OPTIKON Keratron Piccolo User manual

Cod. 161301EN
2012-01-17 Rev.D
KERATRON™ PICCOLO
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 S.p.A. is an ISO 9001 and ISO 13485 certified company
that manufactures surgical and diagnostic devices for ophthalmology.
All Optikon 2000 products are manufactured in compliance with the
requirements of Directive 93/42/EEC on medical devices.

TABLE OF CONTENTS
Page
1DISCLAIMER .................................................................1-1
2LIMITED WARRANTY CONDITIONS........................................2-1
3WARNINGS ..................................................................3-1
4SYMBOLS ....................................................................4-1
5GENERAL INFORMATION...................................................5-1
5.1 SYSTEM DESCRIPTION ................................................................................5-1
5.2 TECHNICAL SPECIFICATIONS ........................................................................5-2
5.3 EMC TABLES ...........................................................................................5-5
5.3.1 ELECTROMAGNETIC EMISSIONS..................................................................5-5
5.3.2 ELECTROMAGNETIC IMMUNITY ..................................................................5-6
5.3.3 RECOMMENDED SEPARATION DISTANCES.......................................................5-7
5.4 CIRCUIT DIAGRAMS ...................................................................................5-8
5.5 COMPOSITION .........................................................................................5-8
5.6 ACCESSORIes that can be provided separately ..................................................5-8
5.7 NOT SUPPLIED ACCESSORIES........................................................................5-8
6INSTALLATION..............................................................6-1
6.1 INTRODUCTION........................................................................................6-1
6.2 UNPACKING AND INSPECTION.......................................................................6-1
6.3 INSTALLATION PROCEDURE .........................................................................6-1
6.3.1 Configuration ......................................................................................6-1
6.4 SOFTWARE INSTALLATION...........................................................................6-3
6.4.1 INTRODUCTION ....................................................................................6-3
6.4.2 DOWNLOAD THE SCOUT SOFTWARE FROM THE WEB.........................................6-4
6.4.3 SCOUT SOFTWARE INSTALLATION ..............................................................6-5
6.4.4 IMPORTING OLD KERATRON™ TESTS ...........................................................6-5
6.4.5 SCOUT SOFTWARE STRUCTURE..................................................................6-7
6.4.6 CUSTOMIZING THE SCOUT SOFTWARE .........................................................6-8
6.4.7 USB DRIVERS INSTALLATION .....................................................................6-8
6.4.8 CONFIGURING SCOUT SOFTWARE...............................................................6-9
6.4.9 UNINSTALL SCOUT SOFTWARE................................................................. 6-10
7COMMANDS AND SCREEN DESCRIPTION .................................7-1
7.1 INTRODUCTION........................................................................................7-1
7.2 CALIBRATION.......................................................................................7-2
7.3 HOW TO ACQUIRE A GOOD IMAGE .................................................................7-2
7.4 HOW TO PROCESS, PRINT AND SAVE IMAGES.....................................................7-6
8CLEANING, STERILIZATION AND MAINTENANCE........................8-1
8.1 CLEANING AND DISINFECTION ......................................................................8-1
8.2 STERILIZATION ........................................................................................8-1
9TROUBLESHOOTING GUIDE ...............................................9-1
9.1 SOFTWARE INSTALLATION...........................................................................9-1
9.2 THE SCOUT.INI FILE ..................................................................................9-1
9.3 SHARING KERATRON SCOUT WITH OTHERS.......................................................9-1
9.4 CHANGING THE PC ...................................................................................9-2
9.5 MISCELLANEOUS PROBLEMS.........................................................................9-3

10 INDEX....................................................................10-1
11 APPENDIX ...............................................................11-1

Keratron™Piccolo 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. 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 responsible for the safety, reliability and
performance only if:
•updates, calibrations and repairs are carried out by personnel which has been
authorised by OPTIKON 2000 S.p.A.;
•the system is used in compliance with the user instructions
•the mains electric installation to which the system is connected complies with
the IEC Safety Regulations.
IMPORTANT NOTICE:
Every effort has been made so that all the illustrations and information
precisely represent the product and its operation as they were at the time this
manual was printed. It is possible, however, that during the existence of this
manual modifications have been made in order to continue to effectively
satisfy the needs of the users. At times, such modifications are made without
advance notice.
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni 13
00138 Roma
Phone [phone]
Fax [phone]
e-mail [email protected]
www.optikon.com
NOTICE: The information contained in this manual is the exclusive property of
OPTIKON 2000 S.p.A. Partial or total reproduction of this manual is permitted only
upon written authorisation by OPTIKON 2000 S.p.A.
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2 LIMITED WARRANTY CONDITIONS
All the OPTIKON 2000 S.p.A. instruments and accessories sold and installed in the
European Union are guaranteed against manufacturing and material defects for
ONE YEAR from the invoicing date. Warranty on consumable material is limited to the
first use of the apparatus.
For the warranty conditions outside the European Union, contact your authorised
OPTIKON 2000 S.p.A. distributor.
All items covered by warranty will be repaired or replaced free of charge.
The warranty includes the research for the defect’s cause, repair of the failure and
final inspection of the unit or components
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 the event of an explicit request for work by OPTIKON 2000 SpA technicians, all
travelling and lodging expenses shall be charged to the customer.
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
General warnings
•The Keratron™ Piccolo has been developed and optimised to measure human
eyes. The use and the evaluation of the Keratron™ Piccolo 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.
Environmental issues
•Do not dispose of Keratron™ Piccolo as unsorted municipal waste. Collect it
separately according to the local laws/regulations on disposal of waste electrical
and electronic equipment.
Electrical warnings
•Caution when inserting/ de-inserting the Base-VK cable
To insert the cable:
oTurn the base off before plugging the cable to VK.
oCheck the connector orientation
oInsert perpendicularly.
oTighten the locking crown
To unplug
•Turn the instrument off before unplugging the cable to the VK.
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OPTIKON 2000
•Loosen the locking crown.
•Remove without teasing.
•Be careful to maintain conformity to Standard EN60601-1 when
connecting the PC to Keratron™ Piccolo.
Make the connection between the PC and Keratron™ Piccolo in such a manner
that the two devices’ leakage currents are the same. If the computer or monitor
are not equipment with Class II isolation (represented by the symbol )
according to Standard EN60950, or in conformity with Standard EN60601, the
following are the risks:
•Under normal operating conditions an excessive DISPERSION CURRENT of
the system towards the ground could occur due to dispersion current
towards the ground from the nonconforming device.
•In the case of a single breakdown (interruption of the common protective
ground) the DISPERSION CURRENT IN THE COVERING of the entire system can
become excessive due to the value of the dispersion current in the
covering of the nonconforming device.
Under these conditions it is advisable to adopt countermeasures in order to limit the
leakage currents in the case of a single breakdown.
Below are listed some precautions:
1. Do not use multiple power outlets or extension cords to power Keratron™
Piccolo and the PC. In fact, under these conditions, in the case of a single
breakdown, both the PC and Keratron™ Piccolo will be connected to the
ground in an inadequate manner or both will be isolated from the ground. In
this case, the overall leakage currents will be those of the PC.
2. Use an electrical isolation transformer.
Mechanical warnings
•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.
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Keratron™Piccolo Installation and operating manual
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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 Piccolo™ and 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)
WARNING!
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™ PICCOLO is a “Computer Assisted VideoKeratographer”
(also said CAVK in the literature) that, just like the KERATRON™ and the
KERATRON™ SCOUT, 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™ PICCOLO consists of:
•A Videokeratoscope (VK), for the acquisition of the image of mires reflected
on the eye;
•A Base (to be placed on a table) for powering the VK and the connection of a
control footswitch. Communication with a PC (not included) takes place
through a USB 2.0 port (Universal Serial Bus).
The monitoring operation during acquisition, by the operator, is performed by
observing the live image from the video camera on the PC’s screen. At the same
time the position of the eye’s apex is indicated by a signal from five virtual LEDs
located to the left of the live image.
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.
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 - phototransistor 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.
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.
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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 Roma - Italia
Model........................................... Keratron™ Piccolo
Regulatory conformity: ................ 93/42/EEC Directive on medical devices
Technical standards ................... EN 60601-1 ; EN 60601-1-1;
..................................................... EN 60601-1-2
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
BASE
Input voltage:............................... 90÷264 V AC
Frequency:................................... 50/60 Hz.
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Power consumption..................... 16 VA
Fuses:……………………………. 100/240 Vac 3.15A TH
KERATRON™ Piccolo
Input voltage................................ 10-11 Vdc supplied by the Base
Power consumption..................... 12 VA
ACCURACY:
Simulated K-Readings:................ Within +/- 0.25D on a normal cornea..
Focusing......................................BFS deviation with Slit Lamp Adapter typical within+/0.15D
Within +/- 0.25D handheld To be checked by the
“repeatability check” function.
Misalignement.............................. Mean deviation on the map: +/- 0.1 with misalignement
up to 1mm
EQUIPMENT CLASSIFICATION ACCORDING TO IEC 60601-1
Type of protection against electric shock :
Base............................................. Class I
Keratron™ Piccolo....................... Class IIa
Degree of protection against electric shocks:
Base............................................. Type B
Keratron™ Piccolo....................... Type BF
Degree of protection against harmful ingress of water:
Base............................................. Ordinary
Keratron™ Piccolo....................... Ordinary
Degree of safety of application in the presence of a flammable
anaesthetic mixture:..................... not protected
Mode of operation........................ continued
DIMENSIONS
BASE
Height .......................................... 60 mm
Width:........................................... 130 mm
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Keratron™Piccolo Installation and operating manual
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Depth........................................... 210 mm
Weight.......................................... about 1,000 g
KERATRON™ PICCOLO
Height .......................................... 250 mm
Width:........................................... 110 mm
Depth........................................... 160 mm
Weight.......................................... about 1,000 g
NOTES
The weight and dimensions indicated are approximate.
2) Specifications are subject to change without notice.
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Keratron™Piccolo Installation and operating manual
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5.3 EMC TABLES
5.3.1 GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC EMISSIONS
The Keratron™ Piccolo is intended for use in the electromagnetic environment
specified below. The customer or the user of the Keratron™ Piccolo should assure
that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment – Guidance
RF emissions
CISPR 11 Group 1
The Keratron™ Piccolo uses RF energy only for
its internal function.
Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11 Class B
Harmonic emissions
IEC 61000-3-2 N/A ( P <75W)
Voltage fluctuations/Flicker
emissions
IEC 61000-3-3 Complies
The Keratron™ Piccolo is suitable for use in all
establishments including domestic establishments
and those directly connected to the public low
voltage supply network that supplies buildings
used for domestic purposes.
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5.3.2 GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY
The Keratron™ Piccolo is intended for use in the electromagnetic environment
specified below. The customer or the user of the Keratron™ Piccolo should
assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic Environment - Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
•±6 kV contact
•±8 kV air
•±6 kV contact
•±8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%
Electrical/fast
transient/burst
IEC 61000-4-4
•±2 kV for power supply lines
•±1 kV for input/output lines
•±2 kV for power supply
lines
•±1 kV for input/output lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5 •±1 kV differential mode
•± 2kV common mode
•±1 kV differential mode Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
•<5% UT(>95% dip in UT) for
0.5 cycle
•40% UT(60% dip in UT) for 5
cycles
•70% UT(30% dip in UT) for
25 cycles
•<5% UT(>95% dip in UT) for
5 sec
•<5% UT(>95% dip in UT)
for 0.5 cycle
•40% UT(60% dip in UT) for
5 cycles
•70% UT(30% dip in UT) for
25 cycles
•<5% UT(>95% dip in UT)
for 5 sec
Mains power quality should be that of a
typical commercial or hospital environment. If
the user of the Keratron™ Piccolo requires
continued operation during power mains
interruptions, it is recommended that the
Keratron™ Piccolo be powered from an
uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m Not applicable.
The equipment does not
contain any magnetically
sensitive components.?
Power frequency magnetic field should be at
level characteristic of a typical location in a
typical commercial or hospital environment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3V/m
80 MHz to 2.5 GHz
3 Vrms
3V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Keratron™ Piccolo, including
cables, than the recommended separation
distance calculated from he equation
applicable to the frequency of the transmitter.
Recommended separation distance:
d= 1.2 √P
d= 1.2 √P 80MHz to 800 MHz
d= 2.3 √P 800MHz to 2.5 GHz
where P is the maximum output power rating
to the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a, should be less than the compliance level
in each frequency range. b
Interference may occur in the vicinity of
equipment marked with the following symbol:
A
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NOTE:
UTis the a.c. mains voltage prior to application of the test level
Note 1:At 80 MHz and 800 MHz, the higher frequency range applies.
Note2:These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To access the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength
in the location in which the Keratron™ Piccolo is used exceeds the applicable RF compliance
level above, the Keratron™ Piccolo should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or
relocating the Keratron™ Piccolo unit.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
5.3.3 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE
AND MOBILE RF COMMUNICATION EQUIPMENT AND KERATRON™
PICCOLO
Keratron™ Piccolo is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of Keratron™
Piccolo can help preventing electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters)
and Keratron™ Piccolo as recommended below, according to the maximum output
power of the communications equipment.
Separation distance according to frequency of transmitter
(m)
Rated maximum
output power of
transmitter (W) 150 kHz to 80 MHz
d= 1.2 √P 80 MHz to 800 MHz d= 1.2 √P
800 MHz to 2.5
GHz
d= 2.3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rates at maximum output power not listed above, the
recommended separation distance in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE:
Note 1-At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2-These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
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5.4 CIRCUIT DIAGRAMS
OPTIKON 2000 S.p.A. will make available on request wiring diagrams, component
part lists, descriptions, calibration instructions, and other information to assist the
user’s qualified technical personnel in making repairs to those parts of the equipment
that are repairable.
5.5 COMPOSITION
MODULE CODE DESCRIPTION
VIDEOKERATOSCOPE
WITH BASE 161103 VK unit complete with 28-mire cone, power supply Base, cable for connection to the
power supply, calibration sphere, multifunction
cable, footswitch, software, and user manual.
5.6 ACCESSORIES THAT CAN BE PROVIDED SEPARATELY
MODULE CODE DESCRIPTION
SCOUT “FAR” MIRES
CONE 162211 Mires cone for sunken eyes with calibration sphere.
KIT FOR ANALYSING
CONTACT LENSES 162216 Kit for measuring the front and back surfaces of rigid and semi-rigid (gas-permeable),
spherical, aspherical, toric, and axially
symmetric contact lenses.
5.7 NOT SUPPLIED ACCESSORIES
COMPUTER minimal requirements Pentium IV (1.7 GHz) or superior
RAM 512 Mbytes (absolute minimum,
expandable)
100 GBytes Hard Disk
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