OPTIKON Keratron Nova Reference manual

Cod. 161601EN
2016-12-28 Rev.B
KERATRON™ NOVA
Videokeratoscope
REF. 161601
MANUAL FOR INSTALLATION AND USE
OPTIKON 2000 SpA
Via del Casale di Settebagni, 13 - 00138 Roma
Telefono [phone] - Fax [phone]
e-mail [email protected] - www.optikon.com

Optikon 2000 SpA is a company certified ISO 9001 and ISO 13485
which produces surgical and diagnostic devices for ophthalmology.
All Optikon 2000 products are manufactured in accordance with the
requirements of Directive 93/42 / EEC on medical devices.

SUMMARY
Page
1PRELIMINARY STATEMENTS............................................1-1
2LIMITED WARRANTY CONDITIONS ....................................2-1
3WARNINGS ...............................................................3-1
3.1 General advice ....................................................................3-1
3.2 Environmental precautions......................................................3-3
3.3 Electrical Warnings ...............................................................3-3
3.4 Mechanical precautions..........................................................3-5
4SYMBOLS .................................................................4-1
5GENERAL INFORMATION ...............................................5-1
5.1 System Description ...............................................................5-1
5.1.1 The topography in the Keratron NOVA......................................5-2
5.1.2 The cone bivalent mire and Topography ...................................5-2
5.1.3 Main characteristics............................................................5-4
5.2 Technical specification ..........................................................5-5
5.3 Electromagnetic Compatibility Tables.........................................5-7
5.3.1 Guide and Manufacturer’s Statement-Electromagnetic emissions......5-7
5.3.2 Guide and Manufacturer’s Statement - Electromagnetic immunity....5-8
5.3.3 Recommended distance of separation between portable and mobile
radio communication devices and the Keratron®Onda device..................5-10
5.4 Light emission ....................................................................5-11
5.5 Circuit diagrams..................................................................5-11
5.6 STANDARD CONFIGURATION ....................................................5-12
5.7 Software Designer................................................................5-12
5.8 Accessories not supplied........................................................5-13
6INSTALLATION...........................................................6-1
6.1 Introduction........................................................................6-1
6.2 Opening the packaging and inspection ........................................6-1
6.3 Installation procedure............................................................6-2
7USE OF THE KERATRON™ NOVA - Home Screen ....................7-1
7.1 Topography calibration [Calibration] ..........................................7-2
7.2 Settings [Settings] ................................................................7-6
7.2.1 ABOUT............................................................................7-6
7.2.2 GENERAL.........................................................................7-7
7.2.3 DATABASE........................................................................7-9
7.2.4 NETWORK.......................................................................7-11
7.2.5 PROCESS/PRINT................................................................7-12
7.2.6 LOCALIZATION .................................................................7-12
7.3 Corneal topography [Topography].............................................7-13
7.3.1 TBUT ............................................................................7-19

7.3.2 PUPILLOMETRY.................................................................7-20
7.4 DATABASE .........................................................................7-20
7.4.1 IMPORT SOFTWARE ON SCOUT...............................................7-25
7.5 SHUTTING DOWN.................................................................7-26
8GUIDE TO TROUBLESHOOTING........................................8-1
8.1 Troubleshooting...................................................................8-1
9KERATRON SCOUT™ SOFTWARE ON PC EXTERNAL.................9-1
9.1 Introduction........................................................................9-1
9.2 Keratron®Scout software download from the Web..........................9-1
9.3 Installation of the Keratron®Scout software .................................9-2
9.4 Setting up the direct Ethernet connection to the external PC ............9-3
9.4.1 Setting Personal Computer in Windows XP.................................9-3
9.4.2 Setting Personal Computer in Windows Vista and Windows 7 ...........9-5
9.4.3 Configuration of the Keratron™ NOVA.......................................9-7
9.5 Configuring the connection to an external PC via the local network ....9-8
9.5.1 Automatic address configuration (DHCP)...................................9-9
9.5.2 Configuration with static address...........................................9-10
9.6 Structure of the Keratron® Scout software (on EXTERNAL PC)...........9-13
9.7 Customization of the Keratron Scout™ software............................9-14
9.8 Identification of the Scout software version.................................9-14
9.9 Uninstalling the Keratron™ Scout software ..................................9-15
9.10 Tool Tips and screens of the Keratron™ Scout software ...................9-16
9.10.1 Introduction..................................................................9-16
9.10.2 Transfer of an image from KERATRON™ NOVA..........................9-16
9.10.3 How to process, save and print images..................................9-16
9.11 Troubleshooting the Keratron Scout™ software .............................9-17
9.11.1 Keratron Scout™ software installation...................................9-17
9.11.2 The Scout.ini file............................................................9-18
9.11.3 Sharing Keratron™ Scout between different operators................9-18
9.11.4 PC replacement .............................................................9-19
9.11.5 Various problems............................................................9-20
9.12 NOVA.exe update ................................................................9-21
10 CLEANING, STERILIZATION AND MAINTENANCE ...................10-1
10.1 Cleansing and disinfection......................................................10-1
10.2 Mire cone..........................................................................10-1
10.3 Sterilization.......................................................................10-2
10.4 Cleaning of the not supplied accessories.....................................10-2
10.5 Maintenance ......................................................................10-2
11 Backup battery replacement ........................................11-1
12 INDEX....................................................................12-1
13 APPENDIX ...............................................................13-1

1 PRELIMINARY STATEMENTS
OPTIKON 2000 SpA requires the user of this system to carefully read the specific
information in this manual. It is the operator's duty to ensure the staff has a thorough
understanding of the operation of the instrument before use. In no event OPTIKON
2000 SpA is responsible with respect to any injury, incidental or consequential
damages caused to the buyer, to operators or patients following use of the product.
The use of this system is subject to professional medical evaluation. Optikon 2000
SpA is not responsible for any clinical problem resulting from incorrect use of this
device and do not provide any medical recommendation.
Optikon 2000 SpA declares himself responsible for the safety, reliability and
performance only if:
•updates, calibration, repairs are performed by OPTIKON 2000 SpA authorized
personnel
•the system is used in accordance with the instructions for use
•the electrical system to which the system is connected conforms to IEC
standards for safety.
NOTE
Every effort has been made to ensure that all illustrations and information to
accurately represent this product and its operation which were actual at the
time of printing this manual. It is possible that, over the life of this manual,
changes are made in order to continue to meet, effectively, the needs of users.
Sometimes, these changes are made without prior notice.
OPTIKON 2000 SpA
Via del Casale di Settebagni, 13
00138 Rome - Italy
Tel. [phone]
Fax [phone]
e-mail [email protected]
www.optikon.com
NOTE: The information contained in this manual are property of Optikon 2000
SpA Their total or partial reproduction is allowed only upon written consent of
OPTIKON 2000 SpA

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2 LIMITED WARRANTY CONDITIONS
All OPTIKON 2000 SpA equipment and accessories sold and installed in the
European Union are guaranteed against manufacturing defects and defective parts
for ONE YEAR from the date of billing. The warranty on consumables is limited to the
first use of the device.
For information on the warranty conditions outside the European Union, please
contact your local OPTIKON 2000 SpA authorized distributor.
All parts covered by warranty will be repaired or replaced at no charge.
The warranty includes the search for the causes of defects, the repair of the fault and
the final inspection of the unit or of the component/s.
This warranty does not cover the result of misuse, accident, misuse and tampering or
alteration by persons not belonging to the OPTIKON SpA authorised technical
service.
OPTIKON 2000 SpA reserves the right to verify, in case of failure, if the instrument
and / or its accessories have been altered or tampered with in any way, or have been
damaged by improper use.
OPTIKON 2000 SpA also reserves the right to modify the instrument and / or its
accessories when required by operating techniques.
No guarantee will be granted in the event that the serial number of the device and/or
accessories assigned by OPTIKON 2000 SpA is missing, tampered with and/or not
clearly legible.
The guarantee does not include the costs for the return of the instrument and
accessories: all expenses for transportation, packaging etc. are responsibility of the
user.
The device and accessories must be returned in their original packaging. When
returning a packaging differing from standard, any damage caused by transport will
not be covered under warranty. OPTIKON 2000 SpA, in case of absence of the
original packaging, however, will return the product with the standard packaging and
charge the relative cost.
In the event of an explicit request for the intervention of the OPTIKON 2000 SpA
technicians, all travel and accommodation expenses will be charged to the customer.
LEGENDA
DM Medical device
LAF Slit Lamp
PC Personal Computer

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Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 3-1 2016-12-28 Rev.B
3 WARNINGS
3.1 GENERAL ADVICE
•Aa thorough reading of this manual is required in order to ensure a proper use
of Keratron™ Nova . The use must be in accordance with the procedures and
operating instructions described herein.
•Keratron™ Nova must be connected to the mains exclusively as indicated on
the power panel. Only use the mains cable supplied or a cable conforming to
safety standards.
•Do not connect devices or accessories to the system other than those
described in this manual.
•The use of different accessories and cables other than those supplied with the
unit, may result in increased emissions or decreased immunity of the system.
Emissions from mobile telecommunications equipment can affect drive
performance.
•Carefully follow the instructions for installing and using the unit, in order to
prevent dangerous interferences with other equipment located in its vicinity. If
the instrument does cause harmful interferences with other devices (which
can be determined by turning equipment off and on), the user is encouraged
to try to correct the interference by one or more of the following methods:
-Reorient or relocate the other devices.
-Increase the distance between the devices themselves.
-Connect the unit to a different power outlet other than that to which other
devices are connected.
-Consult your dealer or authorized Optikon 2000 SpA technical service.

Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 3-2 2016-12-28 Rev.B
•Keratron™ Nova has been developed and optimized for the human eye
measurement. The use and evaluation of Keratron™ Nova in conditions not
specified in this manual, or performed using surfaces that have a reflectivity or
a different shape from those typical of the human eye (for example: contact
lenses , surfaces with discontinuity in tangent or concavity in any of its section
profiles, or surfaces such as to create multiple reflections or disappearance of
some mires) can not guarantee the same degree of accuracy and are
therefore strongly advised against.
•When used as a corneal topographer, situations may occur which cause an
overlap of mires in the human eye in limited areas. This must be prevented by
ensuring good lacrimation and acquisitions of suitable quality images (see
especially the chapters devoted to the acquisition of images of the eye and the
last page of this manual) and, if necessary, proceed with correction using
appropriately the “Process editing” revision functions” . Thus, it is possible to
adjust the mire detection parameters, or at the end discard the artefacts. In
any case, the operator must ensure that every single reconstruction of the
mire is adequate before accepting as valid the data coming from the
topography.
•The Keratron™ Nova topographer does not provide diagnosis. The
operator should not rely solely on the parameters of the measure of the
cornea curvature by the instrument, but refer his own experience and
qualifications for the correct interpretation of the results.
•In this manual as decimal separator character the "." (Period) instead of the
character "," (comma) was adopted in order to maintain consistency with the
figures and messages of software that adopt the Anglo-Saxon notation.
•“ATTENTION: Do not modify this equipment without the manufacturer's
permission”.