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OPTIKON KERATRON SCOUT Installation And Operating Manual

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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 +39 06 8888355 - Fax +39 06 8888440
e-mail
sales@optikon.com
-
www.optikon.com

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  • Page 1 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 +39 06 8888355 - Fax +39 06 8888440 e-mail sales@optikon.com www.optikon.com...
  • Page 2 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.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS Page DISCLAIMER .............. 1-1 LIMITED WARRANTY CONDITIONS........2-1 WARNINGS ............... 3-1 GENERAL WARNINGS .................3-1 ENVIRONMENTAL WARNINGS ................3-2 ELECTRICAL WARNINGS ................3-2 MECHANICAL WARNINGS................3-4 SYMBOLS ..............4-1 GENERAL INFORMATION ..........5-1 SYSTEM DESCRIPTION ................5-1 TECHNICAL SPECIFICATIONS ................5-2 ELECTROMAGNETIC COMPATIBILITY TABLES .............5-6 5.3.1 ELECTROMAGNETIC EMISSIONS ..............5-6 5.3.2...
  • Page 4 7.1.3 VIDEOKERATOSCOPE PANEL ..............7-4 7.1.4 OR TROLLEY..................7-6 CALIBRATION ..................7-7 HOW TO ACQUIRE A GOOD IMAGE ..............7-8 7.3.1 SLIT LAMP CONFIGURATION ..............7-8 7.3.2 HANDHELD CONFIGURATION..............7-9 HOW TO PROCESS, PRINT AND SAVE IMAGES ........... 7-12 PUPILLOMETRY ..................7-13 CLEANING, STERILIZATION AND MAINTENANCE..... 8-1 CLEANING AND DISINFECTION ..............8-1 8.1.1 FOREHEAD REST AND MIRES CONE ..............8-1...

  • Page 5: Disclaimer

    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.
  • Page 6 ™ Keratron Scout Installation and operating manual OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK 2010-02-01 Rev.C cod. 161204EN...

  • Page 7: Limited Warranty Conditions

    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.
  • Page 8 ™ Keratron Scout Installation and operating manual OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK 2010-02-01 Rev.C cod. 161204EN...

  • Page 9: Warnings

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 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.

  • Page 10: Environmental Warnings

    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 •...
  • Page 11 ™ Keratron Scout Installation and operating manual OPTIKON 2000 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.

  • Page 12: Mechanical Warnings

    Keratron Scout Installation and operating manual OPTIKON 2000 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.
  • Page 13 • 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.
  • Page 14 ™ Keratron Scout Installation and operating manual OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK 2010-02-01 Rev.C cod. 161204EN...

  • Page 15: Symbols

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 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.
  • Page 16 ™ Keratron Scout Installation and operating manual OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK 2010-02-01 Rev.C cod. 161204EN...

  • Page 17: General Information

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 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...

  • Page 18: Technical Specifications

    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: ....
  • Page 19 ™ Keratron Scout Installation and operating manual OPTIKON 2000 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.
  • Page 20 ™ Keratron Scout Installation and operating manual OPTIKON 2000 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...
  • Page 21 ™ Keratron Scout Installation and operating manual OPTIKON 2000 Width:........... 250 mm Depth ........... 150 mm Weight.......... about 2200 g VIDEOKERATOSCOPE Height .......... 240 mm Width:........... 280 mm Depth ........... 100 mm Weight.......... about 1,000 g BATTERY MODULE Height ..........

  • Page 22: Electromagnetic Compatibility Tables

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 5.3 ELECTROMAGNETIC COMPATIBILITY TABLES 5.3.1 GUIDANCE MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Keratron Scout is intended for use in the electromagnetic environment ™ specified below. The customer or the user of the Keratron Scout should assure that ™...

  • Page 23: Electromagnetic Immunity

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 5.3.2 GUIDANCE MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY ™ The Keratron Scout unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Keratron ™...

  • Page 24: Recommended Separation Distances

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTES is the a.c. mains voltage prior to application of the test level Note1: At 80 MHz and 800 MHz, the higher frequency range applies.

  • Page 25: Light Emission

    950 nm (AEL = Admissible Emission Limit) 5.5 CIRCUIT DIAGRAMS Optikon 2000 S.p.A. will make available on request circuit diagrams, component pa lists, descriptions, calibration instructions, or other information which will assist the qualified technical personnel authori zed by Optikon 2000 S.p.A. to repair those parts of equipment which are repairable.

  • Page 26: Software Designer

    5.7 SOFTWARE DESIGNER The s ystem is controlled by the Keratron™ Scout software beginning from version 3.6. or questions regarding updates and reporting errors or corrections, please contact: Optikon 2000 S.p.A. Via del Casale di Sett ebagni, 13 00138 Rome 5.8 ACCESSORIES...

  • Page 27: Upgrade Kit

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 ™ 69201 Keratron Scout carrying case. For ™ eratron Scout and accessories. 63202 Base for VK with joystick and forehead rest, surface for XYZ movement, as an alternative the slit lamp.

  • Page 28: Not Supplied Accessories

    “double deck board” (Main Board with code 380260 and CPU Board with code 380280) with the Scout Board (380290). To know the production year call the local distributor or Optikon 2000 S.p.A. 5.10 NOT SUPPLIED ACCESSORIES OMPUTER minimal requirements Pentium IV (1.0 GHz) or superior...
  • Page 29 NOTES: ™ All parts added to the Keratron Scout system s uch as monitors and printers must be in compliance with standard EN 60601-1 or standard EN 60950 Refer to Electrical warnings (refer to section...

  • Page 30: Discontinued Article Codes

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 5.11 DISCONTINUED ARTICLE CODES MODULE CODE DESCRIPTION VIDEOKERATOSCOPE 161201 VK with memory expansion unit complete with ™ 28 mires cone, calibration sphere, "Keratron Scout " software and user manual. 161202 VK with memory expansion unit complete with ™...
  • Page 31 ™ Keratron Scout Installation and operating manual OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK 2010-02-01 Rev.C cod. 161204EN 5-15...

  • Page 32: Installation

    If the package or contents are damaged, notify the carrier (post office, railway or shipping agent) and Optikon 2000 as soon as possible. Check that the contents correspond to those indicated on the attached shipping documents.

  • Page 33: Installation Procedure

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 6.3 INSTALLATION PROCEDURE Before proceeding to install the Keratron™ Scout system, make sure that the mains voltage corresponds to the value selected on the voltage setter of the Docking Base or the operating room cart. The default setting set in the factory is for a mains voltage of 220 V.
  • Page 34 Keratron Scout Installation and operating manual OPTIKON 2000 3. Insert the VK in the slit lamp adapter (take care that it is properly inserted in its slot (not just leaned nor sideway) until the two sphere pins will eventually click.

  • Page 35: Portable" (Battery Operated) Configuration

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 figure 6-3: Slit Lamp configuration Docking Base cables connection 6.3.2 “PORTABLE” (BATTERY OPERATED) CONFIGURATION For this configuration, referring to figure 6-4: Handheld Configuration 1. Insert the Battery Module (11) under the VK and screw the white knob until the two parts do match tightly.

  • Page 36: Intra-Operatory Configuration

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 figure 6-4: Handheld Configuration It’s strongly suggested, after every move, to make a calibration, before the test. NOTES When the battery is almost out of charge, a red led will turn on the display panel, and a random be- beep will warn you that you still have a few minutes in order to download and save all the images, and to put it back to charge, too.
  • Page 37 Keratron Scout Installation and operating manual OPTIKON 2000 1. Caution always block the wheels under the basement of the OR Trolley Base (18). 2. Connect the PC to the base of the operating room cart by means of a USB cable.

  • Page 38: Software Installation

    The installation of the Keratron™ Scout software does not require special instructions as it is based on a system setup file on the provided CD-ROM or that can be downloaded via Internet from the Optikon 2000 S.p.A. website. The following precautions are recommended: 1.

  • Page 39: Identification Of The Software Version

    A printer has to be installed and set as default before running the software. 6.4.2 IDENTIFICATION OF THE SOFTWARE VERSION figure 6-6: Keratron Scout software Splash screen ™ The Keratron Scout software version in use can be identified in various ways: •...

  • Page 40: Keratron ™ Scout Software Installation

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 • by using Explorer to enter the folder c:\Keratron and using the right mouse button to select “Properties.” In the window that appears, select “Version” (Figure 6-7: Scout software version Figure 6-7: Scout software version ™...

  • Page 41: Importing Old Keratron Tests

    Keratron Scout Installation and operating manual OPTIKON 2000 • Using “Explore Resources” select the folder where the downloaded files are; • Run the “Setup.exe” by double-clicking on it. Independently if the installation has been made from CD or downloaded version, the setup procedure could notify some messages, like DLLs version conflicts etc.

  • Page 42: Keratron ™ Scout Software Structure

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 ™ 6.4.5 KERATRON SCOUT SOFTWARE STRUCTURE Default database folder Scout Trialsets folder (void after first installation ™ Keratron Scout system files Be careful to this folder!! Put here imported print-templates, and those you create new The SW puts here temporary files *.tb...

  • Page 43: Usb Drivers Installation

    USB drivers NOTE The USB driver provided by Optikon 2000 S.p.A. only supports the 32- bit version of the XP operating system. As the interface is a Plug & Play device the operating system will recognize it and will display the Dialog Box “Add New Hardware Wizard”.

  • Page 44: Configuring Keratron Scout Software

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 Figure 6-8 : Completing the driver installation The window shown in Figure 6-8 : Completing the driver installation confirms that the driver has been installed correctly. Complete by clicking the Finish button;...
  • Page 45 ™ Keratron Scout Installation and operating manual OPTIKON 2000 figure 6-9 Select the tab labeled “Print” and the dialog box will display as shown in Figure 6-10 Figure 6-10 Select in the Port Type frame the USB option then press OK.

  • Page 46: Uninstall Keratron Scout Software

    DLLs, click on the “Yes to all” button The second one calls directly a specific uninstall utility: 1. From Windows menu “Start” -> “Programs” -> “Keratron Scout”, choose “Uninstall Keratron Scout” item For both methods verify that these files has been really unloaded/deleted from the •...

  • Page 47: Description Of The Commands

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 7 DESCRIPTION OF THE COMMANDS 7.1 INTRODUCTION In this section only the basic operation are described. For a more comprehensive and updated description of the software functions, refer also to the HELP menu (command or key “?”...
  • Page 48 Keratron Scout Installation and operating manual OPTIKON 2000 fast charge by pressing the FAST CHARGE button (4) is not permitted unless you wait for the Battery Module to cool down or remove it temporarily. It is also possible to turn off the Docking Base and turn it back on.

  • Page 49: Docking Base Rear Panel

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 7.1.2 DOCKING BASE REAR PANEL figure 7-4 : Docking Base rear panel IEC power outlet. Connection to the power supply. Before powering the unit, check the voltage selected by the voltage setter (3) and compare it with the voltage used in the country in which the equipment is being used.

  • Page 50: Videokeratoscope Panel

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 7.1.3 VIDEOKERATOSCOPE PANEL Figure 7-5: Videokeratoscope control panel 1. [OD] and [OS] buttons: Selection of the right eye (OD) or the left eye (OS). When the videokeratoscope is on and in standby, these two LEDs flash alternately until one of them is pressed by the operator.
  • Page 51 6. [P,S,C] Reversed buttons. They were developed for intraoperatory use and can be used to control software functions such as Processing, Saving, or Deleting. Such assignments are governed by the Keratron Scout software in the menu under Instruments->Options->Process.

  • Page 52: Or Trolley

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 8. LCD display. A 2.5” monochromatic monitor on which it is possible to view the image of the patient’s eye in real time during the acquisition phase. 7.1.4 OR TROLLEY This paragraph is simply a brief overview of commands and signals of the rear panel of the operating room cart.

  • Page 53: Calibration

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 8. Supplementary outlet: this outlet is available to connect a laptop PC with a maximum load of 220 VA. Important: the outlet continues to be energized even when the base is turned off.

  • Page 54: How To Acquire A Good Image

    Keratron Scout Installation and operating manual OPTIKON 2000 • Press the OK button and wait that the image is transferred to the PC and accepted automatically. If the software cannot find the center automatically, then follow the instructions on the screen.

  • Page 55: Handheld Configuration

    Keratron Scout Installation and operating manual OPTIKON 2000 closer to the eye. The upper LEDS with arrows pointing downwards indicate that you should move back from the eye; if the arrow inverts its direction pointing upwards, the correct focusing has been exceeded. Correct focusing is reached when the central OK LED is on.
  • Page 56 Keratron Scout Installation and operating manual OPTIKON 2000 Nevertheless, after a short training, and with the following trick-and-tips, it is possible to learn to take quickly results having a repeatability as good as those that can be obtained with the Slit Lamp configuration.
  • Page 57 ™ Keratron Scout Installation and operating manual OPTIKON 2000 figure 7-7: Patient Operator position Figure 7-3: correct position Figure 7-4: incorrect position 2010-02-01 Rev.C cod. 161204EN 7-11...

  • Page 58: How To Process, Print And Save Images

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 It is very important that the patient keeps opens BOTH eyes OPENED WIDE to prevent the typical artifacts due to the presence of eyelashes (see the last page in this manual).

  • Page 59: Pupillometry

    Keratron Scout Installation and operating manual OPTIKON 2000 These keywords will be essential to find tests into selected groups, even when your database would become huge. To print the screen, simply choose from the “File” menu “Print Screen”. You can print while in Acquisition mode only if the “Transparent printing”...
  • Page 60 Keratron Scout Installation and operating manual OPTIKON 2000 figure 7-14: Accommodate both eyes to dark Then wait for at least 10-15 seconds in order to allow the pupil time to accommodate to its size to dark conditions. Then acquire the dilated-pupil picture as a normal capture.
  • Page 61 ™ Keratron Scout Installation and operating manual OPTIKON 2000 software Release . 3.6.0 or later, the chapters about “Pupil Editing” and “Pupillometry”. 2010-02-01 Rev.C cod. 161204EN 7-15...
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  • Page 63: Cleaning, Sterilization And Maintenance

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 8 CLEANING, STERILIZATION AND MAINTENANCE The medical personnel are responsible for keeping the instruments and equipment in the best operating conditions. The simple steps described below constitute a practical guideline for defining a suitable care and maintenance program.

  • Page 64: Cleaning The Accessories That Are Not Provided

    Periodically verify the good condition of the connection cables and the power cables. To maintain system safety, the compliance to EN60601-1 leakage current limits should be tested at least once a year. Please, inquire with the Bioengineering Department in your clinic or with your local Optikon 2000 S.p.A. Distributor/Service Center. ™...
  • Page 65 Scout is properly powered, proceed to use the unit. • If this is not the case, if the unit does not begin functioning, or the fuse burns out again, contact the authorized Optikon 2000 S.p.A. Technical Service Department. 2010-02-01 Rev.C...
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  • Page 67: Troubleshooting Guide

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 9 TROUBLESHOOTING GUIDE 9.1 SOFTWARE INSTALLATION ™ While the installation utility is coping Keratron Scout files in the PC hard disk the following message could appear: THE FILE YOU ARE COPYING IS OLDER THAN THE FILE PRESENT IN THE PC •...

  • Page 68: Sharing The Keratron™ Scout Among Several Operators

    • Create more databases. (recommended) • Create one folder for each user (using “Windows Explorer”). • Create one database for each folder (using “Keratron Scout” function, “File” -> “New Database”). • Every user will point to his database using “File->Open Database”, or from “File->Recent Database”...

  • Page 69: Miscellaneous Problems

    The following guide lists some malfunctions which may occur, the symptoms and the ™ corrective actions. If the Keratron Scout system remains inoperative even after performing the corrective actions indicated below, contact Optikon 2000 S.p.A. sales/service department.. SYMPTOMS CORRECTIVE ACTION A.C.
  • Page 70 ™ Keratron Scout Installation and operating manual OPTIKON 2000 SYMPTOMS CORRECTIVE ACTION d. Check the USB port settings in the motherboard’s BIOS, making sure that the USB port is enabled. The Scout software cannot find some file a. If possible, identify the missing or damaged file (for example, DLL, INI files..
  • Page 71 ™ Keratron Scout Installation and operating manual OPTIKON 2000 SYMPTOMS CORRECTIVE ACTION database and therefore it is automatically created by the program if it was not found. e. Import tests from the folder “C:\My Documents\Database_old” Solution B (if you are working in a LAN group) a.
  • Page 72 ™ Keratron Scout Installation and operating manual OPTIKON 2000 SYMPTOMS CORRECTIVE ACTION again. 2010-02-01 Rev.C cod. 161204EN...

  • Page 73: Index

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 10 INDEX Electrical warnings........3-2 Electromagnetic emissions......5-6 electromagnetic immunity......5-7 [P] button in pupillometry......7-13 EN 60601-1..........3-4 entrance pupil ..........5-2 environment ..........3-2 environmental specifications ....5-3 accuracy ............5-3 Environmental warnings ......
  • Page 74 ™ Keratron Scout Installation and operating manual OPTIKON 2000 meridians ............5-2 Mires cone ............5-3 Scout _far_ mires cone......5-10 Mires Cone ...........5-3 separation distances........5-8 Mixed (IR+visible) Pupillometry picture .7-14 Slit Lamp ............ 5-13 mobile multiple power outlets .......3-4 Slit Lamp Adapter ........6-1 Slit Lamp Adaptor ........

  • Page 75: Appendix

    ™ Keratron Scout Installation and operating manual OPTIKON 2000 11 APPENDIX Eyelash artifacts Shadow projected Cone by eyelashes Detector This map shows a high-energy zone Artifact!! Caution! Eyelashes fool the detector The eyelashes’ shadow High-energy zone crosses the horizontal line...

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