OPTIKON KERATRON SCOUT User manual

Code 161204EN
2010-02-01 Rev.C
KERATRON™SCOUT
Videokeratoscope
INSTALLATION AND OPERATING MANUAL
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni, 13 - 00138 Rome, Italy
Phone [phone] - Fax [phone]
e-mail [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..............................................................................3-2
3.4 MECHANICAL WARNINGS.............................................................................3-4
4SYMBOLS .................................................................4-1
5GENERAL INFORMATION ...............................................5-1
5.1 SYSTEM DESCRIPTION ................................................................................5-1
5.2 TECHNICAL SPECIFICATIONS ........................................................................5-2
5.3 ELECTROMAGNETIC COMPATIBILITY TABLES .....................................................5-6
5.3.1 ELECTROMAGNETIC EMISSIONS..................................................................5-6
5.3.2 ELECTROMAGNETIC IMMUNITY ..................................................................5-7
5.3.3 RECOMMENDED SEPARATION DISTANCES.......................................................5-8
5.4 LIGHT EMISSION.......................................................................................5-9
5.5 CIRCUIT DIAGRAMS ...................................................................................5-9
5.6 COMPOSITION .........................................................................................5-9
5.7 SOFTWARE DESIGNER .............................................................................. 5-10
5.8 ACCESSORIES ........................................................................................ 5-10
5.9 UPGRADE KIT........................................................................................ 5-11
5.10 NOT SUPPLIED ACCESSORIES...................................................................... 5-12
5.11 DISCONTINUED ARTICLE CODES................................................................... 5-14
6INSTALLATION...........................................................6-1
6.1 INTRODUCTION........................................................................................6-1
6.2 UNPACKING AND INSPECTION.......................................................................6-1
6.3 INSTALLATION PROCEDURE .........................................................................6-1
6.3.1 SLIT LAMP CONFIGURATION .....................................................................6-1
6.3.2 “PORTABLE” (BATTERY OPERATED) CONFIGURATION.......................................6-3
6.3.3 INTRA-OPERATORY CONFIGURATION...........................................................6-4
6.4 SOFTWARE INSTALLATION...........................................................................6-6
6.4.1 INTRODUCTION ....................................................................................6-6
6.4.2 IDENTIFICATION OF THE SOFTWARE VERSION.................................................6-7
6.4.3 KERATRON™SCOUT SOFTWARE INSTALLATION ...............................................6-8
6.4.4 IMPORTING OLD KERATRON™TESTS ............................................................6-9
6.4.5 KERATRON™SCOUT SOFTWARE STRUCTURE................................................. 6-10
6.4.6 CUSTOMIZING THE KERATRON™SCOUT SOFTWARE......................................... 6-10
6.4.7 USB DRIVERS INSTALLATION ................................................................... 6-11
6.4.8 CONFIGURING KERATRON™SCOUT SOFTWARE.............................................. 6-12
6.4.9 UNINSTALL KERATRON™SCOUT SOFTWARE.................................................. 6-14
7DESCRIPTION OF THE COMMANDS ....................................7-1
7.1 INTRODUCTION........................................................................................7-1
7.1.1 DOCKING BASE FRONT PANEL ...................................................................7-1
7.1.2 DOCKING BASE REAR PANEL .....................................................................7-3

7.1.3 VIDEOKERATOSCOPE PANEL .....................................................................7-4
7.1.4 OR TROLLEY........................................................................................7-6
7.2 CALIBRATION..........................................................................................7-7
7.3 HOW TO ACQUIRE A GOOD IMAGE .................................................................7-8
7.3.1 SLIT LAMP CONFIGURATION .....................................................................7-8
7.3.2 HANDHELD CONFIGURATION.....................................................................7-9
7.4 HOW TO PROCESS, PRINT AND SAVE IMAGES................................................... 7-12
7.5 PUPILLOMETRY...................................................................................... 7-13
8CLEANING, STERILIZATION AND MAINTENANCE.....................8-1
8.1 CLEANING AND DISINFECTION ......................................................................8-1
8.1.1 FOREHEAD REST AND MIRES CONE..............................................................8-1
8.1.2 CLEANING THE ACCESSORIES THAT ARE NOT PROVIDED ....................................8-2
8.2 STERILIZATION ........................................................................................8-2
8.3 MAINTENANCE.........................................................................................8-2
9TROUBLESHOOTING GUIDE............................................9-1
9.1 SOFTWARE INSTALLATION...........................................................................9-1
9.2 THE File SCOUT.INI...................................................................................9-1
9.3 SHARING THE KERATRON™ SCOUT AMONG SEVERAL OPERATORS.............................9-2
9.4 CHANGING THE PC ...................................................................................9-2
9.5 MISCELLANEOUS PROBLEMS.........................................................................9-3
10 INDEX....................................................................10-1
11 APPENDIX ...............................................................11-1

Keratron™Scout 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
IMPORTANT NOTICE
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 [email protected]
www.optikon.com
NOTICE: 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. Warranty on consumable materials is
limited to the first use.
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.
In case of an expressly requested intervention of our technicians, all travel and hotel
expenses will be debited to the client.
OPTIKON 2000 S.p.A. is not liable for damages caused during transport. If this
occurs, the customer must immediately notify the carrier that handled the delivery.
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3 WARNINGS
3.1 GENERAL WARNINGS
• For the correct use of the Keratron™ Scout system, it is necessary to
completely read this manual. It must be used in compliance with the procedures
and instructions described herein.
• The Keratron™Scout system has been developed and optimised to measure
human eyes. The use and the evaluation of the Keratron™Scout 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
disappearance of some mire) cannot insure to have the same degree of
accuracy and thus it is strongly discouraged.
• Situations that create mires jamming can happen on 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 “Photo
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™ Scout system must be connected to the power supply only as
shown on the rear panel of the Docking Base or the operating room cart. 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:
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- 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.
3.2 ENVIRONMENTAL WARNINGS
• The environment in which the Keratron™ Scout 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.
Recycle the Ni-MH batteries or dispose properly
• Do not dispose of Keratron™Scout as unsorted municipal waste. Collect it
separately according to the local laws/regulations on disposal of waste electrical
and electronic equipment.
• 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.
3.3 ELECTRICAL WARNINGS
In order to reduce the risk of electric shock
• Do not remove the instrument's cover or any related accessories. Use qualified
technical personnel to perform maintenance and repairs to the instrument.
• Ni-MH batteries: Warning!
o The batteries inside this module can explode or leak if put on fire
• Do not open the Battery Module and do not short-circuit its electric contacts.
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o Do not wet or put into water. You could have electrical shocks or
hazard..
• Caution when inserting/ de-inserting the Docking Base-VK cable
To insert the cable:
o Turn the base off before plugging the cable to VK.
o Check the connector orientation.
o Insert perpendicularly.
o Tight the blocking screws.
To unplug:
• Turn the instrument off before unplugging the cable to the VK.
• Loose the blocking screws.
• Remove without teasing.
• The Keratron™ Scout 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 Docking Base is connected or, alternatively, to use an
isolation transformer between the PC and the wall power outlet.
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The PC and relative devices must be placed outside of the patient area (at least
1.0 meter from the SLA or from the operating room table). In the patient area
could be placed, in the configuration for SLA (refer to section 6.3.1), only the VK
and the Docking Base, while in the operating room configuration (refer to section
0), could be placed the VK and the operating room cart.
• In the case of the operating room cart, the supplementary power outlet must be
used only to power devices that are in compliance with standard EN 60601-1
(or class II according to standard EN60950). Furthermore, after inserting the
plug, proceed to attach it in a stable manner by screwing the Perspex plate into
position.
The risks that are encountered when equipment, whose compliance with EN
60601-1 is unknown, is connected to the trolley are:
• the EARTH LEAKAGE CURRENT of the equipment could lead to an
excessive EARTH LEAKAGE CURRENT of the system, in normal
condition;
• the ENCLOSURE LEAKAGE CURRENT of the equipment could lead to an
excessive ENCLOSURE LEAKAGE CURRENT of the system, in single
fault conditions (interruption of common protective earth conductor).
• Do not use mobile multiple power outlets or extension cords to power the
unit.
• 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
• Block the handle before removing the Videokeratoscope from the staff. The arm
of the OR trolley base is weight-balanced for an average weight of the Scout VK. .
Prior to remove the VK, you should block the spring mechanism within the arm by
the proper handle, or the staff can hurt your face
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• Insert the pin of the Slit Lamp Adaptor into the Slit Lamp hole before tightening
the hand-wheel. Tightening of the knob with the pin only partly inserted can
permanently deform it.
• When the instrument is powered by the Battery Module, tighten well the latter to
the videokeratoscope to prevent the Battery Module from accidentally falling on
the operator’s feet.
• If the instrument accidentally falls out of the operator’s hands, especially when
the device is in the configuration in which it is powered by the Docking Base, it is
advisable to turn off the instrument and report this situation to the Optikon 2000
S.p.A. Technical Service Department.
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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 symbols are used in the Keratron™Scout, the VK and Docking Base labels.
Before using the unit, familiarize yourself with the symbols and definitions provided in
the table. SYMBOLS PUBLISHED BY IEC
SYMBOL DESCRIPTION
ALTERNATING CURRENT
DIRECT CURRENT
PROTECTIVE EARTH (GROUND)
ATTENTION, CONSULT ACCOMPANYING DOCUMENTS
OFF (POWER DISCONNECTION FROM THE MAINS)
ON (POWER DISCONNECTION FROM THE MAINS)
TYPE B
PART APPLIED TO THE PATIENT (BODY)
TYPE BF
FLOATING PART APPLIED TO THE PATIENT (BODY-
FLOATING)
CLASS II EQUIPMENT II
DANGEROUS VOLTAGE
SEPARATED WASTE COLLECTION FOR ELECTRICAL/ELECTRONIC
EQUIPMENT
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5 GENERAL INFORMATION
5.1 SYSTEM DESCRIPTION
The Keratron™Scout unit is a Modular “Computer Assisted VideoKeratographer”
(also said CAVK in the literature) that, is designed to measure the shape of the
cornea and to represent it as symbolic colour map of the corresponding axial or
refractive powers, of its local curvatures or of its elevations in several formats
(corneal topography).
The KERATRON™SCOUT is made of:
• a Videokeratoscope (abbreviated VK), for the acquisition of the image of
mires reflected on the eye;
• either a table-top Docking Base or an OR Trolley base for intra-operative
use, to power supply the VK and to communicate via Universal Serial Bus
(USB) of any PC (not included) to the VK itself
• a selection of accessories, including a Slit Lamp Adapter and Cable, a
Battery Module, and an Head Rest.
These modules, with some additional accessories like a Scout “far” Mires Cone
and Sterile Sleeves, can create a system to allow to get a corneal topography in one
or more of the following operating conditions.
• On a generic Slit Lamp, with the Slit Lamp Adapter inserted into the hole for
accessories of the slit lamp itself and a supplied cable inserted between the
VK and the Docking base;
• Portable, with a battery module to be inserted below the VK and in the
Docking Base and a forehead rest mounted on the VK.
• Intra-operative, inserting the VK into a staff of the OR Troll base, with a weight
balanced arm, which both supports and power supply it
The VK carries 28 mires, which are shaped as back-lighted concentric rings,
alternatively 14 black and 14 whites, arranged into the internal conical surface of a
cone, made of transparent Perspex, called Mires Cone which is removable and
which carries a opto-electronic couple, made of an IRED and a photo-transistor, set
at two opposite sides of its external edge.
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The Cone is back illuminated by the Lamp Board which contains a tight array of
LEDS. Behind the Lamp Board there are the fixation led, focused at a large distance,
and the TV Camera.
The IRED - photoelectric couple at the edge of the optical head intercepts the eye
vertex when this is at the preset distance from the optical head. . An electronic circuit
(EPCS) eliminates the background light and measures the “degree of coverage”,
which is used to accept the acquisition only within a preset range. An array of 5
LEDS at the right hand side of the TV monitor of the VK, indicates the operator how
to move forth and back towards the eye.. If the eye is not at the right distance the
image capture will be inhibited.
The operator thus can only take images, by pressing a footswitch or the OK
pushbutton, 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.
During a test, 2 or 3 photos are usually taken on each eye, then they are processed
by algorithms to reconstruct the shape of the cornea at more than 7000 points
arranged at the crossways between the 28 black-to-white and white-to-black mire
borders and 256 radials or “meridians”.
Graphic routines then interpolates and traces this values in the form of color 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..
5.2 TECHNICAL SPECIFICATIONS
PARAMETER SPECIFICATIONS
Manufacturer:............................... OPTIKON 2000 S.p.A.
Via del Casale di Settebagni 13
00138 Rome - Italy
Model........................................... Keratron™Scout
Regulatory conformity: ................ 93/42/EEC Directive on medical devices
Technical standards: ................. EN 60601-1:1998; EN 60601-1-1:2000;
..................................................... EN 60601-1-2:2001+A1:2006;
..................................................... IEC 60825-1:1993+A1:1997+A2:2001;
..................................................... EN 60601-1-4:1997+A1:1999
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PARAMETER SPECIFICATIONS
ENVIRONMENTAL SPECIFICATIONS
Storage:....................................... temp. range between -10°C and +60°C
humidity 0-100% (cond.included)
atm. pressure 500 to 1060 hPa
Operating:.................................... temp. range between 0°C and +40°C
humidity 0-90% (non condensing)
atm. pressure 700 to 1060 hPa
ELECTRICAL SPECIFICATIONS
DOCKING BASE
Input voltage:............................... selectable at 100/120/220/230 Vac
Frequency:................................... 50/60 Hz.
Power consumption..................... 60 VA
Fuses:.......................................... 220/240 Volt: 1 A T
100/120 Volt: 2 A T
OR TROLLEY
Input voltage:............................... selectable at 100/120/220/230-240 Vac
Frequency:................................... 50/60 Hz.
Power consumption..................... 60 VA
Fuses:.......................................... 220/240 Volt: 2 A T
100/120 Volt: 4 A T
VIDEOKERATOSCOPE
Input voltage................................ 14-18 Vdc supplied by the Docking Base, by the Battery
or by the OR Trolley
Power consumption..................... 28 VA
ACCURACY:
Simulated K-Readings:................ Within ± 0.25D on a normal cornea..
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Focusing: .................................... BFS deviation: with Slit Lamp Adapter typical within±
0.15D
Within ± 0.25D handheld To be checked by the
“repeatability check” function.
Misalignment................................ Mean deviation on the map: ± 0.1 with misalignment up
to 1mm
EQUIPMENT CLASSIFICATION ACCORDING TO IEC 60601-1
Type of protection against electric shock :
Docking Base............................... Class I
OR Trolley.................................... Class I
Videokeratoscope........................ Class II
Degree of protection against electric shocks:
Docking Base............................... Type B
OR Trolley.................................... Type B
Videokeratoscope........................ Type BF
Degree of protection against harmful ingress of water:
Docking Base............................... IPX0.
OR Trolley.................................... IPX1
Videokeratoscope........................ IPX0.
Control footswitch........................ IPX1
OR Footswitch............................. IPX8
NOTE:
The switches located inside the footswitch are immersion-proof (protection class: IPX8). Therefore this
accessory is suitable for use in operating room environment .
Degree of safety of application in the presence of a flammable
anaesthetic mixture:..................... not protected
Mode of operation........................ continued
DIMENSIONS
DOCKING BASE
Height .......................................... 80 mm
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