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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Keratron®Onda Installation and operating manual
OPTIKON 2000
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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