OPTIKON KERATRON ONDA User manual

Code 161401EN
2010-06-07 Rev.0
KERATRON®ONDA
Videokeratoscope Aberrometer
INSTALLATION AND OPERATING MANUAL
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni, 13 - 00138 Rome, Italy
Phone [phone] - Fax [phone]
e-mail sa[email protected] - www.optikon.com

Optikon 2000 SpA is an ISO 9001 and ISO 13485 certified company
which manufactures surgical and diagnostic devices for ophthalmology.
Its products are manufactured to satisfy the requirements of 93/42/EEC
Medical Devices Directive.

TABLE OF CONTENTS
Page
1DISCLAIMER..............................................................1-1
2LIMITED WARRANTY CONDITIONS.....................................2-1
3WARNINGS ...............................................................3-1
3.1 GENERAL WARNINGS ...............................................................3-1
3.2 ENVIRONMENTAL WARNINGS......................................................3-2
3.3 ELECTRICAL WARNINGS............................................................3-3
3.4 MECHANICAL WARNINGS...........................................................3-4
4SYMBOLS .................................................................4-1
5GENERAL INFORMATION ...............................................5-1
5.1 SYSTEM DESCRIPTION ..............................................................5-1
5.1.1 TOPO-ABERROMETRY WITH THE KERATRON ONDA .........................5-2
5.1.2 THE BIVALENT CONE AND TOPOGRAPHY.....................................5-4
5.1.3 ABERROMETRY....................................................................5-4
5.1.4 MAIN FEATURES ..................................................................5-6
5.2 TECHNICAL SPECIFICATIONS ......................................................5-7
5.3 ELECTROMAGNETIC COMPATIBILITY TABLES ...................................5-9
5.3.1 ELECTROMAGNETIC EMISSIONS ................................................5-9
5.3.2 ELECTROMAGNETIC IMMUNITY............................................... 5-10
5.3.3 RECOMMENDED SEPARATION DISTANCES................................... 5-12
5.4 LIGHT EMISSION................................................................... 5-13
5.5 CIRCUIT DIAGRAMS ...............................................................5-13
5.6 COMPOSITION ..................................................................... 5-14
5.7 SOFTWARE DESIGNER ............................................................5-14
5.8 NOT SUPPLIED ACCESSORIES.................................................... 5-15
6INSTALLATION...........................................................6-1
6.1 INTRODUCTION......................................................................6-1
6.2 UNPACKING AND INSPECTION.....................................................6-1
6.3 INSTALLATION PROCEDURE .......................................................6-2
7USING THE KERATRON® ONDA........................................7-1
7.1 INITIAL SCREEN .....................................................................7-1
7.2 TOPOGRAPHY CALIBRATION [CALIBRATION] ...................................7-3
7.3 SETTINGS ............................................................................7-7
7.4 SERVICE ............................................................................ 7-11
7.5 CORNEAL TOPOGRAPHY .........................................................7-12
7.6 TOPO-ABERROMETRY [TOPO-ABERROMETRY]: ACQUISITION OF IMAGES 7-16
7.7 TOPO-ABERROMETRY: ACQUIRED IMAGE......................................7-18
7.8 ABERROMETRY .................................................................... 7-26

8TROUBLESHOOTING GUIDE............................................8-1
8.1 TROUBLESHOOTING ................................................................8-1
9KERATRON® SCOUT SOFTWARE ON THE EXTERNAL PC ...........9-1
9.1 INTRODUCTION......................................................................9-1
9.2 DOWNLOAD THE KERATRON SCOUT FROM THE WEB..........................9-1
9.3 KERATRON®SCOUT SOFTWARE INSTALLATION.................................9-2
9.4 CONFIGURATION OF THE ETHERNET CONNECTION............................9-3
9.5 INSTALLATION OF THE WI-FI CONNECTION.....................................9-7
9.6 KERATRON®SCOUT SOFTWARE STRUCTURE....................................9-8
9.7 CUSTOMIZING THE KERATRON® SCOUT SOFTWARE...........................9-9
9.8 IDENTIFICATION OF THE SCOUT SOFTWARE VERSION.........................9-9
9.9 UNINSTALL KERATRON®SCOUT SOFTWARE................................... 9-10
9.10 DESCRIPTION OF THE COMMANDS AND SCREENS OF THE KERATRON® SCOUT
SOFTWARE.................................................................................. 9-11
9.10.1 INTRODUCTION .............................................................. 9-11
9.10.2 TRANSFERRING AN IMAGE FROM KERATRON® ONDA...................9-11
9.10.3 HOW TO PROCESS, PRINT AND SAVE IMAGES............................9-11
9.11 TROUBLESHOOTING OF THE KERATRON®SCOUT SOFTWARE ..............9-12
9.11.1 KERATRON®SCOUT SOFTWARE INSTALLATION..........................9-12
9.11.2 THE FILE SCOUT.INI ......................................................... 9-13
9.11.3 SHARING THE KERATRON® SCOUT AMONG SEVERAL OPERATORS.... 9-13
9.11.4 CHANGING THE PC .......................................................... 9-14
9.11.5 MISCELLANEOUS PROBLEMS................................................9-15
9.12 UPDATING ONDA.EXE ............................................................ 9-17
10 CLEANING, STERILIZATION AND MAINTENANCE....................10-1
10.1 CLEANING AND DISINFECTION ..................................................10-1
10.1.1 FOREHEAD REST AND MIRES CONE ........................................ 10-1
10.1.2 CLEANING THE ACCESSORIES THAT ARE NOT PROVIDED .............. 10-2
10.2 STERILIZATION ....................................................................10-2
10.3 MAINTENANCE..................................................................... 10-2
10.3.1 VERIFICATION OF ABERROMETRY ACCURACY USING THE CALIBRATION
SPHERE 10-2
10.3.2 REPLACING THE FUSE.......................................................10-4
10.3.3 REPLACING THE BUFFER BATTERY........................................10-4
11 INDEX....................................................................11-1
12 APPENDIX ...............................................................12-1

Keratron®Onda Installation and operating manual
OPTIKON 2000
1 DISCLAIMER
OPTIKON 2000 S.p.A. requires the user of this system to carefully read specific
warnings found in this manual. It is responsibility of the user to provide its personnel
with a thorough understanding of the equipment operation before use. In no event
shall Optikon 2000 S.p.A. be liable for any injury, incidental or consequential
damages incurred by the purchaser, users or patients as a result of operation of the
product.
Use of this system is a matter of professional medical judgment in all cases. Optikon
2000 S.p.A. is not responsible for any clinical problem resulting from mishandling this
equipment and makes no medical recommendations.
Optikon 2000 S.p.A. declares to be liable for safety, reliability and performance only
if:
• upgrades, calibrations, repairs are carried out by OPTIKON 2000 S.P.A.
authorized personnel.
• the system is used in accordance with its instructions for use
• the mains electric installation to which the system is connected complies with
the IEC Safety Regulations
NOTE
Every effort has been made to have all the illustrations and information
accurately represent the product and its operation as it actually was at the time
this operation manual was printed. Changes in some items may be made
during the life of this manual, so that we may effectively continue to meet the
requirements of users. At times, such modifications are made without advance
notice.
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni, 13
00138 Rome (Italy)
Phone [phone]
Fax [phone]
e-mail sa[email protected]
www.optikon.com
NOTE: Information contained in this manual is proprietary with Optikon 2000
S.p.A. reproduction of any part or whole may only be performed with written
permission from OPTIKON 2000 S.p.A.
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2 LIMITED WARRANTY CONDITIONS
All OPTIKON 2000 S.P.A. equipment and accessories sold and installed in the
European Union are guaranteed against defective workmanship and faulty parts for
ONE YEAR, from the date of the invoice. The guarantee on the consumable material
is limited to the first use of the apparatus.
Please, inquire with your local Optikon Distributor for warranty conditions in countries
outside the European Union.
All items under warranty will be repaired or replaced free of charge.
Warranty includes the research of causes of the faults, reparation of the defect and a
final inspection of the unit, or part(s).
This warranty does not cover any problems which are the result of improper use,
accidents, incorrect use and tampering or modifications made by persons who are
not part of the authorised OPTIKON S.p.A. technical service.
OPTIKON 2000 S.p.A. reserves the right to verify, in case of failures, if the
instrument and/or its accessories have been modified or tampered with in any way, or
if they have been damaged by improper use.
OPTIKON 2000 S.p.A. also reserves the right to modify the instrument and/or its
accessories in the event operating techniques require such modifications.
The warranty is not valid if the serial number of the instrument and/or accessories
attributed by OPTIKON 2000 S.p.A. is missing, tampered with and/or unreadable.
The warranty does not include the expenses for returning the instrument and
accessories: all charges for shipping, packaging etc. shall be borne by the buyer.
The instrument and accessories must be returned in their original packing. If a return
is made with different packing, any damage resulting from shipping will not be
covered by the warranty. If the original packing is not present, OPTIKON 2000 S.p.A.
will ship the product with the prescribed packing materials in any case and will charge
the customer the corresponding cost of such packing materials.
In case of an expressly requested intervention of our technicians, all travel and hotel
expenses will be debited to the client.
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3 WARNINGS
3.1 GENERAL WARNINGS
• For the correct use of the Keratron® Onda system, it is necessary to completely
read this manual. It must be used in compliance with the procedures and
instructions described herein.
• The Keratron® Onda must be connected to the power supply only as specified
on the power supply panel. Use exclusively the mains power cable provided or
a cable that is in compliance with safety regulations.
• Do not connect to the system devices or accessories different from those
described in this manual.
• The use of accessories or cables different from those provided with the unit
could cause an increase in emissions or a decrease in the immunity of the
system. The emissions originating from portable equipment for
telecommunications could affect the unit’s performance.
• Carefully follow the instructions for the installation and use of the unit, so as to
prevent dangerous interference with other equipment located nearby. If this
instrument causes dangerous interference with other equipment (this can be
caused by turning the unit on and off), it is recommended that the user attempt
to correct the interference with one or more of the following methods:
- Reorient or reposition the other instruments.
- Increase the distance between the instruments themselves.
- Connect the unit to a power outlet that is different from the one to which the
other instruments are connected.
- Consult the distributor or authorized Optikon 2000 S.p.A. Technical Service
Department.
• The Keratron®Onda has been developed and optimised to measure human
eyes. The use and the evaluation of the Keratron®Onda in conditions that not
comply with this manual, or made by using surfaces having a reflectivity or a
shape which is far from those typical of human eyes (for example: contact
lenses, surfaces having discontinuity in the tangent or concavity in any of its
section profiles, or surfaces such to create multiple reflections or
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disappearance of some mire) cannot insure to have the same degree of
accuracy and thus it is strongly discouraged.
• When used as a corneal topograph, situations that create mires jamming can
occur in human eyes in limited areas. This must be prevented by insuring a
good tearing and good image acquisitions (see in particular the chapters
dedicated to the eye acquisition and the last page of this manual), and
eventually corrected by properly using “Process Editing ” functions. Therefore,
you can either adjust mires detection parameters or eventually discard artefacts.
In any case, the user must individually check that the mires reconstruction has
been adequate before accepting the topographic resulting data as valid.
• Repeat the calibration of the instrument on a daily basis and verify, by
measuring the spherical aberration of the eye being tested, the accuracy of the
aberrometric measurement when in doubt about the precision of the results.
• The Keratron® Onda topo-aberrometer does not perform a diagnosis. The
operator must not exclusively rely on the parameters resulting from the
measurement of the wave front by the instrument, but must also count on his or
her own experience and qualifications to correctly interpret the results.
• In this manual the “.” (point) character has been adopted in place of the “,”
(comma) character as the decimal separator to maintain coherence with the
software messages and figures which use the Anglo-Saxon convention.
3.2 ENVIRONMENTAL WARNINGS
• The environment in which the Keratron® Onda system is installed and used
must be in compliance with safety regulations.
• Do not install the instrument near sources of heat or expose it to direct sunlight
or high temperatures.
• The system must never be used in the presence of inflammable anesthetics,
inflammable disinfectants, or other substances which may cause fires or explosions.
• The use of flammable anaesthetics (N2O), (O2), should be avoided unless they
are removed by a gas aspiration system.
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The device contains a lithium battery. The used batteries must be disposed
of in an adequate manner.
• Do not dispose of Keratron®Onda as unsorted municipal waste. Collect it
separately according to the local laws/regulations on disposal of waste electrical
and electronic equipment.
3.3 ELECTRICAL WARNINGS
• The Keratron® Onda system functions in conjunction with a PC and
relative peripherals. The PC system (including the monitor and any
additional peripherals) to be connected to the device must be in
compliance with Standard EN 60601-1 or must be isolation class II
(represented by the symbol ) according to Standard EN 60950.
If the device in question is connected to an apparatus whose compliance with
Standard EN 60601-1 is uncertain, the following are the risks:
Under normal operating conditions the risk of an excessive DISPERSION CURRENT
• of the entire system towards the ground due to the dispersion current
from the noncompliant device;
• in the case of a single breakdown (interruption of the common protective
ground), the risk of an excessive dispersion current in the covering
resulting from the dispersion current from the noncompliant device
To avoid such risks, in the case of a PC that is not in compliance with EN
60601-1, it is advisable to connect the PC to a power outlet that is different from
the one to which the Keratron®Onda is connected or, alternatively, to use an
isolation transformer between the PC and the wall power outlet.
The PC and relative devices must be placed outside of the patient area (at least 1.0
meter). Only the Keratron® Onda topo-aberrometer may be placed in the patient
area.
• Do not use mobile multiple power outlets or extension cords to power the unit.
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• In case of use in the operating room, if several units are connected to the
patient or if these units are interconnected, have qualified personnel evaluate
any risks with regard to dispersion currents or system connections made
according to EN 60601-1 and EN 60601-1-1.
• The operator should never touch at the same time the patient and parts
outside the patient area.
3.4 MECHANICAL WARNINGS
• Be careful not to hit the patient with the cone, during measurements, when
moving the Keratron®Onda forward.
• Do not touch any of the optical surfaces. Cleaning or maintenance is to be
performed by personnel authorized by Optikon 2000 S.p.A.
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4 SYMBOLS
The table below shows some I.E.C. approved symbols and their meanings. In the
absence of sufficient space, these symbols are often used on medical instruments to
enable quick and simple communication of information and warnings. At times two or
more symbols are combined together in order to obtain special meanings.
These are the symbols used on the Keratron®Onda labels. Before beginning to use
the units, familiarize yourself with the symbols and the definitions shown in the table.
SYMBOLS PUBLISHED BY IEC
SYMBOL DESCRIPTION
ALTERNATING CURRENT
PROTECTIVE EARTH
ATTENTION!
OFF (POWER DISCONNECTION FROM THE MAINS)
ON (POWER DISCONNECTION FROM THE MAINS)
TYPE B
PART APPLIED TO THE PATIENT (BODY)
SEPARATED WASTE COLLECTION FOR
ELECTRICAL/ELECTRONIC EQUIPMENT
MANUFACTURER AND MANUFACTURING DATE
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5 GENERAL INFORMATION
5.1 SYSTEM DESCRIPTION
Figure 5-1: Keratron®Onda
The Keratron® Onda system is a topograph aberrometer designed to provide
information on the cornea by representing it using the chromatic maps that are typical
of corneal topography (axial powers, curvatures, and corneal aberrometry) and to
provide information on the optical aberrations of the ocular or total wave front.
The main identifiable elements in the Keratron Onda are shown in Figure 5-1:
Keratron® Onda
They are:
1. Power switch
2. 7” LCD display with touch-screen:
• allows a live view of the patient’s eye for proper positioning of the
instrument during the measurement
• allows the operator to send commands by using a special pen to touch
virtual cursors and buttons on the screen
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• employs a user-friendly interface to notify the operator of the status of
the unit and any errors
3. Joystick with button: allows the cart to be moved in the X-Y-Z directions for
proper positioning of the optical head in relation to the patient and the start or
confirmation of the image acquisitions.
4. X-Y-Z cart
5. Optical head, with mires cone
6. Adjustable chin-rest with forehead-rest for positioning the patient during the
measurement.
5.1.1 TOPO-ABERROMETRY WITH THE KERATRON ONDA
The requirements for conducting the topography and the aberrometry are not the
same. A good reflection topography requires uniform mires and especially, for those
at the center of the cone or Placido disk, a very small and distant hole.
Instead, aberrometry requires a larger field of view of the maximum pupil and optics
placed relatively close to the eye. For this reason topo-aberrometers generally
sacrifice the coverage of the central zone.
To solve this problem, the Keratron Onda adopts a patented system of “back-mires”
located behind the filter mirror that separates the two optical paths (refer to Figure
Figure 5-2: Operating principle of the back-mire).
.
Figure 5-2: Operating principle of the back-mire
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The mires cone possesses 26 alternating black/white and white/black edges to which
two from the back-mire are added (211 and 212 in Figure 5-2). In this manner the
mires reflected on the cornea of the Keratron Onda are the same as the other
Keratrons (28, at a uniform rate for the arc-step algorithm) without any compromise in
the center (Figure 5-2, in the lower left-hand corner).
To establish when the eye is at the ideal distance from the cone, the Keratron Onda
uses an advanced version of the EPCS (Eye Position Control System) electronic
circuit adopted in the other topographs produced by Optikon 2000 S.p.A.
The eye’s apex is intercepted when it is located at the preset distance from the
optical head to accept the acquisition only within a preset range. If the eye is not at
the correct distance, it is not possible to capture the image.
Figure 5-3: EPCS with traditional Keratron and with Keratron Onda
In the original version the photoelectric cells guarantee a precision of a tenth of a
diopter within a “range OK” of only ±0.05mm. Within this range the image is accepted.
Topo-aberrometric acquisitions require more time; therefore, the eye may have
greater movement in the axial direction.
Therefore, the Keratron Onda uses larger photoelectric cells and an A/D Converter
that measures and associates each image with its forward or backward misalignment.
Using such measurement to compensate these variations, the measurement of the
curvature of a normal eye is precise to within a tenth of a diopter with axial
movements of up to 0.55 mm (Figure 5-3: EPCS with traditional Keratron and with
Keratron Onda).
If, instead, the patient’s movement with respect to the cone is too fast, and the
relative movement exceeds these limits, the Keratron Onda notifies the operator that
the videokeratographic image is “too close” or “too far away” for a good topograph,
even if it can be adjusted for the measurement of the pupil.
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5.1.2 THE BIVALENT CONE AND TOPOGRAPHY
The adoption in the Keratron Onda of a double pair of photoelectric cells on the
external edge of the optical head makes it possible to choose between the near
distance, for maximum peripheral coverage, and the distance that is 3 mm farther
away, to reduce invasiveness. This choice can be made during the topographic or
topo-aberrometric acquisition using the touchscreen (for example, buttons 3 and 4 in
Figure Figure 7-2: Topography: Live view.
The cone is backlit by an LED matrix with two wavelengths: Near infrared (λ=750nm)
for aberrometric recordings under scotopic conditions, and yellow-amber (λ=590nm)
to capture the topographic images and the pupil contraction in daylight. A video
camera monitors and captures images of the eye in the two phases.
The operator thus can only take images, by pressing the pushbutton on the joystick
only when the patient eye is at a preset distance, which is the same distance at which
the instrument was formerly calibrated on a sphere having a known curvature radius.
After the image has been acquired, specific algorithms reconstruct the shape of the
cornea by analyzing more than 7000 points located on the intersection between the
28 mires edges from black to white and from white to black and the 256 radials or
“meridians.”
The curvature values are represented on the screen in the form of chromatic maps.
The center of the rings is the corneal vertex, that is the point of the cornea which is
closer to the observing TV-camera, and that is an important reference point for all
corneal maps. The entrance pupil is also detected.
5.1.3 ABERROMETRY
The projection of an emission band with a small cross-section, produced by a
superluminescent diode (SLD), inside the eye for the purpose of generating a point of
light on the fovea, causes a wave front emerging from the eye itself. This front, which
is commonly called “retinal reflection,” is “distorted” on the return path by the eye’s
aberrations.
By means of the analysis of the wave front, it is possible to accurately quantify these
aberrations.
In the Keratron Onda a measurement method is used in the image space (modified
Hartmann-Shack type sensor) in which the emerging band is projected in turn on a
lenslet array (Figure 5-4: Hartmann-Shack method (or S/H, example)).
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Figure 5-4: Hartmann-Shack method (or S/H, example)
Behind the array is placed a CCD sensor that acquires the points projected by the
lenslets. The pattern acquired in this manner is analyzed on a personal computer
with the help of an algorithm developed specifically for this purpose.
Figure Figure 5-5: shows the patterns of a Hartmann-Shack sensor in the case of a
perfectly flat wave front and in the case of an aberrated wave front. In the former
case the light points projected on the CCD are arranged uniformly, while in the latter
case the arrangement of the points is decidedly less uniform.
Figure 5-5: Images projected by a lenslet for an ideal wave front and an aberrated wave front
In the classical method of the centroids, the deviation of these points from the ideal
position gives us the measurement of the X and Y gradients of the wave front. From
the gradients the wave front itself can be reconstructed.
The problem with this method is that the deviation can only be measured provided
that the points remain within these cells.
In the Keratron® Onda a different method is used: Demodulation of spatial
frequency
To the pattern projected by the lenslet on the CCD are applied both the fast Fourier
transform (FFT) and the corresponding antitransform. From this sequence of
operations is extracted the wave front’s phase, and from the wave front’s phase we
can obtain the X and Y gradients by means of a procedure called “phase
unwrapping”.
An advantage of this technique is an increase in the dynamics. In comparison to the
classical method, the points do not necessarily need to remain closed within the cells
(Figure Figure 5-5: ), therefore, it is possible to measure larger aberrations.
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The price to be paid for this is a greater complexity of the algorithm, which results in a
longer calculation time.
5.1.4 MAIN FEATURES
KERATRON® ONDA is comprised of a central unit built around an embedded PC.
The commands are sent by means of a touchscreen built into a 7” LCD display. The
user interface is intuitive and, in addition to being entered by means of the
touchscreen, the commands of most immediate execution can also be input using the
button on the joystick.
For processing and viewing, as well as for operations in connection with printing and
storing the exams, communications are possible with any external PC (not included)
on which the Keratron “Scout” software is installed, by means of an Ethernet cable or
Wi-Fi connection.
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