-matched
data in the RNFL Normative Databases. Normative data that is age-matched to the patient
appears when you perform the ONH & RNFL Analysis on patients at least 18 years old.
Data was not collected from subjects less than 18.
The RNFL Normative Database uses a white-green-yellow-red color code, as seen in the
legend at left, to indicate the normal distribution percentiles. The color code applies to the
quadrant, and whole-circle averages, and to the OD and OS columns of the data table.
Among same-age individuals in the normal population, the percentiles apply as follows:
• The thinnest 1% of measurements fall in the red area. Measurements in red are
considered outside normal limits (red ≤ 1%, outside normal limits).
• The thinnest 5% of measurements fall in the yellow area or below
(1% < yellow ≤ 5%, suspect above normal).
• 90% of measurements fall in the green area (5% ≤ green ≤ 95%).
• The thickest 5% of measurements fall in the white area (white > 95%).
Note: Clinicians must exercise judgment in the interpretation of the normative data. For
any particular measurement, note that 2 out of 20 normal eyes (10%) will fall either above
or below green.
Interpretation of the 1st Percentile: Values color-coded as “1st percentile” are lower than
99% of the database sample, but may not extrapolate well to the general population with
fewer than 300 subjects in the reference database. Results falling in this region should be
interpreted with caution.
Interpretation of the 5th Percentile: Values color-coded as “5th percentile” are lower than
95% of the database sample. The 95% Confidence Interval on the 5th Percentile extends
from the 2.5th percentile to the 7.7th percentile of the normative database.
Information icons on the ANALYSIS screen offer additional information about the
normative database limits. Hovering over the icon will display a tooltip, and clicking the
icon allows you to create a printout of the additional information presented.
Note: Normative data colors will not appear if the patient is less than 18 years old.
The ONH database was developed using the same data as the RNFL database, and the
Normative data colors for the Rim Area is implemented in the same manner as described
above. The other ONH parameters, ACDR, VCDR and Cup Volume, increase as Rim Area
and RNFL decrease. Therefore, these are implemented so that red represents the largest
1% of measurements, and yellow the measurements between the 5% largest and the 1%
largest. See the following table for specifics about the implementation of normal limits for
ONH and RNFL analysis.

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5-12 Analyze Reports: Glaucoma

Distribution of Normals
The grey color, shown in the legend to the left, represents “Not applicable”. Values will be
shown in grey when normative data is not applicable because the database has insufficient
data to match with the disc area.
The Distribution of Normals color scheme is used for both the RNFL and the Optic Nerve
Head analysis parameters. The table below clarifies how the color scheme is used for each
of the parameters.

Measurement Matched to Grey White Green Yellow Red

Normal Based On
RNFL
Average RNFL Age Grey shading does The thickest 5% of 90% of The thinnest 5% The thinnest 1%
Thickness, not apply to RNFL measurements fall measurements fall of measurements of measurements.
RNFL Quadrants, measurements in the white area in the green area fall in the yellow Measurements in
RNFL Thickness (white > 95%). (5% < green < area or below red are considered
(graph) 95%). (1% < yellow ≤ outside normal
5%, suspect). limits
(red ≤ 1%, outside
normal limits).
Optic Nerve Head
Rim Area and Disc Area and Age ONH Normative The thickest 5% of 90% of The thinnest 5% The thinnest 1%
Neuroretinal Rim Database is not measurements fall measurements fall of measurements of measurements.
Thickness (graph) applicable if: in the white area in the green area fall in the yellow Measurements in
(white > 95%). (5% < green < area or below red are considered
1) The disc area is 95%). (1% < yellow < outside normal
larger than 2.5 5%, suspect). limits
mm2 or smaller (red < 1%,
than 1.33 mm2, or outside normal
2) The Average or limits).
Vertical C/D Ratio
Average C/D Ratio, is below 0.25, or The thickest 5% of 90% of The thinnest 5% The thinnest 1%
Vertical C/D Ratio, 3) The ONH measurements fall measurements fall of measurements of measurements.
Cup Volume Normative in the white area in the green area fall in the yellow Measurements in
Database license (white > 95%). (5% < green < area or below red are considered
has not been 95%). (1% < yellow < outside normal
activated. 5%, suspect). limits
(red < 1%,
outside normal
limits).

Note: For patients under 18 years old, the legend and Normative data colors are not
displayed. Data was not collected from patients under 18.
There is measurement variability for the retinal nerve fiber layer and optic nerve head
parameters which may impact the normative data colors. If the true value is near the limit
of what the software uses to determine the normative database color code, then it is
possible that the color code could vary from exam to exam. When at least one parameter is
close to a normative limit, a blue icon button is displayed. When your cursor hovers
over this icon button, the tooltip appears as shown below.

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 Analyze Reports: Glaucoma 5-13

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If you click on the icon, a PRINT PREVIEW screen displays the Normative Data Details Report,
as shown in Figure 5-5 below. The report can be printed from the PRINT PREVIEW screen.
Each eye will print on a separate page for an OU Printout. See Normative Database for
the Retinal Nerve Fiber Layer on page 5-11 for more information.

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Scan Display Left to Right Orientation

See Scan Direction, on page 3-6.

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5-14 Analyze Reports: Glaucoma

Data Cube Orientation

See Data Cube Orientation, on page 4-12.

Exporting to the USB or External Hard Drive

Note: See Export PDF Analysis to USB Device, on page 7-16 for details

Reports and Printing

PRIMUS enables you to generate analysis reports in color, which you can then either print
on paper or export in an electronic format, such as PDF. PRIMUS provides a standard
(stock) print mode. This section describes each in turn.
The report page has a header with fields for patient details (Name, DoB, ID, Gender),
Referring Doctor, Doctor, Technician, and Institution details (name with logo, Telephone
number and Email). See Administrator User Account on page 2-7). The layout of
these fields limit the number of characters that can be displayed on the report, even
though you can enter additional characters on the instrument when creating the Name, ID,
etc. Specifically, reports can display 64 characters for ID; 40 for Institution name; and 25
characters for Name (first and last name combined). These character limits include spaces.
If you create patient names, IDs, etc., longer than can be displayed on the report, be aware
that the information you see on screen may not be complete ( ..... suffixed to the patient
names, IDs, etc., on the report shows that some text is missing and you may have to find
the same on patient screen).
The body of all reports consists of:
• Scan information such as date and time, signal strength,
• OD and OS sections with:
• Fundus image with RNFL Circle, Spoke, Optic disc and Cup Outline
• RNFL Thickness maps
• B-scan image(s)
Note: The B-scan image can be either ONH or RNFL—depends on what is on the screen at
the time of printing.
• RNFL Quadrants
• Thickness—RNFL and Neuro-retinal Rim (with current sample selected)
Note: You have to take separate prints for ONH and RNFL images and also for different
spoke angles and disc centers. PRIMUS does not offer customizing of report printing.
• Summary Parameter Table—ONH and RNFL
• Comments (if any added during analysis)
• Signature of the report analyst and Zeiss logo.
The footer of all reports includes the time at which the report was printed, the user’s name
and the PRIMUS equipment with the software version.

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 Analyze Reports: Glaucoma 5-15

Note: If an analysis is edited and not saved, printing a report does not save the edited
analysis, but will display the editions on the report only.
Note: A date/time of printing an analysis is printed in the footer of the page.

Hardcopy When you click the Print button, three options (as shown to the left), are available. If you
want to print to an attached printer without using other options, simply click the Printer
icon.
Note: To save the toner, on the analysis screen before you click Print button, change the
b-scans to gray-scale. Then on the print preview, click to switch from gray-scale to
Eco/Normal mode which will effect b-scan images to appear dim than the gray-scale.
Selecting Printer icon presents a dialog like any other print dialog of Windows, as
described below.
The print (whether a hard copy or pdf) generated is a report based on what is currently on
screen. The system presents a print preview, as shown in Figure 5-6, of the current
analysis report.

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5-16 Analyze Reports: Glaucoma

PDF Formats This screen also gives you the options to export in .pdf (Portable Document Format) format.
Click the to export to USB device and to burn to CD/DVD. See Export PDF
Analysis to USB Device, on page 7-16 and/or See Export to Optical Media, on
page 7-14 for details.
Export to USB Burn to CD/DVD Click the appropriate button(s) to generate a printout or to export the file to the .pdf
format. After completion of the printing or export, click the in the upper right corner
of the screen to close the REPORTS PREVIEW screen and return to the ANALYSIS screen.

Export to DICOM Server

See Export to DICOM Server, page 4-34.

ONH & RNFL Printout

The stock or standard printout for ONH & RNFL, Figure 5-7, includes all information that
is currently seen on the analysis screen (See Reports and Printing, on page 5-14). You
can print either with ONH or RNFL B-scan images.

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 Analyze Reports: Glaucoma 5-17

Below is a sample of ONH Printout.

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5-18 Analyze Reports: Glaucoma

Below is a sample of RNFL Printout.

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 Anterior Segment Scan Acquisition and Analysis 6-1

(6) Anterior Segment Scan Acquisition and Analysis

This chapter explains how to use the Anterior Segment Scan Acquisition and Analysis1
features. Topics covered in this chapter include:
• Acquiring Anterior Segment Scan, page 6-1
• Auto Central Corneal Thickness (CCT), page 6-6
• Scan Review, page 6-7
• Anterior Segment - Scan Analysis, page 6-8
• Reports, page 6-11
Note: The PRIMUS is used primarily for imaging and measuring structures in the posterior
eye. By changing the focus of the OCT beam (using an external lens), it can also be used to
image the anterior segment such as the cornea. This chapter provides instructions and
information about imaging the anterior segment—anterior chamber angle and the central
cornea, with the PRIMUS instrument.
Note: Add on lens should be mounted before acquiring anterior segment scan. Note that
the working distance between the eye and lens will be reduced.

CAUTION: Make sure that you follow the correct guideline to acquire anterior scan
to avoid touching patient eye or nose.

Acquiring Anterior Segment Scan

Note: Refer to Warning in Optional Dilation of Patient’s Eye(s), page 3-18.
This section addresses the two scan type(s)—Angle View & Cornea for the anterior
segment scan. See Chapter 3, Acquire Scans, for general scan acquisition instructions.
The HD-OCT imaging specifications for anterior segment scanning are the same as
described in Chapter 10, Specifications, within the central 0.5 mm depth and central
2mm width of the displayed tomograms.
Upon choosing an anterior segment scan(s):
• The cSLO illumination of the retina is turned off.
• With an external lens attached, the patient sees a blurry flashing red dot against green
background.
Some controls and displays used for posterior eye scanning are not present for anterior
segment image acquisition. These are:
• The Optimize–Center button (Z-offset) for the OCT scan display is not present, but the
Center Slider (Z-offset) is still made available. The OCT display can be centered vertically
in the live OCT window by moving the Center slider or by scrolling the mouse on the
b-scan view-port. See Figure 6-1.

1. Anterior Segment Scan Acquisition and Analysis is an optional feature that may not be available in all markets and, when available
in a market, may not be on all instruments. If you do not have this feature and want to purchase it, please contact your local ZEISS
distributor.

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6-2 Anterior Segment Scan Acquisition and Analysis

• There is no fundus image.

The scan pattern is displayed over the iris image. The scan pattern can be moved, rotated
in 5 degree increments, but the size of the scan pattern is fixed. The scan pattern can also
be toggled between horizontal (0 degree) and vertical (90 degree) directions.

Angle View & Cornea Scan(s)

These scan types generate data through single line HD Raster and are used to view high
resolution images of the anterior chamber angle and cornea. By default, the line is
horizontal and the line length is fixed at 8 mm, but the scan direction is adjustable. The
line is composed of 1024 A-scans. Choosing (see Patient Screen, page 2-14) the Angle
View and/or Cornea report(s) produces the ANTERIOR SEGMENT ACQUISITION screen, as shown
in Figure 6-1.
Note: The instrument focuses the OCT beam onto the anterior segment, in an arc to allow
the curved cornea to better fit into the 2 mm scan depth.

1 2 3
6 7
4 5

8 9

10
11

12

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1 Patient information 5 B-Scan Direction 9 B-Scan image Display

2 Alert to the Operator 6 Brightness / contrast Control for B-Scan 10 Orientation
3 Current Scan report and Total no. of Scan report(s) selected 7 Gray-scale / Color Toggle button 11 Image Optimize (Enhance
and Centre-slider)
4 Brightness / contrast Control for Iris 8 Live Iris View-port with scan overlay 12 Navigation Bar

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 Anterior Segment Scan Acquisition and Analysis 6-3

• If the patient’s cornea is perfectly centered, a strong reflection from the anterior cornea
can produce bright artifact in the OCT scan display (Figure 6-2). The scan alignment
should be slightly offset from the center by fixating the patient to an external fixation or
moving the scanner head to avoid the corneal reflection if needed.

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Changing Scan Pattern Orientation

PRIMUS allows only rotation adjustment to the scan pattern using the ORIENTATION port,
found at the bottom of the IRIS view-port (see annotation 10 in Figure 6-1).
• Default orientation is 0 degrees (horizontal). Click the vertical line icon to orient the
scan pattern line vertically and click the horizontal line icon to orient the scan pattern
line horizontally.
• You can also click the counterclockwise/clockwise rotation arrows—By default, the line
rotates by 5 degree increments. You can also enter a value to adjust the angle in the
ranges of 0 to 360 degrees when using rotation arrows. Values entered from 91 to 269
are automatically changed to the corresponding value 180 degrees opposite.
• You can also hold and rotate (clockwise/counter clockwise) the symbol (next to the
single line overlay) to change the orientation, as shown on left.

Rotate the scan lines

Vertical / 90 degree orientation counter-clockwise Enter Value

Horizontal / 0 degree orientation Rotate the scan lines

clockwise
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6-4 Anterior Segment Scan Acquisition and Analysis

Alignment for Scanning the Anterior Chamber Angle

The Anterior Segment Single Line HD raster scan is the preferred scan type for imaging the
anterior chamber angle because it can be rotated to image a cross section perpendicular to
the limbus at any location. The following instructions apply for anterior chamber angle
imaging:
1. Rotate refractive error knob to 0 diopter. When the refractive error knob reaches to “0”
diopter, you will detect the knob settling in the notch.
2. When scanning the anterior chamber angle, you will need to use the external fixation
target to direct your patient’s gaze beyond the ocular lens housing. This moves the eye
position to expose the limbus optimally, allowing scanning to be done without
interference from the eyelids. When imaging the temporal angle, it is helpful to cover
the fellow eye, to allow the patient to fixate with the scanned eye.
3. Adjust the area of the eye visible in the Iris View-port until you are able to view the
corneo-scleral junction. Coarse adjustments are made by moving the scanner using
the joystick, as needed, until the pupil is visible. If required, use the focus adjustment
knob to move the scanner precisely towards the eye for good iris focus. The angle
recess often appears shadowed by the sclera. Moving the scan slightly to another
location along the limbus can sometimes avoid local shadowing.
4. Center the scan on the corneal limbus. The live OCT image should show the top of the
cornea and should be almost horizontally aligned; a slight tilt is acceptable and can
improve visualization of angle structures. Figure 6-4 shows a well-aligned scan and
live OCT image. Note that the iris may not be well focused when scanning the angle.

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Alignment for Scanning the Cornea

The Anterior Segment Single Line HD raster scan is used for imaging the cornea. The
following instructions apply for cornea imaging:
1. Rotate refractive error knob to 0 diopter. When the refractive error knob reaches to “0”
diopter, you will detect the knob settling in the notch.
2. When scanning the cornea, you do not need an external fixation target. Ask the
patient to look at the blurry flashing red dot against a green background.

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 Anterior Segment Scan Acquisition and Analysis 6-5

3. Adjust the area of the eye visible in the Iris Viewport until you are able to view the
pupil. Coarse adjustments are made by moving the scanner using the joystick, as
needed, until the pupil is visible. If required, use the focus adjustment knob to move
the scanner precisely towards the eye for good pupil.
4. Center the scan on the pupil. The live OCT image should show the top of the cornea
and should be almost horizontally aligned. Figure 6-5 shows a well-aligned scan
and live OCT image.

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6-6 Anterior Segment Scan Acquisition and Analysis

Auto Central Corneal Thickness (CCT)

The Auto Central Corneal Thickness feature allows you to automatically measure and
display the Central Corneal Thickness on the B-scan of the scan analysis. You can modify or
delete this auto generated value. You can manually measure the corneal thickness between
two given points on the B-scan through the caliper icon. PRIMUS will display both auto
generated and the manually selected values on the B-scan. Both the values are
differentiated through distinct colors as shown below.
Note: Add on lens should be mounted before acquiring anterior segment scan. Note that
the distance between the eye and lens will be reduced. A message will appear on selecting
the Auto CCT option for the first time.
Below procedure outlines how to access the Auto CCT feature:
1. From the PATIENT screen, select Auto CCT option. Select the required image laterality.
Click Acquire.
2. Follow the same procedure that you followed for scanning the cornea for Auto CCT.
Refer the Alignment for Scanning the Cornea procedure on page 6-4. Move to
the Analysis screen.
3. The below figure shows a well-aligned scan and live OCT image. The Auto generated
Central Corneal Thickness is displayed adjacent to the B-scan as shown below.

Central Corneal
Thickness Value

Horizontal Slice
Indicator
Auto Detected
Central Corneal
Thickness
Manually Selected
Corneal Thickness
Value

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During the review phase, on moving the horizontal slice indicator over the iris image the
corresponding B-scan image will be displayed. There will be 32 B-scan images created
during the scan review phase.

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 Anterior Segment Scan Acquisition and Analysis 6-7

If the central corneal thickness is not detected for some reason, an error message will be
displayed as shown below.

Scan Review
Scan review of anterior segment images (Figure 6-7) is similar to that of posterior scan
images, except the fundus (cSLO) image is not displayed.
The Single Line HD Raster overlay on the iris image (upper left in Figure 6-7) indicates the
location of the acquired OCT data scan and allows the line movement on the iris image.
Double-click the OCT B-scan image to enlarge in full screen. Double-click again (or click
the button) to return.

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6-8 Anterior Segment Scan Acquisition and Analysis

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Anterior Segment - Scan Analysis

To analyze or print an anterior segment scan, click Skip to Analysis from the ACQUISITION
screen or select a report from the PATIENT screen. See Access Analysis on page 4-1 and
Angle View & Cornea Scan(s) on page 6-2 for more information about the ANALYSIS
screen and selecting an analysis.
Note: Anterior Segment Single Line HD Raster scan is not corrected to account for scanning
geometry, the optics of the PRIMUS system, or refraction at the anterior and posterior
surfaces.
Figure 6-9 shows an Anterior Segment Analysis of the iris/cornea angle.

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 Anterior Segment Scan Acquisition and Analysis 6-9

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Double-click OCT window to enlarge to full screen. Double-click again (or click the
button) to return.

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6-10 Anterior Segment Scan Acquisition and Analysis

Anterior Segment Imaging

The PRIMUS can produce high resolution images of the anterior segment allowing
visualization of fine details of the corneal and anterior chamber anatomy.

The Central Cornea

The Tear Film, Corneal epithelium, Bowman's membrane, stroma and Descemet’s
Membrane & Endothelium are generally visible in the tomograms (Figure 6-11).
Tear Film

Epithelium
Bowman’s
Membrane

Stroma

Descemet’s Membrane & Endothelium

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Anterior Segment Function Buttons

Some of the function buttons found on analysis screens for posterior segment scans are
also found on anterior segment analysis screen.
Brightness / Contrast Control
Color / Grayscale toggle

Line Measurement
These buttons appear to the top right in the Primary B-scan image viewport of the analysis
screen. If you keep mouse cursor over the buttons, their function appears in the form of a
tool tip. The following paragraphs describe the additional features available on the
CORNEAL ANALYSIS screen.
• Ruler button: Click Ruler and then click and drag on a scan image to draw a
straight line that measures the distance between the start and stop points. The resulting
measurement appears next to the line in micrometers.
• You can create several additional measurement lines when the cursor remain as .
• The changes appear on the analysis reports (printout).
Note: You may use the ruler tool with the high definition images too, and separate
measurements can be added / deleted to different b-scan slices. Clicking Save once saves
all the changes made on the individual slice(s) before you move out of the analysis screen.
• Delete Measurements button: Click Delete and then keep the cursor on the line.
When the cursor changes to cross-hair, click to delete the currently selected
measurement line. To de-select a line, move cursor anywhere on the image, off the line.

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 Anterior Segment Scan Acquisition and Analysis 6-11

The Anterior Chamber Angle

The termination of the Descemet's membrane called Schwalbe's line, Schlemm's canal,
and anterior iris can often be seen and identified by trained clinicians (Figure 6-12). The
angle recess and scleral spur may be difficult to visualize at times. The shorter wavelength
(840 nm) used by the PRIMUS is more strongly scattered by the sclera and iris. Scattering
by the sclera causes the angle recess to often be obscured in shadow.

Schlemm’s
canal
Schwalbe’s line Cornea
Scleral spur
Iris

Anterior Chamber Angle

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Reports
Printing any Anterior Segment analysis is done in the same way as posterior segment
analysis (see Reports and Printing on page 4-22). The report includes an iris image
showing the placement of the overlay and only one b-scan image that corresponds to the
cyan colored scan line in the iris image.

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6-12 Anterior Segment Scan Acquisition and Analysis

Auto CCT Report

The Auto Central Corneal Thickness Report contains the information that is currently seen
on the analysis screen. Below is a sample of the Auto CCT printout.

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 Data Management 7-1

(7) Data Management

Chapter Overview
This chapter explains how to manage data with the PRIMUS instrument. The topics
covered in this chapter include:
• The Administrator User, page 7-1
• Create Institution Name and Logo, page 7-2
• System Information, page 7-3
• User Registration, page 7-3
• Patient Record Search, page 7-5
• Add, Edit, Delete, Exam and Merge Patient Records, page 7-9
• Edit or Print Analysis Report(s), page 7-14
• Export to Optical Media, page 7-14
• Export PDF Analysis to USB Device, page 7-16
• Networking, page 7-18

The Administrator User

To manage administrative functions, PRIMUS instrument dedicates a special user account
with the user name Administrator. Only the Administrator user can create and edit
the user accounts.
The Administrator account appears in the drop-down list of user names on the login
screen. When the Administrator user is logged in, the available functions are:
• PATIENT > Log off / Shut down
• PATIENT > Patient Search
• PATIENT > Scan
• PATIENT > Settings > Systems Information
• PATIENT > Settings > General Settings > (Institution Information, Application,
Locale Settings, System Date and Time, Carl Zeiss Meditec Teleservice, Patient
Management, Multi Component Names, Printer and Report).
• PATIENT > Settings > Advanced Settings (Add/Update Doctor, B-Scan
Brightness and Contrast, Fundus/Iris Brightness and Contrast, Detailed ONH&RNFL
Report, Eye Health Report, Usage Report.)
• PATIENT > Settings > Network (Network Configuration, Network Drive
Configuration, DICOM Network)
• PATIENT > Settings > Maintenance (Configuration Wizard, Data backup,
Data Restore, Software update, export of audit recordings and log files)
• PATIENT > Settings > User Management (General, Users)

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7-2 Data Management

• PATIENT > Settings > Licenses (Details, Off-line activation, On-line activation)
Only the Administrator user can edit the information in SETTINGS screen. These special
administrative functions are explained next.
Note: The user group–Doctor–can also edit the GENERAL and ADVANCED SETTINGS
section.

Create Institution Name and Logo

Institution Information
To edit the INSTITUTION INFORMATION dialog, you must be logged in as either the
Administrator or Doctor user group.
Use the INSTITUTION INFORMATION dialog to customize your system. Besides the institution
name, it also gives you the option of adding a logo graphic in JPEG format. Once you have
supplied the name and logo, they will appear on all analysis printouts. See Institution
Information, page 2-7.

Institution Logo Graphic (Optional)

You can designate a clinic graphic logo. Recall that the graphic must be in JPEG format
(and have a .jpg file extension after its name).
1. To add a logo graphic and enable access to the graphic file:
• Copy the logo graphic file from the source system to removable media and insert the
media into its drive on the PRIMUS instrument.
2. Click Settings > General Settings > Printout > Logo of institution.
3. Click Browse. A standard directory browser will appear. The Files of type field will be
limited to JPEG, so you can view and select only files with the .jpg extension.
4. Locate and select the logo graphic file in removable media and click ‘Select’ and
return to the GENERAL SETTING screen. The Preview pane displays the selected logo.
Note: The graphic file is copied to the database on the PRIMUS instrument back in the
GENERAL SETTINGS.
Note: The logo area is 70x14mm (5:1 ratio). The selected graphic will be scaled to
accommodate that area (graphic will not be squeezed or constrained to fit it). The graphic
will appear in these proportions on analysis printouts, though in a smaller size. To avoid
distortion of the logo graphic, we suggest you select one (or edit one to be) approximately
the same size as the logo area.
Note: The selected and saved logo graphic will appear in all the prints.
5. Click Back to save your selection and return to the PATIENT screen.

Patient Management
Note: The Patient ID Issuer field denotes assigning authority of patient ID’s entered at a
particular site or practice. As a recommendation, it should be set to the same value on

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 Data Management 7-3

every instrument in the practice and to the same value as in the leading patient
information system, if applicable.
Click Settings > General Settings > Patient Management
In the Patient Management, add the value of the Issuer of Patient ID in the field.
Note: A new Patient ID Issuer can be added. Any change made only applies to patients
going forward; the change does not appear on patient information already in the
database.

System Information
To access, Click Settings > System Information
This section presents information about the system’s identity, including the model, serial
number and software version. This system information is fixed; the user(s) cannot change
it.

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All the messages displayed during startup check(s) are saved in Message history section
with dates.

User Registration
To access, Click Settings > User Management

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7-4 Data Management

Using the User management, the Administrator can create (register) medical staff
records and assign a user name, password and privileges to users. PRIMUS instrument
automatically and permanently associates saved scans with the current user when saving
and also displays on the analysis reports.

User Groups
Only staff registered can access the system application because only the user names of
Operators are available in the drop-down list on the login screen.
Three user groups are defined: Administrator, Operator and Doctor.
The Operator privilege provides access to the system application and all functions to scan
acquisition only. The user with operator privilege cannot edit the equipment settings.
The Doctor privilege provides access to the system application and all functions to scan
acquisition. The user with Doctor privilege cannot edit the equipment settings, except the
General and Advanced settings.
The Administrator privilege provides access to the system software and to edit the
equipment settings (see The Administrator User on page 7-1). The user with
administrator privilege can also acquire scan(s).

Add, Edit and Delete User

To add, edit or delete staff records, use the ADD USER dialog. To access this dialog, you must
be logged in as the Administrator user, and the Administrator user must have created an
institution name previously (See Create Institution Name and Logo on page 7-2).
All registered staff appear in the user list, sorted alphabetically by last name.

Add User
CAUTION: Do not attempt to delete a User immediately after you have added, doing
so will delete all newly created Users instead of the selected User. In such situation,
navigate to the PATIENT screen and back to the SETTING screen to delete any newly
created Users.

From the Patient screen, select Settings > User Management > Add Users.... The ADD USER
dialog opens (See Add User Accounts on page 2-9).

Edit User Records

To edit user records in the User management section, follow these steps:
1. To edit user details, select a user for the user details fields to appear. Change the
required details and click Back to save the changes.
2. To edit user password, select the user and click Change password.... Enter the new
password and then click Reset password (To discard the changes, click Cancel.). Click
Back to save the changes.

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 Data Management 7-5

Delete User Records

To delete user records, follow these steps:
1. In the USER MANAGEMENT section, select a user record and click Delete User. A dialog
will ask you to confirm your choice. (also see CAUTION in Add User, page 7-4).

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2. Click Delete User to confirm deletion, or click Cancel to cancel deletion.

Patient Record Search

Search functionality is incorporated within the PRIMUS system software. The software
provides basic search functionality and an Advanced Search link on the PATIENT screen.
With advanced search, you can search using all possible parameters (see Advanced
Search on page 7-6). Dialogs that include basic search sometimes provide different sets
of search parameters. This section presents basic search using the most common example:
the PATIENT screen. Also, see Find Existing Patient, page 3-10.

Basic Search
1. To search for patient records, use the Search Patient field of the PATIENT SCREEN,
which appears automatically after login (See Figure 7-3). From other screens,
navigate to the Patient screen.

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2. Click to return all patients (with matching text in the search field) in the patient
list zone. To search for patients Last/first Name, DoB or Patient ID, type in the
corresponding fields and click Search.
• You can search using partial information.
Note: You can type in ‘%’ and click to display all patients records available in the
system.
• Click Advanced Search if you want to search using additional parameters (see
Advanced Search on page 7-6 for details).
• The search returns all patients that match all defined parameters, sorted
alphabetically.

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7-6 Data Management

• When you search by Last Name, the search returns all patients that match from
the beginning of the last name.
• Click the Today or All
tab on the PATIENT
screen to see the search
results. Click on the X in basic search field to see the default patient list.
• In this list, you can select only one patient at a time. When you select a patient,
then select any scan report, the Acquire button becomes active. If the patient has
saved exams, the View Reports button becomes active.

Advanced Search
Click Advanced... if you want to search using additional parameters.

Worklist
query
parameters

Patient
list

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1. In the ADVANCED search dialog (Figure 7-4), using the available fields (one or more in
combination), enter or select search parameter(s) and then click Search. The search
parameters you type in are not case-sensitive. The ADVANCED search dialog returns all
matching patients, sorted alphabetically by last name, as default.
Note: You can also change the sorting by first name, patient ID, date of birth and gender.
Note: The search returns only the patients that match all search parameters used. If your
search does not return all patients desired, you may have to broaden your search by using

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 Data Management 7-7

fewer parameters or partial information. Clicking Search without using any parameters
returns all patients in the PRIMUS instrument’s All patient list.
2. Select the patients you wish to populate the patient list where your search originated.
• Click to select one patient; Ctrl-click to select multiple patients; Shift-click two
patients to select all intervening patients; Ctrl-Shift-click to select all intervening
patients plus those already selected.
• Click Reset in case you wish to start the search again.
• Click Back to return to the PATIENT screen.
3. After you select patients, click Select. The selected patients will appear in the TODAY
patient list on the PATIENT screen.
Once the operation is complete, click the Today tab on the PATIENT screen to see the
patients selected.

DICOM Workflow for Modality Worklist

When the DICOM Network is Enabled, PRIMUS instrument can retrieve a list of patients
scheduled for exams (DICOM Modality Worklist) (also see DICOM Network, page
2-10).
To retrieve patients from the DICOM server:
• Click > Network > DICOM Network—Enabled. Click Back.

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7-8 Data Management

• Click on Advanced... in the ID PATIENT screen. A SEARCH dialog appears which is used to
perform refined search for patients from the configured PACS, similar to the one shown
in Figure 7-5.

Worklist
query
parameters

Patient
list

Active when
scheduled patients
are found
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Set the query parameters for the desired patients, then press the Search button. A list of
patients appear in the Patient list. If you want to view details of a particular patient, click
the desired patient, and then click the Details button.
Note: Details button is active only when scheduled patients are found.
You can specify a range of visit dates. The default setting for the Visit Date is set to the
current date. If left unchanged, all studies for the selected patients will be retrieved. If the
check box is checked the default date range is today's date, then only studies performed
on today's date are retrieved. If the check box is checked and a date range is specified,
then the studies performed during that date range are retrieved.
The PATIENT DETAILS screen appears, as shown below (Figure 7-6) for the scheduled
patients only.
When finished viewing this information, click the Back button. The application returns to
the ADVANCED SEARCH window.

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 Data Management 7-9

Note: Modality for the PRIMUS instrument is OPT. Other modality options are provided for
searching purposes only. A patient with a modality other than OPT can be retrieved on a
PRIMUS instrument, but without patient data (exams).

Note: If you encounter connectivity issues, follow the instructions on the dialog message
and/or contact your network administrator for assistance. If the problem still exists, contact
ZEISS customer service or your local CZM distributor.

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Add, Edit, Delete, Exam and Merge Patient Records

Note: In the connected mode, edit, delete and merge options are not available.
To manage patient records, start in the PATIENT screen, which appears automatically after
login. From other modes, click the Cancel button to return to the PATIENT screen.

Add a New Patient

To add a new patient, click the Add (Figure 3-9) and fill in at least the required fields,
which are indicated with brown borders (see Add New Patient on page 3-12) for more
information.
Note: The date of birth entered always appears in the MM-DD-YYYY format in the software
and printouts.
• When you select a patient, the PRIMUS instrument initiates a new exam for that patient
by enabling the scan reports zone (See Select Reports for the Patient, page 3-14).

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7-10 Data Management

Edit Patient Record

Note: In the connected mode, edit option is not available.
Note: Every patient and the associated report has an identifier that consists of the Name
(Last and First), Date of Birth, Gender and Patient ID in combination.
1. In the PATIENT screen, select a patient from the All or from the Today patients tab of
the ID PATIENT screen. (To populate the patient list, see Patient Record Search on
page 7-5).
2. Edit the desired fields (Figure 7-7). The changes made are saved automatically.
(Also see Add New Patient on page 3-12 and Optional Patient Information
on page 3-13).

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Delete Patient Record

Note: In the connected mode, delete option is not available.

CAUTION: Deletion is permanent in PRIMUS—you cannot recover a patient record

nor retrieve its exams, because deleting a patient record includes deleting the
patient’s scan data.

You can delete one or more patient records from the Patient screen.
PRIMUS instrument permits you to delete a patient record and all its associated visit and
exam records at once. You must delete one patient record at a time. To do so, follow these
steps:
1. In the Patient screen, select the patient record (name) you wish to delete.
• Select patient from the All or Today Patients Tabs of the Patient screen. If
necessary, perform a Patient Record Search to access the desired patient record
(To populate the patient list, see Patient Record Search on page 7-5).
2. Click Delete.
3. You must confirm your choice in the dialog box that appears.

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Click Delete Patient to confirm deletion or Cancel to cancel deletion.

In the PATIENT screen, you can verify that deleted patients no longer appear in the list.

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 Data Management 7-11

The deleted patient record is removed forever. In this situation, the only way to retrieve the
patient record is from the backup in external storage media (See chapter 8 Backup and
Restore).

Exam Patient Record

PRIMUS lets you to view the patient details. To view or exam a patient record. From the
patient search screen, select the required patient and click Exam.

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The patient details like name, age, patient id, gender and so on will be displayed.

Merge Patient Records

Note: In the connected mode, merge option is not available.
Every patient record has a unique identifier that consists of the Name (First, Last), Date of
Birth, and Patient ID in combination. It is possible that two or more patient records may
exist for the same patient because this information was entered differently on separate
occasions. To correct such errors, it is possible to merge two patient records.
To merge two patient records, follow these steps:
1. From the PATIENT SCREEN, select > Network > Connection configuration.
Disable the DICOM network.
2. On the PATIENT SCREEN, select a patient and right click. Click Merge—A MERGE PATIENT
DATA screen opens.

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7-12 Data Management

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3. To populate the patient list with the records you wish to merge, either click Search to
return all patients, or specify search parameter in the field provided.

CAUTION: Make sure that you select the correct patient records to merge.

4. If required, click Compare to do a comparison of patient data(s) you wish to merge.

Click Close.

CAUTION: Note that merging is not reversible.

5. Select the patient whose record you wish to merge. The Merge button will not be
active unless the other patient is selected.
6. Write the reason for merging patient data. Click Merge.

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 Data Management 7-13

When merging is completed, you will return to the PATIENT screen, where you will observe
just one record (the first patient selected) for the patient in the patient list. The reports of
the merged patient will be added to the first selected patient’s reports.
If you wish to merge additional records, repeat the steps above.

Usage Report
The Usage Report feature lets you to fetch details of all reports or examinations that have
been performed on a particular device for the previous month. You can generate this report
without any user profile restriction. You can retrieve the Usage report for the previous
calendar month only. Suppose, if the current date is April 12th, then you will be able to
generate the report from Mar 1st to Mar 31st. This report contains the summary of total
number of patients examined during the previous month. The report further elaborates
about patient information like the patient id, patient's name, type of report generated for a
particular patient. If a report is deleted either intentionally or unknowingly then the
deletion date and time is also shown on this report.
Follow the below procedure to generate the Usage report:
1. Click Settings icon, navigate to ADVANCED SETTINGS. Under the Usage Report pane,
click on Generate Usage Report button.

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You can view the details of patients scanned and reports generated for the current month
under the Usage report pane as shown in the above image.
2. On the subsequent window that appears, click on Export 32Usage Report button.
A message appears. The report will be saved under the location as pre-configured by you.

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3. Browse to the location where you have saved the Usage report. Mail this report to the
ZEISS Support team.

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7-14 Data Management

Edit or Print Analysis Report(s)

Edit Reports
To edit an existing patient report, follow these steps:
1. In the patient list, click a name to select the desired patient record, the patient TODAY’S
/ PREVIOUS REPORTS zone appears on the lower right of the Patient screen. See Patient
Screen, page 2-14.
2. In the patient TODAY’S / PREVIOUS REPORTS zone, select the desired date and scan report
to open the Analysis screen.
3. You can edit the report by drawing line measurement(s) (See Line Measurement,
page 4-6). After editing the desired data, click the Save button to accept the changes.
If required you can print (print a hard copy, export to USB or burn to CD/DVD) (See
Reports and Printing, page 4-22).

Print Analysis Reports

1. In the patient list, click a name to select the desired patient record, the patient TODAY’S
/ PREVIOUS REPORTS zone appears on the lower right of the Patient screen. See Patient
Screen, page 2-14.
2. In the patient TODAY’S / PREVIOUS REPORTS zone, select the desired date and scan report
to open the Analysis screen.
3. Print (print a hard copy, export to USB or burn to CD/DVD) (See Reports and
Printing, page 4-22).

Export to Optical Media

PRIMUS instruments are equipped with IMAPI™ (CD and DVD Creator) and is capable of
writing to optical media which enable you to save each analysis report in .pdf format.
This section explains how to export .pdf(s) to CD/DVDs. See also Export PDF Analysis to
USB Device, page 7-16, Network Drive Configuration, page 7-19—to export to
Network server and DICOM Network, page 7-20—to export to DICOM server).
Note: The IMAPI software is pre-installed on the PRIMUS instrument and specially
configured for use with it.
Note: Only a ZEISS service personnel can install software updates. The windows
environment can only be reached through Service login.

Compatible Optical Media Formats

You can use the following types of optical media to transfer data:
• Compact Disc-Recordable (CD–R)
• Compact Disc-ReWritable (CD–RW)
• Digital Virtual Disk-Recordable (DVD-R)
• Digital Virtual Disk-ReWritable (DVD-RW)

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 Data Management 7-15

Note: Universal Disk Format (UDF) formatting is required for compatibility with PRIMUS
instrument. Blank CD-R discs used for export are automatically formatted in a UDF format.

Use and Care of Optical Media

Take care to protect these media from damage. We recommend you use hard plastic cases
when transporting and shipping these media. DVDs in particular are very susceptible to
scratches that could render them unreadable.

CD/DVD drive
You need to use an external CD/DVD drive for exporting data using the native CD/DVD
writing features of Windows. The external CD/DVD drive needs a USB end which can be
plugged in the USB port on the back connector panel. (See USB Connectors on page
1-21).

Data Integrity
See Data Integrity, on page 7-16.

Export PDF
PDF Format
1. Select the report to be exported to optical media (See chapter Analyze Reports:
Retina and/or Analyze Reports: Glaucoma).
2. On the print preview screen, click the Burn to CD/DVD icon for the pdf analysis
Burn to CD/DVD
report to be saved to the optical media. A burning in progress dialog appears till the
burning is complete.
3. When the burning has either completed or failed, a dialog notifies you of success/fail
burning (see below).

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Note: If the burning process fails, try again. If the problem still exists, contact ZEISS
customer service or your local CZM distributor.
4. A PDF with a unique number is generated automatically in the optical media (as seen
on left).

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7-16 Data Management

Export PDF Analysis to USB Device

PRIMUS instruments are equipped with USB ports which enable you to save single analysis
report in .pdf format.
This section explains how to export .pdf(s) to a USB device.

Data Integrity
PRIMUS instrument supports incremental export to the same export location. That is, you
can export repeatedly to the same removable media and PRIMUS instrument adds only
those reports (.pdf) that were not already exported and does not overwrite any reports
(.pdf) previously exported.
Note: If you repeat to export the same report within a minute, the later pdf overwrites the
previous pdf.
For example, a pdf with report details ‘12345678_Mta_OD’ is exported at 13-37 hours
(01:37pm) will be overwritten by a same pdf with report details ‘12345678_Mta_OD’
exported at 13-37 hours, with the changes made in it. But not at 13-38 hours (01:38pm).

CAUTION: A USB device should not be inserted or removed while the system is
starting up or shutting down, or while being accessed. If a USB storage device has
an LED flashing light that indicates “in use”, it should not be removed when the
light is flashing.

Export Process
Path Selection
To export a PDF report to USB device(s), follow these steps:
1. Insert the removable media into a USB port.
2. In PATIENT screen, select SETTINGS icon from the menu.
3. Click General settings tab, scroll down to view the REPORT FILE LOCATION section.
4. Click Browse... to select the USB device. By default, the storage is set to E:\ drive
which is a USB device. If there are two USB devices inserted, you need to select the
desired USB device.

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 Data Management 7-17

5. Once you have selected the USB device, click a desired folder until you find no
sub-folder in it or click to create a new folder if required. You can always create
a folder with date or name to distinguish each export.

Click to create folder or Select any folder

Click to start log file export

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6. After the folder is selected, click Select button for the Report file location path to be
saved.
PDF Format Export PDF
1. Select the report to be exported to USB device (See chapter Analyze Reports:
Retina and/or Analyze Reports: Glaucoma).
Export to USB 2. On the print preview screen, click the Export to USB icon for the backup to happen.
3. When the export is complete, a dialog notifies you of successful export (see below).

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4. A PDF with unique number is generated automatically in the USB device.

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7-18 Data Management

PDF Export Behavior

PDF export behavior of PRIMUS instrument is as follows:
• Before export, make sure that the export destination device has sufficient available
space. The system does not check the destination for sufficient available space and does
not return an error message if insufficient space is available.
• The system always remembers the last directory path when a report is saved as PDF.
• See Data Integrity, on page 7-16.

Networking

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Using a network file server is recommended in offices that have a local area network,
especially if you have multiple OCT instruments.

WARNING: When networking the PRIMUS instrument, use only network

cables with an unshielded RJ-45 connector. Use of a shielded network
cable in the PRIMUS instrument could result in electrical shock to the
patient and/or examiner.

Note: Configuring the server and the instrument should be attempted only by a network
administrator or system administrator. Users are responsible for network setup and
maintenance. ZEISS Technical Support is limited to testing network connectivity of the
PRIMUS instrument. Technical Support cannot troubleshoot or repair problems with
network connectivity.

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 Data Management 7-19

Network Configuration
From the patient screen, click Settings icon and select the Network tab for NETWORK
CONFIGURATION fields to appear (Figure 7-17).
• Click Configure... for the network registration dialog to appear. Fill1 the fields with the
network file server details and click Save to save the changes.

Create and Share a Folder on the Network Drive

On the network file server, create a folder. Make this a shared folder. To ensure access to
the shared folder on the network file server, create a new account with the user name and
password. Plug the PRIMUS instrument into your existing office network.

Network Drive Configuration

Designate a Drive on the Network Server
1. On the network file server, create a shared folder with the user name and password.
2. On the PRIMUS instrument, you must register the new export location on the network
file server to make it current.
• From the patient screen, click Settings and select the Network tab for NETWORK
DRIVE CONFIGURATION fields to appear (as shown below).

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• Click Map network drive.... Enter the network path, choose the drive letter with the
user name and password and click Map (see Figure 7-18 and Figure 7-19).
Once you have configured the instrument and the server for exporting, you are ready to
export PDF(s) from the print preview screen and export logs from the S ETTINGS screen to the
designated drive, and import institution logo too.
Note: If you attempt a pdf / log export when the network is down or the server is down, the
export will fail and the instrument will notify you that an export is failed.

1. If DHCP radio button is enabled, then the IP address, Subnet mask and Gateway are retrieved from the DHCP server. When in
disabled, the IP address, Subnet mask and Gateway fields must be entered manually.

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7-20 Data Management

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DICOM Network
From the patient screen, click Settings icon and select the Network tab for DICOM
NETWORK CONNECTION CONFIGURATION to appear (Figure 7-20).

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Enable the DICOM network radio button (Figure 7-20) to view the Local and Remote
entities. Enter the available options.
In the REMOTE APPLICATION ENTITY, enter the Station name, AE title and port in the fields
provided. If required, enable the Automatic MWL update with frequency in minutes
(Figure 7-20).
In the REMOTE APPLICATION ENTITY, you can either configure by AutoConnect or Manually.
• AutoConnect™ button is used for performing an automatic configuration. Click
on to view all detected DICOM servers (as shown below). Select the
desired DICOM server and click on Select. The connection will be automatically
configured.

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 Data Management 7-21

Detected
DICOM servers

• Manually connect button is used to configure the DICOM services manually. To do this,
select the desired service and click on the Manually connect button. A window will open
in which the service can be activated/deactivated. The values must be entered manually
in the AE title, Host and Port input boxes.
Use the Test connection button to test the connection of the individual services.
Note: If you check the option for Use the DICOM storage configuration for Query / Retrieve
/ Storage Commitment, then whatever changes are made to DICOM Storage will be applied
Query / Retrieve / Storage Commitment services too.
Note: In multiple PACS environment, Manual connect is useful when you wish to relate
each service (MWL, Storage,....) to different servers.
Manual data export to server enables you to export all ePDF(s) which failed exporting to
DICOM from the ANALYSIS screen.

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7-22 Data Management

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 Backup and Restore 8-1

(8) Backup and Restore

Chapter Overview
The PRIMUS instrument offers the capability of exporting image data to USB devices like
flash drive or to external hard disks for backup. This chapter explains how to backup and
restore PRIMUS image data. The topics covered in this chapter are:
• Data Integrity, page 8-1
• Backup Media, page 8-1
• PRIMUS Hard Disk Drive(s), page 8-2
• Backup Data Process, page 8-2
• Restore Data Process, page 8-4
• Export Log files, page 8-6
Note: PRIMUS data is not encrypted.
It is the user’s responsibility to observe applicable privacy restrictions and to maintain data
integrity.

Data Integrity
Backup—PRIMUS instrument overwrites the data previously backed-up in the same
removable media. This means that the most recent data backed up is only available for
restore.
Restore—During data restoration, the PRIMUS instrument updates patient data by
overwriting existing data. This means that you have lost all the existing patient records you
had. So, make sure that you take a backup of the latest patient records before you restore
data based on backup dates.

Backup Media
To removable media. Compatible removable media includes USB devices1.

CAUTION: A USB device should not be inserted or removed while the system is
starting up or shutting down, or while being accessed. If a USB storage device has
an LED flashing light that indicates “in use”, it should not be removed when the
light is flashing.

1. In the future release of PRIMUS equipment, an option of data export to a network destination and/or directly to a PRIMUS instrument
will be made available. The Export Options dialog enables you to select a network destination. Users are responsible for setting up
and maintaining their own networks, and for selecting the desired network destination when exporting.

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8-2 Backup and Restore

PRIMUS Hard Disk Drive(s)

Note: The PRIMUS instrument’s hard drive is partitioned into C: and D: drives, and the C:
drive is reserved for operating system and PRIMUS application files. By default, the D: drive
is reserved for patient and scan data that you acquire and restore and therefore is relatively
large. When you backup data, a location E: drive is set as the default target (with a USB
male plug icon) (as seen on left).

Backup Data Process

To backup a PRIMUS database to USB device(s), follow these steps:
1. Insert the removable media into its drive.
Note: We recommend you to always keep a USB device inserted so as to create data
backup upon shutdown if the data backup setting is set to Smart (as seen on left).
2. In PATIENT screen, select SETTINGS icon from the menu.
3. Click Maintenance tab to view the DATA BACKUP section. By default, the “Smart”
backup option is selected as shown below.

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The Smart backup feature is an incremental backup which will backup only the last
modified changes. Similarly, the scheduled backup is a cumulative backup of all the
changes made since the last backup.
4. You can schedule the backup based on your convenience like daily, weekly, bi-weekly,
or monthly by selecting the appropriate option. If you do not want the backup your
data then you can select the “No backup copy” option.

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 Backup and Restore 8-3

Note: You must shut down the PRIMUS application based on the schedule, otherwise the
backup operation will not be performed. For e.g if you have selected “Weekly” as the
backup option, and your shutdown happens on Friday in that case, every Friday you must
power off the PRIMUS application. PRIMUS will backup your database before shutting
down.
5. By default, the storage location is set to E:\ drive which is a USB device. If there are
two USB devices inserted, you need to select the desired USB device.

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6. After the source is selected, click Start data backup now for the backup to happen.

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7. A unique folder with serial number of the device is generated automatically for the
backup in the USB device.
8. Backup in progress sign appear in the middle of the screen (as seen on left).
Note: It can take several minutes to a few hours for the PRIMUS instrument to finish
backup to the USB device, depending on the number of exams in the local database.
9. When the backup process is complete, a dialog notifies you of successful data backup
(as seen on left).
10.Click OK and return to SETTINGS screen. A summary LOG file is saved back in the
database. Export log files if required (See Restore Data Process on page 8-4).

Data Backup Behavior

PRIMUS data backup behavior is as follows:
• Before backup, make sure that the destination device has sufficient available space. The
system does not check the destination for sufficient available space and does not return
an error message if insufficient space is available. Automatic Backup failed at shutdown
does not display the reason at next Restart.
• PRIMUS instrument overwrites any data previously backed-up. This means if you delete
any patient record and take a backup, the recent backup overwrites the previous
backup. Be sure before you delete any patient record. Paper records and/or pdfs stored
on CD/DVDs will be the only patient information available.

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8-4 Backup and Restore

Restore Data Process

On PRIMUS instrument, you can restore data only from a PRIMUS export database (on
removable media or in a network location) to the local PRIMUS database. You cannot
select an alternate removable media to restore data. You can either overwrite or append to
an existing data in local database.

Restore Source
Compatible removable media used to restore data includes External hard disk and USB
flash drive devices—that were used to take backup. You need to have a dedicated source
for your equipment. Hence, label the device with the serial number of the PRIMUS
equipment so as not to lose the relationship of the USB device and PRIMUS equipment.
Failure to do so may lead to loss of backup data.
CAUTION: If you use a USB device for restore, which was used for backup of data on
other PRIMUS equipment with different software version, then all the data of that
equipment will overwrite the local database of your equipment leading to loss of
your data.

CAUTION: A USB device should not be inserted or removed while the system is
starting up or shutting down, or while being accessed. If a USB storage device has
an LED flashing light that indicates “in use”, it should not be removed when the
light is flashing.

Restore Instructions
To restore data, follow these steps:
1. Insert the media containing backup data created with your PRIMUS instrument into its
drive.
2. In Patient screen, click Settings > Maintenance. From the Data backup section, click
the backup details for the Merge or Replace buttons to appear.

Click here for the Merge & Replace buttons to appear.

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 Backup and Restore 8-5

3. Click Merge to append patient data of backup copy with the patient data available on
the device. Click Replace to overwrite backup copy with the patient data available on
the device.

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4. Click Restore to confirm and continue—the restoration begins, or Cancel to stop the
restore operation.

CAUTION: When Restore is clicked, all the local data of the equipment will be
overwritten with the data of backup source.

5. Restore progress sign appears in the middle of the screen (as seen on left).
Note: It can take several minutes to few hours for the PRIMUS instrument to finish
restoring to the hard drive, depending on the number of exams in the export database.
6. After considerable amount of time depending on the amount of data restored, a
successful restoration dialog is displayed along with the instruction to restart the
equipment, as shown in Figure 8-6. In a circumstance where the restoration fails, as
shown in Figure 8-7, contact ZEISS customer service or your local CZM distributor.

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7. Click Restart, and the equipment software runs system checks.

• A summary LOG file is saved back in the database. Export log files if required (See
Restore Data Process on page 8-4).
8. Login to access the PRIMUS instrument functions. Restored records will appear in the
All patient list.

Restore Behavior
• Before importing, the system checks for sufficient available space on the system hard
drive and if insufficient space is available, an unsuccessful restoration dialog appears.
At this moment, contact ZEISS customer service or your local CZM distributor.
• Restored data overwrites already existing records in the database.

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8-6 Backup and Restore

Export Log files

1. Click the SETTINGS icon and then click the Maintenance tab to view the Log
files section.
2. Click on Export to save the log files in the inserted USB device.

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3. By default, the storage location is set to E:\ drive which is an USB device. If there are
two USB devices inserted, you need to select the desired USB.
4. Click a desired folder until you find no sub-folder in it or click to create a new
folder if required. You can always create a folder with date to distinguish each export.

Click to create folder

Click to start log file export

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5. After the folder is selected, click Select for the log files to export.
6. Export in progress sign appear in the middle of the screen (as seen on left).
Note: It can take several seconds to several minutes for the PRIMUS instrument to finish
export of log files to the USB device, depending on the number of logs in the local
database.

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 Backup and Restore 8-7

7. When the log file export process is complete, a dialog notifies you of successful export
(as seen on left).
8. Click OK and return to SETTINGS screen.

Log File Export Behavior

PRIMUS instrument’s export behavior is as follows:
• Before export, make sure that the export destination device has sufficient available
space. The system does not check the destination for sufficient available space and does
not return an error message if insufficient space is available.
• If the export location is the same, the system will not overwrite previously exported
data, but it will supplement previously exported logs with new logs. This way, it may be
difficult to track the export record. We recommend that you can always create a new
folder with date to distinguish each export.

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8-8 Backup and Restore

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 Routine Maintenance 9-1

(9) Routine Maintenance

Chapter Overview
ZEISS designed the PRIMUS instrument to require very little user maintenance. Most
maintenance activities covered here are required only occasionally, except for routine
cleaning between patients.
This chapter covers the following topics:
• Fuse Replacement, page 9-1
• Handling Error Messages, page 9-2
• Routine Cleaning, page 9-3

Note Regarding Warranty

Note: Except for the main power fuse(s), the PRIMUS instrument has no user-replaceable
parts. The user must not attempt hardware repairs, except fuse replacement, without
consulting ZEISS service personnel. To do so voids the instrument warranty.

Fuse Replacement
The instrument has two fuse(s). Instructions to check and replace the fuse(s) is included
below. First we offer help in determining the source of power problems.
Note: Except for fuse(s) replacement, only ZEISS authorized personnel may disassemble the
instrument and replace parts. If fuse replacement does not solve the problem, or if another
sort of problem prevents normal operation, contact ZEISS customer service or your local
CZM distributor.

Determine the Source of the Power Problem

This section assumes that you power the instrument directly from a wall outlet and then
instrument will not power on.
Check the following to determine the source of the power problem, in order:
1. Is there power available everywhere in your office?
• If not, there may be a localized power outage in your office or a general power
outage in your neighborhood.
• If so, proceed to Step 2.
2. Is the instrument power cord plugged in at both ends (at the wall outlet and the input
port in the power supply module)?
• If not, plug in the cord and try to power up the instrument.
• If so, check the instrument fuse(s) and replace them if necessary. See Check and
Replace Instrument Fuse(s) on page 9-1 for instructions.

Check and Replace Instrument Fuse(s)

The fuse holder is located in the appliance inlet on the side of power supply module.

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9-2 Routine Maintenance

WARNING: Carefully follow these instructions to safely check and replace

fuse(s). Always power down the instrument and unplug the power cord
from the wall outlet before proceeding. At all times, use the minimum
force necessary to accomplish each step so as to prevent damage or injury.

1. Power down the instrument. Unplug the power cord from the wall outlet and from the
appliance inlet on the side of power supply module. The fuse holder is at the inlet on
the side of power supply module.
2. Using a narrow-bladed screwdriver, gently pry open the fuse holder from the top. Pull
the fuse holder with fingers. Push the fuse(s) out of its slot with thumb and then pull
the fuse(s) out of the fuse holder. Dispose of the defective fuse(s).

Power cord inlet With screwdriver, pry open fuse holder.

Fuse holder Remove fuse holder with fingers.

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WARNING: Always replace fuse with the same type and rating. Failure to
do so may create a risk of fire.

3. Insert the new fuse(s) into the fuse holder.

Note: Fuse type and rating: T3.15A H 250V (or) T3.5A H 250V as marked adjacent to fuse
holder.
4. Push the fuse holder back in the slot near the power inlet port of the power supply
module.
5. Plug in the power cord at both ends. Your instrument is now ready to be powered on.

Handling Error Messages

In normal instrument start-up, the Startup check status dialog appears. If the system fails
the system check, or if some other error prevents the system’s normal function, document
the circumstances and any associated error messages, and report it to ZEISS customer

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 Routine Maintenance 9-3

service or contact your local ZEISS distributor. Often error messages can be resolved with
solutions provided over the telephone.
Please be prepared to provide CZSZ the serial number of your instrument, affixed on the
Cross table.

Routine Cleaning
The forehead and chin-rest, and to a lesser extent the imaging aperture and LCD screen,
are the only parts that require routine cleaning. Instructions are included below for
occasional cleaning of the instrument, computer parts and height adjustable table.

CAUTION: The instrument has no special measures to protect against harmful

ingress of water or other liquids (classified IPX0—ordinary equipment). To avoid
damage to the instrument and a safety hazard, cleaning solutions, including water,
must be applied sparingly, with a non-linting cloth that is dampened only—not
dripping wet! You must not use aerosols on or near the instrument.

Forehead and Chinrest

The instrument part that routinely contact the patient—the forehead and chinrest—
should be cleaned between each examination with an alcohol prep wipe. If required, you
can use a disposable barrier on the forehead and chinrest between each patient
examination.

Imaging Aperture
The imaging aperture should not contact the patient’s eye. You may clean it as necessary to
remove dust and oily smudges, ensuring true images. You may use an alcohol prep wipe.
Wipe dry with a soft, non-linting cloth. If the lens inadvertently contacts the patient’s eye,
clean it before proceeding with the examination.

CAUTION: Wipe gently and carefully to avoid scratching the instrument and the
auxiliary lenses.

LCD (Monitor) Screen

Clean the LCD screen when necessary to remove dust and oily smudges that impair
viewing. Turn off the monitor first. We recommend that you use a soft cotton cloth. If a dry
cloth does not completely clean the screen, you can dampen the cloth with water only and
wipe the screen with the damp cloth.

Occasional Cleaning of Instrument, Computer Parts and Height

Adjustable Table
CAUTION: When dusting of the Instrument, Computer parts and Table is necessary,
use a dry non-linting soft cloth. Do not use aerosols, as these can penetrate the
instrument covers and damage the instrument.

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9-4 Routine Maintenance

CAUTION: When the Instrument, Computer parts and Table require cleaning or
disinfecting, wipe the surfaces with a clean and soft non-linting cloth or wipe,
dampened only—not dripping wet!—with water or alcohol.

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 Specifications 10-1

(10) Specifications

OCT Imaging
Methodology Spectral Domain OCT
Optical Source Super Luminescent Diode (SLD), 840 nm
Optical Power ≤ 725 μW at the Cornea
Scan Speed 12,000 ±10% A-Scans/sec
A-Scan Depth 2.0 mm (in tissue), 1024 Points
Axial Resolution 5±1 μm (in Tissue)
Transverse Resolution ≤ 20 μm (in Tissue, FWHM)

Fundus Imaging
Methodology Confocal Scanning Laser Ophthalmoscope (cSLO)
Live Fundus Image During alignment
Optical Source Super Luminescent Diode (SLD), 840 nm
Optical Power ≤ 725 μW at the Cornea
Field of View 29º H x 21º V
Frame Rate ≥ 4 Hz
Transverse Resolution ≤ 80 μm (in Tissue)

Electrical, Physical and Environmental

Weight 40 kg (88 lbs)
Dimensions 120L x 80W x 150H (cm)
Fixation Internal, External
Internal Fixation Focus -23D to +17D (diopters)
Adjustment Focus of Internal fixation will change according to
different refractive error adjustment.
Input Devices Keyboard, Mouse
Fuse rating T3.15A H 250V (or) T3.5A H 250V
(as marked adjacent to fuse holder)
Electrical rating Single Phase, 100-240V~ systems: 50-60 Hz, 3.5A Max.
Line and Neutral are fused.
Peak voltage (based on input 373V
100-240V)
Temperature (transport and –40 to +70º C
storage)

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10-2 Specifications

Atmospheric pressure 500 hPa to 1060 hPa

(transport and storage)
Relative humidity (transport 10 to 90%, including condensation
and storage)
Pollution Degree II
Over-voltage Category II
Altitude (operation) Up to 3000 m above sea level
Atmospheric Pressure 700 hPa to 1060 hPa
(operation)
Temperature (operation) +10 to +40º C
Relative humidity (operation) 30 to 75%, excluding condensation
Computer • Processor—Intel® Core™ i3-2330E
• Operating System: Windows 7
• Memory—4 GB
• Hard disk—500 GB
• USB 3.0 ports—4 portsa
• Ethernet ports—2 10/100 with 2 independent IP
addressb.
• Audio—1 x Audio jack
• 1 x DVI-I
• LED—1 x Power LED; 1 x HDD LED
• PCIE—1 PCIex4

a. One for mouse, one for key board and 2 ports for user (either to printer and/or
external storage device).
b. Only one Ethernet port is usable to the user as the other one is fixed for the
device function (connection to micro controller).

Maintenance
ZEISS recommends regular preventative maintenance.
Note: Only trained CZSZ personnel may perform calibration.

Measurement Units
All units on the PRIMUS instrument are measured in the SI format.

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 Legal Notices 11-1

(11) Legal Notices

Software Copyright
The software program (“Software”) included with your PRIMUS instrument is a proprietary
product of ZEISS and in certain instances contains material proprietary to Microsoft
Corporation. These proprietary products are protected by copyright laws and international
treaty. You must treat the software like any other copyrighted material.
Copyright © 2017 Carl Zeiss Suzhou Co. Ltd. All rights reserved.

Software License Agreement

This Software license agreement (“License”) is a legal contract between the Purchaser
(“You”, “Your” “Licensee”) and ZEISS governing Your use of the Software. Opening the
sealed package indicates Your acceptance of the terms and conditions of this License. If
You have any questions concerning this License, contact Carl Zeiss Suzhou Co., Ltd.

License Terms and Conditions

1. In consideration of payment of the License fee which is part of the price You paid for
Your PRIMUS instrument, and Your agreement to abide by the terms and conditions of
this License and the Limited Warranty, ZEISS grants to You a non-exclusive,
non-transferable and non-assignable license to use and display this Software on a
single PRIMUS instrument, under the terms of this License. If the PRIMUS instrument
on which You use the Software is a multi-user system, this License covers all users on
that single system.
2. The license is granted solely for the use of Your own internal computing requirements
and does not grant You any right, title or ownership in the licensed software or its
documentation. You own the physical media, PRIMUS instrument, on which the
Software is originally or subsequently recorded or fixed, but You understand and agree
that ZEISS retains title and ownership to the Software recorded on the original disk
copies and all subsequent copies of the Software.
3. This Software is copyrighted. Unauthorized copying of the Software, including
Software that has been modified, merged or included with other software, is expressly
forbidden. You may not, nor may You permit others to (a) disassemble, decompile or
otherwise derive source code from the Software (b) reverse engineer the Software, (c)
modify or prepare derivative works of the Software, (d) provide on-line or similar uses
to third parties, or (e) use the Software in any manner that infringes the intellectual
property or other rights of another party. You may be held legally responsible for any
copyright infringement that is caused or encouraged by Your failure to abide by the
terms of the License.
4. ZEISS may create updated versions of the Software, which You may purchase
separately.

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11-2 Legal Notices

5. This license does not include the right to make copies of software, nor to transfer the
software or copies from the Product(s) to third parties, nor to extract, modify or
incorporate any part of the software or source code, without prior written consent
from ZEISS and payment of licensing fees. Further, sales of PRIMUS instruments may
not include any software or software licensee transfers. You may not sub-license, rent
or lease the Software.
6. ZEISS warrants the operation of the Software only with the operating system for which
it was designed. Use of the Software with an operating system other than that for
which it was designed will not be supported by ZEISS. ZEISS does not claim that the
software provided is free from defects and shall have no obligation to supply software
upgrades (i.e., new versions, or new, or in-line releases).

Acknowledgment
You acknowledge that you have read all the provisions in this Chapter, including this
License and Limited Warranty, understand them, and agree to be bound by their terms and
conditions.

PRIMUS 200 - User Manual_EN_201114 000000-2209-318, V01

 Carl Zeiss Suzhou Co. Ltd. Carl Zeiss Meditec AG Carl Zeiss Meditec, Inc.
Modern Industrial Square 3-B Goeschwitzer Strasse 51-52 5160 Hacienda Drive
No. 333 Xing Pu Road 07745 Jena Dublin, CA 94568
Suzhou Industrial Park, Suzhou Germany USA
China 215126 Phone: +49 36 41 22 03 33 Toll Free: 1 800 341 6968
Phone: +86 512 6287 1388 Fax: +49 36 41 22 01 12 Phone: +1 925 557 4100
Fax: +86 512 6287 1115
Fax: +1 925 557 4101
000000-2209-318, V01
PRIMUS 200 Software Version 3.0
Specifications subject to change without notice