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User Manual
ii
Revision Control
Part Software
Number Rev Version Description Release Date
59235-1 A 5.0 Stratus OCT User Manual English 2007.11
Copyright
2007 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
(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
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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.
Intended Use
The Stratus OCT is intended for use as a diagnostic device to aid in the management of
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ocular diseases.
Stratus OCT Review Software is intended to view and analyze data collected by the Stratus
OCT instrument.
Note: The Stratus OCT and Stratus Review Software are not intended to
be used as the sole diagnostic for disease.
This user manual is also intended for operation of the Stratus Review Software. Stratus
Review Software running on a separate computer is functionally identical to the software
running on the Stratus OCT instrument except for the ability to acquire images.
Information specific to Stratus Review Software is noted as such herein. The following
sections or documents, in particular, contain information specific to Stratus Review
Software:
See the installation instructions accompanying Stratus Review Software for specific
requirements for Stratus Review Software, such as minimum system requirements for
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installation.
Appendix (B) Configuration Guide contains information to enable transfer of
Stratus OCT data to a computer running Stratus Review Software via network
connection or removable media.
If you are using Stratus Review Software, you can ignore Chapters (2) Prepare To Scan
and (3) Acquire Scans.
microstructural features in the retina. The Stratus OCT projects a broad bandwidth
near-infrared light beam (820 nm) onto the retina from a super luminescent diode. It then
compares the echo time delays of light reflected from the retina with the echo time delays
of the same light beam reflected from a reference mirror at known distances. When the
Stratus OCT interferometer combines the reflected light pulses from the retina and
reference mirror, a phenomenon known as interference occurs. A photodetector detects
and measures interference. Although the light reflected from the retina consists of multiple
echoes, the distance traveled by various echoes is determined by varying the distance to
the reference mirror. This produces a range of time delays of the reference light for
comparison.
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.
images and data on rewritable DVD-RAM disks. The inkjet printer enables you to generate
color hard copy.
The Stratus OCT system hardware consists of the Patient Module; the Computer Unit; the
Flat Screen Video Monitor; the keyboard, mouse and color inkjet printer. The hardware
mounts on a wheelchair accessible motorized power table. The table accommodates
elevation adjustment to each patient's height. The illustration below labels hardware
elements. System specifications are in Chapter (11).
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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.
partitioned into C: and F: drives. The C: drive is reserved for operating system and Stratus
application files, while the F: drive is reserved for data files. Besides the Stratus database,
the F: drive contains the My Documents folder and the computer Desktop. Thus, files you
save to the Desktop can be found in the F: drive.
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
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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 5.0 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
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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
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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 CZM distributor.
This instrument has no special measures to protect against harmful ingress of water
or other liquids (classified IPXOordinary 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.
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.
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 CZM distributor.
Although this instrument is designed for continuous operation, it should be turned off
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Product Compliance
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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.
the patient cannot touch a peripheral device with any part of his or her body
while being examined. In addition, the instrument operator must not attempt
to touch the patient and a peripheral device at the same time while
examining the patient.
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 patients 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 is not offering and does not offer advice or
instruction in the diagnostic interpretation of OCT images. It is the clinicians
responsibility to make diagnostic interpretations of OCT scans.
for the patients eye be limited to the minimum time that is necessary for
diagnosis. Infants, aphakes and persons with diseased eyes will be at greater
risk. The risk may also be increased if the person being examined has had any
exposure with the same instrument or any other ophthalmic instrument using
a visible light source during the previous 24 hours. This will apply particularly if
the eye has been exposed to retinal photography. Note: This medical device
has no user adjustable intensity settings for light incident on the retina, nor
does it produce UV radiation or short-wavelength blue light.
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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.
guidance
The Stratus OCT uses RF energy only
RF emissions Group 1 for its internal function. Therefore,
CISPR 11 its RF emissions are very low and are
not likely to cause any interference
in nearby electronic equipment.
RF emissions Class A
CISPR 11 The Stratus OCT is suitable for use in
all establishments other than
Harmonic emissions Class A
domestic and those directly
IEC 61000-3-2
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maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the Stratus OCT as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W
d = 1.17 P d = 1.17 P d = 2.33 P
0,01 0.117 0.117 0.233
0,1 0.370 0.370 0.737
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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.
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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
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Manufacturer
Serial number
Model number
European Conformity
Handling Requirements
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Keep Dry
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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
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
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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 programsand thereby
implement Stratus OCT software upgrades.
Only administrators can create new user accounts, manage network settings and read
the files of other users.
3. In the Users and Passwords dialog box, select the checkbox near the top that says
Users must enter a user name and password to use this computer. This activates the
Add, Remove and Properties buttons.
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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.
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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
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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.
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Chapter Overview
This chapter explains in detail how to prepare for scanning with the ZEISS Stratus OCT.
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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).
The computer power switch activates power to all system components. It is the switch on
the upper left corner of the computer (see the Stratus OCT System Hardware drawing
on page 1-4). Press the switch and hold it down for 3-4 seconds to activate power to all
components. The Stratus OCT software loads automatically. It requires about 45 seconds
for the Stratus OCT START WINDOW to display (pictured below). During this time, buttons on
the keyboard and the Patient Module are disabled.
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. For example, to initiate a scan, move the
pointer to the Select Analysis Protocol button and 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
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drops are rare, but could include life- or sight-threatening reactions such as acute
glaucoma, cardiac irregularities, increased intraocular pressure and sudden high blood
pressure.
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.
experienced operator can acquire several scans from each eye in the space of 5-7 minutes.
An exam usually requires the patient to look inside the ocular lens of the Patient Module
for 1-3 minutes at a time for each eye, depending on the number of scans desired. The
instrument acquires most scans in about 1 second. The additional time is required to
position the Patient Module before scanning and to optimize scan quality. The patient
need not remain in the head mount throughout an examination, since the operator can
reposition the patient module as needed. Note that the Stratus OCT is never to contact the
patient's eye.
If you select internal fixation, we recommend that you cover the patient's fellow eye
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Category Field
If you have created patient categories (select Options > Register > Categories to create
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categories), you can use the drop down list to select a category of patients for display in
the patient list.
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.
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.
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For eyes that are smaller or larger than average, we recommend you input the
Spherical Equivalent and Axial Length (in mm).
When the Stratus OCT database reaches capacity, you must make space by clearing scan
data that has been archived. However, you can prevent the exam records of any patient
from being among those cleared, if you click the No radio button in the Allow Clear
Exams area on the right. The Yes radio button is selected by default, allowing the Stratus
OCT to clear this patients exams when necessary, and only if they have been archived
(copied) first. See the section Clear Archived Exams on page 8-21 for more
information.
Chapter Overview
This chapter explains in detail how to acquire Stratus OCT scans. It covers the following
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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).
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The Stratus OCT offers 19 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).
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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.
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double-click the protocol. This activates the SCAN ACQUISITION WINDOW, as pictured
below.
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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.
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 can be useful to Adjust Scan Placementsee
page 3-8.
Caution
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You must position the patient module manually, using the joystick to make adjustments in
three dimensions. It is a reiterative process of positioning with the joystick, focusing the
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 possiblesee Video and Lamp Parameter Tab, page 3-18,
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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 joystickmove for lateral adjustments and twist for vertical
adjustmentsto 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.
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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
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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).
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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 left arrow searches posteriorly (lower in the scan image), and the right 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).
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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
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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.
The two-headed arrow appears when the pointer is near the edge of a scan pattern.
Click and drag with this arrow to adjust the scan size, and the angle if available (see
Size and Angle, page 3-14 for more information).
2-headed arrowChanges the
length and angle of scan patterns. Move the Fixation LED
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Click and drag works on the fixation LED if it is sufficiently separated from the scan pattern,
or if you select Move Fixation LED from the drop-down list as illustrated in Figure 3-5
below. After you save the first scan in a related series, you can no longer move the fixation
LED (see Which Scan Parameters Can Be Adjusted When, page 4-4, for more
information).
Why move the fixation target? Aside from changing between fovea and disc
locations, it may not be clear why one would want to adjust the fixation target
location. The usual reason is to bring another portion of the retina into view or into
the center of view so that the scan pattern may be applied to it. For example, there
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may be a particular area of pathology away from the macula or the optic disc.
When freezing the video image of the macula, you may observe better contrast
when you move the fixation LED to bring part of the optic disc into view on the
edge of the video image. It may also help in orienting your observations.
Landmark
The landmark is a pulsating point of light that is by default centered in every scan pattern.
It can be moved independently and placed on a point of reference to enable reproducibility
of scan pattern placement.
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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 patients 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,
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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 Optional Scan Review
Window on page 13.
Blue patient module buttons: Press the right blue button to save the scan image
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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.
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
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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
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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.
The availability of these parameters for adjustment depends on the scan protocol
see Which Scan Parameters Can Be Adjusted When on page 4-4 for
information on which you can adjust. When available, the Value field has a white
background. Just click in the field and type a value. When unalterable, the Value
field has a gray background.
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
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Angle
0 (also 360 or -360) Scan For the Line scan protocol (page 4-6), you can adjust the angle of the line. The default
proceeds from 9 to 3 oclock. 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 oclock 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 oclock.
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 oclock. image, but the 180 line originates at the 3 oclock 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).
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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
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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
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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
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Details Tab
This tab specifies the x and y position of the scan pattern, the landmark and the fixation
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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.
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Chapter Overview
This chapter explains the applications and attributes of the 19 scan acquisition protocols
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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).
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Retina groups (three are in both). The others may be considered general-purpose scan
protocols, and can be used to build custom scan protocols.
In the Large Icon view, click on the icon to see the entire name.
Glaucoma Protocols
The protocols designed for glaucoma detection and management are:
1. Repeat
2. Macular Thickness Map
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3. Optic Disc
4. RNFL Thickness (3.4)
5. RNFL Thickness (2.27xdisc)
6. Fast Macular Thickness Map
7. Fast Optic Disc
8. Fast RNFL Thickness (3.4)
9. Fast RNFL Map
Retina Protocols
The protocols designed for other retinal pathologies are:
1. Repeat
2. Macular Thickness Map
3. Fast Macular Thickness Map
All Protocols
The All radio button displays all 19 protocols together. They are listed below in their default
order on the Scan Tab.
1. RepeatGlaucoma and Retina
2. Line
3. Circle
4. Raster Lines
5. Cross Hair
6. Radial Lines
7. Macular Thickness MapGlaucoma and Retina
8. Optic DiscGlaucoma
9. Proportional Circle
10.Concentric 3 Rings
11.RNFL Thickness (3.4)Glaucoma
12.Nerve Head Circle
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.
When selecting a scan protocol, it is important to keep in mind the analysis protocol(s) that
you can apply to the resulting scan image. The 19 analysis protocols are of two kinds:
twelve Quantitative Analysis Protocols (see page 6-12) and seven Image
Processing Protocols (see page 6-35). Carl Zeiss Meditec designed the image
processing protocols for use with any scan. However, we designed each quantitative
analysis protocol for use with a certain scan type (line or circle) or scan pattern made on a
certain retinal location (macula or disc). Several of the scan protocols are designed for use
with a limited subset of analysis protocols. An analysis protocol might work on an
unintended scan type, but even if it does, it may not provide meaningful output. The table
below shows the scan protocols for which we designed each quantitative analysis 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 Radial Lines, (Fast) Macular Thickness Map: 1 group on macula
Retinal Thickness/Volume Radial Lines, (Fast) Macular Thickness Map: 1 OS group and/or 1 OD
group on macula
Retinal Thickness/Volume Radial Lines, (Fast) Macular Thickness Map: 1 OS and/or 1 OD group on
Tabular macula
Retinal Thickness/Volume Radial Lines, (Fast) Macular Thickness Map: 2 OS and/or 2 OD groups
Change on 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
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.
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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.
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
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Number of A-Scans
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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.
lines, see Adjust Scan Pattern Parameters on page 3-14. To Adjust Scan
Placement, see page 3-8. To Optimize Scan Image, see page 3-6.
Repeat
The Repeat protocol allows you to repeat any saved scan group using the same set of
parameters. Repeated parameters include scan size, angle and placement, fixation LED
placement and landmark placement. This protocol enables you to best assess retinal
changes between examinations and thereby to monitor pathologies. When you repeat a
scan group, the parameters unique to each scan in the series are recalled and repeated in
the same order. You cannot adjust any parameters except placement. To repeat a scan,
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select the desired scan group in the MAIN WINDOW. Then click Repeat.
The Landmark (see page 3-9) is a useful tool to duplicate placement precisely.
When acquiring or reviewing a Repeat scan, click the Show Old Fundus Image button
to toggle between the current fundus video image and the saved fundus photo of the
scan you are repeating. You can also click Scan > Show Old Fundus Image.
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.
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.
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.
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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
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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.
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 6-26).
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.
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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
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Note: Since you can adjust the placement of the second and third scans, it is
possible to render the circles non-concentric.
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 of two perpendicular
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Adjusting size of bounding box: lines of length 3 mm. You can adjust line scan length by adjusting the height and width of
At left: increased height. 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.
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
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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.
Increased resolution for the fast scan types would require three or more seconds of
scanning, which tends to introduce greater errors from patient movement.
Macular Thickness Map, Fast Optic Disc and Fast RNFL Mapor a 3x1 displayfor
Fast RNFL Thickness (3.4)so that you can observe each line or circle scan
separately as it updates, and align appropriately.
Chapter Overview
Carl Zeiss Meditec equips the Stratus OCT with software to assist you with analysis of scan
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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).
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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
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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
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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.
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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.
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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. In addition, they do not
contain patient information. It is the clinicians responsibility to associate patient
information with exported images.
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.
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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
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Chapter Overview
The Stratus OCT offers 19 analysis protocols, divided between:
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Protocol Lists
While you can group the 19 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 12 Glaucoma and Retina protocols are quantitative analysis protocols.
None of the 7 image processing protocols is a Glaucoma or Retina protocol. They are
applicable to any scan group.
Note: You can apply only one analysis at a time. You cannot apply analysis protocols
additively because no analysis changes the original scan image data on which all
analyses are based.
Glaucoma
1. Retinal Thickness/Volume (OU)
2. Retinal Thickness/Volume Tabular (OU)
3. Retinal Thickness/Volume Change (OU)
4. RNFL Thickness (Single Eye)
5. RNFL Thickness Average (OU)
6. RNFL Thickness Map (OU)
7. RNFL Thickness Change (OU)
8. RNFL Thickness Serial Analysis (OU)
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Retina
1. Retinal Thickness (Single Eye)
2. Retinal Map (Single Eye)
3. Retinal Thickness/Volume (OU)
4. Retinal Thickness/Volume Tabular (OU)
5. Retinal Thickness/Volume Change (OU)
General Tips
The following general information and usage tips apply to all analysis protocols. Starting
below, this chapter provides a description and specific usage tips for each protocol.
scan pattern made on a certain retinal location (macula or disc). Several of the scan
protocols are designed for use with a specific analysis protocol, or with a limited subset of
analysis protocols. An analysis protocol might work on an unintended scan type, but even
if it does, it may not provide meaningful output. The table below shows the scan protocols
designed for each quantitative analysis protocol.
Table of Correlations
Analysis Protocol Designed for Scan Group(s)
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Retinal Thickness Any scan protocol except (Fast) Optic Disc: 1 group on macula
Retinal Map Radial Lines, (Fast) Macular Thickness Map: 1 group on macula
Retinal Thickness/Volume Radial Lines, (Fast) Macular Thickness Map: 1 OS group and/or 1 OD
group on macula
Retinal Thickness/Volume Radial Lines, (Fast) Macular Thickness Map: 1 OS and/or 1 OD group on
Tabular macula
Retinal Thickness/Volume Radial Lines, (Fast) Macular Thickness Map: 2 OS and/or 2 OD groups
Change on 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
degrees, for line scans) is at lower right. See Angle on page 3-14 for an explanation of
the angle notation.
number from 0 (worst) to 10 (best), which it displays in the signal strength field. The
Stratus OCT also analyzes the vertical placement and completeness of the scan image and,
if applicable, returns one of the messages Scan too high, Scan too low or Scan
missing data in the scan message field. The signal strength and scan message fields
appear on the SCAN ACQUISITION WINDOW (Figure 3-3, page 4), the SCAN REVIEW WINDOW
(Figure 3-7, page 3-13), the SELECTION WINDOW (Figure 5-4, page 5-4) and on all
analysis output windows and analysis printouts. The additional message Analysis
Confidence Low can appear in the scan message field on the analysis output windows
and printouts of all quantitative analysis protocols, except for the Optic Nerve Head
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analysis.
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.
The Stratus OCT detects when the scan image being analyzed has anomalies that prevent
reliable detection of the retinal layer boundaries, which reduces the reliability of the
analysis. These anomalies may be due to pathology or to an area of weak signal in the
scan. In these cases, the analysis output screen and printout will include the message:
Analysis Confidence Low. When it appears, the operator should use the Edit
Layers feature (see page 6-8), or repeat the scan. This message can appear on the
analysis output windows and printouts of all quantitative analysis protocols except the
Optic Nerve Head analysis.
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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 90 (6 oclock origin) and 270
(12 oclock 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.
Stratus OCT normative database study was designed to obtain normative data for RNFL
and macular thickness from healthy subjects ages 18 to 86. Reference intervals established
in the normative database study are used by the physician to compare individual patient
measurements to those acquired in a normal population. See Macula Normative
Database, for a detailed description of how this normative database was generated,
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including the selection criteria employed in the clinical study, a discussion of data
acquisition and analysis, and the establishment of normal limits.
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.A., call 1-877-486-7473; outside the
U.S.A., contact your local Carl Zeiss Meditec 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 is not offering and does not offer advice or
instruction in the diagnostic interpretation of OCT images. It is the clinicians
responsibility to make diagnostic interpretations of OCT scans.
Note: Clinicians must exercise judgment in the interpretation of the normative data.
For any particular measurement, note that 1 out of 20 normal eyes (5%) will fall
below green.
Tabular, or Retinal Map analysis protocols on a Fast Macular Thickness Map scan.
When the Retinal Thickness, Retinal Thickness/Volume Tabular, or Retinal Map
analysis protocols are applied to a Fast Macular Thickness Map scan, the
age-matched normative data appears. It uses a light red-light yellow-green-yellow-red
color code, as seen in the legend at left, to indicate the normal distribution percentiles. The
color code applies as follows:
In the Retinal Thickness output, to each particular A-scan location in the thickness
chart.
In the Retinal Thickness/Volume Tabular output, to the circular maps of retinal
thickness or volume, and to the OD and OS columns of the data table.
In the Retinal Map output, to the circular maps of retinal thickness.
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).
Note: Clinicians must exercise judgment in the interpretation of the normative data.
For any particular measurement, note that 2 out of 20 normal eyes (10%) will fall
either above or below green.
Edit Layers
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
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available with all of the Quantitative Analysis Protocols (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.
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If the analysis includes multiple scan groups and/or scans from more than one eye, initially
it displays the first scan in the first group for the right eye. The currently selected scan is
open for editing in the large pane at the top; its thumbnail is highlighted in blue at lower
left and it is identified by the text below the thumbnails at bottom left. The layer
boundaries are white (by default) until edited. (They are also white if you leave a scan
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without saving your edits and later return to it.) While editing, the layers are pink, until
saved. Layers already edited and saved are yellow when you open them for editing again.
By default, the last set of layer edits are displayed for each scan, unless another set of layer
edits has been set as the default--see Working with Saved Layer Edits on page 6-10.
Note: The line colors mentioned are the default colors. You can Adjust the Edit
Layer Line Colors, as explained on page 6-9 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
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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
filed 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
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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.
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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 Cancel or the at upper right to close the Layer Edit Dialog. You will return
the analysis window from which you began.
layers.
or
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The example below displays edited layers and highlights the message.
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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:
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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
Retinal Thickness/Volume
Application: Select Retinal Thickness/Volume to obtain for each eye two circular maps
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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 Radial Lines or (FAST)
Macular Thickness Map protocols.
Output Display
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made with the Radial Lines or (FAST) Macular Thickness Map protocols. Normative
data will appear in the output if you analyze a Fast Macular Thickness Map scan, as
described in Macula Normative Database on page 6-7.
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.
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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)
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Note: Clinicians must exercise judgment in the interpretation of the normative data.
For any particular measurement, note that 2 out of 20 normal eyes (10%) will fall
either above or below green.
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Output Display
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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
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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:
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Output Display
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Note: Clinicians must exercise judgment in the interpretation of the normative data.
For any particular measurement, note that 1 out of 20 normal eyes (5%) will fall
below green.
patients under 18 years of age. The normative data appears only when you analyze
either Fast RNFL Thickness (3.4) scans or a single RNFL Thickness (3.4) scan at
the default 512 A-scans. Normative data will not appear when you analyze two or
more RNFL Thickness (3.4) scans that have been averaged, or if you analyze a Fast
RNFL Thickness (3.4) scan from which scans have been deselected.
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Output Display
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Output Display
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Output Display
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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.A., call 1-877-486-7473; outside the U.S.A., contact
your local Carl Zeiss Meditec 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 eyeup 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).
Application: Select GPA Advanced Serial Analysis to do a statistical analysis of RNFL
thickness over time. You can apply this analysis simultaneously to up to eight OD and/or
eight OS scan groups of equal radius and same scan type. All scans you choose must be
from either RNFL Thickness (3.4) or Fast RNFL Thickness (3.4).
Output Display
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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%).
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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 (/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 /year
then there is 95% confidence that the rate of change of average RNFL thickness is
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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,
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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%.
scan (on the left side of the screen). The other measure is the minimum distance between
the RPE and the RNFL surface. On each side of the nerve head, the analysis calculates this
distanceindicated as yellow linesthen averages them to yield the Avg Nerve Width
@ Disc. The analysis calculates these values for each of the radial line scans and then
integrates them to give results for the entire nerve head. The analysis screen presents the
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integrated values on the right side along with a composite image of the nerve head
constructed from all scans.
features of disc anatomy based on the anatomical markers (disc reference points) on each
side of the disc where the RPE ends. It locates and measures the Disc Diameter by
tracing a straight line between the two disc reference points. It measures Cup Diameter
on a line parallel to the disc line and offset anteriorly by 150 micrometers (by default
Cup Offset is adjustable). It determines Rim Area using the cup line as a posterior
boundary; for the rim lateral boundaries it uses lines extended from the disc reference
points perpendicular to the disc line and up to the anterior surface of the disc. The results
of these detection and measurement algorithms are displayed graphically on the scan
image. In the output display, you can adjust the placement of the disc reference points,
and thus the resulting measurements. Optic Nerve Head analysis then combines the
analysis and measurement of each individual scan into a composite image and
measurements of the whole optic nerve head.
Output Display
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Note: The ONH analysis is unique in that you can deselect individual scans on the
analysis output window and thereby exclude them from the analysis. To deselect a
scan, clear the Use This Scan Data checkbox. The analysis changes immediately
when you deselect the scan. Note further that deselecting individual scans in the
Selection Window (see page 5-4) is not effective when performing an ONH
analysis. That is, all six radial line scans are always included even if you deselect the
exams in the SELECTION WINDOW.
The scan image has a color graphic overlay that defines the measured anatomical features,
as follows.
Individual Scan Image Measurements
Rim Area (Vertical Cross Section): The red-hashed area above the cup line
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disc/cup ratios. At far right and lower right are tools to adjust the composite image and its
analysis, and to save multiple analysis results and select results previously saved.
The path of each scan is traced with a blue line, except for the scan currently
displayed on the left side. It is traced in yellow and has a small yellow cross at one
end that indicates its point of origin. You can click each line to change it to the
currently displayed scan. If you adjust the scan image appearance or the placement of
its disc reference points, its scan line will thereafter be traced in a lighter shade of
blue, until you Reanalyze it. The new position of the disc reference points will be
reflected in the composite image.
You can click buttons to Zoom In, Zoom Out and Clear Points on the composite image.
Composite Image Measurements
Vertical Integrated Rim Area (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.
Horizontal Integrated Rim Width (Area): This is an estimate of the total rim
area calculated by multiplying the average of the individual nerve widths times
the circumference of the disc.
Disc Area: The area bounded by the red outline of the disc in the composite
image.
Cup Area: The area bounded by the green outline of the cup in the composite
image.
Rim Area: Disc area minus cup area.
Cup/Disc Area Ratio: Ratio of cup area to disc area.
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.
Plot Background Options: You can select among three image background options.
Click a checkbox at lower right to change the appearance of depth and contour in the
image:
None: This option shows a solid gray background without any appearance of
depth.
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Absolute: This option shows the retina surface as background to the disc and cup
plots using a shaded gray surface in a way similar to a shaded relief topographic
map. This option attempts to correct for movement of the retina between scans by
using the disc positions within each radial scan. The blue shading represents the
surface and volume of the cup, as if it were filled with water to its surface. The
surface of the cup, and hence the blue shading, is adjustable via the Cup Offset
for Topo setting. (Topo refers to the topographic map of the retinal surface.)
Cup Area and Cup Volume measurements based on the adjustable cup
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surface appear at bottom right. Because of the scan alignment, the cup area
calculated from the topo can differ from the cup area calculated from the planar
cup positions.
Aligned and Shaded: This default option differs from the previous option only in
the type of alignment used to correct for retinal motion. In this case, the retinal
surface is used. For each scan, an estimate is made of the retinal surface height,
ignoring the area near the optic nerve head. The scans are then aligned to make
all the individual surfaces match. The retina surface is displayed in shaded relief to
enhance the visibility of surface features.
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.
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 scan, as described in Macula Normative Database on page 6-7.
Output Display
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considered below normal limits (red < 1%, below normal limits).
Note: Clinicians must exercise judgment in the interpretation of the normative data.
For any particular measurement, note that 2 out of 20 normal eyes (10%) will fall
either above or below green.
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
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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 Radial Lines 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 scan, as described in Macula
Normative Database on page 6-7.
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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
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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 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
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Note: Clinicians must exercise judgment in the interpretation of the normative data.
For any particular measurement, note that 2 out of 20 normal eyes (10%) will fall
either above or below green.
5. Median Smoothing
6. Proportional
7. Scan Profile
These protocols apply mathematical algorithms to change the appearance of the scan
image. They do not change the raw scan data. All these protocols operate on only one
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scan group at a time. If you select more than one group, only the first group will be
processed.
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.
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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 0255. Normalize
displays as zero (black) data points with values less than or equal to the average noise
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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
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to shift vertically, resulting in low-frequency wiggles. (This also happens if the scan beam
is not perpendicular to the retina over the whole scansee 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.
Gaussian 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
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
average value weighted by location. The advantage of Median Smoothing is that it
removes noise while preserving small details in the data.
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
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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.
Scan Profile
Select Scan Profile to display an interactive profile of all signal values for any single scan
group, as pictured below.
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Click the Mirror Image checkbox to horizontally reverse the scan image and the
corresponding Scan Profile Chart.
Select Grayscale or Color (default) for the OCT image. Use the + and buttons to
adjust the image brightness.
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Chapter Overview
This chapter explains how to perform data management functions. The topics covered in
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only during database export or retrieve. In the EXPORT WINDOW or RETRIEVE WINDOW, click
the Records Search button or select Advanced Search from the Record menu.
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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).
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.
When the Stratus OCT database reaches capacity, you must make space by clearing scan
data that has been archived. However, you can prevent the exam records of any patient
from being among those cleared, if you click the No radio button in the Allow Clear
Exams area on the right. The Yes radio button is selected by default, allowing the Stratus
OCT to clear this patients exams when necessary, and only if they have been archived
(copied) first. See the section Clear Archived Exams on page 8-21 for more
information.
WARNING: 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 to unintentionally merge patient records by editing a patient record
so that it has the exact same identifying information as another record. Once
this occurs, Stratus OCT recognizes only one record, and there is no way to
separate the combined records of the erroneously merged patients. However,
it is possible to Delete Exam Records that do not properly belong to a
patient record (see page 7-17). To avoid unintentional merging of patient
records, you must make certain that you enter a unique combination of Name
(Last, First, Middle), DOB, Gender and Patient ID when editing patient records.
Stratus OCT recognizes all records with the same identifiers as a single patient record, and
you will observe just one record for the patient in the patient list.
The identifier fields are case-sensitive and do consider spaces as characters. If the
identifier fields in two patient records appear to be identical, check for extra spaces
between words or at the end of the fields.
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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.
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To discard the changes before saving, click the Undo Changes button. You must
confirm your choice in the CONFIRM dialog box.
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.
2. In the EXAM RECORD WINDOW, if necessary, click the Edit Current Exam Record button.
This activates the Exam Notes field.
3. Add or edit the desired information. When finished, 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.
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In general, the advantage of the categories function is that it provides you the ability to
create groups of your own design for any reason, and to directly control their membership.
All other search criteria arise from objective data (with the exception of diagnoses that you
create and assign, albeit based on exam data).
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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.
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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.
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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.
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Note: When this radio button is selected, all categories appear in the list, not just
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different diagnoses.
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
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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
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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
description will read Glaucoma, as if the record were created on importing
instrument B.
To delete a diagnosis and remove references to it in all records, click the diagnosis you wish
to delete and then click the Delete Selected Diagnosis Forms button. You must confirm your
choice in the CONFIRM dialog box.
2. In the PATIENT RECORD WINDOW, click the Diagnoses Tab to bring it to the front.
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Note: Medical staff names are not case-sensitive. For example, Richards and
richards would be treated as the same name in a search.
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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.
1. In the MAIN WINDOW, select the desired patient and click the Edit button, or select Edit
Patient from the Patient menu (click Patient > Edit Patient). The PATIENT RECORD
WINDOW appears with the default General Data Tab showing (see Figure 7-2).
2. Use the Attending Physician and/or Referring Physician drop-down lists to
select one from among those registered.
3. Click the OK button to accept the 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.
Stratus OCT enables you to create and edit insurance company records and assign them to
patient records. Besides its record-keeping function, once you assign insurance companies
to patient records, you can search for patients by insurance company during export and
retrieve. See Advanced Record Search on page 7-1 for more information.
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.
1. From the MAIN WINDOW, select the desired patient and click the Edit button. The
PATIENT RECORD WINDOW appears with the default General Data Tab showing (see
Figure 7-2).
2. In the Insurance area near the bottom, use the Company drop-down list to select
one from among those registered. You can also type an identification number in the
Insurance ID field.
3. Click the OK button to accept the 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: 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.
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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
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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
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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,
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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.
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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.
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Chapter Overview
The Stratus OCT offers several functions that together enable you to preserve your valuable
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patient data and maintain excellent 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.
Note: Starting with Stratus OCT instruments that ship with software version 5.0,
Stratus OCT is not equipped with a writable DVD drive, and therefore cannot write
(cannot archive) to DVD. This is to implement the use of a network server or network
attached storage device for archive and backup purposes, which provide a more
secure and higher capacity long-term storage solution. The instructions in this
section remain for the benefit of Stratus OCT users whose units include a writable
DVD drive. Units with DVD-ROM units can read from DVD archive disks.
1 2
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Scan data
reference locations
Scan data includes the OCT images generated during an examination, along with the
associated patient, visit and exam data.
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The index database identifies each saved scanby patient, visit, scan acquisition protocol
and location where the scan images are saved.
1 2
Archive Backup
scan data when prompted, eventually the hard disk will reach capacity and prevent you
from saving new scans. At that point, you must clear scan data to save new scans.
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.
Media Requirements
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Note: This manual uses the terms archive (as a noun), archive volume and
archive location interchangeably.
Note: Stratus OCT software version 5.0 does not support manual backup. Software
versions before 5.0 supported manual backup, including to removable media,
provided your system had the necessary hardware.
Note: Users who do not have a DVD-RAM drive on their Stratus OCT should ignore
portions of the manual that refer to archive and backup to DVD-RAM disks (or to
removable media).
Note: Later versions of Stratus OCT hardware support export and import using CDs
and DVDs. See Appendix (D) Data Transfer Using CDs and DVDs for more
information and instructions.
Brand: Carl Zeiss Meditec has qualified the following brands to work with the Stratus OCT:
Verbatim 4.7 GB DVD-RAM Type 2
Panasonic 4.7 GB DVD-RAM Type 2
OptoDisk 4.7 GB DVD-RAM Type 2
Imation 9.4 GB double-sided DVD-RAM
We recommend that you use one of these brands.
Quantity: Adherence to the Recommendations For Automated Data
Maintenance initially requires one DVD-RAM disk per instrument. Two more disks are
required each time you fill up an archive disk: one to duplicate the archive disk, and
another to continue the archiving process.
WARNING: You must not use the same archive or backup disk in more than
one Stratus OCT instrument. Use of an archive or backup disk in more than
one instrument could cause the incorrect identification of patient data. We
strongly advise that you physically label disks with the serial number of the
instrument to which it is dedicated.
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network drive can be either a network file server (computer) or a network attached storage
device (NASD); their behavior is the same with respect to the Stratus OCT. (This manual
uses the terms network drive and network file server interchangeably.) We recommend
the use of a network drive for archive and backup, for increased long-term data security
and convenience. See Networking Guidelines for information and recommendations
regarding your network setup.
The Stratus OCT archives to the current archive location. See Set Current Archive on
page 8-8.
Note: For archive and backup to a network file server, configuring the server and the
instrument should be attempted only by a network administrator or system
administrator. Instructions for network administrators to set up network archive and
backup can be found in Networking Guidelines. Users are responsible for network
setup and maintenance. 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.
WARNING: It is the users 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 8-21.
Auto Archive
When selected, each time you save a new scan, the Stratus OCT will automatically archive
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Note: The Stratus OCT will archive scans only to the current archive location. (For
details, see Set Current Archive on page 8-8.) If an error occurs that prevents a
successful automatic archive, the Stratus OCT will notify you of the failure and Auto
Archive will be suspended until the error condition is removed. In such cases, you
must archive scans manually when the error condition is removed. (See Manual
Archive on page 8-11 for instructions.) You will be prompted to archive the
un-archived scans on startup and shutdown, if the Archive Check option
(described next) is active.
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Note: Starting with Stratus OCT instruments that ship with software version 5.0,
Stratus OCT is not equipped with a writable DVD drive, and therefore cannot write
(cannot archive) to DVD. This is to implement the use of a network server or network
attached storage device for archive and backup purposes, which provide a more
secure and higher capacity long-term storage solution. The instructions in this
section remain for the benefit of Stratus OCT users whose units include a writable
DVD drive. Units with DVD-ROM units can read from DVD archive disks.
2. On startup, the Stratus OCT checks the remaining disk space of the current archive
volume. When an archive volume nears capacity, the Stratus OCT prompts you to
create a new one. If you click Yes to proceed, the Archive Registration dialog appears.
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Synchronization Disabled
For each network archive, it is possible to disable synchronization. To make sure a newly
added network archive is available for synchronization, select the archive and click Edit.
The Edit Archive Registration dialog appears, as in Figure 8-3. If the Disabled checkbox is
selected, you cannot synchronize from that archive.
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You can select or de-select the Disabled checkbox. If you make changes, click Save to
save your changes and return to the Archive Registration dialog.
about 0.4 seconds per exam (equivalent to ~150 exams per minute). A database
with 50,000 un-synchronized exams will require about 5.5 hours to synchronize.
After the first time, only new exams are synchronized, so the process is often much
faster.
To synchronize, follow these steps:
1. From the MAIN WINDOW, select Refresh Patient List from the Data menu (click
Data > Refresh Patient List).
The Stratus OCT adds all index database references from all registered and available
network archives to the system database. You will see the names of new patients
appear in the Patient List. You can now access their exams as if they were created on
your Stratus OCT, when the source archive is available.
2. In the Archive Registration dialog, click on the archive you want to make current and
then click Edit. The Edit Archive Registration dialog appears.
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Note: The Disable checkbox appears only when you are editing a network archive.
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3. Select the Mark as Current checkbox and click Save to save your changes. A message
reports that the archive volume is saved. Click OK to return to the Archive Registration
dialog, where the archive you selected will be marked as the current archive.
Note: Starting with Stratus OCT instruments that ship with software version 5.0,
Stratus OCT is not equipped with a writable DVD drive (nor a floppy drive), and
therefore cannot write (cannot archive) to DVD-RAM as previously. This is to
implement the use of a network server or network attached storage device for
archive and backup purposes, which provide a more secure and higher capacity
long-term storage solution. The instructions in this section remain for the benefit of
Stratus OCT users whose units include a writable DVD drive. Units with DVD-ROM
units can read from DVD archive disks.
A DVD-RAM archive volume can be registered in two ways:
When you create a new DVD archive volume, you register the archive as part of the
process.
When you retrieve scan data from an archive created on another Stratus OCT, that
archive volume is registered automatically.
Note: This manual uses the terms archive (as a noun), archive volume and
archive location interchangeably.
The Stratus OCT will prompt you when you need to create a new archive volume, or you
can create a new DVD archive at any time through the Archive Registration dialog.
On startup, the Stratus OCT checks the remaining disk space of the current archive volume.
When an archive volume nears capacity, the Stratus OCT prompts you to create a new one.
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The Mark as Current checkbox is selected by default. Do not change this selection if
you wish to use the archive you are about to create as the current archive.
Note: The Disable checkbox appears when you are creating or editing a network
archive; see Figure 8-3 above for an example.
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4. In the Local Path field, click Browse to find and select the desired archive location.
Users with a DVD-RAM drive can create a DVD archive by typing D: or selecting the D:
drive.
If desired, you can type a description in the Description field.
5. When finished, click Create. The Stratus OCT will create a new archive in the location
you specified. Unless you de-selected the Mark as Current checkbox, newly acquired
scans will be archived to this archive location.
Manual Archive
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Manual archiving is not required if you follow the Recommendations For Automated
Data Maintenance, described above. If you have opted not to use the automated
archive feature, follow the instructions below to archive un-archived scans manually. You
can archive scan data manually at any time.
Note: It does not affect the instrument or its performance to leave it running
overnight for archive or backup purposes.
Follow these steps to perform manual archiving:
1. From the MAIN WINDOW, select Archive from the Data menu (click Data > Archive).
The Archive dialog appears as below. You have the option to archive all un-archived
exams, or to select which exams to archive.
To select which exams to archive, click Select Exams for archiving. The ARCHIVE
WINDOW opens.
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thumbnails will be shown, while its selection checkbox is clear. In this case, its
scans will not be archived.
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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. When you have made your selections, click the Archive button or select Archive from
the File menu (click File > Archive). Archiving begins and a Progress dialog appears.
It can take several seconds to several minutes for the Stratus OCT to finish writing
to the archive volume, depending on the number of exams you selected. When
complete, a dialog notifies you, as at left.
Click Cancel to abort the archive process after the next whole patient record has
been archived. Already archived patients shall not be removed from the archive
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volume.
If you are using a new DVD archive disk, when the archive process is complete, a
Notice dialog will prompt you to write the new label on the archive DVD.
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location for use with the instrument as needed. Store the duplicate copy off-site in a secure
location.
9. Using the mouse, drag the selected files to the Archive Copy folder you created on the
desktop. Copying will begin immediately. (Duplication time can be up to 2 hours, so
plan accordingly).
As an alternative, you can copy the selected files by pressing Ctrl-C. Then go to
the Archive Copy folder you created on the desktop, open it and press Ctrl-V to
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14.Remove the duplicate A1 Copy disk from the drive, verify that it is properly labeled,
write protect the disk cartridge, and store the duplicate A1 Copy off-site in a secure
location.
15.Store the original Archive Disk A1 in a secure location for use as needed.
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!
2. Double-click the STRATUS DVD Formatter desktop icon, or click Windows Start >
Programs > Stratus OCT > STRATUS DVD Formatter. The Stratus OCT DVD Ram
Format Utility appears.
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Figure 8-16 Format the DVD using the UDF 1.5 File System
Click OK to close the dialog and proceed with formatting. The DVDForm dialog
appears.
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Format (UDF1.5).
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
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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.
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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
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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.
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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.
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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:
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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 7-4.)
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
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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
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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 clinics 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
Cannot Edit Identifying Information
The Stratus OCT applies a permanent electronic tag to patient records that are imported
without patient identifying information and treats them as a protected category of data.
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.
For all imported patient records, it is possible to import new scan data and update patient
data. In the case of records imported without patient identifying information, the Patient
Export ID enables updating of the patient record. Once created, the Patient Export ID
is fixed. It is also unique among those created on all Stratus OCT instruments because part
of it is derived from the unique serial number of the Stratus OCT instrument on which it
was created. If during import the Stratus OCT encounters information associated with a
Patient Export ID already imported, the Stratus OCT does the following:
imports all scan data (exams) not previously imported, but never deletes nor
overwrites any scan data already imported;
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updates patient data (e.g., axial length, patient categories, etc.) only if it was created
on a later date than the data already imported. This prevents overwriting of newer
patient data with older.
Note and WARNING: It is possible to reuse removable media for export, but
you must overwriteand in the process deletethe current export database.
You can also repurpose any dedicated removable media, but only if you first
delete all files on the media or reformat itand thereby permanently erase all
data on it.
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 7-18.
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.
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
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thumbnails will be shown, while its selection checkbox is clear. In this case, its
scans will not be exported.
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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.
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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.
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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 7-18.
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
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ports. It is the users 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.
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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.
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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:
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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 instruments 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
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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.
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number of exams in the export database. A message notifies you when the operation
is complete.
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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 to require very little user maintenance besides
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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 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.
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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.
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To order: In the U.S., call 800-341-6968. Outside the U.S., contact your local Carl Zeiss
affiliate or distributor.
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(11) Specifications
Tomographic Imaging
Purpose: Cross sectional imaging of fundus
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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
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Start-up
No special operator precautions needed for initial start-up.
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Measurement Units
All units on the Stratus OCT are measured in the SI format. Unless otherwise noted,
measurements are made in micrometers.
Calibration
Calibration is not required.
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).
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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.).
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Limited Warranty
This Warranty gives you specific legal rights, and you may have other rights, which vary
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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 4000, 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,
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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
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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.
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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 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
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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
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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.
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Notice
Users are responsible for network setup and maintenance, including installation and
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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 5.0 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
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connection to the local area network. Accessing the Internet with the Stratus
OCT can disable or degrade system performance. When exposed to the
Internet, the Stratus OCT is vulnerable to serious security risks, including
viruses and worms that could disable your system or adversely affect its
performance. Internet connectivity enables third party software, software
drivers and operating system updates to be downloaded to your system,
either automatically or intentionally. Installation of any unapproved software,
including drivers and operating system updates, could degrade the
performance of the instrument and/or lead to corrupted diagnostic or
therapeutic information and may void the instrument warranty.
Note: Stratus OCT Software Version 5.0 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
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The following activities are prohibited using the Stratus OCT instrument.
Do not share Stratus OCT folders with other computer systems via the network.
Do not share the Stratus OCT system printer on the network.
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
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compressed
It is the users responsibility to protect their exam data from loss by frequent
backup of the network server. Backup media should be of archival quality, and the
media should be stored in a secure, remote location.
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
A. Open Windows Explorer: Right-click the Windows Start button and select Explore.
B. In Windows Explorer, select Map Network Drive from the Tools menu (click Tools
> Map Network Drive). The Map Network Drive dialog appears.
C. Select a drive letter.
D. Click Browse to find and select the shared folder you created on the network file
server. You will have to first find the file server name (machine name), and then
the folder. (Do not clear the Reconnect at logon checkbox, which is selected by
default.)
E. When you have selected the correct folder and returned to the Map Network Drive
dialog, click Finish. You have now mapped a network drive to the shared folder.
4. On the Stratus OCT instrument, you must register the new archive on the network file
server to make it current.
A. From the Stratus OCT MAIN WINDOW, select Register Archive from the Options
menu (click Options > Register Archive). The Archive Registration dialog appears.
B. In the Archive Registration dialog, click New. The New Archive Registration dialog
appears.
C. In the New Archive Registration dialog, the Archive Name field is made up of
two parts. The first part is generated automatically and cannot be changed; it is
composed of the model number, serial number and archive sequence number. You
can add a suffix to the name using the second part of the field, if you wish.
The Mark as current checkbox is selected by default. Do not change this
selection if you wish to use the archive you are about to register as the current
archive.
completed automatically.
E. If you wish, you can enter up to about 85 characters in the Description field to
describe the archive you have registered.
F. When finished, click Save to register the new archive. It will now be the current
archive to which scan data is copied when you save scans.
(8), Archive, Retrieve & Backup, and Chapter (9), Export and Import Scan Data,
for instructions to archive, retrieve, backup, import, export and synchronize Stratus OCT
data.
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 Manual Archive on page 8-11.
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 users 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
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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
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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.
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Overview
This document provides configuration instructions to enable transfer of Stratus OCT data
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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
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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 users 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.
Note: For information on using CDs or DVDs to transfer data from the Stratus OCT
instrument, including hardware and software requirements, see Appendix (D) Data
Transfer Using CDs and DVDs. Specific limitations apply to the type of removable
media you can use to transfer data from the Stratus OCT instrument. These
limitations vary depending on whether or not the Stratus OCT instrument has a DVD
Multi-Drive and Roxio software.
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.
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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 users 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
users PC, nor support the installation and configuration of a DVD-RAM drive on the
users 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.
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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 8-18.
How to Import
To import data, follow the steps under Import Data on page 9-10.
a standard network patch cable. It is the users responsibility to acquire and install the
necessary cables.
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
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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
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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).
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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).
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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).
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Note: The default share name is the same as the folder name. We recommended you
use the default share name.
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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.
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
Database Export on page 9-6.
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
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the Review Station utilizing the Stratus software's Export feature. A direct network
connection should not be used to synchronize with archived data.
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.
2. The Network (and Dial-up) Connections dialog appears (Figure B-14).
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.
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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
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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).
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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).
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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).
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Note: The default share name is the same as the folder name. We recommended you
use the default share name.
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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
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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.
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Introduction
The Stratus OCT normative database study was designed to obtain normative data for
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macular 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
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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,
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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 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,
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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,
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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, Manlys 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
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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.
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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 (m/yr) and the x-axis is the A-scan number (1 through 128).
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Figure C-4 illustrates the relationship between Total Macular Volume (mm3) and age, as
observed in the study population.
Conclusion
The Macula Normative Database was based upon Stratus OCT retinal scans collected from
subjects whom, per protocol, were deemed representative of a normal population. The
Macula Normative Database establishes 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.
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Overview
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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.
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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 ConfigurationEject Settings on page D-4plus 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.
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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
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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 >
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For a DVDRW you can perform a full format or a quick format at any time. A full format
requires 40 to 90 minutes; a quick format requires a few minutes.
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 CDRW and DVDRW, 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
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configuration of the Roxio Drag-to-Disc software, particularly the eject settings. The correct
eject settings are seen in Figure D-6 below.
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Introduction
This appendix provides safety information, requirements, recommendations and
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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.
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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.
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Note that many network drives you purchase may contain patch cords that are
shielded or of insufficient length to use with Stratus OCT. In such cases, you must
purchase this cord separately.
Drive media formatted using NTFS: Stratus OCT data is compatible only with NTFS.
Approvals: The NAS device you select must conform with local agency requirements.
In Europe, CE approval is required. In North America, UL, CSA or equivalent approval
is required; and FCC approval is required.
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
manufacturers instructions for details regarding installation of the NAS device.
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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 manufacturers 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
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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 defaultthis
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.
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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.
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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.
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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 manufacturers
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.
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Introduction
This document instructs you how to configure a printer for use with Stratus OCT. These
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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:
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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.
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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.
incorrectlyfor example, by plugging the printer into the wall while using a
USB connection, or by using a shielded network (UTP) cableyou could
invalidate the system safety approval. See the general warning regarding
Accessory Equipment below and the warnings regarding USB and network
connections on page F-1 above.
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
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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.
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C
D
Calibration 11-2
Data Management 7-1
Caliper On 6-5
Data Management Preferences 8-5
Cancel 3-11, 3-13, 4-4, 5-5
data management preferences 8-5
Care in Handling 1-6
Data menu
case-sensitive records 7-11, 7-15
Export 9-8
Categories, Create and Edit 7-8 Import 9-10
Categories, Place Patient Records in 7-10 Data Protection Requirements 8-2
Categorize Patient Records 7-7 Data Protection, Media Requirements 8-3
Category Field 2-6 Database Export 9-6
Caution--avoid contact with patient eye 3-5 Database, Defragment 7-19
CE Mark 1-7 Database, Patient 8-2
central circle button 3-9 Default button 5-5
Change button 6-39 Define Custom Scan 3-16
chin cup 3-2 Define Custom Scan dialog box 3-16
Circle protocol 4-6 Defragment Database 7-19
Cleaning 10-2 degrees and angle 3-14
Cleaning Forehead and Chin Rests 10-2 Delete Exam Records 7-17
cleaning the ocular lens 10-2 Delete Patient Records 7-16
Clear Graphics button 6-29 Delete Patient, Visit and Exam Records 7-16
Clearing Scan Data 8-3 Delete Visit Records 7-18
clinical notes, editing 7-7 deleting exams 7-17
color scale and interferometer signal range depicted 3-17 deleting patients 7-16
color scale of scan image 3-17
How It Works for You 1-3 insurance companies, create, edit and assign 7-15
How The Stratus OCT Works 1-3 insurance records are case-sensitive 7-15
How to Acquire Scans 3-10 Intended Use 1-1
How to Adjust The Height 3-1 interferometer signal range, adjusting 3-17
How to Position the Patient Module 3-5 interferometry
analogous to ultrasound 1-3
I low-coherence, explained 1-3
Illumination 11-1 principles 1-3
Image Processing Protocols 6-2, 6-35 Internal Fixation 2-4, 11-1
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move the fixation target 3-9 Composite Image Features and Functionality 6-30
Composite Image Measurements 6-30
Move the Scan Pattern 3-8
Cup Area 6-30
Cup/Disk Area Ratio 6-30
N
Cup/Disk Horizontal Ratio 6-30
Name drop-down list 3-16
Cup/Disk Vertical Ratio 6-30
NAS Device configuration E-1
Disk Area 6-30
NAS Device Safety Warnings E-1
Horizontal Integrated Rim Width (Area) 6-30
Navigation in General 2-3
Image Background Options 6-31
Nerve Fiber Layer Thickness, Measuring 4-5
Aligned to Disk 6-31
Nerve Head Circle protocol 4-8
Aligned to Surface 6-31
Network Activities Not Supported A-3 None 6-31
network activities, not supported A-3
patient records, deleting 7-16 Quantitative Analysis Protocols, listed by application 6-2
Register, Edit and Assign Insurance Companies 7-15 Scan Direction Legend 6-3
Register, Edit and Assign Medical Staff 7-13 Scan drop-down list 3-16
Repeat protocol 4-6 Scan Group Images Tab 5-2
Repeat protocol and the landmark 4-6 scan image 3-5
Replacement Accessories 10-3 bringing it into view 3-7
Report Signs Of Wear 10-2 scan image and axial window 3-7
Resize Functional Areas 2-3 scan image color scale 3-17
resolution, transverse 3-15 scan image optimization
Retina analysis protocols 6-2 optimize polarization 3-7
Retina Protocols 4-2 optimize Z-offset 3-7
Retinal Map protocol 6-34 scan image vs. video image 3-6
Retinal Thickness protocol 6-31 Scan List 5-2
Retinal Thickness/Volume Change protocol 6-15 Scan menu
Retinal Thickness/Volume protocol 6-13 Define Custom Scan 3-16
Schedule for Archive and Backup 8-4 Table Loading Capacity 11-3
Tomographic Imaging 11-1
search by name 5-1
Spherical Equivalent 2-8
Stratus OCT U
How it works 1-3 unlock the patient module 3-6
Stratus OCT password 1-15 USB Configuration F-3
STRATUSOCT User Changes to Software or Hardware 1-5
applications 1-3 User Name 1-15
features and benefits 1-3 Using the Wireless Printer B-1, E-1, F-1
histories and monitoring 1-3
How it works for you 1-3 V
Main Window 2-2, 2-3 Validated Antivirus Software A-2
12/6/07