Galilei Manual v5.0

Operator Manual
5.0

1 Introduction
Thank you for purchasing this Galilei system and for your confidence in Ziemer. We are
committed to assuring your complete satisfaction with this product.
At Ziemer, we continue our research and development to further extend the capabilities of all
our products and solutions. This may result in improvements of certain features of the Galilei
system that have not yet been updated in the user manual. We strive to minimize these
differences and come with regular updates of the manual.
For your safety it is essential that you read this manual carefully and that you familiarize
yourself with its contents before you start using this device. In particular, pay close attention
to the warnings and instructions in paragraph 1.2 of this manual.
The GALILEI is a non-invasive, diagnostic system designed for the analysis of the anterior
eye segment based on a rotating Dual-Scheimpflug Camera, integrated with a Placido
topographer. The GALILEI is a device intended to take images of the anterior segment of the
eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyze
the corneal shape, pachymetry (thickness of the cornea), pupil size, anterior chamber (size,
volume and angle), and Scheimpflug Images.
The GALILEI system includes:

Measurement Unit, mounted on a height adjustable instrument table
Headrest
Control Unit, containing PC and Power Supply
Monitor
Keyboard
Mouse
System and analysis software
Power cable
Operator manual
CM3910-035-1005-01 2008-05-10 GALILEI Operator Manual ii

1. Measurement Unit
1 2. Monitor
2 3. System ON/OFF switch and table level control
4. Joystick for positioning the measurement unit
5. Height adjustable Instrument Table
4
5
6. USB connectors for mouse/keyboard

7
7. Headrest
8. PC compartment
Optional accessories:
Analysis software for separate workstation
CM3910-035-1005-01 2008-05-10 GALILEI Operator Manual iii

To assure safe operation, it is imperative that the instrument is used according to the
instructions in this manual. Therefore, you should become thoroughly familiar with the
content of the instruction manual before putting the system into operation.
The GALILEI system must therefore only be operated by trained personnel capable of
using it properly on the basis of their training, expertise and practical experience.
Please save this instruction manual and ensure that it is accessible to operating personnel at all times.
This instrument must only be used for purposes as laid down in Indications for Use of this instruction
manual. Before using this instrument for the first time, you must be instructed on how to use it by our
staff or an authorized dealer.
Only operate the instrument with the original components supplied from SIS AG and if the instrument
is in good working condition. Should the instrument be defective, do not operate it, and contact the
supplier.
Before maintenance and cleaning the instrument, always pull out the plug of the GALILEI and all
equipment attached to it, for example a printer. Do not connect cables if this proves difficult. If it is
impossible to make a connection, check to see whether the plug fits into the socket. In case you
ascertain a defect, contact your authorized dealer to have it repaired by our service team.
When disconnecting electrical connections, always pull on the plugs, not on the cables.
Supplementary equipment which is connected to the analog or digital interfaces of the instrument must
comply with pertinent EN / IEC specifications. All configurations must conform consistently to standard
IEC 60601-1.
If the GALILEI is coupled with non-medical electrical equipment (for ex. a printer) this must not result
in a decrease of patient safety beyond the tolerance levels laid down in IEC 60601-1. If the coupling of
equipment causes the tolerance levels for leakage current to be exceeded, safety features, which
include a disconnection device, must be provided for.
Do not operate the delivered equipment
in areas with risk of explosion,
in the presence of flammable anesthetics or volatile solvents such as alcohol, benzene or
similar substances.
Do not use or store the instrument in damp rooms. Avoid placing the instrument in the vicinity of
dripping, running or spraying water and ensure that no moisture can penetrate the instrument. For this
reason, do not place any containers filled with fluids near the instrument. When cleaning the
instrument with a damp cloth, be sure that no moisture enters it.
Do not cover up ventilation holes.
This instrument is a high-quality technical product containing sophisticated optics. In order to assure
faultless and safe operation, service inspections must be performed according to the service plan of
SIS AG.
Because prolonged intense light exposure can damage the retina, the use of the device for ocular
examination should not be unnecessarily prolonged.
While no acute optical radiation hazards have been identified for slit lamps, it is recommended that the
amount of light directed into the patients eye be limited to the minimum level which is necessary for
diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also
be increased if the person being examined has had any exposure with the same instrument or any
other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply
particularly if the eye has been exposed to retinal photography.
For US market only: Federal U.S. law restricts this device to sale by, or on the order of, a
physician or practitioner.
CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual iv

Type B applied part
Must be returned to the distributor or manufacturer for

disposal
User must consult User Manual before operating the

device.
Manufacturer's part no. / order no.
Caution
CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual v

Contents
1 Introduction.....................................................................................................................ii
1.1 Description ......................................................................................................................................... ii
1.1.1 Components.......................................................................................................................... ii
1.2 Safety Instructions............................................................................................................................. iv
1.2.1 Explanation of Symbols ........................................................................................................v
Contents .............................................................................................................................6
2 Operating the Galilei.......................................................................................................8
2.1 Setting up and installing equipment ...................................................................................................8
2.1.1 Software installation ..............................................................................................................8
2.1.2 Connection to an existing network ........................................................................................8
2.1.3 Connecting supplementary equipment .................................................................................8
2.1.4 Printers..................................................................................................................................8
2.1.6 Software installation on a separate PC (Remote Workstation) ............................................8
2.1.7 Transport and storage...........................................................................................................9
2.2 Switching ON the system and logging in .........................................................................................10
2.3 Patient database management ........................................................................................................10
2.3.1 Importing and exporting ......................................................................................................12
2.3.2 Patient data and measurement pop-up ..............................................................................13
2.4 Making a scan ..................................................................................................................................14
2.4.1 Preparation..........................................................................................................................14
2.4.2 Making the scan according to the best practice method ....................................................14
2.4.3 Quality checking..................................................................................................................15
2.4.4 Trouble shooting .................................................................................................................17
2.4.5 Different scan settings ........................................................................................................19
3 Analyzing the results....................................................................................................20
3.1 Customizing the lay-out of the results ..............................................................................................20
3.1.1 Overlays ..............................................................................................................................20
3.1.2 Color scales ........................................................................................................................21
3.1.3 Personalized layout profile..................................................................................................21
3.2 Printing the results............................................................................................................................22
3.3 Getting support.................................................................................................................................22
3.4 Standard reports...............................................................................................................................23
3.4.1 Refractive report .................................................................................................................23
3.4.2 Keratoconus report .............................................................................................................26
3.4.3 Wavefront report .................................................................................................................28
3.4.4 IOL Power report.................................................................................................................29
3.5 Display..............................................................................................................................................30
3.5.1 Five Custom reports............................................................................................................30
3.5.2 Map x4 ................................................................................................................................31
3.5.3 Map x1 ................................................................................................................................31
3.5.4 Scheimpflug ........................................................................................................................32
3.5.5 How to Zoom any Scheimpflug image ................................................................................33
3.5.6 Overview .............................................................................................................................33
3.6 Diagnostics .......................................................................................................................................33
3.6.1 Densitometry .......................................................................................................................33
CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 6

3.6.2 Eye metrics .........................................................................................................................34

3.6.3 Difference maps ..................................................................................................................36
3.7 Z Lasik report ...................................................................................................................................36
4 Settings .........................................................................................................................37
4.1 Profile ...............................................................................................................................................37
4.1.1 Galilei support data ............................................................................................................37
4.2 Licenses ...........................................................................................................................................38
4.2.1 How to get the license request number ..............................................................................38
4.2.2 Now that you have the license key, how to activate it? ......................................................38
4.3 Scales...............................................................................................................................................38
5 Glossary ........................................................................................................................39
5.1 Axial vs. instantaneous curvature ....................................................................................................39
5.2 Curvature vs. power .........................................................................................................................40
5.3 How does Galilei treat data? ............................................................................................................41
5.4 Central anterior curvature accuracy: Placido vs. SPF .....................................................................43
5.5 How does Galilei calculate Anterior Chamber Volume? ..................................................................44
6 Care and maintenance .................................................................................................45
6.1 Customer service information ..........................................................................................................45
6.2 Remote support................................................................................................................................45
6.3 Cleaning and disinfection procedures ..............................................................................................46
6.4 Replacement of fuses.......................................................................................................................46
6.5 Disposal............................................................................................................................................47
Appendix A.......................................................................................................................48
DICOM....................................................................................................................................................48
What is DICOM? ..........................................................................................................................48
What can Galilei SW 5.0 do? .......................................................................................................48
Appendix B.......................................................................................................................49
Setting up and installing equipment .......................................................................................................49
Placement of your Galilei system.................................................................................................49
Connecting the measurement unit to the table ............................................................................49
Disconnecting the measurement unit from the table ...................................................................51
Connecting the power cable ........................................................................................................53
Electrical safety when connecting third party equipment.............................................................53
Appendix C.......................................................................................................................54
Installing a printer ...................................................................................................................................54
Appendix D.......................................................................................................................57
Backing up the Galilei database.............................................................................................................57
Incremental backup......................................................................................................................59
Restoring a backup ......................................................................................................................60
Appendix E.......................................................................................................................62
Remote Workstation (RW) .....................................................................................................................62
Appendix F .......................................................................................................................64
Labels .....................................................................................................................................................64
Technical data ........................................................................................................................................65
Manufacturers EMC Declaration ...........................................................................................................67

2 Operating the Galilei
Galilei will be set up and connected by either our service department or that of your
authorized dealer.
Please make sure that the room in which you put the Galilei can be darkened, as the high
precision optical components demand an environment free of external light that could
adversely influence the exam.
Before starting an exam, the brakes on the tables rollers must be set.
Your Galilei system comes with system and analysis software already installed.
The Galilei can be connected to an existing network. Please contact Ziemer Customer
Service for further instructions to minimize any software conflicts.
When connecting the Galilei to a network, we strongly recommend installing an anti-virus
program. Please contact Ziemer Customer Service for further instructions.
The operator of the Galilei is responsible for the compliance with the standard IEC 60601-1-1
if any supplementary equipment is connected to the analog or digital interfaces of the Galilei
system.
By default the following printer-drivers are pre-installed on a Galilei:

PDF printer (You can use this printer to directly generate a PDF document)
Generic postscript printer driver over LPT
Generic postscript printer driver over USB
HP DeskJet 5700 series Printer
For detailed instructions on how to install a printer please turn to Appendix B of this manual.
Galilei analysis software also features a remote workstation for a separate PC (optional
accessory). This remote workstations allows full access and analysis of the measurements
that are in the patient database of the Galilei via a network connection. For a more complete
description, please turn to Appendix D. To purchase a license, please contact your Ziemer
distributor or Ziemer Customer Service.

This is an optical device and should be handled with due care. Do not subject it to vibrations,
jolts, contamination or high temperatures.
CAUTION
If you have to move the equipment to another location, please take special care when
moving the Measurement Unit. The internal components are sensitive to any jarring or
bumping, and re-calibration may be necessary after a move. To avoid this, ensure that the
Measurement Unit is protected by using the packaging material it was originally shipped in,
or ensure that it is well protected from shock.
Transport and storage conditions:

Ambient temperature: -5 C to +70 C, 23 F to +158 F
Relative humidity: 10 % to 95 %
Air pressure: 500 hPa to 1060 hPa

To start using the Galilei, simply use the switch located at the front of the table. The
computer will then start automatically and a login screen will appear
Click on the drop-down arrow and select [galilei_user] and press [ENTER] on the keyboard;
this will start the Galilei software.
Per default there is no password set. Contact the Ziemer service department or your local
distributor should you want to create a password or different user names.
After switching ON the system and logging in, the software will open with the patient
database.
*fictitious names were used for this database.

If you would like to create a new patient, first use the search tool, located right above the list
of patient names to check that a particular patient doesnt already exist. To create a new
patient in the database, click on [New]. Now fill out the last name and first name of the
patient.
After adding the name and first last name of the patient it is easiest if you type the year of
birth in the relevant space.
After inserting the year you can use the calendar tool and select the month and then the birth
day. Now click on [Save] and you are done.
After selecting or creating a patient you can go to the [Scan] screen to make a measurement
or go to the results of scan that was made earlier.
To go to the [Scan] screen you either double click on the appropriate patient name or single
click on the [Select & Examine] bar.

To move to the results of a previous measurement, either double click on the intended scan
or single click on the [Display] bar.
In the bottom right corner of the [Patients] screen you find a possibility to enter IOP and OPA
data measured with the Pascal dynamic contour tonometer. This data will then also be
displayed in the Z Lasik report (see 3.7 in this manual)
There are 2 levels for exporting exams: If you click on [Export] under [patients personal data]
panel your will export all existing measurements of that particular patient. Note that if there
are many measurements, this export can take long to finish.
If however you click on [Export] under the [Examinations] panel you will just export that single
measurement.
After clicking on [Export]. The following pop-up will appear:

This pop-up allows you to select where you want to export the data to and also the level of
detail in [Export Options]. After making your selections, click on [Export Examinations] to
execute.
Importing goes in a similar fashion: click on [Import] in the examinations panel and select the
file you would like to import in the pop-up that appears with the file structure of the computer.
Now click on [Import Examination] to execute.
At all times can the data of the selected patient be called up in a pop-up box. To do this, go
to the top bar of the screen and click on [Examination] and then on [About Examination]. Now
you can see the details of the specific patient and the selected measurement as illustrated
below.

CAUTION
The following instructions can have a significant impact on your measurement success.
Please read and then follow these instructions carefully.
At the start, check that the table is at the right height and that the patient has his or her
forehead against the strap and the chin fully in the chin rest. Tell the patient to look at the
target and that it is okay to blink if needed.
Next step is to bring the device in focus by aligning the measurement head of the Galilei. The
Galilei is correctly aligned for the measurement when the red cross (aka cross hair) passes
through the four white spots, and the single red line touches the corneal epithelium. You can
see this on the big screen or on the small screen at the back of the measurement head.
Small screen picture Big screen picture
For good measurements, it is essential to get the red cross aligned very precisely. The single
red line (in the Scheimpflug images) needs to be about right. One good alternative way to get
this single red line correctly aligned is to only look at the top view (where the red cross is)
and get the Placido rings that are projected on to the patients eye into the best possible
focus. This method will allow you to concentrate on one picture only whilst aligning the
device. This makes it quicker and easier as well.
Other factors of importance are tear film and shadows of the nose and eye lashes.
All these success factors lead to the following best practice for taking measurements:
1. Align the instrument to about the right position: get the red cross on the four spots
and get the Placido rings into sharp focus.
2. Now ask the patient to BLINK and OPEN EXTRA WIDE.
3. Quickly make the final adjustments of the device to get the red cross in the right place
and the Placido rings sharp.

4. And push the button on top of the joystick.
The data will now be processed and as soon as that is done the [Verify] screen will appear
This overview verify screen gives you detailed information on the quality of the
measurement. In the top left corner of this Verify screen, you will see a short list of
measurement quality percentages and you have the possibility to either discard or accept the
measurement.

The [Motion Compensation] is an important factor that should also be higher than 85%. The
[Motion Compensation] indicates how well the patented eye tracker system was able to
follow the eye movement during the procedure. Eye tracking is critical for combining all the
data points of the different images that are taken in one measurement. Note that the [Motion
Distance] is of less importance and can be as low as 70%. [Placido] and [Scheimpflug] are
also important indicators. Finally the [Overall Quality] is there for general information
purposes only and has no minimum required percentage associated with it.
Note that to the left hand side of the measured percentages, icons are displayed to help with
the quick recognition: is indicated when all is OK and is indicated when a quality
percentage is below the threshold value. These symbols are also displayed on all screens
and all print-outs to prevent any confusion about the quality of a particular scan.
The quality percentages give you the first general quality indication but there are more. It is
recommended that you also look at more detailed information; particularly when one of the
quality percentage indicators was below the minimum value.
SC stands for Scheimplug images

TV stands for Top View
Lim shows the limbus and pupil edges and centration can also be checked here
PD 1 and 2 show the 2 Placido images that are taken
Overview is the all-in-one page with all the images. This is only available for new scans

What are the most common causes of low quality indicator percentages and what can be
done about it?
- Shadow of the nose of the patient blocks some of the Scheimpflug images.
An indicator of this is a lower percentage score for Scheimpflug Quality on the pop up. Also
when checking the Quick Review of the Scheimpflug images some of these images will be
very dark (because the nose blocked the light for those particular images).
How to improve? Most often you can already see clear indications of the problem when
aligning the instrument. On the image on the next page on the left you can clearly see that
part of the Placido rings on the nasal side is not visible: it is very likely that there will be a
nose shadow problem with this patient. To resolve this, you need to (ask the patient to) turn
the head a few degrees towards the temporal side. You should now be able to see almost
the complete Placido ring reflection. Note that a small shadow will pose no problem.

Nose shadow Eye lashes
- Shadow of the upper eye lid and eye lashes.

An indicator of this is a lower percentage score for Placido Quality on the pop up. Also when
looking at the Top View, you will be able to see that the eye lid and / or eye lashes block out
part of the Placido rings. Also, the top Scheimpflug image will appear darker than the bottom
one.
How to improve? Again, most often you should already be able to see this during the
alignment of the Galilei (see picture above on the right). The shadows of the lashes can be
seen on the camera images. Also you will notice that the top Scheimpflug image on the big
screen will be much darker than the bottom one. To resolve this you need to ask the patient
to open extra wide right before you take the measurement.
- Tear film break up.

Indicators can be failed measurements and more often low Placido Quality scores in the pop
up. Also when looking at the Top View, you will be able to see a blurry spot where the
Placido rings are interrupted (see image below). Using the false colors display option one
can clearly see the tear film break up.
How to improve? Allow the patient to blink during the initial aligning as described in step 1 of
the best practice method. This will keep the tear film intact. When you have aligned the
measurement unit, ask the patient to blink once more and then keep the eye wide open. Now
it is a question of getting the last alignment corrections in quickly and starting the scan.

Please note that the two blue oval shapes have been added later in this document to point
out the two blurry spots indicating the tear film break up in this particular example.
You have a number of options when making a scan. On the bottom right hand side you can
change the proportions of the two Scheimpflug images and the Top View. It is recommended
that you increase the size of the Top View as is shown in the image above.
There are three choices for the resolution of the scan: standard, enhanced and user defined.
It is recommended to take the first measurement in the standard mode; this will give good
results in the vast majority of cases.
Also, the fixation target can be moved by specifying the position in diopters (-20.0D - +20.0D)

3 Analyzing the results

To help you with the analysis, the Galilei system offers many different ways that you can
display the data that has been gathered during the scan. There are four standard reports that
give all the information a refractive surgeon needs and for more detailed analysis there are a
number of options under the [Display] tab and also under the [Diagnostics] tab. The Z-Lasik
report proved a connection between Galilei and LDV femtosecond laser. All these above
mentioned ways of displaying the results will be described in the following paragraphs.
When you right-click on any map, anywhere in the Galilei software you are offered a
number of options as overlays.
For anterior maps and indices, you can select here the refractive index used to
calculate them. The choice is between the keratometric index (1.3375) and the actual
refractive index of the cornea (1.376).
Numeric values display 2 concentric rings of values at the indicated locations and a
central value.
The thinnest location is indicated on the map. In the list of parameters, you can also
find the location and the thinnest value described.
Pupil will display the pupil edge and also indicates the pupil center.
With Avg r1 and r2 you can define inner (r1) and outer (r2) radius of the zone over
which the average will be calculated. This average will then be displayed on the top
right hand side of the map. For example, if you want to know the average value of the
central 3 mm, in the pop-up, type in 0 for r1 and 3 for r2 and hit enter.

In any map with a color scale anywhere in the Galilei software, you have a choice of four
different color scales: Default, ANSI, german and American. Default is based on the color
schemes as recommended by Klyce and Wilson.
You can also change the minimum and maximum values of the scale. You do this by placing
the mouse pointer over the color scale next to the map and right clicking the mouse. This will
pull up the following context menu:
It is possible to let the software define the value range of a scale

automatically. The range is then defined by the lowest and highest
value occurring in the data. By defining a minimum and maximum
value you can fix the value range of a scale. You do this by typing the
min and max value in the boxes in the pop up menu shown above and
then pressing [ENTER]. Only by pressing [ENTER] will the values be
stored. For example, if there is an outlier in a measurement, it can lead
to confusing scales, since a single (very high or very low value) can
spread the automatic scale dramatically. In such cases it is
recommended not to use the automatic scale but a customized scale
or Type I to IV instead.
To preserve the preferred look and feel of the Galilei software, you can create your own
layout profile where your settings will be stored. First you will need to create a profile: do this
by going to the menu at the top of the screen and select [Options] and then [Profile] and
finally [New profile]. You can give it any name you want and this will then be listed as is
shown below for the profile My Profile. Note that Default Profile cannot be deleted since it
contains the profile with the factory settings.
After creating your profile, make the settings to the layout of the maps to your preferred
settings and once this is done return to [Options] and [Profile] and now click on [Save
Selected profile]. Next time you start the Galilei, all you have to do is select your profile to
have all your preferred settings for the maps.

In the top-left corner of any screen of the Galilei software you can select [File] and then
[Print].
Alternatively, you can click on the print icon in the top right hand corner of each screen
This will give you the option to print a report on paper with your printer or create a PDF file
with the pre-installed PDF writer.
Additionally, after launching MWSnap in your Windows Start menu, you can at any point
create screen-shots by pressing [Shift]+[Ctrl]+[D] for a screenshot of the full desktop or
[Shift]+[Ctrl]+[A] for a selected area of the screen.
See also chapter 4.1 on how to add your logo and text to any printed report.
Sometimes clinical interpretation can be difficult and in such circumstances getting a second
opinion can be helpful. In the top right hand corner of each screen is the DAN button. DAN
stands for Doctors Advice Network, created for those ambiguous cases.
Clicking this DAN button will create a screenshot where the patient name and details have
been removed. This anonymous screenshot can be attached to an email, or posted on the
Ziemer user group website. Add notes and highlight areas in the maps with the square
overlays to explain your query.

Alternatively, you can attach a measurement and export the measurement anonymously and
share that with someone else
For technical support from the Ziemer service department please see 6.1 in this manual.

The refractive report consists of 4 fixed maps and a set of parameters that give a
comprehensive overview of the cornea.
Anterior Axial Curvature map
Corneal Pachymetry map
Anterior Elevation (Best Fit Sphere) map
Posterior Elevation (Best Fit Sphere) map
Parameters
For your convenience, we placed an i button at the right hand side of

the parameter bar. Clicking on this button will bring up on screen help
text about the specific parameter.
SimK parameters (Anterior Curvature) are calculated with the so

called keratometric index, which is known from Placido
topographers, and is equal to 1.3375. This does not correspond to
the actual index of refraction of the cornea (1.376) since it takes into
account the posterior surface parameters calculated with
keratometric index are called simulated (SimKf, SimKs, ).
Posterior parameters (Posterior Curvature) are calculated with the
indices of refraction of the cornea (1.376) and aqueous humor
(1.336).
Anterior Curvature: SimKavg
This parameter is the arithmetic mean or average of the steep and
flat axis (SimKf, SimKs) and is being calculated as:
SimKf + SimKs
SimKavg =
2
Anterior Curvature: SimKf and SimKs

SimK steep (SimKs) and SimK flat (SimKf) are calculated from the pair of meridians 90
apart with the greatest difference in average power, from 0.5 to 2.0 mm distance from the
center.
This maximizes the Astigmatism parameter, which is the difference between SimKf and
SimKs.
Curvatures in diopters in general are calculated as:

( n 2 n1 )
k = 1000
r
n1 = index of refraction of the first medium (air, n1=1)

n2 = index of refraction of the second medium (keratometric index for simulated anterior
curvatures)
r = Radius of Curvature in meters
Anterior Curvature: Atigmatism

As mentioned above, the astigmatism value is the difference between SimKs and SimKf.
Anterior Curvature: Axis

The axis parameter is the direction of the meridian of the steepest axis (SimKf), and
therefore shows the orientation of the Astigmatism.
Anterior Curvature: Eccentricity

Eccentricity is reported as its square 2. This term is one of four parameters by which the
shape of a conic section, can be described: Q (asphericity), p value and E (corneal shape
factor) are the others. These terms are mathematically related by the following equation: 2 =
E = 1 - p = -Q. Eccentricity can also be directly calculated:
2
=
(R * R )
2
0
3
R 02
X2
R = Instantaneous Radius of Curvature

R0 = Average central Instantaneous Radius of Curvature
X = Radial position
Galilei calculates the eccentricity 2 of the surface within a central diameter of 8 mm
averaged over all meridians. This is done for the anterior and posterior surface.
Posterior Curvature: Kavg, Kf, Ks, Cylinder, Axis, Eccentricity

These parameters are basically the same as the ones from the anterior surface. The only
difference is that the K values are not simulated, but calculated with the real indices of
refraction of the cornea and the aqueous humor.
Total Cornea
Total Corneal Refractive Power is calculated by ray-tracing through the anterior surface and
posterior surface using Snells Law and the thin lens equations. The index of refractions
used are n = 1.0 for air, n = 1.376 for cornea, and n = 1.336 for aqueous. Pachymetry data is
used for thicknesses in the ray tracing.
Flat + Steep
Mean _ Power =
2
The corneal volume is calculated over a diameter of 8mm.
Central, Paracentral and Peripheral zones

Central zone diameter = 0 4 mm

Paracentral zone diameter = 4 7 mm

Peripheral zone diameter = 7 10 mm for pachymetry and 7 8 mm for other parameters.
Pupil: Average Diameter

The pupil is fitted with a best-fit-circle in the top view image. The average diameter
parameter is then taken from this circle.
Pupil: Center x, y
The center of the best-fit-circle is given as the pupil center.
Limbus: Nasal-Temporal
The limbus is fitted with a best-fit-ellipse in reference top view image. The maximum length in
horizontal direction of the ellipse (not the ellipse long or short axis) is taken as the Nasal-
Temporal Limbus parameter.
Limbus: Superior-Inferior
The limbus is fitted with a best-fit-ellipse in reference top view image. The maximum length in
vertical direction of the ellipse (not the ellipse long or short axis) is taken as the Superior-
Inferior Limbus parameter.
The Keratoconus report is structured in a similar fashion to the Refractive report. There are
two main differences:
1. Instead of the Anterior Axial Curvature map, the Anterior Instantaneous Curvature
map is displayed. For a detailed description of the differences between Axial and
Instantaneous curvature, please see the Glossary at the back of this manual.
2. A set of specific indices are included, on which the keratoconus interpretation is
based. The indices displayed are based on formulas in the literature using a Placido
device,1 and simulated on the Galilei by translating the ring numbers used in the
original Placido equations into corneal regions in the Galilei.2
1
Maeda N, Klyce SD, Smolek MK, et al. Automated keratoconus screening with corneal topography analysis. Invest
Ophthalmol Vis Sci 1994;35:274957.
2
Mahmoud, A.; Roberts, C. PhD, et al. Simulation of Machine-Specific Topographic Indices for Use Across Platforms.
Optometry & Vision Science. 83(9):682-693, September 2006.

Keratoconus Prediction Index (KPI)

The keratoconus prediction index is a compilation index of DSI, OSI, CSI, SAI, SimK1,
SimK2, IAI, and AA. It is simulated on the Galilei as a percent probability based on a 100
point scale. The mathematical formula for the simulated KPI, using simulated component
indices, is described below:
KPI = 4.62*[0.30 + 0.01 (-41.23 0.15*DSI + 1.18*OSI + 1.49*CSI + 4.13*SAI

0.56*SimKs + 1.08*SimKf 3.74*IAI + 0.10*AA)] 60.25
CAUTION
Keratoconus indices are designed to be an adjunct to a clinical examination, and should
never be used as a sole assessment tool in the diagnosis of keratoconus.
Area Analyzed (AA)

The simulated index is the ratio of the actual data area to the area circumscribed by a circle
4.5 mm in radius.
Average Central Power (ACP)

ACP is simulated as the average dioptric power of all points within the central 3 mm.
Central/Surround Index (CSI)

The simulated center/surround index reports the difference between the average area-
corrected power between the central area (3-mm diameter) and an annulus surrounding the
central area (36 mm).
Differential Sector Index (DSI)

The simulated differential sector index reports the greatest
difference in average area-corrected power between any two
45 sectors.
Irregular Astigmatism Index (IAI)

Irregular astigmatism index is simulated as the average
summation of area-corrected dioptric variations along every semi-meridian for the entire
analyzed surface and normalized by the average corneal power and number of all measured
points. The mathematical description of the simulated IAI index is:
j = 2.40
{A Pij ( Pij +1 + Pij 1 ) / 2 }
IAI = 3.19 ln i =1.360 0 . 27

j = 2.40

1.360
A

i: semimeridional position; j: point location relative to center; Pi,j: corneal power on the point
(i,j); A: area which corresponds to power Pi,j

Inferior-Superior (I-S)
Inferior-Superior index is simulated as the difference between the
inferior and superior average dioptric values approximately 3 mm
peripheral to the corneal vertex as defined by the center of the map.
Opposite Sector Index (OSI)

The simulated opposite sector index reports the greatest difference in
average area-corrected power between opposite 45 sectors
Surface Asymmetry Index (SAI)

The surface asymmetry index is simulated as the centrally weighted average of the
summation of differences in corneal power between corresponding points 180 apart on all
meridians.
Standard Deviation Powers (SDP)

SDP is simulated as the standard deviation of all measured powers present on the map.
Surface Regularity Index (SRI)

The surface regularity index is simulated as a difference in power gradient between
successive points on a hemimerdian that is assigned a positive value and added to the
running sum. This sum is divided by the number of points that went into the sum and then
scaled. The mathematical formula of the simulated SRI index is:
3 j = 2.10
e { Pij ( Pij +1 + Pij 1 ) / 2 }
SRI = 0.85 ln i =1.360
+ 0.72
N

i: semi-meridional position; j: point location relative to center
Galilei displays the wavefront maps of the total cornea (front and back surfaces) in micron as
well as in diopter. Wavefront is viewed as an increasingly important way to describe the
optical condition of an eye. The accepted standard in the industry is to use a Zernike
Polynomial to describe the surface of a wavefront. The factors of the Zernike polynomial are
usually displayed in the shape of a pyramid. You see this pyramid also in Galileis wavefront
report. For the second, third and fourth order in this pyramid, the individual coefficients are
displayed; the orders five to eight are displayed in a summarized fashion.
Both the displayed wavefront maps and the RMS indices have been re-calculated recentered
on the pupil center. All other maps in the Galilei are centered on the system axis.

Next to the coefficients, you can either view a map of the wavefront or select a pie chart
giving an easy to interpret overview of the proportional representation of the aberration
factors present in the measured cornea. RMS is an index that gives the root mean square of
the wavefront error for the selected factors.

Most important features of this report are the ray traced total corneal power indices some
additional parameters describing the anterior chamber: the chamber depth and angles.
For dilated eyes only there also is the Average Anterior Segment Length (ASL).
ASL = ACD + crystalline lens thickness
the anterior chamber depth is computed as the largest distance between the crystalline lens
and the posterior cornea, measured along normals to the line between the outer iris
endpoints. The returned value is the average of valid measurements for all frames.
Drs Hill, Wang and Koch have created the iol.ascrs.org website to facilitate IOL power
calculation and have recently added Galilei TCA as an input factor to the post LASIK page on
this website, allowing surgeons to use ray traced Total Corneal Power data to calculate IOL
Power. Galilei TCA stands for Central Average of Total Corneal Power and can be found in
the IOL Power report.
To help you make an in depth analysis of specific cases there are 6 options under the
[Display] tab: [Custom Reports], [Map x 4], [Map x 1], [Scheimpflug] and [Overview].
You can define up to 5 reports with the report name that you choose, the maps that you
prefer and indices selected by you. To create a custom report, select [Options] in the top
menu and then [Custom Reports] in the dropdown. Now select the custom reports that you
would like to generate.
Select the custom report that you would like to configure and in the dropdown menu shown
above click on [Configure Current View]. This will bring up the following pop-up:

Here you can select the maps and indices that you would like to have displayed in your
custom report. These custom reports can be saved under your Personalized Layout Profile.
Please see chapter 3.1.3 on how to set up your Personalized Layout Profile.
In both the Map x4 and the Map x1 you can select the map that you want to see. To do this
place the mouse pointer over the map you want to change and right click on the mouse. This
will bring up the following pop-up:
One of 13 different maps can be selected by left clicking with the mouse on the desired map
type name on the right hand side of the pop-up.
As the name indicates, here you can get a full screen view of a particular map. You can also
superimpose this map over the image of the eye. To do this you first have to select the
[Show Eye] box at the bottom left of the map. Now you can fade the map with the slider
below the map (see image below)

You can also overlay the pupil edge by right clicking with the mouse and choosing [Pupil] in
the pop-up.
Here the Scheimpflug images are displayed from both Scheimpflug cameras. In the [Image
Selection] you see a graphical representation of the angle and position of the cameras
towards the eye. You can also either display the images continuously by clicking on the
lowest button or you can go to the image at the angle of interest by clicking on the arrow
buttons.
Below the Scheimpflug images you can manipulate the brightness and contrast of the
images.
Under [Image Control] you have a number of options to improve the image quality to your
preferences

By clicking on [Inverse Image], you will display negative (inverse) Scheimpflug images. This
can be helpful in making details better visible. Also good for bringing out details is the
[Colorized Image] option.
To zoom any Scheimpflug image, make sure that the mouse pointer is over the image that
you want to change the zoom factor of. By hitting the [F1] key on your keyboard, you reduce
the image to fit-to-screen size. By pressing [F2], 100% size is displayed. To zoom in or out,
press the [s] key and roll the scroll wheel on your mouse. Alternatively, press [s] and left
mouse click and then drag the pointer to the bottom right of the image to zoom in or to the
top left to zoom out. When zoomed in you can move the image around by pressing [Shift],
and left mouse click to drag the image to the desired location.
This tab gives at-a-glance overview of the results of a scan. It is also the location to compare
a specific Scheimpflug image with the map of choice.
In this tab the user can measure the relative density of the different layers of the anterior
chamber over two axes. By dragging the mouse over the Scheimpflug image different
locations can be analyzed. The user has the same control over the image quality and
selection of Scheimpflug image as is described in chapter 3.3.3.

Light rays are refracted while passing the border between two different media. Therefore, to
allow for manual measurement of Scheimpflug images, Anterior Chamber ray-tracing needs
to take the anterior and posterior corneal surface into account.
Due to optical limitations of the device, not the entire Scheimpflug image is susceptible for
ray tracing. Those zones are indicated in red and should not be used for manual
measurement.

To make a manual measurement, place the mouse pointer over the Scheimpflug image and
right click the mouse. This will bring up a menu as is shown above. If you now select
[Pachymetry] and then left click once, you are able to slide the line over the cornea to the
exact location and when you click again the pachymetry is fixed.
When you select [Distance] you can make manual measurements in two mouse clicks. First
click to place the starting point; second click to place ending point on the image.
When selecting [Annotation] you can add your comments in any image at a mouse click
Selecting [Show Chamber Values] toggles the chamber angles for that particular meridian.
Should you want to delete a pachymetry, distance or annotation entry, select [no tool] and
then left lick on the particular item so that it is highlighted and then press the [Delete] key on
your keyboard.

A B difference maps can be generated from maps from a patient. In the top left of the
screen you can select the two different scans that you want to have compared. Then on the
large difference map, you can select what map you want to compare, as is show in the image
above.
The Z Lasik reports provides the first connection between Galilei and FEMTO LDV laser.
When printed, this report can be scanned in by the FEMTO LDV. Transfer patient data from
Galilei to FEMTO LDV electronically, saving LASIK setup time and eliminating sources for
data entry error.

4 Settings
[Settings] is the bottom tab on the left hand side of the Galilei software. This tab is sub-
divided in three other tabs: [Profile], [Licenses] and [Scales]. These two tabs will be
described in the following paragraphs.
All the screens in the Galilei software can be printed. The software will automatically create a
printed report of the page that is on display. Also all the overlays and other customizations
will be printed. Instead of printing to paper via a printer, you can also create an Adobe
Acrobat file, since all Galilei systems come with a PDF writer.
You can further customize your printed reports by adding your logo in the [Profile] tab. Simply
upload your logo by clicking on [Load] .
For more information on how to create your personalized layout of maps and reports, please
go to chapter 3.1.3
Support data is raw data that normally is discarded, however in extraordinary circumstances
it might be necessary to save them. There are three settings. [Save_NONE] will result in
none of the raw data being kept. [Save_LAST_10] is the default setting where the raw data of
the last 10 measurements are kept and any older raw data is automatically deleted. The last
setting is [Save_ALL], this setting should only be selected when instructed to do so by a
Ziemer service engineer.
CAUTION
Disk space can run out rapidly if [Save_ALL] is selected. It is therefore important to only
select this check-box after the explicit instructions to do so from Ziemer Support.

Licenses can be activated by a license key. These license keys need to be purchased from
Ziemer or your Ziemer distributor. License keys are based on the unique License Request
Number which can be found here in the Galilei software:
This can also be done in the [Settings] and then [Licenses] tab. Now click on [Add new
license key] and type in the key in the pop-up.
Here you can create your own custom scales. Once created they can be selected like the
other types of color scales as is described in chapter 3.1.2.
To create your custom scale, first click on [New]. Now select the step type and click on
[Create].
Click on the drop down list to select the [Associated Map] for your color scale. Next you type
in the preferred reference value and the color scale step size. You now have the option of
either ANSI or Klyce/Wilson color scales. To make your selection, place your mouse pointer
over the color scale on the right hand side and right click your mouse. Now select the
preferred color scale.
In order to see the effects of your selection on the scale on the right hand side, you have to
select [inverse scale] twice if you want normal scale order or once if you want inverse
scales. Final step is to give your custom scale a short name and click on [Save]. The saved
color scale is now visible in the list on the left hand side.

An example, as suggested by Dr Carlos Arce: go to [Settings] and click on create scale.

Choose Pachymetry. Set the reference value (that corresponds to the 2nd green going
down) to 560 and set the step size to 20. Next right click on the color scale and select ANSI
and click on [inverse] once so you will see that the 500 micron is indeed in the 2nd yellow.
Save the scale under the name of "CGA 20 micron"
5 Glossary
Curvature is mathematically defined as the rate of change of the tangent vector to the curve
with respect to the arc length of the curve.
d2y
K= dx 2
2
[1 + dy ] 2
3
dx
K = curvature
x,y = 2D plane of the curve
Axial curvature is sometimes incorrectly named sagittal. Instantaneous is also known as

tangential.
C1 and C2 are the center or curvature of the respective points where the red lines intersects
with the curve.
Axial curvature is calculated using the axial length that runs perpendicular from the
intersection point I to the reference axis. Axial curvature is therefore dependent on the
position of the reference axis. Instantaneous curvature is calculated using the actual radius
of the curvature in intersection point I.

Axial curvature gives a more global description of shape and will underestimate areas of
relative high curvature (I1) and overestimate areas of relative lower curvature (I2).
Instantaneous curvature can give a more detailed description of local curvature, but on the
other hand can become noisy.
The direct correlation between corneal curvature and power with which clinicians are familiar
is not valid in the peripheral regions measured by topographic devices. Topographic devices
measure curvature, which should not be interpreted as corneal power except in the central
region3.
Construction for specifying refractive power. For an off-axis ray at height y, the focal length f
is calculated from ray-tracing using Snells Law. The distance z represents the corneal
sagittal depth.
For each point on the Total Corneal Power map the angle of incidence is calculated relative
to the anterior surface normal for incoming parallel rays. The angle of refraction is calculated
using Snell's law with nair =1.0 and ncornea=1.376
This angle of refraction is used to determine the nonparallel direction of incoming rays
relative to the posterior surface normal and is used to calculate the angle of incidence for the
posterior surface. A new angle of refraction is calculated for the posterior surface using
Snell's law with ncornea=1.376 and naqueous=1.336.
This final angle of refraction is used to calculate the intersection of the ray along the (0,0)
axis. This is the resultant focal length that is used to determine Total Power for that point on
the map, relative to the corneal first surface.
Take note that you cannot take the sum of the central anterior K value (simK * 376 / 337.5)
and the central posterior K value to calculate the central total corneal power: simK
approximates the posterior cornea, while Total Power is ray-traced through the entire cornea.
SimK (anterior) and K (posterior) are "powers" in the center assuming parallel rays are
coming from infinity. After ray-tracing through the anterior surface, the rays are not parallel
for the posterior surface. They have been refracted by the anterior surface. Also, the axes
for simK (anterior) steep and K (posterior) steep may be different.
3
Roberts C. The accuracy of 'power' maps to display curvature data in corneal topography systems.
Invest Ophthalmol Vis Sci. 1994; 35:3525-3532.

1. Scanning process acquires a series of Scheimpflug (SPF) images (meridians) and 2

Placido Top View images at 90 degrees apart.
2. From the SPF images the edges are detected (anterior cornea, posterior cornea,
anterior lens and iris). On the Placido images the ring edges are detected. In a
separate process, the limbus and pupil are detected from a top view image. The
limbus and pupil do not influence any of the other calculations
3. From the SPF edges, height data is determined. The slope data from the Placido
images are transformed into height data. Now the data are ready to be merged.
4. The combined height data are then used to create a surface fit. Depending on the
location of the fitted surface point, different weights are applied for the SPF data and
Placido data.
5. Indices are calculated and maps are generated
Lost SPF meridians and how to detect them

Critical for successful SPF meridians is the detection of the edges (see step 2 above). This
is the main factor that determines the SPF quality percentage in the pop-up that appears
right after taking a scan. For version 3.0, the sensitivity of this quality percentage has been
improved. Currently, when more than 2 SPF meridians have failed, the quality percentage
will fall under the minimum required level.
Users can check the SPF quality for themselves in the Scheimpflug tab of the Verify screen.
Look for edges: have they been detected for all surfaces?
Consequences of lost SPF meridians

The simK values for the anterior surface are calculated over the central 0.5 - 4 mm diameter
of the cornea, and in that zone the surface is more heavily weighted by the Placido data.
Therefore missing SPF meridians will have less influence.
SPF has full weight for determination of the posterior surface, and therefore effects of
missing SPF meridians can be noticed in the posterior K values. Anterior chamber depth is
calculated for all meridians and then averaged. Therefore missing SPF meridians have
limited effect on the ACD value. In general it can be said that the effects have a negligible
influence on accuracy of ACD, as long as the SPF quality percentage is above the set
minimum value.
Significance of the red zones in the Manual Metrics tab

The red zones indicate those areas where ray tracing was not possible, and therefore where
the manual measurements done by the user will be unreliable. To warn the user of this, we
artificially insert this red zone. How much of a particular SPF image will be covered depends
on what edges have (not) been detected. This is illustrated below.
1 2 3

Three typical red zone situations are depicted in the top row of the above figure, and in the
bottom row are the corresponding SPF images from the Verify screen. Situation 1 has a
minimal red zone and the edges have been detected correctly except for the bottom part of
the cornea in the left SPF image indicated by a yellow dot in the upper left corner this
explains why the red zone covers more of the chamber angle on the bottom than on the top
of the image. In situation 2, the lens is unavailable for manual measurements. This is
because the lens edge has not been recognized in the yellow dot SPF image. The third
example is completely red because in the blue dot image, the corneal edges have not been
found at all.
If we look at the quality percentages for Situation 3 we see that SPF is just above the limit,
but that the Placido image is under the threshold level. This scan had to be re-done.
Accuracy of the anterior chamber angle

As can be seen in the images above, the angles are almost always in the red zone, since
SPF systems cannot image through non-transparent tissue such as sclera. Galilei calculates
its anterior chamber angles by extrapolating edges that have been detected. The accuracy of
the angles is therefore foremost dependent on the quality of our extrapolation algorithm.
Dual SPF and accuracy

The image above is from the Galilei brochure. It illustrates how eye motion during a scan
affects the edge coming from the posterior surface only. Having a dual SPF solution allows
this distortion to be corrected by averaging from the dual images, which makes the
measurement of the posterior edge eye-motion independent.
Therefore, accurate anterior surface calculations require only one of the two SPF images,
along with the Placido. For posterior surfaces, both SPF images are needed to compensate
for decentration due to eye motion, and thus corneal pachymetry, anterior chamber depth
and posterior curvature require complete dual SPF images. Loss of one of the two means
that both will be discarded and the quality percentage will drop accordingly.
Placido topography is the gold standard for central anterior curvature, because it measures
slope directly. To transform slopes into curvatures is straight forward. However, it can be
argued that any Placido system has a hole in the middle for the top view camera. Then
again, it is important to realize that this hole is much smaller when projected onto the anterior
surface of the cornea; In Galileis case, the projected size of first ring is approximately 1 mm
in diameter.

SPF systems measure elevation data directly and the transformation of elevation data to
curvature data has extreme resolution requirements. The example below has been
developed by Dr Cynthia Roberts4 with a similar approach by Dr Steven Klyce.
h d
45D vs. 45.25 D curves
7.5mm (R2) vs. 7.46 (R1)mm
d h
R1
1mm 0.1
2mm 0.4
R2 3mm 0.9
4mm 1.6
The industry standard for corneal topographers dictates that they should be able to detect a
0.25 Diopter curvature difference. The image above provides a schematic simulation of two
curves, with curve 2 being 0.25D flatter than curve 1. The table indicates the elevation
difference between the two curves at the edge of the indicated central diameter. It shows that
even at 5mm diameter, the elevation difference is only 2.5 microns. For a diameter of 3mm,
which is analogous to keratometry measurments, the eleveation difference is less than one
micron. This puts unrealistically high demands on the accuracy of any SPF based system.
SPF derived curvatures are more accurate in the periphery of the cornea where the elevation
differences are greater. However, it is critical to accurately measure central curvature over
the pupil, where rays that pass through the cornea contribute to visual acuity.
4
Roberts C: "The Resolution Necessary for Surface Height Measurements of the Cornea" Optical
Society of America Annual Meeting, October 2-7, 1994.

Due to Scheimpflug limitations, the sulcus cannot be precisely detected and therefore
the AC Volume calculation is limited to a 8mm diameter.
For each meridian image taken with the Scheimpflug cameras the following steps are
taken:
The posterior surface is detected
A smoothed surface for the iris and lens is determined (not indicated on the
image above)
Rectangles are fitted to fill the 8mm delimited space of the Anterior Chamber.
On the basis of this surface, a 360 volume is determined for each meridian
The displayed Anterior Chamber Volume is the average of all volumes based on the
available meridians.
6 Care and maintenance
Please note: As your first point of contact for support we strongly recommend to always
contact the distributor from whom you purchased your instrument. The list of distributors can
be found on our website in the support section.
If you wish to contact Ziemer Customer Support directly, you can go to our website:
www.ziemergroup.com
In there, look in the left top corner for [Click here] to access the public contents of our
website as a visitor (without registration) and then for [SERVICE & SUPPORT] on the right
hand side. Next look for [Galilei Support] and fill out a Galilei Repair / Complaint form.
Alternatively, you can also send us an email using the following email-address:
customer-support@ziemergroup.com (world-wide)
If you wish to contact Ziemer Customer Support by phone and during office hours you can
call our Customer Support numbers as follows:
International Customer Support Center in Switzerland: phone +41 848 ZIEMER (943 637)
American Customer Support Center (USA and Canada): phone 866-708-4472
Every Galilei is equipped with a tool that allows remote control so that a support engineer
can resolve issues more quickly and efficiently.
In order to do this, your Galilei must be connected to the Internet. This can be done by
connecting an Ethernet cable (network or directly to a cable/ADSL modem) using the
Ethernet port inside the PC compartment of the Galilei.

Nest step is to start the Team Viewer software. You will find it listed in the Windows Start
Menu on your Galilei.
As soon as you have started the Team Viewer software the pop-up displayed above will
appear. The Ziemer or distrinutors service engineer will guide you through the rest of the
process.
The patient contact surfaces can be disinfected by users and

operators according the following directions and methods.
Purpose The purpose of this procedure is to establish a consistent method
by which users may clean and disinfect the patient contact surfaces
as a routine operation to help reduce the potential of cross
infection.
Materials required Disinfecting agent such as an anti-germicide or isopropyl
alcohol.
Cloth or cleaning towels
Procedure Locate the patient brow rest
Soak the cleaning cloth or towel in disinfecting agent and wipe
the surfaces that come in contact with the patient
Locate the patient chinrest
Take the cleaning cloth used in the previous step and wipe the
exposed surfaces of the chin rest.
The Placido disc is best cleaned with pure alcohol without any
additives.
Frequency Repeat this procedure following each exam.
Before removing the fuses, disconnect the system from the mains plug.
The system is equipped with two fuses of the same kind. To access the fuse holders, unplug
the power cable from the system plug.
Using a screw driver, remove both fuse holders. Remove the fuses from the holder and
identify the broken fuse(s). Replace the broken fuse(s) with new fuse(s).

Table types 110.xxxx and 230.xxxx

System plug
Fuse holder female
Fuse type (230V): F6,3A, 250VAC

Fuse type (110V): F8A, 250VAC
Table types 110.xxxx and 230.xxxx

Fuse holder male
Fuse type (230V): F6,3A, 250VAC
Fuse type (110V): F8A, 250VAC
Table types 300.xxxx
Fuse type: T 6.3A H
Galilei systems must be returned to the distributor or manufacturer for disposal.

Contact customer service for further instructions.

Appendix A
Digital Imaging and Communications in Medicine (DICOM) is a standard for handling,

storing, printing, and transmitting information in medical imaging. It includes a file format
definition and a network communications protocol. The communication protocol is an
application protocol that uses TCP/IP to communicate between systems. DICOM _les can be
exchanged between two entities that are capable of receiving image and patient data in
DICOM format. The National Electrical Manufacturers Association (NEMA) holds the
copyright to this standard. It was developed by the DICOM Standards Committee, whose
members are also partly members of NEMA. DICOM enables the integration of scanners,
servers, workstations, printers, and network hardware from multiple manufacturers into a
picture archiving and communication system (PACS). The different devices come with
DICOM conformance statements which clearly state the DICOM classes they support.
DICOM has been widely adopted by hospitals and is making inroads in smaller applications
like dentists' and doctors' offices. For more information see:
http://en.wikipedia.org/wiki/DICOM
For Galilei, DICOM is an separate software package for which a separate license is
required.
SW 5.0 includes a DICOM networking layer and the two basic services: modality work-list
and encapsulated PDF. This allows the Galilei system to obtain details of patients and
scheduled examinations electronically from the front desk administration. It also allows for
searchable pdfs to be generated of Galilei reports that can be stored in a central DICOM
database.
The DICOM patient data pull functionality can be controlled from the patient database and
the DICOM report push functionality can be controlled from the configuration panel of the
[Custom report] (see 3.5.2 in this manual)
CAUTION
Integrating a Galilei into a DICOM network will always require considerable amount of local
tweaking and development work. This should be done by your service integrator and is not
part of the Galilei DICOM license.

Appendix B
For optimum results please ensure that the room you will be using for eye acquisitions can
be darkened. During the exam it is very important not to have overhead lights on where light
can shine on the patients eye. We recommend turning off overhead lights. Since GALILEI
projects a slit light beam onto the eye, any extra light illuminating the cornea may interfere
with edge detection, which could result in a poor exam.
A little light is acceptable in the room for maneuverability; however if the system is in close
proximity to bright light coming in from a hallway; light bouncing off white walls or even from
a window with blinds where strong light comes in at various times of the day, a poor exam
could result. If in doubt, darken the room completely.
Before starting an exam, the brakes on the table's rollers must be set.
The GALILEI is an optical device and should be handled with due care. Do not subject it to
vibrations, jolts, contamination or high temperatures.
1. Open the cardboard box carefully on its top

side.
2. Lift the foamed material from the top of the

package. Keep the foam parts for later use.

Mounting the Measurement Unit on the cross slide:

3
3. By turning the joystick clockwise ensure that the
insertion is completely extended
4. The white mark on the exocentric screw should
be set to 12 clock
4
5. Check the inner surface of the guideway and
5 make sure that the Allen screw (located just
above the exocentric screw (2)) does not extend
into the guideway. Turn the Allen screw
counterclockwise to move it out of the guide
6
6. On the cross slide, check the sub D female
plugs. Make sure they are clean and all pins are
straight.
7. Lift the Measurement Unit carefully out of the

box, holding it on the round part as shown in the
figure.
8. On the Measurement Unit side, check the sub D

male plugs. Make sure there are no broken or
bent pins and there are no lose parts
obstructing the pins.

9. When assembling the Measurement Unit on the

9 cross slide, make sure that the Placido disc
points towards the headrest (hr).
hr
10. Turn the exocentric screw (metric Allen 8mm)

about 180 so that the white mark points to the
6:00 oclock position (down).
11. Push smoothly to check if the Measurement

Unit fits.
1. Prepare the cardboard box with the underside of

the foam material.

2. Turn the exocentric screw (metric Allen 8mm)

about 180 so that the white mark points to the
12:00 oclock position (upwards).
3. Lift the Measurement Unit carefully with both

hands, pulling it straight upwards.
4. Carry the Measurement Unit carefully to the

cardboard box.
5. Place the Measurement Unit carefully into the

box, with the Placido disc pointing up.

6. Make sure that the Measurement Unit fits into

the shape of the foam material.
7. Place the upper foam material on the

Measurement Unit.
8. Close the box.

For further packaging instructions, please
contact your authorized distributor or Ziemer
support.
Before connecting to the mains supply, assure that the voltage and frequency of your mains
supply comply with the electrical requirements of your GALILEI system (230V or 110V as
marked).
To connect the GALILEI to the mains supply, first connect the power cable to the GALILEI
system and then to the mains supply.
Do not use a power cable other than the one delivered with your GALILEI system!
Galilei is fully compliant with the electrical safety as described in IEC 60601-1. This includes
leakage current levels. However, when you connect a third party device, such as a printer, to
the Galilei, this other device might cause the leakage current to exceed IEC 60601-1 level of

500 A. Some printers push the value over the limit and should this be the case, then you
can resolve this by placing an isolation transformer with multiple socket outlets.
Galilei
mains isolation
transformer USB
printer
Additionally, some printers with a class 1 switching power supply generate a small patient
leakage current (DC). This can be resolved by a USB connecting cable with a USB isolator.
Appendix C
Installing a printer driver is a Windows function and not a Galilei one, therefore Ziemer
provides the following information as an extra gesture to its customers. Before the
installation, close the Galilei software and other programs that might be running.
Often printers come with special applications that can interfere with the Galilei software. For
example, with an HP printer, you can install a print-monitor which shows you the status of the
ink cartridges. We strongly recommend that you do not install these kinds of applications, but
instead use the wizard provided by Windows as is described below.
Step 1: open the Add Printer Wizard Step 2: select the Local Network Printer
- Click Start, Settings, "Printers & Faxes" - Select "Local Printer"
- Click "Add Printer" to start Wizard - Make sure there's NO checkmark next to
"Automatically detect and install

Step 3: select the Printer-Port

Select USB00x (Virtual printer port for USB) under "Use the following port". X stands for an
available USB port.
Step 4: install Printer Software

First see if your printer is listed. If so, then select your printer manufacturer and printer
model here and click Next and go to step 5.
If your printer is not listed by the wizard then you have to go to the website of the printer
manufacturer and download the latest driver for your printer model. This driver would have
the suffix .INF. Ask your printer manufacturer for details. Copy this driver to a memory stick
and insert that into a USB port of your Galilei. Click on the Have Disk button. Now select
Browse and find the right folder where you copied the driver.

Step 5: name the printer Step 6: print a test page

- You can give the printer a name or accept - Select Yes to let the wizard printing a test
the suggested name page after the driver is installed
- Click "Yes" under "Do you want to use this
printer as the default printer
Step 7: Complete the wizard and check for the test page.
If the Test-Page does not print, a likely cause is that you have selected a wrong USB port
number. Here is what you should do to try another USB port:
Step 1: open the Printer properties window Step 2: select the next USB-Printer-Port
- Click Start, Settings, "Printers & Faxes" to - Take the next port number. For example if
open the Printer and Faxes Window you have selected the port USB002 while
- Select the Printer you have installed installing the driver, take now the Virtual
previously printer port for USB USB001.
- Click on Set printer properties, in the Task - Click an the Button Apply to apply the new
frame at the left side of the window. port
- Click on the Tab Ports - Select the tab General and print a test
page
Step 3: verify that the test Page has printed this time. If not, repeat the USB port changing
procedure.

Appendix D
Please read this section in its entirety before starting a backup or a restore.
The backup is optional and it is completely up to the user to make regular backups and to
manage the USB device with the backup files on it. It is also the users responsibility that
there is enough space left on the USB Device. This USB device can be any Windows
compatible portable hard disk with a USB connection that is compatible with Windows back-
up tools. Please check with the USB device manufacturer for compatibility.
Please note that making a backup can take a long time, therefore it is recommended that you
make this backup overnight or during the weekend. If you start a backup on a new USB hard
disk, you have to create a full backup as described in this chapter.
Step 1: start up the backup application Step 2: backup wizard

- Connect a USB hard disk - The backup wizard starts up with the
- Click on the [Backup] in the [Database] following image:
screen of the Galilei software
Step 3: select backup operation Step 4: Let me choose what to back up:

Step 5: select the Database-Folder
- Click on the + in front of My Computer

- Click on the + in front of Data (D:)
- Select the Checkbox in front of Database
Step 6: set the location of the backup file Step 7: backup file continued
- click browse - Click on My Computer
- Select the drive and directory where you
want to save the backup
Step 8: enter the name of the backup-file Step 9: check summary screen
- Click Finish to start the backup process.

Step 10: backup in progress Step 11: backup completed
If there is already a Galilei-Backup on the USB hard disk, you can use the following, space
saving, incremental backup. Proceed with the steps 1-6 that were described above: those
steps are identical for the full and incremental backup.
Step 7: re-find backup file Step 8: check name and location

- Go to the drive and directory where the
previous backup is stored, select it, and
click on Save.
Step 9: click on Advanced Step 10: select Incremental from the

Select Type of backup dropdown menu

Step 11: click Next Step 12: select Append this Backup to
existing backups
Step 13: select Now Step 14: verify and click on finish
Note that it is possible to restore a backup to a new Galilei device; however this action
requires a Ziemer service engineer. Here below we will describe restore of a backup to an
existing Galilei device.
Step 1: start up the restore application Step 2: click on Next

- Connect the USB hard disk
- Click on the [Restore] in the [Database] screen
of the Galilei software

Step 3: select Restore files and settings Step 4: select the backup file to be
restored
Step 5: verify and click on Advanced Step 6: select Original location
Step 7: select Replace existing files Step 8: select all three check-boxes
Step 9: click on Finish Step 10: wait until the process is

completed

Appendix E
The RW can only work if you:

Have the Galilei connected to your local network (see chapter 2.1.2)
Have a RW license key activated (see chapter 4.2)
Java version 1.6 or higher has been installed on the remote workstation computer
To connect the RW computer, you will need to know the IP address of the Galilei. This you
can easily find in the Galilei software by opening [Galilei] dropdown menu (top left on the
screen) and then click on [About Galilei]. In the [Platform] tabel, you will see the IP address.
Now on your intended RW computer, start your internet browser and type in the IP address
of the Galilei machine. This will launch this pop-up:

Now click on the hyperlink [Launch Galilei Remote Workstation]
First Java will start and then will the applet be downloaded.
Ignore the signature warning and click on [Run]
In the Galilei Login pop-up, you need to fill in remote_user as User Name and galilei as
password. Now your RW is running and you have full reading and analyzing access to your
Galilei.

Appendix F
Mains Voltage: 100-120 VAC
Mains Voltage: 220-230 VAC

Mains Voltage: 100 120 OR 220 230
Classification according to IEC 60601-1:

Type of protection against electric shock Protection: Class 1
Degree of protection against electric shock: Type B Applied part
Degree of protection against damaging penetration of water: IP20
Electrical Conditions:
Power Requirement: 220-230 VAC, 50/60 Hz, 1300VA
Power Requirement: 100-120 VAC, 50/60 Hz, 950VA
Power Requirement. 100-120/220-240VAC, 50/60Hz, 720VA
Fuses (230V): 2x F6,3A, 250VAC
Fuses (110V): 2x F8A, 250VAC
Fuses (110/230V) 2x T6,3A, 250VAC
Voltage input selector:

Galileis with serial numbers 300.XXXX come with a voltage selector built into the power inlet
so they can be used at both 110V and 230V supply voltages. When used at 220-230 V, 60
Hz, equipment must be connected to a center-tapped 240 V single phase transformer.
Before connecting your Galilei to the supply for the first time, you have to make sure that the
right voltage is selected. The fuse holder is also the voltage selector. The arrow underneath
the voltage on the fuse holder has to face the arrow on the housing. In the example below
the input voltage is set to 230V.

Operating conditions:
Temperature: +10 C to +40 C, +50 F to 104 F
Transport and storage conditions:

Ambient temperature: -5 C to +70 C, 23 F to +158 F
Measurement unit characteristics:

Measuring Principle: Rotational scan of Dual-Scheimpflug slit images merged with
Placido Disc images
Observation Infrared LED 810nm
Illumination:
Flash Output Blue LED Light (UV-free) 470 nm
Illumination:
Cameras: Two CCD Cameras
No of images per scan: 15-60
Hardware interfaces:
USB:
2 USB connectors are provided on the front panel of the control unit (behind the front cover)
to connect mouse and keyboard to the system.

USB connectors
Note:
The operator of the GALILEI is responsible for the compliance with the standard IEC 60601-
1-1 if supplementary equipment is connected to the analog or digital interfaces of the
GALILEI system.
Physical Characteristics:
Table width: 935mm

Table depth: 642mm
Table height: 718-900mm
Table weight: 98kg (with Computer; without Measurement Unit)
Measurement Unit weight: 13kg
Addendum to GALILEI Operator Manual
Electromagnetic Compatibility (EMC)
Changes or modifications to this system not expressly approved by SIS AG could cause EMC issues with this or
other equipment. This system is designed and tested to comply with applicable regulations regarding EMC and
needs to be installed and put into service according to the EMC information stated as follows.

Guidance and Manufacturers Declaration Electromagnetic Emissions
Guidance and manufacturers declaration electromagnetic emissions

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

GALILEI is intended for use in the electromagnetic environment specified below. The customer or the user of the
Immunity tests IEC 60601 Compliance level Electromagnetic environment - guidance
Test level
Electrostatic discharge +/- 6 kV contact +/- 6 kV contact Floors should be wood, concrete or ceramic
(ESD) tile. If floors are covered with synthetic
material, the relative humidity should be at
+/- 8 kV air +/- 8 kV air least 30 %.
IEC 61000-4-2
Electrical fast +/- 2 kV for power +/- 2 kV for power Mains power quality should be that of a typical
transient/burst supply lines supply lines commercial or hospital environment.
IEC 61000-4-4 +/- 1 kV for +/- 1 kV for

input/output lines input/output lines
Surge +/- 1 kV differential +/- 1 kV differential Mains power quality should be that of a typical
mode mode commercial or hospital environment.
IEC 61000-4-5
+/- 2 kV common +/- 2 kV common
mode mode
Voltage dips, short < 5 % UT < 5 % UT Mains power quality should be that of a typical
interruptions and (> 95 % dip in UT ) (> 95 % dip in UT ) commercial or hospital environment.
voltage variations on
power supply input for 0,5 cycle for 0,5 cycle
lines If the user of the GALILEI requires continued
40 % UT 40 % UT operation during power mains interruptions, it
(60 % dip in UT ) (60 % dip in UT ) is recommended that the GALILEI be
IEC 61000-4-11 powered from an uninterruptible power supply
for 5 cycles for 5 cycles or a battery.
70 % UT 70 % UT
(30 % dip in UT ) (30 % dip in UT )
for 25 cycles for 25 cycles
< 5 % UT < 5 % UT
(> 95 % dip in UT ) (> 95 % dip in UT )
for 5 sec for 5 sec
Note: UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturers declaration electromagnetic immunity

The GALILEI is intended for use in the electromagnetic environment specified below. The customer or the user of the
Immunity tests IEC 60601 Compliance level Electromagnetic environment - guidance
Test level
Portable and mobile RF communications
equipment should be used no closer to any part
of the GALILEI, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:

Conducted RF 3 V rms 3 V rms d = 1,2 root P
IEC 61000-4-6 150 kHz to 80 MHz
outside ISM bands
Radiated RF 3 V/m 3 V/m d = 1,2 root P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz
d = 2,3 root P 800 MHz to 2,5 GHz
where P is the maximum output power rating in
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as

a
determined by an electromagnetic site survey,
should be less than the compliance level in each
b
frequency range.
Interference may occur in the vicinity of

equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a
Fixed strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the
electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the
measured field strength in the location in which the GALILEI is used exceeds the applicable RF compliance level above, the
GALILEI should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the GALILEI.
b
over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between

portable and mobile RF communications equipment and the GALILEI
The GALILEI is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the GALILEI can help prevent electromagnet interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the GALILEI as recommended
below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output m
power of transmitter (P) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W d= 1.2 root P 2,3 root P
d= 1.2 root P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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 higher frequency range applies.
Note 1: At 80 MHz and 800 MHz, the separation distance fort he higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
Title GALILEI Operator Manual

Product Part Numbers 410.010.001 (110V)
410.010.002 (230V)
410.010.003 (110V / 230V)
Product GALILEI Dual Scheimpflug Analyzer
Author SIS, Port, Switzerland
Disclaimer Please note that while every effort has been made to
ensure that the data provided in this document is accurate,
it is the policy of SIS to continuously improve the operating
performance and overall quality of its medical devices.
Accordingly, the information, figures, illustrations, tables,
specifications and schematics herein are subject to
change without notice.
Copyright 2005 SIS Surgical Instrument Systems ag
This manual contains proprietary information. All rights are
reserved. This document may not in whole or in part be
copied, photocopied, reproduced, translated or reduced to
any electronic medium or machine readable form without
prior consent in writing from Surgical Instrument Systems
Ltd.
Trademarks GALILEI is a trademark of SIS. Other trademark names
are used in an editorial fashion only with no intention of
infringement of the trademark of the respective owner
Manufacturer SIS Surgical Instrument Systems AG,
Port, Switzerland; www.ziemergroup.com
Licensee and distributor
Caution
Federal U.S. law restricts this device to sale by, or on the order
of, a physician or practitioner

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Operator Manual

The GALILEI system includes:

CM3910-035-1005-01 2008-05-10 GALILEI Operator Manual ii

6. USB connectors for mouse/keyboard

CM3910-035-1005-01 2008-05-10 GALILEI Operator Manual iii

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual iv

Type B applied part

Must be returned to the distributor or manufacturer for

User must consult User Manual before operating the

Manufacturer's part no. / order no.

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual v

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 6

3.6.2 Eye metrics .........................................................................................................................34

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 7

2 Operating the Galilei

By default the following printer-drivers are pre-installed on a Galilei:

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 8

Transport and storage conditions:

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 9

*fictitious names were used for this database.

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 10

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 11

After clicking on [Export]. The following pop-up will appear:

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 12

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 13

Small screen picture Big screen picture

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 14

4. And push the button on top of the joystick.

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 15

SC stands for Scheimplug images

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 16

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 17

Nose shadow Eye lashes

- Shadow of the upper eye lid and eye lashes.

- Tear film break up.

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 18

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 19

3 Analyzing the results

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 20

It is possible to let the software define the value range of a scale

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 21

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 22

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 23

For your convenience, we placed an i button at the right hand side of

SimK parameters (Anterior Curvature) are calculated with the so

Anterior Curvature: SimKf and SimKs

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 24

n1 = index of refraction of the first medium (air, n1=1)

Anterior Curvature: Atigmatism

Anterior Curvature: Axis

Anterior Curvature: Eccentricity

R = Instantaneous Radius of Curvature

Posterior Curvature: Kavg, Kf, Ks, Cylinder, Axis, Eccentricity

Central, Paracentral and Peripheral zones

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 25

Paracentral zone diameter = 4 7 mm

Pupil: Average Diameter

CM3910-035-1005-01 2009-04-28 GALILEI Operator Manual 26

Keratoconus Prediction Index (KPI)

KPI = 4.62*[0.30 + 0.01 (-41.23 0.15*DSI + 1.18*OSI + 1.49*CSI + 4.13*SAI

Area Analyzed (AA)

Average Central Power (ACP)

Central/Surround Index (CSI)

Differential Sector Index (DSI)

KPI = 4.62[0.30 + 0.01 (-41.23 0.15DSI + 1.18OSI + 1.49CSI + 4.13*SAI