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IOLMaster Manual V.5

1. Import of lens constant data Lens constants in the import database Surgeons of the current user data base John Q Public 0 D Dr Schmidt MP2125 a Dr Schmidt MS612 Gen Innov 310 Gen Innoy XP 55 22 Hoya AF 1 U VABOBB HumanQOptics 1CU OLtech Haptibag lOLtech Stabibag lOLtech XL Stabi Lenstec LS 106 DII Aqua Sense III Ophtec PC265 Ophtec PC410 Ophtec PC420 Ophtec PC430 Ophtec REF510 Pharm Tecnis Z9000 Pharm Upj 808C Pharm Upj CeeOn 9114 Polytech Polylens 460 Polytech Polylens A6 Polytech Polylens 580 Prutech Polulens P R5 Fig 15 Import lens constant data textbox 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 will show 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 1476 299 IOLMaster 27 03 2007 Import 31 32 Program Settings Regional Settings Printer SW Option gt Update Operation Setup The Setup submenu contains the following entries LI Date Time Opens the Windows routine for setting the system clock 1 Progra
2. Fig 58 Triple peak double zoom The automatic peak detection system will find an axial length value that is too short by approximately 150 to 350 um Following the comparison of all measured values and curves for this eye the measuring cursor must be moved manually to the middle 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 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 signal from the pigmented epithelium has the greater amplitude The measuring cursor may not be moved L Note Such a curve may only be evaluated correctly by viewing all measuring curves of this eye Such a curve must be clearly distinguished from double peaks produced by the inner limiting membrane and the RPE see Fig 55 It may be advisable to perform further individual measurements Up to 20 measurements may be taken on one day 000000 1476 299 IOLMaster 27 03 2007 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 de
3. Bae 5 eee tg agi tn Ra et Beene 14 40 fun Clear signal SNR display GREEN Secondary maxima visible Relatively clear media i PEER E EE O Signalin Borderline SNR uncertain range SNR display YELLOW Steep rise of measuring signal Such readings are accompanied on the display by an exclamation mark and the message Borderline SNR uncertain reading Warning This reading may be used after verification and comparison with other data from this series of measurements 000000 1476 299 IOLMaster 27 03 2007 75 76 In the measurement of pseudo phakic eyes and with specific intraocular lenses e g Acysof two peaks may appear The first higher peak is a side maximum of 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 Evaluation of ALM results Recognition of maladjustments on the graph 14 40 Low signal SNR display RED Error message is displayed The measuring signal cannot be clearly distinguished from the noise mm 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 A UU ad Viewer True 23 44 mm gt Fa
4. Start IOLMaster and wait until New Patient is displayed y Switch on printer and connect it to l OLMaster USB LPT 1 The Windows installation routine will be displayed y Select option No not at this time and confirm with NEXT y Insert installation CD for printer driver and wait for language selection to appear in selection window y Select appropriate language and confirm with NEXT E a If a dialog box for the installation of additional printer software is displayed exit this box without installing another printer The windows installation routine will confirm that installation of the selected printer is finished Exit with FINISH Fig 8 Installing the printer 20 Operation General notes on 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 All attempts to manipulate the operating system are strictly 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 L Note The system does not support all key combinations of Windows The special Windows keys that exist on some keyboar
5. 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 I Note After each change of side the overview mode OVW is automatically activated for coarse alignment Printout of results Once the measurements have been completed the readings composite signal and a diagram of iris pupil and WTW can be printed out Caution Consult the user manual supplied with the printer Connect the printer as described in Setting up the device for use on page 19 oes 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 readings 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 r 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 ras 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 77 In WTW mode the current reading can be printed out using lt CTR gt lt P gt 000000 1476 299 IOLMaster 27 03 2007 Operat
6. The Assistant has no right of access to the User Database 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 l 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 IL Note The rights of the Surgeon and Assistant user groups in the User Group Administration may be extended to include access to the lOLMaster Setup menu and the deletion of patient data 000000 1476 299 IOLMaster 27 03 2007 m Operation 37 Regional settings Opens the Windows routine for regional settings Printer Opens the 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 operating and maintaining the printer removing a printer that is no longer required see also page 19 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 on the screen up to the restart prompt see Section Update Installation page 102 Remove update CD from the drive If the IOLMaster reappears in New Patient mode after restarting the installa
7. e clicking on OL or pressing the lt gt button e selecting Prior refractive surgery Warning This step is necessary only with corneas pretreated by refractive surgery With untreated corneas IOL calculation starts instantly upon selection of the biometric formula see IOL calculation on page 56 Refractive history method The following values must be known for the refractive history method LJ Preoperative corneal refraction i e before corneal refractive surgery LJ Preoperative refraction LI Stable postoperative refraction L Corneal vertex distance As the change in refraction was achieved by variation of the corneal refraction the currently effective corneal refraction directly results from the difference between 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 is 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 000000 1476 299 IOLMaster 27 03 2007 e A 59 60 Operation Contact lens method The contact lens method contact lens overrefraction attempts to determine the currently effective corneal refrac
8. 3 8 Mustermann John 05 23 2005 Mustermann John 05 23 2005 Impl IOL p f23 Mustermann John 01 07 1977 05 23 2005 Mustermann mein 05 26 2005 PostOpRef pif f xfs0 Mustermann Mo 07 07 1977 05 23 2005 5 Dat Mustermann test 01 01 191 1 05 03 2005 econ Mustermann Userinterface 04 22 2005 A gt Post Op Date Basis New A Const 1193 _ lt lt SRK II_ Data Records 15715 A Const 1195 lt lt SRKe T 14 22mm B ad i425 lt Haigis 22 25mm 6 PACD 577 lt lt Hoffer 25 40mm 0 sF 208 lt lt Holladay Ave AL mm 2203 khia oi Last Optimize 06 03 2005 Load New Optimize Erase Gk Cancel SRK is a trademark of CTI Computational Technology Inc Fig 47 Assign data records dialog box 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 The boxes beneath it show the number of data records in the specified axial length ranges 000000 1476 299 IOLMaster 27 03 2007 Operation 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 OI If a data record is highlighted in yellow no ACD value
9. Automatic will always be switched back on for a new patient 000000 1476 299 IOLMaster 27 03 2007 Operation To delete one of the three displayed readings highlight it and press lt DEL gt Or lt CTRL gt lt Z gt Then confirm with YES If the last three readings differ by gt 0 5 D 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 Potential measuring errors inaccurate measurements must be deleted as necessary since the readings obtained in the Evaluation state will not be accepted for ACD measurement IOL calculation and the database for optimization of constants Warning To obtain consistent results we recommend checking the individual keratometer measurements and carrying out further measurements if necessary The following plausibility tests will be made with the keratometer reading R gt 84mm gt Indicates possibility of a very flat corneal curvature keratoglobus R lt 7 2 mm amp Indicates a very steep corneal curvature R lt 7 0 mm amp Indicates possible keratoconus IR1 R2 gt 0 5mm gt Indicates
10. resetting the zoom function page 77 continuous positioning of the measuring cursor while dragging see page 79 Single click Selection of menu textbox or entry Operation of Windows buttons or icons Double click 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 26 and Overview of buttons and shortcut keys on page 23 ff 000000 1476 299 IOLMaster 27 03 2007 21 22 Operation Screen layout Carl Zeiss IOLMaster Advanced 7echnology OoOON DU BPWDN o 1 Superimpose 2 Focus 3 Push 3 amp button 10 9 8 7 6 5 Menu bar Display field for measurements of right eye 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 Fig 11 Screen layout 000000 1476 299 OLMaster 27 03 2007 Operation Overview of buttons and shortcut keys Icon Key Function Explanations ar lt N gt Activates patient data For new patients input of EE entry screen patient data is essential Z lt O gt Activates overview Functions in all modes and mode and light spots for every measurement ont Activates axial length mode oe Activates keratometer lt K gt corneal curva
11. 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 value between 4 0 and 13 0 mm use decimal point Continue 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 refractive power make sure that the same keratometer refractive index is set on the lOLMaster as on the keratometer used for the measurement see page 32 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 overwritt
12. 2005 07 04 2005 08 04 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 the Nbutton 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 L Note Data is available in the internal database for the period preset in the Database box under Program Settings see page 32 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 viewing post treatment printing rss Note The file is not designed for archiving patient and measurement data The database field is structured similar to Windows Explorer see Fig 25 left side A sign at the branch indicates that the database already contains measurement results for this patient e Click on to display the treatment data for the last measurement s To close click on the sign The data records are sorted alphabetically
13. 6 The following plausibility tests are performed with the axial length measurement AL from the composite signal AL lt 22mm indication of short ocular axis use corresponding biometric formula AL gt 25mm indication of long ocular axis use corresponding biometric formula When both eyes have been measured the difference in axial lengths between right and left is also checked If the latter exceeds 0 3 mm a message appears to check the readings once again If this warning appears be sure to verify that no pathological changes have occurred in the eye If necessary the measurements must be repeated provided the maximum of 20 measurements per eye and day has not already been reached Only confirm the warning with OK if you are certain that the readings are plausible Otherwise determine what has caused the implausible readings A reference to the displayed plausibility test message will be transferred to the comments box 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 000000 1476 299 IOLMaster 27 03 2007 45 46 Aphakic Pseudophakic Silicone Pseudophakic Memory Pseudophakic PMMA Pseudophakic Acrylate Silicone Filled Eye Silicone Filled Ey
14. Mustermann Auge 01 07 1977 05 2 A 7 C Mustermann Auge 01 07 1977 05 2 Freha Mustermann Auge 01 07 1977 05 2 Date of Birth Mustermann Auge 01 07 1977 05 2 Mustermann Auge 01 07 1977 05 2 Exam Date C Mustermann Auge 01 07 1977 05 2 Mustermann Auge 01 07 1977 06 0 ID Number C Mustermann Auge 01 07 1978 05 2 Mustermann Augejhih 01 07 1977 08 SOON te po Mustermann Augek 01 07 1977 05 AL mm Mustermann Augek 01 07 1977 05 Mustermann Augekh 01 07 1977 05 K1 D Mustermann Auger 01 07 1977 05 2 Mustermann D250505 01 701 71990 0 K2 D Mustermann Ethard 11 11 1888 05 1 Opt ACD mm Mustermann Franz 07 07 1977 05 2 Mustermann g 01 011911 05 31 2C a Deea Mustermann g 01 07 1977 05 24 2C ele Sate Mustermann Haigis L 01 01 1911 05 Mustermann Hanna 11 11 1922 05 Mustermann Hanna 11 11 1922 05 Mustermann Hans 05 01 1955 05 0 Mustermann Hermann 11 11 2003 0 Mustermann Hermann 11 11 2003 0 Mustermann heute 01 01 1911 05 3 Mustermann jjj 05 25 2005 Mustermann jji 05 25 2005 Erase Mustermann jj 07 07 1977 05 25 2C Mustermann John 05 23 2005 Ok Mustermann John 01 0771377 06 23 Fig 45 Assign data records dialog box 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 OD righ _OS left e Select the ey
15. The position of the device in relation to the patient s eye thus found serves as a Starting point for fine adjustments to be made in the respective measurement mode 000000 1476 299 IOLMaster 27 03 2007 Operation Axial length measurement ALM with Advanced Technology The IOLMaster with Advanced Technology features superior signal processing in axial length measurement mode compared to the OLMaster without this technology In many cases this enables an overall evaluation of individual axial length measurements composite signal producing an axial length result without the need for manual evaluation as described on page 75 In some cases the axial length can even be determined where this would not have been possible from individual readings The lOLMaster displays the single signal of the axial length measurement in red and it is marked with an S on the ordinate The SNR signal noise ratio is shown on the x axis In contrast the composite signal is shown in blue and marked with a C on the ordinate The increased SNR of the composite signal is likewise shown on the x axis The SNR ranges Measuring error red Uncertain value Borderline value yellow Value with good SNR green are signalised by a traffic light Axial lengths are measured with the lOLMaster with Advanced Technology in the customary manner or as described on page 43 Take at least five individual measurements The axial length measurement signa
16. 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 Deviations may nevertheless occur between the displayed axial lengths and ultrasonic readings particularly in the applanation procedure At this point the importance of re personalising the lens constants should be stressed because the OLMaster is based on a new more precise measuring technology Refer to the specialist literature and publications by the originators of the IOL formulae regarding the personalisation 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 optimally aligned device relatively clear eye media and slight 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 th
17. device is properly used no electrical hazards exist to either patients or operators d 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 lancer Kiacce 4 be observed if the device is operated as intended Requirements for operation Please take care that the following operational requirements are met A when using the IOLMaster LJ 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 Ly The power supply plug must be inserted into a power outlet that has an intact protective conductor connection LY All cables and plugs may be used only if they are in perfect working condition In particular the spring action plug for device control 7 Fig 3 must remain plugged in and should not be pulled out LJ If the earth contact is impaired or if electrical wiring is damaged the device must be taken out of service and measures taken to prevent inadvertent use Following this call Carl Zeiss Service LY 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 Li A network isolator can be orde
18. high astigmatism When both eyes have been measured the difference in the keratometer readings between the right and left eye will be checked If this exceeds 0 2 mm or 1 D you will be prompted to check the readings once again If this warning appears be sure to verify that no pathological changes have occurred in the eye It may be necessary to repeat the measurements Only confirm the warning with OK if you are certain that the readings are plausible Otherwise determine what has caused the implausible readings A reference to the displayed plausibility test message will be transferred to the comments box 49 x Oo R2 7 76 mm x 90 D 0 86 dpt x oO D 0 80 dpt x17 n 1 332 Fig 32 Three keratometer readings A 000000 1476 299 IOLMaster 27 03 2007 50 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 I 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 the lt V gt key 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 brig
19. in the optimisation If less than 11 data records exist for optimisation or data records are rejected 0 D will appear in the New column In this case the optimisation has failed Repeat the optimisation process in this case with a larger number of data records or perform several optimisations 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 optimised constant To obtain optimum constants patients with pre intra or postoperative complications which could affect the refraction state should be excluded rs Note The displayed aO value does not take into account the data records highlighted in yellow e To reject the last optimisation run click on CANCEL In this case the optimised constants will not be saved to the lens data base even if a new data record has been entered e Confirm the newly optimised lens constants by clicking on the lt lt button to the right of the Basis field In this case all optimised constants will be accepted If you want to accept a special constant only e g a0 click on the lt lt button right of this constant 000000 1476 299 IOLMaster 27 03 2007 Operation John Q Public 0 D Acrimed Acriflex 45C Mustermann Egon U7 707 197 7 05 23 2005 Last Name Mustermann Surgical Eye 05 left Mustermann Erhard 11 11 1888 05 08 2008 4 Preece a 1717
20. maximum safety for both the patient and operator when using the OLMaster 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 000000 1476 299 IOLMaster 27 03 2007 13 14 Description the readings The device is controlled by the joystick and computer keyboard with integrated touchpad Based on the readings the program can make suggestions for the choice of intraocular lens strengths The latter are based on internationally accepted calculation formulae The Haigis HofferQ Holladay SRK Il and SRK T formulae are implemented in the software The Haigis L formula may be used to calculate IOLs after myopic LASIK PRK The refractive 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 uot 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 refraction results the lens constants entered into the calculation formulae may be optimised personalised for each individual user Literature on the formulae in case of specific questions please contact Carl Zeiss Meditec e Haigis http Awww augenklinik uni wuerzburg de uslab ioltxt haid htm e HofferQ HOFFER KJ The Ho
21. middle line appearing in bold type indicates which refraction of the corresponding IOL comes closest to the desired target refraction Warning The IOL calculation is valid only if the biometric measurement was correct an appropriate IOL calculation formula was selected and the IOL constants were optimized 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 32 e Click on OK to finish IOL calculation 000000 1476 299 IOLMaster 27 03 2007 Operation IOL calculation after corneal refractive surgery optional Corneal refraction is an important quantative factor in IOL calculation Presently it is impossible to exactly measure the corneal refraction that was subjected to corneal refractive surgery e g by RK PRK LTK Lasik or Lasek 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 LY Contact lens method LY Haigis L method should the preLasik or corresponding contact lens values not be available Prior to calculating an option for an intraocular lens the corneal refraction must be determined Start the calculation by
22. 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 000000 1476 299 IOLMaster 27 03 2007 89 Cause Remedy 90 Tips for keratometer measurement Other findings Pseudophakic eyes Reflections from cornea Reflections from IOL front surface artifacts Cause Remedy Fig 63 Pseudophakic eyes In the measurement of pseudophakic eyes images of the measuring marks may be visible at the front of the intraocular lens beside the reflections of the cornea The reflections from the IOL are fainter and lack definition Try moving the device approximately 1 mm away from the patient s eye defocusing and take the measurement The images produced at the cornea will now be slightly larger while the artifacts 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 measured 000000 1476 299 IOLMaster 27 03 2007 Tips for keratometer measurement Dry eye Fig 64 Multiple reflections produced by a dry eye Fig 65 Light trail bottom due to a dry e
23. to choice of lens type and critical distance to the endothelium IOL Calculation id Haigis SRK II Hoffer Holladay SRK T Multi Formula Haigis L phakic IOL Prior Refractive Surgery Eye Surgeon Dr Mustermann ha r Elf 01 01 1911 Axial Length mm Zg 0 faa 12 Comeal K s mm 7 88 247 75 7 93 417 86 Target Refraction Optical ACD mm 3 26 g 50 op yao Retr sph cyl p f 4 50 1 75 5 75 4 50 Vertex mm fi 2 fi 2 phak psph phak psph Surgical Eye id oD Vv os 101 Calculation Calculation Print IOL Calculation Data OS D 0 0 Ophtec Artisan fio LTECH PRL x r TN safety warning IOL D REF D 1OL D REF D Please refer to the manufacturer s quidelines regarding a 6 50 0 52 8 00 1 21 lens type and critical distances to the endothelium 0 10 7 50 0 69 5 50 0 33 7 00 0 16 5 00 fi 0 76 650 Ex e50 F 1 19 g oo jose 5 88 joo Emm IOL F 5 85 ooo OK Cancel Fig 42 Calculation of phakic 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 JOL CALCULATION to display the results To print out the page with the results press PRINT 000000 1476 299 OLMaster 27 03 2007 Operation 63 Optimisation of lens constants Selecting lens data The lens data available in the database may be optimised by the followin
24. with an exclamation mark after the reading and the message Borderline value will appear evaluation of SNR see Post run editing of axial length measurements page 78 ff Readings that deviate from the internally calculated mean value by more than 50 um are shown in red and marked multiple peaks 03 gt Note Borderline value Uncertain 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 other readings the readings marked Borderline value should also be accepted as valid axial lengths 43 1 Vertical line 2 Reflection of alignment light 3 Cross hairs Fig 27 View prior to axial length measurement 000000 1476 299 IOLMaster 27 03 2007 44 Operation is Note The lOLMaster requires five measurements to be taken The message Measure again will thus appear Only then will the composite signal be calculated and displayed as a blue measurement curve following the red individual measuring signal If an axial length measurement can be determined from this composite signal it will be transferred to the IOL calculation and an evaluation will be performed Only the number of measurements is crucial here To obtain consistent results we recommend che
25. with the password m Screen Saver IV Activate r Idle Time EM min Password Protection Fig 23 Program settings User adminstration Screensaver textbox 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 000000 1476 299 IOLMaster 27 03 2007 35 36 Operation x User Management User Membership dministrator New Delete Change password Add rUser 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 Program settings User administration User Manager textbox Each user may be a 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 Database see page 27 and the Setup menu The Surgeon only has an access right to the respective tab in the User Database This tab is created automatically when the user account Is established in the User Manager
26. 0 15 mm very rare or LJ the images produced optical sections do not contain relevant structures normally without the edge of the crystalline lens or disturbances are preventing their detection Incorrect settings 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 recognised 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 recognised correctly Improve the focus adjustment of the device and repeat the measurement The fixation point must be optimally focused 95 Cause Remedy 000000 1476 299 IOLMaster 27 03 2007 96 Cause Tips for anterior chamber depth measurement ce 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 light is reflected back into the viewing optics of the device A slight lateral misalignment may make the lens invisible This problem may also appear with patients who are restless or fixate poorly Cause Remed
27. 000000 1476 299 IOLMaster 27 03 2007 Safety instructions LJ Use only printers approved by Carl Zeiss Meditec Use only the CD supplied by the printer manufacturer to install the printer software Prior to using older printers consult http support microsoft com to determine whether printer drivers compatible with the Windows xP 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 simultaneously 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 17 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 17 is connected into the printer power line The required isolation transformer can be obtained from our sales organisation The power isolation transformer may not be used for printers whose wattage power consumption exceeds the permissible connected load of the power isolation transformer e g laser printers Such printers must always be positioned outside the range of the patient 1 5 m from the patient s seat at the device Protection Class Il printers without pro
28. 1 ene hee cai First Name Egon AL mm 24 23 Mustermann Ema 11 11 1866 05 08 2005 rth Mustermann Franz 07 07 1977 05 23 2005 Date ol Baste AAE Ten pedal ejo IMustermann g 01 01 1911 05 31 2005 Exam Date 0572372005 K2 or f4a4g Mustermann Haigis L 01 01 1911 05 30 201 Mustermann Hermine 02 02 1911 05 07 20 ID Number Dpt ACD mmf 3 8 Impl IOL D f23 Mustermann John 05 23 2005 Mustermann John 01 0771977 05 2372005 i Mustermann mein 05 26 2005 Post Op Ref pifi M fso Mustermann Mo 07 07 1977 05 23 2005 S Date Mustermann test 01 01 1911 05 03 2005 E ERE Mustermann Userinterface 04 22 2005 4 gt Post Op Date New A Const ps3 lt lt i193 SRK II Data Records fisvis A Const ngs lt lt 119 5 A 14 22mm fs al i425 j5 Haigis 22 25mm je pACD E7 E77 Hofferg 25 40mm j SE jz lt lt 208 Holladay Ave AL mm 22 03 Last Optimize 0670372005 Load New Optimize Erase OK Cancel SRK is a trademark of CTI Computational Technology Inc Fig 49 New data record has been added e Click on OK to return to the User Database Optimised lens constants will only be saved to the lens database and for use in future IOL determination if they are confirmed with OK e Click on OK to return to the IlOLMaster main module 000000 1476 299 IOLMaster 27 03 2007 69 70 1OLMaster 3 Mustermann Max 01 01 1911 29 03 2005 01 04 2005 04 04 2005 05 04
29. 3 2007 97 Cause Remedy 98 Tips for anterior chamber depth measurement Reflections in the corneal image Cause Remedy Fig 74 Reflection in corneal image due to lateral misadjustment The lateral adjustment of the device is not correct Illumination 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 rule the fixation point will then be between the image of the anterior lens and that of the cornea Repeat the measurement 000000 1476 299 IOLMaster 27 03 2007 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 000000 1476 299 IOLMaster 27 03 2007 99 Cause Remedy 100 Tips for anterior chamber depth measurement Irregularities of the corneal surface scars Cause Remedy Fig 76 Condition after keratoplasty same eye as shown in Section Tips for keratometer measurement F
30. 350 um towards shorter axial lengths The reading can be corrected by dragging the measurement cursor in the composite signal to the lower peak that of the pigmented epithelium This manipulation is only permissible in the context of the single signals of this series of measurements 000000 1476 299 IOLMaster 27 03 2007 Evaluation of ALM results 85 Signals from the choroid Triple peaks In rare cases the measuring beam may also be reflected by the vessels of the choroid Signal from 1st secondary maximum inner limiting membrane choroid pigment epithelium 0 15 0 25 mm 0 15 0 35 mm Fig 57 Rare triple peak triple zoom The measuring peak produced by the choroid appears shifted towards longer axial lengths by approximately 150 to 250 um from the peak of the pigmented epithelium In the above example the signal from the RPE middle peak has the A 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 clearly differs from the secondary maxima produced through the light source by the distance from the RPE reflected peak 000000 1476 299 IOLMaster 27 03 2007 Evaluation of ALM results In very 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
31. 76 299 IOLMaster 27 03 2007 115 CARL ZEISS MEDITEC AG Goeschwitzer Str 51 52 D 07745 Jena Germany Phone 49 3641 220 333 Fax 49 3641 220 282 Email info meditec zeiss com Internet www meditec zeiss com 000000 1476 299 lOLMaster 27 03 2007 Specifications subject to change
32. A plus Select export settings Select the desired form of file printout Identification or Readings 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 000000 1476 299 IOLMaster 27 03 2007 Identification M Last Name IV First Name MV Date of Birth M Exam Date TF ID Number 33 Fig 18 Data export form Identification Measurement Values IV Axial Length V Mean Value List of Values V Keratometer Active Value C List of Values MV Anterior Chamber Depth V White To White Active Value List of Values Operation File output Field separator Semicolon Decimal separator Comma Output path CD RW USB stick File name export csv Fig 19 Data export form Measurement values Fig 20 Program settings Export file output textbox 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 V Operator login with password User manager Fig 21 Program settings User adminstration textbox Caution The o
33. Corneal K s D Radius mm Apply r Contact Lens Method r Contact Lens Method CL power D Vertex mm CL power D 025 Vertex mm 12 CL base cuve D CL base curve D 41 50 Refr with CL D sh t Refr with CL D sph 1 75 cyt 0 50 Refr without CL D sph cyt Refr without CL D sph 3 25 cyt 1 25 Corneal K s prf Radius mmk Apply Corneal K s Dif 46 98 Radius mm 7 18 Apply M Cancel 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 radii values may not be edited in the 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 1476 299 IOLMaster 27 03 2007 Operation 61 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 10L Calculation x Haigis SAK II Hoffer Holladay SRK T Multi Fomula Haigis L phakic IOL Prior Refractive Surge
34. Printer Prior to using older printers please consult Carl Zeiss Meditec whether the printer is approved for use with the lOLMaster 4 5 Q S MOUSE KEYB i j S o O NET COM 1 LPT 1 9 8 7 6 1 Power switch 6 Printer port LPT1 2 Power supply plug 7 External PC port COM 1 3 Monitor port VGA 8 Network connector NET 4 Mouse port MOUSE 9 USB interface USB 5 Keyboard port KEYB Fig 9 Connection panel AN Warning If connecting external devices e g an external PC to the connectors or an external monitor to the VGA connector the operator must ensure to meet the safety requirements as per DIN EN 60601 1 1 medical electrical systems A network isolator can be ordered from Carl Zeiss for connection to an external network NET The IOLMaster 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 Once this has been completed successfully the device may be operated Certain operating parameters are factory set and may be changed in the Setup menu see page 32 000000 1476 299 IOLMaster 27 03 2007 19 Install printer according to manufcturer s user manual Do not connect it to the lOLMaster yet
35. a 03 29 2005 SN IE mandatory 04 04 2005 ID Number 04 05 2005 i 04 07 2005 Refraction OD D fo 0 fo hpm a 04 08 2005 0S D fo oS fo re y a 04 20 2005 and visua 04 21 2005 Visual Acuity OD acuity 04 22 2005 os z i 04 25 2005 Se er i optional 04 26 2005 05 24 2005 06 01 2005 Room for 06 03 2005 notes optional Database field Fig 25 New Patient dialog box The personal data of patients not yet listed in the database New Patient must be entered via the keyboard no special characters other than and _ are permissible 000000 1476 299 IOLMaster 27 03 2007 Operation To move the text cursor to the next dialog box press the TAB or ENTER key or click the mouse rs Note Depending on the program setting see page 32 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 entered as a four digit number yyyy mandatory for patients over a hundred years old 38 gt 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 32 Up to 255 characters may be entered in the Remarks field comments diagnoses etc L Note Refer to page 70 for working with the database field In Program Settings yo
36. ainst possible health risks or mortal danger Observe all safety notes and information in this manual and on device labels 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 Fe Disconnect the device from the power QD i gt caution supply before servicing Information and notes for a better under cS NOME standing of the operating instructions Warning Correct operation of the device is imperative for safe functioning 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 Accessibility of the user manual Always keep this user manual and all accompanying documents in the immediate vicinity of the device The user manual should be readily accessible at all times 000000 1476 299 IOLMaster 27 03 2007 Safety instructions Compliance with standards and regulations m m This device is a Class Ila medical instrument as defined by the European Medical Device Directive MDD This device complies with EC Medical Device Directive 93 42 EEC and the national implementation of this directive in the form of the German Medical Products Act see Manufacturer s Declaration on
37. atically snaps in over the desired peak The display will show the corresponding axial length and SNR always smaller than the maximum SNR found automatically and the recalculated value will appear in the display field denoted by an asterisk 79 000000 1476 299 IOLMaster 27 03 2007 Evaluation of ALM results Example hold left mouse button depressed drag a line is moving along with cursor a m release mouse button Fig 53 Moving the measuring cursor to a different peak signal curve zoomed in 3 times 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 this automatic method unless the curve adjoining them drops down below a value which is less than half the amplitude of their maxima oss Note While the measuring cursor is being dragged the original reading and SNR are always displayed alongside the composite signal The new axial length value and corresponding SNR will be calculated and displayed only when the button is released 000000 1476 299 IOLMaster 27 03 2007 Evaluation of ALM results 2 Fine shifting the measuring cursor 03 gt Note This manipulation should always be performed in a zoome
38. by last name 000000 1476 299 IOLMaster 27 03 2007 Operation 71 Use the Search textbox to quickly access a data record Place the cursor Patient Options in this box and type in the desired last name to list all relevant data aot Bee 2 records The following letters of the name can also be entered this Eae i 1OLMaster ensures fast access to the desired data record SaaSiSE REN ESR ULTUIRTR 03 29 2005 On repeat visits data can be instantly transferred to the input area by 04 04 2005 clicking on the patient s name 04 05 2005 To take a new measurement click the NEW button or use the keyboard shortcut lt ALT gt lt N gt Rees 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 To view the measured data press the OPEN icon use the keyboard o i r pen 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 measurement e To delete a patient from the patient list highlight the name and press lt DEL gt or select Erase from the Patient menu Rename lt Ct gt R e Confi
39. cessed in the appropriate form m3 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 32 f depending on the setting in Program Settings Export Exporting data to a storage medium e Select the desired storage medium in the menu Options Setup Program settings Export see page 34 res 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 should enable at least a transfer rate to USB 1 1 e 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 1476 299 IOLMaster 27 03 2007 73 74 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 Switch the device off at the power switch e Wait until the switch lamp goes of
40. cking 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 L 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 overall refraction and checked for plausibility It is likewise helpful to compare the right and left eyes The composite signal is calculated after the fifth measurement Initially the individual signals are displayed in red After a delay of about 1 second the composite signal is then displayed in blue In addition the axial length reading determined from this composite signal will appear The composite signal will be re calculated after each further ind
41. ctive 93 42 EEC and its national equivalent in the form of the German Medical Product Act MPG Instrument class according to the Medical Device Directive lla UMDNS No 18 014 If changes are made to the product or it is opened without the manufacturer s authorisation this declaration will be rendered invalid 000000 1476 299 IOLMaster 27 03 2007 ACD ALM CD RW COM csv DIN EN Fig HIPAA ID IOL KER LC display LED mm MS MMLD um OVM PC PCI SRK USB VGA WTW Abbreviations Glossary 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 Deutsches Institut f r Normung German Technical Standards Institute European standard Figure American Health Insurance Portability and Accountability Act Identification Intraocular lens Keratometer Liquid Crystal Display Light emitting diode millimetres Microsoft Multi mode laser diode micrometre Overview mode Personal computer Partial coherence interferometry Sanders Retzlaff Kraff Universal serial bus standard interface for PC peripherals Video graphic adapter video standard for PC with 640 x 480 pixels and 16 colours White to white distance 000000 14
42. d 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 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 axial length measurement mode after the current individual measurement and in post run editing mode 000000 1476 299 IOLMaster 27 03 2007 81 82 a x 0 8 mm Fig 54 Undisturbed measurement signal with secondary maxima 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 retinal pigmented epithelium of the eye This signal is utilised for axial length measurements oes Note Ultrasonic biometrical instruments measure the axial length
43. de with acknowledgment from the list lt M gt Briefly inactivates Briefly interrupts adjustment automatic operation aid automatic function in KER mode lt Ctrl gt lt Z gt Restores deleted readings Effective only in ALM KER and WTW mode lt Ctrl gt lt D gt Effective in ALM mode Prints the image of the selected graph Effective in WTW mode Prints the selected image of the eye ALM One graph only WTW Right and left eye 000000 1476 299 IOLMaster 27 03 2007 Summary of result displays Operation Display Meaning Notes 22 73 mm 3 axial length measurement 22 55 mm selected Displays measurement curve of this measurement ratio 22 72 mm ERTE Unreliable value Borderline SNR appears 23 21 mm SNR displays YELLOW above graph 23 27 mm SNR signal to noise Result should be examined by the user for validity Measuring error SNR display RED Error appears above axial length graph Result has been manipulated remains displayed even if manipulation has been undone Measuring cursor is positioned above signal peak SNR display and SNR Values for the peak below the 3 signal to noise ratio measuring cursor beside signal curve SNR 6 4 000000 1476 299 IOLMaster 27 03 2007 25 26 Patient New Opens dialog box for entry of new patient entry compulsory Erase Deletes patien
44. djusts various settings Date time 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 software options Update Installs software update Service Only for service password protected About lOLMaster Display and print information on program version 000000 1476 299 IOLMaster 27 03 2007 Operation Options menu Test eye The calibration of the device can be checked with this function see Section Checking the measurement functions on page 104 User database Since the device may be used for the preparation of eye surgery by a number of surgeons at a group practice or clinic surgeon specific records may be created This is performed using the User Manager in the Options menu e Click on User Database in the Options pull down menu The dialog box for entering surgeon specific data will appear x Password Cancel I Change password New password Confirmation 27 Test Eye User Database Setup gt Service Fig 13 Please input password dialog box rss Note When the device is delivered the User Database only contains the administrator without any password specifications Only the administrator is entitled to add or delete users and edit their databases Caution Individual users may edit their databases only if
45. ds 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 might be the case for instance if the program run is affected mostly by external disturbances Multiple safety mechanisms in the instrument s hardware and software ensure that there is no risk of injury Caution If warning messages appear frequently the device should be taken out of service and labelled as such Then call Carl 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 L keyboard or LJ menus Measurements are initiated by pressing the button on the joystick 000000 1476 299 IOLMaster 27 03 2007 Operation Operation by touchpad and keyboard 1 Touchpad Left button 3 Right button Fig 10 Touchpad control L 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 button LJ To drag the cursor hold the left mouse button depressed while moving the finger across the touchpad LY The right button is only functional for
46. e Aphakic Silicone Filled EYE Pseudophakic Operation Phakic IOL PMMA 0 2mm Primary Piggy back Silicone SLM 2 Primary Piggy back Hydrophobic Acrylate Fig 28 Video image after axial length measurement ALM measurement of non phakic eyes To measure non phakic 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 settings is to be measured the following compensation values according to PD Dr Wolfgang Haigis of W rzburg University Clinic Germany should be used Fig 29 AL settings 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 A IOL centre thickness 0 2 mm 0 5 mm 0 8 mm IOL material Silicon 3 SLM2 0 02 mm 0 04 mm 0 07 mm PMMA 0 02 mm 0 06 mm 0 09 mm Acrysof 0 03 mm 0 08 mm 0 13 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 result will be slightly elevated The reading must be corrected depending on the mat
47. e 95 Incorrect settings esseseessesesrsreereeeerrereerterenrereorreresre recse 95 Pathological TINGS 2 swuyskacncee so vacnsciacninniacdecoveteietenieic 99 Tips for WTW measurement optional s ccssseeeeeeeeeeeeees 101 How to adjust the device cci g5ccccscec2oesacececcedeaddsonecddxedennsccsiinnd 101 Servicing ANd maintenance cccceeeeeeeeeeeeeeeeeeeeneeseeeeeneeeeeeeeeeeeees 104 Checking the measurement FUNCTIONS 0ceeeeeeceeeeeeeeeeeneee 104 Axial length measurement and keratometer 25 105 Anterior chamber depth measurement 0 cccccee 105 Verifying WTW measurements optional 0ee 106 Printer troubleshooting asccceches vonntahclerantsercaesiunceccausiniaraeanccane 107 Care Of NE COMIC seart atenen anie ee en 107 Safety INSpECtIOTS me een meee ear ea E TA 108 Technical specificationsS esseesssessuurnnuennnrnunnnnnnrnnnnnnnnnnnnnnnnnnnnne 109 Manufacturer s Declaration cc ccccseceeseeeesseeeeeeeeeeseeeeeeeeeeeeees 114 AbDbDreviations Glossary asiiccsscieececeeceedesssenecienensccencacnestieneeantuccncanees 115 Important for your safety Safety instructions Servicing and maintenance 000000 1476 299 IOLMaster 27 03 2007 Notes on the user manual Symbols The following warning symbols refer to important safety information in this user manual Whenever you see these symbols read the accompanying notes carefully They may warn ag
48. e drive Once the OLMaster has booted up and a message prompting a check of the calibration appears the software update has been completed If you wish to switch off the IOLMaster after the software update click on the EXIT icon and confirm with OK Do not switch the IOLMaster off at the power switch until the cursor on the screen can no longer be moved using the touchpad for OLMaster with black power switch or the screen is completely black IOLMaster with green illuminated power switch Please check the current software version of your OLMaster after restarting For this purpose click on About lOLMaster in the pull down menu After updating to version 5 patients already measured on the same day with version 4 cannot be re measured Patient measurements should therefore be completed before the update is carried out These patients can be measured with version 5 in a completely new session on the following day The mean value of single measurements taken with version 4 will continue to be displayed The composite signal and composite reading are not determined here 000000 1476 299 IOLMaster 27 03 2007 Calibration instructions for the keratometer adjustment aid 103 Calibration process for the keratometer adjustment aid traffic light display 1 If the Advanced Technology Software version 5 has been installed on your device and you wish to use the keratometer adjustment aid traffic light display it must first of al
49. e 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 000000 1476 299 IOLMaster 27 03 2007 Evaluation of ALM results 83 Indications of this are broader smeared signal peaks of the measuring curve variations of approx 150 to 350 um in axial length data in one measurement series and display of Evaluation in place of the mean value composite reading Examples pe 22 76 mm 22 74 mm 22 72 mm o No 22 74 mm NS 22 74 mm 22 74 mm or or or 74mm 22 73 mm 22 72 mm Such measuring curves or measurement series require immediate verification either between individual measurements in ALM mode or in post run editing without the patient in front of the device Interpretation or post run editing should always be performed with the help of the zoom function rss 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
50. e printers not connected except New Printer and press the lt DEL gt key Follow the instructions displayed on 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 19 Care of the device Warning Before cleaning the device switch it off and pull the power supply A plug gt Caution t When cleaning the greatest care must be taken to prevent moisture from penetrating the device or keyboard as this may cause damage O 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 LJ Never use aggressive or abrasive cleaning agents LJ Use conventional cleaning cloths for wiping off the display and keyboard of computers and monitors 000000 1476 299 IOLMaster 27 03 2007 108 Servicing and maintenance LI 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 comp
51. e starting measurements it 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 50 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 beam path for the measurements is rotationally symmetric it is recommended that the asymmetrical holder 5 Fig 77 be reversed when checking the anterior chamber depth measurement 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 is positioned exactly vertically in front of the device 1 Note The test eyes are ideally suited to practising the operation of the IOLMaster The status of the Test eye is also reset each time a new patient lt N gt or icon is admitted 000000 1476 299 IOLMaster 27 03 2007 105 106 Fig 78 WTW scale 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 optio
52. e to be used for the optimisation calculation The fields below show the measurement data of the OLMaster e If you wish the data of the other eye to be kept in the data table for further optimisation activate Keep other side in the check box lt e Click on the lt lt button to load the selected data record in the left 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 gt e Click on the gt gt button to return the selected data record to the right hand table if it is not to be used for optimisation but should be kept for possible later use Erase e Click on the ERASE button to irrevocably delete the data record to the right or left e When all the desired data records have been 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 ae Bea Ease 000000 1476 299 IOLMaster 27 03 2007 Operation 65 res 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 IOLMaster result New table click on the NEW button T
53. ected iris edge is marked After checking that the iris and fixation point have been correctly recognised confirm with OK Only then will the data be valid and available for further processing 000000 1476 299 lOLMaster 27 03 2007 Operation Warning The validity of the WTW determination depends on this check of correct recognition of the iris edge The WTW value is the horizontal diameter of the iris In addition to the WTW value the deviation 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 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 res 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 000000 1476 299 IOLMaster 27 03 2007 A 53 54 M L Operation Measuring the other eye The system automatically registers which eye is being measured OD or OS
54. ections 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 The size and shape of measurement points will be 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 will be displayed rss Note The OLMaster 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 I Note In some cases keratoconus keratoglobus corneal lesions etc it may not be possible to reach the green traffic light In such cases the traffic light display can be briefly deactivated enabling a measurement to be taken even when the light is on yellow or red To do this press the lt M gt key The Automatic display will disappear However now pay attention to the correct setting as described above Press the lt M gt key once again to reactivate automatic
55. ed power Slit illumination for anterior chamber depth measurement integral irradiance UV 300 to 400 nm IR 700 to 1100 nm A phakic eye aphakic eye re LED 880 nm lt 100 pW Semiconductor diode laser MMLD 780 nm 450 pW 80 uW 0 55 20 per eye and day 1 DIN EN 60825 1 2003 3B LED 590 nm lt 1 uw LED 880 nm lt 50 uw 0 00087 mW cm 0 04 mW cm in spectral range of 860 to 1100 nm no detectable emission from light source 122 8 W m sr 125 5 W m sr 000000 1476 299 IOLMaster 27 03 2007 112 Technical specifications Spectral irradiance Spectral irradiance of slit illumination white LED determined in the optical axis 0 and at an angle of 33 0 1 Emission 33 Ee 0 814 mW cm 0 08 2 Emission 0 Ee 0 91 mW cm 0 06 Irradiance in Wim nm 0 04 0 02 300 350 400 450 500 550 600 650 700 750 800 850 900 Wavelength in 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 Photochemical radiation density of a light source white LED slit illumination for the phakic eye Lg 122 8 W m sr 50 400 45 300 3 0 500 550 600 650 700 000000 1476 299 IOLMaster 27 03 2007 Technical specifications 113 Photochemical
56. en To restore the last just overwritten readings press shortcut keys lt CTR gt lt Z gt UNDO function o gt Note This UNDO function itself is irrevocable 000000 1476 299 IOLMaster 27 03 2007 51 52 Operation Determination of white to white WTW optional Activate the WTW mode by clicking on the WTW icon or pressing the lt W gt key pressing the lt SPACE BAR gt in ACD mode ACD The patient should look at the yellow fixation point in the centre Align the device so that the six peripheral light spots are symmetrical to the cross hairs 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 the pupil or iris because only in the rarest cases does the visual axis correspond to the optical axis of the eye Warning The patient should be asked if he or she sees the fixation point If the patient fails to fixate properly the visual axis will not be correctly recognised which may result in measuring errors e Trigger the measurement by pressing the knob on the joystick Carl Zeiss 1OLMaster gt Patient Functions Options 1 Center fixation point in ring 2 Focus iris 3 Push joystick button 4 Evaluate image Galue of ala Ready John Mustermann WTW OD Fig 34 WTW determination Each time the joystick knob is pressed an image of the eye is displayed in which the det
57. ere should be a period of at least 8 weeks between the surgery and post op dates This period however will not be checked e If you wish to reject the entries made and return to the optimisation calculation 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 In the IOL D box enter the power of the implanted IOL e In 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 ras 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 0 D Acrimed Acriflex 45C ann Eg Last Name Mustermann Surgical Eye 0S left Mustermann Erhard 11 11 1888 05 08 200 A Mustermann Ema 11 11 1856 05 08 2005 First Name Egon AL mm 2423 Mustermann Ema 11 11 1866 05 08 2005 ith Mustermann Franz 07 07 1977 05 23 2005 Date of Birth 07 07 1977 se ERIA eN Mustermann g 01 01 1911 05 31 2005 Exam Date 05 23 2005 K2 D1 43 49 Mustermann Haigis L 01 01 1911 05 30 201 Mustermann Hermine 02 02 1911 05 07 20 ID Number l Opt ACD mm
58. erial used and the centre thickness Warning 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 76 It is expedient to measure at a number of different points 000000 1476 299 lOLMaster 27 03 2007 Operation 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 OLMaster and the readings thus obtained entered into the appropriate boxes Measurement of corneal curvature KER Keratometer measurement Activate the KER measurement mode by clicking on the KER icon pressing the lt K gt key pressing the lt SPACE BAR gt in ALM mode ALM Tell the patient to focus on the yellow light 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 The JlOLMaster with Advanced Technology indicates the optimum measurement setting by means of a green traffic light L 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 sho
59. ernal 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 In accordance with applicable EU guidelines at the time at which the product was brought onto the market the product specified on the consignment note is not to be disposed of via the domestic waste disposal system or communal waste disposal facilities For further information on disposal of this product please contact your local dealer or the manufacturer or its legal successor company Please read the latest internet information provided by the manufacturer Where the product or its components are resold the seller must inform the buyer that the product must be disposed of in accordance with the currently applicable national regulations 000000 1476 299 IOLMaster 27 03 2007 Safety instructions Package contents The device is delivered completely assembled 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 returning it to the manufacturer or dispose of it properly Warning and information labels on the device The device casing carries the follow
60. f before pulling the power supply plug or switching off at the main room switch L Note The device may not be switched on again until the switch lamp goes off Caution If the device is switched off at the power switch while it is in operation the program will quit automatically before the device shuts down It is thus important to wait until the switch lamp goes off before pulling the power supply plug or switching off at the main room switch If the device is unplugged or switched off at the main room switch while the device is still running the program cannot quit and the operating system cannot be shutdown properly this can lead to loss of saved data and or defects in the devices s control software This does not present a hazard to patients or the operator L Note The procedure described below does not apply in the case of breakdowns see page 101 or if the device does not respond to your input If this occurs switch off the device immediately and pull the power supply plug Label the device as being defective and call Carl Zeiss Service 000000 1476 299 IOLMaster 27 03 2007 Evaluation of ALM results Signal curves of axial length measurements Valid signal curves Secondary maxima system specific distance about 0 8 mm maximal peak Very good signals signal to noise ratio gt 10 Several secondary maxima visible system specific Clear media patient correctly fixating Slight ametropia
61. ffer 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 6SRKII 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 corneal refraction after corneal refractive surgery HOLLADAY JT IOL calcualtions 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 Optische Konsequenzen der Implantation einer negativen Intraokularlinse bei myopen Patienten Klin MB1 Augenheilk 192 99 102 1988 HOLLADAY JT Refractive power calculations for intraocular lenses in the phakic eye Am J Ophthalmol 116 63 66 1993 HAIGIS W Biometry in complicated situations 9th Conv of DGII 1995 Rochels et al Hrsg Springer 17 26 1996 000000 1476 299 IOLMaster 27 03 2007 Description Overall view Ay iM v
62. g procedure e In the Options menu open User Database Select the respective eye surgeon and confirm your choice with OK Fig 44 Choose a lens The input mask contains constants calculated from A Constant Manufacturer or previously optimised constants 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 Database x Administrator Dr Mustermann Lenses Name flens 1 frie pens sis nes neat Basis lt lt New Z anufacturer A Const DE lt lt SRK II A Const fis SRK II fie A Const 118 SRKe T A Const Eal SRK T a0 fi 273 al 1 273 lt lt Haigis al fo 4 Haigis pACD 4 96 lt lt Hoffer a2 01 SF 22 Holladay pACD 4 96 HofferQ SF 1 22 Holladay Power Steps 1 2D 1 4D Load New Erase Add Erase Set Optimize Fig 43 Lens data in dialog box for SRK is a trademark of CTI Computational Technology Inc selected lens Fig 44 Lens data in the User Database dialog box 000000 1476 299 IOLMaster 27 03 2007 Operation Loading existing data records e Click on the LOAD button to load the data records of all patients available for optimization Assign data records John Public 0 D Actimed Acriflex b z Measurement Table mia Semen Mustermann Auge 01 07 1977 05 2 a News o Mustermann Auge 01 07 1977 05 2 Last Name
63. g the OLMaster on the keyboard support Paper pads for patient chinrest Power isolation transformer for connection of external accessory units Network isolator Software option A plus Software option B Connecting cable for coupling with PC DOUUOUW COUO 000000 1476 299 IOLMaster 27 03 2007 Description Power isolation transformer for external devices AN Warning Always connect all peripheral devices printers and monitors to the power isolation transformer No components other than those prescribed for the system may 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 Likewise excepted are laser printers as their rated supply voltage usually exceeds the permissible connected load of the power isolation transformer Position the laser printer outside the patient s range 1 5 m from the patient s seat at the device 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 placed on the floor A Warning The lOLMaster should never be operated via the power isolation transformer The power isolation transformer is not a constituent part of the lOLMaster 17 1 B B E l 2 1 Power cable connector with fuses 2 P
64. ge of the fixation point appears optimally focused in the green square on the display LJ 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 0 the image of the anterior crystalline lens is visible in the pupil os Note The image of the fixation point may not lie in the image of the lens or cornea 000000 1476 299 IOLMaster 27 03 2007 93 94 Tips for anterior chamber depth measurement If the device has been properly aligned the images of the fixation point and the anterior 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 rer Note The image of the fixation point should be near but not in the image of the lens Fig 69 Optimally adjusted optical section lens with cataract Fig 68 and Fig 69 show optical sections of right eyes 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 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 Depend
65. h RENAME Rename record Last Name Mustermann First Name Max Date OfBinh OST Exam Date fu ID number ea Cancel Fig 50 Rename record dialog box Transmitting exporting data optional Patient data can be exported to connected office administration systems or personal computers a USB storage medium or a CD TW The data is then available for further processing Note Transmitting exporting does not work in the Patient Manager only in measurement modes 000000 1476 299 IOLMaster 27 03 2007 Operation Exporting data to another system LJ Data can only be exported to office management systems by the supplier of such systems Please contact the respective supplier LI The appropriate accessories are required for exporting to a connected Windows based personal computer These can be obtained from 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 e To export data press the lt S gt key not in Patient Manager or the SEND button The data will be exported os Note The PC must have been switched on and the software for data receipt started A progress bar will be visible on the IOLMaster screen Data can be archived on the PC or pro
66. his will bring up an input mask for creating a new data record to be optimised However 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 fast Namie m Pre Op Values First Name SS s AL mm ial ail Date of Birth SSS R1 mm if ES E Exam Date Ol R2 mm i ID Number Opt ACD mm E Remark Surgical Eye OD right C OS left Post Op Yalues 7 Implant IOL D Post Op Ref D rs x Surgery Date Post Op Date e Coree Fig 46 Input new data record dialog box Warning Only data obtained from the IOLMaster may be entered in the fields for AN 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 surgery of the cornea should be excluded from optimisation e Complete the entries in the input mask 000000 1476 299 IOLMaster 27 03 2007 66 Implant IOL D Post Op Ref D Surgery Date Post Op Date a Operation rss Note The entry of the Exam date is mandatory Entry of ACD data Surgery Date and Post Op Date is optional rss Note Th
67. ht to patients Nevertheless the patient should continue to concentrate on 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 the other image details reflections do not cause interference to the image of the cornea otherwise the reading will be incorrect the anterior crystalline lens is optimally visible As a rule 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 Setting for anterior chamber depth 000000 1476 299 OLMaster 27 03 2007 Operation 3 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 anterior chamber depth measurement page 93 ff e Trigger the measurement by pressing the knob on the joystick 38 gt 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
68. ig 67 page 92 Scars and local irregularities of the anterior cornea impair the image quality of the optical section of the cornea Depending on the extent and 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 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 1476 299 OLMaster 27 03 2007 Tips for WTW measurement optional 101 How to adjust the device Ask the patient to relax and look at the yellow fixation light Focus on the iris not on the light spots 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 t
69. in rest the holding pins for the paper pads 4 Fig 77 may need to be removed beforehand The test eye 1 Fig 77 is secured by a locking screw and mounted on a mandrel which allows it to rotate 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 In the delivery condition a patient CHECK DEVICE with birth date 01 01 1911 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 000000 1476 299 IOLMaster 27 03 2007 Servicing and maintenance e Highlight the patient CHECK DEVICE and click on NEW 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 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 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 for checking the anterior chamber depth measuring device The surface structure simulates the cornea Befor
70. inform you if the restore action was a SUCCESS Caution 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 I Note Download IOL data using a PC connected to the Internet and a CD RW recorder or USB storage medium Caution Do not use a network connected OLMaster for the download Log into www meditec zeiss com iolmaster lOLMaster gt Download Select Optimized IOL constants Follow the prompts now appearing on the screen Save the file do not select Open on the desired storage medium Do not extract the ZIP file 000000 1476 299 IOLMaster 27 03 2007 Operation Importing IOL data from the storage medium to the OLMaster e inthe User Database activate Administrator e Click on the IMPORT button Import of lens data X Please insert the USB stick 7 CD containing the lens data base for import Cancel e Insert the CD RW or USB flash drive with the database to be imported and confirm with OK
71. ing on the lighting conditions in the examination room the front side of the lOLMaster as reflected by the cornea may also be visible These artifacts 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 measuring errors may under certain circumstances not be recognised as such The OLMaster must be adjusted very carefully for anterior chamber depth measurements 000000 1476 299 OLMaster 27 03 2007 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 res Note It is advisable to measure accommodating patients under cycloplegia Measuring errors The Error message may have two basic causes Q The results of the five internal individual measurements vary by more than
72. ing warning and information labels Vor Offnen Netzstecker ziehen Caution disconnect power supply gt before opening 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 w lOLMaster 50 60 Hz A 90 VA 0297 C R IP20 6R Complies with 21 CFR c US Subchapter J Fig 1 Warning and information labels on the device 000000 1476 299 IOLMaster 27 03 2007 12 Safety instructions Customer s safety obligations The user is responsible for ensuring that m m 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 measurements 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 o
73. ion 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 Database open the Please enter password dialog box Select the appropriate name and enter password as necessary The database window for entering the specific lens data will open for registering a new user see page 27 User Database x Administrator Dr Mustermann Lenses Name Lens 1 Lens 2 Const 118 Manufacturer ACD ja Manufacturer A Const 118 SRK Il A Const 118 SRK T al f 273 al 0 4 Haigis a2 01 pACD 4 96 Hoffer SF 1 22 Holladay Power Steps 1 2D 1 4D Add Erase Set Optimize SRK is a trademark of CTI Computational Technology Ine Fig 36 Database window for the input of lens data e In the lines Name A Const Manufacturer and ACD Manu facturer enter the respective data for the manufacturer from 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 de
74. ion class Protection type Device type Device should be connected only to sockets with an intact earth conductor l IP 20 B DIN EN 60601 1 Power isolation transformer Rated voltage frequency power isolation transformer 100 to 127 V AC 10 60 Hz or 220 to 240 V AC 10 50 Hz Power consumption power isolation transformer max 115 VA Total power consumption of connected external devices Power isolation transformer fuses 2 x T3 15 A H 250 V 5x20 IEC 60127 for 100 to 127 V AC 2 x T1 6 A H 250 V 5x20 IEC 60127 for 220 to 240 V AC Environmental conditions for intended use Temperature Relative humidity Air pressure 10 to 35 C 30 to 75 no condenation 800 to 1060 hPa Storage environment Temperature Relative humidity Air pressure 10 to 55 C 10 to 95 no condensation 700 to 1060 hPa Ambient conditions for storage and transport in original packaging Temperature Relative humidity Air pressure 40 to 70 C 10 to 95 no condensation 500 to 1060 hPa 000000 1476 299 IOLMaster 27 03 2007 109 110 Technical specifications Measuring range Axial length Area 14 to 40 mm Resolution of display 0 01 mm Keratometer Area 5 to 10 mm Resolution of display 0 01 mm Anterior chamber depth Area 1 5 to 6 5mm Resolution of display 0 01 mm White to White optional Area 8 to 16mm Resolution of display 0 1 mm Compa
75. ividual measurement and an axial length calculated therefrom Should a reading deviate from another by more than 0 05 mm it will be displayed in red and the message Multiple peaks will appear This indicates that the individual measurements should be scrutinised and the composite signal may need to be post run edited see Post run editing of axial length measurements page 78 ff 000000 1476 299 IOLMaster 27 03 2007 Operation Until an axial length can be determined from the composite signal the word Evaluation will be displayed below the horizontal line in the list of measurements If necessary the potential individual measurement errors must be deleted or the composite signal post run edited as the readings obtained will not otherwise be accepted for the IOL calculation and database for optimisation of the lens constants Until the fourth individual measurement has been taken the last reading will be highlighted in blue From the fifth individual measurement onwards the composite signal is highlighted in blue The blue highlighting can be moved through the table of individual readings with the aid of the cursor buttons NN In this way the signal curves of the individual measurements can be displayed Deleted individual measurements can be restored with the shortcut lt CTRL gt lt Z gt The composite signal can be displayed by clicking on the composite reading Error in the display field denotes readings with an SNR smaller than 1
76. l be calibrated 2 Switch the OLMaster on 3 Wait until all internal system tests have been completed and the Patient Manager appears upon confirming the calibration prompt with OK 4 In the Options pull down menu click on Setup and use the Program Settings to display the Program dialog Activate the Adjustment aid here and Automatic if you wish 5 Create a new patient with New 6 Change to keratometer mode by clicking the appropriate icon or pressing the lt K gt key 7 Follow the instructions on the screen The test eye must be clean If the test eye for the IOLMaster is not available abort the calibration process with Cancel The Adjustment aid will then be deactivated in the Program Settings dialog and can no longer be used If the software is unable to perform the calibration message described under item 10 is repeatedly displayed the cause may be inadequate room lighting It is recommended that the front panel and test eye be shielded from direct or lateral light The best results will be obtained when the examination room is slightly darkened 8 Then you will be prompted to repeat the process once again 9 If the calibration process was successful a message to this effect will be displayed The keratometer adjustment aid traffic light display can now be used to position the keratometer at the optimum measurement setting 10 If a message appears stating that variance between the calibra tion values of
77. l for the first four measurements is displayed as usual immediately after the measurement From the fifth individual measurement the composite signal is calculated in the background After each individual measurement the axial length signal red is thus first of all briefly displayed for about 1 second This is followed by the display of the composite signal blue In addition insofar as it could be determined the axial length measurement of the composite signal is displayed below the horizontal bar in the list of measurements 000000 1476 299 IOLMaster 27 03 2007 41 SNR SNR SNR Ca S Measuring Uncertain error value Value with good SNR 42 Operation If no axial length reading could be determined after the first five individual measurements additional measurements should be taken With stronger lens opacities it may be advisable to defocus the device You may choose a reflection as large as the circle on the display Also try measurements by height variation turning the joystick of the refocused reflection at the lower and or upper edge of the circle on the display Ensure that the device permits no more than 20 measurements per eye and day The overall axial length measurement is post run edited as described on page 78 onwards 000000 1476 299 IOLMaster 27 03 2007 Operation Axial length measurement ALM Activate the ALM measurement mode by e clicking on the ALM icon e pressing key A or e pre
78. lOLMaster with Advanced Technology Software Release 5 xx User manual Copyright Knowledge of this user 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 safe operation of the device The specifications are subject to change the manual is not covered by an update service Unless expressly authorised dissemination or duplication of this document and commercial exploitation or communication of its contents are not permitted Persons in contravention of this copyright are liable to pay compensation for damages All rights reserved in the event of granting of patents or registration as a utility patent 000000 1476 299 IOLMaster 27 03 2007 Trademarks All names of companies and products mentioned in this manual may be trademarks or registered trademarks Third party products are cited for information purposes only and this does not represent approval or recommendation of these products Carl Zeiss Meditec AG accepts no liability for the performance or use of such products I Windows XP is a registered trademark of Microsoft Corporation Inc T SRK is a trademark of CTI Computational Technology Inc Other brand names software and hardware names used in these operating instructions are subject to trademark or patent protection The quoting of product names is for information purpo
79. ll VEW nirerncani ne an E 15 eile 9 ee ol 1 3 pa ee eee me tae ee eee eee eer 16 Power isolation transformer for external devices 17 a ee Installaatio sepeser an a iins Electrical CONNECHION sy ccccacccccccacaseiaeecedasbcnccadeadaananhccceddbacces Operation epee ne rte Ponte eer EDP ea Se AAEE a aeaea aaie 20 General notes on COMtral scrscce her eceiaeeed es eset 20 Operation by touchpad and keyboard eeeeeeeteeeeeeeeeeeees 21 Sereen TOU prensesinin ii ceo kiko ccees eee annaa ae eais 22 Overview of buttons and shortcut keyS cccceeeeeeeeeeeees 23 Menu OVEPVICW 0 0 0 0 cee ce ee ceeeceee cee eeeeeeeeeeeeeteeceeeeeeaeaeaaaeaaaeeaaeeaees 26 NOMS eI sireenin ienen niee E e a Et 27 TEST EV esie ei a R 27 User oF S ck een nee Ree en me eon rerne rren 27 29 SOLU O PE A jenna E E E E EE 32 000000 1476 299 IOLMaster 27 03 2007 Contents Preparing for Me aSUreMeNts ccceeeeceeeeeeeeeeeteeeeeeeeeetteeenes 38 Switching the device On cuts ccc ec eta cta 38 Patient Manager New Patient ccccccccccesseeeeeeseeeees 38 Adjusting the device to the patient ccccccceeeeee 40 Axial length measurement ALM with Advanced Technology 41 Axial length measurement ALM ineeie 43 Measurement of corneal curvature KER 0 0 cccseeeeeeee 47 Keratometer measurement eee eee cece eee e eee e eet teeeteeeteeeees 47 Measurement of anterior cha
80. lse gt A ind T WA wwe Why WV Fig 51 Axial length measurement of pseudophakic eyes double peaks with certain IOL Source W Hill Mesa Arizona 000000 1476 299 OLMaster 27 03 2007 Evaluation of ALM results Zooming the graph display AUP iyne aa m St tt ttt tt Ht 14 40 run left mouse button n ee i P ah 4 tt Pate a get YAM a left mouse button 000000 1476 299 IOLMaster 27 03 2007 right mouse button right mouse button right mouse button right mouse button 77 The system allows zooming the graphs in 4 steps to improve the presentation of signal curves Move the cursor on the longitudinal axis x axis to the desired centre of the zoomed image and press the left mouse button This procedure may be repeated four times To return to the original view zooming out place the cursor at any position on the longitudinal axis and press the right mouse button L Note In zoomed views the axial length scale is not visible 78 Evaluation of ALM results 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 75 The manipulations described here can be performed on the individual measurements but have no influence on the composite signal Manipulations are the
81. m Settings Program Language OLMaster dialogs in German English or other Fig 16 Setup submenu r Database Erase records after 100 Days Patients willbe Name first name identified by D Number Y m Send Data to PMS old new with IOL calc table COM speed 19200 Standard languages change requires 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 figures 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 Number Caution Please note that when switching from Name first name mode to ID Number all 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 Choose old if the connected office management system only allows import of data of interface software versions 1 01 to 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 000000 1476 299 IOLMaster 27 03 2007 Operation Keratometer displa
82. mber depth ACD 50 Determination of white to white WTW optional 52 Measuring the Other yO cesses 54 Printout Of resultSet o cece 54 Generation of IOL Options eeecceeeeeeeeeeeeeeeeeeeeeeeeeeeteeenes 55 Filling the IOL database sc sccenessscesendacecensascnceesavestoes 55 IOL calculati ee ee nee ete rt ee ene 56 IOL calculation after corneal refractive surgery optional 59 Calculation of phakic implants optional 0 66 61 4 in 1 calculation ete dace ciate cast rete ec adhe ia sbehidacneueencatied se 62 Optimisation of lens COMSTAIIS 565 ence sccin decay cd canedecaudetensdtanMecedcetece 63 Selecting lens data Ree eee een epee eee Pea ene ae eset 63 Loading existing data records cccccccceeeeeseeeeeteeteeeees 64 Entering new data records cccceeeeeceeeeeeteeeeeeeeeeeees 65 Starting OO UMISAUOM ous nn a i E 68 N w patient ssa testcase ra tas sncende data ie iii 70 Working with the Patient Manager c cccceeeeee 70 Retrieving a reading from previous measurements 71 Deleting a patient measurement ceeeeeeeeeeeereeeees 71 Renaming a PAUCE Nica scctenedeiatcieni ici glescascotenadaconsitenstachiaskoe 72 Transmitting exporting data optional c ceeeeeeeeeeeeeees 72 Exporting data to another system cccseeeeeeeeeeetees 73 Exporting data to a storage MedIUM cceeeeeeereeee 73 Switchi
83. n After you have entered the necessary data click on the IOL IOL Calculation 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 Surgical Eye The lenses calculated for the other eye will now be displayed IOL Calculation x Haigis SRK II Hoffer Holladay SRK T Multi Formula Haigis L phakic IOL Prior Refractive Surgery Mustermann Max 01 01 1911 Axial Length mm 23 81 23 67 Eye Surgeon Dr Mustemann k Comeal K s mm 7 21 47 19 7 35 47 33 Target Refraction D 0 5 Optical ACD mm Surgical Eye OD C os i Print IOL Calculation Data Cc co on z IOL D REF D 1OL D REF D 1OL D REF D IOL D REF D 185 1 88 pass 1 88 73 0 223 13 0 2 23 17 0 0 87 17 0 0 87 ps fpe mi eha 16 5 0 55 fe Fee fit o 0 36 16 0 0 23 16 0 0 23 10 5 0 09 fos 0 03 155 0 03 155 0 03 poo fose poo poese KEE 15 0 041 15 0 0 41 35 ose SRK is a trademark of CTI Computational Technology Inc fias 0 72 145 0 72 9 0 1 42 OK Cancel Fig 38 Calculated IOL data in IOL calculation window SRK T 000000 1476 299 IOLMaster 27 03 2007 58 Operation In the columns below each specified lens you will find the calculated refractive powers and target refractions for those lenses The
84. n 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 However the lens constants must be changed for use with the PCI method Please consult the scientific literature on this subject 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 the operator is only required to adjust the device to the patient s eye and initiate the measurement For this reason the complex biometry of the eye can be rapidly learnt with the OLMaster but should be practised with the greatest of care and attention to detail Extensive integrated safety features independent redundant hard and software safety features ensure
85. n 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 the device is inspected according to Checking the measurement functions on page 104 before any patient measurements are taken 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 108 in order to guarantee its perfect operating condition 000000 1476 299 IOLMaster 27 03 2007 Description Intended use of the device 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 Responsibility for using the device other than as intended lies with the user The device may only be used in combination with accessories delivered by Carl Zeiss Meditec see Section Optional accessories on page 16 Please consult Carl Zeiss Service regarding the use of other accessories Functional description The OLMaster 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 sessio
86. nal The WTW scale optional 2 Fig 78 is for verifying the WTW reading WTW calibration 1 Please mount the WT calibration scale on OLMaster see manual 2 Center WTVW calibration scale Scale must fill whole video window 3 Focus on the black lines in the scale 4 Push joystick button performs calibration coe Fig 79 WTW calibration e Take a measurement If the reading is within the tolerances WTW determination has been properly calibrated IL Note The WTW scale must completely fill the video window The scale black lines must appear in focus 000000 1476 299 IOLMaster 27 03 2007 Servicing and maintenance 107 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 setting up see page 19 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 Open the queue by double clicking on the standard printer and delete all print jobs in the list by highlighting and pressing the lt DEL gt key e Select th
87. ng off the device seca ores acerca ce caee ice ac 74 Evaluation of ALM results 2 cccscccceseeeeeeeeeeseeeeeeeeeeeneeeeeeeeeeneeeees 75 Signal curves of axial length measurements 0 ceeeeee 75 Valid signal a sete cate eed er selaee Sestetdlncdaeennedectbaraeeeads 75 Recognition of maladjustments on the graph 0 76 Measuring errors with pseudophakic eyes eeeee 76 Zooming the graph display ce seteeccte cade ccc astecetoses Hasendeaeadesedakeates 77 Post run editing of axial length measurements 00 0eee 78 SNR categories sas5h accu caadesaeassstanianse tus andixenta maaan 78 Shifting the measuring CUISOTM cccceceeeeeeeeeteeeeteeeees 79 Interpretation of axial length measurements 00eeeee 82 Signals from the inner limiting membrane ILM 84 Signals from the choroid ieee cachet tent le ca tesananeenaeceededeteuans 85 000000 1476 299 IOLMaster 27 03 2007 Contents Tips for keratometer measurement cccceceeeeeeeeeeeeeeeeeeeeneeeees 87 How to adjust the measuring Marks cceceeeeeeeeeeteeeeeeeeeeeees 87 M as ring ErrOTS neniet reie o ea 88 I fret ol Wis 12 0 sae ee me meee near rape ete ene 88 Other TONGS ssmesisnns aine a an 90 Tips for anterior chamber depth measurement 2 s ceeeeees 93 How to adjust the device ssnnseneneeseniieseninssnrrsrrrrrsrerrrrnne 93 DVT eer UN WIG Err OTS eisene e E E ea
88. o confirm the results and save the data 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 Pulling the power supply 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 000000 1476 299 IOLMaster 27 03 2007 102 Update Installation The following is a description of the installation of the software upgrade to version 5 as well as the calibration of the keratometer adjustment aid To install the software carry out the following steps 1 No USB device may be connected to the IOLMaster while the update software is being installed 2 Switch the OLMaster on 3 Wait until all internal system tests have been performed and the Patient Manager appears 4 Open the CD RW drive on the left side of the OLMaster and insert the update CD 5 To launch the update procedure click on Setup in the Options pull down menu and select Update 6 Follow the instructions on the screen After installation the lOLMaster will be automatically shut down and then booted up again 7 Remove the upgrade CD from th
89. ounds 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 LY Remove dust from optical surfaces by means of a fine brush LI If necessary carefully clean these surfaces with a water free ether spirit mixture 9 1 applied with a cotton swab The swab or lens cleaning instrument should be moved with a circular motion from the centre of the lens to the edge Ensure that the regulations for inflammable liquids are observed LI To protect from dust cover the system using the dust cover provided when not in use LY Packaging materials should be retained for future relocation or repair or may be returned to the supplier as required Safety inspections 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 authorised specialist Please observe national safety regulations 000000 1476 299 IOLMaster 27 03 2007 Technical specifications lOLMaster Basic Device Dimensions footprint Height Weight 390 mm x 300 mm max 610 mm headrest approx 18 kg Rated voltage frequency basic device 100 to 240 V AC 10 50 60 Hz Power consumption basic unit 90 VA Earth conductor Protect
90. ower switch Fig 4 Power isolation trans former input side 1 Instrument connector 2 Power junction connector Fig 5 Power isolation trans former output side 230 V A DAD CS Fig 6 Power isolation trans former output side 120 V 000000 1476 299 IOLMaster 27 03 2007 18 Fig 7 Mounting holding bracket Description Setting up the device for use The device must be set up and commissioned by authorised representatives of Carl Zeiss the latter will also instruct the users on operation of the device In general Carl Zeiss Service will perform the following operations Installation d Remove and unpack box containing accessories LY Carefully remove the device from the box the device not should be lifted or carried by the measuring head Ly Removing shipping braces Loosen device lock knob 4 Fig 2 Basic setup 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 from the wheel housing of the device base Secure device with holding bracket The IOLMaster can be permanently secured with the aid of a holding bracket 3 Fig 7 Holding brackets with two different widths are available 7mm holding bracket for securing to the instrument table 5 5mm holding bracket for secu
91. page 114 Instructions for installation and use This device is a high quality technical product To ensure perfect and reliable operation it must undergo a safety inspection once a year m m E The device may not be stored or operated in environmental conditions other than those prescribed see Technical specifications on page 109 Do not operate the device in areas subject to explosion hazard in the presence of inflammable anaesthetics or volatile solvents such as alcohol benzene or similar Do not store or use this device in damp rooms Do not expose the device to water splashes dripping water or sprayed water 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 The manufacturer accepts no liability for damage caused by unauthorised access to the interior of the device Such actions will render all warranty claims invalid 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 The device may only be operated by instructed and trained personnel In USA this device may only be purchased or ordered by physicians and ophthalmologists The user manual should always be kept at hand for reference It is also important to comply with the instructions supplied with accessories
92. 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 000000 1476 299 IOLMaster 27 03 2007 Abb 12 Options menu 28 Administrator Operation 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 Database xl Administrator Name Password as Confirmation Fo oo Add crase Data store Backup Restore Import Fig 14 User Database Administrator dialog box Type in the name of the new user If several users share the device it is recommended specifying a password each which must be repeated in the Confirmation text box You can ADD the new users you have thus entered In the case of existing users you Can SET any changes in the name or password If you wish to delete user data from the database click on the ERASE button after having selected the name in the left window Click OK to confirm your user entries The new user is now registered in the database For the entry of lens data refer to Filling the IOL database page 55 f oss Note Should a user forget his or her password the administra
93. ption Operator login with password and screensaver together with password protection should not be activated further users see below have been registered and their passwords entered If you change the Admin password you are advised to note down the new password e g in the device record book The user administration system cannot be accessed without the Administrator password If the password is lost a number code will be displayed after three unsuccessful attempts This number code will enable service personnel to reset the device As soon as you have confirmed the new program settings with OK a login dialog 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 Database To change the password select the option Change password enter your user name and old password and confirm with OK 000000 1476 299 IOLMaster 27 03 2007 Operation User name Password Ef r nge password Shutdown Fig 22 Login dialog box In addition a screensaver with a freely adjustable interval can be activated The screensaver appears if the IOLMaster has been inactive for longer than the set interval This prevents unauthorised access to protected patient data The Password protection option offers added protection If this is activated you will only be able to work with the IOLMaster and its database after logging on again
94. radiation density of a light source white LED slit illumination for the aphakic eye La 125 5 W m2sr L in W m sr nm The spectrally assessed photochemical radiation densities L and L are a measure of the risk 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 in excess of 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 OLMaster 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 delivery packaging subject to change 000000 1476 299 IOLMaster 27 03 2007 114 CE 0297 Manufacturer s Declaration The device meets the requirements of the Medical Device Dire
95. red from Carl Zeiss for connection to an external network NET LI If either of the error messages Laser adjustment too high or Laser power measurement too high measurement aborted appears the device must be shut down Following this call Carl Zeiss Service 000000 1476 299 IOLMaster 27 03 2007 10 Safety instructions Important when using the device Always enter the patient data last and first name date of birth or ID No depending on setting in Setup menu LY Pull the power supply cable immediately if damage or unspecified problems occur LY Switch off the device as follows Click on the EXIT icon on the toolbar Confirm with oK and switch the device off at the power switch The program will automatically close the readings for the last patient will be saved and the device will shut down automatically lamp in the switch goes off Caution For as long as the switch lamp is lit internal components are still under voltage even after the device has been switched off at the power switch All pole disconnection of the device has not been achieved until the switch lamp goes off The lamp must be off before the power supply is unplugged or the device switched off at the main room switch Failure to observe these instructions may result in loss of data LJ The device contains a computer Please follow the instructions for the Switching off the device on page 74 Disposal The device s int
96. refore only expedient on the composite signal For simplification reasons the illustrations below do not show the video image a ee S ee a ee ae AA ee re ce or i ee Oe ee ee ee ee ss se 14 40 fm Fig 52 Presentation of the graph of the third axial length measurement without video image SNR categories The SNR is automatically analysed while the system is internally calculating the axial length from the interference signal SNR display at GREEN gt reading is valid SNR display at YELLOW gt Reading is uncertain Borderline SNR 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 IL Note In this case Borderline SNR or uncertain does not mean an incorrect result it is only to remind you to verify this measurement 000000 1476 299 IOLMaster 27 03 2007 Evaluation of ALM results Should multiple peaks occur in the composite signal it may be possible to identify the correct signal peak by comparison with the individual readings for this and the other eye and the anamnesis See sections Signal curves of axial length measurements page 75 and Shifting the measuring cursor below SNR display at RED reading should not be used It is marked on the display as a mea
97. ring to the keyboard support 1 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 OLMaster to one side so that it rests on the patient head support e Remove the three hexagon socket Allen screws SW3 1 Fig 7 The screws may be very difficult to loosen 1 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 lift 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 000000 1476 299 IOLMaster 27 03 2007 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 described in Fig 8 1 Caution Use only printers recommended by Carl Zeiss Meditec Only one printer may be installed De install all surplus printer drivers using menu Setup
98. rison reproducibility Comparison of IOLMaster measurements vs 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 a In comparison to manual keratometer Standard deviation basic calculated simple standard deviation acc to abstract First experiences with a New Optical Biometry System by B A M Lege W Haigis cf Reproducibility of Measurement in Optical Biometry Intraobserver and Interobserver Variability by A Vogel B Dick 000000 1476 299 IOLMaster 27 03 2007 Technical specifications 111 Optical radiation Light spots WTW determination Source Wavelength Delivered power Axial length measurement Source Wavelength Max power for measurement Max power for alignment Measuring time for individual measurement 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 Deliver
99. rm the delete action with YES Personal data and individual Exit measurements for this patient will be irrevocably deleted in the Patient Manager The numerical measurement data will still be available in the database for optimisation of lens constants 1OLMaster I Note Mustermann Max 01 01 1911 29 03 2005 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 35 If a measurement date is highlighted only the data for this examination date will be deleted The patient name and other measurement data will be retained 000000 1476 299 IOLMaster 27 03 2007 72 Erase Del Rename lt Ctri gt A Exit 1OLMaster Mustermann Max 01 01 1911 29 03 2005 01 04 2005 04 04 2005 05 04 2005 07 04 2005 08 04 2005 Operation ras 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 name and press lt CTRL 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 Measurement results cannot be renamed e Confirm the changes wit
100. rtly 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 possible Precise measurements are possible only if the 6 peripheral measuring points appear optimally focused on the display e Trigger the measurement by pressing the knob on the joystick Depending on the setting under Program settings Program see page 33 a traffic light will assist in finding the optimum measurement setting When the optimum measurement position has been reached the traffic light will change from red to yellow to green Once the optimum measurement setting green traffic light has been reached and remains constant for all three measurements pressing the knob on the joystick in Automatic mode Automatic activated will trigger three consecutive measurements The automatic measurement procedure will be interrupted if the optimum measurement setting green light wavers and is resumed when the optimum setting is reinstated 000000 1476 299 IOLMaster 27 03 2007 47 Fig 30 Setting for keratometer measurement 48 Fig 31 Measurement point not identified Operation Five internal individual measurements are taken for a single keratometer measurement within 0 5 seconds Following this the radii or corneal K s depending on program settings of the two main s
101. ry Mustermann Max 01 01 1911 Axial Length mm Eye Surgeon for Mustermann p Corneal K s mm Target Refraction D 0 5 Optical ACD mm Surgical Eye OD Cos 10L Calculation Print IOL Calculation Data flens 1 x Lens 2 7 Lens 3 x fens 4 7 IOL D REF D IOL D REF D IOL D REF D IOL D REF D Fig 40 IOL calculation window Haigis L Warning The formula may only be used for eyes with myopic Lasik myopic PRK Z and myopic Lasek Lenses by hyperopic Lasik Lasek PRK or myopic hyperopic RK should never be calculated The corneal radii and axial lengths measured by the lOLMaster 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 chamber angle supported lenses to be calculated 000000 1476 299 IOLMaster 27 03 2007 62 Ophtec Artisan AMO Verisyse Staar ICL IOLTECH PRL Fig 41 Lens model A 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 CVD and lens model must be entered The manufacturer s IOL constants are used for calculating lens strength Warning Please observe the manufacturer s recommendations for the phakic IOL employed with regard
102. s exist as yet a0 Haigis formula will not be optimised with such data records LJ Patient data records appearing on a white background contain all the data required for optimisation oss 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 000000 1476 299 IOLMaster 27 03 2007 A 67 68 Basis lt lt New A Const 1191 _ lt lt _ 193 sRKeN A Const 1186 _ lt lt 195 sRKe T a0 117 ky 425 Haigis PACD 53 _ lt 577 Hoffera sF 56 lt lt 208 Holladay Fig 48 Optimised lens constants Operation Starting optimisation e Start the optimisation 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 optimised lens constants will now be displayed in the New column I Note Data records with an IOL power of O D will not be included in the optimisation process The optimisation 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 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
103. secondary maxima are about 800 um from the maximum peak 000000 1476 299 IOLMaster 27 03 2007 84 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 from the measurement peak is between 150 and 350 um Both peaks can be observed separately in a zoom view of the graph 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 may be higher than that of the reflected light from the pigmented epithelium In this case the automatic peak detection will recognise the signal from the ILM D 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 to
104. ses only and does not constitute a trademark misuse 000000 1476 299 IOLMaster 27 03 2007 Contents Page Copyright cadets Gecceda pc esei neha dusinaet cecsubuenixnnsdecetendeteieanesteccsvists 1 Trademarks seernes neee AEREE EEEE ira E Ea 2 CONTENTS oisi ra ienaa ae aa a aa er aae H aeae rE 3 Notes on the user manual ccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 6 SYMON 6 Purpose of this docuimentanOnic 4 cce ee 6 Accessibility of the user Manual ccccceeeeeeeeeeeeeeeeetteeenteees 6 Safety INStruCtioOnS en ec ee once oece be etetamtin ee tcentnentecneienet 7 Compliance with standards and regulations cceeeeeee 7 Instructions for installation and USC cceeeeeeeeeeeeeeeeteeeeeeeeenees 7 Safe operation h2 c535 c ol ccaseeeeabigsahscenaceces cette icra eeneehcareeewuevadeads 9 Electrical Safety arniarna neiaa 9 Light emission from the AeVICC ceeeeeeteeeeteeeeteeeeeeeees 9 9 Important when using the device ccceeeeeeeeeeeeees 10 Dispos l a nccatsctcacescacticalesecte Sisto acetal aE NAA 10 Disposal of the product within the EU 0 cece 10 Package contents ae en oe ee eee ear eee ee eee 11 Warning and information labels on the deViCe ccceee 11 CUES ee siete ie 2 Description ee en ee eel none een a ne ee ee ee ene e ener 13 E Functional description 222 2c2cc 2accatcelacdccetineeccdacalcabcedareddacadsecabls 13 Overa
105. ssing the button on the joystick in Overview mode OVM 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 A Warning The patient should be asked if he or she sees the fixation point If the patient fails to fixate properly the visual axis will not be correctly recognised which may result in measuring errors In the case of poor visual acuity high ametropia gt 4 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 this will result in measuring errors e Trigger the measurement by pressing the knob 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 red graph similar to those in ultrasonic measuring instruments The signal noise ration SNR will be displayed simultaneously as a value This value is a gauge of the quality of measurement Measurements with an SNR between 1 6 and 1 9 appear
106. suring error This means that the true measuring signal does not stand out sufficiently from the noise As a rule such readings are not usable and should be rejected They can be deleted from the list by highlighting them and pressing the lt DEL gt key The reading may be transferred to the list by clicking on the measuring cursor white dot Before doing so ensure that the readings 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 measuring 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 autom
107. t data Rename Renames patient data Export Exports patient data to CD RW Send Sends data via interface Remark 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 WTW mode Print preview Displays print preview Printer setup Select printer options Logout Logs current user off and opens login window Exit Exits application and Windows Operation Menu overview The illustration below provides an overview of available menus and submenus for program operation using the menu commands Functions Undo Undoes last KER ACD value Recover Recovers deleted ALM readings 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 IOL Calculation AL Settings Accessible in ALM mode only Pseudophakic silicon Pseudophakic memory 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 Primary piggy back hydrophobic acrylate Pseudophakic PMMA Test eye Activates deactivates measurement mode for test eye User database Enters and edits user and IOL data Setup A
108. tective earth terminal whose wattage power consumption exceeds the permissible connected load of the power isolation transformer may not be used LY Additional portable multiple sockets or extension cords may not to be used LI The electrical supply must conform to IEC 60364 7 710 guidelines For USA and Canada only Single phase 120 VAC connectors with NEMA 5 15P connector type 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 devices is dependent on various factors and therefore unpredictable To avoid electromagnetic interference the device must be installed and put into operation in accordance with the user manual and using the components supplied by Carl Zeiss Meditec D With the exception of compatible printer drivers the installation of other software on the system is not permitted A software routine prevents external third party software from being installed on the system A The OLMaster may only be connected to private networks which are protected from public networks Internet by firewalls conforming to the latest technical standards 000000 1476 299 IOLMaster 27 03 2007 Safety instructions Safe operation Electrical safety LY The built in power supply unit is short circuit proof and does not contain any fuses which are accessible from the outside LJ Provided the
109. the two calibrations was too wide the entire calibration process must be repeated from Step 7 onwards 000000 1476 299 IOLMaster 27 03 2007 104 ON AU RPWDN Test eye holder Test eye for ACD Set values and tolerances Location hole Asymmetrical holder Set value and tolerance Locking screw Test eye for ALM and KER Fig 77 Setting up the test eye Servicing and maintenance Checking the measurement functions After switching on the device will prompt a daily calibration check prior to patient measurements Upon confirming with OK a check will be performed of measuring functions and work on the device can begin 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 mandatory here as well The supplied scale is to be used for checking the WTW value optional A 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 e Insert the asymmetrical holder 5 Fig 77 into the holes adjacent to the ch
110. tion of the software update has been completed Service For servicing purposes and password protected Caution Unauthorised persons may under no circumstances use the service AN password The safety warranty for the medical device will otherwise become invalid 000000 1476 299 IOLMaster 27 03 2007 38 The following special characters are permitted for entering patient data Minus Dot Apostrophe j Underline Operation Preparing for measurements Switching the device on e Turn the device on at 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 After switching on the device will prompt a daily calibration check prior to patient measurements e After confirming with oK check the measurement functions as described on page 104 Caution Axial length ALM corneal curvature KER anterior chamber depth ACD and white to white WTW should never be measured through contact lenses as this produces incorrect results 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 70 To admit a new patient proceed as follows Now Patient nnn Patient Options 2 Search textbox Last Name Input of S Mustermann Max 01 01 1911 desea patient dat
111. tion on the basis of two refraction measurements once with and once without a hard plane contact lens The following parameters are needed d Refraction with contact lens d Refraction without contact lens LI Refractive power of the plane or almost plane hard contact lens refractive power of contact lens back surface and d 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 45D 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 Calculation xj Haigis SRK II Hoffer Holladay SRK T Multi Formula Haigis L phakic IOL Prior Refractive Surgery r Mustermann Max 01 01 1911 OD fright OS left r Measurement Values r Measurement Values Axial Length mm ooo KER mm 0 00 7 aoo Axial Length mm 000 KER Imm f 0 00 000 r Clinical History Method r Clinical History Method Corneal K s pre OP D 50 50 Vertex mm 18 Corneal K s pre OP D Vertex mm Refr pre OP D sph 7 50 cyl 0 75 Refr pre OP D sph cyl Refr post OP D sph 0 25 yk 0 50 Refr post OP D sph cyl Corneal K s Df 44 10 Radius mmf 7 65 Apply M
112. together with the data required for lens optimization Individual values of axial length corneal curvature refractive power anterior chamber depth WTW are not saved and may get lost e g in the case of a hard disk fault Follow this procedure to create a backup copy e In the User Database 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 It 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 will show the status of the copying process e Finally you will be informed that data backup was successful 000000 1476 299 IOLMaster 27 03 2007 Backup 29 30 Restore Operation Restore By using the Restore function you can retransfer saved data from a CD RW to the lOLMaster Follow this procedure to restore saved data e inthe User Database activate Administrator e Click RESTORE e Insert the CD RW with the latest backup copy confirm with OK e Confirm with yes that all surgeon data currently stored on the OLMaster is to be copied together with the respective IOL data and patient data available for optimising the IOL constants Database data will now be copied from the CD RW to the OLMaster A progress bar will show the status of the copying process e Finally the program will
113. tor may assign a new password To do this the logged on administrator must highlight the user in the left box and assign a new password with the SET command button Caution A forgotten administrator password can only be recovered by Carl Zeiss Service 000000 1476 299 IOLMaster 27 03 2007 Operation Data storage Backup creating a backup copy With the Backup function you can save to a CD RW the patient data used for the optimisation of IOL constants together with the IOL data of all surgeons and corresponding lenses used for the calculation res 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 should enable at least a transfer rate to USB 1 1 Caution 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 measurement readings 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 rer Note In this way all critical patient and IOL data can be saved
114. tuations or measuring errors may occur Fig 67 Condition following keratoplasty IL Note In this case keratometer measurements cannot be taken with the lOLMaster 000000 1476 299 IOLMaster 27 03 2007 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 from a temporal direction The slit illumination will appear subjectively bright to the patient The measured values of the light load see Technical specifications page 109 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 through 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 LJ the ima
115. ture mode a lt p gt Activates anterior chamber depth mode Activates WTW WTW white to white lt W gt determination optional e lt l gt Activates IOL calculation Calculation already possible after measurement of one eye lt P gt Prints results obtained hitherto lt S gt Sends data Requirement A suitable 1 computer must be connected to the serial interface 5 25 Transfers data to CD Requirement CD RW has we lt X gt RW or USB flash drive been inserted into the drive or USB flash drive is connected to USB port lt E gt Exits IOLMaster Functions in all modes and software and Windows and shuts down the device for every measurement In case of damage Pull out power supply plug immediately 000000 1476 299 IOLMaster 27 03 2007 23 Warning If connecting external devices e g an external PC monitor or an external network the operator must ensure to meet the safety requirements as per DIN EN 60601 1 1 medical electrical systems 24 Operation Key functions without icons Key Function Notes Space bar Cyclic change of modes ALM KER gt ACD WTW ALM KER ACD WTW Joystick Program continuation In overview mode change to button activates measurement ALM mode In ALM KER ACD and WTW mode lt Del gt Deletes the selected ALM Only in ALM KER and WTW or KER measurement mo
116. u 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 000000 1476 299 IOLMaster 27 03 2007 39 40 1 2 Circle of light spots for focusing Cross hairs Fig 26 Video image with correctly set device Operation Adjusting the device to the patient The two red ring marks 3 Fig 2 on the side rails of the headrest are for rough vertical adjustment of the chin rest 3 Fig 3 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 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
117. ure as the position of the fixation point will not be evaluated 000000 1476 299 IOLMaster 27 03 2007 87 88 Tips for keratometer measurement Measuring errors The Error message may have two basic causes LY The results of the internal individual measurements vary by more than 0 05 mm very rare defocused device L The measuring marks are either indiscernible or not recognised as such The marks not recognised will be shown on the screen after measurement The possible reasons for this are described below Misadjustments Defocused device Cause Remedy Fig 61 Image of a defocused device The images of the measuring marks are too large because the device is 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 to minimise 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 focusing is optimum 000000 1476 299 IOLMaster 27 03 2007 Tips for keratometer measurement Concealed measuring marks Fig 62 The upper two measuring marks are concealed by the eyelid Error appears the display field 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
118. values D or Radii mm Calculation of corneal refraction after corneal refractive surgery Select an eye optional Haigis SAKE I Hole Holaday SRK T Muti Fomula Haigis phakic IOL Prior Refractive Surgery Mustermann Max 07 01 1811 Select eye Axial Length imm 2s 2367 Eye Surgeon Dr Mustermann x surgeon s Comealk s mmh 721 4713 725 722 Target Retraction 0 05 name Optical ACD fmt I Surgical Eye oD oS JOL Calculation Bint JOL Caton Dats Select the lens types Fig 37 IOL calculation window SRK T 000000 1476 299 lIOLMaster 27 03 2007 Operation 57 e Click on the appropriate tab to select the desired formula The IOL Haigis HofferQ 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 Warning Edited readings appear with an asterisk in the printout of the lens calculation and the lens calculation is no longer based on the lOLMaster readings Select an eye for which the IOL is to be calculated on the screen Enter the desired target refraction No entry means O D plano Select suitable lenses from the lens types show
119. viations 000000 1476 299 IOLMaster 27 03 2007 55 xi Name z oK coe Cancel J Change password Newpasswoit Confimatio Fig 35 Please input password textbox 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 L Note Only constants optimized 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 63 and 82 e f you use lenses graded in 0 25 D intervals in future activate the Power Steps 0 25 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 Lens 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 Database by clicking on OK IOL calculation Start the calculation by e clicking on OL 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 radii in the Program Settings submenu page 32 the keratometer readings are displayed in either Corneal K
120. vice 1 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 Provided the traffic light function has been activated a green light will appear when the measurement setting is optimum 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 cross hairs 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 curvat
121. y 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 recognise this kind of maladjustment The system will display values that are too short These values do not correspond to the actual anterior chamber depth 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 necessary ask the patient to look steadily at the fixation light Then repeat the measurement r Note It suffices if a relatively small section of the lens is visible The picture below shows an alignment which permits accurate measurement 000000 1476 299 lOLMaster 27 03 2007 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 non disturbing artefact Image of fixation point in lens rf 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 fixation point lies between the images of crystalline lens and cornea Then repeat the measurement 000000 1476 299 IOLMaster 27 0
122. y If you activate the adjustment aid a traffic light will asist the corneal curvature measurement When the optimum measurement position for the patient has been reached the traffic light will change from red to yellow to green If Automatic measurement is also activated as soon as the best possible adjustment to the patient has been reached and the traffic light display turns to green pressing the knob on the joystick will automatically trigger three successive measurements Following a software update this function must be calibrated prior to first use see page 103 Radius or Corneal K s for IOL calculation Cylinder or Cylinder Refractive Index Entry of equivalent refractive index for conversion of corneal radii to corneal K s Enter the refractive index implemented on your keratometer refer to respective user manual Printout of the IOL calculation 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 Keratometer Display Radius Corneal K s C Cylinder Cylinder Adjustment aid Vv IV Automatic Caution Keratometer indices affect corneal power for a given Refractive Index 1 3315 EET Fig 17 Program settings Program Keratometer textbox J Program settings Export requires Option
123. y NR V 0 N NO gt A Ys ny 0 x A N ANN V 4 W YN VVA VY x Y x NV Y K yy Me s Yl ry VN y x gt Le KY l 0 N KY AAN XK A Y Va ry ve X NK K 0 KY amp a UN Xp X VN Mi R 1 Joystick with release button for adjusting the measuring device horizontally X Y and vertically Z by turning 2 Display Patient eye alignment and display of results 3 Red eye level marks patient eye level needed for optimum measurement Instrument lock knob Connector panel see also Fig 9 Mouse connector light green Keyboard connector purple Keyboard see also Fig 10 Optional Printer not shown ON OU RA 15 Fig 2 View from doctor s side 000000 1476 299 IOLMaster 27 03 2007 Description J K J Ul x Te A a Ey NS WA YA MG Po LL Y D Nae mS 1 DVD drive CD RW drive for 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 for semiconductor diode laser MMLD 7 Device control connector Fig 3 View from patient s side Optional accessories Instrument table IT 3L Holding bar for securing the OLMaster on the instrument table Printer Keyboard support Narrow holding bracket for securin
124. ye at top additional disturbance by an eyelash 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 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 000000 1476 299 IOLMaster 27 03 2007 Cause Remedy 92 Cause Tips for keratometer measurement Irregularities of the corneal surface scars Scars and local irregularities on the corneal surface impair the imaging quality of the measuring marks Depending on the extent and location of the artefacts measuring errors may occur Remedy Fig 66 Local corneal scar impairing right measuring point Try to position the measuring mark adjacent to above or below the scar by slightly displacing the 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 fluc

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