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Keratron™

Installation and operating manual

OPTIKON 2000

Cod. 161501EN

5-7

2014-04-23

Rev.0

5.3 ELECTROMAGNETIC COMPATIBILITY TABLES

5.3.1 GUIDANCE AND MANUFACTURER'S DECLARATION

–

ELECTROMAGNETIC EMISSIONS

Il Keratron

™ intended for use in the electromagnetic environment specified below. The

customer or user of the Keratron

™

should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic Environment -

Guidance

RF emissions

CISPR 11

Group 1

The Keratron

™

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

The Keratron

™

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.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/Flicker
emissions

IEC 61000-3-3

Complies

Содержание 161501

Страница 1: ...0 KERATRON Videokeratoscope Aberrometer REF 161501 INSTALLATION AND OPERATING MANUAL OPTIKON 2000 S p A Via del Casale di Settebagni 13 00138 Rome Phone 39 06 8888410 Fax 39 06 8888440 E mail sales o...

Страница 2: ...A 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 Dev...

Страница 3: ...CIRCUIT DIAGRAMS 5 11 5 6 COMPOSITION 5 12 5 7 SOFTWARE DESIGNER 5 12 5 8 NOT SUPPLIED ACCESSORIES 5 13 6 INSTALLATION 6 1 6 1 INTRODUCTION 6 1 6 2 UNPACKING AND INSPECTION 6 1 6 3 INSTALLATION PROCE...

Страница 4: ...OOTING KERATRON SCOUT SOFTWARE 9 17 9 11 1 KERATRON SCOUT SOFTWARE INSTALLATION 9 17 9 11 2 THE FILE SCOUT INI 9 18 9 11 3 SHARING THE KERATRON SCOUT AMONG SEVERAL OPERATORS 9 18 9 11 4 CHANGING THE P...

Страница 5: ...ity 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 i...

Страница 6: ...Keratron Installation and operating manual OPTIKON 2000 Cod 161501EN 1 2 2014 04 23 Rev 0 THIS PAGE IS INTENTIONALLY BLANK...

Страница 7: ...rves 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 als...

Страница 8: ...Keratron Installation and operating manual OPTIKON 2000 Cod 161501EN 2 2 2014 04 23 Rev 0 THIS PAGE IS INTENTIONALLY BLANK...

Страница 9: ...ent 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...

Страница 10: ...use his her own experience and qualifications to correctly interpret the results In this manual the point character has been adopted in place of the comma character as the decimal separator to maintai...

Страница 11: ...isk of an excessive dispersion current in the covering resulting from the dispersion current from the noncompliant device To avoid these risks with a PC not compliant with EN 60601 1 we advise using a...

Страница 12: ...2014 04 23 Rev 0 3 4 MECHANICAL WARNINGS Be careful not to hit the patient with the cone during measurements when moving the Keratron forward Do not touch any of the optical surfaces Cleaning or main...

Страница 13: ...o or more symbols are combined together in order to obtain special meanings These are the symbols used on the Keratron Before beginning to use the units familiarize yourself with the symbols and the d...

Страница 14: ...Keratron Installation and operating manual OPTIKON 2000 Cod 161501EN 4 2 2014 04 23 Rev 0 THIS PAGE IS INTENTIONALLY BLANK...

Страница 15: ...orneal aberrometry and to provide information on the optical aberrations of the ocular or total wave front The main identifiable elements in the Keratron are shown in Figure 5 1 They are 1 Power switc...

Страница 16: ...tic map of the axial powers of the local or Gaussian curvatures or of the elevations in various formats From a ray tracing calculation on this shape the corneal aberrometry is calculated and represent...

Страница 17: ...y The adoption of a double pair of photocells on the outside of the optical head in the Keratron enables selection between the near distance for the maximum peripheral coverage and that 3mm further aw...

Страница 18: ...the point of the cornea nearest to the video camera as well as being an important reference point for all the corneal maps The entrance pupil is also detected in photopic conditions by the removal of...

Страница 19: ...l 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 ENVIRONMENTAL SPECIFICATIONS Storage temp range between 10 C and 60 C...

Страница 20: ...EQUIPMENT CLASSIFICATION ACCORDING TO IEC 60601 1 Type of protection against electric shock Class I Degree of protection against electric shocks Type B Degree of protection against ingress of water I...

Страница 21: ...liance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The Keratron uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause...

Страница 22: ...r 0 5 cycles 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...

Страница 23: ...cellular cordless and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed...

Страница 24: ...um output power of transmitter W Separation distance according to frequency of transmitter m 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...

Страница 25: ...n the maximum power emitted is less than the values indicated in the table below Operating condition Wavelength peak Power emitted Pmeas Topography 591 nm 1mW 940 nm 1mW IR pupillometry 940 nm 1mW 5 5...

Страница 26: ...include support surface screws to be tightened with the appropriate wrenches chin rest plastic touch pen wheel cover user manual sphere calibration sphere and target power cable and crossed LAN cable...

Страница 27: ...nfiguration In any case Optikon 2000 S p A advises using PCs powered with mains power of 100 240 V 50 60 Hz with minimum absorption of 1 8 Amp Compliance with standard EN 60601 1 or compliant with EN...

Страница 28: ...1EN 5 14 2014 04 23 Rev 0 TRADEMARKS Windows 2000 Windows XP Windows Vista Windows 7 and Windows 8 are registered trademarks of Microsoft Corporation Access is a registered trademark of Microsoft Corp...

Страница 29: ...Keratron Installation and operating manual OPTIKON 2000 Cod 161501EN 5 15 2014 04 23 Rev 0 THIS PAGE IS INTENTIONALLY BLANK...

Страница 30: ...Keratron 6 2 UNPACKING AND INSPECTION The unit has been packed to reduce the risk of damage during shipping to a minimum Open the package and examine the components When opening the package handle all...

Страница 31: ...g the front cover Starting from the left side it is possible to use the label Figure 6 2 to identify the socket for the LAN connection the socket for the power supply cable and a socket for the USB co...

Страница 32: ...ood practice to use a network PC monitor and related accessories with class II insulation in accordance with standard EN60950 represented by symbol or that are in conformity with standard EN 60601 1 o...

Страница 33: ...Keratron Installation and operating manual OPTIKON 2000 Cod 161501EN 6 4 2014 04 23 Rev 0 THIS PAGE IS INTENTIONALLY BLANK...

Страница 34: ...l screen It shows in an intuitive manner not only all of the instrument s measurement functions but also the configuration and accessories functions Settings and the topography calibration functions C...

Страница 35: ...sk calibration target shown in Figure 7 2 and calibration sphere Figure 7 3 are necessary for this operation Figure 7 2 Calibration target Figure 7 3 Calibration sphere The entry screen requires that...

Страница 36: ...message shown in Figure 7 5 Figure 7 5 Warning message if the measurement with the calibration target was not successful Otherwise the message in Figure 7 6 requires the removal of the target and the...

Страница 37: ...teps will be presented as an example When Start is pressed the monitor will appear as shown in Figure 7 7 the screen shows the live image from the video camera 1 and the relative position of the photo...

Страница 38: ...that it is clean pressing Yes will cause the software to trace the 28 mires and the screen will appear as shown in Figure 7 9 where the operator must verify that the reconstruction of the rings at th...

Страница 39: ...ou turn on the Keratron However it is indispensable to perform the calibration after the instrument has been installed or any time it is moved or cleaned 7 2 SETTINGS Selecting on touchscreen function...

Страница 40: ...1 In the General Figure 7 12 folder the appropriate cursors can be used to modify the volume of the system s loudspeaker Audio Volume Control the intensity of the LCD s backlighting Backlight LCD and...

Страница 41: ...how to configure the external PC in the first case or change the local settings in the second case refer to sections 9 4 or 9 5 Figure 7 13 Configuration for the connection to a PC by means of Ethern...

Страница 42: ...meaning of the messages and controls is the same in all languages 7 3 CORNEAL TOPOGRAPHY TOPOGRAPHY If the unit has not been previously calibrated refer to Calibration in section 7 1 pressing Topograp...

Страница 43: ...s with arrows pointing down indicates moving away from the eye if the arrow changes direction and points up this means that the exact focus point has been passed When the OK indication lights up this...

Страница 44: ...oid eyelash effects refer to the last page of the manual If the patient blinks discard the photograph using Discard 7 and repeat the operation NOTE Be careful not to hit the patient with the cone when...

Страница 45: ...PC by pressing Accept 6 even without having processed it This same action can be taken by pressing the button on the joystick If the PC is connected begin the data transfer as shown in Figure 7 18 if...

Страница 46: ...1 in Figure 7 20 that takes into account the number of locally memorized images and also a button Accept 2 in Figure 7 20 to be pressed at the end of the test to send the entire sequence of images to...

Страница 47: ...eight Height of the point shown by the pointer that can be easily placed on the curvature map Also present are the Sim K with the maximum red and minimum blue curvature axes and the astigmatism Diff t...

Страница 48: ...Keratron Installation and operating manual OPTIKON 2000 Cod 161501EN 7 15 2014 04 23 Rev 0 THIS PAGE IS INTENTIONALLY BLANK...

Страница 49: ...essage Significance Action Keratron does not turn on The unit is not correctly powered the power cable is not connected or the mains fuse has burned out Check the power cable Replace the fuse see sect...

Страница 50: ...Keratron Installation and operating manual OPTIKON 2000 Cod 161501EN 8 2 2014 04 23 Rev 0 THIS PAGE IS INTENTIONALLY BLANK...

Страница 51: ...4x768 pixels 3 Do not alter any of the system files installed by the Keratron Scout Setup software nor any file in the Database unless you have a specific competence on the PC and LAN management If su...

Страница 52: ...ted write your Username and Password then click OK button Create an empty folder on your Hard Disk e g C ScoutSW Right click on the hyperlink Setup exe choose Save Target As when prompted and save it...

Страница 53: ...ate with the Keratron using the crossed Ethernet cable directly connected to the unit it is necessary to correctly configure the network connection on the external PC on which Keratron Scout is runnin...

Страница 54: ...of a network connection In the General folder at point 1 select Internet Protocol TCP IP and press button Properties 2 Figure 9 2 Network card protocols In the new window Figure 9 3 it is possible to...

Страница 55: ...g specific rules and not randomly The configuration should be changed under the supervision of a network administrator 9 4 2 CONFIGURATION OF THE PC IN WINDOWS VISTA AND WINDOWS 7 In the case of Vista...

Страница 56: ...ection center Figure 9 5 shows the connection status of the selected network Figure 9 5 Connection status of the selected network Pressing the Properties button 1 allows you to access the protocols wi...

Страница 57: ...elect 1 Use the following IP address and enter the numbers shown in the Figure 2 and 3 Figure 9 7 Configuration of the TCP IP protocol in Windows Vista Windows 7 NOTE The configuration shown in Figure...

Страница 58: ...o exchange data with Keratron Scout If a direct Ethernet connection is used this address is the one set on the PC as specified in sections 9 4 1 and 9 4 2 If it is necessary to change the PC IP addres...

Страница 59: ...resses DHCP and a static one 9 5 1 AUTOMATIC CONFIGURATION OF THE ADDRESS DHCP If Keratron is connected to a network where addresses are changed dynamically it is possible to follow the procedure show...

Страница 60: ...rk using a static IP address following the procedure shown in Figure 9 11 The configuration fields IP Address Subnet Mask Gateway must be completed using the touchscreen The values that have to be ent...

Страница 61: ...have default values Therefore it is advisable to set the required values for all parameters The existence of the network flow can be checked using field Status Figure 9 12 Setting the subnet mask The...

Страница 62: ...8 9 5 3 INSTALLATION OF THE WI FI CONNECTION Keratron can be connected using a wireless device connected to the USB port behind the door shown in Figure 6 1 to the local network that uses address auto...

Страница 63: ...rted print templates and those you create new The SW puts here temporary files tb Toolbar settings Scout ini Software settings cnt Help contents files hlp Localized help files ScoutTSE exe Trial set e...

Страница 64: ...it 9 8 IDENTIFICATION OF THE SCOUT SOFTWARE VERSION Figure 9 13 Splash screen of Keratron Scout The Keratron Scout software version in use can be identified in several ways By means of the splash scre...

Страница 65: ...3 Select the Keratron Scout item 4 Click on the Add Remove button 5 Follow the instructions if the uninstall procedure asks you to remove some DLLs click on the Yes to all button The second one calls...

Страница 66: ...ity Check until a satisfactory result is obtained As a standard procedure it is advisable to take 3 4 photographs per eye to check repeatability and to save the best one or the best two 9 10 3 HOW TO...

Страница 67: ...Patient Form 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 pr...

Страница 68: ...mm and retry 9 11 3 SHARING THE KERATRON SCOUT AMONG SEVERAL OPERATORS If more than one user performs tests with Keratron Scout how can I separate tests to avoid confusion There are two ways to procee...

Страница 69: ...toolbar settings Change the PC Reinstall the Keratron Scout software Reinstall the trial sets Restore the database s from network cd rom Restore the Scout ini into the C Keratron fol der Restore the...

Страница 70: ...me the folder of the database in use the selected database is indicated on the bar at the top of the Scout desktop e g from C My Documents Database in C My Documents Database_old c Launch Scout progra...

Страница 71: ...ion prior Access database version No test is visible in the database explorer a An empty database has been selected b Check whether the Group selection has been pressed and no Group is present in the...

Страница 72: ...into the PC Using the Keratron Scout software it is possible to proceed with the manual updating by means of the command Tools Make Keratron Onda Keratron key Figure 9 15 Make Keratron key Press Writ...

Страница 73: ...oftware version If you would like to restore it you just need to insert the UBS flash drive and select Restore previous version when the window shown in Figure 9 17 opens NOTE At the time of each conn...

Страница 74: ...e patient places his or her chin on the chin rest during the measurement Before the exam sterile and or biocompatible disposable paper tissues must be placed on the chin rest and on the forehead rest...

Страница 75: ...here and compare the curvature value you obtain with the value listed on the sphere itself If the difference between the two values is greater than 0 3 D it is advisable to recalibrate the instrument...

Страница 76: ...eed 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 10 3 2 REPLACING T...

Страница 77: ...Keratron Installation and operating manual OPTIKON 2000 Cod 161501EN 10 4 2014 04 23 Rev 0 THIS PAGE IS INTENTIONALLY BLANK...

Страница 78: ...9 21 database 9 20 9 21 9 21 Default addresses 9 10 Default Map Type 9 17 Default settings 9 21 DHCP 9 9 diagnosis 3 2 Dimensions 5 6 disinfectants 3 2 disposal of waste electrical and electronic equ...

Страница 79: ...Process Editing 3 2 Processing 9 16 Pupil 7 14 R Radius 7 14 reflections 3 1 reflectivity 3 1 Remote Computer 7 8 Remote Host Computer 9 8 9 9 Repeatability Check 9 16 Restore previous version 9 23 S...

Страница 80: ...ed by eyelashes Caution The eyelashes shadow crosses the horizontal line The eyelashes shadow is below the horizontal line This map shows a high energy zone High energy zone Eyelash artifacts Suggesti...

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