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Keratron™ Nova

Manual for installation and use

OPTIKON 2000

Cod. 161601EN

5-5

2016-12-28 Rev.B

5.2 TECHNICAL SPECIFICATION

PARAMETER

SPECIFICATION

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

OPTIKON 2000 SpA

Via del Casale di Settebagni, 13

00138 Rome - Italy

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

Keratron™ Nova

Reference: ..................................

161601

Regulatory compliance: .............

Medical Device Directive 93/42/EEC

Technical standards: ..................

IEC 60601-1:2005/A1:2012;

… ................................................

IEC 60601-1-6:2010;

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

IEC 62366:2007;

...................................................   IEC 62304:2006
...................................................   IEC 60601-1-2:2007
……………………………………..   IEC 60825-1:1993 + A1:1997 + A2:2001

ENVIRONMENTAL SPECIFICATIONS

Storage/Transport: ......................

temperature range between -20 ° C and 60 ° C

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

humidity 0-100% (including condensation)

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

atmospheric pressure from 500 to 1060 hPa

In operation: ................................

temperature range between 10 ° C and + 40 ° C

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

25-65% humidity (non-condensing)

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

atmospheric pressure 700 to 1060 hPa

CLASSIFICATION OF THE DEVICE ACCORDING TO IEC 60601-1

PARAMETER

SPECIFICATIONS

Type of protection against electric shock: ............................

Class II

Degree of protection against electric shock .........................

Type BF

Degree of protection against entry of liquids: .......................

IPX0

Degree of safety in the presence of a

flammable anaesthetic mixture: ...........................................

Non protected

Operating mode ...................................................................

Continuous

Содержание 161601

Страница 1: ...Rev B KERATRON NOVA Videokeratoscope REF 161601 MANUAL FOR INSTALLATION AND USE OPTIKON 2000 SpA Via del Casale di Settebagni 13 00138 Roma Telefono 39 06 8888410 Fax 39 06 8888440 e mail sales optik...

Страница 2: ...mpany certified ISO 9001 and ISO 13485 which produces surgical and diagnostic devices for ophthalmology All Optikon 2000 products are manufactured in accordance with the requirements of Directive 93 4...

Страница 3: ...5 3 2 Guide and Manufacturer s Statement Electromagnetic immunity 5 8 5 3 3 Recommended distance of separation between portable and mobile radio communication devices and the Keratron Onda device 5 10...

Страница 4: ...the Keratron Scout software on EXTERNAL PC 9 13 9 7 Customization of the Keratron Scout software 9 14 9 8 Identification of the Scout software version 9 14 9 9 Uninstalling the Keratron Scout softwar...

Страница 5: ...rmance only if updates calibration repairs are performed by OPTIKON 2000 SpA authorized personnel the system is used in accordance with the instructions for use the electrical system to which the syst...

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Страница 7: ...e been altered or tampered with in any way or have been damaged by improper use OPTIKON 2000 SpA also reserves the right to modify the instrument and or its accessories when required by operating tech...

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Страница 9: ...han those supplied with the unit may result in increased emissions or decreased immunity of the system Emissions from mobile telecommunications equipment can affect drive performance Carefully follow...

Страница 10: ...f suitable quality images see especially the chapters devoted to the acquisition of images of the eye and the last page of this manual and if necessary proceed with correction using appropriately the...

Страница 11: ...ll the instrument near a heat source or expose it to direct sunlight or other high temperature sources The system should never be used near flammable anaesthetics flammable disinfectants and other sub...

Страница 12: ...s to the risk of an excessive leakage current towards the ground of the entire system due to the device leakage current does not conform in conditions of a single failure interruption of the common pr...

Страница 13: ...leaning or maintenance should be performed by Optikon 2000 SpA authorized personnel If the device suffers mechanical damage as a result of a collision or fall dangerous electrical parts may be uncover...

Страница 14: ...Keratron Nova Manual for installation and use OPTIKON 2000 Cod 161601EN 3 6 2016 12 28 Rev B THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK...

Страница 15: ...016 12 28 Rev B 4 SYMBOLS The table below shows the symbols used on Keratron Nova and their meanings SYMBOLS AFFIXED ON THE UNIT SYMBOL DESCRIPTION ALTERNATING CURRENT DIRECT CURRENT OFF POWER ON POWE...

Страница 16: ...2 2016 12 28 Rev B SYMBOL DESCRIPTION MANUFACTURER AND DATE OF MANUFACTURE IDENTIFICATION CODE SERIAL NUMBER RECYCLING OF ELECTRICAL AND ELECTRONIC EQUIPMENT OPERATING INSTRUCTIONS POLARITY OF THE POW...

Страница 17: ...Keratron Nova Manual for installation and use OPTIKON 2000 Cod 161601EN 5 1 2016 12 28 Rev B 5 GENERAL INFORMATION 5 1 SYSTEM DESCRIPTION Figure 5 1 Keratron Nova...

Страница 18: ...ttons informs the operator through a user friendly interface about the machine status and any errors 3 Ignition switch 4 Handle to help with movement on the LAF 5 Mire cone 6 Push button 7 Hand wheel...

Страница 19: ...photocells when it is located within a range around the predetermined distance from the optical head An indicator on the monitor and a sound alert the operator when the eye is too close or to far and...

Страница 20: ...i e the point of the cornea closest to the camera as well as being an important reference point for all corneal maps Furthermore once detected the input pupil in photopic conditions with the subtracti...

Страница 21: ...3 A1 1997 A2 2001 ENVIRONMENTAL SPECIFICATIONS Storage Transport temperature range between 20 C and 60 C humidity 0 100 including condensation atmospheric pressure from 500 to 1060 hPa In operation te...

Страница 22: ...s II Input voltage between 100 and 240 Volts AC Frequency 50 60 Hz Adsorption 45VA Output voltage 12 Vdc VIDEOKERATOSCOPE Electrical insulation Class II Input voltage 12 Vdc TOPOGRAPHY PRECISION Kerat...

Страница 23: ...Emission test Conformance Electromagnetic environment guide RF emissions CISPR 11 Group 1 The Keratron Nova uses RF energy only for its internal workings Therefore its RF emissions are very low and n...

Страница 24: ...0 hole in UT for 5 cycles 70 UT 30 hole in UT for 25 cycles 0 UT for 5 sec IEC 60601 1 2 Test Level The quality of the network voltage must be that of a typical retail or hospital environment If the u...

Страница 25: ...less telephones and land mobile radios amateur radio AM and FM radio broadcasting and TV broadcasting units can not be predicted theoretically and with accuracy To assess the electromagnetic environme...

Страница 26: ...ion devices Maximum specified transmitter output power W Separation distance at the transmitter frequency m from 150kHz to 80MHz d 1 2 P from 80 MHz to 800 MHz d 1 2 P from 800 MHz to 2 5 GHz d 2 3 P...

Страница 27: ...ating condition Wavelength peak Emitted power Pmeas Topography visible LED 594 nm 140 W LEA Class 1 Pupillometry Infrared LED 950 nm 150 W LEA Class 1 If the cone is removed while capturing or calibra...

Страница 28: ...included 1 Calibration sphere 2 Pedal 3 Stylus for touch screen 4 Pen drive specific for each DM 5 User manual 6 Power Supply 7 Power cable 8 LAN crossed cable 9 Keratron Scout software version 5 3 1...

Страница 29: ...mains voltage of 100 240V 50 60Hz with a minimum of 1 8 amperes absorption EN 60601 1 or EN 60950 Class II compliant see electrical instructions in the manual 3 3 PRINTER Colour Graphics Monitor Slit...

Страница 30: ...Keratron Nova Manual for installation and use OPTIKON 2000 Cod 161601EN 5 14 2016 12 28 Rev B THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK...

Страница 31: ...ary for the proper functioning of the Keratron Nova system 6 2 OPENING THE PACKAGING AND INSPECTION The unit has been packaged to minimize the risk of damages during transport Open the packaging and e...

Страница 32: ...thernet Alternatively if your PC is already on a local network the Keratron Nova can be inserted as an additional terminal client of the same network with an ordinary LAN cable see 9 5 In order to mak...

Страница 33: ...essories of the same LAF or movable base and turn the knob in the direction indicated by TIGHT tight i e clockwise This will expand the pin so as to provide a firm connection Avoid extending the pin b...

Страница 34: ...Keratron Nova Manual for installation and use OPTIKON 2000 Cod 161601EN 6 4 2016 12 28 Rev B THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK...

Страница 35: ...ayed to the user with the screen shown in figure 7 1 Figure 7 1 Initial Keratron Nova screen In it are intuitively represented in addition to all the measurement functions of the instrument also the c...

Страница 36: ...bration of the topography instrument For this operation the calibration sphere supplied is needed Figure 7 x1E 7 2 Transcription of the refractive power of the calibration sphere The front screen prom...

Страница 37: ...iddle finger place the calibration sphere on the cone rotate the rear knob of the sphere until the position indicator is brought into the correct position green labelled OK and the associated acoustic...

Страница 38: ...perator confirms cleaning by pressing Yes the software draws the 28 mires and the screen looks like figure 7 5 here the operator must make sure the reconstruction of the rings to the edge of the mires...

Страница 39: ...r the Far photocells of the bivalent cone The sequence of calibrations is considered successfully completed if the message figure 7 6 appears Figure 7 6 Completion with success of the procedure NOTE D...

Страница 40: ...r upon moving the unit or accidental bumping the cone the cone may be slightly misaligned due to dislodgment 7 2 SETTINGS SETTINGS With the selection on the touch screen of the Settings function you c...

Страница 41: ...e by which each map is transferred through the network cable to an external PC Furthermore you can choose between different styles for the visualization of the eye focus as shown in figure 7 20 After...

Страница 42: ...can differ depending on the controller used and must be carried out with caution and only if really necessary You can also change the date and time by pressing the button and changing it on page figu...

Страница 43: ...e service password This option is in any case protected by a password to avoid accidental inputs Any entry attempt in this section violates the terms of the guarantee 7 2 3 DATABASE Clicking on the DB...

Страница 44: ...161601EN 7 10 2016 12 28 Rev B You can choose how many items per page to display and also which columns to display and their width Furthermore it is also possible to protect the database from unauthor...

Страница 45: ...on in the second refer respectively to Sections 9 4 or 9 5 Figure 7 13 Configuration or the connection to a a PC via Ethernet NOTE In the case of direct connection the variation of the parameters in f...

Страница 46: ...can choose a network printer which may be connected to the device and the print mode of topographies text or graphics 7 2 6 LOCALIZATION The section Localization figure 7 14 you can set the software...

Страница 47: ...raphy on the home screen if the machine was not previously calibrated see Calibration 7 1 the following message appears Figure 7 15 Warning due to the absence of calibration files Figure 7 16 Patient...

Страница 48: ...urnames and names of the patients already present in the unit s database During this input you may modify the keyboard layout for special characters for English German Spanish and Italian EN DEU ESP I...

Страница 49: ...Capture window It is possible to switch between the Near and Far sensors by clicking on the Sensor icon see 5 1 2 for details on both the standard and bivalent cones The acquisition can be started by...

Страница 50: ...e device does not automatically recognize the eye under investigation this must be selected by the operator An erroneous eye selection will lead to a wrong diagnosis On the right sidebar an arrow poin...

Страница 51: ...positioning rather than on the light indicators NOTE To stop at any time simply press Abort on the top left Once it image is acquired it is freezed Press the footswitch or the button to acquire more o...

Страница 52: ...in which the acquisition of the image is complicated it is possible selecting in the capture screen figure 7 19 the Burst option In this operating mode the device will acquire an image whenever the ph...

Страница 53: ...picture with Discard and repeat the operation IMPORTANT Ask the patient during the examination to look at the green fixing LED NOTE Be careful not to bump the patient with the cone when moving the Ke...

Страница 54: ...type of test SS field and operator Fields can be made visible or not and changed in width through the changes outlined in this manual at the point 7 2 By clicking on the heading of the field such as...

Страница 55: ...ernal PC Instead clicking on the name and patient name and then selecting one of his exam and then clicking the OK button you can see him on Keratron Nova as shown in figure Figure 7 24 Review test Cl...

Страница 56: ...e 7 26 The map of curvatures By pressing the i button you will be able to see the patient data see figure 7 27 and pressing the usual button export the exam on the USB stick if connected Figure 7 27 P...

Страница 57: ...n mm Radius distance from the centre in millimetres Distance meridian Meridian and height Height of the point highlighted by pointer freely placeable on the map of curvatures by pressing on the touch...

Страница 58: ...The device contains a patient database and thus sensitive data In the case in which such device is not in a protected area and accessible to the authorized personnel only access should be protected by...

Страница 59: ...tabase area the device will display this screen 7 31 Screen privacy policy and the software will move to the main menu any operation on the database is left suspended 7 4 1 IMPORT SOFTWARE ON SCOUT Op...

Страница 60: ...and use OPTIKON 2000 Cod 161601EN 7 26 2016 12 28 Rev B import the exam that will be added to the database in accordance with the patient s name and surname 7 5 SHUTTING DOWN The Keratron Nova is turn...

Страница 61: ...Keratron Nova Manual for installation and use OPTIKON 2000 Cod 161601EN 7 27 2016 12 28 Rev B THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK...

Страница 62: ...does not turn on The apparatus is not powered correctly The network cable is not connected Check the network cable and if its connection intact The power supply is broken Check whether the power supp...

Страница 63: ...Keratron Nova Manual for installation and use OPTIKON 2000 Cod 161601EN 8 2 2016 12 28 Rev B THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK...

Страница 64: ...s you have a specific preparation on PC and LAN management Refer to the service manual Updating the Keratron Scout software is simple and does not change neither the database nor the instrument calibr...

Страница 65: ...the new Scout software remove from your PC all previous versions In the case of CD ROM installation insert the CD ROM in the drive wait a few seconds the HTML page will load select the hyperlink Engl...

Страница 66: ...ately taken into account 9 4 1 SETTING PERSONAL COMPUTER IN WINDOWS XP In the case of Windows XP starting from the desktop select the sequence Start Settings Control Panel Network Connections At the e...

Страница 67: ...following IP address 1 and in the IP address 2 and Subnet Mask 3 fields input respectively the following configurations 192 168 0 140 255 255 255 0 figure 9 3 Configuration Protocol TCP IP in Windows...

Страница 68: ...COMPUTER IN WINDOWS VISTA AND WINDOWS 7 For Vista and Windows 7 a possible configuration sequence is Start Control Panel View Network Status and Activity At the end of the sequence within the Network...

Страница 69: ...ou can access the protocol window figure 9 6 Inside the Network folder select with the mouse Internet Protocol Version 4 TCP IPv4 1 and then press Properties 2 figure 9 6 Network card protocols The fi...

Страница 70: ...that the choice of the address is dictated by precise rules and can not be accidental If you intend to change this configuration you should make these changes under the supervision of the Network Admi...

Страница 71: ...on Keratron Nova A network administrator can change the TCP IP configuration of the Keratron Nova by selecting the button Local TCP IP Settings 2 Further information about Local TCP IP Settings for K...

Страница 72: ...addresses are dynamically changed this mode can be enabled with the selection shown in figure 9 9 figure 9 9 Selection of the DHCP mode As for the Remote Host Computer if the latter is also configure...

Страница 73: ...a static IP address can be made in Keratron Nova as shown in figure 9 11 The selection of the configuration component fields IP Address Subnet Mask Gateway must be made through the touch screen The va...

Страница 74: ...ng of the Keratron Nova In figure 9 12 is shown as an example the configuration of the subnet mask NOTE The configuration parameters do not have default values so the enhancement of all parameters is...

Страница 75: ...ttributed uniquely to every single network card whether wired or wireless It may necessary to provide this address to the network administrator to authorize the Keratron Nova connection within an exis...

Страница 76: ...ere the imported printing models and new ones The software stores here the temporary files tb Toolbar settings Scout ini Software Settings cnt File guide content hlp Localized guide file ScoutTSE exe...

Страница 77: ...simple click with the right mouse button 9 8 IDENTIFICATION OF THE SCOUT SOFTWARE VERSION figure 9 13 Splash Screen Keratron Scout software The version of Keratron Scout software that can be identifi...

Страница 78: ...art Control Panel 2 Click on the Add Remove Programs icon 3 Select Keratron Scout 4 Click on the Add Remove button 5 Follow the instructions if the uninstall procedure requires removing some DLL click...

Страница 79: ...first use it is recommended to take 6 8 photos of the same eye and check the repeatability with the Acquire menu Capture Repeatability Check until a satisfactory result is obtained As standard proced...

Страница 80: ...save disk space and significantly increases the checking speed Fill in the patient s record if it was not done earlier Always insert name date of birth sex group diagnosis and operator v Patient Fold...

Страница 81: ...d in the Export section check the path since it probably is pointing to a network path currently not available or to a not connected external drive Delete the string path x nnnn mmmm and try again 9 1...

Страница 82: ...k up of the database s network CD ROM Make a backup of the file C Keratron Scout ini options settings location MRU Make a backup of the file C Keratron Tb toolbar settings Replace the PC Reinstall the...

Страница 83: ...in Solution A a Exit the Scout program b Rename the database folder in use the selected database is shown on the top bar of the Scout screen e g C My Documents Database to C My Documents Database_old...

Страница 84: ...nd are independent of chronological or alphabetical selection The default settings do not match the most recent or the database is non existent a Exit the Scout program b Delete or change the file nam...

Страница 85: ...e 9 10 Make Keratron key Press the Write button figure 9 11 Once the operation is finished insert the memory stick into the USB port of the Keratron and switch on the device If the version on the memo...

Страница 86: ...of the previous version of the software If you want to restore the previous version simply re insert the USB memory stick and select Restore previous version when the window appears in Figure 9 12 NO...

Страница 87: ...Keratron Nova Manual for installation and use OPTIKON 2000 Cod 161601EN 9 24 2016 12 28 Rev B THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK...

Страница 88: ...parts of the device must be done by avoiding the use of abrasive products and the penetration of liquid inside the device itself With the exception of the cone see 10 2 the casing of the Keratron Nova...

Страница 89: ...t or any other accessories NOT PROVIDED refer to the instructions in the respective user manuals 10 5MAINTENANCE Periodically check the integrity of both networking and power supply wiring For system...

Страница 90: ...ry voltage is 3V NOTE The replacement of an exhausted battery with its wiring must be made by the Optikon 2000 SpA technical assistance or by personnel authorized by the latter in order to avoid a dan...

Страница 91: ...Keratron Nova Manual for installation and use OPTIKON 2000 Cod 161601EN 11 2 2016 12 28 Rev B THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK...

Страница 92: ...s 9 55 Default Map Type 9 62 default settings 9 66 DHCP 9 54 diagnosis 3 2 Dimensions 5 8 disinfectants 3 3 distance 7 42 dynamic pupillometry 7 31 E Editing Process 3 2 electrical and Electronic Equi...

Страница 93: ...pil 7 42 R radius 7 42 reflectivity 3 2 reflexes 3 2 Remote Host Computer 9 53 9 54 repeatability Control 9 61 Restore previous version 9 68 S Sim K 7 42 software version 9 59 Subnet Mask 9 55 T TCP I...

Страница 94: ...Keratron Nova Manual for installation and use OPTIKON 2000 Cod 161601EN 13 1 2016 12 28 Rev B 13 APPENDIX...

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