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Zeiss GDX VCC UserManual
Zeiss GDX VCC UserManual
User Manual
ii
PLEASE
Read this entire manual
before setting up and operating your GDxVCC™.
Important Information
The GDxVCC is a medical device. The software and hardware have been designed in
accordance with U.S., European and other international medical device standards
designed to protect clinicians, users and patients from potential harm caused by
mechanical, diagnostic or therapeutic failures. Unauthorized modification of GDxVCC
software or hardware (including peripherals) can jeopardize the safety of users and
patients, the performance of the instrument, and the integrity of patient data; it also
voids the instrument warranty.
Carl Zeiss Meditec does not offer advice in the diagnostic interpretation of GDxVCC
scans. We do provide with the instrument a primer on clinical application of
scanning laser polarimetry using the GDxVCC. It is the clinician’s responsibility to
make diagnostic interpretations of GDxVCC scans.
• The use of accessories, transducers and cables other than those specified may
result in increased emissions or decreased immunity of the equipment.
• The equipment 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.
Equipment Classifications
• Type of protection against electric shock: Class I equipment
• Degree of protection against electric shock: Type B equipment
• Degree of protection against harmful ingress of water: IPXO—ordinary
equipment.
• Mode of operation: Continuous operation equipment
Indications
The Carl Zeiss Meditec GDxVCC is used for diagnosing and monitoring diseases and
disorders that manifest themselves in the posterior pole of the eye, e.g. for
diagnosing and monitoring of glaucoma and other optic neuropathies.
Contraindications
The GDxVCC may not produce reliable results for patients in the following
categories:
• Patients with cornea retardance greater than 120 nm. The system will provide
an error message when such a retardance measurement is detected.
• Patients with dense cataracts. Patients with cataracts will have a dark fundus
image and low image quality score.
• Patients who are unable to fixate on a target with the subject eye. These
typically are patients with loss of central vision.
• Patients with refractive errors outside the following ranges: +5 D to -10 D (for
earlier VCC Systems) or +7 D to -15 D (for later VCC Systems).
• Patients less than 18 years of age; such patients can be imaged, but they are
not supported by the normative database.
International Customers
Please contact your CZM Sales Representative for a listing of printers that CZM has
approved for use with this product.
Product Compliance
0297 93/42/EEC Medical Device Directive
Symbols Defined
Indicates that there are important operating and maintenance instructions found in the manual.
Indicates risk of electrical shock due to the presence of uninsulated high voltage inside the
instrument. Do not remove the instrument cover or parts.
Handling Requirements
Fragile
Keep Dry
This end up
Instrument Disposition
When it comes time to upgrade the device, 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.
Contents
Important Information.................................................................................. -iii
WARNING: User Changes to Software or Hardware ............................................. -iii
Disclaimer: Clinicians Responsible for Diagnostic Interpretation ........................... -iii
WARNING: Accessory Equipment ........................................................................ -iii
General Warnings & Precautions ......................................................................... -iii
Equipment Classifications..................................................................................... -v
Indications .......................................................................................................... -v
Contraindications................................................................................................. -v
International Customers....................................................................................... -v
Embedded Windows License ......................................................................... -v
Product Compliance....................................................................................... -v
Symbols Defined........................................................................................... -vi
Protective Packing Symbols ................................................................................. -vi
Instrument Disposition ................................................................................ -vii
Results.........................................................................................................2-16
(C) Importing, Exporting, & Printing Data via a Network .............. C-1
Overview....................................................................................................... C-1
Importing and Exporting Data.............................................................................C-1
The Relationships between Doctors, Clinics, and Networks ................................. C-2
Data Files and Folders ..................................................................................C-4
Tab-Delimited Text Files...................................................................................... C-5
HTML and SVG (Scalable Vector Graphics) Files .................................................. C-5
Configuring the System for Network Import/Export .....................................C-6
To Configure the Network Connection ................................................................ C-6
Basic Networking Procedures .......................................................................C-8
To View the Currently Selected Doctor/Clinic ....................................................... C-8
To Change the Currently Selected Doctor/Clinic................................................... C-9
To Convert an SVG File to Another Graphic Format (JPG, BMP, etc.).................... C-10
Exporting Data Over a Network.................................................................. C-10
To Export Selected Exams for a Single Patient .................................................... C-10
To Send Exam Reports as Email Attachments .....................................................C-11
To Export the Complete Database...................................................................... C-12
Importing Data Over a Network ..................................................................C-15
To Import Data Over the Network...................................................................... C-15
To Import Data from Another GDxVCC............................................................... C-15
Importing and Exporting Data to a Floppy Disk ..........................................C-16
To Export Patient Data to a Floppy Disk ............................................................. C-16
To Export Error Logs.......................................................................................... C-17
Using a Fixed IP Address for the GDxVCC....................................................C-17
To Specify a Fixed IP Address for a GDxVCC ....................................................... C-17
Printer Setup................................................................................................C-19
To Convert a Desktop Printer into a Network Printer.......................................... C-20
Index ..................................................................................................i-i
(1) Introduction
Overview
The GDxVCC™ employs patented GDx Scanning Laser Polarimetry (SLP) technology to provide
quantitative information about the retinal nerve fiber layer (RNFL). The near infrared laser beam
passes the retinal nerve fiber layer twice. Due to an optical property of the RNFL called
birefringence, part of the beam is phase-shifted. This phase shift (retardation) directly correlates to
the thickness of the RNFL.
The GDxVCC compares the patient’s retinal nerve fiber layer (RNFL) distribution with that of the
nerve fibers of healthy eyes from a normative database. This information, in conjunction with other
diagnostics, assesses the patients’ ocular health, in particular with respect to glaucoma.
☞ Note: For conceptual clarity, the output of the GDxVCC analysis is expressed in polarimetric
microns and called Polarimetric Thickness. However, the actual quantity being measured
through polarimetry is birefringence, which is affected by not only thickness but also by
retinal tissue structure. Therefore, Polarimetric Thickness is not to be compared to
anatomical thickness measured by other devices.
A unique feature of the GDxVCC is its Variable Corneal Compensation. When using this feature, the
system will measure the birefringence of each cornea and then optically cancel the corneal
birefringence when imaging the RNFL for each eye. We recommend you use this feature due to
variations in the cornea characteristics in the patient population. However, the system is also able to
perform exams using fixed compensation, which may be useful if you have used a previous version
of the GDx technology. Notes specific to this option are designated by “FCC” in this manual. For
Fixed Mode operation, refer to the User Manual for the Access system.
The GDxVCC allows you to take exams consisting of measurements (scans) for one or both eyes of a
patient at a given office visit. Each measurement contains images representing the RNFL of one eye
and analysis based on those images. You may also create a variety of reports based on one or more
measurements for a given patient.
Setup
The GDxVCC contains sensitive electronic, mechanical and optical components, as well as an
internal computer. Handle it gently.
☞ Note: The GDxVCC weighs approximately 45 pounds (21 kg). To avoid injury, exercise proper
lifting techniques when lifting or moving the GDxVCC.
☞ Note: Do not turn power on until all connections are made and all steps are completed.
1. Place the GDxVCC on a sturdy table, preferably one that is height adjustable.
2. Connect the keyboard to the keyboard connector on the underside of GDxVCC (Figure 1-4).
3. To export reports to a network server or PC, connect a crossover cable from the network server
or PC to the network connector on the underside of the GDxVCC (Figure 1-4). Refer to
Appendix B: Directly Attaching a PC to the GDxVCC and Appendix C: Importing,
Exporting, & Printing Data via a Network for detailed instructions.
4. Connect the external color printer data cable to the printer connector located on the underside
of GDxVCC (Figure 1-4). Plug the printer power cord into the power outlet. Be sure the ink
cartridges and paper are installed per the manufacturer’s directions.
5. Grasp the end of the plastic bag/foam objective lens shipping protector and pull it out and
away from the face mask. Place the protector in a safe place for future transport. Remove the
lens cap.
6. Read and remove the Caution label from the LCD Display.
7. Unlock GDxVCC scan head optics using the screwdriver and instructions provided in the
accessory kit. See Unlocking the system section in this chapter for more information (Figure
1-5).
☞ Note: Be sure to remove the objective lens foam block protector and unlock the scan head
optics before applying power to GDxVCC. System warm up and self tests will fail if the scan
head optics are not unlocked with power applied.
8. Position and insert the AccessCard into the card slot located to the left of the LCD Color
Display. See AccessCard section in this chapter for more information (Figure 1-6).
9. Connect the female end of the power cord into the power cord connector on the underside of
GDxVCC (Figure 1-3). Plug the power cord male end into the power outlet.
Power Up
Confirm that the system is unlocked (see above). Make sure the power cord is plugged in as
described in Setup. The power on/off switch is located on the underside of the unit by the power
cord inlet. Power up the system by flipping the switch to the on position (I = on, O = off).
☞ Note: It is recommended to leave the system running during daily use and to power down at
the end of each day.
☞ Note: Some (rare) units do not have a power on/off switch. For these units, you may plug and
unplug the power cord to power up and power down the system.
At power-up, GDxVCC will run a warm up test procedure. The test usually takes several minutes. If
the unit is cold (e.g. if the unit was transported from another office), allow it to acclimate to normal
room temperature before turning on the power. It may take up to 30 minutes for GDxVCC to
“warm-up” and pass the system test. As the test is being performed, there will be a screen indicated
that the test is in progress. If there are no errors, the system will start up normally. See Disk
Backup Options on page 5-7 for more information. Once the GDxVCC Logo screen is displayed,
the system is ready for operation.
Power Down
CAUTION: Only power down your system from the LOGO screen or the SHUT DOWN FOR
TRANSPORT screen.
Whenever the system will be left idle for more than 6-8 hours, it is recommended to turn off the
power. To do so, first turn off the external printer, if connected, at the printer’s power switch. Power
down the system by flipping the power switch to the off position (I = on, O = off).
The AccessCard
To perform scans with GDxVCC, an AccessCard must be inserted into the slot located to the left of
the LCD Display. Insert the card with the GDxVCC logo side facing left, placing the end with the gold
smart chip and black arrow into the slot (Figure 1-6). The system will not take images if an
AccessCard is not inserted. It is best to leave the AccessCard inserted at all times, however, if it must
be removed (for example, to transport), return to the LOGO screen (press Cancel/Go Back (8) until
the LOGO screen is displayed) before removing the AccessCard.
☞ Note: Never remove or insert the AccessCard during scan acquisition or processing.
See AccessCards and Supplies on page 6-6 for more AccessCard information.
Data Entry
You will use the keyboard when entering initial setup data and patient information. After that, most
inputs are made by pressing the two operation and six function buttons on the operator console.
The buttons are backlit when active.
The six function buttons below the LCD Display change function depending upon which screen is
displayed. The current function of each button is indicated on the LCD Display just above the
respective button.
The two operation buttons to the right of the LCD Display are marked 9 and 8.
9 is the OK button. Pressing this button accepts the current screen and any data entered and
moves to the next screen.
8 is the Cancel/Go Back button. Pressing this button will cancel current activity on the current
screen and return the display to the previous screen.
The operation and function buttons provide for simple quick operation; the keyboard is necessary
only for inputting patient and initial setup data. However, each function on the LCD Display above
the six function buttons has one letter in its label that is underlined. Holding down the “Alt” key on
the keyboard, while simultaneously pressing the keyboard letter that corresponds to the underlined
letter in the label, will select that function just as if the related function button had been pressed.
Use the Tab key to advance through the input fields, and the Shift+Tab keys to go back.
exported data on removable media such as floppy disk or CD, and transport it to another clinic
where it can be imported from a networked PC to any GDxVCCs resident at that clinic. In this way,
doctors who see the same patients at different clinics can easily transfer data from clinic to clinic.
The security features of the GDxVCC can be employed to keep patient information private, even
when several doctors transfer data among a number of different GDxVCCs.
To use the data importing and exporting features, see Appendix B: Directly Attaching a PC to
the GDxVCC, or Appendix C: Importing, Exporting, & Printing Data via a Network.
Appendix C also describes how to set up a network printer.
☞ Note: This chapter describes Full exams. See Appendix A: Screening Exams for
information on Screening (abbreviated) exams.
☞ IMPORTANT: For a patient’s first scan only, steps 5 through 10 will be performed for the
cornea measurement, and then repeated for the RNFL measurement.
5. Ask the patient to gaze at the blinking fixation target in the red field; the right eye will be first
and the target will be on the patient’s left.
6. Move and rotate the joystick to center the yellow crosshairs on the pupil, then move the
joystick forward or back to center the white focus dot on the horizontal red line.
7. With the patient’s eye and focus dot properly aligned, press the Image Acquisition button on
top of the joystick to scan the eye. The system will automatically switch to the other eye.
Repeat steps 4 through 6.
8. If the ellipse is not well centered on the optic nerve head (ONH) or on the macula (for cornea
measurement), reset the position of the ellipse. Press OK (9) to return to IMAGE CHECK.
9. Review the scans on the IMAGE CHECK screen. If the images are not acceptable, select Retake
Image and repeat steps 5 through 8. (On the IMAGE RETAKE SELECTION screen, choose Retake
Both Eyes, Retake Right (OD) Eye, or Retake Left (OS) Eye as appropriate.)
10.When ellipse placement and image quality are satisfactory, select Accept. If this is a cornea
scan, the ACQUISITION screen will reappear for the compensated RNFL scan (go to step 5).
Otherwise, REVIEW CALCULATIONS will appear.
11.At the REVIEW CALCULATIONS screen, select Print, Export, Print & Export Options, Serial Analysis,
or Save Only, as appropriate. If desired, enter operator initials and comments.
At the PATIENT INFORMATION SCREEN (Figure 2-2), review all the patient information. If the
information is not accurate, select Edit to change any or all of the information for this patient.
Otherwise, proceed to Scan Procedure on page 2-4.
Scan Procedure
☞ IMPORTANT: The GDxVCC quantifies the RNFL by first measuring the value of corneal
birefringence contribution for each eye imaged. The corneal contribution only needs to be
measured once per eye and only on the first exam performed on each eye (excluding patients
with LASIK or cataract surgery). The corneal compensation value for each eye is stored in a
database and will then be used for all subsequent exams for that eye.
The scan procedure described in this section applies to both cornea measurement scans and
compensated RNFL scans. The procedure is the same except as indicated.
On the PATIENT INFORMATION screen (Figure 2-2), select Full Exam. To perform a screening exam
instead, select Screen (see Appendix A: Screening Exams for information on screening exams).
The scan procedure described in this section applies to both types of exams.
Refraction Settings
You must enter patient refraction manually.
☞ Note: The refractive correction settings are stored in a database and are used for subsequent
exams. Repeat the refraction setting if patient refraction has changed (for example, if the
patient has had refractive surgery, cataract surgery, or is wearing contact lenses).
At the SELECT REFRACTION screen, use the Up Right (OD), Down Right (OD), Up Left (OS), Down Left
(OS) buttons to select the correct spherical equivalent refraction for the appropriate eye.
Alternatively, you may use the Tab key to highlight a refraction value box and then use the up and
down arrow keys to select or use the keyboard to enter the correct value.
The spherical equivalent (SE) is calculated by algebraically adding ½ the cylinder value to the sphere
value from the spectacle refraction.
Examples:
If patient’s spectacle refraction is +1.00 –1.00 x 90,
SE = +1.00 + ½ (-1.00) = +1.00 – 0.50 = +0.50.
If patient’s spectacle refraction is –1.00 –1.00 x 120,
SE = -1.00 + ½ (-1.00) = -1.00 – 0.50 = -1.50.
GDxVCC uses the refraction information to set the best focus for scanning the eye. Before pressing
OK (9), position the patient in front of the face mask, and prepare to perform the exam (as
described earlier in this chapter).
☞ Note: When the previous step is completed, the system will automatically activate the
scanning laser and the scanning laser active light at the top-right of the operator console.
patient is comfortable. The patient should remain stationary; head movement interferes with the
quality of the acquired image.
Patient Fixation
With the patient in position, instruct him/her that he/she will see a field of thin red horizontal lines.
On one side of the field, the patient will see short, bright, blinking, red horizontal lights, similar to
an equal (=) sign. This is the patient fixation target. For the right eye, the target will be on the left
side of the red field; for the left eye it will be on the right side. Ask the patient to keep his/her gaze
fixed at the blinking target (if there are two, the lower of the two). Instruct the patient to hold as
steady as possible, and to blink normally until told to not blink.
Image Acquisition
The ACQUISITION screen provides a live image of the patient’s eye (Figure 2-4). You will use the
joystick to align the eye and focus the instrument, and the image acquisition button to acquire the
scan images.
For compensated RNFL scan only: If a patient has had refractive or cataract surgery since their last
exam, it is recommended to repeat the cornea measurement by selecting Reset Compensation.
FCC: Users of earlier versions of GDx systems may wish to select Fixed Compensator in the
ACQUISITION screen to produce scans comparable to those produced by earlier systems. Such scans
will not benefit from the simplified interpretation provided by custom corneal compensation. Refer
to the User Manual for your previous system.
The system will initially be in position to scan the right eye first. Right (OD) will be displayed on the
top-left of the screen. If you want to skip to the other eye, wait for the Please Wait message to
disappear and select Other Eye.
Ask the patient to remain still and focus on the fixation target.
To align focus dot: After approximately centering the pupil on the yellow crosshairs, adjust the
joystick forward and backward until the focus dot is centered on the horizontal red line. With the
focus dot equally above and below the horizontal red line, GDxVCC is at optimum focus.
To align pupil: Use the joystick to center the patient’s pupil with the yellow crosshairs. Rotate the
joystick to move the image up and down. Tilt the joystick to the right to move the eye image left; tilt
the joystick to the left to move the image right. See Figure 2-4 for an example of correct
alignment.
☞ Note: You may notice two or three additional white areas within the area of the patient’s
pupil. These are reflections from the eye and have no bearing on the image and the focus,
and should be disregarded.
☞ Note: Pupil dilation is not recommended and may make focus dot alignment difficult, since
the focus dot is a reflection from the iris. For a partially dilated eye follow the steps below to
catch the edge of the iris. Measurements on fully-dilated eyes are not recommended.
1. Use the joystick to adjust the yellow crosshairs slightly off the center of the pupil until the focus
dot becomes visible.
2. Adjust the joystick forward and backward until the horizontal red line bisects the focus dot
evenly.
3. Adjust the joystick left-right and up-down (twisting motion) to center the partially-dilated pupil
on the yellow crosshairs.
Small adjustments are often helpful as the image approaches alignment with the red line. You may
need to refine alignment of the yellow crosshairs now. Instruct the patient to blink once. Promptly
check the pupil alignment and focus dot, make necessary fine adjustments, and press the Image
Acquisition button on top of the joystick to acquire the scan, making sure the Please Wait indicator
is not displayed.
☞ The pupil must be centered on the yellow crosshairs and the red line must be centered on the
focus dot. Otherwise, the scan may not pass the image quality check and will need to be
repeated.
☞ Ask the patient to blink just before pressing the Image Acquisition button, then not to
blink during acquisition (between the first and second beeps, less than 1 second).
☞ Do not move or push any controls/buttons, including the joystick, during the image
acquisition period while the Please Wait indicator is red.
The system will beep once when the Image Acquisition button is pressed and again as soon as it has
completed. At the sound of the second beep, instruct the patient to remain in position and blink
normally.
Image Quality
When image acquisition (cornea or RNFL) is completed, the system displays the IMAGE CHECK screen.
A good image is one that has a scan quality score of 7 or above, OK’s fo Alignment, Fixation,
Refraction, and Other, and is well focused. In some cases and for some eyes, it will not be possible
to achieve the recommended score value and avoid all warning messages. In those cases, accept
the best scan that can be obtained. Strive to obtain the best image possible, and note any problems
on the printout. See Appendix E: Image Check Messages for more information on image
quality messages.
☞ Note: For accurate patient fixation, ensure that the ONH is within the dotted square.
To change the macular ellipse position, use the arrow buttons. A dot in the center of the ellipse
makes it easier to center the ellipse (Figure 2-6). Do not change the size of the macular ellipse.
If the macula “bow tie” is not well-defined, press the Irregular Pattern button. When Irregular
Pattern is selected, the software uses an alternative cornea calculation based on the macula area
within the dotted square which does not require macular ellipse placement, and the position
buttons are not available (Figure 2-7). Press the Macula Ellipse button to re-enable the macular
ellipse placement options.
ONH located
inside dotted
square indicates
accurate patient
fixation
Macular ellipse
centered on
macula “bow
tie” pattern
Dotted square
indicates that
Irregular Pattern
is selected, the
macula pattern is
not well-defined
ONH located
inside dotted
square indicates
accurate patient
fixation
When finished, press OK and then Accept to the IMAGE CHECK—MEASURING CORNEA screen.
Dotted square
indicates that
Irregular Pattern
is selected
☞ IMPORTANT: Proper ONH ellipse placement influences image quality messages. Verify
placement is correct before deciding to retake an image.
At the IMAGE CHECK screen (Figure 2-9), select Modify Right (OD) Ellipse. The screen displays how
the system automatically placed the ONH ellipse. It should be placed such that the ellipse is
centered over the ONH.
For continuous movement, press and hold down the direction buttons. Proper placement of the
ellipse over the ONH should appear as shown in Figure 2-10.
Select Modify Left (OS) Ellipse and position the ONH ellipse.
Calculation Circle
The Calculation Circle is the area between the two outer concentric circles on the IMAGE CHECK
screen (Figure 2-11). This area is where measurement data is acquired for the TSNIT and NFI
parameters. The Calculation Circle can be resized, if necessary, in order to obtain more meaningful
results for patients with parapapillary atrophy (PPA) and scleral crescent. By default, the Calculation
Circle is set to the smallest size.
PPA
1. From the IMAGE CHECK screen, select Modify ONH Ellipse for the desired eye.
(The IMAGE CHECK screen appears immediately after image acquisition. You can also bring up
this screen when you review an image.)
The MODIFY CALCULATION CIRCLE AND ONH ELLIPSE screen appears, as shown in Figure 2-12.
Figure 2-13 Thickness Map and Fundus Image, with Small Circle Intersecting PPA Area
3. Circle Small is the default setting. You can select Circle Medium or Circle Large to expand the
Calculation Circle beyond the PPA or affected area in the image. The Calculation Circle is
resized accordingly. The currently selected button is deactivated. Figure 2-14 shows examples
of small, medium, and large Calculation Circles.
4. You can see the results superimposed on the image, and visually determine whether or not the
calculation circle is positioned optimally.
☞ Note: When performing a serial analysis, the software overlays the circle size from the
baseline image onto each subsequent image to calculate change. If it becomes necessary to
resize the calculation circle for previously imaged patients, you must also resize the
calculation circle on the baseline scans prior to performing serial or advanced serial analysis
Retaking Exams
During an exam, the system may alert you to reset compensation (obtain a new measurement for
the corneal contribution), or you may choose to remeasure the corneal contribution to reestablish or
update its value (for example, following cataract or refractive surgery) prior to a new RNFL exam.
To retake an exam, select Retake Image. The IMAGE RETAKE SELECTION screen appears, and allows you
to choose Retake Both Eyes, Retake Right (OD) Eye, or Retake Left (OS) Eye. After you make your
selection, the system returns to the ACQUISITION screen. Select Reset Compensation and the
ACQUISITION—MEASURING CORNEA screen appears. Refer to the Image Acquisition section on page
2-5 to re-measure the cornea.
When satisfied with the image quality on the IMAGE CHECK screen, select Accept. The REVIEW
CALCULATIONS screen appears (Figure 2-15).
Results
The REVIEW CALCULATIONS screen (Figure 2-15) provides an abbreviated summary of the exam
results including the TSNIT, RNFL image and parameter table. Refer to Chapter 4: Reports for
greater detail.
Print, Save and Export options will automatically save the exam and display the OPERATOR
INFORMATION (OPTIONAL) screen where you may enter the operator’s initials and Tab to the Comments
Box to enter comments. The comments are stored with the exam file and can be viewed on screen
(see Chapter 3: Record Management), but are not printed on the reports.
In addition to saving exam results, the REVIEW CALCULATIONS screen allows you to print and export
reports (see Chapter 3: Record Management).
☞ Note: If you are using an AccessCard with a plan that does not have unlimited use, you will
be debited one full exam when you press Accept.
Your exam is now complete, the system will automatically return to the LOGO screen.
While entering characters in any of the fields, the View Full List button may be selected. The system
will automatically display the PATIENTS LIST screen, starting with the first patient meeting the criteria
of the characters entered up to that point.
If the information on the SEARCH FOR PATIENT screen is not what is desired, select Clear to begin the
selection process again.
Once the desired patient is selected, press OK (9) and the system will display the PATIENT
INFORMATION screen.
Full Exam
For a Full Exam, a full analysis of results will be performed and the exam will be saved. The number
of remaining Full Exams on the AccessCard may be debited, depending upon what plan you
purchased. See Scan Procedure on page 2-4 for details on conducting a full exam.
Screen
For a Screening Exam, an abbreviated analysis of results will be performed, and the exam will not be
saved. The number of remaining Screenings on the AccessCard may be debited, depending upon
what plan you purchased. See Appendix A: Screening Exams for details on conducting a
screening exam.
Review
At the PATIENT INFORMATION screen, select Review to display the MEASUREMENTS LIST screen for the
selected patient. Each measurement is of one eye. The next step is to select one or more
measurements. For a typical exam, you will select one right and one left eye. The following section
explains how to select measurements and what can be done with them.
Select Measurements
The MEASUREMENTS LIST screen (Figure 3-3) allows you to select one or more patient measurements.
You can review these on screen, create reports, export, or delete.
To select measurements, first highlight one by using the Previous or Next buttons to scroll up and
down the list. A highlighted measurement is indicated by a surrounding dotted box and a selected
measurement has a blue background. Only one measurement is highlighted at a time. Use
Select/Deselect to change whether or not the highlighted measurement is selected. This allows you
to select more than one measurement.
As a measurement is highlighted, a thumbnail image is displayed in the upper right of the display.
This display shows a larger image area than is visible in other screens, including the macula area as
well as the ONH, and thus may be helpful in understanding the patient’s exam printout as discussed
in Chapter 4: Reports. You can also review full images in the MODIFY ELLIPSE screen.
On the MEASUREMENTS LIST screen, measurement types are identified by a small icon at the left of the
screen. Standard (cornea compensated--VCC) image icons are green; Fixed compensation (FCC)
icons are gray with the word “Fixed” to the right; and Cornea image icons are yellow.
☞ Note: You cannot review together images of different types, e.g., VCC images cannot be
reviewed with Cornea images.
Select Review and the system will display the selected measurement results on the REVIEW
CALCULATIONS screen (Figure 3-4).
At the IMAGE CHECK screen you may review the TSNIT graphs and the thickness maps, as well as the
parameter table of values computed from the thickness maps and how they compare to the
normative database (see Chapter (4) Reports for detailed information).
Press OK (9) to return to the MEASUREMENTS LIST screen.
Print/Export Exams
GDxVCC provides multiple report formats for printing and exporting. See Chapter 4: Reports for
information on different report formats and their components.
With the desired measurements selected at the MEASUREMENTS LIST screen (see Select
Measurements page 3-4), you may print and/or export the measurements without reviewing
them on screen, or review the measurement(s) on screen and then print and/or export them.
If you wish to review the exam on screen before print and/or export, select Review. The REVIEW
CALCULATIONS screen will be displayed for RNFL measurements, and the IMAGE CHECK - MEASURING
CORNEA screen will be displayed for cornea measurements. When finished reviewing, select either
Print, Export, Print & Export Options, Serial Analysis, or Save Only (for newly-acquired images) or
Image Check (for previously-acquired images).
☞ Note: If a network destination has not been set up or selected, see System Tests on page
5-5 before exporting. Otherwise, export to a floppy disk or system directory.
If you wish to print and/or export exam(s) without review, at the MEASUREMENTS LIST screen select
Print and Export Options.
If you have selected two, three or four exams of the same eye, you will receive a Serial Analysis or
Advanced Serial Analysis when you select Print or Export.
☞ Note: You can create a Serial Analysis or Advanced Serial Analysis report from the
MEASUREMENTS LIST screen. The MEASUREMENTS LIST screen is accessible from the REVIEW
CALCULATIONS screen or by selecting Review from the PATIENT INFORMATION screen.
Each exported report includes several files with various formats. One .jpg file is provided for each
fundus image and thickness map in the report. The .svg and .html files contain the entire report for
viewing. These files can be viewed by installing SVGViewer, a free application provided by Adobe.
For additional information or to obtain the software, contact a Carl Zeiss Meditec service
representative or Adobe on the Internet: http://www.adobe.com.
(4) Reports
This chapter presents explanations of report content (Report Content) and information about
report formats (Report Formats). For assistance with interpretation of results, refer to your
GDxVCC Primer.
Report Content
The following are descriptions of the components used in various reports. Results are based on data
extracted from the area defined by the Calculation Circle.
Calculation Circle
The Calculation Circle defines the area where data is acquired for the TSNIT parameters. The data
acquired in this area also affects the NFI calculation. The Calculation Circle appears on reports, and
is described in Calculation Circle on page 2-12.
Fundus Image
The Fundus Image is a reflectance image depicting a 20° x 20° image of the posterior pole of the
eye. GDxVCC utilizes more than 16,000 data points from the scan area to produce and display the
Fundus Image showing the optic nerve head. This image allows the initial quality evaluation of the
scan to determine if it is adequate for further analysis and is used for centering the ONH ellipse. For
information on image quality, refer to Image Quality on page 2-7.
☞ Note: For conceptual clarity, the output of the GDxVCC analysis is expressed in polarimetric
microns and called Polarimetric Thickness. However, the actual quantity being measured
through polarimetry is birefringence, which is affected by not only thickness but also by
retinal tissue structure. Therefore, Polarimetric Thickness is not to be compared to
anatomical thickness measured by other devices.
A typical normal pattern is characterized by bright yellows and reds (thicker) in the superior and
inferior sectors, and greens and blues (thinner) in the nasal and temporal sectors.
Deviations from normal may reflect:
• Lack of the typical RNFL distribution.
• A diffuse loss of RNFL resulting in blue areas where you would normally expect yellow or red.
• Focal defects, or areas of concentrated dark colors.
• Asymmetry between the superior and inferior quadrants.
• Asymmetry between right and left eye.
TSNIT Graph
The Temporal-Superior-Nasal-Inferior-Temporal (TSNIT) graph displays the normal range (shaded
area) and the patient’s values (dark line) of Polarimetric Thickness developed from the data
obtained along the Calculation Circle.
The left side of the TSNIT graph starts the plot from the Calculation Circle, beginning at the temporal
side of the retina. As the map progresses to the right it plots the Polarimetric Thickness values
obtained by tracing around the Calculation Circle, passing through the Temporal, Superior, Nasal,
Inferior, and then back to the Temporal positions.
☞ Note: Although the TSNIT graph provides a quick, easy look at how a patient compares to
normal, it must be recognized that this analysis is based only on the data points within the
Calculation Circle.
☞ Note: In Advanced Serial Analysis, this same map has the name Difference from Baseline.
TSNIT Parameters
This table presents parameters computed from the Calculation Circle and compared to similarly
computed values from the normative database. They are color coded to indicate deviation from
normal (based on p-values).
☞ Note: The parameters listed on the first page of the printout were determined to be the most
effective in helping doctors differentiate glaucoma patients from normal patients. These
values should be evaluated together and in conjunction with all other clinical information for
the patient.
Patient scan data obtained from within and outside the Calculation Circle are evaluated based on
these criteria to generate the NFI.
The NFI is displayed as a number between 0 - 100. The higher the NFI, the more likely the patient
has glaucoma. This is not an indicator of disease severity or progression. While there are exceptions,
generally the following scale can be used as a guideline in considering the NFI:
< 30 low likelihood of glaucoma
30 – 50 glaucoma suspect
> 50 elevated likelihood of glaucoma
The NFI is dependent upon proper ellipse placement centered over the ONH. Change in the ellipse
position may affect the NFI.
Extended Parameters
The Extended Parameters include alternative parameters that are generally less frequently used in
clinical practice than those presented in the TSNIT Parameters Table. They are provided to allow
comparison to data from exams conducted with earlier versions of the GDx. These parameters are
available only by selecting Extended Print on the PRINT & EXPORT OPTIONS screens. These parameters
will appear as a second page of the active report format. (* indicates parameters that also appear
on Page 1.)
*The Number: see NFI (Nerve Fiber Indicator).
Symmetry: Ratio of the average of the 210 thickest measurements in the superior quadrant over the
average of the 210 thickest measurements in the inferior quadrant. The closer the ratio is to 1.0, the
more symmetric the nerve fiber layer of the superior and inferior quadrants (Superior quadrant ÷
Inferior quadrant).
Superior Ratio: Ratio of the average of the 210 thickest measurements in the superior quadrant over
the average of the 210 median measurements in the temporal quadrant (Superior quadrant ÷
Temporal quadrant).
Inferior Ratio: Ratio of the average of the 210 thickest measurements in the inferior quadrant over
the average of the 210 median measurements in the temporal quadrant (Inferior quadrant ÷
Temporal quadrant).
Superior/Nasal: Ratio of the average of the 210 thickest measurements in the superior quadrant over
the average of the 210 median measurements in the nasal quadrant (Superior quadrant ÷ Nasal
quadrant).
Max. Modulation: This parameter provides an indication of the difference between the thickest parts
of the nerve fiber layer and the thinnest parts. The higher the number, the greater the difference
between the thickest and thinnest parts of the nerve fiber layer. In a normal eye, where the superior
and inferior nerve fiber layer is much thicker than the nasal or temporal nerve fiber layer, the
modulation number will usually be greater than 1.
Superior Maximum: The average of the 210 thickest measurements in the superior quadrant.
Inferior Maximum: The average of the 210 thickest measurements in the inferior quadrant.
Ellipse Modulation: Like Max Modulation, Ellipse Modulation is an indication of the difference
between the thickest and thinnest parts of the retinal nerve fiber layer. Rather than using all of the
points in the image, Ellipse Modulation uses only the data points along the data ellipse surrounding
the optic nerve.
Normalized Superior Area: This parameter examines the modulation in the data ellipse, but only in
the superior portion. A high value represents high modulation as seen in normal eyes; a low value
represents low modulation as seen in eyes with RNFL loss.
Normalized Inferior Area: This parameter examines the modulation in the data ellipse, but only in
the inferior portion. A high value represents high modulation as seen in normal patients; a low value
represents low modulation as seen in patients with RNFL loss.
*Ellipse Standard Deviation: see TSNIT Standard Deviation.
Discriminant Analysis: Only available for Fixed Mode exams, refer to your previous manual for
information.
*Ellipse Average: see TSNIT Average.
Report Formats
This section describes the various report formats available with GDxVCC, the details of each
component are described in Report Content. Two basic types of report exist: Nerve Fiber Analysis
and Serial Analysis. Space for comments, signature and date are provided.
Format
Nerve Fiber
Analysis Serial Analysis Advanced Serial
(Single Eye or (FCC or SCC Analysis
Format Content Symmetry) scans) (VCC scans only)
Fundus image OD or OS or both OD or OS OD or OS
RNFL thickness map 9 9 9
TSNIT graph 9 9 9
Deviation from normal map 9 9 9
Deviation from reference (baseline) map 9 9 9
TSNIT parameters table and NFI 9 9 9
Difference from Baseline 9 9
% Change from Baseline 9
Trend Analysis with Probability Graph 9
Table 4-1 Printout Format Contents
Serial Analysis
The Serial Analysis printout (Figure 4-3) displays a selection of up to four scans of the same eye
chronologically (from top to bottom) to help track RNFL changes over time. This report presents an
RNFL thickness map, Deviation from Normal map, Deviation from Reference map, TSNIT Parameters
Table and NFI for each eye. In addition, a combination TSNIT graph provides an overlay showing the
TSNIT values for each eye as a different colored line.
The exam at the top of the report is considered the baseline measurement for the selected serial
analysis. The Deviation from Reference map for each additional measurement (after baseline)
illustrates changes from baseline. The TSNIT Parameter Table also contains a difference column
(from baseline).
☞ Note: If the comparison scans do not align well, see Alignment Options on page 5-10.
☞ Note: Difference from Baseline, found in this analysis, is the same as Deviation from
Reference found in other analyses.
☞ Note: If the comparison scans do not align well, see Alignment Options on page 5-10.
Alignment Options
If scans used for Serial Analysis or Advanced Serial Analysis are not well aligned, you should
examine the Compare Alignment Options function. For details, see Alignment Options on page
5-10.
☞ Note: Make sure you write down the Administrator password and put it in a safe place. If
you lose your Administrator password, call CZM customer service: in the U.S., call
800-341-6968; outside the U.S., contact your local CZM distributor.
8. You are now logged on as the Administrator. At this point, you can setup user names and
passwords for all other users of the GDxVCC. See the procedure, To Setup User Names and
Passwords below.
☞ Note: To setup or modify user names (and initial passwords), you must be logged on as the
Administrator. If you lose your Administrator password, call CZM customer service: in the
U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor.
1. If you are not currently logged on as the Administrator, log onto the system by entering ‘admin’
as the user name and specifying the Administrator password.
2. From the LOGO screen, select System.
3. The SYSTEM OPTIONS screen appears. Select Doctor Information.
4. The USER LIST screen appears. If you wish to create a user name and password for a doctor who
has already been entered into the system, highlight the name of the doctor in the list and select
Modify User. If you wish to enter a user name and password for a new doctor (who isn’t
already shown in the user list), select Add User.
5. The USER INFORMATION screen appears. All fields in this screen are required to be filled in. Enter
the user name and password, and then re-enter the password, as shown in Figure 5-1 below.
☞ Note: As the screen indicates, you are specifying the GDx user name and password. This is
different from the network user name and password that the Administrator needs to setup in
a networked environment (e.g. a clinic where Windows PCs and GDxVCCs are attached to a
local area network). The GDx user name and password allows a doctor to log onto the
GDxVCC. The network user name and password (which is described in Appendix C:
Importing, Exporting, & Printing Data via a Network), allows the GDxVCC to log onto a
Windows PC over the network.
6. Optionally, click Clinic Info, and enter or modify the clinic information for the doctor.
7. When you have finished entering the user information, select Save. You are notified “User
Logon information was added to the database”. Press OK (9).
8. You must log out before the new user names and passwords will take effect.
To Log Out
Use this procedure to log out, so that no other user can access the GDxVCC without entering a valid
user name and password.
1. From the LOGO screen, select System.
2. Select Security Setup.
3. The SECURITY OPTIONS screen appears. Select Log Out. You are prompted, “Are you sure you want
to log out the current user?” Press OK (9).
☞ Note: To disable security, you must be logged on as the Administrator. If you lose your
Administrator password, call CZM customer service: in the U.S., call 800-341-6968; outside
the U.S., contact your local CZM distributor.
1. When you startup the GDxVCC—or when you log on—you are asked for a user name and
password. (If you are not asked for a user name and password, then security is not currently
enabled.) Enter ‘admin’ for the user name, and then enter the administrator password.
2. From the LOGO screen, select System.
3. Select Security Setup.
4. The SECURITY OPTIONS screen appears. Select Security.
5. The SECURITY screen appears. Select Disable.
6. The SECURITY OPTIONS screen appears again. Press OK (9).
☞ Note: You must know either the administrator password and/or the user name and password
of a user in order to log onto the system once security mode is re-enabled. If you lose your
Administrator password, call CZM customer service: in the U.S., call 800-341-6968; outside
the U.S., contact your local CZM distributor. If you forget the user name and password for a
normal user, ask the Administrator to retrieve that information from the USER INFORMATION
screen, shown in the procedure To Setup User Names and Passwords on page 5-1.
System Tests
System tests verify that your system is operating correctly. As a part of the tests, the software will
verify that the calibration is consistent over time. Some system test measurements are classified as
“critical.” Failure of these critical tests will cause image acquisition to be disabled.
System Test
If you feel your system is not operating properly, it is recommended that you run the System Test
prior to calling CZM customer service: in the U.S., call 800-341-6968; outside the U.S., contact your
local CZM distributor. Information on whether or not the system passed the System Test will be
helpful to your CZM service representative.
To run the System Test, at the LOGO screen select System, More, System Test, and System Test again.
The System Test will run one time and progress during the test is displayed on the LCD Display. The
System Test may be stopped at any time by pressing Cancel/Go Back (8). If the test is cancelled
before the end of the test, the system may take up to a minute before testing actually stops.
On completion, if there were no errors the software will display that the test is complete, press OK
(9) to return to the LOGO screen. If there were errors or if the test was terminated before
completion, errors will be displayed on the SYSTEM ERROR LIST screen (Figure 5-3). Additional
information to display is indicated by the scroll bar below the list of errors.
Continuous Test
If you suspect that your system is intermittently demonstrating a problem, it is recommended to run
the Continuous System Test for a period commensurate with the period between suspected problem
occurrences. Continuously passing the system test over that suspect period indicates that the system
operation is stable.
To run the System Test continuously, at the SYSTEM TEST screen select Continuous. The System Test will
run until Cancel/Go Back (8) is pressed. If the test is cancelled before the end of a full test
sequence, the system may take up to a minute before testing actually stops.
Once you end the test, errors will be displayed on the SYSTEM ERROR LIST screen. Additional
information to display is indicated by the lightly shaded portion(s) of the horizontal scroll bar below
the list of errors.
Button Test
To test the function and control buttons and their backlights, select Button Test at the SYSTEM TEST
screen. When this test is initiated, GDxVCC will step the user through a button test, one button at a
time. The system will light each button in sequence, and display an instruction on the LCD Display to
press the lighted button. When instructed, press the scan acquisition button on top of the joystick.
At the completion of the test the LOGO screen is displayed.
☞ Note: If you press the wrong button, the test results will be invalid and the failure dialog will
appear. The system will return to the LOGO screen and you should repeat the test.
Database Options
The Database Options allow the user to optimize database performance, merge the exam files
between the two hard drives, and synchronize all data, databases, application files, and the
operating system.
Optimize
As with any computer-based system, the more reading and writing to and from a database, the
more the data becomes fragmented on the hard disk. Therefore, the performance of these
operations will slow over time. The system is routinely optimized during the system warm up. Only
run the Optimize function at the recommendation of the CZM Service department.
At the LOGO screen select System, then Database, then Optimize. GDxVCC will optimize the database
and return to the LOGO screen automatically.
Merge
Merge is used to merge the database files from the backup drive to the main drive. Normally, the
main and backup drives contain identical data.
Merge should only be necessary when the backup drive contains data that is not present on the
main drive. This could occur if you have multiple GDxVCC units and you wish to have all patient
exams on all units, or if one of the two hard drives was out of service and needed to be updated
with the exams stored on the other drive during the out of service period.
To perform the Merge operation, at the LOGO screen, select System, then Database, then Merge. You
will see the CZM OPTIONS PASSWORD screen. This screen will instruct you to call CZM service for a
password. Coordinate with the CZM service representative for the remainder of the Merge
operation.
If the system is unable to merge a patient record because of differences between the main database
and backups on the system, you will be prompted to replace the record. There are four ways to
replace that record:
• Main Record: The two records belong to the same patient, and the main record is more correct.
• Backup Record: The two records belong to the same patient, and the backup record is more
correct.
• Main Change Patient ID: The two records have the same patient ID, and the main record
belongs to different patient. Assign a new patient ID number to the main record.
• Backup Change Patient ID: The two records have the same patient ID, and the backup record
belongs to different patient. Assign a new patient ID number to the backup record.
If during a Merge operation, a patient ID conflict occurs the system will display the UPDATE PATIENT
ID – DATABASE MERGE screen. Enter an appropriate ID for the patient. Press OK (9) and the LOGO
screen will be displayed.
Sync Disks
Sync Disks is used to make the backup drive identical to the master drive. This includes databases,
application files, and operating system. Everything on the backup drive will be overwritten such that
it is contains identical information as the main drive. As a precaution, if the main drive and backup
drive contain different versions of GDx software, disk synchronization cannot be performed.
☞ Note: Sync Disks will overwrite all data on the backup drive with data from the master drive.
This feature should not be used unless instructed by an CZM Service Representative.
Recalculate Data
All records in the database will be updated with the most current version of calculations. This
function may be performed after a software update and may take a while depending on the number
of records in the database.
Export Data
Selecting Export Data exports all the information required to regenerate the database. If security is
enabled, only the data for the doctor who is currently logged on will be exported.
Import Data
Selecting Import Data imports the data into the current systems database. If security is enabled the
database is imported to the database for the doctor who is currently logged on. Importing only
imports updated or new database records. All calculation records are recalculated prior to saving
into the database.
Software Update
You may receive update disks from CZM with directions to insert a floppy disk and turn on power.
This is the preferred technique for updating software. This technique does not use the Software
Update function which appears on the ADDITIONAL SYSTEM OPTIONS screen.
☞ IMPORTANT: Software Update is not a general purpose function and should not be used
without direction from CZM personnel.
Alignment Options
If scans used for Serial Analysis or Advanced Serial Analysis are not well aligned, you should
examine the Compare Alignment Options function.
At the LOGO screen, select System, More, More then Compare Alignment.
The COMPARE ALIGNMENT OPTIONS screen (Figure 5-6) is displayed and allows setting up the type of
alignment when performing a serial analysis or advanced serial analysis of images of the same eye
over time. The default settings are Image Alignment and Image Rotation.
The choices on the COMPARE ALIGNMENT OPTIONS screen to select from are:
XY Alignment options:
• No Alignment to deactivate XY alignment. Only use this option if all other alignment types fail.
• Ellipse Alignment to have GDxVCC align the scans based on the position of the ellipse on each
scan. As the user sets the position of the ellipse, almost any position of XY alignment may be
achieved with this option.
• Image Alignment (the default) to have GDxVCC align the scans based on features in the scans.
If this option is successful, it provides the best XY alignment automatically.
Rotational Alignment options:
• No Rotation to deactivate rotational alignment. Only use this option if Image Rotation failed.
• Image Rotation (the default) to perform rotational alignment based on features in the scans. If
this option is successful, it provides the best rotational alignment, automatically.
Other Recommendations
• Use a UPS (Uninterrupted Power Supply) to protect data from power failures.
• Always place the lens cap over the patient lens when not in use.
• Use the CZM carrying case if transporting the GDxVCC.
• Wrap the GDxVCC in a plastic bag while the unit is in the carrying case to protect the optics
from dust.
Never remove any panels except the side panel (which covers the removable hard-drives) and the
top panel (which covers the internal printer in some models) from the GDxVCC.
Never clean with harsh chemicals or detergents.
Never use fluids or aerosol on or near the GDxVCC. These products can damage the GDxVCC surface
and affect the delicate optics.
Never attempt to change any of the batteries in the system. Attempting to change a battery can
cause damage and loss of data.
the fuse and the label adjacent to the fuse box. Gently return the GDxVCC to its upright, operating
position.
☞ Note: Improper removal of one or both Hard Disk Drives may result in loss of valuable data.
Do not attempt to remove the Hard Disk Drives in GDxVCC without specific instructions from
CZM customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local
CZM distributor.
☞ Note: The Hard Disk Drives have a warning label (Figure 6-3) to guard against removal
without first removing the GDxVCC from any power source.
CAUTION: Be sure to remove the objective lens foam block protector and unlock the
scan head optics before applying power to the GDxVCC.
CAUTION: Be sure to remove power from the external printer, if applicable, prior to
powering down the GDxVCC.
Laser Safety
The GDxVCC is equipped with three different low power laser devices:
• The Imaging laser - a laser diode, 780 nm wavelength, primary output power of 40mW, that
emits directionally variable radiation.
• The Fixation laser - a visible laser diode, 635 nm wavelength, primary output power of 5mW,
that emits directionally variable radiation.
• The Trigger laser - a diode laser, 650 nm wavelength, primary output power of <500µW, that
does not exit the internal structure of the GDxVCC.
The system fulfills the “Radiation Safety Regulations for Laser Systems” (ANSI Z136.1), complies with
US 21 CFR 1040.10 and 1040.11, and is classified as Class I. It does not produce hazardous radiation
to the human eye.
The GDxVCC is equipped with electronic safety circuitry that constantly monitors the function of the
scanning mirrors. In the case of a malfunction of any of the scanning mirrors, the laser beam is shut
off automatically. The laser and its associated optics are enclosed in modules within the system’s
protective housing. Do not attempt to open the protective housing for any reason as the radiation
inside the protective housing is hazardous (Class IIIb Laser) and could cause personal injury! There
are no user-serviceable parts inside the protective housing. If the unit fails, contact CZM for
instructions.
WARNING: Do not attempt to open the protective housing of the GDxVCC for any
reason. No user maintenance is required, or allowed.
☞ Note: The Laser Safety label (Figure 6-5) has been attached to the protective housing of the
GDxVCC optics box in compliance with United States and /or international requirements.
AccessCards
An AccessCard is necessary to operate your GDxVCC. There are different types of AccessCards
depending upon your GDxVCC acquisition program.
Ownership:
If you purchased your GDxVCC, the unit comes with an Ownership AccessCard with an unlimited
number exams and no expiration date.
Transporting
☞ Note: The optics of the GDxVCC may be damaged if the system is jarred during a move or
transportation. If there is any chance of the GDxVCC being bumped or jarred, perform the
Shut Down for Transport procedure.
This Shut Down For Transport procedure moves the optics to the docked position. This enables the
locking screw to be engaged and protects the optics from damage during transportation.
At the LOGO screen, select System, More, Shut Down for Transport. GDxVCC will display a message
asking you to confirm that you wish to shut the system down. Press Cancel/Go Back (8) if you do
not want to shut the system down. Press OK (9) if you do want to shut down the system. The
GDxVCC internal optics will start moving towards its home position and the SHUT DOWN FOR
TRANSPORT screen will be displayed.
The SHUT DOWN FOR TRANSPORT screen provides pictures and instructions for inserting the Phillips
screwdriver, provided with the GDxVCC accessory kit, into the optics lock down screw hole (larger of
the air vent holes) on the right side of the system (when facing the LCD Display). You are instructed
to insert the screwdriver head through the hole, engage the spring-loaded screw, and tighten the
screw firmly with a clockwise rotation of the screwdriver.
It is not possible to escape from this screen until power to the GDxVCC is cycled off, and then back
on again. Pressing the operation keys will merely toggle an Attention! message, alerting you to
disconnect the system power, release the locking screw, then reconnect and power up.
After transporting the GDxVCC and placing it in a secure position, release the locking screw by
placing the Phillips screwdriver in the optics lock down screw hole on the right side of the system,
engaging the spring loaded screw, and turning the screw counterclockwise until it is loose and turns
freely. Then perform the power up procedure (Power Upon page 1-5).
☞ Note: Carl Zeiss Meditec offers an optional transport case for your convenience to safely
transport your GDxVCC. We recommend that you use it whenever the need arises to
transport the GDxVCC from one location to another. Contact CZM sales department to order
a transport case: in the U.S., call 877-486-7473; outside the U.S., contact your local CZM
distributor.
(7) Troubleshooting
If you are unable to resolve a problem with your GDxVCC please contact CZM customer service. In
the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor.
GDxVCC Locks Up
Write down any error message received, including all numbers and codes.
Write down the steps that were taken to produce the problem.
Cycle power by unplugging and re-plugging the power cord, or…
Reset GDxVCC by carefully inserting the end of a straightened paper clip into the small Reset Hole in
the lower right-hand corner of the operator faceplate, below the Cancel/Go Back (8) button (see
Figure 1-1 on page 1-3). Push gently then remove the paper clip.
2. The SELECT REFRACTION screen appears (Figure A-1). Enter the refraction as instructed on
screen.
Perform a normal data acquisition procedure. See Image Acquisition on page 2-5. When
you arrive at the IMAGE CHECK screen, continue with step 4.
4. After acquiring the images, the IMAGE CHECK - SCREENING screen appears:
☞ Note: Proper ONH and macula ellipse placement and scan image quality influence image
quality messages.
B. Verify that the Macula Ellipse is positioned properly, as described in Image Quality on
page 2-7.
☞ Note: If the Macula Ellipse is not positioned correctly, the cornea compensation is not valid.
Check the size and position of the Macula Ellipse on both the right eye and left eye scans.
Select Modify OD Macula Ellipse. The screen shows where the system automatically placed
the Macula Ellipse.
To modify the Macula Ellipse position, select Set Position. Four positioning buttons are
activated for right, left, up, and down movement. Press the positioning buttons as
necessary to center the Ellipse over the macula. For continuous movement, press and hold
down the direction buttons.
You do not need to modify the macula ellipse size unless this helps you center the macula
ellipse.
When you have optimized the placement of the Macula Ellipse for the right macula, press
OK (9) to return to the IMAGE CHECK - SCREENING screen.
Select Modify OS Macula Ellipse and repeat this process for the left eye. When finished,
press OK (9) to return to the IMAGE CHECK - SCREENING screen.
C. Verify that the ONH Ellipse is centered about the optic nerve head.
Select Modify OD ONH Ellipse for the right eye. The screen displays where the system
automatically placed the ONH Ellipse. It should be placed such that the ellipse is centered
over the optic nerve head (ONH).
☞ Note: You may find it helpful to resize the ellipse so that it fits closely around the optic nerve
head rim, since this helps you to verify that the ellipse is centered properly. However, the size
of the ellipse is not important.
To modify the ONH Ellipse position, select Set Position. Four positioning buttons are
activated for right, left, up, and down movement. Press the proper positioning buttons to
center the ONH ellipse. For continuous movement, press and hold down the direction
buttons. Chapter 2: Exam Procedures shows a proper placement of the ellipse over the
ONH. Select Modify OS ONH Ellipse to center the ONH ellipse for the left eye.
D. Verify that the Calculation Circle is the proper size. See Calculation Circle on page 2-12
for more information on the Calculation Circle.
E. If the images are not acceptable, retake them. (To determine whether images are
acceptable or not, see Image Quality on page 2-7.)
F. When you are satisfied with the image quality on the IMAGE CHECK screen, select Accept.
If not satisfied, select Retake Image. The IMAGE RETAKE SELECTION screen appears, and allows
you to choose Retake Both Eyes, Retake Right (OD) Eye, or Retake Left (OS) Eye. After you
make your selection, the system returns to the ACQUISITION - SCREENING screen to obtain new
scans. The system will only overwrite the image or images that you retake. For example, if
you only retake the image of the right eye, the previous image of the left eye is retained
without being overwritten.
G. When you are satisfied with the image quality on the IMAGE CHECK screen, select Accept.
☞ Note: If you are using an AccessCard with a plan that does not have unlimited use, you will
be debited one screening exam when you press Accept.
H. At this point, the exams are automatically evaluated to verify that the cornea compensation
was set correctly for each eye. If cornea compensation was not set correctly, you are
prompted to reexamine the affected eye(s). This automatic evaluation occurs only once.
After you retake the exam(s)—or if no problems were found after the first set of exams—
the results are displayed, as shown in the next step.
☞ Note: In some cases, it is not possible to obtain a useful image of an eye. In this situation,
the following message is displayed: “RNFL assessment for this exam is not valid.” This can
happen with a small percentage of patients.
☞ Note: You will need an Ethernet cross-over cable that is long enough to connect your PC to
the GDxVCC. A cross-over cable enables two network devices—such as a PC and a
GDxVCC—to connect to each other directly via an Ethernet connection because the cable is
set up so that the transmit pins on one device connect to the receive pins on the other
device. Thus, the transmit and receive wires in the cable are “crossed over”.
iv. Type Tab until the Properties button is selected, and type Enter.
v. Type down arrow to select Specify an IP address. The screen should now appear similar to
Figure B-1:
☞ Note: If your PC is running a version of Windows that is older than Windows 2000, it is
possible that the network settings on your PC may not be set to valid values automatically.
For example, all values may be zero, or there may be no values at all. In this case, you will
need to set the network settings on your PC. You can use any valid IP address (such as
100.100.100.100), the standard subnet mask (255.255.255.0), and any valid default gateway
(such as 100.100.100.1). In order to set these values, bring up the Network Configuration
dialog box and select Properties on your PC, just as you did on the GDxVCC (as shown in
Figure B-1).
i. Tab to the IP Address box. Enter the first three parts of the IP address so that they match
the IP Address on the PC. For the fourth part of the IP address, enter an available number
between 2 and 255. For example, if the IP Address on the PC is 183.62.235.20, you
could enter 183.62.235.30 on the GDxVCC.
ii. Tab to the Subnet Mask box. Enter the subnet mask used by the PC. Usually, this is
255.255.255.0.
iii. Tab to the Default Gateway box. Enter the default gateway used by the PC.
E. Fill in the DNS name server values on the GDxVCC.
i. Type Tab until you select the IP Address tab at the top of the dialog box. Type Right arrow
to select Name Servers.
ii. Tab to the Primary DNS box. Enter the primary DNS value from the listing on the PC. If the
listing only shows DNS Servers, enter that value.
iii. Tab to the Secondary DNS box. Enter the secondary DNS value from the listing on the PC.
If the listing only shows DNS Servers, enter that value.
iv. From the Control Panel, bring up the Configuration Manager, and select Save Settings.
4. Make sure that there is a local user account on the PC. A local user account is a an account
where the user specifies the name of the PC as the domain name when logging onto the PC.
(This is different from a network user account, where the user specifies the name of a network
server as the domain name when logging onto the PC.) Essentially, the GDxVCC will log onto
the PC by using the user name and password for this local user.
☞ Note: Neither this user nor any other users are required to be logged onto the PC at the time
that the GDxVCC is importing or exporting data to the PC.
5. Make sure that there is a shared folder on the PC that has access permissions set such that the
local user account can read and write to this folder.
If you don’t have a shared folder on the PC with these properties, you need to create one. To do
this, create an ordinary folder and give it the name you wish to use.
☞ Note: The folder name must not contain any spaces. For example, use ‘Patient_Data’ not
‘Patient Data’.
Right click on the folder and select Properties. In the PROPERTIES dialog box, set the sharing
properties and security properties so that the local user account has access to the folder. For
more information about sharing and security properties, see the Microsoft Windows documen-
tation or online help for your version of the operating system.
The icon for a shared folder has a special appearance, with a hand at the bottom. You can now
use the name of that folder in the Network Destination screen of the GDxVCC.
If you have multiple GDxVCC users, they can each have their own exclusive shared folder for
importing and exporting. As long as each user has a local user account on the system, the
above procedure can be repeated for each user’s shared folder so that they have exclusive
access to only their own folder.
6. Setup the network destination on the GDxVCC so that it specifies the shared folder on the PC
that was setup in Step 5. To do this, use the following substeps:
A. At the LOGO screen and select System. The SYSTEM OPTIONS screen appears.
B. Bring up the DOCTOR INFORMATION screen for the doctor whose network connection is to be
configured.
C. On the DOCTOR INFORMATION screen, ensure that both a Doctor Name and Clinic Name are
entered. For example, both Henry Johnson and Optimal Eye Care Clinic are specified in the
sample screen, Figure B-2. Then select Network. The NETWORK DESTINATION screen appears,
as shown in Figure B-3:
7. Make sure the doctor/clinic associated with this network destination is selected as the current
doctor/clinic. In Appendix C see Basic Networking Procedures on page C-8, including To
View the Currently Selected Doctor/Clinic on page C-8 and To Change the
Currently Selected Doctor/Clinic on page C-9.
8. You can now export data to the PC (and import data from the PC), as described in Appendix
C: Importing, Exporting, & Printing Data via a Network. For example, see the
procedure To Export the Complete Database on page C-12.
Overview
The folder specified in a network configuration must be a shared folder, i.e. a folder that is setup to
be shared over the network (rather than used only by the person who is logged onto the PC locally).
It is easy to convert an ordinary folder into a shared folder. This is included in the step-by-step
procedure “To Configure the Network Connection”, in this appendix.
If the security feature of the GDxVCC is enabled, a unique system user login name must be assigned
to each doctor. The doctor must then log on using this user name and password. A user (doctor)
must be setup by the administrator, and then the network information for that doctor can be
configured. Subsequently, the doctor can perform exams, and then export the data over the
network.
Using Security Mode
The HIPAA act sets forth patient privacy regulations that medical practices within the United States
must follow. The security features of the GDxVCC help to ensure that patient data can only be
viewed by the appropriate doctor.
The GDxVCC provides a security mode, as described in Using Security Mode on page 5-1. When
the security mode is enabled, each doctor must log on to the GDxVCC with a unique user name and
password. When security is enabled, doctors can only view patient data for their own patients, even
though multiple doctors may use the same GDxVCC. If security is disabled, all doctors can see the
patient data for all other doctors. The security mode applies to importing and exporting data over
the network, as well. A doctor may export patient data to a network destination (a shared folder on
a networked Windows PC), and later import that data. If the security mode is enabled, each doctor
can only import and export data for their own patients. If the security mode is disabled, doctors can
import and export patient data for all other doctors.
In order to help protect patient privacy within a networked environment, following best practices
should be put in place at a minimum:
1. The security mode should be enabled on all GDxVCCs which are used by more than one doctor.
If a clinic has multiple GDxVCCs which are used by multiple doctors, the security mode should be
enabled on all of them. Otherwise, it could be possible to export patient data from a secure
GDxVCC, and then import that data over the network to an unsecured GDxVCC where the data
could be viewed by other doctors at the clinic.
2. Access permissions should be set on all shared folders that serve as network destinations for
importing/exporting patient data.
Only the doctor who exports data to a particular shared folder should have permissions to view and
modify that folder. Otherwise, other doctors could potentially view or modify the data, either over
the network or by logging onto the computer locally. Normal Windows access controls can be used
to restrict access to the folders that contain private data. For example, the doctor who is assigned a
shared folder as a network destination, should also be the only doctor who knows the user name
and password that makes it possible to log on to that PC with access to that folder.
☞ Note: The image data is stored according to the initial of the last name that was originally
entered for the patient. For example, if Mary Johnson changes her name to Mary Smith and
you update her patient information accordingly, her image data will still be stored in the ‘J’
folder when you perform an export.
2. PatientLastName_PatientID – A folder that is created automatically when you export data for
specific patients (see “To Export Exams for a Single Patient”,
and “To Export Flagged Exams for One or More Patients”). For
example, this folder might be named Jones_137. The folder
contents are:
PatientLastName_DateOfBirth.html – An HTML file containing an exam report
PatientLastName_DateOfBirth.svg – An SVG file containing an exam report
PatientLastName_DateOfBirth.xml – An XML file containing an exam report
.JPG files containing image data that is referenced by the SVG and HTML files
3. PatientLastName2_PatientID2 – E.g. Smith_138
4. PatientLastName3_PatientID3 – E.g. Brown_139
5. Etc.
When you perform complete database exports, the DatabaseExport folder and its contents are
created (the first time) or updated (on subsequent exports). A proprietary format is used to store the
image data during this type of export, because the data is only intended to be used if you import it
into a GDxVCC. However, when you export data reports for individual patient’s (as opposed to a full
database export or a raw data export), the data is first converted to popular file formats, including
HTML, SVG, and XML. This type of export is intended to make it possible for you to access the
reports with software applications, if you wish.
☞ Note: You may find it beneficial to familiarize yourself with the files and folders that are
created during exports, even those that contain data in proprietary format. If you know what
files and folders should be created by an export, you can verify that they were indeed
created after the operation is complete. Although the GDxVCC provides a message that
indicates whether or not an export operation was successful, it is still a good idea to actually
view the files and folders on the PC, just to be sure.
☞ Note: The HTML files contain links to SVG files. Because of this, you cannot view the HTML
reports within a web browser unless you install an SVG viewer. An SVG viewer can be
downloaded from Adobe Systems. See http://www.adobe.com.
If you don’t know the computer name or domain name, click Start (on the PC), click Settings,
and select Control Panel. Double click on System. Select the Computer Name tab on Win-
dows XP Professional, or the Network Identification tab on Windows 2000. The Full Com-
puter Name and the Domain are shown. These are the names you should use in the NETWORK
DESTINATION screen.
If you don’t have a shared folder on the PC, you need to create one. To do this, create an ordi-
nary folder and give it the name you wish to use.
☞ Note: The folder name must not contain any spaces. For example, use ‘Patient_Data’ not
‘Patient Data’.
Right click on the folder and select Properties. In the PROPERTIES dialog box, set the sharing
properties and security properties so that the local user account has access to the folder. For
more information, see the Microsoft Windows documentation or online help for your version of
the operating system.
The icon for a shared folder has a special appearance, with a hand at the bottom. You can now
use the name of that folder in the NETWORK DESTINATION screen.
If you have multiple GDxVCC users, they can each have their own exclusive shared folder for
importing and exporting. As long as each user has a local user account on the system, the
above procedure can be repeated for each user’s shared folder so that they have exclusive
access to only their own folder.
5. Select Test Connection to verify that the connection between the GDxVCC and the PC can be
established.
If the test fails, you may receive one of the messages shown in the subsection What if ‘Test
Connection’ Fails? on page B-6 of Appendix B.
6. If the Test Connection was successful, select Save. You should see the message: “Network
information was added to the database.”
7. Make sure the doctor/clinic associated with this network destination is selected as the current
doctor/clinic. See Basic Networking Procedures below, including To View the
Currently Selected Doctor/Clinic on page C-8 and To Change the Currently
Selected Doctor/Clinic on page C-9.
that will be used if you perform an import or export operation. This procedure allows you to
determine which doctor/clinic combination is currently selected.
☞ Note: If you are logged on as the administrator, any of the doctor/clinic combinations setup
for the GDxVCC might be specified as the current doctor/clinic. If you are logged on as a
doctor and you use the GDxVCC at more than one clinic, any of your doctor/clinic
combinations might be specified as the current doctor/clinic.
☞ Note: If the currently selected doctor/clinic does not have a network destination setup, or if
there is any problem with the network connection (e.g. the Windows PC is not up and
running, or the shared folder is not accessible), any import/export operations will prompt
you for a location on the hard drive or floppy disk of the GDxVCC, rather than use the
network destination.
☞ Note: If the currently selected doctor/clinic does not have a network destination setup, or if
there is any problem with the network connection (e.g. the Windows PC is not up and
running, or the shared folder is not accessible), any import/export operations will prompt
you for a location on the hard drive or floppy disk of the GDxVCC, rather than use the
network destination.
4. Select Print & Export Options. The PRINT AND EXPORT OPTIONS screen appears, as shown in
Figure C-4.
1. Create a folder to hold just the files you wish to send via email. Copy the files to this location
from your network destination shared folder. See Data Files and Folders on page C-4 to
determine which files you need to include.
For example, if you want to email a report in HTML format, copy the file
PatientLastName_DateOfBirth.html. Remember to copy the associated .SVG and .JPG files.
(The HTML file references an .SVG file, which in turn references .JPG files.) It is easier to deter-
mine which files you need to email if you first export only the exam reports that you wish to
email to a shared folder that is initially empty.
2. To help ensure patient privacy, it is a good idea to encrypt the files before emailing them.
The export operation then proceeds, with a status line indicating how many database records
have been processed and exported. If the export operation is successful, you will see the mes-
sage: Exporting Completed.
If the network destination cannot be accessed for any reason, a Windows dialog box appears
allowing you to choose a folder or a floppy disk on the GDxVCC internal disk drive where you
can export the database of exams.
4. Verify that the data was exported properly.
You should verify that the data that you expected to be exported is now saved correctly on the
PC. This is an important safety measure, especially if you are archiving data that you may need
to retrieve or import at a later point. In order to verify the export, you should be familiar with
the files that are created during an export, as described in Data Files and Folders on page
C-4.
Here is an example. Assume you are the administrator, and you are exporting a database consisting
of three patients who are seeing two doctors, as shown in Figure C-6 below.
operation completes, you should expect to see that six records were processed, as shown in Figure
C-7 below.
imported, if necessary, at a later time. If you want to create graphics files that can be used outside
of the GDxVCC, you should export exam reports. This will save JPG files as part of the export.
☞ Note: Patient information is exported only for those patients for whom measurement data
exists in the database. If the basic patient information has been entered, but a full exam has
not been administered for that patient (and, therefore, no measurement data exists in the
database for that patient), the corresponding patient information is not exported during a
database export.
☞ Note: If data on the GDxVCC hard drive is corrupted, you can import a valid backup.
However, since the data already exists internally in the GDxVCC database (in a corrupted
state), you must first delete that data before you perform the import.
☞ Note: You cannot import exam reports that were previously exported. You can only import
raw data (which results from either from a full database export, or from a raw data export
for one or more individual patients).
should export that patient’s data to a shared folder that is currently empty. If you want to trans-
fer the data for some (but not all) patients, repeat the procedure “To Export Selected Exams for
a Single Patient” as necessary for each patient, to a shared folder that is initially empty.
2. Setup that same network destination (shared folder) for the second GDxVCC, as described in
the procedure To Configure the Network Connection on page C-6.
3. Perform an import to the second GDxVCC, as described in the procedure To Import Data
Over the Network on page C-15.
☞ Note: Floppy disks can hold at most two images exported from the Measurements List.
☞ Note: The AccessCard Log File (which maintains a history of exams) is not described in this
section. To export this file, see Appendix D: The AccessCard Log File.
☞ Note: If the network destination is not specified properly or there is a problem accessing the
network destination, then a Windows dialog box appears allowing you to specify a location
either on the internal hard drive of the GDxVCC or on the floppy drive. This can happen
because the PC is not running, not connected, or no longer has the shared folder that is
designated as the network destination. This can also happen because the GDxVCC is not
connected to the network, or there is a problem somewhere within the network. In this
procedure, you purposefully set things up so that the network destination is not found.
3. After you press the button that performs the export, an Open dialog box appears. Select
FloppyA by navigating through the Open dialog box with the tab key and down arrow.
When you perform an export to a floppy disk, the same files are exported as when you perform
an export over the network. See Data Files and Folders on page C-4.
To Import Patient Data from a Floppy Disk
Purpose: Use this procedure to import data that was previously exported to a floppy disk (or the
internal hard disk).
1. Make sure a network destination is not configured. If you normally import from a network
destination, you can temporarily alter your user name so that the network doesn’t recognize it,
by editing the Network Destination screen. Alternatively, you can disconnect the network cable
from the GDxVCC.
2. From LOGO screen, select System.
3. From SYSTEM OPTIONS screen, select Database.
4. From DATABASE OPTIONS screen, select Import Data.
5. Use tab and down arrow to select FloppyA, and press Enter.
6. When prompted, place the floppy in the GDxVCC floppy drive and press Enter.
2. Bring up the NETWORK CONFIGURATION dialog box and select the Identification tab, as follows:
A. Type right arrow and down arrow as necessary until Network is highlighted.
B. Type Enter. This brings up the NETWORK CONFIGURATION dialog box.
C. Highlight the PCI Ethernet Controller in the list. (For example, the full name may be Intel
8255x PCI Ethernet Controller.)
D. Type Tab until the Properties button is selected, and type Enter.
E. Type down arrow to select Specify an IP address. The screen should now appear similar to
Figure C-8:
If you are not sure what IP addresses are available on your LAN, it is best to ask your system
administrator. Alternatively, you can use the ping command to test IP addresses for availability,
but this is not a foolproof method. For example, suppose your LAN uses IP addresses that begin
with 124.56.79. If you want to get a better idea as to whether 124.56.79.33 is available, perform
the following on any Windows PC connected to your LAN:
A. From the Start menu, select Run.
B. In the RUN dialog box, type in ‘cmd’ and click OK. A command line window appears.
C. In the command line window, enter the command: ping xxx.xxx.xxx.yyy and type Enter,
where xxx.xxx.xxx is the IP address parts for your LAN, and yyy is the host part of the IP
address that you are checking for availability. If this IP address is available, the ping
command will time out, with no response from the host. Normally, if the IP address is
already in use by another host on your LAN, the ping command return a response from that
host. However, if that host is not running or is not connected to the LAN, the ping request
will time out, just as if the IP address was available. So, you must be careful when using this
method for determining IP address availability. You can at least use this method to verify
that certain IP addresses are not available. This may help you in determining which IP
addresses are available.
D. From the Control Panel, bring up the Configuration Manager, and select Save Settings.
Printer Setup
1. From the LOGO screen, select System.
2. From the SYSTEM OPTIONS screen (Figure C-9), select Printer Setup.
☞ Note: The doctor information is not stored in the AccessCard Log File for screening exams
that are performed on new patients (patients that have not yet been entered into the
GDxVCC system). This is because the transaction is added to the log file when the user
presses Accept on the IMAGE QUALITY – SCREENING screen. This occurs before the user enters the
doctor information during a screening procedure. To work around this, you can put in place a
policy where patient and doctor information is entered before screening exams are
performed.
The exam data within the AccessCard Log File accumulates for 12 months. Older entries are deleted
from the log. By exporting or printing the AccessCard Log File from time-to-time, you can maintain
accounting files that track GDxVCC usage for longer periods of time.
When you perform an export, the content of the AccessCard Log File is sent to your network
destination (a shared folder on a networked PC), if a network destination has been setup by your
administrator. The data is stored under the TransactionLog folder, which is automatically created the
first time you perform an export to a particular shared folder on your networked PC. The content
from subsequent exports is appended to the existing data in the TransactionLog folder. If a network
destination has not been setup or is temporarily unavailable, a dialog box appears that allows you
to export the AccessCard Log File to the GDxVCC internal hard disk or floppy disk.
When you print the content of the AccessLog Card File, a printed report is sent to your external
printer. Some early models of the GDxVCC have an internal printer, but this printer cannot be used
to print the contents of the AccessLog Card File.
In the printed report, the total number of screening exams and the total number of full exams are
tallied for each month. At the bottom, the grand totals are shown for the entire period. When the
data is exported (rather than printed), these totals are not generated. The exported data is
converted to a tab-delimited format which can be read into applications such as Microsoft Excel,
where you can sort, analyze, and summarize the data in whatever manner you wish.
☞ Note: If you are exporting and the network destination is setup and available over the
network, the export will proceed to that location. Otherwise, a dialog box appears which
allows you to choose a location on the hard drive or floppy drive of the GDxVCC as the
destination for the export. To export to the floppy disk, navigate to FloppyA (using tab and
down arrow), insert a blank floppy disk into the drive of the GDxVCC, and press OK.
(F) Specifications
Illumination Laser Source: GaAlAs laser diode, 780nm nominal value (780nm –798nm actual),
40mW primary power
Fixation Laser Source: Laser diode 635nm, 5mW primary power
Trigger Laser Source: Laser diode, 650nm, <500µW (totally enclosed)
Laser Classification: Class 1 laser system
Max. power at cornea: 3.0 mW
Measurement Area: 40° x 20°
Digital Resolution: 256 x 128 pixels x 8 bit
Reproducibility: thickness measurement < 15 µm/pixel; 50 µm lateral
Ametropia Correction: -10 to +5 diopters (original VCC Systems), -15 to +7 diopters (for
later VCC Systems)
Mechanical Movement: omni-directional joystick
Data Acquisition Time: < 1 second
Normative database: Age-adjusted normals with diverse ancestry
Display: Integrated color liquid crystal display
Electrical Supply Voltage: 100-240 V ~ 50/60 Hz
Power Consumption: 200 VA
Fuse ratings (2 fuses): T 2 A 250 V (each)
GDxVCC dimensions: 35.6 cm H x 25.4 cm W x 61.0cm D (14” x 10” x 24”)
Weight: 21 kg (45 lbs.)
Environmental Conditions
Operation
Temperature: +18 to +24 deg. C
Relative Humidity: 20% to 60%, excluding condensation
Atmospheric Pressure: 700 hPa to 1060 hPa
Limited Warranty
This Warranty gives you specific legal rights, and you may have other rights, which vary from state to state. For
one year from the date of delivery (the “Warranty Period”) to the original purchaser (“You,” “Your,”
“Purchaser”), Carl Zeiss Meditec Inc. (“Zeiss,” “Seller,” “We,” “Our,” “Us”) warrants its GDxVCC, excluding
components and software as stated below (the “GDxVCC”) to be free from defects in material or workmanship.
In the event of failure, Seller's obligation is limited to repairing or replacing on an exchange basis the parts that
have been promptly reported as defective by Purchaser during the Warranty Period and are confirmed as
defective by Seller upon inspection. This Warranty covers all parts, labor, travel and expenses for the Warranty
Period, except as otherwise stated herein. This Warranty only applies to the original Purchaser and shall not, in
any way, be transferable or assignable.
The procedure for warranty claims shall be as follows: when You believe the GDxVCC is defective, promptly
report the defect to Zeiss. Whenever possible, We will provide “in the customer's office” service to repair Your
GDxVCC. However, at Our discretion, repairs may be made in Our repair department. In this case, We will pay
all shipping costs unless Your GDxVCC is found upon inspection not to be eligible for repair under this Warranty,
in which case You will be responsible for one-half the shipping costs. If Your GDxVCC is ineligible for repair
under Warranty, We will notify You, and any repairs You authorize will be performed at Our normal rates. All
replaced parts will become the property of Zeiss.
This Warranty specifically covers the GDxVCC. This Warranty does NOT cover: consumable items such as
operating supplies, paper or storage media, or the servicing of any external printer. Those items will be covered
by their manufacturer's warranty and arrangement for service must be made through that manufacturer. This
Warranty will NOT apply if repair or parts replacement is required because of accident, neglect, misuse, acts of
God, transportation or causes other than ordinary use, or supplies or accessories that do not meet the proper
operating specifications of Zeiss. This Warranty does NOT apply to any articles that have been repaired or
altered except by Zeiss.
All data stored on the hard disk and/or removable electronic media are the Purchaser's records, and it is Your
responsibility to preserve the integrity of these files. Zeiss is not responsible for the loss of patient files stored on
the hard disk or removable electronic media.
You bear the entire risk as to the quality and performance of the software. Zeiss does not warrant that the
software will meet Your requirements, that the operation of the software will be uninterrupted or error-free, or
that all software errors will be corrected. You assume the responsibility for the installation, use and results
obtained from the GDxVCC and programs.
The Warranty does NOT extend to any software or electronic media that has been damaged as a result of
accident, misuse, abuse, or as a result of service, or modification by anyone other than Zeiss. Should such
software prove defective following its purchase, You (and not Zeiss) assume the entire cost of all necessary
service, repair, or correction. Zeiss has no liability or responsibility to any person or entity with respect to any
claim, loss, liability, or damage caused or alleged to be caused directly or indirectly by any software supplied
with the GDxVCC or by Zeiss.
Every reasonable effort has been made to ensure that the product manuals and promotional materials
accurately describe the GDxVCC specifications and capabilities at the time of publication. However, because of
on-going improvements and product updates, We cannot guarantee the accuracy of printed materials after the
date of publication, and disclaim liability for changes, errors or omissions. All instrument specifications are
subject to change without notice.
Limitation Of Liability
THE WARRANTIES CONTAINED HEREIN ARE IN LIEU OF AND EXCLUDE ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR PARTICULAR USE. NEITHER ZEISS, MICROSOFT
CORPORATION NOR ANY OTHER PARTY INVOLVED IN THE CREATION, PRODUCTION, OR DELIVERY OF THIS
INSTRUMENT OR SOFTWARE (COLLECTIVELY REFERRED TO AS “CONTRIBUTOR(S)”) SHALL BE LIABLE FOR ANY
DAMAGE, LOSS OF USE OR LOSS OF ANY KIND, ARISING OR RESULTING FROM ACTS OF GOD, YOUR
PURCHASE, POSSESSION, FAILURE TO FULFILL YOUR RESPONSIBILITIES AS TO PROPER INSTALLATION,
MANAGEMENT, SUPERVISION OR USE OF THE GDxVCC 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 GDxVCC
warranty expires. For information, call CZM customer service: in the U.S., call 800-341-6968; outside the U.S.,
contact your local CZM distributor.
Software Copyright
The software program (“Software”) included with your GDxVCC is a proprietary product of Zeiss and in certain
instances contains material proprietary to Microsoft Corporation. These proprietary products are protected by
copyright laws and international treaty. You must treat the software like any other copyrighted material.
2. You own the physical media, GDxVCC, on which the Software is originally or subsequently recorded or
fixed, but You understand and agree that Zeiss retains title and ownership to the Software recorded on the
original disk copies and all subsequent copies of the Software.
3. This Software is copyrighted. Unauthorized copying of the Software, including Software that has been
modified, merged or included with other software, is expressly forbidden. You may not, nor may You
permit others to (a) disassemble, decompile or otherwise derive source code from the Software (b) reverse
engineer the Software, (c) modify or prepare derivative works of the Software, (d) provide on-line or
similar uses to third parties, or (e) use the Software in any manner that infringes the intellectual property
or other rights of another party. You may be held legally responsible for any copyright infringement that is
caused or encouraged by Your failure to abide by the terms of the License.
4. Zeiss may create updated versions of the Software, which You may purchase separately.
5. You may not sublicense, rent or lease the Software, but You may permanently transfer this License by
delivering the original GDxVCC, media, written materials and materials comprising the Software package,
including the Certificate of License, to a third party who accepts the terms and conditions of this
Agreement. Upon transfer, You will simultaneously destroy all copies of the Software and accompanying
materials in your possession. The new recipient of the Software and accompanying GDxVCC accepts this
Agreement and is licensed under the terms of this Agreement upon initially using the Software.
6. Zeiss warrants the operation of the Software only with the operating system for which it was designed.
Use of the Software with an operating system other than that for which it was designed will not be
supported by Zeiss.
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.
Those installed software products of MS origin, as well as associated media, printed materials, and
"online" or electronic documentation ("SOFTWARE") are protected by international intellectual
property laws and treaties. The SOFTWARE is licensed, not sold. All rights reserved.
Use of the Device, will constitute your agreement to this MS End User License Agreement (EULA).
Please contact CZM if you have any questions about the agreement.
GRANT OF SOFTWARE LICENSE. This MS EULA grants you the following license:
You may use the SOFTWARE only on the DEVICE
NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. CZM HAS INDEPENDENTLY
DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE, AND MS HAS RELIED CZM TO
CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH
USE.
NO WARRANTIES FOR THE MS SOFTWARE. THE SOFTWARE is provided "AS IS" and with all
faults. THE ENTIRE RISK AS TO SATISFACTORY QUALITY, PERFORMANCE, ACCURACY, AND
EFFORT (INCLUDING LACK OF NEGLIGENCE) IS WITH YOU. ALSO, THERE IS NO WARRANTY
AGAINST INTERFERENCE WITH YOUR ENJOYMENT OF THE SOFTWARE OR AGAINST
INFRINGEMENT. IF YOU HAVE RECEIVED ANY WARRANTIES REGARDING THE DEVICE OR THE
SOFTWARE, THOSE WARRANTIES DO NOT ORIGINATE FROM, AND ARE NOT BINDING ON,
MS.
Note on Java Support. The SOFTWARE may contain support for programs written in Java. Java
technology is not fault tolerant and is not designed, manufactured, or intended for use or
resale as online control equipment in hazardous environments requiring fail-safe
performance, such as in the operation of nuclear facilities, aircraft navigation or
communication systems, air traffic control, direct life support machines, or weapons systems,
in which the failure of Java technology could lead directly to death, personal injury, or severe
physical or environmental damage. Sun Microsystems, Inc. has contractually obligated MS to
make this disclaimer.
No liability for Certain Damages. EXCEPT AS PROHIBITED BY LAW, MS SHALL HAVE NO LIABILITY
FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM
OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE. THIS
LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE. IN NO
EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS OF U.S. TWO HUNDRED FIFTY
DOLLARS (U.S. $250.00).
Limitations on Reverse Engineering, Decompilation, and Disassembly. You may not reverse
engineer, decompile, or disassemble the SOFTWARE, except and only to the extent that such
activity is expressly permitted by applicable law notwithstanding this limitation.
SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS. You may permanently transfer rights
under this EULA only as part of a permanent sale or transfer of the Device, and only if the
recipient agrees to this EULA. If the SOFTWARE is an upgrade, any transfer must also include
all prior versions of the SOFTWARE.
EXPORT RESTRICTIONS. You acknowledge that SOFTWARE is of US-origin. You agree to comply
with all applicable international and national laws that apply to the SOFTWARE, including the
U.S. Export Administration Regulations, as well as end-user, end-use and country destination
restrictions issued by U.S. and other governments. For additional information on exporting
the SOFTWARE, see http://www.microsoft.com/exporting/.
☞ Note: The GDxVCC needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided herein.
☞ Note: Portable and mobile RF communications equipment can affect medical electrical
equipment.
WARNING: The GDxVCC 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.
WARNING: The use of accessories, transducers and cables other than those specified
may result in increased emissions or decreased immunity of the equipment.
The Carl Zeiss Meditec GDxVCC is intended for use in the electromagnetic environment specified in
the tables below. The customer or the user of the Carl Zeiss Meditec GDxVCC should assure that it is
used in such an environment.
IEC 60601-1-2
Immunity Test Test Level Compliance Level Electromagnetic Environment— Guidance
IEC 61000-4-2 ±6 kV contact ±6 kV contact Floors should be wood, concrete, or ceramic
Electro-Static ±8 kV air ±8 kV air tile.
Discharge (ESD) If floors are covered with synthetic material,
the relative humidity should be at least 30%.
If connector testing exemption is used, the
following symbol for ESD sensitivity appears
adjacent to each connector. “Caution – Do Not
Touch”.
IEC 61000-4-4 ±2 kV for power ±2 kV for power Mains power quality should be that of a typical
Electrical Fast supply lines supply lines commercial or hospital environment.
Transient, Burst (EFT) ±1 kV for ±1 kV for
input/output input/output
lines lines
IEC 61000-4-5 ±1 kV differential ±1 kV differential Mains power quality should be that of a typical
Power Line Surge mode mode commercial or hospital environment.
±2 kV common ±2 kV common
mode mode
IEC 61000-4-8 3 A/m 3 A/m 50 Hz Power frequency magnetic fields should be at
Power Frequency 3 A/m 60 Hz levels characteristic of a typical location in a
Magnetic Field typical commercial or hospital environment.
(50/60 Hz)
IEC 61000-4-11a <5% UTb <5% UT Mains power quality should be that of a typical
Voltage Dips, Short (>95% dip in UT) for (>95% dip in UT) commercial or hospital environment.
Interruptions, and 0.5 cycle for 0.5 cycle
Voltage Variations If the user of the Carl Zeiss Meditec GDxVCC
40% UT 40% UT requires continued operation during power
(60% dip in UT) for 5 (60% dip in UT) for mains interruptions, it is recommended that
cycles 5 cycles the Carl Zeiss Meditec GDxVCC be powered
70% UT 70% UT from an uninterruptible power supply.
(30% dip in UT) for (30% dip in UT) for
25 cycles 25 cycles The Carl Zeiss Meditec GDxVCC does not
employ an internal short duration battery.
<5% UT <5% UT
(>95% dip in UT) for (>95% dip in UT)
5 sec. for 5 sec
Table I-2 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
a. Performed at the Minimum and Maximum Rated Input Voltage.
b. UT is the AC mains voltage prior to application of the test level.
IEC 60601-1-2
Immunity Test Test Level Compliance Level Electromagnetic Environment—Guidance
Portable and mobile RF communications equipment should
be used no closer to any part of the Carl Zeiss Meditec
GDxVCC including cables, than the recommended
separation distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distances between portable and mobile RF communications equipment and the GDxVCC
The GDxVCC is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the GDxVCC can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the GDxVCC
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
1 1.170 1.170 2.330
10 3.700 3.700 7.368
100 11.700 11.700 23.300
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
C
F
Calculation Circle 2-12
FCC 1-1, 2-5, 4-6
Care 6-1
Full Exam 2-1–2-16, 3-3
CE Mark -v
Fundus Image 4-1
Cleaning the Objective Lens 6-2
Copyright, Software G-2
H
Cornea Measurement Image Check 2-10 Handling Requirements -vi
Cornea Measurment Ellipse, modifying 2-9 Hard Disk Drives 6-3
D I
Data Entry 1-6 Image Check 2-7–2-15
Data Files and Folders C-4 Cornea Measurement Image Check 2-10
Database Options 5-8 RNFL Measurement Image Check 2-11
Delete Patient and Exams 3-3 Image Quality 2-7–2-11
Deviation from Normal Map 4-2 Import Data 5-9
Deviation from Reference Map 4-3 Inferior Average 4-3
Disable Security Mode 5-4 Inferior Maximum 4-4
Discriminant Analysis 4-5 Inferior Ratio 4-4
Disk Backup 5-7 Instrument Disposition -vii
Doctor Information 2-2, B-4, C-6–C-7, D-1 Inter-Eye Symmetry 4-3
Irregular Pattern 2-8–2-9
E
Edit Patient Information 3-3 L
Electromagnetic Compatibility Information I-1–I-3 Laser Safety 6-5
elliipse, cornea measurement 2-9 Legal Notices G-1
ellipse 2-11 License Agreement, Software G-2
Ellipse Average 4-5 License Terms and Conditions, Software G-2
Ellipse Modulation 4-4 Limitation Of Liability G-2
M Power Up 1-5
Macula Ellipse 2-8, A-3 Print Exams 3-6
macula ellipse A-3 Printer Setup C-19
macular ellipse placement 2-9 Protective Packing Symbols -vi
Macular Ellipse, modifying 2-7 Purpose Of This User Manual 1-1
Main Fuse 6-2
Maintenance 6-1–6-6 Q
Manage Patient Exams 3-4–3-6, C-10–C-19 Quick Start Guide 2-1
Manage Patient Information 3-3
Manual
R
Recalculate Data 5-9
Purpose 1-1
Recommendations 6-1
Max. Modulation 4-4
Record Management 3-1–3-6
Measurements List 3-4
Re-enable Security Mode 5-4
Merge 5-8
Refraction Settings 2-4
Model and Serial Number Information 6-2
Refractive Error Correction 2-4
Modify ONH Ellipse 2-13
Removing Hard Disk Drives 6-3
Modifying the Macular Ellipse 2-7
Replacing the Main Fuse 6-2
N Reports 4-1
Network Configuration 1-2, 1-7, C-1–C-20 Advanced Serial Analysis 4-7
Network printing 1-2, 1-8, 3-6, B-1, C-1, C-2, C-20 Content 4-1
Formats 4-6
NFI (Nerve Fiber Indicator) 4-3
Nerve Fiber Analysis 4-6
Normalized Inferior Area 4-5
Serial Analysis 4-6
Normalized Superior Area 4-5
Results 2-16
O Retake Image 2-15
On Screen Exam Review 3-5 Retaking Procedure 2-1, 2-10, 2-11, 2-15, A-4
ONH Ellipse A-4 Retinal Nerve Fiber Layer (RNFL) 1-1
ONH ellipse placement 2-11, 2-12 Review 3-3
Optimize 5-8 Review Calculations 2-16, 3-5
Overview 1-1 RNFL Measurement Image Check 2-11
Rotational Alignment 5-11
P
Parameters, see TSNIT Parameters S
Patient Exams Safety 6-4, 6-5
Select Existing Patient 2-3 Proper Fuses Vital 6-3
Setup New Patient 2-2 Scan Procedure 2-1, 2-4–2-7
Patient Fixation 2-5 Scanning Laser Polarimetry (SLP) 1-1
Patient Identification 2-2 Screen 3-3, A-1–A-5
Patient Information screen 2-3 Screening Exams 2-4
Patient Record 3-1 Search 3-1
Patients List 2-3 Security 1-7, 5-1–5-4
Positioning the Patient 2-5 Serial Analysis 2-1, 3-5, 3-6, 4-2, 4-6, 4-10
Power Down 1-5 Serial Number Information 6-2
T
Thickness Map 4-1
Time and Date Setup 1-7
Transport and Storage Conditions -vi
Transportation 6-1
Transporting 6-6
Trend Analysis 4-2, 4-7
TSNIT Average 4-3
TSNIT Comparison Graph 4-2
TSNIT Graph 4-2
TSNIT Parameters 4-3
TSNIT Serial Analysis Graph 4-2
TSNIT Standard Deviation 4-3
TSNIT Symmetry Graph 4-2
U
Unlocking the System 1-5
Usage Report D-1
User Changes to Software or Hardware -iii
V
Variable Corneal Compensation 1-1
W
Warranty, defined G-1
X
XY Alignment 5-11