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”.

Keratron™ Nova Manual for installation and use
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Cod. 161601EN 3-3 2016-12-28 Rev.B
•The device contains a patient database and thus sensitive data. In the case in
which such device is not in a protected area and therefore accessible to the
authorized personnel only, access should be protected by a password as
shown in 7.2.3. The privacy option is disabled by default.
3.2 ENVIRONMENTAL PRECAUTIONS
•The environment in which the Keratron™ Nova system is installed and used
must comply with the safety requirements.
•Do not install the instrument near a heat source or expose it to direct sunlight
or other high temperature sources.
•The system should never be used near flammable anaesthetics , flammable
disinfectants, and other substances that can cause fires or explosions; the
device is not protected.
•Avoid the use of flammable anaesthetics, (N2O), (O2), unless they are
evacuated by means of a suitable gas extraction system.
The device inside has a lithium battery. Batteries must be disposed of
adequately. The lifespan of this battery is at least 5 years.
•Do not dispose of the Keratron™ Nova as unsorted municipal waste. Collect
separately in compliance with local laws/regulations regarding the disposal of
electrical and electronic equipment.
3.3 ELECTRICAL WARNINGS

Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 3-4 2016-12-28 Rev.B
The Keratron™ Nova, when mounted on a LAF, constitutes an electro medical
system. It is responsibility of the organization installing the system (in general the
hospital) or operator, to verify the whole system compliance with the IEC 60601-1.
Make sure, in particular, that the system leakage currents are less than the
maximum permissible value and adopt, if necessary, an isolation transformer.
Keratron™ Nova system operates in conjunction with a PC and its peripherals or
a router (or similar) via the Ethernet connection. The system (PC including
monitor and/or any peripherals) to be connected to the device must comply with
EN 60601-1.
•If the device is an apparatus connected to an appliance which one is not sure
of its compliance to EN 60601-1 one is exposed to:
under normal operating conditions, to the risk of an excessive leakage current
•towards the ground of the entire system due to the device leakage
current does not conform;
•in conditions of a single failure (interruption of the common protection
ground), to the risk of an excessive dispersion current of the casing in
consequence of the non-compliant device leakage current.
To avoid these risks, with a PC which does not comply with EN 60601-1 or
with a connection to a router, it is recommended to use an isolation
transformer set between the PC (including the monitor and any additional
peripherals) and the power socket on the wall.
The PC with the related devices and/or router must be positioned outside of the
patient area (at least 1.0 meters). In the patient area you may position only the
Keratron™ Nova topographer and the slit lamp or the movable base with the
Optikon joystick.
•Do not use multiple portable power outlets or extension cords to power the
apparatus.
•In a possible use in the operating room, if multiple devices are connected to
the patient, or these are interconnected, have qualified personnel evaluate

Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 3-5 2016-12-28 Rev.B
any risks for leakage currents or system connections coming to be created in
accordance with EN 60601- 1 and EN 60601-1-1.
•The operator must never touch the patient and parts outside the patient area
at the same time.
3.4 MECHANICAL PRECAUTIONS
•During measurement be careful not to hit the patient with the cone, when
you move Keratron™ Nova forward.
•Do not touch any of the optical surfaces. Cleaning or maintenance should be
performed by Optikon 2000 SpA authorized personnel .
•If the device suffers mechanical damage as a result of a collision or fall,
dangerous electrical parts may be uncovered; DO NOT touch the device and
remove the electrical supply by pulling the power plug before touching the
Keratron™ Nova.
•Plug in the pin in the slit lamp adaptor before tightening the knob. If you
insert the pin only
partially, tightening the knob, you are likely to deform it
permanently.
•During acquisition the handle must be used as an aid, while the device is
mounted on a slit lamp and should not be used as a handle for moving from
a slit lamp to a supporting table or vice versa.

Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 3-6 2016-12-28 Rev.B
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Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 4-1 2016-12-28 Rev.B
4 SYMBOLS
The table below shows the symbols used on Keratron™ Nova, and their meanings.
SYMBOLS AFFIXED ON THE UNIT
SYMBOL
DESCRIPTION
ALTERNATING CURRENT
DIRECT CURRENT
OFF (POWER)
ON (POWER)
APPLIANCE OF CLASS II
APPLIED PART TYPE BF
FOLLOW THE INSTRUCTIONS FOR USE

Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 4-2 2016-12-28 Rev.B
SYMBOL
DESCRIPTION
MANUFACTURER AND DATE OF MANUFACTURE
IDENTIFICATION CODE
SERIAL NUMBER
RECYCLING OF ELECTRICAL AND ELECTRONIC
EQUIPMENT
OPERATING INSTRUCTIONS
POLARITY OF THE POWER CONNECTOR
IN DIRECT CURRENT
LAN (CONNECTOR)
PEDAL (CONNECTOR)
USB (CONNECTOR)

Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 5-1 2016-12-28 Rev.B
5 GENERAL INFORMATION
5.1 SYSTEM DESCRIPTION
Figure 5-1: Keratron™ Nova

Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 5-2 2016-12-28 Rev.B
Keratron™ Nova system is a topographer designed to provide information on the
cornea, representing it with the chromatic maps characteristic of corneal topography:
of the axial powers, of the curves.
The device is designed to be fixed on the tonometer hole of the slit lamps most used
in the world or to the base with joystick (not supplied) of the Optikon (ref. 163202 and
following).
The main elements identified in Keratron™ Nova are shown in figure 5-1 and are:
1. Shell
2. TFT display 5.7” with touch-screen:
•allows the vision directly into the patient's eye, for a correct positioning
of the instrument during measurement
•it allows the operator to relay commands by touching the screen with a
special cursor pen and virtual buttons
•informs the operator, through a user-friendly interface, about the
machine status and any errors
3. Ignition switch
4. Handle to help with movement on the LAF
5. Mire cone
6. Push button
7. Hand wheel and fixing bolt on the slit lamp
5.1.1 THE TOPOGRAPHY IN THE KERATRON NOVA
The Keratron™ Nova is a corneal topographer designed to measure the shape of the
cornea and to represent it as a colour map of the axial powers, local curvature or
elevations in various formats.
Exporting the examination on the Scout software you can also see the representation
of the Gaussian map and a "ray tracing”, the corneal aberrometry is also calculated
and displayed, that is the main component of the wave front and its aberrations, due
to the interface cornea-air.
5.1.2 THE CONE BIVALENT MIRE AND TOPOGRAPHY
The mires cone of the Keratron™ Nova has 28 B/W and W/B alternated edges. In
this way the aims reflected on the cornea (figure 5-2: lower left) are the same as the
other Keratrons (28, in uniform step for the arc-step algorithm).

Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 5-3 2016-12-28 Rev.B
Figure 5-3: Topography
To determine when the eye is at the ideal distance from the cone, the Keratron™
Nova unit uses an evolved version of the EPCS (Eye Position Control System)
electronic circuit as in the other topographer products from Optikon 2000 SpA
The apex of the eye is intercepted by the photocells when it is located within a range
around the predetermined distance from the optical head. An indicator on the
monitor and a sound, alert the operator when the eye is too close or to far, and allow
to acquire an image only at the correct distance.
The adoption of a double pair of photocells on the outer edge of the optical head in
the Keratron™ Nova allows to choose between the near distance, for the maximum
peripheral coverage, and the one 3mm more distant, to reduce the invasiveness.
This choice can be made during the topographical acquisition from the touch-screen
(figure 7-19).

Keratron™ Nova Manual for installation and use
OPTIKON 2000
Cod. 161601EN 5-4 2016-12-28 Rev.B
The cone is backlit by a two wavelength LED matrix: the yellow-amber (λ = 590nm)
to capture the topographical images and the infrared (λ = 940nm), for the tracking of
the pupillary edge in scotopic conditions. Behind this matrix are the fixation LED,
focused at a great distance focus, and a camera.
This camera monitors and captures images of the eye n the two phases.
This way the operator is able to take pictures by pressing the button on the joystick
or the pedal, only when the patient's eye is on a preset distance, the same with
which the instrument was previously calibrated based on a sphere with a known
radius of curvature.
After taking the picture special algorithms ensure the reconstruction of the shape of
the cornea by analysing more than 7000 points arranged on the intersections
between 28 aim edges from black to white and white to black and 256 radial or
"meridians” .
The curve values are displayed on the screen in the form of colour maps.
The centre of the rings is the corneal apex, i.e. the point of the cornea closest to the
camera, as well as being an important reference point for all corneal maps.
Furthermore, once detected the input pupil in photopic conditions with the
subtraction of the light rings in the image, and in scotopic conditions activating and
acquiring one or more images with infrared pupillometry.
The bivalent cone is in any case replaceable through a standard cone depending on
the patient's request
5.1.3 MAIN CHARACTERISTICS
The Videokeratoscope Keratron™ Nova consists of a central unit built around an
embedded PC. The commands are sent via a touch-screen integrated in a 5.7” TFT
display. The user interface is intuitive to use and the controls are of more immediate
execution, as well as through the touch-screen, may be given with the button on the
joystick or pedal.
Besides processing, displaying and storing exams locally the communication through
an Ethernet cable with a generic external PC (not included) on which you have
installed the Keratron™ "Scout” software is provided for; in this software there will
be possible further functionality.
The exams stored locally can be exported to the USB pen drive supplied, so that
these may be imported to a PC on which the Scout software is installed, avoiding, if
desired, the Ethernet connection.