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.
Cod. 161301EN 1-1 2012-01-17 Rev.D

Keratron™Piccolo Installation and operating manual
OPTIKON 2000
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Cod. 161301EN 1-2 2012-01-17 Rev.D

Keratron™Piccolo Installation and operating manual
OPTIKON 2000
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.
Cod. 161301EN 2-1 2012-01-17 Rev.D

Keratron™Piccolo Installation and operating manual
OPTIKON 2000
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Cod. 161301EN 2-2 2012-01-17 Rev.D

Keratron™Piccolo Installation and operating manual
OPTIKON 2000
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.
Cod. 161301EN 3-1 2012-01-17 Rev.D

Keratron™Piccolo Installation and operating manual
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.
Cod. 161301EN 3-2 2012-01-17 Rev.D