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IOLMaster Manual V.4

1. Fig 62 The upper two measuring marks are concealed by the eyelid The display field shows the Error message This error may also occur if the patient blinks during measurement 0 5 s This is particularly the case with restless or anxious patients Ask the patient to open his or her eyes wide and repeat the measurement If measurement is still not possible gently lift the upper eyelid as is usual in tonometry Warning Take care not to deform the eyeball Pressure on the globe causes a deformation of the cornea and results in incorrect radius and refraction measurements OO00000 1371 524 IOLMaster 24 08 2005 Tips for keratometer measurement 85 Other findings Pseudophakic eyes Reflections from cornea Reflections from IOL front surface artifacts Fig 63 Pseudophakic eye In the measurement of pseudophakic eyes images of the measuring Cause marks may be visible at the front side of the intraocular lens are visible beside the reflections from the cornea The reflections trom the IOL are fainter and out of focus Try moving the device approximately 1 mm away from the patient s Remedy eye defocusing and take the measurement The images produced at the cornea will now be slightly larger while the artefacts of the IOL become fainter such that the evaluation process may not identify them as measuring points a measurement is then possible If this procedure does not succeed the corneal curvature cannot be
2. Fig 9 Connection panel N Warning When connecting an external device e g PC to a port or an external monitor to the VGA port the operator must ensure that the safety requirements of IEC 60601 1 1 are observed medical electrical systems A network isolator can be ordered from Carl Zeiss for connection to an external network NET The lIOLMaster may only be connected to private networks which are protected from public networks Internet by firewalls conforming to the latest technical standards When the device is turned on at the power switch it will run through an internal test The instrument can be operated after this has completed successful Certain operating parameters are factory set and may be changed in the Setup menu see page 33 OO0000 1371 524 OLMaster 24 08 2005 21 Install printer according to manufacturer s user manual Do not connect to the lOLMaster now Start IOLMaster and wait until New patient is displayed Switch on printer and conntect to lOLMaster USB LPT 1 The Windows installation routine is displayed SELECT OPTION NO NOT AT THIS TIME AND CONFIRM WITH NEXT Insert installation CD for printer driver and wait for language selection in the selection window SELECT APPROPRIATE LANGUAGE AND CONFIRM WITH NEXT If a dialog box for the installation of additional printer software is displayed exit this box without installing another printer Windows installation routin
3. Display field for video images Display field for measurements of left eye Eye Mode additionally in ALM mode number of measurements Last name First name Icons System messages progress bar O ON AU BPWN O Fig 11 Screen layout 000000 1371 524 lOLMaster 24 08 2005 Operation Overview of buttons and shortcut keys Button Key Function Explanations lt N gt Activates data entry For new patients input of j screen patient data is essential G Activates overview Functions in all modes and lt O gt mode and surrounding for every measurement field illumination oh Activates axial length mode S Activates keratometer lt K gt mode C gt Activates anterior chamber depth mode ex lt W gt Activates WTW WTW white to white determination optional O lt I gt Activates IOL Calculation already possible calculation after measurement of one eye D gt Prints results obtained hitherto lt S gt Exports data Prerequisite A suitable computer must be connected to the serial interface Transfers data to CD Prerequisite CD RW has X gt RW or USB flash drive been inserted into the drive or USB flash drive is connected to USB port p T lt E gt Exits lOLMaster Functions in all modes and software and Windows for every measurement In the and shuts down the case of breakdown pull plug device immediately 00000
4. Test eye for ACD Set values and tolerances Location hole Asymmetrical holder Set value and tolerance Locking screw Test eye for ALM and KER e Insert the asymmetrical holder 5 Fig 77 into the holes adjacent to the chin rest the holding pins for the paper pads 4 Fig 77 may need to be removed beforehand The test eye 1 Fig 77 is mounted on a mandrel which allows it to rotate and secured by a locking screw 7 Fig 77 The respective set value and tolerance 3 and 6 Fig 77 for checking the calibration Status are marked on the test eye 1 Fig 77 CON OU RP WYN In the delivery condition a patient CHECK DEVICE with birth date Fig 77 Setting up the test eye 02 05 1956 has been entered Because of the exclamation mark in front of the name this patient will always be at the top of the patient tree in the Patient Manager and can thus be easily found every day O00000 1371 524 IOLMaster 24 08 2005 98 Servicing and maintenance e Highlight the patient CHECK DEVICE and click on NEW e Select Options Test Eye Axial length measurement and keratometer The test eye 8 Fig 77 marked with AL R the respective set values and tolerances 6 Fig 77 is used for checking the axial length measurement AL and keratometer R The measurements should be taken in the same way as for a human eye If the readings in the case of the keratometer the radius are within the tolerances stated on the
5. 23 81 23 67 Comeal E s mm Fa 719 E HERCE Optical ACD mm Eve Surgeon Dr Mustermann Target Refraction D 1 0 5 Surgical Eye OD O pS Print IOL Calculation Data IOLO REF IOL D FEF D IOL D REFL IOLE FEF D 18 5 1 88 15 5 1 55 18 0 1 54 15 0 1 54 13 0 cored 13 0 2 25 12 5 1 75 12 5 1 75 16 0 0 23 16 0 0 23 10 5 0 03 10 5 0 03 SAE is a trademark of CTI Computational Technology Inc OF Cancel Fig 38 Calculated IOL data in IOL calculation window SRK T 000000 1371 524 OLMaster 24 08 2005 Operation 53 In the columns below each specified lens you will find the calculated refractive powers and target refractions for those lenses The middle line appearing in bold type indicates which refraction of the corresponding IOL comes closest to the desired target retraction Warning AN The IOL calculation is valid only if the biometric measurement was correct an appropriate IOL calculation formula was selected and the IOL constants were optimised for the specific application The data calculated for the IOL to be implanted can be printed out e For this purpose click on the PRINT button The IOL data of both eyes or of one eye and emmetropic IOL will be printed out either on a single page or on separate pages depending on the option selected in the Program Settings menu page 33 e Click on OK to finish IOL calculation O00000 1371 524 IOLMaster 24 08 2005 54 Op
6. After backed up data has been restored the user database in the User Manager will reflect the status at the time of backup All newly registered patients since this time will be irretrievably lost Import The Import function permits IOL data name and respective IOL constants to be transferred back to the IOLMaster from a database saved to CD RW or USB flash drive Version 1 1 or later Imported data may be assigned to one or several surgeons Prior to import download the available IOL data from the Internet Copy the IOL data to a storage medium ms Note Download IOL data using a PC connected to the Internet and a CD RW recorder or USB storage medium Caution r Do not use a network connected lOLMaster for the download e Log into www meditec zeiss com iolmaster e Select lOLMaster gt Download Optimised IOL constants e Follow the prompts now appearing on the screen e Save the file do not select Open on the desired storage medium e Do not extract the ZIP file O00000 1371 524 IOLMaster 24 08 2005 32 Operation Importing IOL data from the storage medium to the OLMaster e In the User Manager activate Administrator Import e Click on the IMPORT button e Insert the CD RW or USB flash drive with the database to be imported and confirm with OK A Please insert the USB stick CD containing the lens data base for import NE E Import of lens constant data Lens constants in the import
7. Pulse width Number of possible individual measurements Laser class Embedded not accessible Fixation light for keratometer and anterior chamber depth measurement and WTW determination Source Wavelength Delivered power Illumination for keratometer measurement Source Wavelength Delivered power Slit illumination for anterior chamber depth measurement integral irradiance UV 300 400 nm IR 700 1100 nm L phakic eye L aphakic eye Technical specificatons LED 880 nm lt 100 uW Semiconductor diode laser MMLD 780 nm 450 uW 80 uW 0 55 20 per eye and day 1 3B LED 590 nm lt 1 uW LED 880 nm lt 50 pW 0 00087 mW cm 0 04 MW cm in spectral range of 860 1100 nm no detectable emission from light source 122 8 W m sr 125 5 W m sr 000000 1371 524 lOLMaster 24 08 2005 Technical specifications 105 Spectral irradiance Spectral irradiance of slit illumination white LED determined in the optical axis 0 and at an angle of 33 0 12 Emission 33 Ee 0 814 mW cm a 2 Emission 0 Ee 0 91 mW cm 2 ft ff She 7 Sst SS P in NM Irradiance in W m nm Optical axis or O corresponds to the direct view into the illuminating projector 33 is the angle for the intended use In anterior chamber depth measurement Spectrally assessed photochemical radiation densities Photochem
8. jj 05 25 2005 Mustermann ji 070771977 05 252 Mustermann ohn 05 23 2005 Mustermann John 01 071 977 05722 Fig 45 Dialog box Assign data records Special filter functions allow fast selection of patient data The right column shows the list of all patients available for optimisation e Click on the desired patient data record in this list to select it e Select the eye to be used for the optimisation calculation The fields OD fright _OS left below show the measurement data of the OLMaster e f you wish the data of the other eye to be kept in the data table for IM keep other side in table further optimisation activate Keep other side of table in the check box e Click on the lt lt button to load the selected data record in the left ag hand table These data records are intended for IOL optimisation e Transfer at least 11 data records into the left hand table in this way e Click on the gt gt button to return the selected data record to the gt right hand table if it is not to be used for optimization but should be kept for possible later use e Click on the DELETE button to irrevocably delete the data record to Erase the right or left e When all the desired data records are loaded into the left hand table press OK to return to the optimisation box Fig 44 e Further patient records can be added to the left hand list for Subsequent additional optimisations O00000 1371 524 IOLMaster 24 08 20
9. Caution Do not remove any other screws on the base plate Damage may otherwise be caused to the device e Attach the holding bracket with adhesive strips 2 Fig 7 facing outwards e Secure the holding bracket with the three hexagon socket screws Do not yet remove the protective film from the adhesive strips e Set the device upright and place it in the desired position e Now litt tilt the device slightly and remove the protective film 2 Fig 7 e Bring the device carefully into the proposed position The adhesive strips will hold immediately The device can no longer be shifted once it has been brought into position OO00000 1371 524 OLMaster 24 08 2005 Description Electrical connection e Connect mouse and keyboard e Optional Plug in and secure monitor VGA and interconnecting cable NET COM 1 e Connect power cable e Install printer as shown in Fig 8 Go Caution Use only printers recommended by Carl Zeiss Meditec Only one printer may be installed De install all surplus printer drivers using the menu Setup Printers Before using an older printer enquire at Microsoft or the manutacturer whether it is compatible 1 2 3 4 5 MOUSE KEYB s ae j S COM 1 NET 9 8 7 6 1 Power switch 6 Printer port LPT1 2 Power socket 7 Port for external PC COM 1 3 Monitor port VGA 8 Network connector NET 4 Mouse port MOUSE 9 USB interface USB 5 Keyboard port KEYB
10. Egon AL mm 24 23 Wustermann E ma 1171171866 057 0872005 T raar Mustermann Frang 07 07 1 977 05 23 2005 ar Kpa efa Mustermann g 01 01 1911 05 31 72005 Exam Date 0523 2005 K2 D 43 49 Mustermann Haigis L 01 0779170530201 Wiustermann Hermine 02702 1911 057 07 20 ID Number Opt ACD mm 3 8 MustermnannJohn 052372005 Mustermann Jahn 05 24 2005 Impl 10L p23 Mustermann dohn 01 07 1977 057 2372005 Mustermann mein 05 26 2005 PostOpRef DL 1 f 50 Mustermann Mo 070771977 05 23 2005 D ate Mustermann test 01 4011911 05 03 2005 e wie ane MustermannUserntertace 04 22 2005 r Post Op Date Basis aE Mer A Const 113 3 ii SREE I Data Records js 715 A Const 1135 ii SRK amp T 14 22mm 3 all EE ea E H aigis 22 25mm E PACD 577 lt Hoffer 25 40mm 0 sF f208 e Holladay Ave AL mm 2203 Ss Last Optimize 06 03 2005 Load Hew Optimize Erase TK Cancel SRE is a trademark of CTI Computational Technology Ine Fig 47 Dialog box Assign data records e Complete all selected patient data records in this way The number of data records containing IOL and post op ref data and the total number of loaded data records is specified in the Data Records box 000000 1371 524 lOLMaster 24 08 2005 61 Post Op Values Implant IOL DE PostOpRef p xf Surgery Date Post Op Date ft 62 Operation The boxes beneath it s
11. be saved and the device will shut down automatically display goes off Caution Internal components remain electrically live after the instrument has been switched off at the mains To completely disconnect from the power supply the instrument must be unplugged The power cable should not be pulled or the mains switch of the room installation activated until the screen is blank Failure to observe these instructions may result in loss of data Li The device contains a computer Please follow the instructions for Switching off the device on page 69 Disposal The device s internal control computer contains electronic components and a lithium battery type CR 2032 At the end of its useful life it must be properly disposed of in compliance with local regulations Disposal of the product within the EU EU directives and national regulations currently in force at the time of marketing prohibit the disposal of the product specified on the delivery note in domestic waste or by municipal waste disposal companies For more information on disposal of the product please contact your local dealer the manufacturer or their legal successors Please also take note of the manufacturer s current online information If the product or its components are resold the seller has the duty to notify the buyer that the product must be disposed of in accordance with currently valid national regulations 000000 1371 524 OLMaster 24 08 2005 Safety in
12. clearly differs from the secondary maxima produced through the light source by the distance from the RPE reflected peak OO00000 1371 524 IOLMaster 24 08 2005 Evaluation of ALM results 81 In rare cases depending on the anatomical conditions of the measured eye the signal produced by the pigmented epithelium may not be the one with the highest amplitude D SHR 3 7 AL 21 92 Fig 58 Triple peak double zoom The automatic peak detection system will find an axial length value that is too short by approximately 150 350 um Following the comparison of all measured values and curves for this eye the measuring cursor must be moved manually to the middle AN smaller peak produced by the RPE This measured value is thus corrected and shown in the display field with an asterisk Double peaks In very rare cases signals may be produced by both the pigmented epithelium and the choroid i oh R50 AL 22 86 Fig 59 Double peak produced by pigmented epithelium and choroid double zoom Here again the automatic peak detection system has placed the measuring cursor at the correct position as the correct axial length A N signal from the pigment epithelium has the greater amplitude The measuring cursor may not be moved L Note Such a situation may only be evaluated correctly by viewing all measuring curves of this eye and must be clearly distinguished from double peaks produced by the inner limiting membrane and
13. control 7 Fig 3 must remain plugged in and should not be pulled out Li If the earth contact is impaired or if electrical wiring is damaged the instrument must be taken out of service and measures taken to prevent inadvertent use Following this call Carl Zeiss Service LI Do not cover obstruct ventilation slots in the computer casing right and left Li If peripheral devices are connected CRT monitor and or PC are possible the user must ensure that safety requirements of DIN EN 60601 1 1 medical electrical systems are observed LJ A network isolator can be ordered from Carl Zeiss for connection to an external network NET Li If either of the error messages Laser adjustment too high or Laser measurement power too high measurement aborted appears the device must be shut down Following this call Carl Zeiss Service O00000 1371 524 OLMaster 24 08 2005 11 12 Safety instructions Important when using the device Li Always enter the patient data last and first name date of birth or ID No depending on setting in Setup menu LI Disconnect the power cable immediately if damage or unspecified problems occur LI Switch off the device as follows Click on the EXIT icon on the toolbar Contirm with OK When the It s now safe to turn off message appears turn the device off by the mains switch The program will automatically close the readings for the last patient will
14. control knob for vertical adjustment Tell the patient to look steadily at the fixation point in the centre Adjust the device to patient distance until the 6 light spots 1 Fig 26 appear focused If possible the 6 light spots should be centred on the cross hairs and the edge of the pupil iris structure should appear in focus The position of the device in relation to the patient s eye thus found 1 Circle of light spots for serves as a Starting point for fine adjustments to be made in the n Laat ross Nalrs respective measurement mode Fig 26 Video image on correctly adjusted device O00000 1371 524 IOLMaster 24 08 2005 40 1 Vertical line Reflection of alignment light 3 Cross hairs Fig 27 View prior to axial length measurement Operation Axial length measurement ALM Activate the ALM measurement mode by e clicking on the ALM Icon e pressing key A or e pressing the button on the joystick in Overview OVW mode Switching to ALM mode will automatically change the magnification ratio a smaller section of the eye becomes visible with the reflection of the alignment light and a vertical line 1 Fig 27 e The patient should look at the red fixation point in the centre A crosshair 3 Fig 27 with a circle in the middle will appear on the display e Fine align the device so that the reflection of the alignment light 2 Fig 27 appears within the circle N Warning Ask the patient if he o
15. database Surgeons of the current user data base Dr Schmidt MP2125 John Public 0 D Dr Schmidt MS612 Gen Innov 310 Gen Inno P 55 Hoya AF 1 UV VABOBB HumanOptics 1CU OLtech Haptibag S CLtech Stabibag OLtech XL Stabi Lenstec LS 106 Ol Aqua Senee Ill Ophtec PCZ surgeon 3 Pharm Upj 808C Pharm Upj Cee0n S114 Poljtech Pollensa 460 Polytech Pollen Fig 15 Dialog box Import lens data e Choose the desired lenses select several lenses with lt CTRL gt cursor click selected lenses appear highlighted in blue e Choose the surgeon one or more with lt CTRL gt cursor click selected surgeons appear highlighted in blue if not already existent the desired surgeons must be created beforehand e Accept with gt gt A progress bar informs you of the status of the copying process The selected lens data will be added to the selected Surgeons e Close the dialog box with EXIT 000000 1371 524 OLMaster 24 08 2005 Operation Setup The Setup submenu contains the following entries L1 Date Time Opens the Windows routine for setting the system clock Li Program settings Program Language OLMaster dialogues in German English or other languages changes require system restart Display of visual acuity Decimal or Snellen Entry of visual acuity in Patient Data dialog box Database Storage time of datasets 5 365 days All fig
16. edited in the A IOL calculation window for the selected formula The corneal K s transferred to the IOL calculation are marked in the printout of the lens calculation with and the calculation method 000000 1371 524 lOLMaster 24 08 2005 56 Operation Haigis L method In contrast to the above described methods of determining corneal refraction the Haigis formula allows for surgical changes to the cornea and permits the calculation of the IOL from the measured values AL Corneal K s and ACD IOL Calculation x Haigis SRK I Hoffer Holladay SRK T Multi Formula Haigis L phakic IOL Prior Refractive Surgen Mustermann Mas 01 01 1911 Axial Length mm poo lo Eve Surgeon Dr Mustermann ae o Target Refraction E Lh a Dh hi i gt i ae ee es ee ee Dh i hh ia SS TSS SIS il Valid for myopic LASIELASER PRE only Do not use after AE or hyperopic treatments Abbrechen Fig 40 IOL calculation window Haigis L Warning The formula may only be used for eyes with myopic Lasik myopic PRK and myopic Lasek Lenses by hyperopic Lasik Lasek PRK or myopic hyperopic RK should never be calculated The corneal radii and axis lengths as measured by the IOLMaster are required for the formula The measured values cannot be edited here Calculation of phakic implants optional This program component enables the thickness of phakic implants iridocorneal anterior and posterior chambe
17. holder 6 Fig 77 the device is properly calibrated Anterior chamber depth measurements The larger test eye 2 Fig 77 on the side of the test eye holder 1 Fig 77 marked with the ACD set value and tolerance is tor checking the anterior chamber depth measuring device Before starting measurements the surface structure simulates the cornea and must therefore be clean and grease free wipe off with a dry cloth e The measurements should be taken in the same way as for a human eye On the video screen verify that the adjustment criteria for an optimum optical section are correct as for measuring the ACD on the human eye see page 45 e Here again if the measured values lie within the given tolerance the anterior chamber depth measurement is functioning correctly Note Although the side right or left on the simulated eye is immaterial for checking the axial length measurement and keratometer because the optical path for the measurements is rotationally symmetric when checking the anterior chamber depth measurement it is recommended that the asymmetrical holder 5 Fig 77 be reversed and the check performed on the other side When comparing right and left however care must be taken to ensure that in both cases the test eye 2 Fig 77 stands exactly vertically in front of the device ms Note The test eyes are ideally suited to practising the operation of the lOLMaster The status of the Test Eye can be reset i
18. may be higher than that of the reflected light from the pigmented epithelium In this case the automatic peak detection will recognise the signal trom the ILM oO oh Rd 3 AL 2 AS Fig 56 Signal curve with higher signal from inner limiting membrane double zoom In measurement series such individual measurements stand out by deviations in the range of approx 150 350 um towards shorter axial lengths The measured value may be corrected by moving the measuring cursor to the smaller peak produced by the pigmented epithelium This manipulation is permissible only with the other signal curves of this measurement series OO0000 1371 524 IOLMaster 24 08 2005 79 80 Evaluation of ALM results Signals from the choroid Triple peaks In rare cases the measuring beam may also be reflected by the vessels 1 secondary maximum of the choroid Signal from inner limiting membrane choroid pigment epithelium SHE 3 0h oe 3c IG 0 15 0 25 mm Fig 57 Rare triple peak triple zoom The measuring peak produced by the choroid appears shifted towards longer axial lengths by approximately 150 250 um from the peak of the pigmented epithelium In the above example the signal from the RPE middle peak has the highest amplitude The automatic peak detection system has correctly recognised this measured value as the axial length so that the measuring cursor may not be moved This type of rare triple peak
19. measured O00000 1371 524 IOLMaster 24 08 2005 86 Tips for keratometer measurement Dry eye Fig 64 Multiple reflections produced by a dry eye Fig 65 Light trail bottom due to a dry eye at top additional disturbance by an eyelash Cause If the tear film is suddenly interrupted the reflectivity of the cornea will be greatly reduced at these points and the cornea will scatter the light more strongly If a measuring mark is projected to such a region the otherwise circular or ellipsoid image of the measuring mark will become irregular Irregular marks and or multiple reflections will form In this case a precise measurement of the corneal curvature will not be possible The results will fluctuate or the Error message will be displayed Remedy Ask the to patient blink several times to replenish the tear film on the cornea then take the measurement immediately or use a tear supplement to prevent rapid drying OO00000 1371 524 IOLMaster 24 08 2005 Tips for keratometer measurement 87 Irregularities of the corneal surface scars Scars and local irregularities on the corneal surface impair the imaging Cause quality of the measuring marks Depending on the expansion and location of these irregularities measuring errors may arise Fig 66 Local corneal scar impairing measuring points at 3 and 5 o clock Try to position the measuring mark next to above or below the scar by Remedy slightly displacing the
20. member of one or more user groups For this purpose highlight the respective user The user groups to which this user belongs are shown in the right hand window Membership The user can be assigned to one of the following user groups by clicking On ADD The Administrator has unrestricted access rights to User Management the User Manager see page 28 and the Setup menu The Surgeon only has an access right to the respective tab in the User Manager This tab is created automatically when the user account is established in the User Manager The Assistant has no right of access to the User Manager All user groups may enter rename patient data and perform measurements calculate IOLs Users who are not members of any of the above user groups may work on the OLMaster in the usual way but they may not change any of the system settings To remove a user from a user group highlight the name and click on REMOVE ms Note The rights of the Surgeon and Assistant user groups in the User Group Management may be extended to include access to the lOLMaster Setup menu and the deletion of patient data OO0000 1371 524 OLMaster 24 08 2005 Ld Operation 37 Regional settings Opens the Windows routine for setting the system clock Printer Open Windows printer folder This function is only needed for showing the printer queue displaying the properties of the installed printer Here you will find advice on operat
21. of CTI Computational Technology Ine Fig 49 New data record accepted Click on OK to return to the User Manager Optimized lens constants will only be saved to the lens database and for use in future IOL determination if they are confirmed with OK Click on OK to return to the IOLMaster main module 000000 1371 524 OLMaster 24 08 2005 Operation New Patient If you have completed measurements on one patient and wish to continue with another patient click on the PATIENT MANAGER icon or thew button The readings of the previous patient to the left and or right will be stored and removed from the display The Patient Manager appears and new patient data can be entered ms Note Data is available in the internal database for the period preset in the Database box under Program Settings see page 33 After entering new patient data and confirming with lt ENTER gt or NEW the device switches to Overview OVW mode i Note The above order of measurements is only an example You may also run the above described measurements in a different order The only requirement is that the keratometer measurement precedes the anterior chamber depth measurement Working with the Patient Manager The lOLMaster keeps an internal patient file All data is stored here and can be retrieved view post treatment printing ms Note The file is not designed for archiving patient and measurement data El lOLM aster 6
22. of anterior chamber depth ACD 45 Determination of white to white optional a src 47 Measurement of the other eye eesssiiiessssiireessrrrrirerrrrrrersrrn 49 Printout Of results ste axa ccre cuales eini aaier kereda iert au Traan daian 49 Generation OllOLODUOIS wis cits tecre suchas E a S 50 Filing the IOL Gata ase serseri Mae ea 50 IOL Calculati cack ehte tastes ERE E a GAE Ea 51 IOL calculation after corneal refractive surgery optional 54 Calculation of phakic implants optional cccceee 56 Dine eaclar e R ues 57 Optimisation of IEMS lt CONSTANUS iaccacutescaveniecaienewauieicalesnctawnaluce 58 SS AEL e E E A E EN E ENT 58 Loading existing data recordS wadicsicartssatbovetvomseanchieveiba dens 59 Entering new data records assercion a 60 Staring opua UON eeen a A 63 NOW Ra UCN ipanen E A 65 Working with the Patient Manager n 65 Retrieving a reading from previous measurements 66 Deleting a patient measurements cesiieeeiieenireerrneennn 66 Renaming a patient osna a naar Sebenaee en 67 Transmitting exporting data Optional s eesieesieerirerrrennnn 67 Exporting data to another SySteM cccccceseececeeeeeeeeeees 68 Exporting data to a storage MedIUM cceccceeeeeeeeees 68 SWCNT Onl THE COW CS jaar se cscel n ea ua ne utua dance dee acwn ae 69 Evaluation of ALM reSults ccccccccsssseeeeesseeeeseeeseeeseeeseesseeeeeees 70 Signal curves of a
23. of the anterior cornea impair the image quality of the optical section of the cornea Depending on the expansion and the degree of these irregularities this may lead to measuring errors In such a case the fixation point is imaged as a cloud and it is Remedy impossible to improve the adjustment If apparently plausible anterior chamber depth results are nevertheless displayed they can only be regarded as reference points Warning To obtain reliable data all the other known facts and findings of this eye should be included in the evaluation 000000 1371 524 IOLMaster 24 08 2005 96 Tips for WTW measurement optional How to adjust the device Ask the patient to relax and look at the yellow fixation light Focus on the iris not on the illuminated dots Adequate room lighting will facilitate the detection of iris structures Avoid direct exposure of the eye and device front panel to extraneous light In particular ensure that the visible right and left edge of the iris is not disturbed by reflections from lamps and windows If the iris structure is not discernible focus on the edge of either iris or pupil Serious defocusing will result in incorrect data After the image has been taken the operator should check if the software has correctly detected the edge of the iris If the circle segments drawn in the image do not define the iris correctly the result must be discarded Click on OK to confirm the results an
24. separator Semicolan Decimal separator Comma C USB stick Output path amp CD R File name export csv Fig 20 Dialog box Program settings Export file output Li Program settings User management System login OLMaster and the patient database can be protected by means of a password acc to HIPAA For this purpose activate the option User login with password A password must contain at least one character Program Export User management System login M Operator login with password User manager Fig 21 Dialog box Program settings User management 000000 1371 524 OLMaster 24 08 2005 Operation Caution The option User login with password and the screensaver together with password protection should not be activated until a further user see below has been registered and his her passwords entered As soon as you have confirmed the new program settings with OK a login dialogue will appear From now on the lOLMaster can only be used by logging in with password The default setting is user Admin with the password 0000 4x zero in the User Manager To change the password select the option Change password enter your user name and old password and confirm with OK Llser name Password Change password Fig 22 Login dialogue box In addition a screensaver with a freely adjustable interval can be activated The screensaver appears if the IOLMaster has been in
25. setting up see page 22 are observed the OLMaster printer system will operate reliably Should printing problems occur delete all printer drivers not used e Click on Printer from the Options Setup pulldown menu e Select the connected printer and designate it as the standard printer check the appropriate box in the File menu e Select the printers not connected except New Printer and press the lt DEL gt key Follow the prompts appearing on the screen e Re close the printer file once the unwanted printer drivers have been removed If the printer problem persists notify Carl Zeiss Service If you connect a printer yourself it may be connected to either the USB or LPT 1 parallel port Please note that the printer must be compatible with Windows XP driver To install follow the instructions provided on page 22 Care of the device Warning Before cleaning the device switch it off and disconnect the power cable Caution When cleaning the greatest care must be taken to prevent moisture from penetrating the device or keyboard as this may cause damage L All parts of the casing may be wiped off with a moist but not drip wet cloth Wipe off any marks or stains with distilled water to which a drop of household washing up liquid has been added LI Do not use aggressive or abrasive cleaning agents Li Use conventional cleaning cloths for computers and monitors for wiping off the display and monitor OO00000 13
26. third party software from being installed on the system LI The lOLMaster may only be connected to private networks which are protected from public networks Internet by firewalls conforming to the latest technical standards This instrument is a high quality technical product To ensure perfect and reliable operation it must undergo a safety inspection once a year OO00000 1371 524 IOLMaster 24 08 2005 Safety instructions Safe operation Electrical safety Li The built in power supply unit is short circuit proof and does not contain any fuses which are accessible from the outside LI Provided the device is properly used no electrical hazards exist to either patients or operators Li The device may be opened only by persons authorised by the manufacturer Light emission from the device The limit values as specified for Class 1 laser devices to EN 60825 1 will be observed if the device is operated as intended Operational requirements Please take care that the following operational requirements are met when using the lOLMaster Li Use the power cable supplied with the device If the device is mounted on an IT3L instrument table it will receive its power supply through the table LI The mains plug must be inserted into a power outlet that has an intact protective conductor connection LI All cables and plugs may be used only if they are in perfect working condition In particular the spring action plug for device
27. 0 1371 524 IOLMaster 24 08 2005 101 102 Technical specifications lOLMaster Basic Device Dimensions footprint Height Weight Rated voltage frequency basic device Power consumption basic unit Earth conductor Protection class Protection type Device type Power isolation transformer Rated voltage frequency power isolation transformer Power consumption power isolation transformer Power Isolation transformer fuses Ambient conditions for intended use Temperature Rel humidity 390 mm x 300 mm max 610 mm headrest approx 18 kg 100 240 V AC 10 50 60 Hz Device should be connected only to sockets with an intact earth conductor IP 20 B DIN EN 6061 1 100 127 V AC 410 60 Hz or 220 240 V AC 10 50 Hz max 115 VA Total power consumption of connected external devices 2 x 73 15 AH 250 V 5x20 IEC 60127 for 100 127 VAC 2x11 6 AH 250 V 5x20 IEC 60127 for 220 240 V AC 10 35 C 30 75 non condensing 800 1060 hPa Atmospheric pressure Storage environment Temperature Rel humidity 10 55 C 10 95 95 no condensation Atmospheric pressure 700 1060 hPa Ambient conditions for storage and transport in original packaging Temperature Rel humidity Atmospheric pressure 10 70 C 10 95 no condensation 500 1060 hPa OO00000 1371 524 IOLMaster 24 08 2005 Technical specificati
28. 0 1371 524 lOLMaster 24 08 2005 25 Warning When connecting external devices e g PC monitor or an external network the operator must ensure that the safety requirements of IEC 60601 1 1 medical electrical systems are observed Operation Key functions without icons Key Space bar Function Cyclic change of modes ALM KER ACD WIW Explanations ALM KER ACD gt WTW Joystick button Program continuation activates measurement In overview mode change to ALM mode In ALM KER VKT and WTW mode lt Del gt Deletes the selected ALM or KER measurement from the list Only in ALM KER and WTW mode with acknowledgment lt Ctrl gt lt D gt In ALM mode Prints the image of the selected graph In WTW mode Prints the selected image of the eye ALM Only one graph WTW right and left eye Summary of result displays Display 22 3 mm Meaning The third axial length measurement 22 55 mm has been selected Explanations The axial length graph of this measurement is displayed 22 2 mm PEYE Unreliable value 1 6 lt Borderline SNR appears 23 21 mm SNR lt 2 0 SNR above graph The result should 3397 mm signal to noise ratio be examined by the user for validity 7U b6 mm mm Erroneous result SNR lt 1 6 Error appears above graph Result has been manipulated remains displayed even if manipu
29. 05 60 Operation ms Note The data contained in the database right and left hand table will not be deleted automatically and are thus available for later additional optimisations A backup should be made at regular intervals by transferring data to an office management system or a printout Entering new data records e To enter data records which do not exist on the OLMaster result table click on the NEW button This will bring up an input mask for creating a new data record to be optimised This data record may be used for optimisation only not for IOL calculation Nor does it appear in the patient database Input new data record coat ene Pre Up Values First Name AL mm Date of Birth R1 mm al al Exam Date R2 mm ID Number Opt ACD mm Remark Surgical Eye OD right OS left Post Up Values Implant IOL C Post Op Ref D Surgery Date Post Op Date cancel Fig 46 Dialog box Input new data record Warning Only data obtained from the IOLMaster may be entered in the fields for pre operative data When entering the refractive power make sure that the same keratometer refractive index is set on the IOLMaster as on the keratometer used for the measurement see page 33 The entry of data measured on ultrasound devices will yield incorrect results Warning The data records of patients who have undergone refractive su
30. 1 524 IOLMaster 24 08 2005 33 Date Time Program Settings Regional Settings Printer SW Option b Update Fig 16 Setup submenu Database Erase Records after 100 Days Patients willbe mame first name identified bw ID Number u Send Data to PMS C old new with IOL calc table COM speed 119200 Standard 34 Identification M Last Name IY First Name M Date of Birth M Exam Date TID Number Fig 18 File output form Identification Measurement Values M Axial Length IY Mean Value List Of Values If Keratometer Active Value List OF Values MW Anterior Chamber Depth I White To White Active Value List OF Values Fig 19 File output form Measurement values Operation Keratometer Display C Radius f Corneal K s f Cylinder Cylinder Parade Het fi 3375 l Caution Keratometer indices attects comeal power for a given radius of curvature Fig 17 Dialog box Program settings Program Keratometer LI Program settings Export requires Option A plus Select export settings Select the desired form of file printout Identification or Measurement values and the required printout path The file name can be freely selected By convention the file name may not contain the separators Data will be saved in csv text format separator selectable and may be read with other applications e g MS Excel File output Field
31. 1 524 IOLMaster 24 08 2005 Operation e Click on the appropriate tab to select the desired formula The IOL Haigis HotferQ Holladay SRK Il and SRK T formulae are implemented as standards e After refractive corneal surgery the Haigis L or Prior refractive surgery tabs may be selected e Selected phakal implants may be calculated with the Phakic IOL tab e Select the eye surgeon s name This gives the surgeon access to lens types saved to his database e The measured values may be edited if desired A Warning Edited readings appear with an asterisk in the printout of the lens calculation and the lens calculation is no longer based on the IOLMaster readings e Select an eye for which the IOL is to be calculated on the screen e Enter the desired target refraction No entry means O D plano e Select suitable lenses from the lens types shown e After you have entered the necessary data click on the JOL CALCULATION button This will start IOL calculation of each lens type selected The calculation will be performed for every measured eye However only the data of the selected eye is displayed on the screen e To change the display select the other eye under Eye for surgery The lenses calculated for the other eye will now be displayed IOL Calculation x Haigis SRK II Hotfer Holladay SRK T Multi Formula Haigis L phakic IOL Prior Refractive Surgery Mustermann Max 01 01 1911 Asal Length mrm
32. 25 4 D radio button e To add data to the database click the ADD button e To delete the data of the lens type selected in the Lenses field click the ERASE button e By clicking the SET button existing lens data will be overwritten by edited data e To enter the data of the next lens overwrite the name of the lens Exit the User Manager by clicking on OK IOL calculation Initiate the calculation by e clicking on IOL or pressing the lt gt button The IOL calculation window appears in which the measured values of both eyes are automatically entered Depending on the choice of refractive power radil in the Program Settings submenu page 33 the keratometer readings are displayed in either Corneal K values D or Radii mm Calculation of corneal refraction after corneal refractive surgery Select an eye optional IOL Calculation Mustermann Max 01 01 1911 r Select ia Axial Length mm 23 81 23 67 Eye Surgeon Dr Mustermann v surgeon s Comeal K s ram 7 21 JAEN 7 35 2 7 33 Target Refraction D 0 5 name Optical ACD mm Surgical Eye OD 3 z D1 IOL Calculation Print IOL Calculation Data s at th 5 IOL D REF D IOL D REF D IOL D REF D Lens 1 lens types La ia i he is ee ee ee o O C rh i ee ee es el ns a a as es SS as ee SRK is a trademark of CTI Computational Technology Inc Fig 37 IOL calculation window SRK T O00000 137
33. 5 The database field is structured similar to Windows Explorer see Fig Mustermann Max 01 01 1911 2 29 03 2005 25 left side A sign at the branch indicates that the database already _01 042005 contains measurement results for this patient 14 04 2005 05 04 2005 e Click on the to display the treatment data for the last 07 04 2005 measurement s To close click on the sign 08 04 2005 The data records are sorted alphabetically by last name O00000 1371 524 IOLMaster 24 08 2005 66 New Patient Patient Options 7 Mustermann E lOLMaster Mustermann Max 01 01 1911 e 0329 2005 0470472005 04 05 2005 Open Erase Del Rename lt Ctr F E mit El lOLM aster Mustermann Max 01 01 1911 Operation Use the Search textbox to quickly access a data record Place the cursor in this box and type in the desired last name to list all relevant data records The following letters of the name can also be entered this ensures fast access to the desired data record On repeat visits data can be instantly transferred to the input area by clicking on the patient s name To take a new measurement click the NEW button or use the keyboard shortcut ALT N Retrieving a reading from previous measurements The system permits the review of data records of previous sessions e Click on the sign in front of the patient s name e Use the cursor to mark the examination date being sought e
34. 71 524 IOLMaster 24 08 2005 LI Oo Servicing and maintenance Contaminated parts with which the patient has come into contact during the examination chin rest forehead rest should be cleaned with a disinfectant approved for the purpose These parts are resistant to wiping off with low toxic agents e g suds quaternary ammonium compounds and intermediate agents e g alcohol Javel water iodine classification pursuant to Disinfectants and activity spectrum according to the Center for Disease Control and Prevention Atlanta USA Remove dust trom optical surfaces by means of a fine brush If necessary carefully clean these surfaces with a _ water free ether spirit mixture 9 1 applied with a cotton swab The swab or optical cleaning medium should be applied with circular movements from the centre to the edge Ensure that the regulations for inflammable liquids are observed When not in use the device should be covered with the dust cover provided to protect it from dust The packaging material should be kept for future relocation or repair of the device On request it may also be returned to the supplier Safety checks To ensure it remains in perfect operating condition the device should undergo an annual safety check visual inspection protective conductor resistance and discharge current measurement The safety checks must be carried out by an authorized specialist Local safety regulations must be observed O0000
35. 97 TOUDE OO LINC auenraatcan ast a enuinet aa earanentaat 97 Checking the measurement TUNCTIONS cece cceee cece ee eeeeee anes 97 Axial length measurement and keratometer 00 98 Anterior chamber depth measurement n 98 Verifying WTW measurements optional o n 99 Printer hOUDIESNOOUNG acct eanevamuanlennwn cation Nennddatacruamasics 100 CaO CC ch aie aac pirates ieee ENE 100 Sale CHECKS S eerror OO 101 Technical SOECITICATIONS vicassiinidsscnnsrscndcssideniedadontincideieiendentasendeeeies 102 Manufacturer s Declaration ccccccsssseeseessseeeseassseeseanseeesseaaaes 107 Abbreviations GlOSSAary ccccccsseeeeeeseeeeeseeeneeesseaneeesseanneessaaaees 108 Important for your safety Safety instructions Servicing and maintenance O00000 1371 524 IOLMaster 24 08 2005 Notes on the user manual Symbols The following warning symbols refer to important safety information in this user manual Whenever you see these symbols carefully read the accompanying notes which may warn against possible health risks or death Observe all safety notes and information in this manual and on device labels These notes are marked by the following pictograms AN Warning Risk to the user or patient Caution Risk of damage to the device Type B medical device conforming to DIN EN 60601 1 gt gt Caution Disconnect the instrument from the power gt supply before servicing Information
36. K to confirm your user entries The new user is now registered into the database e For entering lens data see Filling the IOL database page 50f L Note Should a user forget his or her password the administrator may assign a new password For this purpose the logged on administrator highlights the user in the left box and assigns a new password with the SET command button Caution A forgotten administrator password can only be recovered by Carl Zeiss Service O00000 1371 524 IOLMaster 24 08 2005 29 Administrator u 30 Backup Operation Saving data Backup creating a backup copy With the backup function patient data used for the optimization of IOL constants together with the IOL data of all surgeons used for the calculation of respective lenses is saved to a CD RW see page 67 Warning A compressed and password protected file is created in the CD RW Do not attempt to read or manipulate this file using other programs The respective recordings are saved together with the patient s personal data regardless of the set deletion date The backup process also includes the tables used for IOL constant optimisation assignment of surgeon lens patient eye post operative data Additionally the IOL constants currently used for calculation will be saved for all surgeons ms Note In this way all critical patient and IOL data can be saved together with the data required for lens optimisation Individ
37. SNE 2 5 AL 22 29 right mouse button right mouse button SNE 2 5 AL 22 29 right mouse button OO0000 1371 524 OLMaster 24 08 2005 Evaluation of ALM results 73 Post run editing of axial length measurements The results of axial length measurements must be interpreted on the basis of the signal to noise ratio and the appearance of the graphs cf Signal curves of axial length measurements page 70 For reasons of simplification the illustrations below do not show the video image oNAR5 9 AL 22 66 Fig 52 Presentation of the graph of the third axial length measurement 22 66 mm SNR 5 9 without video image SNR categories While the system is internally calculating the axial length from the interference signal it automatically analyzes the SNR SNR gt 2 0 gt The measured value is valid 3 26 mm 23 21 mm SNR in the range 1 6 2 0 gt Measured value is uncertain eo eo om The signal to noise ratio may be low for the following reasons Dense medial opacity along the visual axis restless patients alignment of device to patient eye is not optimal very high ametropia gt 6 D corneal scars pathological changes in the retina ms Note In this case Borderline SNR does not mean an incorrect result it is only to remind you to verity this measurement O00000 1371 524 IOLMaster 24 08 2005 74 7U b6 mm mm Evaluation of ALM results Accu
38. They must not affect the image of the cornea see below At the left margin of the picture additional reflections of the patient s Surroundings in this case a window are visible Depending on the lighting conditions in the examination room the front side of the lOLMaster as reflected by the cornea may also be visible These artefacts do not affect the measurement of anterior chamber depth unless the significant image details images of cornea and crystalline lens and the image of the fixation point are eclipsed by this extraneous light This may be alleviated by slightly darkening the examination room Warning Failing to satisfy the above requirements for the measurement of the anterior chamber depth will either result in measuring errors or the measured values shown will be incorrect Because of the complexity of the images measured under certain circumstances measuring errors may not recognized as such The lOLMaster must be adjusted very carefully for anterior chamber depth measurements O00000 1371 524 IOLMaster 24 08 2005 89 90 Cause Tips for anterior chamber depth measurement The measurement of the anterior chamber depth on eyes with very small pupils e g with glaucoma is particularly problematic and needs some practice The anterior chamber depth of the human eye also depends on the accommodative state of the eye This cannot be assessed from an optical section of the anterior segment ms Note It is
39. To view the measured data press the OPEN icon use the keyboard Shortcut lt ALT gt lt F gt or double click on it The data record is now ready for further editing However no new measurements can be taken e Automatic right left detection is deactivated To select a side click the cursor on the appropriate display or press the lt R gt or lt L gt key Deleting a patient measurements e To delete a patient from the patient list highlight the name and press lt DEL gt or select Delete trom the Patient menu e Confirm the delete action with YES Personal data and individual measurements for this patient will be irrevocably deleted in the Patient Manager The numerical measurement data will still be available in the database for optimization of lens constants ms Note If you are working with the option User login with password you may only delete patient data if you have the appropriate rights see User Manager on page 33 If an examination date is highlighted only the data for this examination date will be deleted The patient name and other measurement data will be retained 000000 1371 524 OLMaster 24 08 2005 Operation ms Note In Options Setup Program Settings you can set the number of days after which a data record is automatically deleted 5 to 365 days Renaming a patient To edit the last name first name date of birth or ID No of a patient follow this procedure e Highlight the patient s nam
40. Y value will be positive if it is below the value will be negative X values to the left of the centre are negative those to the right are positive ms Note If the software has difficulty detecting the iris or fixation point this may be due to inadequate room lighting It is recommended that the front panel and examined eye be shielded from direct or lateral light The best results will be obtained when the examination room is slightly darkened WTW measurement may be repeated as often as desired OO00000 1371 524 IOLMaster 24 08 2005 Operation Measurement of the other eye The system automatically registers which eye is being measured OD or OS All past readings of this patient are still stored and may be retrieved as necessary Measurements of the other eye must be performed analogously to the previous eye ms Note After each change of side the overview mode is automatically activated for coarse alignment Printout of results Once the measurements have been completed the readings may be printed out together with a measurement curve of the axial length with the highest signal to noise ratio and a diagram of the iris pupil and WTW Caution Consult the user manual supplied with the printer Connect the printer as described in Setting up on page 20 ms Note The following print formats are supported upright format only A4 210 x 297 mm Letter 8 5 x 11 0 B5 182 x 257 mm The printout of the read
41. abelled as such Then call Zeiss Service The device does not support the submission of automatically generated problem reports to Microsoft The device may be operated by LI using the icons by cursor touchpad LI keyboard or J menus Measurements are initiated by pressing the button on the joystick OO00000 1371 524 IOLMaster 24 08 2005 Operation Operation by touchpad and keyboard 1 Touchpad 2 Left button 3 Right button Fig 10 Touchpad control Li Move the cursor by touching the touchpad with your finger and moving it as desired LI Single and double clicks are possible by tapping a finger on the touchpad or pressing the left mouse button L To drag the cursor hold the left mouse button depressed while moving the finger across the touchpad LI The right button is only functional for resetting the zoom function page 72 continuous positioning of the measuring cursor while dragging see page 721 Selection of menu textbox or entry Operation of Windows command buttons or icons OK confirmation of actions In addition to program control via touchpad you may also activate certain menus by pressing individual keys or key combinations see Menu overview on page 27 and Overview of buttons and shortcut keys on page 25ff O00000 1371 524 IOLMaster 24 08 2005 23 24 Operation Screen layout Carl Zeiss IOLMaster 10 9 8 7 Menu bar Display field for measurements of right eye
42. active for longer than the set interval This prevents unauthorised viewing of protected patient data Screen Saver W Activate Idle Time ji mir Password Protection Fig 23 Dialog box Program settings User management Screen saver User Manager Click on the USER MANAGER button The dialog box on the left hand side of the User Management in the User Manager permits further users to be registered with the New button their password to be specified Password or users to be deleted Delete O00000 1371 524 IOLMaster 24 08 2005 35 u Caution If you change the Admin pass word you are advised to note down the new password e g in the device record book The user management system cannot be accessed without the Administrator password In the event the password is lost the device can only be reset by Service The Password protection option offers added protection If this is activated you will only be able to work with the lIOLMaster and its database after logging on again with the password 36 Operation user manager jj x Manage users Ser Membership o 7 Mew Delete Change password Add Retro ye User Group Management Under user groups you will find an overview of all user groups with their privileges Here you can change the privileges of the groups User Groups Fig 24 Dialog box Program settings User management User Manager Each user may be a
43. advisable to measure accommodating patients under cycloplegia Measuring errors The Error message may have two basic causes Li The results of the five internal individual measurements vary by more than 0 15 mm very rare or Li the images produced optical sections do not contain relevant Structures normally without the edge of the crystalline lens or disturbances are preventing their detection Maladjustments Defocused device Fig 70 Image of a strongly defocused device If the device is not optimally focused the image of the fixation point will be larger and fainter At the same time the images of the front edge of the lens and or the cornea may become so faint that they cannot be recognized as such In such a case the system displays an Error message and an explanatory text indicates which image details are either missing or could not be recognized correctly Improve the focus adjustment of the device and repeat the measurement The fixation point must be optimally focused OO00000 1371 524 IOLMaster 24 08 2005 Tips for anterior chamber depth measurement 91 ms Note As a rule slight defocusing of the device does not have a significant affect on the anterior chamber depth measurement Missing lens image with phakic eyes Particularly in the case of eyes with small pupils it is possible that no Cause light is reflected back into the viewing optics of the device A slight lateral misalignment
44. alue between 4 0 and 13 0 mm use decimal point Proceed with OK or the lt ENTER gt key If you have selected the display Corneal K s please enter a number between 26 and 80 D When entering the corneal K s make sure that the same keratometer refractive index is set on the IOLMaster as on the keratometer used for the measurement see page 33 A blue status bar will appear in the message bar Five ACD readings will be listed in the display field next to the video image together with the calculated mean value The anterior chamber depth measurement may be repeated as often as desired If additional measurements are taken of anterior chamber depth the previous readings will be overwritten To restore the last just overwritten readings press shortcut keys lt CTR gt lt Z gt UNDO function ms Note The UNDO function itself cannot be undone OO00000 1371 524 IOLMaster 24 08 2005 Operation 47 Determination of white to white optional Activate the WTW mode by e clicking on the WTW icon or e pressing the lt w gt key e pressing the lt SPACE BAR gt in ACD mode ACD e The patient should look at the yellow fixation point in the centre e Align the device so that the six peripheral measuring points are symmetrical to the crosshair and the iris structures or the edge of the pupil appears optimally focused The fixation point in the centre of the 6 light dots is usually not in the centre of th
45. and advice for a_ better cS Note understanding of the instructions to be observed in the operation of the device Warning Correct operation of the instrument is imperative for its safe function Please familiarise yourself thoroughly with the contents of this user manual before using the device Purpose of this documentation The purpose of this user manual is to acquaint the user with the design operation setup handling of the device together with the safety cleaning and maintenance procedures for the system Availability of the user manual Always keep this user manual and all accompanying documents in the immediate vicinity of the device This user manual must always be readily available OO00000 1371 524 IOLMaster 24 08 2005 Safety instructions Standards and regulations Li This device is a Class lla medical instrument as defined by the European Medical Device Directive MDD LI The device complies with the EC Medical Device Directive 93 42 EEC and its national equivalent in the form of the German Medical Products Act MPG gt Manufacturer s Declaration on page 107 Notes on installation and use Li The device may not be stored or operated in environmental conditions other than those prescribed see Technical specifications on page 102 LI Do not operate the device in locations subject to explosion hazard in the presence of inflammable anaesthetics or volatile solvents such as alcohol benzene or
46. axial length measurement mode after the current individual measurement and in post measurement editing mode OO00000 1371 524 IOLMaster 24 08 2005 Evaluation of ALM results Interpretation of axial length measurements As a rule an interference signal is produced if the measuring light is reflected by the tear film and the retinal pigmented epithelium of the eye This signal is utilized for axial length measurements ms Note Ultrasonic biometrical instruments measure the axial length as the distance between the cornea and the inner limiting membrane because the sound waves are reflected at this membrane To ensure that the measured values obtained with the OLMaster are compatible with those obtained through acoustic axial length measurement the system automatically adjusts for the distance difference between the inner limiting membrane and the pigmented epithelium The displayed axial length values are thus directly comparable to those obtained by immersion ultrasound At this point the importance of re personalizing the lens constants should be stressed because the IOLMaster is based on a new more precise measurement technology Refer to the specialist literature and publications by the originators of the IOL formulae regarding the personalization of constants Updated information is available in the Internet at http www meditec zeiss com iolmaster and or http www augenklinik uni wuerzburg de ulib With an optimall
47. constants divided by the number of patients and standard deviation are then calculated Lens constants which are more than double the standard deviation are not included in the optimization If less than 11 data records exist for optimization or data records are rejected 0 D will appear in the New column In this case the optimization has failed Repeat the optimization process in this case with a larger number of data records or perform several optimizations for various groups of eyes e g short normal and long eyes This procedure also ensures a higher degree of accuracy in IOL calculation The resulting mean value will be displayed as an optimized constant To obtain optimum constants patients with pre intra or postoperative complications which could affect the refraction state should be excluded ms Note The displayed aO value does not take into account the data records highlighted in yellow e To reject the last optimization run click On CANCEL In this case the optimized constants will not be saved to the lens data base even If a new data record has been entered e Confirm the newly optimized lens constants by clicking on the lt lt button to the right of the Basis field In this case all optimized constants will be accepted If you wish to accept only a specific constant only e g a0 click on the lt lt button to the right of this constant O00000 1371 524 IOLMaster 24 08 2005 63 Basis lt
48. d enable at least a transfer rate to USB 1 1 To export data to a USB storage medium or a CD RW press the lt X gt key or the EXPORT icon Data will be available in a text file conforming to the export settings see page 34 for archiving and data analysis 000000 1371 524 OLMaster 24 08 2005 Operation Switching off the device e When all measurements have been completed exit the program by pressing the EXIT icon or lt E gt key e Then press OK or lt ENTER gt The data of the current last patient will be saved automatically e When the It s now safe to turn off message appears turn the device off by the mains switch e Wait until the screen goes off before pulling the mains plug or switching off at the mains Caution If the power switch is turned off while the device is in operation the program automatically quits and the device is shut down You should therefore wait until the screen is blank before unplugging the instrument or switching off the main room switch If you unplug the instrument or switch off the room switch whilst the instrument is running the software cannot quit automatically and the operating system cannot be shutdown properly which can lead to loss of saved data or errors in the instrument s control software This does not present any hazard to patients or the operator ms Note The procedure described below does not apply in the case of breakdowns see page 97 or if the device does not re
49. d save the data OO00000 1371 524 IOLMaster 24 08 2005 Servicing and maintenance 97 Troubleshooting If the system fails during operation take the following steps to restart e Switch on the power supply at the power switch 1 Fig 9 An automatic test program will run before Windows is launched Once this has been successfully completed Windows and the device program will be restarted and work can be resumed Caution 1 Pulling the mains plug or cutting off the power while the device is running may cause a loss of data and or defects in the device s control software However no danger to the patient or user ensues as a result Checking the measurement functions The test eyes supplied with the device 1 Fig 77 are for verifying that the device Is serviceable and properly calibrated Measurements can be performed on these test eyes as with a human eye Last first name and date of birth are essential here as well The supplied scale is to be used for checking the WTW value optional N Warning The calibration must be checked every day before starting measurements on a patient The measured values can be printed out and filed for documentation purposes If the values obtained from the test eye are not within the given tolerances no patient measurements may be taken The device must be shut down immediately and secured against inadvertent use Then notify Carl Zeiss Service Test eye holder
50. de 120 V 20 Fig 7 Mounting holding bracket Description of the device Setting up The device must be set up and commissioned by authorised representatives of Carl Zeiss the latter also instruct the users on the operation of the device In general Carl Zeiss Service will perform the following operations Installation LI Remove and unpack box containing accessories L Carefully remove the device from the box the device not should be lifted or carried by the measuring head LI Removing shipping braces Loosen device lock knob 3 Fig 3 Basic securing Turn joystick clockwise one turn to move the device upward and pull out the red plate underneath the base axis patient side Remove red pads trom the wheel housing of the device base Securing device with holding bracket The OLMaster can be permanently secured with the aid of a holding bracket 3 Fig 7 Holding brackets with two different thicknesses are available 7mm holding bracket for securing to the instrument table 5 5 mm holding bracket for securing to the keyboard support Go Caution The two holding brackets are mounted in the same way Make sure you use the correct holding bracket Do not lift or carry the device by the measuring head e Tilt the IOLMaster to one side so that it rests on the patient head support e Remove the three hexagon socket screws SW3 1 Fig 7 The screws may be very difficult to loosen r
51. device relative to the eye then take a measurement In such cases it is advisable to repeat the measurement several times Depending on the degree of irregularity fluctuations or measuring errors may occur Fig 67 Condition following keratoplasty i Note In this case keratometer measurements cannot be taken with the lOLMaster O00000 1371 524 IOLMaster 24 08 2005 88 Tips for anterior chamber depth measurement How to adjust the device Ask the patient to relax and look at the yellow fixation light If the patient cannot see the fixation light he or she should look straight ahead into the device When the anterior chamber depth mode is turned on the system automatically activates the lateral slit illumination The illumination always originates trom a temporal direction The slit illumination will appear subjectively bright to the patient The measured values of the light load see Technical specifications page 102 however are smaller by several orders of magnitude compared to slit lamp examinations When the measurement is taken the slit illumination will start to flicker The patient should continue to look at the yellow fixation light not the slit Note Although it is not dangerous to look into the slit projector this leads to erroneous anterior chamber depth values Fig 68 Optimally adjusted optical section for anterior chamber depth measurement An image similar to that of a slit lamp optical section t
52. e confirms that installation of the selected printer is finished EXIT WITH FINISH Fig 8 Installing the printer 22 Operation General remarks on instrument control The operating system of the device s control computer works in the background For safety reasons it is not accessible to the user Caution Attempts to modify the operating system are prohibited In particular deactivation of the Windows firewall is not permitted Windows operating conventions apply analogously to the user interface of the lOLMaster software This relates to working with a mouse touchpad the use of icons working with dialog boxes and menus confirmation by double click etc ms Note The system does not support all Windows key shortcuts e g the special Windows keys existing on some keyboards are ineffective The software uses only a few forced processes The user may switch freely between the individual modes For rational working the user is urgently advised to observe the sequence of measurements described from page 38 onwards In rare cases Windows error messages may appear on the LC display This could happen for instance if the program flow is interrupted mostly by external interference e g from mobile phones Risks to human beings are reliably precluded by multiple safety mechanisms in the device s hardware and software Caution If warning messages appear frequently the instrument should be taken out of service and l
53. e operator is only required to adjust the device to the patient s eye and initiate the measurement Biometric eye measurements with the lOLMaster can be learned very quickly without time consuming training courses Extensive integrated safety features independent redundant hard and software safety features ensure maximum safety for both the patient and operator when using the OLMaster O00000 1371 524 IOLMaster 24 08 2005 15 16 Description The control program for the computer in the device base runs under Windows A backlit LCD serves to observe the patient s eye and display the readings The device is controlled by the joystick and computer keyboard with integrated touchpad From the measured values the integral computer can make suggestions for optimum intraocular lenses The latter are based on internationally accepted calculation formulae The Haigis HotferQ Holladay SRK Il and SRK T formulae are implemented in the package contents The Haigis L formula may be used to calculate IOLs following myopic Lasik PRK The retractive history or contact lens method may be used to correct the measured corneal radii refraction following refractive corneal surgery Selected phakal implants may be calculated by the calculation for nm 1 phakic implants An IOL database is likewise implemented Prior to calculation the latter must be filled with data for the desired lens On the basis of postoperative refracti
54. e 97 Patient Manager New Patient The Patient Manager manages all existing patient data and the admission of new patients see Fig 25 for working with existing patients see page 65 To admit a new patient proceed as follows New Patient Patient Options First Name Input of patient data Mustermann Max 0170171911 Apostrophe D Underline oe 4 06 03 2005 notes optional l 0372972005 Date of Birth mandatory The following special characters 0470472005 a 0470572005 P T ee ne patient data 0470872005 08 D o b Wb refraction 04 20 2005 i D and visual i 04 21 2005 Visual meee acuity 04 22 2005 l as Minus Oe l 04 25 2005 1 Reman optional l 04 26 2005 Dot 2 3 05 24 2005 i 06 01 2005 Room for l l SE SE Database field Fig 25 Dialog box New Patient The personal data of patients not listed yet in the database New Patient must be entered via the keyboard no special characters other than and _ are permissible To move the text cursor to the next dialog box press the TAB or ENTER key or click the mouse ms Note Depending on the program setting see page 33 the entry of either the last and first name case sensitive and date of birth or an ID No is mandatory The date of birth will be accepted depending on the Windows setting the year may also be e
55. e and press lt CTR gt lt U gt or select Rename in the Patient menu The patient data can be edited in the dialog box which now appears Once the renaming has been confirmed patient data for all measurements will be changed If personal data is to be changed for only one examination date the examination date must be highlighted before the lt CTR gt lt U gt keys are pressed Measurement results cannot be renamed e Confirm the changes with RENAME Rename record Last Name Mustermann First Name Max Date Of Binh 1017911 OO Exam Date Ei IO number PO Cancel Fig 50 Dialog Rename record Transmitting exporting data optional Patient data can be exported to connected office administration systems or personal computers a USB storage medium or a CD RW The data is then available for further processing ms Note Transmitting exporting does not work in the Patient Manager only in measurement modes O00000 1371 524 lOLMaster 24 08 2005 67 Erase Del Rename lt Ctrl F El lOLM aster Mustermann Max 01 01 1911 EEEEITE 01 04 2005 04 04 2005 05 04 2005 07 04 2005 08 04 2005 68 Operation Exporting data to another system LI Data can only be exported to office management systems by the Supplier of such systems Please contact the respective supplier The appropriate accessories are required for exporting to a connected Windows based personal co
56. e pupil or iris because only in the rarest cases does the visual axis correspond to the optical axis of the eye Warning Ask the patient if he or she sees the fixation point If the patient Tails to fixate properly the visual axis will not be correctly detected which may result in measuring errors e Take the measurement by pressing the button on the joystick Carl Zeiss IOLMaster Patient Functions Options 7 1 Center fixation point in ring 2 Focus iris 3 Push or button 4 Evaluate image J at John Ziz wie OD Fig 34 WTW determination Each time the joystick button is pressed an image of the eye is displayed in which the detected iris edge is marked After a check of correct recognition of the iris and the fixed point has been performed confirm with OK Only then is the data valid and available for further processing Warning AN The validity of the WTW determination depends on this check of correct recognition of the iris edge 000000 1371 524 lOLMaster 24 08 2005 48 Operation The WTW value is the horizontal diameter of the iris In addition to the WTW value the distance of the visual axis from the centre of the iris x y will also be displayed Fig 34 The values are stated in millimetres with reference to a Cartesian coordinate system the zero point of which is assumed to be in the established centre of the iris or pupil If the visual axis is above the iris or pupil centre the
57. easuring cursor to another peak it is recommended that these manipulations be carried out in a zoom view of the measurement curve 1 Automatic positioning over a distant peak e Place the arrow cursor on the white dot hold the left button depressed and move the measuring cursor over the other peak For easier orientation a vertical blue line will appear below the white dot This line can be dragged with the cursor e When the button is released the measuring cursor automatically snaps in over the desired peak The display will show the corresponding axial length value and SNR always smaller than the maximal SNR found automatically and the recalculated measured value will appear in the display field denoted by an asterisk OO0000 1371 524 OLMaster 24 08 2005 Evaluation of ALM results Example hold left mouse button depressed SM Re AL as 1F blue line is moving along with cursor release mouse button SMR 1 5 AL 2 44 recalculated axial length and SHR Fig 53 Moving the measuring cursor to a different peak signal curve zoomed in 3 times Please note This manipulation will work only if the measuring cursor is moved across the local maximum of the desired target peak This procedure is necessary for the search algorithm to reliably find the desired peak without returning and snapping in to the original higher peak Closely adjacent peaks double peaks cannot be separated by thi
58. echnology Irie Power Steps 1 2D tL Fig 44 Lens data in the User Manager dialog box 000000 1371 524 OLMaster 24 08 2005 Operation 59 Loading existing data records e Click on the LOAD button to load the data records of all patients available for optimization Jahn O Public O D Actimed Actflex Measurement Table Filter l Search Mustermann Auge 01 07 1977 05 22 l a lustermann Auge 01 07 1977 05 2 Last Name Mustermann Auge 01 07 1977 05 2 C lustermann Auge 01 07 1977 05 2 mna Mustermann Auge 01 07 1 977 0572 Date of Birth C Mustermann Auge 017071977 05 2 Mustermann Auge 01 07 1977 057 2 Exam Date 2 Mustermann Auge 01 07 1977 05 2 Mustermann Auge 017 0771977 06 0 I Humber 2 Mustermann Auge 01 071 978 052 Mustermann Augejhjh 01 07 1977 0 Mustermann Augek 0170771977 05 Mustermann Augek 017 0771977 05 7 Mustermann Augekh 01 07 197 7 05 Mustermann Auger 010771977 05 2 Mustermann D 250505 017 0171990 0 Mustermann Erhard 117 11 1888 05 1 Mustermann Franz 07071977 05 2 Opte tmini Mustermann g 01 01 1911 05 31 2 Ble E Mustermann g 01707 1977 05 24 21 AE EE Mustermann Haigis L 01 01 41911 05 Mustermann Hanna 11 1777 922 057 HMustermann Hanna 11 1171 922 057 Mustermann H ans 05 07 1955 05 01 Mustermann Hermann 117 1172003 0 Mustermann Hermann 11711720030 Mustermann heute 01701 1911 05 3 Mustermann jj 05 25 2005 Mustermann
59. ements if necessary 000000 1371 524 OLMaster 24 08 2005 Operation Measurement of anterior chamber depth ACD Warning The anterior chamber depth may only be measured on phakic eyes ACD measurements of pseudophakic eyes result in measuring errors and or incorrect readings The readings for pseudophakic eyes do not reflect the anterior chamber depth ms Note The keratometer measurement must be performed before anterior chamber depth measurement Activate the ACD mode by e clicking on the ACD icon e pressing key lt V gt or e pressing the lt SPACE BAR gt in KER mode KER The lateral slit illumination will automatically be turned on This illumination subjectively appears to be very bright to patients Nevertheless the patient should continue looking at the yellow fixation light e Fine adjust the device so that the fixation point Is displayed in optimum focus in the rectangle on the screen only the fixation point should be within the rectangle not all the other image details the image of the cornea is not interfered with by reflections otherwise the reading will be incorrect the anterior crystalline lens is optimally visible As arule the image of the fixation point will lie between the images of the cornea and the crystalline lens It should be close to but not within the optical section of the crystalline lens For system reasons the corneal image will be out of focus Fig 33 Adjus
60. eration IOL calculation after corneal refractive surgery optional Corneal refraction is an important quantative factor in IOL calculation Precise measurement of the refractive power of a cornea subjected to refractive surgery e g by RK PRK LTK Lasik or Lasek is currently not possible For this reason a different method of determining corneal refraction must be adopted for the IOL calculation Three methods are available LI Refractive history method LI Contact lens method LI Haigis L method should the preLasik or corresponding contact lenses not be available Prior to calculating an option for an intraocular lens the corneal refraction must be determined Initiate the calculation by e clicking on JOL or pressing the lt gt button e Select the Prior refractive surgery tab Warning This step is necessary only with corneas pretreated by refractive surgery With untreated corneas IOL calculation is started instantly upon selection of the biometric formula see IOL calculation on page 51 Refractive history method The following values must be known for the refractive history method LI Preoperative corneal refraction i e before corneal refractive surgery LI Preoperative retraction LI Stable postoperative refraction L Corneal vertex distance As the change in retraction was achieved by variation of the corneal refraction the currently effective corneal refraction directly results from the difference betwee
61. erformed with the help of the zoom function i Note The resolution of fine retinal structures is clearly distinguishable from the previously mentioned secondary maxima which are further away from the multiple peaks and symmetrical to them The distance between the maximum peak and internal limiting membrane or choroid is 350 um whereas the secondary maxima are about 800 um from the maximum peak OO00000 1371 524 IOLMaster 24 08 2005 Evaluation of ALM results Signals from the inner limiting membrane ILM The measuring beam is relatively often reflected at the inner limiting membrane likewise producing an interference signal The respective signal peak lies to the left of the actual measurement peak to the shorter axial lengths The distance of the peak generated by the reflection on the inner limiting membrane trom the measurement peak is between 150 and 350 um Both peaks can be observed separately in a zoom view of the graph oh R64 AL a4 Fig 55 Double peak produced at inner limiting membrane triple zoom Usually the signal amplitude of the peak from the inner limiting membrane is smaller than that of the interference on the pigmented epithelium In such a case the automatic algorithm finds the correct axial length Warning Never move the measuring cursor manually to the left peak produced by the inner limiting membrane see above In rare cases the amplitude of the signal from the inner limiting membrane
62. es of the CUStOMET eessinnneesriiiueesrririresrrirrerrrrrrn 14 Desp COM nnna a a 15 EDO 21 MI S EESE E Pe eae AEE E AE E 15 UIST ona aeset r Aaecems sent 15 Overal EW eer e a a eer a 17 Optonakacc ess oNE Sen a E 18 Power isolation transformer for external devices 19 SEINO Uere A E E Gt aes sen aa tadies 20 SEEE E E A E EEE A E EAS 20 Electrical COMME CTI OM assen E E I AA 21 Opera tUo Nie a eta rider a 22 General remarks on instrument control sineesiieesriieerrreennn 22 Operation by touchpad and keyboard eesneessiesiieenreerinennnn 23 reemIay oU ar E meets 24 Overview of buttons and shortcut keyS ceessiieeeesriireeerrrrnn 25 MENU OVENI EW doseren E 27 TONS MENU eent 28 OSTROW aana a aaa ana ane ea case acces 28 DS OP INA OC nexare ntataaceerucastaaergnertelatamich H 28 Sel IMI Cl ce eset tg PT fu EEE E A Gla toa te ad fons 30 S110 0 Renee te eee Cane Serene ee emer E ee eee E 33 Preparing for measurements cece cece cee eeeccceceeeeeeeeeeeeesaneeeeees 38 SWITENHING TNE device ON sessi i aT 38 Patient Manager New Patient ccceccceeecceeseeeeeseeeeens 38 000000 1371 524 lOLMaster 24 08 2005 Contents Adjusting the device to the patient ccceccceeeeeeeeeees 39 Axial length measurement ALM AO Measurement of corneal curvature KER c cccecceeeeeeeeeeeeees 43 Keratometer Me aSUreMe N Eis vccisiesciiscciecteieactieceeteccnceasetaes 43 Measurement
63. g 29 Additional AL functions Sample calculation for a phakic implant Acrysof with a centre thickness of 0 2 mm Measured value 23 51 mm Compensation value 0 03 mm Correct axial length 23 51 0 03 23 48 mm Operation The number of measurements of the respective eye taken on this particular day is displayed in the Mode field of the status bar next to ALM If the count reaches 20 no further measurements of this eye can be taken on this day The counter cannot be reset Deleted readings see above do not affect the measurement counter SHR 4 2 AL 22 045 A ee Fig 28 Video image after axial length measurement ALM measurement of non phakic eyes To measure non aphakic eyes select the corresponding mode from the AL Settings menu This special AL mode is displayed in the video image field and will be active until you reset it via the menu The device will also be reset to phakic mode if you change to the patient s other eye or a new patient If the axis length of eyes with phakic implants not listed in the additional AL functions is to be measured the following compensation values according to PD Dr Wolfgang Haigis of Wurzburg University Clinic Germany should be used IOL centre hickness IOL material mma 002mm 006mm 0 09 mm Every implant e g a phakic IOL influences the measurement of axial length in PCI biometry If a phakic implant is measured in a normal phakic mode the resul
64. how the number of data records in the specified axial length ranges Once all IOL and post op data has been entered the requirements for the optimisation calculation have been met LI If a patient data record is highlighted in red no IOL and or post op ref data has been entered for this data record or a measured value AL or KER is missing LI If a patient data record is highlighted in yellow no ACD values exist as yet for this data record a0 Haigis formula is not optimised with these data records LI Patient data records appearing on a white background contain all the data required for optimisation ms Note Only the a0 can be optimised with the device software for the Haigis formula For the optimisation of a0 a1 and a2 more than 200 data records required please send this clinical data to Carl Zeiss Meditec OO00000 1371 524 IOLMaster 24 08 2005 Operation Starting optimisation e Start the optimization calculation by clicking on the OPTIMIZE button Depending on the number of data records to be processed the computing process may take some seconds The optimized lens constants will now be displayed in the New column ms Note Data records with an IOL power of O D will not be included in the optimization process The optimization calculation supplies lens constants for every patient s data record as they should have been on the basis of the measured values and results of surgery The mean value sum of all lens
65. hrough the anterior segment of the eye is visible on the display Align the device to the patient s eye by lateral adjustment using the joystick until Li the image of the fixation point appears optimally focused in the green square on the display Li the image of the cornea right eye deflected to the left left eye to the right is free of reflections system related lack of definition and LI the image of the anterior crystalline lens is visible in the pupil ms Note The image of the fixation point may not lie in the image of the lens or cornea O00000 1371 524 IOLMaster 24 08 2005 Tips for anterior chamber depth measurement If the device has been properly aligned the images of the fixation point and the front surface of the crystalline lens will be simultaneously in focus as they are approximately in the same plane As a rule the image of the fixation point lies between the image of the anterior lens and that of the cornea if the device is optimally aligned ms Note The image of the fixation point should be near but not within the optical section of the crystalline lens Fig 69 Optimally adjusted optical section lens with cataract Fig 68 and Fig 69 show optical sections of the right eye The patterns to the left of the corneal image are direct reflections of the luminous light exit aperture of the lateral slit projector These reflections are not needed for the calculation of the anterior chamber depth
66. ic silicon IOL data Pseudophakic memory Setup Adjusts various settings Pseudophakic PMMA Date time Pseudophakic Acryl Silicon filled eye Silicon filled eye aphakic Silicon filled eye pseudophakic Phakic IOL PMMA 0 2 mm Primary piggy back silicon SLM 2 Sets system clock Program settings Adjusts program and export settings User management User manager Regional settings Windows routine Printer Opens system folder SW option Installs de installs Primary piggy back software options hydrophobic acrylate Update Installs software update Service Only for service password protected About lOLMaster Displays program version 28 Fig 12 Test Epe User Database Setup d Service Options menu Operation Options menu Test eye The calibration of the device can be checked with this function see Section Checking the measurement functions on page 97 User manager Since the device may be used for the preparation of eye surgery by a number of surgeons at a group practice or clinic surgeon specitic records may be created This is performed using the User Manager on the Options menu e Click on User manager in the Options pull down menu The dialog box for entering surgeon specitic data will appear Please input password Name Password Cancel Change Password New Password Comparison if a x Fig 13 Dialog box Please ente
67. ical radiation density of a light source white LED slit illumination for the phakic eye Lp 122 8 W m sr O00000 1371 524 IOLMaster 24 08 2005 106 Technical specificatons Photochemical radiation density of a light source white LED slit illumination for the phakic eye Lp 122 8 W m sr The spectrally assessed photochemical radiation densities L and L are a measure of the possibility of photochemical damage of the retina through light L represents the measure for the phakic eye L represents the measure for the aphakic eye or for the eyes of very young children Readings of L and L more than 800 W m sr are considered high The radiation dose of the retina for a photochemical risk is calculated as the product of radiation density and exposure time The recommended radiation dose is based on calculations of the American Conference of Governmental and Industrial Hygienists ACGIH Threshold Limit Values for Chemical Substances and Physical Agents Edition 1995 1996 The measured photometric values of the IOLMaster are far below the levels that are regarded as high Thus the risk of damage through optical radiation is extremely low Nevertheless anterior chamber depth measurement with the IOLMaster should be limited to the time absolutely necessary for the diagnosis The risk of damage may be higher if fundus photography of the patient to be examined has been taken within the last 24 hours Technical details and deli
68. in The device may only be used in combination with accessories delivered by Carl Zeiss Meditec see Section Optional accessories on page 18 Please consult Carl Zeiss Service regarding the use of other accessories Functional description The lOLMaster is a combined biometry device for measurements on the human eye required for the preoperative computation of intraocular lens power It is capable of fast and precise consecutive measurement of the following eye parameters in one session axial length corneal curvature anterior chamber depth and optionally white to white All measurements are non contact providing excellent patient comfort The axial length measurement is based on a patented interference optical method known as partial coherence interferometry PCI The displayed results of the axial length measurements are compatible with the ultrasonic immersion measurements of axial length via the use of an internal statistically verified calculation algorithm The familiar formulae for IOL calculation can thus be used The corneal curvature is determined by measuring the distance between reflected light images projected onto the cornea The anterior chamber depth is determined as the distance between the optical sections of the crystalline lens and the cornea produced by lateral slit illumination White to white is determined from the image of the iris The individual measurement procedures are automated so that th
69. ing and maintaining the printer removing a printer which is no longer required see also page 21 SW option Installing or de installing a software version Update To Install a new software version from a CD Insert an update CD into the drive Click on Update to start the software update installation routine Follow the instructions shown on the screen After installation the system will be automatically shut down and restarted Remove update CD from the drive If the OLMaster reappears in New Patient mode after restarting the installation of the software update has been completed Caution 1 To switch the device off first press the EXIT icon and confirm with OK Do not switch the device off at the mains switch for as long as the cursor can still be moved on the display using the mouse pad Operate the mains switch only when the cursor can no longer be moved LJ Service For servicing purposes and password protected Warning Unauthorised persons may under no circumstances use the service AN password The safety warranty for the medical device will otherwise become invalid 000000 1371 524 lOLMaster 24 08 2005 38 Operation Preparing for measurements Switching the device on e Turn on the power switch 1 Fig 9 The device will start automatically and perform a self test after which the Patient Manager screen will appear Fig 25 e Then check the measurement functions as described on pag
70. ings may be started from every measurement mode ALM KER ACD WTW The printout will include all results obtained so far also those of the other eye if already available It is advisable to start the printout only if all results of both eyes are available ms Note Do not take any further measurements during the printing process Press the PRINT icon or lt P gt key to start the printing process i Note In ALM mode the printout of the graph with the blue highlighted reading can be enlarged by pressing lt CTR gt lt P gt For enlarging the display of the graph see page 72 In WTW mode the current reading can be printed out using lt CTR gt lt P gt O00000 1371 524 IOLMaster 24 08 2005 i ll 49 Please input password Ea Password MAUSE Cancel l Change Password New Password Comparison Fig 35 Entering a password Operation Generation of IOL options Once all measurements have been taken depending on the IOL calculation formula options can be generated for intraocular lenses to be implanted Filling the IOL database Before the system can calculate IOL options the available lens types must be entered into the database e In Options User Manager open the input box Password Input e Select the appropriate name and enter password as necessary The database window for entering specific lens data will open for registering a new user see page 28 User Manager Administrat
71. ion of piggy back implants 4 in 1 calculation To compare the results of four different calculation formulae select one of the four selection boxes for the desired formula Select CALCULATE IOL to display the results To print out the page with the results press PRINT 000000 1371 524 lOLMaster 24 08 2005 58 E aziz lt lt Mew AConst 118 lt lt fs SRK I AConst 118 lt lt sake ad 1 273 _ lt lt zz Haigis pac 496 lt lt Hoffer sF i22 e Holada Load Hptimee Erase Fig 43 Lens data in dialog box for selected lens Operation Optimisation of lens constants Selecting lens data The lens data available in the database may be optimised by the following procedure e In the Options menu open User Manager Select the respective eye surgeon and confirm your choice with OK Fig 44 e Choose a lens The input mask contains constants calculated from Manufacturer s A Constant or previously optimized constants e Click on the OPTIMIZE button The dialog box for the selected lens will appear and the lens constants can be seen in the Basis column Fig 43 User Manager Administrator Or Mustermann Lenses Mame es s lt s A Const pme Manufacturer ACD hae Hanufacturer A Const 1E SRK I A Const 118 SAKSAT a ha al pe o Ha igi ae jor PACD 4 96 Hotie SIP j 22 Holladay C 140 Erase Optimize SARS is a trademark of CTI Computational T
72. l be displayed L Note The IOLMaster requires three measurements to be taken The message Measure again will thus appear Only then will a mean value be passed on to the IOL calculation and an evaluation enabled Only the number of measurements Is crucial here To restore the last just overwritten readings press shortcut keys lt CTR gt lt Z gt UNDO function is irrevocable To delete one of the three displayed readings select it and press the lt DEL gt key Now confirm with YES If the last three readings differ by gt 0 5 dpt mean value of the spherical equivalent of the last three measurements or if the tolerance of the mean radius of the last three readings of 0 08 to 0 1 is exceeded dependent on n the Evaluation message will appear on the screen e In this case check the tear film of the eye being examined ask the patient to blink if necessary and repeat the measurements until the results are within the tolerances The Evaluation message will then disappear e The measuring errors must be deleted if necessary as the readings obtained in the Evaluation state will not be accepted tor ACD measurement IOL calculation and the database for optimisation of constants e Highlight the reading to be used for IOL calculation By default the last reading will be highlighted in blue Warning To obtain consistent results we recommend checking the individual keratometer measurements and carrying out further measur
73. l refraction and checked for plausibility It is likewise helpful to compare the right and left eyes After the second measurement the mean of the axial length measurements will also appear This value will be recalculated and updated with each additional measurement If the result of one measurement differs by more than 0 1 mm from the other s an Evaluation message will be displayed This indicates that the measurement results must be edited later see Post run editing of axial length measurements page 73ff As long as Evaluation is displayed in place of the mean value the potential measuring errors must be deleted or adjusted as the readings will otherwise not be adopted in the IOL calculation and the database for optimisation of the constants The last reading is always displayed with a blue background The blue marking can be moved through the table of readings with the help of the cursor buttons TY Error in the display tield denotes readings with an SNR smaller than 1 6 Such individual readings are excluded from the generation of a mean value and do not need to be deleted O00000 1371 524 IOLMaster 24 08 2005 41 42 Phakic Aphakic Pseudophakic Silicone Pseudophakic Memory Pseudophakic PMMA Pseudophakic Acryl Silicone Filled Eye Silicone Filled Eye 4phakic Silicone Filled EYE Pseudophakic Phakic IOL PMMA 0 2mm Primary piggy back Silicone SLM 2 Primary piggy back hydrophobic acrylate Fi
74. lOLMaster Software Version 4 01 User Manual Copyright Knowledge of this manual is required for operation of the device You should therefore familiarise yourself with the contents of this manual and pay special attention to instructions concerning the sate operation of the device We reserve the right to make changes to the product in light of technical developments these operating instructions will not be updated Unless expressly authorised dissemination or duplication of this document and commercial exploitation or communication of Its contents is not permitted Persons in contravention of this copyright are liable to pay compensation for damages All rights reserved in the events of granting of patents or registration as a utility patent O00000 1371 524 IOLMaster 24 08 2005 Trademarks All names of companies and products mentioned in this manual may be trademarks or registered trademarks The quoting of product names is for information purposes only and does not represent a trademark MISUSE Carl Zeiss Meditec AG accepts no liability for the performance or use of these products LY Windows XP is a registered trademark of Microsoft Corporation Inc LY SRK is a trademark of CTI Computational Technology Inc In general other brand names as well as names of software and hardware products are subject to trademark or patent protection Quoting of product names is for information only and does not represe
75. lation has been undone SNR 6 4 SNR signal to noise Values for the peak below the Als 93 38 ratio and axial length measuring cursor besides signal curve D SN The measuring cursor is always positioned above the signal peak 000000 1371 524 lOLMaster 24 08 2005 Menu overview Operation 27 The illustration below provides an overview of available menus and submenus for program operation using the menu commands Opens dialog box for entry of new patient entry compulsory Erase Deletes patient data Rename Renames patient data Export Exports patient data to Sends data via interface Edits a comment Print Prints measurement table Print current graph Prints the selected graph in ALM mode Print current WTW images Prints the current images in WIW mode Print preview Displays print preview Printer setup Select printer options Exit Exits application and Windows OO0000 1371 524 lOLMaster Functions Undo Undoes last KER ACD value Overview Activates overview mode Axial length measurement Activates ALM mode Corneal curvature measurement Activates KER mode Anterior chamber depth measurement Activates ACD measurement White to white determination Activates WTW determination 24 08 2005 AL Settings Accessible in ALM mode Test eye only Activates deactivates measurement mode for test eye User database Enters and edits user and Pseudophak
76. lculations for intraocular lenses in the phakic eye Am J Ophthalmol 116 63 66 1993 HAIGIS W Biometry in complicated situations 9th DGII Convention 1995 Rochels et al publ Springer 17 26 1996 OO00000 1371 524 IOLMaster 24 08 2005 17 Description Overall view tor adjusting the measuring device horizontally X Y and vertically Z by turning Joystick with release button Display 1 Patient eye alignment and display of results Red eye level marks 2 patient eye level needed for optimum measurement Instrument lock knob 3 4 5 6 7 8 Connector panel cf Fig 9 Mouse connector light green Keyboard connector purple Keyboard see Fig 10 Optional Printer not shown View from doctor s side Fig 2 O00000 1371 524 IOLMaster 24 08 2005 18 Description 1 DVD drive CD RW recorder tor data storage and software installation 2 Adjustment of headrest 3 Patient chin rest 4 Holding pins for paper pads also used to test eye alignment 5 Patient forehead rest 6 Aperture tor semiconductor diode laser MMLD 7 Device control connector Fig 3 View from patient s side Optional accessories DOU OO O O C O L Instrument table IT 3L Holding bar for securing the OLMaster on the instrument table Printer Keyboard support Narrow holding bracket for securing the IOLMaster on the keyboard Support Paper pads for patient chinrest Power isolation transtormer for connection of ex
77. lt Mew A Const fisi E 115 3 SARE II A Const 118 6 se 4135 SRKSVT a te _ Eg 1 425 H aigis paca 53 xe B77 Hoffert SF 56 _ s 208 Holaday e Fig 48 Optimized lens constants 64 Operation John Q Public 0 0 Actimed Actriflex 45C Mustermann Egon 001977 05 23 2005 Last Name Mustermann Surgical E ye 05 lett Mushernann Erhard 17 11 17886 05 08 2008 HMustermann Ermna 11 11 1966 05 09 2005 First Mame Egon AL mm 24 23 HMustermann Erna 11 11 1866 05 09 2005 ane raas l Mustermann Franz 07 07 1977 05 23 2005 i Ki prfjas2t efo MMustermanng 01 701 41911 05 31 2005 Exam Date 0523 2005 K2 Dy 43 49 HMusternann H aigis L 07 7017 1911 05 7307201 Mustermann Hermine 02 02 1911 0507 20 ID Humber Opt ACO mmk 3 5 Mushtermnianniahn 05 23 2005 Impl IOL oy 23 Mustermann John 05 23 2005 Post Op Ref prh i 50 Mustermann John 017 0771977 05 24 2005 Surgery ate Mustermann mein 05 26 2005 Fost Op D ate Mustermann Mo 07707 1977 0523 2005 Mustermann test 0170171911 05 03 2005 Mustermann Userntertace 04 22 2005 qe 4 Const 1133 IE SAK Data Records 15 15 A Const IE lt lt iss SREST 14 22mm 3 al EEJ P EEJ H sigs 22 25mm E PACD 577 lt lt 577 HoffeQ 25 40mm 0 SF 208 lt lt 208 Holaday Ave AL Imm 2203 PO Last Optimize 0670372005 Load New Optimize Erase OF Cancel SRE i a trademark
78. ly touch the patient and metal parts of the printer If a Protection Class Il printer without protective earth terminal is used make sure that a power isolation transformer see page 19 is connected into the printer power supply cable If a Protection Class printer with protective earth terminal is used make sure that it is connected to its own stationary wall socket of the room s electrical installation or that a power isolation transformer see page 19 is connected into the printer power line The required isolation transformer can be obtained from our sales organization LI The system may not be connected to portable multiple socket outlets or extension cables LI The electrical supply must conform to IEC 60364 7 710 guidelines USA and Canada only single phase 120 V AC connections with plug tyoe NEMA 5 15P LI Do not use a cellular telephone and other devices not complying with EMC Class B requirements as its signals may cause the equipment to malfunction The effect of radio signals on medical instruments is dependent on various factors and is therefore not predictable To avoid electromagnetic interference the instrument must be installed and operated as described in the operating instructions and using only those components supplied by Carl Zeiss Meditec Li With the exception of compatible printer drivers the installation of other software onto the system is not permitted A software routine prevents external
79. may make the lens invisible This problem may also appear with patients who are restless or fixate poorly PE rF i Fig 71 Slit image on the iris invisible lens In such a case the slit image on the iris is almost continuously visible The automatic evaluation software does not recognize this kind of maladjustment The system will display values that are too short These values do not correspond to the actual anterior chamber depth A but represent the distance between the anterior cornea and the iris The value displayed is not the exact reading for the anterior chamber depth Adjust the device laterally until the anterior lens becomes visible If Remedy necessary ask the patient to look steadily at the fixation light Then repeat the measurement IL Note It suffices if a relatively small section of the lens is visible The picture below shows an alignment which permits accurate measurement 000000 1371 524 lOLMaster 24 08 2005 92 Tips for anterior chamber depth measurement Fig 72 Minimally visible anterior lens This image is sufficient for the calculation of the anterior chamber depth In this photo the front side of the IOLMaster is visible as a nondisturbing artefact Image of fixation point in lens Fig 73 Fixation point in lens image If the image is laterally misaligned the image of the fixation point may possibly lie within the lens image Position the device so that the fixatio
80. mputer These can be obtained trom Carl Zeiss Meditec They include a serial cable null modem female female connector and software on CD ROM to be installed on the PC Data is imported to a database on the PC From there data can be exported to other file formats The graphs of axial length measurements are made available in JPEG format To export data press the lt S gt key not in Patient Manager or the SEND button The data will be exported ms Note The PC must have been switched on and the software for data receipt started A progress bar will be visible on the screen of the lOLMaster Data can be archived on the PC or processed in the appropriate form ms Note The export of measured values depends on whether the additional software Option A plus Is installed Without Option A plus only the measured values and the marked IOL will be exported With Option A plus the measured values and all calculated lenses will be exported see page 33f depending on the setting in Program Settings Export Exporting data to a storage medium Select the desired storage medium in the menu Options Setup Program settings Export see page 33 ms Note If you wish to export to a CD RW you must insert a formatted CD RW into the drive The CD RW must be formatted elsewhere e g office PC in UDF format Alternatively use one of the formatted CD RWs as supplied For exporting to an USB flash drive the latter shoul
81. n point lies between the images of crystalline lens and cornea Then repeat the measurement O00000 1371 524 IOLMaster 24 08 2005 Tips for anterior chamber depth measurement 93 Reflections in the corneal image Fig 74 Reflection in corneal image due to lateral misalignment The lateral adjustment of the device is not correct Illumination Cause reflections can be seen in the corneal image slit and the fixation point lies within the lens image Adjust the device laterally until the corneal image is undisturbed As a Remedy rule the fixation point will then be between the image of the anterior lens and that of the cornea Repeat the measurement O00000 1371 524 IOLMaster 24 08 2005 94 Tips for anterior chamber depth measurement Pathological findings Dry eye Fig 75 Optical sections of dry eyes A locally interrupted tear film considerably changes the scattering properties of the cornea For this reason the optical section of the cornea may become irregular Ask the to patient blink several times to replenish the tear film on the cornea then take the measurement immediately or use a tear supplement to prevent rapid drying O00000 1371 524 IOLMaster 24 08 2005 Tips for anterior chamber depth measurement 95 Irregularities of the corneal surface scars Fig 76 Condition following keratoplasty same eye as shown in Tips for keratometer measurement Fig 67 page 87 Scars and local irregularities
82. n preoperative and postoperative refraction corrected by the corneal vertex distance vertex correction The computational method is described in the technical literature If the corresponding data of the patient are available the refractive history method delivers the most accurate results For the calculation of the IOL the Corneal K s selected by the examiner with APPLY will be transferred to the IOL calculation table The IOL calculation can be started after selection of the biometric formula OO00000 1371 524 IOLMaster 24 08 2005 Operation 55 Contact lens method The contact lens method contact lens over refraction attempts to determine the currently effective corneal retraction on the basis of two refraction measurements one with and one without hard plane contact lens The following parameters are needed LI Refraction with contact lens LI Refraction without contact lens LI Refractive power of the plane or almost plane hard contact lens refractive power of the contact lens back surface LI Corneal vertex distance In the ideal case the refractive power of the contact lens back surface Is equal to the unknown corneal refraction For this purpose several hard plane contact lenses with refractions of the back surface between 30 and 45 D should be available For the calculation of the corneal refraction enter the appropriate patient data into the display mask The values will now be calculated IOL Calcula
83. n the Options menu under Test Eye The status of the Test Eye is also reset each time a new patient lt N gt or icon is admitted OO00000 1371 524 IOLMaster 24 08 2005 Servicing and maintenance Warning If the test eye readings are not within the given tolerances the device must be shut down Notify Carl Zeiss Service Verifying WTW measurements optional The WTW scale optional 2 Fig 78 is for verifying the WTW reading WTA calibration 1 Please mountthe WW TYY calibration scale on the lOLMaster look manual c Center vy vy calibration scale The scale have to till the whole video window 3 Focus on the black lines from scale 4 Push joystick button carries outthe calibration Cancel Fig 79 WTW calibration e Take a measurement If the reading is within the tolerances the WTW determination is properly calibrated ms Note The WTW scale must completely fill the video window The scale black lines must appear in focus O00000 1371 524 IOLMaster 24 08 2005 99 Fig 78 WTW scale 100 Servicing and maintenance Printer troubleshooting Please use only printers recommended by Carl Zeiss Meditec The printers currently recommended can be found at http Awww meditec zeiss com iolmaster The printer models listed there have been tested in conjunction with the lOLMaster and provided the instructions for
84. ndard for PC with 640 x 480 pixels and 16 colours White to white distance 000000 1371 524 lOLMaster 24 08 2005 CARL ZEISS MEDITEC AG Goeschwitzer Str 51 52 07745 Jena Germany Phone 49 3641 220 333 Fax 49 3641 220 282 Email info meditec zeiss com Internet www meditec zeiss com 000000 1371 524 lOLMaster 24 08 2005 Specifications subject to change
85. nt trademark misuse OO00000 1371 524 IOLMaster 24 08 2005 Contents Page COP VUIGINE sxeeecekexicecepes cocci etcaedseecoxetieutsnes Rececneedeideneiseocsmavienteegieceecaeet 1 TAG CIIVAUICS cca sanwe cup wecca ince sen cancsanh stu aatecuatacanducs seuag aces uncwesendedvaracansbeveans 2 End user License Agreement EULA cccsseecssseeeecenseeseneeeseeees 3 CONTENTS ossee NAE a 5 Notes on the user manual ccccceeeeeeeeeeeeeeeeenseeseeneescaneeseeeneeseaaes 8 VADOS eresse SREE E 8 Purpose of this COCUIME La MON ciscsnetinantveneawtaecaie stan slbueniedineietsdss 8 Availability of the user manual ccc cece ccccceseeeeeeeeeeeeeeeeeeeeeas 8 Safety instructions sesesnaseecessececesoccscacncenSrecsenrercosecateeneosesancastncseconscenc 9 Standards and SCO UIAIONS scicorstatentccaencretenttenennancrccnnsetuccetninmosases 9 Notes on installation and use se cnzcusesce disadepsauderhotiaremeneendsandens 9 siS operdona T A O 11 Hectrical sale aa a 11 Light emission from the CeVICE cccceceecccceee ee eeceeeeeee eens 11 Operational requirements cccccceeeccee ee ceeeeeeeeeeeeeeenens 11 Important when USING the GeVICE cece cece cc eee eeeeeee eens 12 PUSS Mise ened a tate deat ari ate hn a ated 12 Disposal of the product within the EU eccerre 12 PACKAGE COMEN ne hinds Wiis taniaw iia wate aeesa runt ategh oaumsatn ee 13 Warning and information labels on the device 13 Safety duti
86. ntered as a four digit number mandatory for patients over hundred years old OO0000 1371 524 OLMaster 24 08 2005 Operation 39 ms Note It is recommended that the patient s refraction data if known be entered in the respective boxes Visual acuity data can only be entered in the data format set in Program Settings see page 33 Up to 255 characters may be entered in the Remark field comments diagnoses etc ms Note Refer to page 65 for working with the database field In Program Settings you can set the number of days after which a data record is automatically deleted 5 to 365 days e To close after entering the date of birth click on the NEW button or press the ENTER key This will automatically activate the Overview OVW mode The fixation light and light spots will be switched on The patient will see a yellow fixation light in the centre and 6 light spots reflex points in the patient s pupil will appear in the video image e Press the NEW PATIENT button to open the New Patient dialog box in the measurement mode e Press the EXIT icon in Patient Manager to quit the program and Windows Adjusting the device to the patient The two red ring marks 3 Fig 3 on the side rails of the headrest are for rough vertical adjustment of the chin rest 3 Fig 2 The patient s eyes should be level with these marks In Overview mode align the device to the patient s eye using the joystick 1 Fig 2 Turn the
87. on results the lens constants entered into the calculation formulae may be optimised personalised for each individual user Literature on the formulae for specific questions contact Carl Zeiss Meditec e Haigis http Awww augenklinik uni wuerzburg de uslab ioltxt haid htm e HofferQ HOFFER KJ The Hoffer Q formula A comparison of theoretic and regression formulas J Cataract Refract Surg 19 700 712 1993 ERRATA 20 677 1994 e Holladay HOLLADAY JT PRAGER TC CHANDLER TY MUSGROVE KH LEWIS JW RUIZ RS A three part system for refining intraocular lens power calculations J Cataract Refract Surg 14 17 24 1988 e SRKII RETZLAFF J A new intraocular lens calculation formula Am Intra Ocular Implant Soc J 6 148 152 1980 e SRK T RETZLAFF J SANDERS DR KRAFF MC Development of the SRK T intraocular lens implant power calculation formula J Cataract Refract Surg 16 3 333 340 1990 e Haigis L HAIGIS W publication in preparation e Correction of corneal radii refraction after refractive corneal surgery e HOLLADAY JT IOL calculations following RK Refract Corneal Surg 5 3 203 1989 HOFFER KJ Intraocular lens power calculation for eyes after refractive keratotomy J Refract Surg 11 490 493 1995 e Calculation of phakic implants vd HEIJDE GL FECHNER PU WORST JGF Optical consequences of implantation of a negative intraocular lens in myopic patients Klin MB1 Augenheilk 192 99 102 1988 HOLLADAY JT Refractive power ca
88. ons 103 Measuring range Axial length Area 14 40 mm Resolution of display 0 01 mm Keratometer Area 5 10mm Resolution of display 0 01 mm Anterior chamber depth Area 1 5 6 5 mm Resolution of display 0 01 mm White to White optional Area 8 16mm Resolution of display 0 1 mm Comparison reproducibility Comparison of OLMaster measurements v conventional measurements of the human eye Mean value of deviation Standard deviation Axial length 0 03 mm 0 21 mm Corneal curvature 0 01 mm 0 06 mm Anterior chamber depth 0 12 mm 0 18 mm lOLMaster reproducibility Relative to standard deviation in human eye Axial length 0 0256 mm Corneal curvature 0 0129 mm Anterior chamber depth 0 0334 mm In comparison to precision immersion ultrasound instrument ji In comparison to the manual keratometer Standard deviation basic calculated simple standard deviation 1 acc to abstract First experiences with a New Optical Biometry System by B A M Lege W Haigis acc to Reproducibility of Measurement in Optical Biometry Intraobserver and Interobserver Variability by A Vogel B Dick O00000 1371 524 IOLMaster 24 08 2005 104 Optical radiation Surrounding field illumination WTW determination Source Wavelength Delivered power Axial length measurement Source Wavelength Max power for measurement Max power for alignment Measuring time for individual measurement
89. or Or Mustermann Lenses Mame es t s i 4 Const pe Manubacturer ACD 4 96 Manufacturer A Const IE SARE II A Const 118 SRAK T al 1 273 al ps Haigiz ad for ACD 4 96 Hotferl SF 1 22 Holladay Power Steps 1 20 1440 Ada Erase Set Optimize SRE S is a trademark of CTI Computational Technology Iric di Fig 36 Database field for entering lens data e Inthe lines Name A const Manufacturer and ACD Manufacturer enter the respective data of the manufacturer catalogues or package inserts Warning If the ACD constant is not available you may click the ADD button after entering the A constant All parameters will automatically be calculated from the A constant according to standard formulae However the manufacturer s A constants are not optimal for optic biometry and may result in refractive deviations OO00000 1371 524 OLMaster 24 08 2005 Operation e Your IOL constants or personally calculated constants for various calculation formulae optimised for optical biometry must be entered changed in the A Const SRKII A Const SRK T a0 a1 a2 pACD and SF boxes ms Note Only constants optimised for optical biometry should be used for calculating the suggested strength of the intraocular lens to be implanted with the IOL Master not the manufacturer s IOL constants see also pages 58 and 77 e f you use lenses graded in 0 25 D intervals in future activate the Power 0
90. osshairs and auxiliary circles the central fixation point Is distinctly fainter than the measuring points Note Depending on the reflectivity of the cornea the image of the fixation point may be barely visible This is irrelevant for the calculation of the corneal curvature as the position of the fixation point is not evaluated OO00000 1371 524 IOLMaster 24 08 2005 Tips for keratometer measurement 83 Measuring errors The Error message may have two basic causes Li The measured values of the internal individual measurements vary by more than 0 05 mm very rare defocused device LI The measuring marks are either indiscernible or not recognized as such The marks not recognized will be shown on the screen after measurement The possible reasons for this are described below Maladjustments Defocused device Fig 61 Image of defocused device The images of the measuring marks are too large because the device is Cause defocused The system cannot calculate a measured value and Error appears in the display field The measurement can be retaken after correcting the focus adjustment Remedy to minimize the peripheral mark size Sometimes with exactly adjusted focus small circles like haloes may be visible around the six peripheral measuring points In this case focussing is optimal O00000 1371 524 IOLMaster 24 08 2005 84 Cause Tips for keratometer measurement Concealed measuring marks
91. other readings the readings marked Borderline value should also be accepted as valid axial lengths 000000 1371 524 OLMaster 24 08 2005 Operation ms Note The OLMaster requires five measurements to be taken The message Measure again will thus appear Only then will a mean value be passed on to the IOL calculation and an evaluation enabled Only the number of measurements is crucial here To obtain consistent results we recommend checking the individual axial length measurements and carrying out further measurements If necessary With stronger lens opacities it may be advisable to defocus the device You may choose a reflection 2 Fig 27 as large as the circle on the display If measurements are even now impossible the device can be refocused and the reflection shifted to the bottom and or top margin of the circle on the display by varying the vertical adjustment turning joystick ms Note Defocusing and shifting the reflection within the circle will have no effect on the result because interferometric axial length measurement is completely independent of distance e For the next measurement of this eye press the button in the joystick Warning Up to 20 such measurements per eye may be taken on a single day Avoid measurements of eyes with retinal detachment In such cases measuring errors cannot be precluded As a rule the axial length should be viewed together with the values for corneal refraction and overal
92. r angle supported lenses to be calculated 000000 1371 524 OLMaster 24 08 2005 Operation Only spherical lenses can be calculated In addition to the anterior chamber depth and corneal radii corneal refraction measured with the lOLMaster the refraction for the appropriate corneal vertex distance CVD and lens model must be entered 57 iL BSMF IOLTEGCH Wiiware Ophtec Artisan AMO Versyse Staar ICL IILTECH PAL The manufacturer s IOL constants are used for calculating lens strength N Warning Use the psph pseudophakic button to calculate secondary piggy back IOLs For this purpose the ACD should be measured by a method other than the lOLMaster and the readings thus obtained entered into the appropriate boxes Fig 41 Lens model IOL Calculation Haigis SRK I Hoffer Holladay SRK T Multi Formula HaigisL phakic IOL Prior Refractive Surgery Eye Surgeon ohn Q Public 0 0 Target Refraction Mustermann ohn 01 07 1977 Axial Length mm 23 93 23 fa Comeal K s mm 7 55 7 75 8 05 HERE Optical ACD mm 3 21 3 25 OD D 0 50 Refr sph cyl py f 7 75 4 50 4 50 175 Vertex mm fi 5 fi 2 phak psph phak pph Surgical Eye 7 OD i os IOL Calculation Print IOL Calculation Data 05 D 0 00 Dphtec Atizan IOLTECH PAL IOL D REF D IOL D REF D 3 50 0 23 3 00 0 56 Em oe emo pa ooo OF Cancel Fig 42 Calculat
93. r password ms Note When the device is delivered the User Manager contains only the administrator no password has been specified Only the administrator is entitled to add or delete users and edit their databases Warning Individual users may edit their databases only if password protection has been set If no password protection was set the databases are accessible to all users If Change Password is checked the administrator may assign himself a password in this dialog box e Type in the password in the Password and Confirmation text boxes e Confirm your entry with OK OO00000 1371 524 OLMaster 24 08 2005 Operation e To create a new user database the administrator must open his or her own database by selecting Administrator in the Name list box A dialog box appears in which new users may be added User Manager Administrator Mame Password Il Comparison Data store Backup Restore Import Fig 14 Dialog box User manager Administrator e Type in the name of the new user e f several users share the device it is recommended specifying a password each which must be repeated in the Confirmation text box e Use the ADD button if you have added a new user or the SET button if you have changed the password of an existing user e f you wish to delete user data from the database click on the ERASE button after having selected the name in the left window e Click O
94. r she sees the fixation point If the patient fails to fixate properly the visual axis will not be correctly detected which may result in measuring errors In the case of poor visual acuity high ametropia 6 D it is advisable to measure through the spectacles If the procedure is followed correctly no measuring errors will be produced Measurements should not be taken while a patient is wearing contact lenses as it will result in measuring errors e Take the measurement by pressing the button on the joystick The corresponding display field next to the video image will show the measured axial length The video image will be overlaid with a graph similar to those in ultrasonic measuring instruments Simultaneously the axial length and signal to noise ratio SNR of the measuring signal will be displayed The SNR is a gauge of the quality of measurement Measurements with an SNR between 1 6 and 1 9 appear with an exclamation mark after the measured value and the message Borderline value will appear For evaluation of the SNR see Post run editing of axial length measurements page 73ff i Note Borderline value does not necessarily mean that the reading is incorrect and must be rejected It rather means that all axial length measurements for the eye should be checked for plausibility and consistency e g according to the usual ultrasonic biometry criteria If the uncertain values are determined to concur with the
95. rate signal peaks can be determined by comparison with other values of the measurement series of this eye and of the other eye if necessary cf Sections Signal curves of axial length measurements page 70 and Shifting the measuring cursor see below SNR lt 1 6 Measured value should not be used It is marked on the display as an erroneous result This means that the true measuring signal does not stand out sufficiently from the noise As a rule the results of such measurements are not usable and should be rejected They can be deleted trom the list by using the lt DEL gt key once they are highlighted L Note Measuring errors display Error are not taken into account in the mean value calculation The reading may be transferred to the list of measured values by clicking on the measuring cursor white dot In doing so ensure that the measured values are consistent Shifting the measuring cursor The measuring cursor white dot is automatically placed on the centre of the signal peak with the highest absolute amplitude The corresponding axial length value is displayed beside the graph and in the display field The SNR is calculated and displayed for this signal peak The measuring cursor is placed in the centre between the regions corresponding to half the maximal amplitude If the signal curve is symmetrical Gaussian curve the cursor is positioned exactly above the maximum of the signal There are two ways to shift the m
96. rgery of the cornea should be excluded from optimisation e Complete the entries in the input mask 000000 1371 524 lOLMaster 24 08 2005 Operation ms Note The entry of the Exam date is essential Entry of ACD Surgery Date and Post Op Date is optional ms Note There should be a period of at least 8 weeks between the surgery and post op dates This period however will not be checked e f you wish to reject the entries made and return to the optimisation calculation mask click on the CANCEL button e To confirm the new data record and add it to the list of data records to be used for optimisation click on the OK button The new data record is shown in the Data Records field It is displayed in the list of data records Entering post operative data e Highlight the patient data record by clicking on it e n the IOL D box enter the power of the implanted IOL e n the Post Op Ref box type in the post operative refraction e The entry of Surgery Date and Post Op Date is optional When entered however the data will be checked for plausibility ms Note There should be a period of at least 8 weeks between the surgery and post op dates This period however will not be checked John Q Public O D Actimed Acnflex 45C Mustermann E gon Orr 07 1977 05 23 2005 Last Hame Mustermann Surgical Eye OS lett Mustermann Erhard 11 711 1888 05 087 2005 i Mustermann Ema 11 1171866 0570872005 First Mame
97. rom the noise Possible reasons unsteady non fixating patient strong ametropia dense medial opacity along the visual axis Repeat the measurement Ask the patient to fixate steadily Measuring errors with pseudophakic eyes False lt 18 97 mm Two peaks may appear when measuring pseudophakic eyes and with certain intraocular lenses e g Acysoft The first peak false is from the IOL while the second peak is produced by the retina In this case manual correction of the axis length is necessary It is expedient to measure at a number of different points Fig 51 Axial length measurement of pseudophakic eyes double peaks with certain IOL Source W Hill Mesa Arizona O00000 1371 524 IOLMaster 24 08 2005 72 The system allows zooming the graphs in 4 steps to improve the presentation of signal curves e Move the cursor on the longitudinal axis X axis to the desired centre of the zoomed image and press the left mouse button You may repeat this procedure four times e To return to the original view zooming out place the cursor at any position on the longitudi nal axis and press the right mouse button 23 gt Note In zoomed views the axial length scale is not visible Evaluation of ALM results Zooming the graph display oe left mouse button left mouse button left mouse button SHR 2 5 AL 29 40 mm SHE 2 3 AL 22 29 right mouse button
98. s automatic method unless the curve adjoining them drops down below a value which is less than halt the amplitude of their maxima i Note While dragging the measuring cursor the original axial length value and SNR remain displayed beside the signal curve The new axial length value and corresponding SNR will be calculated and displayed only when the button is released O00000 1371 524 IOLMaster 24 08 2005 75 76 Evaluation of ALM results 2 Fine shifting the measuring cursor ms Note This manipulation should always be done in a zoomed view e Proceed as described above under Item 1 but use the right button to drag the measuring cursor This way the automatic peak detection is deactivated and the white dot can be positioned at any point over the measuring curve e When the button is released the current axial length and the new SNR will be calculated and displayed This kind of manipulation is advisable with closely adjacent double or triple peaks Here again the recalculated axial length is shown in the display field with an asterisk Please note Even if the manipulations are undone with the measuring cursor by moving it back to the automatically found maximal peak and the measured value agrees with the original one the asterisk after the measured value will remain indicating that the curve has been deliberately manipulated The described manipulations of the measuring cursor may be performed both in
99. similar LI Do not store or use this device in damp locations Do not expose the device to water drips gushes or splashes LI Modifications and repairs in particular those requiring the device to be opened may only be performed by service technicians employed or authorised by the manufacturer L The manufacturer accepts no liability tor damage caused by unauthorized access to the interior of the instrument Such actions will render any warranty claims invalid LI This device may only be used with accessories and software supplied by Carl Zeiss Meditec Mains operated accessories must conform to IEC 60950 1 or 60601 1 Li The device may only be operated by familiarised and trained personnel LI In USA this device may only be purchased or ordered by physicians and ophthalmologists LI The user manual should always be kept at hand for reference LI It is also important to comply with the instructions supplied with accessories O00000 1371 524 IOLMaster 24 08 2005 10 Safety instructions LI Use only printers approved by Carl Zeiss Meditec Use only the CD supplied by the printer manufacturer to install the printer software Before using older printers consult http support microsoft com to determine whether printer drivers compatible with the Windows xXP operating system are available and use these Position the printer at least 1 5 m from the patient s seat at the device The user should not simultaneous
100. spond to your input If this occurs switch off the device immediately and disconnect the power cable Label the device as being defective and call Carl Zeiss Service O00000 1371 524 IOLMaster 24 08 2005 69 70 Evaluation of ALM results Signal curves of axial length measurements Valid signal curves secondary maxima system specific distance about 0 8 mm maximal peak SNE 10 5 AL 62 14 40 mm Very good signals signal to noise ratio gt 10 Several secondary maxima visible system specific Clear media correctly fixating patient Weak ametropia O ol Risa 6 AL 20 50 14 40 mm Clear signal SNR gt 2 0 Secondary maxima visible Relatively clear media D SMR 8 AL a2 BA 14 40 um Valid signal in Borderline SNR range of 1 6 2 0 Steep rise of measuring signal Such readings are marked on the display by an exclamation mark and the message Borderline SNR appears Warning This reading may be used after verification and comparison with other data from this series of measurements OO0000 1371 524 OLMaster 24 08 2005 Evaluation of ALM results 71 Recognition of maladjustments on the graph i i rai T will l JE in ah dhl SHA 1 3 LALE IEA Hihihi y HT P PF 1 A L 28 70 14 40 mmm Low signal signal to noise ratio 1 6 Error message is displayed The measuring signal cannot be clearly distinguished t
101. ssible Precise measurements are possible only if the 6 peripheral measuring points appear optimally focused on the display In the case of dry eyes a tear fluid substitute may help to obtain a reliable measurement e Take the measurement by pressing the button on the joystick Bee oe ee a RONS Fig 30 Settings for keratometer Five internal measurements will be taken within the space of 0 5 s The measurement end of the measurements is indicated by a short acoustic signal Following this the radii or corneal K s depending on program settings of the two main sections will be displayed together with the respective axial orientation and the astigmatic difference In the case of a spherical cornea only the radius or a corneal K will be displayed but no axial orientation or astigmatic difference A blue progress bar in the status bar will indicate the progress of computation O00000 1371 524 IOLMaster 24 08 2005 44 Fig 31 Fig 32 Measurement point not identified Three keratometer measurements Evaluation A Operation The size and shape of measurement points are verified by the software If a measurement point is not correctly identified a blue flashing dot will appear In the printout this will be marked by an x These readings should not be used and a new measurement should be taken as a precaution Keratometer measurements may be repeated as often as desired however only the last three measurements wil
102. structions Package contents The device is delivered in completely assembled form in foam material packaging The enclosed accessory box contains the following components keyboard power cable this user manual dust cover test eye in Its own case 2x CD RW formatted Save the original packaging for storing the device during extended periods of non use or for returning it to the manufacturer or dispose of it properly Warning and information labels on the device The device casing carries the following warning and information labels Vor Offnen Netzstecker ziehen Caution disconnect power supply ae before opening eke D brancher la fiche d alimentation secteur avant d ouvrir Carl Zeiss Meditec AG 07740 Jena GERMANY S N 000000 Manufactured Model 1322 734 100 240 V Vv lOLMaster 50 60 Hz gt 90 VA 0297 IP20 17604 D i Complies with 21 CFR C US Subchapter J Fig 1 Warning and information labels on the device 000000 1371 524 lOLMaster 24 08 2005 13 14 Safety instructions Safety duties of the customer The user is responsible for ensuring that Ly the device is used in accordance with the instructions provided in this manual deviations from the target refraction are precluded by proper handling of the device Patient must fixate correctly Device must be precisely focused for keratometry or anterior chamber depth mea
103. surements Biometry formulae must be properly used Only adjusted IOL constants may be used the device is only used in a perfect operating condition without functional impairment the user manual and all accompanying documents are maintained in good condition and kept on or in the immediate vicinity of the device only sufficiently trained and authorised personnel is permitted to operate maintain and repair the device all operating personnel receives regular instruction on all issues concerning the device and its components that such persons are familiar with the user manual and in particular the safety precautions none of the warning signs on the system are removed or rendered illegible before any patient measurements are taken the device Is inspected according to Checking the measurement functions on page 97 each day no more than 20 axial length measurements are taken on each patient s eye a safety inspection is performed on the device each year see page 101 in order to guarantee its perfect operating condition OO00000 1371 524 IOLMaster 24 08 2005 Description Intended use The device is to be used only for the measurement of axial length corneal radii anterior chamber depth and optionally for the determination of white to white of the human eye as well as for the calculation of the required intraocular lens The user bears all liability for any use other than that intended and described here
104. t will be slightly elevated The reading must be corrected depending on the material used and the centre thickness OO00000 1371 524 OLMaster 24 08 2005 Operation 43 Warning A Two peaks may appear when measuring pseudophakic eyes and with certain intraocular lenses The first peak is a side maximum of the IOL while the second peak is produced by the retina In this case manual correction is necessary see Measuring errors with pseudophakic eyes on page 71 It is expedient to measure at a number of different points Measurement of corneal curvature KER Keratometer measurement Activate the KER measurement mode by e clicking on the KER icon e pressing the lt K gt key e pressing the lt SPACE BAR gt in ALM mode ALM e Tell the patient to focus on the yellow light e Align the device so that the 6 peripheral measuring points are symmetrical to the circular crosshair and appear optimally focused The central point is usually not focused and is not evaluated for keratometer measurement ms Note Ensure that all 6 peripheral points are visible and located in the field between the two auxiliary circles on the display It is recommended that the patient blink his her eye shortly before the measurement to produce a continuous tear film This will improve the reflectivity of the cornea The measuring points should be circular or ellipsoid If the measuring points are irregular i e corneal scar measurement is not po
105. ternal accessory units Network isolator Software option A plus Software option B Connecting cable for coupling with PC OO00000 1371 524 IOLMaster 24 08 2005 Description Power isolation transformer for external devices N Warning Always connect all peripheral devices printers and monitors to the power isolation transformer Components other than the system components described may not be connected to the power isolation transformer or instrument table Non compliance represents a violation of the regulations for use of medical devices under DIN EN 60601 1 1 If the Carl Zeiss IT 3L instrument table is used the power isolation transformer may be mounted to the underside of the tabletop It may be secured elsewhere but not set up on the floor N Warning The biometrical device should never be operated via the power isolation transformer The power isolation transformer is not a constituent part of the IOLMaster 000000 1371 524 lOLMaster 24 08 2005 19 1 Power cable connector with fuses 2 Power switch Fig 4 Power isolation transformer input side 1 Instrument connector 2 Power junction connector Fig 5 Power isolation transformer output side 230 V A O CS Fig 6 Power isolation transformer Output si
106. the RPE see Fig 55 It may be advisable to perform further measurements Up to 20 measurements may be taken on one day 000000 1371 524 lOLMaster 24 08 2005 82 Tips for keratometer measurement How to adjust the measuring marks Ask the patient to relax and look at the yellow fixation light If the patient cannot see the fixation light he or she should look straight ahead into the device ms Note The peripheral infrared measuring marks will be invisible to the patient However in a darkened room an attentive observer may perceive the measuring marks as faint red dots when looking into the projectors of the keratometer When adjusting the device make sure that all 6 peripheral points are visible and located in the field between the two auxiliary circles as closely as possible to the centre of the display The images of the measuring marks on the display must be optimally focused by varying the distance between patient and device The images of the measuring marks should be circular or ellipsoid To improve the reflectivity of the cornea it is advisable to ask the patient to close and open the eyes several times This replenishes the tear film and improves the imaging of the measuring marks on a regular cornea The appropriate reminder will appear below the video image when the keratometer mode is activated Image of fixation point irrelevant for the measurements Fig 60 Optimally aligned device shown without cr
107. tion Ed Haigis SRK II Hoffer Holladay SRK T Multi Formula Haigis L phakic IOL Prior Refractive Surgery Mustermann Max 01 01 1911 OD fright 05 lett Measurement Yalues Measurement Values Axial Length rrn 0 00 KER rari Do0 0 00 Axial Length mara a00 KER rari 0 00 0 00 Clinical History Method Clinical History Method Cornmeal K s pre OP D 50 50 Wertes mm 18 Corneal K s pre OP D Vertex mm Refr pre OF D sph F0 cyl 0 75 Refr pre OF D sph cyl Refr post OP E sph 0 25 cyl 0 50 Refr post OF O sph cyl Corneal E s OF 44 10 Radius mm 7 65 Apply a Cornmeal K s E Radius mm Apply C Contact Lens Method Contact Lens Method CL power D Vertex mm CL power D 0 25 Wertes mm q2 CL base curve D CL base curve E 41 50 Refr with CL D sph cyl Refr with CL sph 1 75 cl 0 50 Refr without CL D sph cyl Refr without CL spk 3 25 cpl 1 25 Corneal K s E Radius Imm Apply Cormeal K s E 46 98 Radius mm 7 18 Appl M Abbrechen Fig 39 IOL calculation window Prior refractive surgery For the calculation of the IOL the Corneal K s selected by the examiner with APPLY will be transferred to the IOL calculation table The IOL calculation can be started after selection of the biometric formula Warning The calculated refractive power radil values may not be
108. tment of anterior chamber depth O00000 1371 524 IOLMaster 24 08 2005 45 46 Operation ms Note The alignment of the device particularly in the case of small pupils requires a certain amount of practice on the part of the operator and cooperativeness on the part of the patient The alignment procedure Is easier on a dilated pupil see also Tips for keratometer measurement page 82ff e Take the measurement by pressing the button on the joystick ms Note Before starting tell the patient to look steadily at the fixation light not into the slit projector as the latter will flicker during the measurement When an acoustic signal is heard the slit will again illuminate steadily the measurement has been completed and the ACD values will be calculated Note Anterior chamber depth on the lOLMaster is interpreted as the distance between the anterior vertex of the cornea and the anterior vertex of the eye lens Hence the displayed distance includes the thickness of the cornea Calculation of the anterior chamber depth requires the input of the corneal radius If a valid keratometer measurement was performed prior to ACD measurement the system will automatically use the measured radius for the calculation If for any reason the IOLMaster was unable to measure the corneal curvature a window will appear requesting you to type in the radius if the cornea Is astigmatic the values of both principal meridians e Enter a v
109. ual values for axial length corneal curvature refractive power anterior chamber depth WTW are not saved and may get lost e g in the case of a defect in the hard disk Follow this procedure to create a backup copy e In the User Manager activate Administrator e Click the BACKUP command button to initiate the backup process e Insert a UDF formatted CD RW into the drive e Confirm with OK e t may be necessary to delete existing data on the CD RW conform with YES Answering with No will abort the backup process The data will now be copied to the CD RW A progress bar intorms you of the status of the copying process e Finally you will be informed that data backup was successful OO00000 1371 524 IOLMaster 24 08 2005 Operation 31 Restore By using the Restore function you can retransfer saved data trom a Restore CD RW to the lOLMaster Follow this procedure to restore saved data e n the User Manager activate Administrator e Click RESTORE e Insert the CD RW containing the latest backup copy contirm with OK e Confirm with YES that all surgeon data currently stored on the lOLMaster is to be copied together with the respective IOL data and patient data available for optimizing the IOL constants Database data will now be copied from the CD RW to the lOLMaster A progress bar informs you of the status of the copying process e Finally the program will inform you if the restore action was a SUCCESS Warning
110. ures between 5 and 365 are possible 365 days are set at the time of delivery Data records can be identified or sorted by name first name or by ID No Caution Please note that when switching trom Name first name mode to ID Number data records without an ID No will not be listed entry of an ID is not essential This also applies analogously to switching from ID Number to Name first name if a name was not previously entered Send data to PMS Choose old if the connected office management system only allows import of data of interface software versions 1 01 2 02 patient data measured values Choose new requires option A plus if the connected office management system can import all offered data according to interface software version 3 0 and higher COM speed provides a choice of standard transfer rates in kBaud Keratometer display Radius or Corneal K s for IOL calculation Cylinder or Cylinder Refractive index Entry of equivalent refractive index for conversion of corneal radii into corneal K s Enter the refractive index implemented on your keratometer refer to respective user manual Printing of IOL calculation data Choose whether you wish to have the calculated IOLs of both eyes printed on a single page or only one eye per page In addition in this field you may enter the name of the clinic to appear on the printout of the IOL calculation Select emmetropy IOL if desired O00000 137
111. very package subject to change 000000 1371 524 OLMaster 24 08 2005 Manufacturer s Declaration 107 The device meets the requirements of the Medical Device Directive 93 42 EC and its national equivalent in the form of the German CE Medical Product Act MPA 0297 Device class pursuant to MPA lla UMDNS No 18 014 This declaration shall become invalid if the product is modified or tampered with other than as authorized by the manufacturer O00000 1371 524 IOLMaster 24 08 2005 Abbreviations Glossary ACD ALM CD RW COM CSV D DIN EN Fig HIPAA ID IOL KER LC display LED um mm MMLD MS OVW PC PCI SRK USB VGA WTW Anterior chamber depth Axial length measurement Cornea Compact disc rewritable Communication serial interface for PC operating systems Colon separated values method of presentation in which the individual values have separators semicolon comma etc in between them Dioptres unit of measurement for refractive power German industrial standard European standard Figure American Health Insurance Portability and Accountability Act Identification Intraocular lens Keratometer Liquid crystal display Light emitting diode micrometer millimetres Multi mode laser diode Microsoft Overview mode Personal computer Partial coherence interferometry Sanders Retzlaff Kraff Universal serial bus standard interface for PC peripherals Video graphic adapter video sta
112. xial length measurements cccceecceeeee eee 70 WAN signal CUVE Sensen auadehdeail aceite T 70 Recognition of maladjustments on the graph eese 71 Measuring errors with pseudophakic eyes cssisesicesn 71 LOOMING he graph display esner sce cidnerheercelinsa tater gone 72 Post run editing of axial length measurements 0ccceceee 73 SNR CAlCOOUIGS diabetes a iaa ar a tei E aa 73 Shifting the measuring CUS OR ies ants nies eile ily tet nes 74 Interpretation of axial length measurements ccccceeceeeeeees 77 Signals from the inner limiting membrane ILM 79 signals OM CC MOL OI C2928 e ett nt arena 80 Tips for keratometer measurement ccccceseeeeeeeeeeeeseeeneeeseeeeeeees 82 How to adjust the measuring Marks cece eeeecece ee eeeeeee ee eeeeees 82 MEAS UMING CUT ONS aen T tes 83 Maladigs timent i a tuae abelian iad 83 Sn aud a6 glo S AEE EE E E E E T 85 000000 1371 524 lOLMaster 24 08 2005 Contents Tips for anterior chamber depth measurement ssssceeeeeees 88 FIOM toadustthe device eri uate aiee sted daccerdem e teu 88 ISAS UII OU ONS ornoa e eaeacdet ootawine T tedaeiees 90 MaNACHOSUMIG MUS horae eE 90 PAT MNOlOGICAL NANG Seer dente 94 Tips for WTW measurement Optional sccccesseeeseseeseeenenees 96 POW TOs JUST the devi Oeics suit ts ida a E R 96 Servicing ANd MAINTENANCE ccceeeeeeeeeeeeeeeeseeeeeeeseeeseeeseeeeeeeseees
113. y aligned device relatively clear eye media and weak ametropia lt 6 D the secondary maxima will be detected symmetrically on each side of the actual measuring peak These are caused by the measuring light source used and maintain a constant distance of approx 0 8 mm to the measurement signal and to each other irrespective of the specific circumstances of the measured object For this reason the secondary maxima are similarly always visible in measurements of the supplied test eye The lOLMaster measuring system is capable of resolving fine structures on the fundus of the eye Depending on the anatomical conditions of the measured eye the measuring beam may also produce interferences when reflected at the inner limiting membrane and or the choroid Indications of this are broader smeared signal peaks of the measuring curve variations of approx 150 350 um in axial length data in one measurement series and display of Evaluation in place of the mean value O00000 1371 524 IOLMaster 24 08 2005 77 ae NN a z 0 8 mm Fig 54 Undisturbed measurement signal with secondary maxima 78 Evaluation of ALM results Examples No oN Such measuring curves or measurement series require immediate verification either between individual measurements in ALM mode or in post measurement editing without the patient in front of the device Interpretation or post measurement editing should always be p

IOLMaster Manual V.4

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