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Keratron

™

Onda Installation and operating manual

OPTIKON 2000

Cod. 161401EN

5-7

2015-03-27

Rev.C

5.2

TECHNICAL SPECIFICATIONS

PARAMETER

SPECIFICATIONS

Manufacturer: .............................

OPTIKON 2000 S.p.A.

Via del Casale di Settebagni, 13

00138 Rome - Italy

Model: .........................................

Keratron

™

Onda

Regulatory conformity: ...............

Directive on medical devices 93/42/EEC

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

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 10°C and +40°C

...................................................

humidity 30-75% (non condensing)

...................................................

atm. pressure 700 to 1060 hPa

ELECTRICAL SPECIFICATIONS

KERATRON

™

ONDA

Input voltage: ..............................

between 100 and 240 Volts AC

Frequency: ..................................

50/60 Hz.

Power consumption ....................

70 VA

Fuses: .........................................

2 x T 3.15 AH ( 5 x 20 mm)

TOPOGRAPHY PRECISION

Simulated K-Readings: ...............

Within ± 0.25D on a normal cornea.

Distance error .............................

BFS deviation: with Slit Lamp Adapter typical within
±0.15D

Misalignement............................. Mean deviation on the map: ± 0.1 with misalignement up

to 1 mm °C

Содержание KERATRON ONDA

Страница 1: ...Rev C KERATRON ONDA Videokeratoscope Aberrometer 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 opti...

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: ...nufacturer s declaration Electromagnetic immunity 5 10 5 3 3 Recommended separation distances between portable and mobile RF communication equipment and the Keratron Onda unit 5 12 5 4 Light emission...

Страница 4: ...ware 9 13 9 8 Identification of the Scout software version 9 13 9 9 Uninstall Keratron Scout Software 9 14 9 10 Description of the commands and screens of the Keratron Scout Software 9 15 9 10 1 Intro...

Страница 5: ......

Страница 6: ...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 el...

Страница 7: ...Keratron Onda Installation and operating manual OPTIKON 2000 Cod 161401EN 1 2 2015 03 27 Rev C THIS PAGE IS INTENTIONALLY BLANK...

Страница 8: ...serves 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 a...

Страница 9: ...Keratron Onda Installation and operating manual OPTIKON 2000 Cod 161401EN 2 2 2015 03 27 Rev C THIS PAGE IS INTENTIONALLY BLANK...

Страница 10: ...ions 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...

Страница 11: ...y measuring the spherical aberration of the eye being tested the accuracy of the aberrometric measurement when in doubt about the precision of the results The Keratron Onda topo aberrometer does not p...

Страница 12: ...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 ris...

Страница 13: ...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 pati...

Страница 14: ...o or more symbols are combined together in order to obtain special meanings These are the symbols used on the Keratron Onda Before beginning to use the units familiarize yourself with the symbols and...

Страница 15: ...Keratron Onda Installation and operating manual OPTIKON 2000 Cod 161401EN 4 2 2015 03 27 Rev C THIS PAGE IS INTENTIONALLY BLANK...

Страница 16: ...typical of corneal topography axial powers curvatures and corneal aberrometry and to provide information on the optical aberrations of the ocular or total wave front The main identifiable elements in...

Страница 17: ...conducting the topography and the aberrometry are not the same A good reflection topography requires uniform mires and especially for those at the center of the cone or Placido disk a very small and...

Страница 18: ...a precision of a tenth of a diopter within a range OK of only 0 05mm Within this range the image is accepted Topo aberrometric acquisitions require more time therefore the eye may have greater moveme...

Страница 19: ...thms reconstruct the shape of the cornea by analyzing more than 7000 points located on the intersection between the 28 mires edges from black to white and from white to black and the 256 radials or me...

Страница 20: ...classical method of the centroids the deviation of these points from the ideal position gives us the measurement of the X and Y gradients of the wave front From the gradients the wave front itself can...

Страница 21: ...central unit built around an touch screen built into a 7 LCD display The user interface is intuitive and in addition to being entered by means of touch screen the commands of most immediate execution...

Страница 22: ...601 1 4 1997 A1 1999 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 10 C and 40 C humidity...

Страница 23: ...ative response from 1D to 4D in addition to the defocus Zernike polynomials 7th order Precision sphere 0 25 D cylinder 0 12 D EQUIPMENT CLASSIFICATION ACCORDING TO IEC 60601 1 Type of protection again...

Страница 24: ...Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The Keratron Onda uses RF energy only for its internal function Therefore its RF emissions are very low and are not likel...

Страница 25: ...or 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 use...

Страница 26: ...ular 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 RF...

Страница 27: ...ated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P da 80 MHz to 800 MHz d 1 2 P da 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0...

Страница 28: ...n the maximum power emitted is less than the values indicated in the table below Operating condition Wavelength peak Power emitted Pmeas Topography 738 nm 1mW 591 nm 1mW Topo Aberrometry 738 nm 1mW 85...

Страница 29: ...essories 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 L...

Страница 30: ...V 50 60 Hz with minimum absorption of 1 8 Amp Compliance with standard EN 60601 1 or compliant with EN 60950 class II refer to electrical warnings section 3 3 Printer Color Graphic Monitor Minimum re...

Страница 31: ...Keratron Onda Installation and operating manual OPTIKON 2000 Cod 161401EN 5 16 2015 03 27 Rev C THIS PAGE IS INTENTIONALLY BLANK...

Страница 32: ...r Keratron Onda 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 han...

Страница 33: ...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 connection or optional Wi Fi key Figure 6 2 Connector housing label The ca...

Страница 34: ...ss II insulation in accordance with standard EN60950 represented by symbol or that are in conformity with standard EN 60601 1 otherwise connect the PC to a power outlet that is separate from the one t...

Страница 35: ...Keratron Onda Installation and operating manual OPTIKON 2000 Cod 161401EN 6 4 2015 03 27 Rev C THIS PAGE IS INTENTIONALLY BLANK...

Страница 36: ...tuitive manner not only all of the instrument s measurement functions but also the configuration and accessories functions Settings and the topography calibration functions Calibration The touch scree...

Страница 37: ...tically after approx 5 seconds Figure 7 3 Figure 7 3 Repetition of the Motor Diagnosis test was successful If instead conditions exist that cause the test to indicate some problem the message will be...

Страница 38: ...the positioning of the motor 7 2 TOPOGRAPHY CALIBRATION CALIBRATION Selecting Calibration on the touchscreen Calibration accesses the section regarding the calibration of the instrument for topograph...

Страница 39: ...that are free of obstacles If the operator presses the Abort key the Keratron Onda returns to the initial screen exiting calibration Figure 7 7 Request for positioning the calibration target in front...

Страница 40: ...f the operator presses the Start key the calibration proceeds through 6 steps the first 3 are the acquisition of the calibration sphere by means of the pair of Near photoelectric cells and the subsequ...

Страница 41: ...the six steps the operator is requested to confirm whether the acquired sphere appears clean and free of dust grains refer to Figure 7 12 Figure 7 12 Check that the calibration sphere is clean If the...

Страница 42: ...the middle OK arrow 3 in Figure 7 11 lights up in a stable manner and THEN press the button to acquire the image Avoid reaching the OK position with the button already pushed down IMPORTANT It is goo...

Страница 43: ...ptikon 2000 S p A can be consulted as the software designer of all of these applications Figure 7 15 Information on the About folder After making any changes the options can be confirmed by pressing t...

Страница 44: ...s are completed successfully the message shown in Figure 7 17 will appear on the screen Figure 7 17 The motors test procedure has been completed successfully The operator can end the operation by pres...

Страница 45: ...on on 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 19 Configuration for the connection to a PC by means of E...

Страница 46: ...and the starting mode for the topo aberrometric acquisitions with Auto RX and or Fogging see Section 7 6 We recommend keeping as default Auto RX and Auto RX turn off active The latter option prevents...

Страница 47: ...Localization Figure 7 22 you can set the language of the Keratron Onda software by choosing one of the available languages Figure 7 22 Selection of the language in the Localization folder NOTE In thi...

Страница 48: ...pear as shown in Figure 7 23 NOTE To stop it at any time you simply need to press Abort in the upper left hand corner The screen in Figure 7 23 shows the live image of the patient s eye 1 In the lower...

Страница 49: ...d press the button within a few seconds so as to avoid breaking the lacrimal film and to avoid eyelash effects refer to the last page of the manual If the patient blinks discard the photograph using D...

Страница 50: ...ing Curvature 4 or Axial 5 respectively Figure 7 24 Reconstruction of the rings on an acquired image After acquiring the image it is possible to send it to the external PC by pressing Accept 6 even wi...

Страница 51: ...e operator can acquire up to 8 images in rapid succession transmitting them to the external PC with the button on the joystick itself or stop to process them locally and decide what to do with them la...

Страница 52: ...on the initial screen will cause you to access the combined aberrometry and topography function When entering topo aberrometry it is necessary to wait a few seconds for the recalibration of the motors...

Страница 53: ...to compensate for as well as possible any refractive error sphere equivalent that is defocus of the eye under examination or to initiate an automatic search of the refraction Auto RX In fact a high d...

Страница 54: ...e defocus automatic search that may require up to 4 steps if the Fogging button is enabled yellow Keratron Onda performs a progressive focus of the target both at closer and larger distance that conti...

Страница 55: ...34 Presence of corneal reflection 7 6 TOPO ABERROMETRY ACQUIRED IMAGE As soon as the topo aberrometry is acquired the screen shown in Figure 7 35 or Figure 7 37 will show three images The first to the...

Страница 56: ...topography as indicated by the arrows in Figure 7 36 Figure 7 36 Images are marked as as not being suitable for corneal topography processing In these cases to prevent artifacts it is advisable to di...

Страница 57: ...g on the buttons that are now enabled For example in Figure 7 38 pressing Curvature to the left shows the corneal topography curvature map with relative Sim K and the data of the photopic pupillometry...

Страница 58: ...cylinder and axis High Astigmatism groups together in the image all of the high orders plus the two coefficients representing astigmatism 2 2 c and 2 2 c All orders adds to the previous image also the...

Страница 59: ...lowest 1 The keratometric data Sim k the most curved meridian is red the flattest is blue and the corneal astigmatism Diff in diopters 2 The pupillar data Pupil mm the most curved meridian is red the...

Страница 60: ...phere is considerably incorrect from a myopic point of view it is very probable that the patient did not focus the target during acquisition In this case try asking the patient to stare or relax the g...

Страница 61: ...a longer amount of time it is possible to access the contextual menus that allow you to vary several parameters of the displayed processed images Figure 7 45 Contextual menu for selecting different s...

Страница 62: ...Figure 7 48 Figure 7 47 Contextual menu of the patient s refraction Rx choice of the distance of the vertex Figure 7 48 Contextual menu of the patient s refraction Rx choice of the resolution If the...

Страница 63: ...procedure used for topo aberrometry described in section 7 5 The controls and options displayed on the screen are the same The only difference lies in the fact that it is not necessary to select the p...

Страница 64: ...measured at a pupil size that can be selected using the methods described in section 7 6 Figure 7 43 and Figure 7 44 The right section of the screen shown in Figure 7 51 shows the map of the wave fron...

Страница 65: ...on can be used to perform a near accommodation in addition to those described in sections 7 5 and 7 7 for far distances that is at the maximum distance at which the eye being examined can presumably a...

Страница 66: ...n has been completed the upper section of the screen shown in Figure 7 53 displays Near 3D to remind the operator that the wavefront map Ocular WA and refraction Rx of the eye being tested OD OS have...

Страница 67: ...ION By selecting Accommodation in the initial screen shown in Figure 7 1 it is possible to run a test that repeatedly measures the eye s aberrometry starting from the remote point and at progressive n...

Страница 68: ...the patient has the time to accommodate without too much effort 5 Graphic X axis Fogging or Stimulus Fogging represents the target defocus referred to the remote point which is displayed in the Foggi...

Страница 69: ...the acquisition is complete a Preview of the aberrometric measurement displays Figure 7 57 These measurements are based on the central pupil area that measures 1 74 mm only In this screen it is possi...

Страница 70: ...the screen shown in Figure 7 59 shows the chart of the pupil diameter trend and the maps of gradients X Y Figure 7 60 shows the defocus chart and the maps of the low orders of the eye s aberrometry O...

Страница 71: ...he pop up menus like the one shown in Figure 7 61 and change the scale of Y ordinates astigmatism step in the example and select Stimulus or Fogging for axis X Figure 7 61 Astigmatism chart and chart...

Страница 72: ...Keratron Onda Installation and operating manual OPTIKON 2000 Cod 161401EN 7 37 2015 03 27 Rev C THIS PAGE IS INTENTIONALLY BLANK...

Страница 73: ...ion has detected a positioning fault Return to the initial screen and restart the test If the problem persists contact the Optikon 2000 S p A Service Department The space between the mires cone s phot...

Страница 74: ...the topo aberrometer and while the BIOS starts repeatedly press F11 until the Select boot device screen in Figure appears Figure 8 1 Kontron left and Advantech selection of the start device in BIOS S...

Страница 75: ...nsidered completed Run a standard calibration section 7 2 and then a topo abberometric examination to check all its features NOTE If the key also contains an update of the Onda exe software this will...

Страница 76: ...Cod 161401EN 8 4 2015 03 27 Rev C THIS PAGE IS INTENTIONALLY BLANK...

Страница 77: ...iles 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 such is the case refer to the Service Manual The...

Страница 78: ...rlink Setup exe choose Save Target As when prompted and save it in the folder you have created 9 3 KERATRON SCOUT SOFTWARE INSTALLATION Both if you are installing the Keratron Scout from the Web and i...

Страница 79: ...orrectly configure the network connection on the external PC on which Keratron Scout is running Therefore it is necessary to take into consideration the network configuration of the PC and the corresp...

Страница 80: ...elect 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 set the communication parameters Select Use the following...

Страница 81: ...upervision of a network administrator 9 4 2 CONFIGURATION OF THE PC IN WINDOWS VISTA AND WINDOWS 7 In the case of Vista and Windows 7 the following is a possible configuration sequence Start Control P...

Страница 82: ...ows you to access the protocols window Figure 9 6 In the Network folder use the mouse to select Internet Protocol version 4 TCP IPv4 1 then press Properties 2 Figure 9 6 Network card protocols The fin...

Страница 83: ...gs of Keratron Onda The address must be selected following specific rules and not randomly The configuration should be changed under the supervision of a network administrator NOTE To configure the ne...

Страница 84: ...configuration are illustrated in section 9 5 that explains how to configure Keratron Onda on a LAN network By pressing Factory Default 3 in Figure 9 8 it is possible to reset the original and factory...

Страница 85: ...ress In this case the assignment can be done using the name that displays on the LAN network By selecting the box shown in Figure 9 10 it is possible to display a virtual keyboard and enter the name o...

Страница 86: ...able to the network it is strongly advisable to request the help of the network administrator when completing these fields Figure 9 11 Setting the IP address for Keratron Onda Figure 9 12 shows an exa...

Страница 87: ...by the user NOTE It is always possible to reset the factory set configuration by selecting Factory Default 3 in Figure 9 8 9 5 3 INSTALLATION OF THE WI FI CONNECTION Keratron Onda can be connected us...

Страница 88: ...ported 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...

Страница 89: ...n 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 sc...

Страница 90: ...Panel 2 Click on Add Remove Programs icon 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...

Страница 91: ...of unsatisfactory quality those that have been clearly moved or those that were taken while the patient blinked can be eliminated immediately In the case of the unit s first use by the operator it is...

Страница 92: ...h it can take a few seconds Finally select the Save Test menu or icon button Discard all images except for the best one for each eye This will save space on disk and will speed up the check If you did...

Страница 93: ...ime error exporting tests When this occurs open the Scout ini file and then in the Export section check the path key probably it is pointing to a network path not available at the moment or to an exte...

Страница 94: ...e s on network cd rom Backup the C Keratron Scout ini file options settings MRU path Backup the C Keratron tb file toolbar settings Change the PC Reinstall the Keratron Scout software Reinstall the tr...

Страница 95: ...t program b Rename 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 Lau...

Страница 96: ...the DAO 3 5 version 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...

Страница 97: ...ve 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 key Figure 9 15 Make Keratron Onda key Press Write...

Страница 98: ...se present on the device with the release corresponding to the version that is being run on the personal computer If the latter release is more recent than the one that is currently in use the softwar...

Страница 99: ...alcohol or antibacterial disinfectant Similar considerations are valid for the optical head s external black conical surface It can be cleaned and disinfected being careful not to touch the two small...

Страница 100: ...r with your local Optikon 2000 S p A Distributor Service Center In topography periodically acquire the calibration sphere and compare the curvature value you obtain with the value listed on the sphere...

Страница 101: ...c map like the one in Figure 10 1 should appear In the panel shown in Rx vd 0 verify the sphere s refection by setting pupil 4mm as well as pupil 6mm and compare it with the nominal data listed on the...

Страница 102: ...ned out fuse in this case it must be replaced The following is the procedure for replacing the fuse Place in the OFF position the mains switch located under the LCD display Remove the mains power conn...

Страница 103: ...TIKON 2000 Cod 161401EN 10 27 2015 03 27 Rev C NOTE The used battery must be replaced by Optikon 2000 S p A Technical Service or by personnel authorized by them NOTE Dispose of the battery in complian...

Страница 104: ...Keratron Onda Installation and operating manual OPTIKON 2000 Cod 161401EN 10 28 2015 03 27 Rev C THIS PAGE IS INTENTIONALLY BLANK...

Страница 105: ...ddresses 9 10 Default Map Type 9 16 Default settings 9 20 defocus 5 8 7 17 7 18 7 30 7 31 7 32 7 33 10 25 Defocus 7 34 demodulation 5 5 DHCP 9 8 diagnosis 3 2 Dimensions 5 8 disinfectants 3 2 dispersi...

Страница 106: ...7 16 precision 5 7 Print Process 7 11 printer 5 15 Process Editing 3 2 Processing 9 16 Pupil 7 16 R Radius 7 16 reflections 3 1 reflectivity 3 1 Remote Host Computer 9 8 9 9 repeatability check 9 15 R...

Страница 107: ...ected 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 Sugge...

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