OPTIKON KERATRON User manual

Cod. 161501EN
2014-08-01 Rev.0
KERATRON™
Videokeratoscope Aberrometer
REF. 161501
INSTALLATION AND OPERATING MANUAL
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni, 13 - 00138 Rome
Phone [phone] - Fax [phone]
E-mail [e-mail] - 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 Topography in the Keratron .................................................. 5-2
5.1.2 The retro-mira, The bivalente mire cone and the Topography ......... 5-2
5.1.3 Main characteristics............................................................ 5-4
5.2 TECHNICAL SPECIFICATIONS ..................................................... 5-5
5.3 ELECTROMAGNETIC COMPATIBILITY TABLES .................................. 5-7
5.4 LIGHT EMISSION ..................................................................5-11
5.5 CIRCUIT DIAGRAMS ...............................................................5-11
5.6 COMPOSITION .....................................................................5-12
5.7 SOFTWARE DESIGNER ............................................................5-12
5.8 NOT SUPPLIED ACCESSORIES....................................................5-13
6INSTALLATION........................................................... 6-1
6.1 INTRODUCTION .................................................................... 6-1
6.2 UNPACKING AND INSPECTION.................................................... 6-1
6.3 INSTALLATION PROCEDURE ...................................................... 6-2
7USING THE KERATRON™ Home Screen............................... 7-1
7.1 TOPOGRAPHY CALIBRATION [CALIBRATION]................................... 7-2
7.2 SETTINGS ........................................................................... 7-6
7.3 CORNEAL TOPOGRAPHY [TOPOGRAPHY]....................................... 7-9
8TROUBLESHOOTING GUIDE ............................................ 8-1
8.1 TROUBLESHOOTING ............................................................... 8-1
9SOFTWARE KERATRON™ SCOUT ON THE EXTERNAL PC ........... 9-1
9.1 INTRODUCTION .................................................................... 9-1
9.2 DOWNLOAD THE KERATRON™ SCOUT FROM THE WEB........................ 9-2
9.3 KERATRON™ SCOUT SOFTWARE INSTALLATION ............................... 9-2
9.4 CONFIGURING THE DIRECT ETHERNET CONNECTIONTO THE EXTERNAL PC 9-
3
9.5 CONFIGURATION OF THE CONNECTION TO THE EXTERNAL PC USING A
LOCAL NETWORK........................................................................... 9-9

9.6 KERATRON™ SCOUT SOFTWARE STRUCTURE .................................9-13
9.7 CUSTOMIZING THE KERATRON™ SCOUT SOFTWARE .........................9-14
9.8 IDENTIFICATION OF THE SCOUT SOFTWARE VERSION .......................9-14
9.9 UNINSTALL KERATRON™ SCOUT SOFTWARE ..................................9-15
9.10 DESCRIPTION OF THE COMMANDS AND SCREENS OF THE KERATRON™ SCOUT
SOFTWARE .................................................................................9-16
9.10.1 INTRODUCTION.................................................................9-16
9.10.2 TRANSFERRING AN IMAGE FROM KERATRON™ .............................9-16
9.10.3 How to process, print and save images ....................................9-16
9.11 TROUBLESHOOTING KERATRON™ SCOUT SOFTWARE ........................9-17
9.11.1 KERATRON™ SCOUT SOFTWARE INSTALLATION............................9-17
9.11.2 THE FILE SCOUT.INI ...........................................................9-18
9.11.3 SHARING THE KERATRON™ SCOUT AMONG SEVERAL OPERATORS.......9-18
9.11.4 CHANGING THE PC ............................................................9-18
9.11.5 MISCELLANEOUS PROBLEMS ..................................................9-20
9.12 UPDATING KERATRON.EXE ......................................................9-22
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 REPLACING THE FUSE .........................................................10-2
10.3.2 REPLACING THE BUFFER BATTERY ..........................................10-3
11 INDEX ....................................................................11-1
12 APPENDIX ...............................................................12-1

Keratron™ Installation and operating manual
OPTIKON 2000
Cod. 161501EN 1-1 2014-04-23 Rev.0
1 DISCLAIMER
OPTIKON 2000 S.p.A. requests the users of this system to carefully read the specific
instructions found in the present 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.
The use of this system is subject to professional medical evaluation. 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 [e-mail]
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.

Keratron™ Installation and operating manual
OPTIKON 2000
Cod. 161501EN 1-2 2014-04-23 Rev.0
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Keratron™ Installation and operating manual
OPTIKON 2000
Cod. 161501EN 2-1 2014-04-23 Rev.0
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 device and its accessories must be returned in their original packaging. If they
are returned in a non compliant packaging, any damage arising from transportation
will not be covered by the warranty. If OPTIKON 2000 S.p.A. receives returned
products in packaging other the original one, it will return the products with the
appropriate packaging and charge the customer its costs.
In case of an expressly requested intervention of our technicians, all travel and hotel
expenses will be debited to the client.

Keratron™ Installation and operating manual
OPTIKON 2000
Cod. 161501EN 2-2 2014-04-23 Rev.0
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Keratron™ Installation and operating manual
OPTIKON 2000
Cod. 161501EN 3-1 2014-04-23 Rev.0
3 WARNINGS
3.1 GENERAL WARNINGS
For the correct use of the Keratron™ system, it is necessary to completely read
this manual. It must be used in compliance with the procedures and instructions
described herein.
Keratron™ 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.
Keratron™ has been developed and optimised to measure human eyes. The use
and the evaluation of Keraton ™Onda's in conditions that not comply with this
manual, or made by using surfaces having a reflectivity riflettività 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 disappearance of some mire) cannot insure to
have the same degree of accuracy and thus it is strongly discouraged.

Keratron™ Installation and operating manual
OPTIKON 2000
Cod. 161501EN 3-2 2014-04-23 Rev.0
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.
The Keratron™ topographer does not perform diagnoses. . The operator should
not rely exclusively on parameters deriving from the instrument's measurement of the
curvature of the cornea, but use his/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™ syste m 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.

The device contains a lithium battery. The used batteries must be disposed
of in an adequate manner.
Do not dispose of Keratron™ as unsorted municipal waste. Collect it
separately according to the local laws/regulations on disposal of waste
electrical and electronic equipment ..