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User Manual
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Copyright
© 2010 Carl Zeiss Meditec, Inc. All rights reserved.
Trademarks
Stratus OCT and GPA are either registered trademarks or trademarks of Carl Zeiss Meditec,
Inc. in the United States and/or other countries.
Windows is either a registered trademark or trademark of Microsoft Corporation in the
United States and/or other countries.
All other trademarks used in this document are the property of their respective owners.
Contents
•Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
•Instrument Network Capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
•Stratus Review Software Network Capabilities . . . . . . . . . . . . . . . . A-1
•WARNING: Risks of Internet Connectivity . . . . . . . . . . . . . . . . . . . .A-2
•Stratus Review Software: Third Party Software . . . . . . . . . . . . . . . .A-2
•Prohibited Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-3
•Network Activities Not Supported . . . . . . . . . . . . . . . . . . . . . . . . . .A-3
•Not Recommended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-3
•Network File Server Minimum Requirements. . . . . . . . . . . . . . . . . .A-3
•Network File Server Recommendations . . . . . . . . . . . . . . . . . . . . . .A-4
•Using The Network File Server. . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
•Configuration for Direct Export to a Personal Computer . . . . . . . . .A-6
(B) Configuration Guide . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
•Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
•Data Transfer Overview: Import or Retrieve Data . . . . . . . . . . . . . .B-2
•Configuration for Export via Preexisting Office Network . . . . . . . . .B-3
•Stratus to Review Station Direct Network Connection (Crossover Cable)
Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-13
(C) Normative Database for Macula and
RNFL Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
•Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
•Selection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
•Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-2
•Data Analysis and Normalization . . . . . . . . . . . . . . . . . . . . . . . . . .C-2
•Age Coefficient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-3
•Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-5
(D) Data Transfer Using CDs and DVDs . . . . . . . . . . . . . . D-1
•Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-1
•Compatible CD and DVD Media Formats. . . . . . . . . . . . . . . . . . . . .D-1
•Compatible Data Transfer Functions . . . . . . . . . . . . . . . . . . . . . . . .D-1
•Stratus OCT Data Transfer Instructions . . . . . . . . . . . . . . . . . . . . . D-2
•Proper CD and DVD Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2
•Formatting for Drag-to-Disc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2
•Roxio Software Configuration—Eject Settings . . . . . . . . . . . . . . . D-4
•Warning: User Changes to Hardware or Software . . . . . . . . . . . . . D-5
(E) Using a Network Storage Device. . . . . . . . . . . . . . . . E-1
•Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
•NAS Device Safety Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
•NAS Device Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-2
•NAS Device Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-2
(1) Introduction
The ZEISS Stratus OCT Model 3000 (Stratus OCT) enables examination of the posterior pole
of the eye at an extremely fine spatial scale, without surgical biopsy or even any contact
with the eye. Stratus OCT Review Software enables you to view, analyze and manage
Stratus OCT data on a personal computer; it provides all the Stratus OCT instrument
functionality, except scan acquisition, in a remote location. The name Stratus OCT (derived
from “stratum,” Latin for “layer”) refers to its unique ability of direct cross-sectional
imaging of the layers of the retina. The Stratus OCT minimizes patient discomfort as it
permits detailed examination of the retina and optic nerve head at the office or clinic. The
Stratus OCT facilitates diagnosis and management of retinal diseases and glaucoma.
Note: The Stratus OCT and Stratus Review Software are not intended to
be used as the sole diagnostic for disease.
Patient Population
The Stratus OCT instrument may be used on all adults and children (over the age of six) 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
• 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).
Application
The Stratus OCT instrument is designed for continuous use, although it is expected that
most sites operate the instrument for 10 hours or less per day, indoors, 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 11. Application related warnings are given in Chapter 1
and elsewhere.
Operator Profile
We assume that users are clinicians with professional training or experience in the use of
ophthalmic imaging equipment, and in diagnostic interpretation of the images generated.
Specific assumptions regarding the profiles of individuals performing instrument operation
or data interpretation are given below. This manual contains information that will aid in
the proper instrument operation and interpretation of the resultant data.
Instrument Operation
Demographic
The user should be adult, and at least one of the following:
• Ophthalmologist
• Nurse
• Certified Medical Technician
• Ophthalmic Photographer
• Non-certified Assistant
Occupational Skills
The user should be able to perform all of the following tasks:
• Power on the unit and log on
• Enter, find, and modify patient identifying data
• Clean surfaces that contact patient
• Position patient with the instrument, including moving the patient, the instrument,
the table height, and the patient’s chair
• Select and acquire a scan
• Review and save a scan or try again
• Generate an analysis report using available analysis protocols
Data Interpretation
Demographic
The user should be one of the following:
• Ophthalmologist or other Medical Doctor
• Optometrist
Occupational Skills
The user should have the following skills:
• Computer literate
• Ability to work with elderly patients and those with disabilities
Job Requirements
The user should have training and certification to interpret the analysis in the treatment of
ophthalmic diseases or other eye-related medical issues, as required by governing bodies.
What's New?
This User Manual includes information on new and modified features of the Stratus OCT
system. For customers who are upgrading from version 6.0 or earlier, the following
describes differences and where information can be found in this user manual.
The Stratus OCT interferometer electronically detects, collects, processes and stores the
echo delay patterns from the retina. With each scan pass, the Stratus OCT captures from
128 to 768 longitudinal (axial) range samples, i.e., A-scans. Each A-scan consists of 1024
data points over 2 mm of depth. Thus the Stratus OCT integrates from 131,072 to 786,432
data points to construct a cross sectional image (tomogram) of retinal anatomy. It displays
the tomograms in real time using a false color scale that represents the degree of light
backscattering from tissues at different depths in the retina. The system stores the scans
you select for later analysis.
Note: We recommend you use the automated data maintenance features to archive
scans and backup the patient database. This helps ensure the preservation of
patient data in case of computer malfunction. See Chapter (8), Archive, Retrieve &
Backup.
WARNING: This warning applies to Stratus OCT systems that shipped with software
version 5.0 and later; these systems have the hard drive partitioned into C: and F: drives.
Do not export or save data to the C: drive of a Stratus instrument. The C: drive
is relatively small and can be filled up quickly, which renders the system
unusable. The F: drive is reserved for data and therefore is relatively large. If
you want to export or save data to the Stratus hard drive, either locally or to a
connected Stratus system on the network, select (a location in) the F: drive as
the target.
Approved Software
Note: Carl Zeiss Meditec does not provide technical support for the use of third party
software.
Please refer to the Stratus OCT Technical Support section of our website
(www.meditec.zeiss.com/stratus) for the current list of approved software, including
updates and patches to the Windows® operating system and security software.
Note Regarding Network Security: Stratus OCT Software Version 7.0 is compatible
with Windows 2000 Service Pack 4, which is primarily a security update to the
Windows operating system. Therefore, if you connect the Stratus OCT to an office
network, we encourage you to install Service Pack 4. Furthermore, please consider
the information in Networking Guidelines. If you connect the Stratus OCT to the
Internet, which is not recommended, see WARNING: Risks of Internet
Connectivity on page A-2.
Instrument Installation
Only an authorized Carl Zeiss Meditec service representative should install the Stratus OCT.
We do not provide assembly and installation instructions. In consultation with the buyer,
Carl Zeiss Meditec schedules a free on-site installation appointment to coincide with
delivery. System installation and initial calibration require approximately one business day.
Care in Handling
Use extreme care when handling and transporting the Stratus OCT shipping boxes. The
instrument contains fragile optics that require highly precise alignment.
Installation Requirements
• The instrument with the optional power table requires an area at least 6' x 8' (1.80 m
by 2.4 m) for installation and patient comfort during use.
• To prevent heat buildup that could 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 the specifications for Environmental Conditions on page 11-2.
• The Stratus OCT should operate on a dedicated power outlet. Based on your
specification, we configure your Stratus OCT at the factory to use either 100/120V or
220/240V line voltage.
Note: Users are not authorized to dismantle or modify the Stratus OCT hardware. To
transport the instrument outside the office, you must consult with a Carl Zeiss
Meditec service technician. Failure to do so voids all warranties offered with the
Stratus OCT.
• Only Carl Zeiss Meditec authorized technicians should disassemble or service this
instrument. In the case of malfunction, error messages or operational problems, call
Carl Zeiss Meditec customer service: In the U.S., call 800-341-6968. Outside the U.S.,
contact your local Carl Zeiss affiliate or distributor.
• This instrument has no special measures to protect against harmful ingress of water
or other liquids (classified IPXO—ordinary equipment). Do not place containers of
liquid on or near the instrument, and do not use aerosols on or near it.
• In case of a non-medical emergency related to the instrument, unplug the power cord
from the wall outlet and call for service immediately.
• There are no user-replaceable parts in the instrument. For the replacement of any
component, accessory, or peripheral, including fuses and lamps, call Carl Zeiss
Meditec customer service: In the U.S., call 800-341-6968. Outside the U.S., contact
your local Carl Zeiss affiliate or distributor.
• Although this instrument is designed for continuous operation, it should be turned off
when not in use for an extended period.
Product Compliance
Complies with 93/42/EEC Medical Device Directive.
Product Safety
• IEC 60601-1
• UL 60601-1
• CSA C22.2 No. 601.1-M90
This 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.
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 warning could result in electrical shock to the patient and/or
examiner.
WARNING: Avoid tipping. To avoid tipping, the printer supplied with the
instrument must be maintained in its place and no others are to be used. 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 could result in tipping of the instrument
and/or table and resulting injury to operator or patient and damage to the
instrument.
WARNING: Do not scan the same location on the retina with the same scan
pattern for more than 10 minutes per day. Failure to follow this guideline
could result in overexposure of the patient’s eye to optical radiation.
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
WARNING: This device contains visual stimuli, including flickering light and
flashing patterns, between 5 and 65 Hz. Medical professionals need to
determine whether this device should be used for patients who may be
photosensitive, including those with epilepsy.
Disclaimer: Carl Zeiss Meditec does not offer advice or instruction in the
diagnostic interpretation of OCT images. It is the clinician’s responsibility to
make diagnostic interpretations of OCT scans.
Note: The Stratus OCT has special EMC precaution requirements and needs to be
installed and put into service according to the EMC information provided herein.
WARNING: The use of accessories, transducers and cables other than those
specified may result in increased emissions or decreased immunity of the
equipment.
WARNING: The Stratus OCT should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the equipment or
system should be observed to verify normal operation in the configuration in
which it will be used.
Accessory Equipment
WARNING: Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC standards (e.g.,
IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore, all configurations shall comply with the system
standard IEC 60601-1-1. Any person who connects additional equipment to
the signal input part or signal output part configures a medical system, and is
therefore responsible for ensuring that the system complies with the
requirements of the system standard IEC 60601-1-1. If in doubt, consult the
technical service department or your local representative.
Caution, consult accompanying documents. Note: There are important operating and maintenance
instructions found in the manual.
Presence of electrical shock hazard. Note: Indicates risk of electrical shock due to the presence of
uninsulated high voltage inside the instrument. Do not remove the instrument cover or parts.
Fuse
Manufacturer
Serial number
Model number
European Conformity
This end up
Note: The instrument is not intended to be transported outside its original package.
Password Protection
Note: The following information and instructions are intended for the use of the
Stratus OCT in a standalone setting. If you have installed the Stratus OCT in a
network environment, we assume that you will apply your own user account
management procedures. We do not offer recommendations or instructions for
password protection in a network environment. In general, we recommend that you
use good practices in creating, administering and securing passwords.
It is the user’s responsibility to implement whatever instrument and data security measures
are desired or appropriate. This section instructs you how to use the Windows operating
system to require users to enter a password before they can access the Stratus OCT
computer. The Stratus OCT is shipped with Windows password protection turned on but
with auto-logon enabled so that users do not have to enter a password. The result is that,
upon system startup, any user has administrator privileges (access to all functions) via the
default user account.
Note: If you disable auto-logon, the Stratus OCT software will not launch
automatically upon system startup. You will be required to log on to the computer
by entering a valid user name and password combination. After logging on, you
may have to launch the Stratus OCT software by double-clicking on the STRATUS
OCT Host desktop icon.
Administrator Privileges
Administrators belong to the Administrators Group by default. The default user account is
an administrator account.
• Users in the Administrators Group can use all Stratus OCT functions.
• Administrators can modify the computer and install programs—and thereby
implement Stratus OCT software upgrades.
• Only administrators can create new user accounts, manage network settings and read
the files of other users.
4. Click the Add button. The Add New User dialog box appears. Enter a user name and
record it. The user name is not case-sensitive. (The other information is optional.)
Click Next.
5. You will be prompted to enter and to confirm a new password for this user name. The
password is case-sensitive. Record the password you have entered. When finished,
click Next.
6. The Add New User dialog box now lets you select the level of access of the new user
account. Select the Other radio button and then select Administrators from the drop
down list, as in the example below.
Note: If the Stratus OCT is connected to a network file server, you may be required to
log on to the server as well as the instrument. Check with your network
administrator for the required log on procedures.
The first time you restart the system after implementing password protection, you will have
to do the following:
1. The Select Netware Logon dialog box will appear. Click Cancel. A Netware Network
dialog box will appear. Click Yes.
2. The Windows Logon dialog box will appear with “Administrator” in the User Name
field. Delete “Administrator” and type in the user name you wish to use. Then enter
the corresponding password in the Password field. The password is case-sensitive.
Click OK.
3. The Getting Started with Windows 2000 dialog box will appear. Uncheck the box at
lower left that says, “Show this screen at startup.” Then click Exit.
4. We recommend that you set the Windows taskbar properties to auto hide. Right-click
on the taskbar and click Properties. In the Properties dialog box, select the checkbox
next to Auto hide. Then click OK.
After the first time you log on with a new user name, you will be prompted to enter the
user name and password only. The system will open to the Windows desktop. Double-click
the STRATUS OCT Host desktop icon to launch the Stratus OCT software.
Instrument Disposition
When it comes time to upgrade the Stratus OCT, please contact Carl Zeiss Meditec to
inquire about trade-in or upgrade values we may offer. Should you not wish to trade in the
instrument, please dispose of it in accordance with local and national requirements.
Chapter Overview
This chapter explains in detail how to prepare for scanning with the ZEISS Stratus OCT.
Along the way, it describes the Stratus OCT MAIN WINDOW, from which all functions
originate. Scan preparation consists of the following:
• Power Up The System (page 2-1).
• Navigate To The Main Window (page 2-2).
• Prepare The Patient (page 2-4).
• Enter Patient Data (page 2-5).
Windows Start menu at lower left. For later models with soft shutdown, this will power
down the whole system. On earlier models, you must flip the computer power switch off to
shut down the whole system.
Soft Shutdown
To prevent abrupt shutdowns of the system, later models of Stratus OCT power down only
through the computer software. On these models, pressing the power switch while the
instrument is running will not power down the system.
Navigation in General
To navigate among alternatives on the screen, use the mouse to move the screen pointer.
Once you reach your selection, click the mouse.
Text Convention
• This manual means “left-click” when it says, “click,” except where “right-click” is
specified.
Note: The forehead and chin rests should be cleaned between each examination
with an alcohol prep swab.
Internal Fixation
In this method, the patient uses the study eye to fixate on a target light inside the ocular
lens. If you select internal fixation, instruct the patient to look at the green light inside the
ocular lens.
• You control the internal fixation target location on screen during scan acquisition (see
Scan, Landmark and Fixation LED Controls on page 3-9).
• With this method, you and/or the patient may find it helpful to cover the patient's
fellow eye with an eye patch. This may increase the patient's ability to fixate steadily
on the target.
External Fixation
With the external fixation method, the patient uses the fellow eye to fixate on a target light
external to the ocular lens. The Stratus OCT is equipped with a detachable external fixation
target arm. It attaches at the top corners of the head mount on either side. You must
position it manually for central or horizontal fixation.
• If you select external fixation, instruct the patient to look at the red blinking target
light at the end of the external fixation arm. You can manipulate the cap at the end of
the target arm to adjust the intensity of the target light.
• It is important to situate the target light level with the patient's fellow eye and as far
as possible from the patient.
Note: The DICOM workflow for Modality Worklist is available if DICOM1 Integration
is licensed and activated.
To display a list of scheduled patients, click on Search Worklist Patients. The MODALITY
WORKLIST dialog appears.
Category Field
If you have created patient categories (select Options > Register > Categories to create
categories), you can use the drop down list to select a category of patients for display in
the patient list.
Today’s Patients
Today’s Patients is the list that is shown when you click on Search Worklist Patients. this list
shows the patients that are scheduled for the day.
Select a Patient
Click the desired name in the patient list to select it. The selected name is highlighted in
blue. You can select only one patient at a time. Use the arrow keys or the scrollbar to move
through the list.
Advanced Search
Stratus OCT provides an Advanced Search dialog to serach for patients using additional
parameters such as patient category, diagnosis, scan type, insurance company, doctor,
clinical trial ID, or subject reading ID, etc. Advanced Search is available from the Toobar.
Note: The search returns only the patients that match all search parameters used. If
your search does not return all patients desired, you may want to broaden your
search by using fewer parameters or partial information. Clicking Search without
using any parameters returns all patients in the source database.
• To edit a patient record, select a patient from the list and click Edit. Edit the fields as
desired and click OK when finished.
• If desired, you can enter a variety of other patient information using the available
tabs. All information entered is for record-keeping only. It has no impact on scanning.
• For eyes that are smaller or larger than average, we recommend you input the
Spherical Equivalent and Axial Length (in mm).
Chapter Overview
This chapter explains in detail how to acquire Stratus OCT scans. It covers the following
steps:
• Adjust the Height for patient comfort (below).
• Initiate a Scan (on page 3-3).
• Position The Patient Module (on page 3-5).
• Optimize Scan Image (on page 3-6).
• Adjust Scan Placement (on page 3-8).
• Acquire Scans (on page 3-10).
• Other Scan Adjustments (on page 3-13).
The Stratus OCT offers scan acquisition protocols to acquire retinal scans. Their
characteristics and applications are covered in Chapter (4).
Note: Before placing the head in the headrest, we recommend the patient touch the
metal base of the Stratus OCT instrument, to prevent electrostatic shock near the
patient's eye.
• 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.
• For finer adjustments, you can raise or lower the chin cup. Use the knobs below the
chin cup on either side (see Figure 3-1 below).
Chin Cup
Initiate a Scan
To position the patient module for scanning, you must initiate a scan. First, select a scan
acquisition protocol using the Scan Tab, below.
double-click the protocol. This activates the SCAN ACQUISITION window, as pictured
below.
In preparation for the next step, the important features to note are the scan image (left
side) and video image (upper right). The other functions available in this window will be
detailed in the usual sequence of their application.
ocular lens and positioning further. All the while, use the live video image to observe the
position and focus with respect to the study eye. (While not usually necessary, adjustments
to the video image are possible—see Video and Lamp Parameter Tab, page 3-18,
for instructions.)
1. At the outset, focus on the study eye from a distance before moving the patient
module. Instruct the patient to look straight ahead. Then press the joystick button to
unlock the patient module and move it toward the study eye. Place it so that the
ocular lens is approximately 25 mm (one inch) from the study eye.
2. Manipulate the joystick—move for lateral adjustments and twist for vertical
adjustments—to center the video image on the pupil. Then, using the joystick, gently
push the patient module toward the eye so the video image moves through the pupil
and the fundus comes into view.
3. Instruct the patient to look at the green target light. With the joystick, carefully
continue to push the patient module toward the eye and make vertical adjustments
until the Stratus OCT beeps, which is a signal that the patient module is the correct
distance from the eye for scanning. It beeps when it begins to acquire a retinal scan
image, which is visible as a band of contrasting color (green, yellow, red) against the
blue background noise on the monitor.
4. Instruct the patient to continue to fixate on the green target light. If necessary, further
adjust the patient module position from side to side, up and down, until the retinal
image fills the screen and is evenly illuminated. Shadows from the edge of the pupil
should be eliminated, if possible, for best scanning results. Press the joystick button
to lock the patient module in place.
While the patient module 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 video image.
Adjust Z-offset
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 Stratus OCT 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, and you see nothing but noise in the live scan image. The 2 mm axial “window”
must be 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
subsequently. Still, you are likely to adjust Z offset from scan to scan to center the
retinal scan image.
• During patient module positioning, the Stratus OCT beeps when it begins to scan the
retina. 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 Z-offset button on the Scan Parameter Tab (pictured below).
2. Click the Z-offset arrow buttons (to the right of the Optimize button) to bring the
entire retinal scan image into view.
• Shift-click (hold down the Shift key and click) the arrows to move in larger increments.
• The up arrow searches posteriorly (lower in the scan image), and the down arrow
searches anteriorly (higher in the scan image).
Optimize Polarization
Polarization is adjustable so you can optimize the interferometer signal strength by
matching the polarization of light reflected from the retina. This optimizes the scan image,
which results in more yellow and red color in the image. It is necessary to adjust Z offset
before polarization so the retina is visible in the color scan image while you adjust
polarization.
• Once you have a retinal scan image on the screen, click the Optimize Polarization
button on the Scan Parameter Tab (pictured above).
• You can incrementally adjust the polarization using the Polarization arrow buttons. If
you do, you may note that there are several local maxima in the 180-degree range of
polarization. These optional polarization settings may yield scan signals comparable
to and occasionally better than the signal achieved using the Optimize button.
• Polarization should be adjusted when initiating scanning on each new eye. It need
not be readjusted when performing a series of consecutive scans on an eye if it has
been done at the beginning of the series.
• You can use the Optimize Polarization button in both Alignment and Acquisition
Scan Modes (see page 3-4). The results of adjusting the polarization may be better
appreciated when the scanner is in slow mode.
Note: Both the scan placement methods described below work in both alignment
and acquisition scan modes.
Note: Right-click anywhere in the scan image and a vertical line appears in the
center of the scan image. Click again to remove it. This is useful to determine if you
have centered the desired retinal feature, e.g., the fovea.
Landmark
The landmark is a pulsating point of light that appears in the video monitor in addition to
the scan pattern. You can move it independently or together with the scan pattern. To
move the landmark, use the menu options on the Scan Parameter Tab.
Fixation can be challenging in patients with significant pathology or poor visual acuity. The
Landmark tool can aid in positioning the scan pattern relative to anatomical landmarks.
For example, it may be placed on the edge of the optic nerve head and used in centering a
Fast Macular Thickness Map scan pattern on the fovea. When using the Repeat Scan
function, the prior image shows the landmark position. The operator can align the new
scan with this position.
Acquire Scans
With the scan image optimized and the scan placed accurately, you can begin to acquire
scans.
WARNING: Do not scan the same location on the retina with the same scan
pattern for more than 10 minutes per day. Failure to follow this guideline
could result in overexposure of the patient’s eye.
• Blue patient module buttons: Again, press the left button once. Flash is used unless
you uncheck the Freeze with Flash option in the Scan menu (click Scan > Freeze with
Flash, as at left).
3. Save the scan.
• On-Screen: If you are satisfied with the quality of the scan image frozen on screen,
click the Save button. The video and scan images will be saved to the hard disk drive.
If not, click Cancel to return to scan acquisition mode and acquire another scan.
• Optional Scan Review: The Stratus OCT continuously scans and saves up to eight
scans in temporary memory. Therefore, you can review the last several scan
images and select which one to save. Click the Review button to go to the SCAN
REVIEW WINDOW. See the detailed instructions for the Scan Review Window on
page 13.
• Blue patient module buttons: Press the right blue button to save the scan image
frozen on screen. The right blue button is only active when a scan is frozen, and
saving scans is its only use. Press the left blue button to cancel saving and return to
scan acquisition mode.
Note: If you click the Cancel button before saving, you will be asked if you want to
save.
Note that media problems associated with many retinal diseases (vitreous opacities,
hemorrhages, lens opacities, etc.) can make it impossible to achieve a signal strength of 5,
even with careful scanning. Nevertheless, such scans can be useful for visual analysis of
the retinal structure and the association between the retinal layers. In assessing retinal
status, visual analysis of the retinal structure is important and may be highly indicative.
Furthermore, if you find that the retinal layer boundaries (white lines generated by the
analysis algorithm) clearly conform to the visible tissue contours, the resulting
measurements are reliable, even if the signal strength is below 5. At the same time, when
the retinal layer boundaries do not conform to the visible tissue contours, the resulting
measurements will not be accurate in those areas, even if the signal strength is 7 or
greater. Note that the RNFL boundary can be difficult to identify, so analysis of RNFL
images with a signal strength below 5 is not recommended.
Scan Messages
The scan messages “Scan too high,” “Scan too low” and “Scan missing data” are
descriptive of what you see on screen. When the scan is too high or too low on the screen,
the analysis algorithm frequently fails. When either message appears, the operator should
repeat the scan, using the Z-Offset arrow buttons to raise or lower the scan image as
necessary. When data is missing, usually from a patient's blink, the scan image is
incomplete and unsuitable for analysis. The operator should repeat the scan, instructing
the patient not to blink during scan acquisition.
Size
For many scan protocols, you can adjust the size of the scan pattern, that is, the length of
line scans or the radius/diameter of circle scans.
• For size parameters, measurements are in mm. The size range of scan lines is from 3
mm to 10 mm. The range of scan circles is from 1.5 mm to 10 mm diameter (0.75 mm
to 5 mm radius).
• To adjust size, you can also move the pointer near the edge of the scan pattern until a
two-headed arrow appears (as at left), and then click and drag the arrow to adjust
2-headed arrow
the size (and the angle, if applicable—see below). It is easier to adjust size exactly by
Changes the length and angle
typing in the new value.
of line scans
• When “Radius 1" and “Radius 2" appear, Radius 1 refers to the aiming circle and
Radius 2 refers to the scan acquisition circle.
Angle
0° (also 360° or -360°) Scan For the Line scan protocol (page 4-7), you can adjust the angle of the line. The default
proceeds from 9 to 3 o’clock. angle is 0° (horizontal from left to right). Compass degree measurements describe the
point of origin and the angle as seen in the video monitor. The 9 o’clock position is defined
as 0° on the compass. Degrees increase on the compass counterclockwise and decrease
180° or -180°. Scan proceeds
clockwise. This notation style enables the user to control not only the angular position of
from 3 to 9 o’clock.
the line, but also its point of origin.
• Of course, this is significant when locating a point of pathology like a macular hole.
90° or -270°. Scan proceeds For example, note that a 180° line looks just like a zero degree line in a frozen video
from 6 to 12 o’clock. image, but the 180° line originates at the 3 o’clock position.
• Also note that with this notation, every positive compass point has an alternative
representation 360° removed on the negative scale. For example, 180° and -180°
yield the same line with the same point of origin, as do 90° and -270°.
Number of Lines
When this field is available, you can adjust the number of lines from 6 to 24 lines.
Number of A-Scans
By default, the number of A-scans is 512 for all protocols except the Fast Scan protocols
(fixed at 768 A-scans total). Before scanning, you can adjust this number to 256 or 128
using the drop-down list. Click the down-arrow to view and select an option.
• Note that in scan alignment mode, the aiming pattern always consists of 64 A-scans.
• The number of A-scans is in effect the transverse resolution of the scan, that is, the
number of transverse data points acquired.
• Changes you make apply to the selected scan protocol until you change it again,
restart the Stratus OCT software or restart the system.
• You can also adjust the number of A-scans using the OCT Image Tab while
scanning (see page 3-18).
signal color). This makes the retinal image poorly defined or appearing as
undifferentiated white.
• The slider operates on a percentage scale. At zero, the weakest detectable signal
is assigned the saturation color in the scan image, and the image is all white. At
100, only the strongest detectable signal is assigned the saturation color in the
scan image, and very little retinal signal is strong enough to be depicted in the
scan image.
Number of A-Scans
The OCT Image Tab also has radio buttons to select the transverse resolution in terms of
the number of A-scans for each scan pass. By default, the number of A-scans is 512 for all
protocols except the Fast Scan protocols (fixed at 768 A-scans total). You cannot adjust this
number after you save the first scan in a series of related scans. In these cases, the radio
buttons will be grayed out. This variable is also adjustable before initiating a scan through
the Scan menu (see Number of A-Scans, page 3-15).
Lamp Brightness
This affects the video image by increasing the illumination inside the eye. Move the slider
or type in the value field to adjust the lamp brightness. Even the 100% setting is safe for
the normal patient's eye.
Information Tabs
The lower left side of the SCAN ACQUISITION WINDOW has three informational tabs:
Indicators, Details and Comment.
Indicators Tab
This tab provides patient and scan information.
Details Tab
This tab specifies the x and y position of the scan pattern, the landmark and the fixation
LED, in mm with respect to the center of the video image. The 0,0 position is perfectly
centered. It also shows the number of A-scans per second, which is fixed at 400.
Comment Tab
Only the Comment Tab is interactive. Click it to type in comments about the scan or
patient and store this information with the scan.
Chapter Overview
This chapter explains the applications and attributes of the scan acquisition protocols
offered by the Stratus OCT. While the previous two chapters provide operating instructions,
this chapter is designed to help the user select which protocol to use and know how to use
it. See Chapter (3) for instructions to apply these protocols. This chapter includes
information about:
• The Scan Tab, from which you select protocols (below).
• The Protocol Groups, listed in Activity groups (below).
• General Tips about the protocols (on page 4-3).
• Scan Protocol Descriptions, Options And Tips (on page 4-6).
Glaucoma Protocols
The protocols designed for glaucoma detection and management are:
• Fast Macular Thickness Map (Fast Mac)
• Macular Thickness Map
• Fast RNFL Thickness (3.4)
• Fast Optic Disc
• RNFL Thickness (3.4)
• RNFL Thickness (2.27xdisc)
• RNFL Map
• Fast RNFL Map
• Optic Disc
Retina Protocols
The protocols designed for other retinal pathologies are:
• Fast Macular Thickness Map (Fast Mac)
• Macular Thickness Map
All Protocols
The All radio button displays all protocols together. They are listed below in their default
order on the Scan Tab.
• Fast Macular Thickness Map (Fast Mac)—Glaucoma and Retina
• Macular Thickness Map—Glaucoma and Retina
• Fast RNFL Thickness (3.4)—Glaucoma
• Fast Optic Disc—Glaucoma
• Line
• Cross Hair
• Line
• Raster Lines
• X-Line
• Circle
• RNFL Thickness (3.4)—Glaucoma
• RNFL Thickness (2.27xdisc)—Glaucoma
• RNFL Map
• Fast RNFL Map—Glaucoma
• Proportional Circle
• Concentric 3 Rings
• Nerve Head Circle
• Optic Disc—Glaucoma
General Tips
The following information and usage tips apply to all scan protocols. Scan Protocol
Descriptions, Options And Tips, starting on page 4-6, provides a description for
each protocol, including its adjustment options and specific usage tips.
Table of Correlations
Analysis Protocol Designed for Scan Group(s)
Retinal Thickness Any scan protocol except (Fast) Optic Disc: 1 group on macula
Retinal Map Line, (Fast) Macular Thickness Map: 1 group on macula
Retinal Thickness/Volume Line, (Fast) Macular Thickness Map: 1 OS group and/or 1 OD group on
macula
Retinal Thickness/Volume Tabular Line, (Fast) Macular Thickness Map: 1 OS and/or 1 OD group on macula
Retinal Thickness/Volume Change Line, (Fast) Macular Thickness Map: 2 OS and/or 2 OD groups on macula
RNFL Thickness Any scan protocol except (Fast) Optic Disc: 1 group around disc
Exiting Scans
You may exit any scan at any time and return to the MAIN WINDOW by clicking the Cancel
button or any of the three Select toolbar buttons.
• Line, Circle, Proportional Circle and the four Fast Scan protocols permit you to repeat
the scan protocol multiple times. You must click Cancel to exit the SCAN ACQUISITION
WINDOW.
• The other scan protocols consist of either a single scan or a limited number of scans.
For these patterns, the Stratus OCT returns you to the MAIN WINDOW automatically
after you save the last scan in the series.
• For scans in a related series, only scan and fixation LED placement are adjustable
after the first scan. Several scan protocols consist of a series of related scans you
acquire one by one. To preserve the design integrity of these scan protocols, you
cannot adjust the size, number of lines, number of A-scans or placement of the
landmark after you save the first scan in the series. In this way, the analyses designed
to apply to these scan protocols will be meaningful.
• Exceptions: The only exceptions are the RNFL Thickness (3.4) and the RNFL Map
protocols. The former permits you to resize the aiming circle for all 3 scans; the
latter permits you to adjust scan size for all 6 scans, and both permit you to adjust
placement of all features for every scan.
• For scans in a related series, the landmark and scan are locked in their relative
position after the first scan. This is so you can use the landmark as a siting feature,
enabling you to keep each scan in a series in its preset pattern of relative placement.
Thus, you can preserve the design integrity of the scan pattern and the
meaningfulness of applicable analyses.
Number of A-Scans
By default, the number of A-scans is 512 for all protocols except the Fast Scan protocols
(fixed at 768 A-scans total). However, you can adjust this number using the OCT Image
Tab while scanning (see page 3-17), or through the Scan Variables option on the Scan
menu before scanning (see Number of A-Scans, page 3-15). Note that in scan
alignment mode, the aiming pattern always consists of 64 A-scans.
image appears most nearly horizontal on your monitor. Try to minimize this variation by
adjusting the patient module laterally by small amounts. This adjusts where the scan beam
enters the pupil and its angle of incidence on the retina.
Line
Select Line to acquire multiple line scans without returning to the MAIN WINDOW. The
default pattern is a horizontal line (0°) of length 5mm. You can adjust the length, angle
and placement of each scan. This general-purpose protocol enables you to acquire multiple
line scans, each of which you can repeat or tailor individually. You can average same-size
scans in later analysis. You can also use this scan to build a custom protocol.
Cross Hair
The Cross Hair protocol consists of two perpendicular line scans that intersect at their
centers to form a cross. This protocol is useful to examine a particular point of clinical
interest in slices through the centers of the four quadrants. The default line scan is 3 mm
long. You can adjust scan length by adjusting the height (affects vertical line) and width
(affects horizontal line) before saving the first scan. After you save the first scan, you
cannot make further adjustments.
Radial Lines
The Radial Lines protocol consists of a series of 6 to 24 equally spaced line scans through a
common central axis, like spokes on a wheel. It is a general-purpose pattern that is
repeated in several other protocols with variations in size and adjustability of parameters.
This protocol provides maximum adjustability, and you can use it to Define Custom
ScanS (see page 3-16). The default pattern has 6 lines of 6 mm length. You can adjust the
length of all the scan lines by adjusting the aiming circle size, or by adjusting the length of
the first scan in the series. After you save the first scan in the series, you cannot make
further adjustments.
Raster Lines
The Raster Lines protocol consists of a series of 6 to 24 equally spaced parallel line scans
over a rectangular region the size of which you determine. This general-purpose protocol
enables you to examine a rectangular region of interest on the retina more or less
thoroughly, depending on the size of the region and number of lines employed. The default
pattern has 6 lines over a 3 mm square. The scan series proceeds from superior to inferior;
each scan proceeds from nasal to temporal.
• You can adjust the height and width of the aiming box, and the number of lines. The
height of the aiming box affects the spacing between the lines. The width of the
aiming box determines the line scan length. After you save the first scan in the series,
you cannot make further adjustments.
X-Line
• The X-Line protocol consists of two line scans that intersect at their centers to form an
X. This general-purpose protocol is useful to examine a particular point of clinical
interest with two line scans that share a center point. You can average same-size
scans later and use this pattern to build custom scans. The default X pattern consists
Adjusting size of bounding box: of two perpendicular lines of length 3 mm. You can adjust line scan length by
At left: increased height. adjusting the height and width of the imaginary box surrounding the X. Adjusting
either height or width affects the length and angle of both lines equally. After you
save the first scan, you cannot make further adjustments.
Circle
Select the Circle protocol to acquire multiple circle scans without returning to the MAIN
WINDOW. Circle scans are normally applied around the optic disc (peripapillary region) to
measure nerve fiber layer thickness. This general-purpose protocol enables you to acquire
multiple circle scans, each of which you can repeat or tailor individually. You can average
same-size scans in later analysis. You can also use this scan to build a custom protocol. The
default pattern is a circle of radius 1.73 mm. You can adjust the radius of each scan.
glaucoma protocol provides a simple way to acquire scans to which you can apply RNFL
thickness analyses.
RNFL Map
The RNFL Map protocol consists of a set of six concentric circle scans of predetermined
radius. The six scans proceed in order of increasing radius as follows, in mm: from 1.44 to
1.69 to 1.90 to 2.25 to 2.73 to 3.40. This glaucoma protocol is designed to thoroughly
assess retinal nerve fiber layer thickness. The predetermined scan sizes provide optimum
results for the RNFL Thickness Map analysis protocol (see page 6-20).
• You can adjust the radius of each scan circle, although it is not advisable to do so if
you plan to apply the RNFL Thickness Map analysis. When you change the radius or
scan placement, the next scan circle reverts to the predetermined size and central
placement.
Proportional Circle
The Proportional Circle protocol enables you to tailor a circle scan of the peripapillary nerve
fiber layer to account for the variability in size of the optic disc. This general-purpose
protocol allows you to acquire multiple scans without returning to the MAIN WINDOW. You
can average measurements from same-size scans later, and you can build custom scans
with this protocol. The default pattern provides an aiming circle of 1.5 mm radius and a
multiplication factor of 1. For each scan, you can adjust the size of the aiming circle and its
multiplication factor, which together determine the scanning circle size. You can match the
aiming circle size with the optic disc size. Then, through the multiplication factor, you can
employ the scanning circle size you prefer, which you can then repeat for multiple scans.
Concentric 3 Rings
The Concentric 3 Rings protocol consists of three equally spaced concentric circle scans
with radii in the ratio of 1:2:3. Like other circle scan patterns, this protocol is designed for
use around the optic disc to measure nerve fiber layer thickness. You can use it to build
custom scans. The default radii of the three circles are 0.9 mm, 1.81 mm and 2.71 mm. The
scans proceed from smallest to largest. You can adjust the radius for each of the three
circles, which can render the 1:2:3 ratio invalid. Note that when you change the radius of
the first or second circle, the radius of the second or third circle reverts its predefined value
of 1.81 or 2.71 mm.
• Note: Since you can adjust the placement of the second and third scans, it is
possible to render the circles non-concentric.
Optic Disc
• The Optic Disc pattern is a 4 mm version of the radial lines pattern. It consists of a
series of 6 to 24 equally spaced line scans through a common central axis. The
diameter of the aiming circle (and thus line length) is fixed at 4 mm. The number of
lines is adjustable until you save the first scan in the series. It is designed exclusively
to examine the optic disc for indications of glaucoma. The scans you create with it are
for use with the Optic Nerve Head analysis protocol (see page 6-23).
7. In the video window you will see the prior and new fundus images toggle back and
forth automatically. The prior scan will have the word PRIOR in the upper left corner.
You can change the toggle speed in the Video and Lamp dialog. Move the slider in
the Prior Fundus Toggle or select a number. The higher the number, the faster the
images toggle. At the “0” setting the image does not toggle.
Chapter Overview
Carl Zeiss Meditec equips the Stratus OCT with software to assist you with analysis of scan
images. This chapter explains how to analyze scans with the Stratus OCT.
We designed the Stratus OCT software for analysis of the posterior segment of the eye. To
analyze scans using the Stratus OCT software involves the following:
• Initiate An Analysis (below).
• Select a Patient and Select Scan Group(s) (below).
• Select an Analysis Protocol (page 5-3).
• Click Analyze or Scan Selection (page 5-3).
• The optional Selection Window (page 5-4).
• Exclude Scans from Analysis and proceed (page 5-5).
Lastly, this chapter explains how to Print Analysis Output (page 5-6). The Stratus OCT
has 19 analysis protocols to analyze scans you have acquired. Their characteristics and
applications are discussed in Chapter (6).
Initiate An Analysis
You must initiate analysis from the MAIN WINDOW. If not in the MAIN WINDOW, click the
Select Analysis Protocol button to display it, as pictured at left. To initiate an analysis
requires that you:
1. Select a patient.
2. Select a scan group or groups.
3. Select an analysis protocol.
• An optional step is scan selection.
Select a Patient
Click the desired name in the patient list to select it, or type in the Search field above to
search by name or patient ID. You can select one patient at a time. See The Patient List
on page 2-6 for tips on using the list and searching.
• Scan selection is optional, and you can do the same by using the Scan Group
Images Tab, as explained on page 5-2.
If you try to run an incompatible analysis, a message will so inform you.
Selection Window
When you click the Scan Selection button at the bottom of the Analyze Tab, the SELECTION
WINDOW appears.
Video image
Patient Data Exam list Scan comments field Fundus video image adjustment controls
Image Adjustment
Adjustments that you make to the scan image Level and Window, and to the fundus image
Brightness and Contrast affect the images here and on the resulting analysis output
window and printouts. You can make the following adjustments.
• For the scan image, select Color or Grayscale. Use the sliders to adjust Level, Window
and % Zoom. Click the Default button to reset the scan image to the default settings.
• Level sets the reflectivity threshold that is filtered out as background noise, and
apportions the color scale according to the relative reflectivity found in the scan
image. At low levels, the scan image appears all white, at high levels, all black.
• Window sets the portion of the color scale that is applied to the scan image
display. At low settings, the scan image appears black and white, at high settings,
red and yellow.
• Select the Log Abs. Reflectance checkbox to display the scan image color scale,
which indicates the reflectivity of the scan image above the background noise.
• For the fundus image, use the sliders to adjust Brightness and Contrast and % Zoom.
The default settings are zero.
Export JPEG
• Click the Export JPEG button to export the selected scan image.
Note: JPEG compression entails loss of image data. Exported JPEG images are not
intended for diagnostic use, but for use in presentations. Each scan image will be
exported in a separate file, which is named by combining the following, in order:
last name, first name, date of birth, date and time of scan, scan type. This is how
Stratus provides the patient and scan data with the image. Note that, if desired, you
can obscure the patient identifying information by changing the file name before
saving.
Note: When you deselect scans to exclude them from analysis, the Stratus OCT
remembers which scans you have excluded and continues to exclude them from
analysis until you change the scan selection again.
When you have made your selections, click Analyze to proceed with the analysis. If you do
not wish to proceed, click Cancel at any time and return to the MAIN WINDOW.
Note: From applicable analysis output windows, Stratus gives you the ability to edit
the retinal boundary layers automatically provided by the retinal and RNFL thickness
algorithms. For more information, see Edit Layers on page 6-8.
1. Click Options > Register > Clinical Site ID. The Clinical Site ID dialog box appears.
Note: The logo is resized to fit the entire Preview pane. When printed, the logo is
resized to fit in a small square area of fixed size. This can affect the appearance of
the logo on printouts, especially if it is rectangular
Export to DICOM
You can export any report to the DICOM system by following these steps:
1. From any analysis screen, click on the Export to DICOM toolbar button, or click on
Export to DICOM in the Data menu. You will see a dialog showing that the report is
being exported to the DICOM system.
2. When the DICOM export is completed, you will see the following dialog confirming
that the report was sent to the DICOM system:
Note: Before using the Export to DICOM function, make sure that the Clinical Site ID
is configured on the instrument. To do this, click Options > Register > Clinical Site
ID. Enter the clinic name and click Save. If you do not do this step, you will get an
error message when you try to export to DICOM.
Chapter Overview
The Stratus OCT offers analysis protocols, divided between:
• Analyses and Reports (page 6-13).
• Image Processing Protocols (page 6-37).
This chapter describes each analysis protocol and provides general and specific usage tips.
See Chapter (5) Analyze Scans for detailed instructions to perform analyses of scan
images.
Protocol Lists
While you can group the analysis protocols by their diagnostic application, it is important
to understand an alternate grouping based on the distinction between quantitative
analysis protocols and image processing protocols. Quantitative analysis protocols measure
the scan images, while image processing protocols process the raw scan images into a
more useful image.
• All Glaucoma and Retina protocols are quantitative analysis protocols.
• None of the image processing protocols is a Glaucoma or Retina protocol. They are
applicable to any scan group.
Note: You can apply only one analysis protocol at a time. You cannot apply analysis
protocols additively. No analysis changes the original scan image data.
Glaucoma
• Retinal Thickness/Volume (OU)
• Retinal Thickness/Volume Tabular (OU)
• Retinal Thickness/Volume Change (OU)
• RNFL Thickness (Single Eye)
• RNFL Thickness Average (OU)
• RNFL Thickness Map (OU)
• RNFL Thickness Change (OU)
• RNFL Thickness Serial Analysis
• GPA Advanced Serial Analysis (Available only if licensed)
• Optic Nerve Head (Single Eye)
• Multi-Slice Report (Available only if licensed)
Retina
• Retinal Thickness (Single Eye)
• Retinal Map (Single Eye)
• Retinal Thickness/Volume (OU)
• Retinal Thickness/Volume Tabular (OU)
• Retinal Thickness/Volume Change (OU)
• Multi-Slice Report (Available only if licensed)
Image Processing
The Stratus OCT offers seven image processing protocols. They apply mathematical
algorithms to assist you with visual analysis of the scan image. They change the
appearance of the scan image. They do not change the raw scan data. These protocols are
applicable to any scan and fall in neither the Glaucoma group nor the Retina group. You
must select the All radio button to access them.
• Proportional
• Align
• Normalize + Align
• Gaussian Smoothing
• Median Smoothing
• Scan Profile
General Tips
The following general information and usage tips apply to all analysis protocols. Starting
with Retinal Thickness/Volume on page 6-13, this chapter provides a description and
specific usage tips for each protocol.
Table of Correlations
Analysis Protocol Designed for Scan Group(s)
Retinal Thickness Any scan protocol except (Fast) Optic Disc: 1 group on macula
Retinal Map Line, (Fast) Macular Thickness Map: 1 group on macula
Retinal Thickness/Volume Line, (Fast) Macular Thickness Map: 1 OS group and/or 1 OD group on
macula
Retinal Thickness/Volume Line, (Fast) Macular Thickness Map: 1 OS and/or 1 OD group on macula
Tabular
Retinal Thickness/Volume Line, (Fast) Macular Thickness Map: 2 OS and/or 2 OD groups on
Change macula
RNFL Thickness Any scan protocol except (Fast) Optic Disc: 1 group around disc
RNFL Thickness Average Circle, Proportional Circle, (Fast) RNFL Thickness (3.4), RNFL Thickness
(2.27xdisc) or Nerve Head Circle: 1 OS and/or 1 OD of same radius
around disc
RNFL Thickness Map RNFL Map, Concentric 3 Rings: 1 OS and/or 1 OD group around disc
RNFL Thickness Change Circle, Proportional Circle, (Fast) RNFL Thickness (3.4), RNFL Thickness
(2.27xdisc) or Nerve Head Circle: 2 OS and/or 2 OD of same radius
around disc
RNFL Thickness Serial Analysis Circle, Proportional Circle, (Fast) RNFL Thickness (3.4), RNFL Thickness
(2.27xdisc) or Nerve Head Circle: Up to 4 OD and/or 4 OS groups of
same radius around disc.
GPA Advanced Serial Analysis RNFL Thickness (3.4) or Fast RNFL Thickness (3.4): Up to 8 OD and/or 8
OS groups of same radius around disc.
Optic Nerve Head (Fast) Optic Disc: 1 group on disc
Multi-Slice Report Any scan protocol
Scan Messages
The scan messages “Scan too high,” “Scan too low” and “Scan missing data” are
descriptive of what you see on screen. When the scan is too high or too low on the screen,
the analysis algorithm frequently fails. When either message appears, the operator should
repeat the scan, using the Z-Offset arrow buttons to raise or lower the scan image as
necessary. When data is missing, usually from a patient's blink, the scan image is
incomplete and unsuitable for analysis. The operator should repeat the scan, instructing
the patient not to blink during scan acquisition.
Layer On/Off
All the quantitative analysis output screens except the Optic Nerve Head protocol include a
Layer On checkbox, which is selected by default. When selected, the retinal layer
boundaries, detected by the analysis algorithm, appear as white lines in the analyzed scan
image. Click to clear the Layer On checkbox and hide the layer boundaries. For information
about editing the layers, see Edit Layers on page 6-8.
Caliper On
All the quantitative analysis output screens except the Optic Nerve Head protocol include a
Caliper On checkbox. When selected, the analysis output displays a set of cross-shaped
calipers you can click and drag to measure distances directly in the analyzed scan image.
The caliper distance is reported at lower right.
Mirror Image
For line scans, click on the Mirror Image checkbox to view the mirror image of the scan and
associated graphical data. When the scan angle is between 90º (6 o’clock origin) and 270º
(12 o’clock origin), the Mirror Image checkbox is selected by default.
After scan acquisition, the Stratus OCT automatically processes OCT scan images
that appear in subsequent screens, such as analysis output windows. A-scan
alignment is included in this processing. As a result of the alignment process, solid
black areas, which represent no reflectivity signal, may appear near the top and
bottom of the scan image. These are artifacts of the alignment processing algorithm
and are not clinically meaningful.
Note: RNFL and Macula Normative Databases are optional features that may not be
activated on all instruments. If you do not have these features and want to purchase
them, contact Carl Zeiss Meditec. In the U.S., call 1-877-486-7473; outside the U.S.,
contact your local Carl Zeiss affiliate or distributor.
Note: Normative data will not appear for patients under 18 years of age. Normative
data will not appear for patients whose records were imported into the system with
their date of birth obscured.
Disclaimer: Carl Zeiss Meditec does not offer advice or instruction in the
diagnostic interpretation of OCT images. It is the clinician’s responsibility to
make diagnostic interpretations of OCT scans.
to each particular A-scan location in the graph, to the quadrant and clock hour averages in
the circular graphs, and to the OD and OS columns of the data table. Among same-age
individuals in the normal population, the percentiles apply to each particular RNFL
thickness measurement 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).
• 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 RNFL normative
data. For any particular measurement, note that 1 out of 20 normal eyes (5%) will
fall below green.
Edit Layers
Note: Edit Layers is an optional feature that may not be activated on all instruments.
If you do not have this feature and want to purchase it, contact Carl Zeiss Meditec.
In the U.S., call 1-877-486-7473; outside the U.S., contact your local Carl Zeiss
affiliate or distributor.
Version 5.0 and higher of Stratus OCT software includes the ability to edit layers, that is, to
manually adjust the placement of the retinal layer boundaries, between which Stratus
measures the retina and RNFL thickness. The functionality described in this section is
available with all of the Analyses and Reports (see the list on page 6-2), except the
Optic Nerve Head analysis, which has a similar but distinct interactive capability.
Carl Zeiss Meditec designed the edit layer capability to give you direct control over
placement of the retinal layer boundaries, enabling you to substitute your judgment in
place of the automated outcome of the Stratus thickness algorithms. This is especially
useful in cases where the retina has structural anomalies or pathology that may cause the
algorithms to incorrectly trace the actual boundaries.
Note: The line colors mentioned are the default colors. You can Adjust the Edit
Layer Line Colors, as explained on page 6-10 below.
Note: After saving, Stratus treats all scans in a series as a group, with respect to
whether they have been edited or not. Therefore, all layers of all scans in a series
will appear yellow after saving, as if all scans had been edited and saved, even if
only one of the scans in that series has been edited. This does not apply between
series.
The scan orientation marker appears at lower right, along with the number of scans in the
current series just to its left. The Layer History field is empty and grayed out (unavailable)
until you edit and save new layers. If edited layers are already saved, the Layer History
field is empty and white; click in it to select the layers you want to use as the basis for the
edits you are about to make. The Undo button becomes available after you begin editing
layers and remains available until you save the current layer edits.
Figure 6-2 Edit Dialog Line Color Tab of the Preferences Dialog
You can click the Color Picker button for the Default Color (original lines before editing),
the Edit Color (line color while editing), and the Edited Color (line color after saving edits).
Click OK to save your changes and exit the Preferences dialog.
Navigation
Within a scan group (or series) you must click on a thumbnail to select it for editing. If
necessary, use the scroll bar to the right of the thumbnails to access all of the thumbnails
in the series. You can navigate to the previous or next series (scan group) by clicking the
Previous or Next arrow buttons in the Series area near the bottom right. When you reach
the last series for the right eye, clicking Next takes you to the first series for the left eye. To
save time, do not click Save until you have completed edits on all scans in a group.
Edit Layers
Editing layers is done manually in a simple click and drag process. Follow these instructions
to edit layers:
1. Click and drag a layer boundary, 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 over a line, it “pops,” or becomes thicker. As long as you
hold the left mouse button down, the layer boundary line tracks your cursor as you
move it in the screen, and each time you release the mouse button, it lets go of the
line on screen. Then you can click again at any point on either boundary line and drag
the line from that point. The boundary lines you trace will never break. However, they
will not cross each other.
Note: You can also hold down the Alt key, click and drag the cursor (Alt-click)
repeatedly; each click creates an anchor at the clicked point, from which the cursor
will trace a straight line until you click again. This method enables you to trace the
desired boundary in straight line segments. It can be used freely in combination
with the regular click and drag method.
2. At any time desired, click Undo to undo the last editing step you completed. You can
click it repeatedly to undo each step in succession.
3. When satisfied with your edits, click Save. Stratus assigns a unique identifier to the
saved layer edits composed of the current date, time, instrument serial number and
software version. This identifier will appear in the Layer History field.
Note: To save time, do not click Save until you have completed edits on all scans in a
group.
4. Click Discard or the at upper right to close the Layer Edit Dialog. You will return
the analysis window from which you began.
or
The example below displays edited layers and highlights the message.
1. Click either of these links and a selection dialog called Edit History Data for the
Selected Exams will appear, as below.
Figure 6-4 Edit History Data for the Selected Exams Dialog
The dialog displays one row for each scan series (scan group) in the current analysis.
You can change the layer edits used for the analysis for each series independently.
2. To do so, click in the Layer History column at right on the row corresponding to the
series you want to change.
That item will change to a drop-list from which you can view and select the saved
layer edits by clicking on the down-arrow at the right edge of the field, for example:
• Click Cancel to discard your selection of saved layer edits without applying them.
A dialog will prompt you to confirm your choice.
General Information
Methods to Measure Retinal and RNFL Thickness
The Stratus OCT calculates retinal thickness as the distance between the vitreoretinal
interface (VRI) and the junction between the inner and outer segment of the
photoreceptors, which is just above the retinal pigment epithelium (RPE). It calculates
RNFL thickness as the distance between the VRI and the RNFL posterior boundary. The
retinal and RNFL thickness algorithms use an iterative process, applying various techniques
in a fixed and logical progression, first to obtain rough estimates of the layer boundaries,
and then to refine the estimates. The algorithm calculations operate on reflectivity values
(in decibels) in the individual A-scans. These algorithms take advantage of the Stratus
OCT’s high resolution, resulting in a highly refined objective measurement of retinal or
RNFL thickness. The processed scan image shows the boundaries in white.
Retinal Thickness/Volume
Application: Select Retinal Thickness/Volume to obtain for each eye two circular maps
centered on the macula that depict retinal thickness and volume. This analysis protocol
operates on one OD and/or one OS scan group made with the Line or (FAST) Macular
Thickness Map protocols.
Output Display
Output Display
The output display includes all the elements of the Retinal Thickness/Volume analysis
(see above), with a different arrangement to accommodate the table.
Output Display
• A key of the map circle diameters appears at upper right. The default diameters are 1,
3 and 6 mm. Click the 3.45 mm radio button above to change to diameters of 1, 2.22
and 3.45 mm.
RNFL Thickness
Application: Select RNFL Thickness to obtain graphs of retinal nerve fiber layer thickness
along circle scans made around the optic disc (peripapillary region). You can apply this
protocol to one scan group of any scan protocol at a time, except (Fast) Optic Disc.
While it functions with line scans, the output includes circle characteristics like quadrant
and clock hour averages, which are not meaningful for line scans. Anomalous results occur
for scans passing through, rather than around, the optic disc.
Output Display
• On the right appear circular diagrams showing quadrant and clock-hour RNFL
thickness averages. Overall RNFL Average thickness appears at lower right.
• Click the Caliper ON checkbox to measure distances between the cross-shaped
calipers that appear. Caliper Length appears at lower right.
Export Results
The Export button enables you to export the results of the RNFL Thickness analysis. This
feature enables you to further analyze and manipulate the data using third party software.
When you click Export, the Export As dialog appears as below:
Output Display
Note: Clinicians must exercise judgment in the interpretation of the RNFL normative
data. For any particular measurement, note that 1 out of 20 normal eyes (5%) will
fall below green.
Output Display
Output Display
Output Display
Output Display
• You can click and drag the Zoom In and Zoom Out sliders, click on and Clear Points on
the composite image.
• Composite Image Measurements:
• Disc Area: The area bounded by the red outline of the disc in the composite
image.
• Rim Area: Disc area minus cup area.
• Rim Cross Sectional Area: This is an estimate of the total rim area calculated
by multiplying the average of the individual scan widths across the nerve head
times the circumference of the disc.
• Rim Volume: This is an estimate of the total volume of RNFL tissue in the rim
calculated by multiplying the average of the individual rim areas times the
circumference of the disc.
• Cup Area: The area bounded by the green outline of the cup in the composite
image.
• Cup Volume: This is an estimate of the total volume, represented by the blue
shading of the cup as if it were filled with water to its surface.
• Cup/Disc Horizontal Ratio: Ratio of the longest horizontal line across the cup
to the longest horizontal line across the disc.
• Cup/Disc Vertical Ratio: Ratio of the longest vertical line across the cup to the
longest vertical line across the disc.
• Cup/Disc Area Ratio: Ratio of cup area to disc area.
• Save Current Result/Select a Saved Result: Click the Save Current Result button on the
lower right to save the current Optic Nerve Head analysis results. This is useful if you
adjust the placement of the disc reference points for one or more scan lines, and wish
to be able to recall the resulting measurements and images. This feature enables you
to save and recall several variations of the ONH analysis, depending on the
combination of adjustments you make to disc reference points of the individual scan
lines. By default, the ONH analysis reanalyzes the scan data and displays the original
result each time you run it. Use the Select a saved Result drop-down list to select a
result you have saved previously.
Note: GPA Advanced Serial Analysis is an optional feature that may not be activated
on all instruments. If you do not have this feature and want to purchase it, contact
Carl Zeiss Meditec. In the U.S., call 1-877-486-7473; outside the U.S., contact your
local Carl Zeiss affiliate or distributor.
The GPA Advanced Serial Analysis protocol is an advanced version of RNFL Thickness Serial
Analysis designed to assist you in managing glaucoma by helping you determine whether
the rate of RNFL loss is statistically significant. When the analysis includes compatible
exam data from four or more visits (per eye), the analysis output includes a linear
regression analysis and reports whether or not any observed RNFL loss over the included
visits is statistically significant with 95% or higher confidence. The analysis can be applied
to one or both eyes and can include up to 8 exams (from 8 visits) for each eye—up to 16
total exams per analysis. If you select two scans taken on the same day, Stratus
automatically selects the best scan from that day (in terms of scan quality factors).
Notes on Using GPA in Clinical Practice
Stratus OCT GPA Advanced Serial Analysis does not evaluate “progression of
glaucoma,” which can only be assessed through evaluating changes in several clinical
factors including optic nerve head appearance and visual fields. GPA only refers to
change in the nerve fiber layer thickness as assessed by statistical analysis. Such change
or progression of RNFL thickness may or may not be clinically relevant.
GPA is not meant to diagnose. Diagnosis is the responsibility of the practitioner, who
should base diagnosis upon many parameters, many or most of which are not assessed
by Stratus.
GPA Advanced Serial Analysis provides a statistical analysis (linear regression) of RNFL
thickness average versus age. Linear regression fits test data to a linear model,
assuming that the measurements are independent, normally distributed, and that
variability does not depend on the size of the measurement. Rates of change estimated
by linear progression may provide useful information, even in cases where change has
not been completely linear. Projections based upon linear regression analysis should be
used to alert the practitioner to what might happen in the future assuming linearity, but
not to predict future change. In any case, linear regression is a statistical analysis, and
cannot replace clinical evaluation of the patient’s status and progress.
RNFL thickness is expected to decrease slowly as a function of normal aging. Literature1
shows an age-related loss as low as 0 μm per year to as high as 0.31 μm per year. All of
these results are based on cross-sectional data. An individual patient’s normal aging
rate may vary.
Because the exact rate of change for any individual is unknown, Stratus reports
statistical significance if the 95% confidence limits on the slope exclude zero, rather
than determining if they exclude normal age-related loss. If Stratus reports that a rate of
change is statistically significant, but the 95% confidence limits include a rate
consistent with normal aging, the observed change may be due to normal aging.
1. Ramakrishnan R, Mittal S, Sonal A, et al. Retinal nerve fibre layer thickness measurements in normal Indian
population by optical coherence tomography. Indian J Ophthalmol. 2006;54:11–15.
Sony P, Sihota R, Tewari Hem K, et al. Quantification of the retinal nerve fibre layer thickness in normal Indian
Eyes with optical coherence tomography. Indian J Ophthalmol. 2004;52:303–309.
Hougaard JL, Ostenfeld C, Heijl A, et al. Modeling the normal retinal nerve fiber layer thickness as measured
by Stratus optical coherence tomography. Graefes Arch Clin Exp Ophthalmol. 2006.
Budenz DL, Anderson DR, Varma R, et al. Determinants of normal retinal nerve fiber layer thickness by Stratus
OCT. Ophthalmology. 2007;114:1046–1052.
Parikh RS, Parikh SR, Sekhar GC, et al. Normal age-related decay of retinal nerve fiber layer thickness. Ophthal-
mology. 2007;114:921–926.
Ronald S. Harwerth Age-Related Losses of Retinal Ganglion Cells and Axons. Investigative Ophthalmology &
Visual Science, October 2008, Vol. 49, No. 10.
Output Display
Trend Line
The line on the plot represents a linear regression to determine if there is a statistically
significant rate of RNFL loss. Linear regression is a common method for determining if a set
of data that is subject to normal variability is consistent with a linear trend. If the trend is
decreasing, the patient may be losing nerve fiber layer.
WARNING: The trend line and regression result represent a statistical analysis.
The clinician should review all scans and all other clinical information, and use
his or her own judgment to determine if clinically relevant change is occurring
in the patient.
• Rate of change (slope): The reported rate of change is the best unbiased estimate of
the slope, or rate of change, based on the given points. Stratus reports the rate of
change in units of micrometers per year (μ/yr).
• Confidence range: Stratus also reports the range of slopes that are consistent with the
data with 95% confidence. The true slope may be larger or smaller than the best
estimate that Stratus reports, but there is 95% confidence that the slope is inside the
region given by the slope +/- the confidence range. For example, if the regression
result reported by Stratus is:
Rate of change: -4.5 micrometers/year +/- 3 µ/year
then there is 95% confidence that the rate of change of average RNFL thickness is
between -7.5 micrometers per year and -1.5 micrometers per year.
• Statement of significance: When the confidence bounds include zero, the regression
result text reports that the rate of change is Statistically not significant,
because there is not 95% confidence that the slope is decreasing. Stratus also reports
Statistically not significant when the best unbiased estimate of the slope is
positive, because increasing RNFL thickness is not consistent with glaucomatous
damage.
When the slope is negative and the 95% confidence range does not include zero,
then there is 95% confidence that a decreasing trend of RNFL thickness exists. Stratus
will then report that the rate of change is Statistically significant with P < 5%,
because there is less than a 5% probability that the negative slope occurred by
chance.
Stratus will also calculate the 99% and 99.9% confidence ranges. If the 99% confi-
dence range does not include zero, and the slope is negative, then the significance
statement regarding the rate of change will be Statistically significant with P <
1%. If the 99.9% confidence range does not include zero, and the slope is negative,
then the significance statement will be Statistically significant with P < 0.1%.
Retinal Thickness
Application: Select Retinal Thickness to obtain graphs of retinal thickness for any scan.
Retinal Thickness analyzes one scan group of any scan protocol at a time, except (Fast)
Optic Disc. Normative data will appear in the output if you analyze a Fast Macular
Thickness Map (Fast Mac) scan, as described in Macula Normative Database on
page 6-7.
Output Display
• 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 below normal limits (red < 1%, below normal limits).
Export Results
The Export button enables you to export the results of the Retinal Thickness analysis. This
feature enables you to further analyze and manipulate the data using third party software.
When you click Export, the Export As dialog appears as below:
Retinal Map
Application: Select Retinal Map to obtain two maps of retinal thickness in a circular area
centered on the macula. One map shows retinal thickness using a color code, and the
other shows average retinal thickness (in micrometers) in nine map sectors. This analysis
protocol operates on one Line or (FAST) Macular Thickness Map scan group at a time.
These scan protocols consist of a group of 6 to 24 line scans arranged in a spoke pattern.
The algorithm computes retinal thickness separately for each line scan, and combines the
results to construct the circular maps. Normative data will appear in the output if you
analyze a Fast Macular Thickness Map (Fast Mac) scan, as described in Macula
Normative Database on page 6-7.
Output Display
• Below the right map a pair of radio buttons appear, to adjust the diameter of the
maps displayed. The default map circle diameters are 1, 3 and 6 mm. Click the 3.45
mm radio button to change to circle diameters of 1, 2.22 and 3.45 mm.
• On the lower right, numeric information includes Center, which represents the
calculation of average thickness (in micrometers) +/- the standard deviation for the
center point, where all six scans intersect; and Total Volume of the retinal map area
in mm3.
When applied to a Fast Macular Thickness Map (Fast Mac) scan, the normative
data color code applies to the circular map on the right. The right map shows average
retinal thickness for each map sector, in micrometers, and applies the normal distribution
percentile colors to those sector averages. The normal distribution percentile legend
appears below the right map.
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%, above normal limits).
• 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 below normal limits (red < 1%, below normal limits).
Multi-Slice Report
Application: Select Multi-slice Report to create a report comparing:
• all slices from a given scan on the same day (example: six scans from Fast Macular
Thickness Map), or
• slices from two different time periods, or
• any combination of slices from up to two time periods.
Note: Multi-Slice Report is an optional feature that may not be activated on all
instruments. If you do not have this feature and want to purchase it, contact Carl
Zeiss Meditec. In the U.S., call 1-877-486-7473; outside the U.S., contact your local
Carl Zeiss affiliate or distributor.
Output Display
To generate a report:
1. Select a patient and highlight the exams that you want to include in your report, You
can select up to two time periods.
3. Thumbnails of the scans appear along the left side of the screen, with checked boxes
indicating they are selected. Un-check the box to the right of each scan you do not
want to include in your report.
4. Near the bottom of the window, click the Multi-Slice Report button.
5. A PDF report is created and will open automatically.
Format of Display
Six of seven image processing protocols share a common format of display, as seen below.
The exception is the Scan Profile protocol.
Proportional
Select Proportional to obtain a processed scan image that is true in its horizontal and
vertical proportions. Compared to the usual presentation of Stratus OCT scan images, the
proportional scan image appears compressed vertically. This is because Stratus OCT scan
images are usually presented in a fixed size that elongates the image vertically, in order to
allow the viewer to perceive more detail throughout the longitudinal plane of the retina.
Since scans are of varying length, the proportional scan image may appear either
horizontally elongated or compressed in comparison to the usual presentation, depending
on the actual scan length.
Normalize
Select Normalize to eliminate background noise and to use the whole color scale in the
processed scan image. This function normalizes scan images with respect to noise and
signal strength. In other words, when you apply this function to scan images made with
different noise or signal strength, the resulting images appear equally “bright,” i.e., have
the same range of color.
The scan image false color scale operates in a signal value range of 0—255. Normalize
displays as zero (black) data points with values less than or equal to the average noise
level. It displays as 255 (saturated or white) data points with values greater than or equal
to the maximum signal value minus a fixed constant. It adjusts intervening signal values to
maintain their relative position in the new range. The resulting scan image uses the entire
color scale to express the relative reflectivity of the retinal structures between the noise and
saturation signal levels.
Align
Select Align to correct the data for effects due to patient motion in the axial direction.
Slight movements of the head toward and away from the instrument cause the scan image
to shift vertically, resulting in low-frequency “wiggles.” (This also happens if the scan beam
is not perpendicular to the retina over the whole scan—see Aligning Large Scan
Patterns on page 4-5.) To correct for this movement, this algorithm compares each of the
longitudinal samples (A-scans) in the data set with its neighbor in a process called
correlation. In effect, it slides A-scan 2 in relation to A-scan 1 until the data align. Then it
slides A-scan 3 in relation to the now-aligned A-scan 2, and so on until all A-scans are
aligned.
Note: The Align function may introduce artifacts in the scan image, since it cannot
distinguish true retinal height changes from apparent changes due to patient
motion. Furthermore, the process does not work equally well on all types of images.
The operator must use judgment in interpreting the results.
Normalize + Align
Select Normalize + Align to perform both the above functions.
Smoothing
The two smoothing functions average out noise and blend the colors of the scan image.
Smoothing may be useful to appreciate more fully the large-scale features in the data. The
drawback, of course, is that some small details may be lost.
Gaussian Smoothing works by calculating a moving average of signal values in a 3 × 3
region. It weights the signal values according to a Gaussian function, such that the outer
points in the region are weighted less than the center point.
Median Smoothing is similar to Gaussian smoothing, except that it uses the median value
of the 3 × 3 region (i.e., the middle value when ordered by size) instead of the moving
Scan Profile
Select Scan Profile to display an interactive profile of all signal values for any single scan
group, as pictured below.
Each A-scan consists of 1024 data points on the longitudinal axis (from 1 to 1024 anterior
to posterior) over 2 mm of depth. There are two vertical cursors. You can drag the red
cursor 1 or green cursor 2 along the 1024 data points. At lower right, the signal value at
the indicated data point appears in decibels. For example, the green “Cursor 2 Value is
31.3 dB at [data point] 10.” At bottom right, “Difference is” and “Distance is” give,
respectively, the signal value difference and distance between the red and green cursors.
The blue horizontal cursor has a particular purpose described next.
Chapter Overview
This chapter explains how to perform data management functions. The topics covered in
the current chapter include:
• Find and Select Records, page 7-1
• Print Patient Data, page 7-2
• Print Clinical Notes, page 7-2
• Add a New Patient, page 7-2
• Edit Patient Records, page 7-4
• Merge Patients, page 7-4
• Create and Edit Visit Records, page 7-6
• Edit Exam Record Notes, page 7-7
• Edit Clinical Notes, page 7-8
• Categorize Patient Records, page 7-8
• Create and Assign Patient Diagnoses, page 7-11
• Register, Edit and Assign Medical Staff, page 7-14
• Register, Edit and Assign Insurance Companies, page 7-15
• Delete Patient, Visit and Exam Records, page 7-17
• Site ID and Logo, page 7-19
• Defragment Database, page 7-20
This manual treats data transfer functions in separate chapters:
• Archive, Retrieve & Backup, Chapter (8).
• Export and Import Scan Data, Chapter (9).
Note: If you are using DICOM Archive we recommend that you perform all patient
data management (merge, edit, delete patients) in FORUM, not on the Stratus OCT
instrument. When you retrieve data from forum the data on your instrument will be
automatically updated. The data is not updated if you archive to FORUM from your
instrument. Please read the instructions that accompany the FORUM application.
Advanced Search
Stratus OCT provides an Advanced Search dialog to search for patient records using
additional parameters such as patient category, diagnosis, scan type, insurance company,
doctor, clinical trial ID or subject reading ID, etc. You can access Advanced Search from the
Toolbar.
Using the available fields, enter or select search parameters and click Search. Search
parameters you type in are not case-sensitive. The search returns all matching patients in
the patient list where you started.
Note: The search returns only the patients that match all search parameters used. If
your search does not return all patients desired, you may want to broaden your
search by using fewer parameters or partial information. Clicking Search without
using any parameters returns all patients in the source database.
Note: Comments printed as part of the patient data printout are taken from the
Comment Tab of the PATIENT RECORD WINDOW. These comments do not include scan
comments. Scan comments are a type of clinical notes, and are printed either as part
of the clinical notes printout, or as part of the analysis output (see Print Analysis
Output on page 5-6).
Merge Patients
In Stratus OCT, every patient record has an identifier that consists of the Name (Last, First,
Middle), Date of Birth, Gender 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, you can merge patient records using the Merge Patients function. To
merge records.
1. In the Patient Menu, select Merge Patients. The Merge Patient dialog appears.
WARNING: Be certain that you select the correct patient records to merge.
Once you merge patient records, there is no way to separate the combined
records of erroneously merged patients, although it is possible to Delete
Exam Records that do not properly belong to a patient record (see page
7-17).
Note: Stratus OCT will not permit you to merge patient records with identical visit
dates because it assumes that patients can visit only once per day. You cannot edit
visit dates in Stratus OCT.
• Or: Select Visit History from the Patient menu (click Patient > Visit History). The
VISIT HISTORY WINDOW appears listing all visits for that patient. To edit one, select it
and click the Edit Current Visit Record button.
3. In either case, you eventually reach the VISIT RECORD WINDOW (Figure 7-5). If
necessary to activate the fields for editing, click the Edit Current Record button.
4. Add or edit the Visit Notes. You cannot edit the visit date.
5. After making the desired changes, click the Save Record button.
• To discard the changes before saving, click the Undo Changes button. You must
confirm your choice in the CONFIRM dialog box.
Note: If you search for records using a clinical trial category, and no regular Patient
ID has been created for a patient in that clinical trial category, then the ID displayed
in the ID column for such patients will be either the Clinical Trial Subject ID or the
Subject Reading ID, depending on which one has been required.
5. When you have entered the desired information, click the Save Patient Record
Category button. You can repeat steps 2 through 5 to create additional categories.
• If before saving you decide not to create a new category, click the Undo Changes
button or just close the window. You must confirm your choice in the CONFIRM
dialog box.
Edit
To edit a category, click the category you wish to edit and then click the Edit Selected
Patient Record Category button. Edit the desired fields and click the Save Patient Record
Category button.
Note: If you edit a category that you have already assigned to one or more patients,
the edited category name is still attached to those patients. Therefore, you can find
those patients by searching for the edited category name.
Delete
To delete a category and remove references to it in all records, click the category you wish
to delete and then click the Delete Selected Patient Record Category button. You must
confirm your choice in the CONFIRM dialog box.
2. At the top in the Select Operation area, select the Add Patients to Selected
Categories radio button.
3. In the Select Patients area, select the patient or patients to whom you will apply
categories. You can either click the checkbox next to the name, or you can select all
patients at once by clicking the Select All checkbox above the list. Click a selected
patient checkbox to clear it, or click Clear All at lower right to clear all the patient
checkboxes and start over.
• When you select a single patient, the Assigned Categories area appears at
lower right, and displays the categories to which that patient already belongs, if
any.
4. In the Select Categories area on the right, select one or more categories to apply
to the selected patients.
5. When you finish making your selections, click Apply. The selected categories are
applied to the selected patients. The window does not close, allowing to make more
category assignments.
6. When finished adjusting category assignments, click Close to exit the window.
Note: When this radio button is selected, all categories appear in the list, not just
those to which the selected records belong.
or • To create a new diagnosis, click the Create New Diagnosis Forms button.
• To edit a diagnosis, click on the diagnosis you wish to edit and click the Edit
Selected Diagnosis Forms button.
3. In either case, this activates the fields for editing. Edit the Diagnosis Code and
Diagnosis Description fields as desired. Only the bolded Diagnosis Code is
required; the Diagnosis Description is optional. Then click the Save Diagnosis
Form button.
• To discard the changes before saving, click the Undo Changes button. You must
confirm your choice in the CONFIRM dialog box.
Note: If you edit a diagnosis that you have already assigned to one or more patients,
the edited diagnosis name is still attached to those patients. Therefore, you can find
those patients by searching for the edited diagnosis name.
Note: Imported diagnosis codes do not retain the descriptions created for them on
the exporting instrument. For example, exporting instrument A has the description
“Retina” for diagnosis code 001, but importing instrument B has the description
“Glaucoma” for diagnosis code 001. When you view on instrument B a patient
record imported from instrument A with diagnosis code 001 assigned, the
4. Click the OK button to accept the diagnosis changes and close the window, or click
the Apply button to apply the changes without closing the window. Click the Cancel
button to discard the changes and close the window.
Note: Medical staff names are not case-sensitive. For example, “Richards” and
“richards” would be treated as the same name in a search.
or • To create a new staff record, click the Create New Staff Record button.
• To edit a staff record, select it from the Available Staff Records list, and then
click the Edit Selected Staff Record button.
3. In either case, this activates the fields for editing. Edit the staff record fields as desired
and then click the Save Staff Record button. Only the bolded Last Name and First
Name fields are required; other fields are optional.
• To discard the changes before saving, click the Undo Changes button. You must
confirm your choice in the CONFIRM dialog box.
To delete a staff record and remove references to it in all records, select it from the
Available Staff Records list, and then click the Delete Selected Staff Record button. You
must confirm your choice in the CONFIRM dialog box.
Note: Insurance company names are case-sensitive, which affects their uniqueness
in searching for them. For example, “Prudential” and “prudential” would be treated
as different names.
Note: An exam record is a single item, named by scan type, under OD Scan Group
or OS Scan Group in the central list in the MAIN WINDOW. An exam record is the
same as a scan group, although an exam may consist of only one scan. The terms
“exam,” “exam record” and “scan group” are used interchangeably.
You can delete one exam record at a time by opening the EXAM RECORD WINDOW, or you can
delete one or more exam records (scan groups) at once using the Delete Scan Group(s)
option in the Patient menu.
Recommended Method
The simpler and therefore recommended method to delete one or more scan groups is to
use the Delete Scan Group(s) option in the Patient menu. Follow these steps:
1. Select any number of exam records from any visit for the current patient. Hold the Ctrl
key and click (Ctrl-click) to select multiple exams.
2. Select Delete Scan Group(s) from the Patient menu (click Patient > Delete Scan
Group(s) to delete the selected exams. You must confirm your choice in the dialog box
that appears.
Note: If you delete all the exam records for a visit using this method, the visit record
also is deleted automatically. The visit record is not deleted automatically if you use
the following method to delete all exams for a visit.
Optional Method
You can delete exam records one at a time using this method, and if you delete all exams
from a visit, the visit will not be deleted automatically.
1. In the MAIN WINDOW, select the exam record you wish to delete.
2. Select Exam from the Patient menu (click Patient > Exam) to open the EXAM RECORD
WINDOW.
3. In the EXAM RECORD WINDOW, click the Delete Current Record button. You must confirm
your choice in the CONFIRM dialog box.
In the MAIN WINDOW, you can verify that the deleted exam no longer appears in the list for
that visit.
Note: If you use the Delete Scan Group(s) option in the Patient menu to delete all
scan groups for a visit, the visit record also is deleted automatically.
You can delete one or more visit records at once. However, you cannot delete a visit record
unless you have first deleted all exam records for that visit. (See Delete Exam Records
on page 7-17.) To delete visits from the patient record, follow these steps:
1. In the MAIN WINDOW, select the visit record (date) you wish to delete. It must first have
no exam records in it or you cannot delete it.
2. Select Visit or Visit History from the Patient menu (click Patient > Visit or Patient >
Visit History) to open the VISIT RECORD WINDOW or the VISIT HISTORY WINDOW.
• If you plan to delete multiple visit records, click Patient > Visit History to open the
VISIT HISTORY WINDOW. All visit records appear there. You can select for deletion at
the same time every visit record that has no exam records in it: click on one,
Ctrl-click on multiple visits, Shift-click on two visits and all intervening visits are
selected, or click and drag to select multiple adjacent visits.
3. In either the VISIT RECORD WINDOW or the VISIT HISTORY WINDOW, click the Delete
Current Record button. You must confirm your choice in the CONFIRM dialog box.
Note: If a selected visit contains exam records, the Delete Current Record button
will not be active and you cannot delete the visit until you delete its exams.
If you are deleting visits one at a time, repeat the steps for each visit record you wish to
delete. In the MAIN WINDOW, you can verify that the deleted visits no longer appear in the
list for that patient.
Note: You must create a Clinical Site ID to successfully export images and data,
because exported data must be associated with the source clinic.
You can create a clinical site ID and designate a graphic logo. The logo graphic must be in
bitmap format and have a “.bmp” extension. You must copy the logo graphic file from the
source system either to compatible removable media or directly to the Stratus OCT hard
drive (for networked systems). For removable media, insert the media into its drive on the
Stratus OCT and follow these steps:
1. In the Stratus OCT MAIN WINDOW, select Register > Clinical Site ID from the Options
menu (click Options > Register > Clinical Site ID). The Clinical Site ID dialog box
appears.
Note: The logo is resized to fit the entire Preview pane. When printed, the logo is
resized to fit in a small square area of fixed size. This can affect the appearance of
the logo on printouts, especially if it is rectangular
Defragment Database
To maintain or restore peak performance of the Stratus OCT database, we recommend that
you defragment the database after each 1,000 patients, or when you notice that the
patient list is loading more slowly.
Note: Depending on the database size, defragmentation may take several minutes.
To defragment the database:
1. In the Stratus OCT MAIN WINDOW, click Options > Defragment Database. The
DEFRAGMENT DATABASE WINDOW appears.
Chapter Overview
The Stratus OCT offers several functions that together enable you to preserve your valuable
patient data and maintain database performance. Archive and backup are the core
functions required to preserve and recover your data in case of computer malfunction.
These functions can be set to occur automatically, and you can also archive manually.
Advisory: If you do not follow the instructions in this chapter, paper records
are the only way to confidently retain patient information.
1 2
Scan Data Index Database
• Scan data
reference locations
Scan data includes the OCT images generated during an examination, along with the
associated patient, visit and exam data.
The index database identifies each saved scan—by patient, visit, scan acquisition protocol
and location where the scan images are saved.
1 2
Archive Backup
WARNING: We recommend that you do not clear scan data unless it has been
archived. If you attempt to clear un-archived scan data, the Stratus OCT will
prompt you to confirm your choice before permanently deleting the scan
data.
WARNING: It is the user’s responsibility to protect their exam data from loss.
New scans acquired since your last archive, and changes to the scan index
database since your last backup are subject to permanent loss in case of
computer malfunction. We recommend that you automate data
maintenance, as described in this section.
Note: The Stratus OCT hard drive can hold several thousand scans before it will
prompt you to clear scan data. Scan data clearance is for long-term database
maintenance.
To preserve it and ensure fast access to it, the Stratus OCT tries to retain exam data, and
clears only enough exams to forestall the reappearance of the yellow or red indicator for
several days or weeks, depending on the acquisition rate of new exams. Exams are cleared
by last modification date, oldest first. For detailed information, see Clear Archived
Exams on page 8-14.
is a process called synchronization. (See Access Archived Scans on page 8-5 for
instructions to do this.) First you must register the network archive(s) of the other
instruments. To do so follow these steps:
1. From the MAIN WINDOW, select Options > Register > Archive. The Archive Registration
dialog appears.
2. In the Archive Registration dialog, click Add Existing. The Select an Archive Database
dialog appears. Only folders and archive volumes (always named ZDBArchive.GDB)
will appear in the dialog. Find and select the desired archive volume. Click OK.
3. Back in the Archive Registration dialog, the newly selected network archive will
appear in the list of registered archives.
4. Click Save to save the change and close the dialog. You can now access scan data
from the network archive folder you registered, when you synchronize as described
below.
• We recommend you keep your DVD archives in a cabinet. Do not expose them to
bright light or sunlight for extended periods.
• To protect them from spills and other office accidents, do not leave them out on desks
for extended periods.
• Do not stack DVD-RAM disks on top of each other, nor place anything else on top of
a DVD-RAM, especially cups containing liquids.
WARNING: Formatting erases any data currently on the disk. Be sure that the
disk is empty before formatting. Formatting a disk that contains archive or
backup data will permanently destroy that data!
Figure 8-7 Format the DVD using the UDF 1.5 File System
• Click OK to close the dialog and proceed with formatting. The DVDForm dialog
appears.
5. Click on the down-arrow next to the Format Type field and select Universal Disk
Format (UDF1.5).
Overview
Features include: Archive to DICOM server and Retrieve from DICOM server. DICOM
Archive and Retrieve is only available with the DICOM2 Integration license. Native archive
is not available when DICOM2 is designated for use with Archive and Retrieve.
begin the process. Confirm archive process by Clicking Yes on the popup dialog, as shown
below.
Note: If you do not establish an exam date interval to archive, DICOM Archive will
attempt to archive every exam it can find on the instrument which has not been
archived.
1. Click on DICOM Retrieve in the Data pull down menu on the MAIN WINDOW, as
shown at left. The QUERY RETRIEVE FORM dialog is displayed, similar to the one shown
below.
Worklist
query
parameters
Patient list
3. If you want to view details of a particular patient, click on the desired patient, and
then click on the Details button. The PATIENT DETAILS screen is displayed:
Note: Modality for the Stratus OCT instrument is OPT. Other modality options are
provided for searching purposes only. A patient with a modality other than OPT will
not be retrieved on a Status OCT instrument.
Note: If you encounter connectivity issues, follow the instructions on the dialog
message and/or ensure that your DICOM Gateway is currently running and is
properly configured. See the DICOM Gateway 2 User Manual for further information.
Note: The Stratus OCT instrument and review software require the DVD drive be set
to drive letter D: in order to retrieve data from version 2.0 and 3.0 archives. Ensure
the DVD drive letter is set to D: before retrieving data from version 2.0 and 3.0
archives. (This is the instrument default when shipped from the factory.)
How To Retrieve
To retrieve scan data, follow these steps.
1. Make sure that the archive volume is accessible. If it is a DVD archive, insert the DVD
into its drive on the Stratus OCT. If it is a network archive, it must be registered, and
the Stratus OCT must have access to the network file server.
2. From the MAIN WINDOW, select Retrieve from the Data menu (click Data > Retrieve).
The RETRIEVE WINDOW opens, showing the archive contents in the path from which you
last retrieved. (The first time you retrieve, it shows the archive contents of any inserted
DVD, by default). If the window is accessing the desired source archive, skip to step
5.
3. To select a different source archive, click the Select Source Archive button, or click
File > Select Source Archive. The Archive Selection dialog appears.
7. The Retrieve Options dialog gives you the option to remove references to the source
archive media, which will enable you to re-archive the exams to a new or different
archive volume. To enable re-archiving, select the Remove reference to the archive
media checkbox. When you retrieve with this option selected, the Stratus OCT will no
longer recognize that the exam data is on the source archive, although a copy of the
data remains. Instead, the Stratus OCT will treat the retrieved exams as un-archived.
Click OK to begin retrieval, or click Cancel to cancel retrieval.
8. When you click OK, retrieval begins and a Progress dialog appears.
WARNING: We recommend that you do not clear scan data unless it has been
archived. If you attempt to clear un-archived scan data, the Stratus OCT will
prompt you twice to confirm your choice before permanently deleting the
scan data.
The Stratus OCT retains patient records on the hard drive to preserve exam data and ensure
fast access to it. Therefore, you can clear hard disk space only when the database indicator
is yellow or red. If you attempt to clear disk space when the database indicator is green,
you will receive the following message:
Note: The exam clearance function, whether automatic or manual, has the same
characteristics:
• The Stratus OCT clears only enough exams to forestall the reappearance of the yellow
or red indicator for several weeks or months, depending on the acquisition rate of
new exams.
• It does not clear exams that have not been archived, nor does it clear exams of
patients for whom you have not allowed clearance of their exams. (For more
information, see Allow Clear Exams on page 7-3.)
• Among those allowed to be cleared, archived exams are cleared oldest first, based on
the last modification date. The modification date for an exam is changed when you
change which scans are selected for inclusion in an analysis and run the analysis.
When the database indicator is yellow or red, perform the following steps to clear disk
space.
1. From the MAIN WINDOW, select Clear Archived Exams from the Options menu (click
Options > Clear Archived Exams). A dialog informs you of the details and asks you to
confirm that you wish to clear archived exams.
Chapter Overview
The Stratus OCT offers the capability of exporting data for viewing and analysis on another
Stratus OCT instrument. This chapter explains how to export and import Stratus OCT data,
but first it details the technical measures employed to ensure patient privacy and data
integrity. These are the topics covered:
• Privacy and Data Integrity Features, page 9-1
• OCT Image Export, page 9-2
• Database Export, page 9-6
• Import Data, page 9-10
Patient Privacy
The Stratus OCT gives you the choice to export exam data without information that could
identify the patient. When you choose to export data in this way, the Stratus OCT does
export the following clinically relevant patient data: gender, ethnic group, axial length,
assigned patient categories and diagnoses and physician comments. You have the further
option to export a complete date of birth, the month and year of birth only, or no date of
birth. The patient name is not exported and neither is the following potentially identifying
information: patient ID, insurance company name, telephone numbers and attending and
referring physician. Instead, anonymous patient records include a unique Patient Export
ID and the originating clinic’s Site ID.
Note: When you import patient records that were exported without identifying
information, the Stratus OCT displays those patients with the originating clinic Site
ID as the last name and the Patient Export ID as the first name. Users who wish to
obtain additional medical information about an anonymous patient must contact
the originating clinic to request information using the Patient Export ID. The
originating clinic can then search for the patient with the Patient Export ID
provided (see Find and Select Records on page 7-1).
Data Integrity
Stratus OCT guards data integrity through the following features.
For these records, you cannot edit the following fields: Last Name, First Name, Middle
Names, Gender, Date of Birth, and Patient ID. You can edit other fields of the
anonymous patient record, as well as analyze, archive and re-export the data. Data that is
imported with identifying patient information can be edited without restriction.
WARNING: It is possible to reuse removable media for export, but you must
overwrite—and in the process delete—the current export database. You can
also repurpose any dedicated removable media, but only if you first delete all
files on the media or reformat it—and thereby permanently erase all data on
it.
Note: OCT Image Export is an optional feature that may not be activated on all
instruments. If you do not have this feature and want to purchase it, contact Carl
Zeiss Meditec. In the U.S., call 1-877-486-7473; outside the U.S., contact your local
Carl Zeiss affiliate or distributor.
To facilitate the transfer of Stratus OCT image data for viewing on electronic medical record
systems or on a standard computer, Stratus offers the ability to export OCT scan images in
standard image formats (JPEG or BMP) to any accessible location. This feature is called OCT
Image Export, and it is available both in the MAIN WINDOW and through the EXPORT
WINDOW.
Note: When you start OCT Image Export through the EXPORT WINDOW, you have the
flexibility to select specific exams for image export. You must export all scan images
for the selected patient when you start OCT Image Export from the MAIN WINDOW.
Note: You must create a Clinical Site ID to successfully export images and data,
because exported data must be associated with the source clinic. See Site ID and
Logo on page 7-19.
2. Select the patients and exams whose scan images you wish to export. When you
select a patient, all their visits and exams appear and are selected by default. Deselect
those you do not wish to export. You can select exams from multiple patients.
• Click the Select All button to select the scan images of all patients for export. The
button toggles to Deselect All. Click Deselect All to clear all your selections and
start over. Be aware that exporting a large number of scans can take considerable
time to complete.
• If the Show Thumbnails button is selected, you can view thumbnails for the scan
group you click on the right, the row for which will be highlighted in blue. See the
example below. Note that a scan group can be highlighted in blue, meaning its
thumbnails will be shown, while its selection checkbox is clear. In this case, its
scans will not be exported.
Note: A gray patient or visit checkbox with a gray checkmark means that some of
the items it contains are selected and some are not selected.
3. Click the OCT Image Export button on the toolbar, or select OCT Image Export from
the File menu. The OCT Image Export Options dialog appears.
Note: Each scan image will be exported in a separate file, which is named by
combining the following, in order: last name, first name, date of birth, date and
time of scan, scan type. This is how Stratus provides the patient and scan data with
the image. Note that the patient name and date of birth can be obscured, as
explained next.
• To obscure patient data upon export, select the Obscure Patient checkbox. You
then will have further options to obscure the patient date of birth: fully, partially,
or not at all. Identifying data is never included on the image itself. It is included,
when not obscured, in the name of the exported image file. If obscured, the site
name is substituted for the patient name in the image file name.
5. When finished making your selections, click OK to start export. A Progress dialog
appears and shows export progress. A Notice dialog tells you when export is finished.
Database Export
The Stratus OCT offers the ability to export data to another Stratus OCT instrument. Unlike
OCT image export, this method exports all available Stratus OCT data for the patients and
exams you select. You have the option to obscure patient data.
Note: You must create a Clinical Site ID to successfully export images and data,
because exported data must be associated with the source clinic. See Site ID and
Logo on page 7-19.
2. To a network destination. 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.
3. Directly to a Stratus OCT instrument. To do this, the sending and receiving platforms
must be connected by an RJ-45 crossover cable between their respective ethernet
ports. It is the user’s responsibility to acquire and install the necessary crossover
cable, to configure both instruments to communicate (see Networking
Guidelines) and to select the correct export path when exporting.
Note: If there is a Stratus export database on the intended export media, the Stratus
OCT warns you first that it will overwrite it.
Click Cancel if you do not wish to overwrite the previously exported data. To
successfully export multiple patient records to a single export media, you must
select them during a single export operation.
Export Steps
To export a Stratus database to another Stratus OCT instrument, follow these steps:
1. If you are exporting to removable media, insert the media into its drive. If not, skip to
the next step.
2. From the MAIN WINDOW, select Export from the Data menu (click Data > Export) to
reach the EXPORT WINDOW. The Patients list displays every name in the patient
database. Each name has an empty checkbox by it.
4. When you have finished making your selections, select Database Export from the File
menu (click File > Database Export). The Export Options dialog box appears:
WARNING: This warning applies to Stratus OCT systems that shipped with software
version 5.0 and later; these systems have the hard drive partitioned into C: and F: drives.
Do not export or save data to the C: drive of a Stratus instrument. The C: drive
is relatively small and can be filled up quickly, which renders the system
unusable. The F: drive is reserved for data and therefore is relatively large. If
you want to export or save data to the Stratus hard drive, either locally or to a
connected Stratus system on the network, select (a location in) the F: drive as
the target.
Note: For all Stratus OCT systems, if you export to the instrument’s hard disk, please
be aware that it is possible to completely fill the hard disk, at which point you will
be unable to save new exams. The Windows operating system will warn you as you
approach hard disk capacity.
7. To export data anonymously, select the Obscure Patient checkbox. The patient name
is not exported and neither is the following potentially identifying information: patient
ID, insurance company name, telephone numbers and attending and referring
Note: Stratus OCT enables you to export cleared archive data. If the cleared data is
on a network archive, the data will be exported from the archive automatically. If
the file server is not connected, you will be prompted to connect with it. If the
cleared data is on a DVD archive, you will be prompted to insert the archive disk by
its label. If more than one archive DVD is required, you must attend the instrument
during export and insert the indicated archive disk(s) when prompted.
9. When you click OK in the Export Options dialog box, export begins. The Progress
dialog box shows export progress. It can take several seconds to several minutes for
the Stratus OCT to finish writing to the disk, depending on the number of exams you
selected for export.
• At any time, you can click the Cancel button to abort export and no data will be
exported.
10.When the export process is complete, a Notice dialog will prompt you to write the
label on the export DVD disk. Label the disk as instructed and click OK.
Import Data
To import data, follow these steps:
1. If you are importing data from removable media, insert the media containing export
data created with Stratus OCT software version 2.0 or later, or with Stratus Review
Software, into its drive. If you are importing from any other path on the network or
hard drive, skip to step 2.
2. From the MAIN WINDOW, select Import from the Data menu (click Data > Import). The
IMPORT WINDOW opens. Proceed to step 3. below unless the Import Options dialog
appears automatically.
database has been copied there) or from any location in a network path through a
mapped drive. Click Browse to find and select the desired import path, or type in
the desired import path. When finished, click OK.
• If you are importing from a network location, the instrument must be connected
to the source system.
number of exams in the export database. A message notifies you when the operation
is complete.
Note: For patients imported with the date of birth obscured, normative data will not
be presented in the analysis.
Chapter Overview
Carl Zeiss Meditec designed the Stratus OCT instrument to require very little user
maintenance besides cleaning. This chapter covers the handling of error messages,
defragmentation of the hard drive, routine cleaning and reporting signs of wear.
Note: The Stratus OCT instrument has no user-replaceable parts, including lamps
and fuses. The user must not attempt hardware repairs, including lamp and fuse
replacement, without consulting Carl Zeiss Meditec service personnel. To do so voids
the instrument warranty. However, we may provide user-installed software updates
to fix software deficits.
Note: Since hard disk defragmentation usually requires several hours to complete,
we recommend that you start defragmentation at the end of the day and let the
process run overnight. If defragmentation is not complete in the morning, it does no
harm to stop defragmentation and continue using the instrument.
To defragment the hard drive, follow these steps:
1. Exit the Stratus OCT software (click File > Exit or click the at upper right) to enter
the Windows environment.
2. Click Windows Start > Programs > Accessories > System Tools > Disk Defragmenter.
The Select Drive dialog appears.
3. Select the C: drive and click OK to begin defragmentation.
Routine Cleaning
The forehead and chin rests, and to a lesser extent the ocular lens, are the only parts that
require routine cleaning.
Note: These latter disinfectants are skin irritants, so be sure to rinse repeatedly and
thoroughly with a clean and soft wet cloth. Wipe dry with a clean and soft
non-linting cloth.
Power Fuses
The Stratus OCT is a modular system with each major subsystem possessing its own power
fuses. Only ZEISS field service engineers are authorized to diagnose power problems and
replace fuses. Tampering with fuses on the Stratus OCT voids all warranties and liabilities.
To order: In the U.S., call 1-800-341-6968. Outside the U.S., contact your local Carl Zeiss
affiliate or distributor.
(11) Specifications
Tomographic Imaging
• Purpose: Cross sectional imaging of fundus
• Signal Type: Optical scattering from tissue
• Signal source: Super Luminescent Diode (SLD), 820 nm
• Optical Power: 750 microwatts at cornea. SLD current will shut off if a safety circuit
is activated (upon scanner failure)
• Spot Size at Retina: 20 μm in tissue
• Longitudinal/Axial Resolution: 10 μm in tissue
• Transverse Resolution: 20 μm in tissue
• Scanners: Galvanometric mirrors
• Scan Patterns: Repeat, Line, Circle, Raster Lines, Cross Hair, Radial Lines, Macular
Thickness Map, Optic Disc, Proportional Circle, Concentric 3 Rings, RNFL Thickness
(3.4), Nerve Head Circle, RNFL Thickness (2.27xdisc), X-Line, RNFL Map, Fast Macular
Thickness Map, Fast Optic Disc, Fast RNFL Thickness (3.4), Fast RNFL Map
• Scan Pixels: Adjustable from 131,072 to 786,432 (1024 longitudinal x 128 to 768
transverse)
• Scan Speed: 400 A-scans per second
• Scan Acquisition Time: Approx. 0.32 seconds (128 A-scans minimum.) to approx. 1.92
seconds (768 A-scans maximum.)
• Longitudinal (Depth) Scan Range: 2 mm in tissue
Fundus Imaging
• Purpose: Fundus alignment for tomographic imaging
• Signal Type: CCD image
• Field of View: 26° (horizontal) x 21° (vertical)
• Focus Adjustment Range: -12 to +20 D (diopters)
• Viewing Method: 15" Color Flat Panel Display
• Illumination: Halogen Lamp
• Internal Fixation: 32 × 16 Green LED dot matrix
• External Fixation: Slit lamp type adjustable blinking LED
Electrical Requirements
• Single phase:
100/120V~ systems:(± 10%), 50/60Hz, 6A
Fuse Ratings
• Main fuses: (under power input of table and back of computer):
Fuse ratings Table Computer Quantity
100/120V~ systems 6.3A 6.3A 2 each
220/240V~ systems 3.15A 6.3A 2 each
Start-up
No special operator precautions needed for initial start-up.
Measurement Units
All units on the Stratus OCT are measured in the SI format. Unless otherwise noted,
measurements are made in micrometers.
Computer
• Internal storage
• Color flat panel display
Environmental Conditions
Transport and Storage
Temperature:-40 to +70 deg. C
Relative Humidity:10% to 100%, including condensation
Atmospheric Pressure:500 hPa to 1060 hPa
Operation
Temperature:+10 to +40 deg. C
Relative Humidity:30% to 75%, excluding condensation
Atmospheric Pressure:700 hPa to 1060 hPa
Physical Dimensions
Fits in a cubic space of 83 cm (depth) x 119 cm (length) x 125 cm (nominal height with 30
cm of table travel) (33 in x 48 in x 50 in).
System Weight
Complete system: 58.6 kg (129 lbs.), comprises Patient Module 24.5 kg (54 lbs.), computer
21.3 kg (47 lbs.), monitor 5.4 kg (12 lbs.), printer 6.4 kg (14 lbs.), keyboard and mouse 0.91
kg (2 lbs.).
Limited Warranty
This Warranty gives you specific legal rights, and you may have other rights, which vary
from state to state. For one year from the date of delivery (the “Warranty Period”) to the
original purchaser (“You,” “Your,” “Purchaser”), Carl Zeiss Meditec, Inc. (“ZEISS,” “Seller,”
“We,” “Our,” “Us”) warrants its Stratus OCT Model 3000, excluding components and
software as stated below (the “Stratus OCT”) to be free from defects in material or
workmanship. In the event of failure, Seller's obligation is limited to repairing or replacing
on an exchange basis the parts that have been promptly reported as defective by Purchaser
during the Warranty Period and are confirmed as defective by Seller upon inspection. This
Warranty covers all parts, labor, travel and expenses for the Warranty Period, except as
otherwise stated herein. This Warranty only applies to the original Purchaser and shall not,
in any way, be transferable or assignable.
The procedure for warranty claims shall be as follows: when You believe the Stratus OCT is
defective, promptly report the defect to ZEISS. Whenever possible, We will provide “in the
customer's office” service to repair Your Stratus OCT. However, at Our discretion, repairs
may be made in Our repair department. In this case, We will pay all shipping costs unless
Your Stratus OCT is found upon inspection not to be eligible for repair under this Warranty,
in which case You will be responsible for one-half the shipping costs. If Your Stratus OCT is
ineligible for repair under Warranty, We will notify You, and any repairs You authorize will
be performed at Our normal rates. All replaced parts will become the property of ZEISS.
This Warranty specifically covers the Stratus OCT, including the instrument table. This
Warranty does NOT cover: consumable items such as operating supplies, paper or storage
media, or the servicing of any external printer. Those items will be covered by their
manufacturer's warranty and arrangement for service must be made through that
manufacturer. This Warranty will NOT apply if repair or parts replacement is required
because of accident, neglect, misuse, acts of God, transportation or causes other than
ordinary use, or supplies or accessories that do not meet the proper operating
specifications of ZEISS. This Warranty does NOT apply to any articles that have been
repaired or altered except by ZEISS.
All data stored on the hard disk, magneto-optical and/or floppy discs are the Purchaser's
records, and it is Your responsibility to preserve the integrity of these files. ZEISS is not
responsible for the loss of patient files stored on the hard disk, floppy discs, backup
magneto-optical discs or backup floppy discs.
You bear the entire risk as to the quality and performance of the software. ZEISS does not
warrant that the software will meet Your requirements, that the operation of the software
will be uninterrupted or error-free, or that all software errors will be corrected. You assume
the responsibility for the installation, use and results obtained from the Stratus OCT and
programs.
The Warranty does NOT extend to any diskette that has been damaged as a result of
accident, misuse, abuse, or as a result of service, or modification by anyone other than
ZEISS. Should such software prove defective following its purchase, You (and not ZEISS)
assume the entire cost of all necessary service, repair, or correction. ZEISS has no liability or
responsibility to any person or entity with respect to any claim, loss, liability, or damage
caused or alleged to be caused directly or indirectly by any software supplied with the
Stratus OCT or by ZEISS.
Every reasonable effort has been made to ensure that the product manuals and
promotional materials accurately describe the Stratus OCT specifications and capabilities at
the time of publication. However, because of on-going improvements and product
updates, We cannot guarantee the accuracy of printed materials after the date of
publication, and disclaim liability for changes, errors or omissions. All instrument
specifications are subject to change without notice.
Limitation Of Liability
THE WARRANTIES CONTAINED HEREIN ARE IN LIEU OF AND EXCLUDE ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE,
INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR PARTICULAR USE. NEITHER ZEISS, MICROSOFT CORPORATION NOR
ANY OTHER PARTY INVOLVED IN THE CREATION, PRODUCTION, OR DELIVERY OF THIS
INSTRUMENT OR SOFTWARE (COLLECTIVELY REFERRED TO AS “CONTRIBUTOR(S)”) SHALL
BE LIABLE FOR ANY DAMAGE, LOSS OF USE OR LOSS OF ANY KIND, ARISING OR
RESULTING FROM ACTS OF GOD, YOUR PURCHASE, POSSESSION, FAILURE TO FULFILL
YOUR RESPONSIBILITIES AS TO PROPER INSTALLATION, MANAGEMENT, SUPERVISION OR
USE OF THE STRATUS OCT OR SOFTWARE WHETHER SUCH LIABILITY IS BASED IN TORT,
CONTRACT OR OTHERWISE. IF THE FOREGOING LIMITATION IS HELD TO BE
UNENFORCEABLE, ZEISS'S (AND CONTRIBUTOR(S)) MAXIMUM LIABILITY TO YOU SHALL
NOT EXCEED THE COST PAID BY YOU FOR THE INSTRUMENT. ZEISS (AND/OR
CONTRIBUTOR(S)) SHALL IN NO EVENT BE LIABLE FOR DIRECT, INDIRECT,
CONSEQUENTIAL OR INCIDENTAL DAMAGES (INCLUDING DAMAGE FOR LOSS OF
BUSINESS OR ANTICIPATORY PROFITS, BUSINESS INTERRUPTION, LOSS OF BUSINESS
INFORMATION, AND THE LIKE), EVEN IF ZEISS OR ANY CONTRIBUTOR(S) HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. SOME STATES DO NOT ALLOW THE
EXCLUSION OR LIMITATION OF IMPLIED WARRANTIES OR CONSEQUENTIAL OR
INCIDENTAL DAMAGES, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO
YOU.
Service Contract
In the U.S.A., a Warranty Extension Agreement (Service Contract) is available after the
one-year, new Stratus OCT warranty expires. For information, call the Customer Service
Department at 1-800-341-6968.
Software Copyright
The software program (“Software”) included with your Stratus OCT 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 © Carl Zeiss Meditec, Inc. All rights reserved.
from ZEISS and payment of licensing fees. Further, sales of Stratus OCT instruments
may not include any software or software licensee transfers. You may not sublicense,
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.
Notification of Copyright
NOTICE TO USER: THIS IS A CONTRACT BETWEEN YOU AND CARL ZEISS MEDITEC, INC.
("ZEISS") BY INSTALLING ANY OR ALL OF THIS APPLICATION COMPONENTS, YOU ARE
ACCEPTING ALL THE TERMS AND CONDITIONS OF THIS AGREEMENT. This ZEISS End User
License Agreement accompanies a STRATUS(r) software product ("Software") and related
explanatory materials ("Documentation"). The term "Software" shall also include any
upgrades, modified versions, updates, additions and copies of the Software licensed to you
by ZEISS. You must read this Agreement carefully before indicating your acceptance at the
end of the text of this Agreement. If you do not agree with the terms and conditions of this
Agreement, decline where instructed, and you will not be able to use the Software. You
should then return this Software, together with all the packaging, to ZEISS or the location
where you obtained it.
This software program is a proprietary product of ZEISS and in certain instances contains
material proprietary to other companies. These proprietary products are protected by
copyright laws, international treaty, and under your purchase agreement with ZEISS
governing your use of the software. Installation of this software indicates your acceptance
of this agreement. If you have any questions concerning this agreement, contact Carl Zeiss
Meditec, Inc., Attention Customer Service, 5160 Hacienda Drive, Dublin, CA 94568.
License Agreement
This is a license agreement and not an agreement for sale. ZEISS continues to own the copy
of the Software and the physical media contained in this package and any other copy that
you are authorized to make pursuant to this Agreement. ZEISS hereby grants to You a
nonexclusive license to use the Software and Documentation, provided that You agree to
the following:
1. Use of the Software.
1.1. You may install the Software in a single location on a hard disk or other storage device
of up to the number of computer licenses that have been purchased from ZEISS.
1.2. You may make one backup copy of the Software, provided your backup copy is not
installed or used on any computer.
2. Copyright. The Software is owned by ZEISS and its suppliers, and its structure,
organization and code are the valuable trade secrets of ZEISS and/or its suppliers. The
Software is also protected by United States Copyright Law and International Treaty
provisions. You must treat the Software just as You would any other copyrighted material,
such as a book. You may not copy the Software or the Documentation, except as set forth
in the "Use of the Software" section. Any copies that You are permitted to make pursuant
to this Agreement must contain the same copyright and other proprietary notices that
appear on or in the Software. Trademarks shall be used in accordance with accepted
trademark practice, including identification of trademark owner's name. Trademarks can
only be used to identify printed output produced by the Software. Such use of any
trademark does not give You any rights of ownership in that trademark. Except as stated
above, this Agreement does not grant You any intellectual property rights or trademark in
the Software.
3. Transfer. You may not rent, lease, sublicense or lend the Software or Documentation.
You may, however, transfer all Your rights to use the Software and Documentation to
another person or legal entity provided that (i) You transfer this Agreement, the Software,
including all copies, updates and prior versions and all copies of font software converted
into other formats, and the Documentation to such person or entity, (ii) You retain no
copies, including copies stored on a computer, and (iii) that the receiving party agrees to
be bound by the terms and conditions of this Agreement.
4. Limited Warranty. Neither ZEISS nor anyone else who has been involved in the creation,
production or delivery of this Software shall be liable for any direct, indirect, consequential
or incidental damages (including damages for loss of business profits, business
interruption, loss of business information, and the like) arising out of the use or inability to
use such Software even if ZEISS has been advised of the possibility of such damages. For
further warranty information, please contact the Carl Zeiss Meditec, Inc., Customer Service
Department.
5. Governing Law and General Provisions. This Agreement will be governed by the laws in
force in the State of California excluding the application of its conflicts of law rules. This
Agreement will not be governed by the United Nations Convention on Contracts for the
International Sale of Goods, the application of which is expressly excluded. If any part of
this Agreement or its application becomes illegal, unenforceable, or void, such provision
will be changed and interpreted so as to best accomplish the objectives of that provision to
the extent allowed by law, and the remaining provisions of this Agreement will continue in
full force and effect. You agree that the Software will not be shipped, transferred or
exported into any country or used in any manner prohibited by the United States Export
Administration Act or any other export laws, restrictions or regulations. This Agreement
shall automatically terminate upon failure by you to comply with its terms. This Agreement
may only be modified in writing signed by an authorized officer of Carl Zeiss Meditec, Inc.
This is the entire agreement between ZEISS and You relating to the Software and the
Documentation and it supersedes any prior representations, discussions, undertakings, end
user license agreements, communications or advertising relating to the Software and the
Documentation.
6. Notice to United States Government End Users. The Software and Documentation are
"Commercial Items," as that term is defined at 48 C.F.R. §2.101, consisting of "Commercial
Computer Software" and "Commercial Computer Software Documentation," as such terms
are used in 48 C.F.R. §12.212 or 48 C.F.R. §227.7202, as applicable. Consistent with 48
C.F.R. §12.212 or 48 C.F.R. §§227.7202-1 through 227.7202-4, as applicable, the
"Commercial Computer Software" and "Commercial Computer Software Documentation"
are being licensed to U.S. Government end users (i) only as "Commercial Items" and (ii)
with only those rights as are granted to all other end users pursuant to the terms and
conditions herein.
Unpublished-rights reserved under the copyright laws of the United States.
Carl Zeiss Meditec, Inc., 5160 Hacienda Drive; Dublin, CA, USA.
For Your future reference a copy of this End User License Agreement will be accessible after
You install the Software. If You have any questions regarding this Agreement or if you wish
to request any information from ZEISS, please use the address information enclosed in this
product to contact the local Carl Zeiss Meditec office serving your country or write to
Customer Support Department, Carl Zeiss Meditec, Inc., 5160 Hacienda Drive, Dublin, CA
94568.
STRATUS(r) is a registered trademark of Carl Zeiss Meditec, Inc. Windows is a registered
trademark of Microsoft Corporation.
By use of the Software, You acknowledge that You have read this license agreement and
limited warranty, understand them, and agree to be bound by their terms and conditions.
Site Survey: Document filled out by Buyer detailing the local operating environment for the
Software.
Term of Warranty: This Warranty will be effective for a period of forty-five (45) days from
the date of shipment to You (“Warranty Term”).
Scope of Limited Warranty for Software: ZEISS warrants that (i) it has the right to license or
sublicense the Software to You for the purposes and subject to the terms and conditions
set forth in ZEISS’ standard terms and conditions (ii) the Software will be fit for the
purposes described in ZEISS' user documentation (iii) that the Software will perform in
substantial conformity to published specifications during the Warranty Term. ZEISS DOES
NOT WARRANT THAT THE ZEISS SOFTWARE IS ERROR-FREE OR WILL OPERATE WITHOUT
INTERRUPTION OR WILL MEET YOUR SPECIFIC NEEDS. YOU ARE RESPONSIBLE FOR ALL
DATA BACKUPS, DATA ARCHIVING, AND DATA TRANSFER.
Updates: At no cost to You, ZEISS will provide You with maintenance updates (i.e.: bug
fixes) during the Warranty Term. ZEISS will not be obligated to provide new Software
releases or 3rd Party Product upgrades.
Remedies for Software Failure: During the Warranty Term, ZEISS' obligation under this
Warranty is limited, at ZEISS’ discretion, to repair, adjustment and/or replacement of any
Software which proves to be defective in material or workmanship. You must give ZEISS
notice of any defect within the Warranty Term to make a claim under this Warranty. If the
Software fails to substantially conform to its published specifications, ZEISS shall, at its
own expense, use all commercially reasonable efforts to correct such failure.
Software support to correct failures will be provided as follows:
• For installation issues, up to two (2) hours of free remote technical support.
• For non-installation issues, unlimited telephone support during the warranty period.
Remote Technical Support will be provided from 6:30 AM to 5:00 PM Pacific Time, except
during ZEISS holidays.
Repair or replacement will be ZEISS' sole obligation and exclusive remedy hereunder.
THESE ARE YOUR EXCLUSIVE REMEDIES AND CONSTITUTE ZEISS' SOLE LIABILITY FOR ANY
WARRANTY CLAIMS. YOU AGREE THAT ZEISS, ITS AFFILIATES AND REPRESENTATIVES,
WILL HAVE NO LIABILITY TO YOU FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL
DAMAGES SUCH AS EXCESS COSTS INCURRED, LOSS OF DATA, OR FOR LOST PROFITS OR
REVENUE FROM SOFTWARE FAILURE. This provision does not affect third party claims for
personal injury arising in products liability or from ZEISS’ negligence. Some states do not
allow the exclusion or limitation of consequential or incidental damages, so the above
limitation or exclusion may not apply.
To maintain this Warranty, You must use the Software in accordance with ZEISS’
instructions for use, and maintain Your hardware and software in the same configurations
as You have provided in Your Site Survey.
You will void this Warranty if: You install Outside Elements not authorized or confirmed for
use by ZEISS in the Site Survey.
Warranty Exclusions: This Warranty does not apply to Software that has been damaged by
accident, virus or similar program based corruption, negligence, misapplication, alteration
or modification, including a change to the configuration of the system as reported in Your
Site Survey (without submitting a new Site Survey and receiving confirmation from ZEISS).
These warranties are exclusive and in lieu of all other warranties, whether written, oral,
express, implied, or statutory. EXCEPT AS PROVIDED HEREIN, NO EXPRESSED OR IMPLIED
WARRANTIES, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, QUIET ENJOYMENT, SYSTEM
INTEGRATION AND DATA ACCURACY, WILL APPLY. THERE ARE NO WARRANTIES WHICH
EXTEND BEYOND THOSE DESCRIBED IN THIS DOCUMENT AND THE PRIOR STATEMENTS
BY ANY ZEISS REPRESENTATIVE SHALL NOT MODIFY OR EXPAND THESE WARRANTIES.
This Warranty May Be Transferred if: before You make the proposed transfer, You provide
ZEISS with a written request and You receive written confirmation from ZEISS that it will
accept the transfer.
Notice
Users are responsible for network setup and maintenance, including installation and
configuration of all necessary hardware and software. Carl Zeiss Meditec Technical
Support is limited to testing network connectivity of the Stratus OCT. Technical
Support cannot troubleshoot or repair problems with network connectivity. Please
observe the following guidelines regarding networking of the Stratus OCT
instrument.
Note: These guidelines apply to version 7.0 of Stratus OCT system software.
Note: The simplest way to transfer data from a Stratus instrument to a review
station is to register the network archive to which the Stratus instrument
automatically archives and synchronize on the review station PC.
See Chapter (5), Archive and Retrieve, and Chapter (6), Import and Export Scan
Data, for instructions to archive, retrieve, import, export and synchronize Stratus OCT
data.
Note: Stratus OCT Software Version 7.0 is compatible with Windows 2000 Service
Pack 4, which is primarily a security update to the Windows operating system.
Therefore, if you connect the Stratus OCT to an office network, we encourage you to
install Service Pack 4.
• It may be possible to install printer drivers for network printing, but this is not
supported by Carl Zeiss Meditec. See the section: Network Activities Not
Supported below.
Note: Carl Zeiss Meditec does not provide technical support for the use of approved
third party software.
Please refer to the Stratus OCT Technical Support section of our website
(www.meditec.zeiss.com/stratus) for the current list of approved software, including
approved updates and patches to the Windows operating system and security software.
Prohibited Activities
The following activities are prohibited using the Stratus OCT instrument.
Note: The user bears responsibility for any system performance degradation or any
other change or defect resulting from the attempt to perform the following
activities. Carl Zeiss Meditec is not responsible for software repairs or
upgrades necessitated by the attempted performance of the following
network activities.
• Network printing, i.e., printing with a printer other than the Stratus OCT system
printer. If you wish to use a third party printer, seek technical support from your
printer manufacturer. Repairs necessitated by the attempt to print using a non-system
printer are not covered under warranty.
Not Recommended
It is not recommended to print to any black and white printer because the printouts
depend on color codes to convey information.
• NTFS drive partition(s) for Stratus OCT data. Stratus OCT is compatible only with NTFS
on network drives.
Note: You can use SAMBA with Unix and Linux file servers.
• 100 GB available disk space for data storage
• Tape backup unit
WARNING: Failure to backup the network file server may result in the loss of
medical exam data.
• The file server must be started prior to networked Stratus OCT instruments and shut
down after Stratus OCT instruments.
• Strongly recommended that the file server not be used for interactive programs, such
as web browsing or word processing.
Note: Configuring the server and the instrument for archiving to a network file
server should be attempted only by a network administrator or system
administrator, and the following instructions are intended only for personnel with
such expertise. Users are responsible for network setup and maintenance. Carl Zeiss
Note: If you attempt a data transfer function when the network is down or the
server is down, the function will fail and the instrument will notify you that a
connection could not be established. In this case, if auto-archive is on, all scans
saved while the network/server is down will not be archived automatically. You must
archive these scans manually when service is restored. See the instructions to
perform Access Archived Scans on page 8-5.
Terminology
The “source system” is the Stratus OCT system, from which you will export; the “target
system” is the remote computer to which you will export data.
Note: The choice and use of third party software on the target system for viewing
and analysis is at the user’s discretion. Carl Zeiss Meditec does not specify
compatible third party software, nor support its use.
Note: Carl Zeiss Meditec does not provide technical support for direct
export to a personal computer. The following configuration requirements
pertain to the example of direct export from the Stratus OCT to a PC running
Windows 2000. We intend these requirements for information technology (IT)
specialists, who will understand how to implement them. The user bears
responsibility for any source or target system performance degradation or any other
change or defect resulting from the attempt to perform these tasks.
Note: The requirements below are for a target system running Windows 2000 or XP.
If your intended target system is running another operating system, it may be
possible to configure it to import from the Stratus OCT, but the configuration
requirements may be different and are not explained here.
Configuration requirements
1. If transferring data via a network, connect both the source and target systems to the
network using a standard cable. If transferring via direct connection between source
and target, connect the two using a crossover cable. The Stratus OCT system has a
network connector (ethernet port) on the rear of the computer.
2. The source and target systems must have computer names, and these must be
different. If necessary, create a computer name of your choice for one or both
computers.
3. Both source and target systems must share the same set of networking protocols, as
follows. (The Stratus OCT is shipped with the following protocols properly configured.)
• Client for Microsoft Networks
• File and Printer Sharing for Microsoft Networks
• Internet Protocol (TCP/IP)
4. On the target system, create a shared folder that will receive the imported data and
enable access to the target system from the source system.
5. On the source system, map a network drive to the shared folder you created on the
target system in step 4. If the target system is password protected, you must access it
with a user account having either Standard User or Administrator privileges in
Windows 2000, or having Computer administrator privileges in Windows XP.
6. The Stratus OCT is configured by default to use DHCP. If the source system is
connected to a network that uses static IP addressing, the following TCP/IP
parameters must be configured: IP address, Subnet, and Default gateway.
Overview
This document provides configuration instructions to enable transfer of Stratus OCT data
from a Stratus instrument to a personal computer (PC) running Stratus Review Software (a
Stratus review station) via network connection or removable media. It provides an overview
of data transfer methods, and addresses two kinds of network connection, as follows:
• Data Transfer Overview: Import or Retrieve Data, starting on page B-2
• Configuration for Export via Preexisting Office Network, starting on page
B-3.
• Stratus to Review Station Direct Network Connection (Crossover Cable)
Instructions, starting on page B-13
Note: Import Data to Complete Process. To access exported data in Stratus Review
Software, you must complete the process by importing the data from the local
shared folder you will create as part of these instructions. See On the Review
Station PC: Import Data from the Local Shared Folder on page B-13.
Once Stratus OCT data is in the database of a review station PC, it is possible to transfer it
among Stratus network endpoints (Stratus instruments or PCs running Stratus Review
Software) via networking or any type of removable media compatible with both systems.
However, this document does not directly address any method of data transfer among PCs,
which is at the user’s discretion.
Note: Carl Zeiss Meditec offers for sale a network attached storage device (network
drive or NASD) for archive and data transfer with Stratus OCT, and a network switch
kit for those with Stratus OCT systems that require retrofitting to use the NASD.
Instructions to install and use each of these items accompany them in their
respective kits.
Note: Carl Zeiss Meditec offers for sale a kit with a USB hub you can attach to the
Stratus OCT to enable data transfer using a USB key (flash drive or jump drive). To
use this method, refer to the Stratus OCT USB Hub & Key Configuration Instructions
that accompany the kit.
WARNING: The user bears responsibility for any source or target system
performance degradation or any other change or defect resulting from the
attempt to perform these tasks.
WARNING: When networking the Stratus OCT, use only network cables with
an unshielded RJ-45 connector. Use of a shielded network cable in the Stratus
OCT could result in electrical shock to the patient and/or examiner.
Terminology
The “source system” is the Stratus OCT system, from which you will export; the “target
system” is the review station PC to which you will export data.
Note: The choice and use of third party software on the target system for viewing
and analysis is at the user’s discretion. Carl Zeiss Meditec does not specify
compatible third party software, nor support its use.
Note: The instructions below are for a review station PC running Windows 2000 or
XP. If your intended target system is running another operating system, it may be
possible to configure it to import from the Stratus OCT, but the configuration
requirements may be different and are not explained here.
Note: See Configuration for Export via Preexisting Office Network (page B-3)
for instructions to set up data transfer from the Stratus instrument to the review
station via a preexisting office network or Stratus to Review Station Direct
Network Connection (Crossover Cable) Instructions (page B-13) for transfer via
direct connection.
Note: To import or retrieve from a DVD-RAM, you must have a DVD-RAM drive
installed on the PC. Users are responsible for installation of a DVD-RAM drive on
their PC. Carl Zeiss Meditec does not provide or specify a DVD-RAM drive for the
user’s PC, nor support the installation and configuration of a DVD-RAM drive on the
user’s PC.
Note: To import from CD or DVD, you must have installed on the importing PC both:
• A CD and/or DVD Read/Write drive (CD or DVD burner); it is not sufficient to have a
CD-ROM or DVD-ROM drive.
And
• Roxio Drag-to-Disc software (part of Roxio Easy CD and DVD Creator Version 6.0 or
higher) installed and properly configured on the importing PC.
For more information, including important details on configuration of the Roxio software,
see Appendix (D) Data Transfer Using CDs and DVDs.Importing from a local
folder
This step is subsequent to data transfer via export from a Stratus instrument or from
another review station PC. Export can occur via direct connection or a preexisting office
network. See the configuration instructions for each of these options below.
Note: To import from a network server, the PC must be connected to the network
server, and both the server and the PC must be properly configured to communicate.
To retrieve from a network server, you must be archiving to the server from the
Stratus OCT. Users are responsible for network setup and maintenance, including
installation and configuration of all necessary hardware and software. Carl Zeiss
Meditec Technical Support cannot troubleshoot or repair problems with network
connectivity. See Appendix (A) Networking Guidelines for more information.
Notes on Retrieving
Note: Stratus OCT does not permit archiving data to CD or DVD. Therefore, you can
retrieve archive data only from DVD-RAM or from a network drive.
Note: You can retrieve Stratus OCT data from archives made with any Stratus OCT
Software Version down to A1.1.
Note: For instructions to retrieve, see Retrieve Scan Data on page 8-11.
How to Import
To import data, follow the steps under Import Data on page 9-10.
WARNING: When networking the Stratus OCT, use only network cables with
an unshielded RJ-45 connector. Use of a shielded network cable in the Stratus
OCT could result in electrical shock to the patient and/or examiner.
Note: If you are using a file server to transfer Stratus data, create and use a user
account with the same username and password on all three network endpoints: the
Stratus instrument, the network file server and the review station PC. Follow the
instruction below.
1. On the Stratus OCT, create a new administrator account for use as the default
account. (See the instructions to create new accounts under Password Protection in
Chapter 1 of the Stratus OCT User Manual.)
2. On the review station (and the server), create and always use a new Administrator
account (Windows 2000) or Computer administrator account (Windows XP) with the
same username and password as on the Stratus OCT. To access user account settings:
• In Windows 2000, click Start > Settings > Control Panel > User Accounts.
• In Windows XP, click Start > Control Panel > User Accounts.
Note: Most networks use a DHCP server to automatically assign an IP address to the
review station PC and the Stratus instrument. In this case, you can skip these
instructions to Configure the Review Station PC, and those in the next section to
Configure the Stratus OCT. Skip ahead to On the Review Station PC: Create a
shared folder on page B-9. If your network uses static IP addresses, follow the
instructions below.
1. Open the Network Connections dialog:
For systems running Windows 2000, select Start > Settings > Network and Dial-up
Connections.
OR
For systems running Windows XP, select Start > Control Panel > Network Connec-
tions.
4. Double-click Internet Protocol (TCP/IP) in the component list. The Internet Protocol
(TCP/IP) Properties dialog appears (Figure B-3).
Note: The first three parts of the review station IP address must match what is used
on the Stratus instrument. The fourth part must be a number between 2 and 255
that is unique to this system among all devices on the same network. In the example
in Figure B-3, the review station's IP address is 192.168.100.101. A compatible IP
address on the Stratus instrument would be 192.168.100.100.
7. Configure the Subnet mask as in Figure B-3. It should read 255.255.255.0. It must
be the same as on the Stratus instrument.
8. Click OK to save your changes and close the Internet Protocol (TCP/IP) Properties
dialog. Click OK again to save changes and close the Local Area Connection
Properties dialog.
Note: The system may prompt you that the computer must be restarted for the
changes to take effect. Restart the computer if so prompted.
Note: The Connect using: hardware will be different for Pentium 4 based
computers.
3. Double-click Internet Protocol (TCP/IP) in the component list. The Internet Protocol
(TCP/IP) Properties dialog appears (Figure B-6).
Note: The first three parts of the Stratus OCT IP address must match what is used on
the review station PC. The fourth part must be a number between 2 and 255 that is
unique to this system among all devices on the same network. In the example in
Figure B-6, the IP address is 192.168.100.100. A compatible IP address on the
review station PC would be 192.168.100.101.
5. Configure the Subnet mask as in Figure B-6. It should read 255.255.255.0. It must
be the same as on the review station PC.
6. Click OK to save your changes and close the Internet Protocol (TCP/IP) Properties
dialog. Click OK again to save changes and close the Local Area Connection
Properties dialog.
Note: The system may prompt you that the computer must be restarted for the
changes to take effect. Restart the computer if so prompted.
2. Right click on the new folder, and then select Sharing and Security as in Figure B-8.
The Netshare Properties dialog opens to the Sharing tab (Figure B-9).
Note: The default share name is the same as the folder name. We recommended you
use the default share name.
Figure B-13 Enter the review station computer name and shared folder name
Note: You must use two backslashes before the computer name as shown in the
example.
Note: You must select the Reconnect at logon checkbox to allow the system to
reconnect to the shared drive each time Windows starts.
4. Click Finish to save your changes and close the Map Network Drive dialog.
On the Review Station PC: Import Data from the Local Shared Folder
To have access in Stratus Review Software to the data exported from the instrument, you
must complete the process by importing it from the local shared folder you created as
described above. In the example, this is the folder named Netshare on the Windows
desktop (Figure B-8). For details, see Import Data on page 9-10.
Note: For patients imported with the date of birth obscured, normative data will
not be presented in the analysis.
WARNING: When networking the Stratus OCT, use only network cables with
an unshielded RJ-45 connector. Use of a shielded network cable in the Stratus
OCT could result in electrical shock to the patient and/or examiner.
Note: You should use a direct connection should only if no other networking
infrastructure exists, for the following reason: In this scenario, the Stratus
instrument and the review station PC will each be configured with a static IP address
and dedicated crossover network cable. While so configured, both the Stratus OCT
and the review station PC will be limited in the ability to communicate via other
network connections.
Note: A direct connection allows patient data to be transferred from the Stratus to
the Review Station utilizing the Stratus software's Export feature. A direct network
connection should not be used to synchronize with archived data.
5. Write down and save any existing configuration parameters such as IP address,
Subnet mask and Default gateway. You may need these to reestablish a connection to
a preexisting network.
6. Select the Use the following IP address radio button, and then type in the IP address.
Note: The first three parts of the review station IP address must match what is used
on the Stratus instrument. The fourth part must be a number between 2 and 255
that is unique to this system among all devices on the same network. In the example
in Figure B-16, the review station's IP address is 192.168.100.101. A compatible IP
address on the Stratus instrument would be 192.168.100.100.
7. Configure the Subnet mask as in Figure B-16. It should read 255.255.255.0. It must
be the same as on the Stratus instrument.
8. Click OK to save your changes and close the Internet Protocol (TCP/IP) Properties
dialog. Click OK again to save changes and close the Local Area Connection
Properties dialog.
Note: The system may prompt you that the computer must be restarted for the
changes to take effect. Restart the computer if so prompted.
2. Right-click on the Local Area Connection icon, and then select Properties as in
Figure B-17. The Local Area Connection Properties dialog appears (Figure B-18).
Note: The Connect using: hardware will be different for Pentium 4 based
computers.
3. Double-click Internet Protocol (TCP/IP) in the component list. The Internet Protocol
(TCP/IP) Properties dialog appears (Figure B-19).
Note: The first three parts of the Stratus OCT IP address must match what is used on
the review station PC. The fourth part must be a number between 2 and 255 that is
unique to this system among all devices on the same network. In the example in
Figure B-19, the IP address is 192.168.100.100. A compatible IP address on the
review station PC would be 192.168.100.101.
5. Configure the Subnet mask as in Figure B-19. It should read 255.255.255.0. It must
be the same as on the review station PC.
6. Click OK to save your changes and close the Internet Protocol (TCP/IP) Properties
dialog. Click OK again to save changes and close the Local Area Connection
Properties dialog.
Note: The system may prompt you that the computer must be restarted for the
changes to take effect. Restart the computer if so prompted.
2. Right click on the new folder, and then select Sharing and Security as in Figure
B-21. The Netshare Properties dialog opens to the Sharing tab (Figure B-22).
Note: The default share name is the same as the folder name. We recommended you
use the default share name.
Figure B-26 Enter the review station computer name and shared folder name
Note: You must use two backslashes before the computer name as shown in the
example.
Note: You must select the Reconnect at logon checkbox to allow the system to
reconnect to the shared drive each time Windows starts.
4. Click Finish to save your changes and close the Map Network Drive dialog.
The new drive letter will now be available during the export process on the Stratus
instrument. In this example, the drive letter N: was mapped to the shared folder on the
review station. To export to the review station PC from the Stratus instrument, select the
mapped drive letter (N: in this case) as the export target. For more detail, refer to the
chapters on import and export in the Stratus OCT User Manual or Stratus OCT Review
Software User Manual.
Introduction
The Stratus OCT normative database study was designed to obtain normative data for
macular and RNFL thickness from healthy subjects ages 18 to 86. Six centers participated
in the prospective, non-comparative study. Enrolled subjects were representative of healthy
individuals with no history of eye disease and were carefully screened and evaluated for
eligibility. Generally, subjects presented to the clinical center for routine refraction analysis.
Medical and ophthalmic histories were taken prior to enrolling the subject in the study.
Subjects who had a history of diabetes, glaucoma, or ocular surgery (other than cataract or
refractive surgery more than 1 year ago) were disqualified from the study.
Selection Criteria
Subjects were given a complete ophthalmic examination (unless the subject was seen at
the clinic for a regular eye examination within the last 60 days); it included the following
tests:
A. Distance visual acuity using the Humphrey 24-2 SITA Standard threshold test,
bilaterally. Any defects found were verified with a second test.
B. Goldmann applanation tonometry.
C. Axial length measurement using an IOLMaster.
D. Slit lamp examination of the anterior segment of both eyes.
E. Dilated ophthalmoscopic examination, bilaterally.
F. Fundus photography of the maculas and the optic nerves of both eyes.
If the various ophthalmic examinations showed any abnormalities, the subject was
disqualified from the study. Excluded from the study were individuals with the following
characteristics:
A. Contraindications to dilation (including occludable anterior chamber angles), or
intolerance or hypersensitivity to topical anesthetics or mydriatics in either eye.
B. Ocular hypertension (IOP = 22 mm Hg in either eye) or glaucoma in either eye.
C. Evidence of reproducible visual field abnormality in either eye, defined as PSD
significant at p < 5% level, or abnormal Glaucoma Hemifield test result, or any
other pattern of loss which is consistent with ocular disease. The test must be
valid, as defined by a false positive rate of 15% or less, and fixation losses as
defined by the Heijl Krakau method of 20% or less. Unreliable visual fields may be
repeated at the discretion of the Investigator.
D. Intraocular surgery in the study eye within one year of enrollment.
E. Best corrected visual acuity in the study eye worse than 20/32 on ETDRS scale
(LogMar +0.2).
F. Evidence of diabetic retinopathy, diabetic macular edema, or other vitreoretinal
disease in either eye upon dilated examination by an ophthalmologist, or upon
evaluation of retinal photos.
G. Evidence of optic nerve or retinal nerve fiber layer abnormality in either eye upon
dilated examination by an ophthalmologist, or upon evaluation of retinal or optic
nerve photos.
H. History of diabetes.
I. Participation in any study involving an investigational drug within the past month,
or ongoing participation in a study with an investigational device.
J. Current or recent (within the past 14 days) use of an agent with photosensitizing
properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline).
Data Collection
After undergoing a thorough ophthalmic examination and qualifying, 260 subjects (aged
18-86 years) had scans of their retinas taken with the Stratus OCT device. The Fast
Macular Thickness Map (Fast Mac) scan protocol was used to acquire the macular
thickness data. For this scan type, a set of six intersecting scan lines, each consisting of
128 data points, was obtained in a single alignment and capture to evaluate macular
thickness. The Fast RNFL (3.4 mm) scan was used to acquire the peripapillary RNFL
thickness data. For this scan type, a set of three circles, each consisting of 256 data points,
was obtained in a single alignment and capture to evaluate peripapillary RNFL thickness
along a circle of radius 3.46 mm from the center of the optic disc.
variation in the distribution of thicknesses does not change with the age of the population.
The distribution was then transformed into a Gaussian distribution, which was then used to
calculate the 1%, 5%, 95% and 99% limits of the normal population. A detailed statistical
description of the data transformation follows:
A standard simple linear regression analysis was used in the data analyses. For each of the
128 data points of the six scan lines, the expected thickness (ET) was estimated as a linear
function of age, i.e., Expected Thickness = a + b X age, where a and b were constants. The
values of a and b could differ among the regression lines for the 128 data points of the six
scan lines. The Normal Limit was then derived based on the percentiles of the residuals,
i.e., the difference between the estimated expected thickness (ET) and the observed
thickness (rt), as follows:
ET(age) + NL(5%) < rt(age) < ET(age) + NL(95%),
Where
NL(5%) and NL(95%) were the estimated 5th and 95th percentiles of the residuals,
and
ET(age) + NL(5%) and ET(age) + NL(95%) were the 5% and 95% Normal Limits.
In order to better estimate the percentiles of the residuals, Manly’s exponential
transformation1 was used to transform the residuals so that the transformed residuals were
normally distributed. The percentiles of the transformed residuals were estimated based on
the normal distribution. Then the estimated percentiles of the residuals were derived by
converting the percentiles of the transformed residuals back to the original scale.
Age Coefficient
Analysis of subject demographics determined that expected thickness was dependent upon
age, but not significantly dependent upon other variables, i.e., right vs. left eye and
gender. Thus age correction is incorporated into the calculated results. Subject ethnicity
was self-reported by the subjects in the population comprising the normative database but
was not used as a variable in constructing the macular normative database.
1. Manly B. F. J. (1976) Exponential Data Transformations. The Statistician. Vol. 25, No. 1, pp
37-42.
As shown in Figure C-1 and Figure C-2, the data for each scan number comprises
multiple data points. As described previously, linear regression analysis was used to
determine the age coefficient.
Figure C-3 illustrates how the age coefficient varies with A-scan number for a
representative scan line. The y-axis is the Age Regression Coefficient in micrometers per
year (μm/yr) and the x-axis is the A-scan number (1 through 128).
Conclusion
The Macula Normative Database and RNFL Normative Database were based upon Stratus
OCT retinal scans collected from subjects whom, per protocol, were deemed representative
of a normal population. The Normative Databases establish reference values for specific
Stratus OCT retinal scans which the physician can use to compare individual patient
measurements to those acquired in a normal population.
Overview
Later models of Stratus OCT instruments are equipped with a DVD Multi-Drive and Roxio™
Drag-to-Disc software (part of Roxio Easy CD and DVD Creator 6), which together enable
you to transfer data using certain kinds of CDs and DVDs. This appendix explains the
features and limitations of Stratus OCT data transfer using CDs and DVDs, and provides
instructions for data transfer using CDs and DVDs.
Note: You cannot use the following distinct media formats, which are incompatible
with the DVD Multi-Drive: DVD+R, DVD+RW.
Note: The CDs or DVDs you use first must be formatted in the Drag-to-Disc format,
as explained in the section Formatting for Drag-to-Disc on page D-2.
Note: On the Stratus OCT, you cannot archive to the E: drive (to a CD or DVD), either
automatically or manually. You cannot perform automatic backup to these media
either.
Note: On a PC, it may be possible to view and analyze Stratus OCT data using third
party software. Beyond the instructions here, Carl Zeiss Meditec does not support
the import of Stratus OCT data to a PC; neither do we specify third party software
you can use on a PC to view and analyze Stratus OCT data, nor support its use.
• To successfully import from CD or DVD, the importing instrument or PC must also have
Roxio software (version 6 or greater)–properly configured, as explained in the Roxio
Software Configuration—Eject Settings on page D-4–plus a CD read/write
drive and/or a DVD read/write drive. You cannot import successfully using a CD-ROM
drive or a DVD-ROM drive.
Note: Because the Stratus OCT export function overwrites any Stratus export
database previously written to that disk, only the exams transferred to that disk in
the last export session will be available for import to another Stratus OCT
instrument.
Note: You must first format the CD or DVD in Drag-to-Disc format, as described in
Formatting for Drag-to-Disc on page D-2.
General Steps
Specific format options for each media type are explained after these general steps, which
are common to all media types.
1. Install the CD or DVD into the Stratus OCT DVD Multi-Drive. Wait approximately 30
seconds for the drive to recognize the media type. If you attempt the next step before
the drive is ready, you will get an error message, “There is no disk.”
2. To access the Roxio Drag-to-Disc software, you do not have to close the Stratus OCT
software. Using your mouse, bring the screen pointer down to the bottom of the
screen. This will cause the Windows Task Bar to appear along the bottom. Notice the
icons in the System Tray at bottom right. (When you mouse-over an icon, its name
appears.) Right-click the Roxio Drag-to-Disc icon and select Format Disc. The
Drag-to-Disc Format Options dialog appears.
• You can also access Roxio Drag-to-Disc through the Windows Start menu: Start >
Programs > Roxio Easy CD and DVD Creator 6 > Drag-to-Disc.
Note: The first time you use Roxio software, you will be prompted to accept the
terms of the End User License Agreement. You must accept the terms to use the
software.
The available format options depend on the installed media type, as explained next.
Note: Both quick and full formatting effectively erase any data currently on
the disk. Use these options with care to prevent loss of patient data.
The Advantage of Full Format
For both CD–RW and DVD–RW, full format has this advantage: the disk ejects immediately
when you eject it. If the disk is quick formatted, it requires 1 to 4 minutes for the disk to
eject, as illustrated below.
or DVD, the CD or DVD must not be “finalized” (or closed), which is a process normally
used to enable the CD or DVD to be read on any computer. Finalizing a CD or DVD prevents
data from being written to it.
When shipped from the factory with the Stratus OCT, the Roxio Drag-to-Disc software is
properly configured so that CDs and DVDs are not finalized. Do not change the
configuration of the Roxio Drag-to-Disc software, particularly the eject settings. The correct
eject settings are seen in Figure D-6 below.
Introduction
This appendix provides safety information, requirements, recommendations and
configuration instructions for using a network attached storage device (NAS device), also
known as a network drive, with Stratus OCT. These instructions provide requirements and
recommendations for the NAS device, but are generic with respect to brand, the choice of
which is at the discretion of the user. You can attach the NAS device directly to the Stratus
OCT Ethernet port, or you can connect it via your office network (local area network or
LAN). These instructions cover both scenarios.
Once installed and correctly configured for use with the Stratus OCT, the NAS device serves
the same functions as a network server (primarily archiving), and the instructions in the
Stratus OCT User Manual for using a network server apply to use of the NAS device.
Please refer to the Stratus OCT section of our website (www.meditec.zeiss.com/stratus) for
the current list of approved hardware and software. If you wish to use a third party
peripheral device, seek technical support from the device manufacturer. Repairs
necessitated by the attempt to use a non-approved peripheral device are not covered under
warranty.
WARNING: To directly connect the NAS device to the Stratus OCT, use a network
patch cord only with an unshielded RJ-45 connector. Use of a shielded network patch
cord will ground the NAS device through the Stratus OCT, which could result in
electrical shock to the patient and/or examiner.
WARNING: Do not use the NAS device or the instrument with an extension cord or a
power strip (multiple portable socket outlet). For additional safety, do not plug the
NAS device and the instrument into the same wall outlet. Failure to observe this
warning could result in electrical shock to the patient and/or examiner.
1. With the Stratus OCT and the NAS device turned off, use a network patch cord to
connect the NAS device either directly to the Stratus OCT, or to the office network
(local area network or LAN) on which the Stratus OCT resides. Refer to the
manufacturer’s instructions for details regarding installation of the NAS device.
Note: For safety, observe the warnings and requirements on page E-1 that relate to
the type and length of cord.
2. Turn on the NAS device and wait for initialization to complete before you turn on the
Stratus OCT. Often a color change in a light on the front of the NAS device indicates
initialization is complete, but see the manufacturer’s instructions for details on
initialization.
3. Turn on the Stratus OCT. After you complete the startup process, exit the Stratus
software, going to the Windows® desktop.
• In the system tray at lower right, you may observe a Local Area Connection
notice resulting from attachment of the NAS device. Ignore the message at
this point.
4. In the Stratus OCT CD drive, install the CD that accompanies the NAS device, which
will install and run the NAS device configuration program. Follow the on-screen
instructions, using the default settings. While running the NAS device configuration,
observe the following recommendations:
A. Installation Type: If you are presented with an option to choose a type of
installation, for example a choice between “typical,” “minimal” and/or “custom”
installation, we recommend you choose “typical” or “minimal.” Do not perform a
“custom” installation unless you have reason to do so and the knowledge and
experience required, which would be equivalent to that of a network or system
administrator.
B. Record Storage Drive Name: If you are presented with the option to change the
name of the NAS device, you can either use the default name or change it at your
discretion, but in either case, you must write it down, because you may need it to
complete configuration on the Stratus OCT. You can use the space below:
NAS Device Name (also known as Network ID):
C. Workgroup Name Must Match Stratus OCT Workgroup Name: If you are presented
with the option to change the workgroup name of the NAS device, you must make
it match the workgroup name of the Stratus OCT, which is “CZM” by default—this
name is not case-sensitive on Stratus OCT. If the Stratus OCT is connected to an
office network as part of a different workgroup name, then you must use that
workgroup name.
5. When you complete NAS device configuration, exit the configuration program and
remove the CD from the Stratus OCT CD drive.
configuration is complete and the NAS device is ready to use. In other cases, you must map
a drive on the Stratus OCT to the proper folder of the NAS device using Windows Explorer,
as instructed below:
1. Back on the Windows desktop, open Windows Explorer: right-click on Start and select
Explore.
2. In the Explorer Address field, type two backlashes and then the NAS device name
you recorded in step 4.B. above, and press Enter. See the example below.
Note: If you failed to record it properly, note that you can often find the NAS device
name on a label on the back of the NAS device. The device name, for this purpose,
may be presented as the Network ID. Enter the entire network ID/device name
after the two backslashes, with no spaces.
If you have typed the device name correctly, and the NAS device is correctly config-
ured and turned on, when you press Enter, Explorer should find the NAS device on the
left and display its contents on the right, as in the example below.
Figure E-2 Explorer Finds NAS Device and Displays Its Contents
3. Now you must map a drive on the Stratus OCT to the NAS device folder that is
accessible to all users for storage. In the example above, the folder named Public is
the correct folder. The folder name for your NAS device may be similarly indicative
that it is intended for use as the storage folder. Consult the manufacturer’s
instructions to determine which folder is intended for this purpose.
4. Click to select the correct storage folder. Then click Tools > Map Network Drive. The
Map Network Drive dialog appears.
Introduction
This document instructs you how to configure a printer for use with Stratus OCT™. These
instructions provide requirements and recommendations for the printer, but are generic
with respect to brand.
Note: Carl Zeiss Meditec supplies and/or identifies specific printers that have been
approved for use with the instrument. An approved printer may come with detailed
configuration instructions, and users are advised to closely follow the instructions
supplied with the approved printer.
These instructions cover two configurations for communication between instrument and
printer:
1. Network Configuration (page 3), either via direct connection between
instrument and printer, or via connection of instrument and printer to a local area
network
2. USB Configuration (page 3), via direct USB connection between instrument and
printer
WARNING: When using the printer in the USB configuration, you must power
the printer through the Stratus OCT isolation transformer. Failure to observe
this warning could result in electrical shock to the patient and/or examiner. To
do so, you must use a special power cable. The required cable has an
IEC-320-14 connector on one end and a IEC-320-13 connector on the other
end. When the printer is purchased through Carl Zeiss Meditec, this cable is
included with the printer.
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 warning could result in electrical shock to the patient and/or
examiner.
Approved Printers
Please refer to the Stratus OCT Technical Support section of our website
(www.meditec.zeiss.com/stratus) for the current list of approved hardware and software. If
you wish to use a third party printer, seek technical support from your printer manufacturer.
Repairs necessitated by the attempt to use a non-approved printer are not covered under
warranty.
Accessory Equipment
WARNING: Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC standards (e.g.,
IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore, all configurations shall comply with the system
standard IEC 60601-1-1. Any person who connects additional equipment to
the signal input part or signal output part configures a medical system, and is
therefore responsible for ensuring that the system complies with the
requirements of the system standard IEC 60601-1-1. If in doubt, consult the
technical service department or your local representative.
Installation Overview
The following three general steps are common to all configurations. These steps are
explained further in the specific sections.
1. Printer hardware setup: Refer to the instructions provided with the printer to unpack
and set up the printer hardware.
2. Connect hardware to enable communication between instrument and printer. The
hardware used depends on the type of configuration you select: either a network
cable or a USB cable.
3. Configure the instrument software to communicate with the printer, including
installation of necessary printer drivers.
Network Configuration
Typically, no printer configuration is required for the network configuration. Three general
steps are required for configuration:
1. Connect the printer to the Stratus OCT via network cabling
2. Power on the printer
3. Install printer drivers on the Stratus OCT.
This is the usual sequence of steps, but follow the instructions provided with the approved
printer for details.
Note: Use the same kind of network cable in all cases. (If you connect instrument
and printer to the network rather than to each other, you will need two network
cables.) Do not use an RJ-45 crossover cable for direct connection between
instrument and printer.
USB Configuration
No printer configuration is required for the USB configuration. Three general steps are
required for configuration:
1. Install printer drivers on the Stratus OCT
2. Connect the printer to the Stratus OCT via USB
3. Power on the printer
However, the sequence of steps may vary. Follow the instructions provided with the
approved printer to observe the correct sequence of steps.
Retinal Thickness/Volume Tabular protocol 6-14 Scan Messages 3-11, 3-12, 6-4, 6-5
Review button 3-13 Scan Messages, Interpreting 3-11, 6-4
right blue button 3-11 Scan Mode button 3-4, 3-10
Rim Area 6-24, 6-26 Scan Parameter Tab 3-7
Rim Area (Vert. Cross Section) 6-23 Scan Pattern Parameter area 3-14
RNFL Map protocol 4-9 Scan Pattern, moving 3-8
RNFL Normative Database 6-6 Scan Patterns 11-1
RNFL Thickness (2.27xdisc) protocol 4-9 Scan Pixels 11-1
RNFL Thickness (3.4) protocol 4-8 scan placement 3-8
RNFL Thickness Average protocol 6-18 and scan mode 3-8
automated features 3-8
RNFL Thickness Change protocol 6-21
Click and Drag 3-8
RNFL Thickness Map protocol 6-20
Move the Fixation LED 3-9
RNFL Thickness Normative Data 6-6
Move the Scan Pattern 3-8
RNFL Thickness protocol 6-17
Scan Profile protocol 6-40
RNFL Thickness Serial Analysis protocol 6-22
Scan Protocol Descriptions, Options And Tips 4-6
Routine Cleaning 10-2
Scan Protocol Groups 4-1
Routine Maintenance 10-1
Scan Protocols
Circle 4-8
S
Concentric 3 Rings 4-10
safety, NAS device E-1
Cross Hair 4-7
safety, printers F-1
Fast Scans
Save button 3-11, 3-13
Fast Macular Thickness Map 4-7
Scan Acquisition Protocols 4-1
Fast Optic Disc 4-7
Scan Acquisition Time 11-1
Fast RNFL Thickness (3.4) 4-7
Scan Acquisition Window 3-4 Line 4-7
Scan Adjustments, Other 3-13 Macular Thickness Map 4-7
Scan button 4-1 Nerve Head Circle 4-10
Scan Direction Legend 6-4 Optic Disc 4-10
Scan drop-down list 3-16 Proportional Circle 4-9
Scan Group Images Tab 5-2 Radial Lines 4-7
scan image 3-5 Raster Lines 4-8
bringing it into view 3-7 RNFL Map 4-9
scan image and axial “window” 3-7 RNFL Thickness (2.27xdisc) 4-9
scan image color scale 3-17 RNFL Thickness (3.4) 4-8
scan image optimization X-Line 4-8
optimize polarization 3-7 scan protocols
application 4-3, 6-3
Scan Protocols Are Correlated with Analysis Protocols 4-3 Software and Storage Media 1-8
Scan Protocols, all listed 4-2 Software Copyright 12-3
Scan Range 11-1 Software License Agreement 12-3, 12-4
Scan Review Window 3-13 Software Support Agreement 12-8
Scan Selection button 5-3 Specifications 11-1
Scan Selection for analysis, optional 5-2 CE Mark 1-11
Scan Speed 11-1 Electrical Requirements 11-1
Scan Tab 4-1 Environmental Conditions 11-2
Scan Tab Views 4-1 Fundus Imaging 11-1
Details View 4-1 Measurement Units 11-2
Large Icon View 4-1 Physical Dimensions 11-2
List View 4-1 Start-up 11-2
Small Icon 4-1 System Control Input Devices 11-2