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IOLMaster Manual V.5.4

1. 1 ual Carl Zeiss Meditec AG Type label 07740 Jena GERMANY ul lOLMaster w wl Manufacturer 100 240 V Manufacturing date CE R 50 60 Hz 5 Eaa Qos 90 VA Application parts c Yis nee type B as per IEC 60601 000000 1322 734 01 DE Vs02 MW IB 2 Identification plate OLMaster REF 1322 734 REF catalogue number SN part number SN serial number G O Zig 0 AD A Connection panel o B c oe aK 000000 1322 734 04 DE Vs02 5 Warning Disconnect the device from ia the power supply before servicing 6 Warning label Observe all safety notes and information in this manual 7 Manufactured label Manufacturing date XX XXXX Month Year e g 06 2007 8 Identification plate REF 1477 889 lOLMaster computer SN REF catalogue number part number SN serial number 11 Complies with 21 CFR Subchapter J 000000 0000 007 US Vs01 Complies with 21 CFR Subchapter J 000000 1322 734_GA_GB US_120608 13 14 Safety instructions Customer s safety obligations The user is responsible for ensuring that LJ the device is used in accordance with the instructions provided in this manual QO 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 mus
2. ceeeeeeeeeeeeeeeeeeees 23 Screen AV OU tn fet Se ene tt ee Na El Ne Nr ae 24 Overview of buttons and shortcut keyS 0 0 ccceeeeeeeeeeeeeees 25 Menu OVERVIEW kta itil eRe eae tebe edie 28 Options Menu ante cah eels ate eclectic brain oyhlatobe cs 29 POST OY E EAA E Gee ctaot meal aue Gag deste 29 Lens databasens rn Pepcid PEN eee Siete Pen Fe Deen Sree 29 DataeS TONG ad EE tne tore E T EEN 31 SOLU Die ciascctetssiadaaee etic ne e oa asia T E e a E 34 Network Broker configuration optional sssssseeeseeee 43 Preparing for MeaSUreMeNts ccceeeeeeeeeeeeeeeeeeeeeteeteeetteeeees 53 Switching the device On x vice koala ine i tens een ieatietceine ohecaes 53 Patient Manager NeW patient 0 ccccccceeseeeeeeeneeeees 53 Adjusting the device to the patient cccc cece 58 Axial length measurement ALM with Advanced Technology 59 Axial length measurement ALM 61 Measurement of corneal curvature KER eeeseeeeeee 66 Keratometer MeaSUreMeN cece cece eee eee ete eeteeeteeetes 66 Measurement of anterior chamber depth ACD 69 Determination of white to white WTW optional 72 Measuring the other eye xrcticde ctiengesds eck henieicsegiee de 74 Piintoutot results anerer sot a e aa ten oO Bad 74 Generation of IOL Options ceecceeeeeeeeeeeeeeeeeteeeeeteeeeeteeeees 75 Filling the IOL databases 2 6 ests eet sta ed 75 lOl calculati Mies morr
3. ib Execute Patient ID Accession Number Patient s Name ICC AN 2 Char ConditionalAa Bb Cc XC BB AN 1 Brecht Bettina Aa Bb Ce XC PID_008 AN_00012 dlle FelderHERR pre suF PID_008 AN_OOO11 4lle Felder HERR pre suf AA AN O Abel Andreas Aa Bb Cc xc Invert selection Clear selection OK Cancel Fig 34 Network Broker Patient based query dialog box The Network Broker input window opens 000000 1322 734_GA_GB US_120608 Operation The number of patients shown can be limited using the four filter criteria Patient ID Patient Name Accession number and Requested Procedure ID on the Patient Based Query tab When entering the search criteria you can use the character as a wildcard parameter for any character To separate the first and last name use the caret symbol If you leave any box empty no filter will be applied for this element If you leave all four boxes empty the entire patient list will be shown I Patient Based Query Scheduled Procedure Step Start Date ca g gt Modality Exact description es al Month Day Year i Description of interval From al Mic to ri ial Me gt Execute Patient ID Patient s Name gt Modality cc AN 2 Char Conditional Aa Bb Cc xc BB aN 1 Brecht Bettina AaBb Cc xc PID_0G8_ AN 00012 _ Alle Felder HERR pre suf o PID_008 AN_OO
4. 1 Power cable connector with fuses 2 Power 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 OL DAD E Fig 6 Power isolation trans former output side 120 V 20 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 LJ Remove and unpack box containing accessories Q Carefully remove the device from the box The device should not be lifted or carried by the measuring head m Remon 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
5. Network Broker Configuration Tool loj x DICOM Application Entity Title of Network Broker step 3 DICOM Application Entity Title floLmaster Q Back Continue Y or Cancel Fig 26 Network Broker Configuration Tool step 3 e Enter the name of the device in the DICOM Application Entity Title field This is the name by which the Network Broker communicates with the DICOM Storage Provider and the DICOM Modality Worklist Provider L Note The name of the Network Broker must be registered with the provider of the DICOM service To register a name contact the DICOM network administrator L Note If you use inadmissible characters when entering the name it will be shown in red in the DICOM Application Entity Title box and an exclamation mark will appear to the left of input field e Click on CONTINUE 000000 1322 734_GA_GB US_120608 Operation Network Broker Configuration Tool ww 5 xj DICOM Modality Worklist Provider Set up step 4 Application Entity Title ffoLMasterwL Host IP localhost Port e104 Timeout 30s 7 Connection test JV Modality Worklist Dialog Selection mode in Modality Worklist Query dialog box Individual selection Multi selection Maximum Ii N For complete list T Help Q Back Continue y Ok Cancel Fig 27 Network Broker Configuration Tool step 4 e Enter the name of the DICOM Modality Worklist Provider in
6. re Note If you wish to export data 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 Only the Nero InCD is suitable for formatting 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 36 for archiving and data analysis 000000 1322 734_GA_GB US_ 120608 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 off before pulling the power supply plug or switching off at the main room switch re 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 swit
7. 104 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 98 and Shifting the measuring cursor below SNR display at RED reading should not be used It is marked on the display as a measuring error This means that the true measuring signal does not stand out sufficiently from the noise As a rule such readings are not usable Carry out further readings insofar as the maximum of 20 measurements per eye and day has not been exceeded 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 th
8. 14 40 mm 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 This reading may be used after verification and comparison with other readings from individual signals red of this series Recognition of misadjustments on the graph I o Lt Vr hy h My WW y ATT hn Malla a EL I AM i gt igr PN eS Low signal SNR display RED Error message is displayed The measuring signal cannot be clearly distinguished from the noise Possible reasons unsteady non fixating patient strong ametropia dense medial opacity along the visual axis Repeat the measurement Ask the patient to fixate steadily 000000 1322 734_GA_GB US_ 120608 99 100 Evaluation of ALM results Measuring errors with pseudophakic eyes Warning In the measurement of pseudophakic eyes and with specific intraocular lenses e g Acrysof two peaks may appear The first higher peak false is aside 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 True 23 44 mm gt i False gt A A Aaa AA a neal MM Fig 61 Axial length measurement of pseudophak
9. Prior to using older printers please consult Carl Zeiss Meditec whether the printer is approved for use with the IOLMaster 4 5 i MOUSE KEYB 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 A 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 must be inserted 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 34 000000 1322 734_GA_GB US_120608 21 Install printer according to manufacturer s user manual Do not connect it to the l1OLMaster yet y Start IOLMaster and wait until New pa
10. 1 Center fixation point in ring 2 Focus iris 3 Push joystick button 4 Evaluate image VIO Lu ofe S at le Ready John Mustermann WTW OD Fig 44 WTW determination Each time the joystick knob is pressed an image of the eye is displayed in which the detected 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 1322 734_GA_GB US_120608 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 44 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 te 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 obtain
11. New Opens dialog box for entry of new patient entry compulsory Erase Deletes patient data Rename Renames patient data Query waiting room Export Exports patient data to Sends data via interface serial DICOM oder EMR Remark Edits a comment Print Prints measurement table Print current graph Prints the selected graph in ALM mode Print current current WTW images Prints the current images in WTW mode Print previev Displays print preview Printer setup Selects printer options Logout Logs current user off and opens login window Exit Exits application and Windows Functions Undo Undoes last KER VKT 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 ALM Settings Accessible in ALM mode only Aphakic Pseudophakic silicon Pseudophakic memory Pseudophakic acrylate 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 Options Test eye Activates deactivates measurement mode for test eye Lens database Enters and edits user and IOL data Set
12. 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 OL calculation on page 76 Refractive history method The following values must be known for the refractive history method QO Preoperative corneal refraction i e before corneal refractive surgery O Preoperative refraction QO Stable postoperative refraction Q 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 1322 734_GA_GB US_ 120608 e A 79 80 Operation Contact lens method The contact lens method contact lens overrefraction attempts to determine the currently effective corneal refraction on the basis of two refraction measurements once with and once without a hard plane contact lens
13. appears in the display field The measurement can be retaken after correcting the focus adjustment Remedy 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 1322 734_GA_GB US_ 120608 114 Tips for keratometer measurement Concealed measuring marks Error Remedy Fig 73 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 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 1322 734_GA_GB US_ 120608 Tips for keratometer measurement 115 Other findings Pseudophakic eyes Reflections from cornea Reflections from IOL front surface artifacts Fig 74 Pseudophakic eyes In the measurement of pseudophakic eyes images of the measuring Error marks may be visible at the front of the intraocular lens beside the reflections of the cornea The refle
14. 70 Operation is 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 118 ff e Trigger the measurement by pressing the knob on the joystick L Note Before starting tell the patient to look steadily at the fixation light not into the slit projector as the latter will flicker during the measurement When an acoustic signal is heard the slit will again illuminate steadily the measurement has been completed and the ACD values will be calculated Note Anterior chamber depth on the IOLMaster is understood 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 the corneal curvature could not be measured with the OLMaster 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
15. Only data obtained from the OLMaster may be entered in the fields for pre operative data When entering the refractive power make sure that the same keratometer refractive index is set on the OLMaster as on the keratometer used for the measurement see page 35 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 1322 734_GA_GB US_ 120608 Operation 87 I Note The entry of the Exam Date is mandatory Entry of Opt ACD data Surgery Date and Post Op Date is optional re Note There should be a period of at least 8 weeks between the surgery and post op dates This period however will not be checked e f you wish to reject the entries made and return to the optimisation calculation 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 Implant 1OL D e In the Impl IOL D box enter the power of the implanted IOL PostOpRef DI e in the Post Op Ref box type in the post operative refraction e The entry of Surgery Date and Post
16. The following parameters are needed Q refraction with contact lens Q refraction without contact lens Q refractive power of the plane or almost plane hard contact lens refractive power of contact lens back surface and UL 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 Muli Formula Haigis L phakic IOL Prior Refractive Surgery m Mustermann Max 01 01 1911 OD fright OS left m Measurement Values m Measurement Values Axial Length mm 0 00 KER mm 0 00 0 00 Axial Length Imm 0 00 KER mm 0 00 7 0 00 Clinical History Method Corneal K s pre OP D 50 50 Vertex mm 18 Refr pre OP D sph 7 50 cyl 0 75 Refr post OP D sph 0 25 cyt 0 50 Corneal K s D 44 10 Radius Imm 7 65 Apply M Clinical History Method Comeal K s pe OP D Vertex mm Retr pre OP D sph cyl fac Refr post OP D sph cyl I Corneal K s 0 Radius mm Apply m Contact Lens Method CL power D Vertex mm CL base cu
17. 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 the measured object For this reason the secondary maxima are similarly always visible in measurements of the supplied test eye The OLMaster 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 a x 0 8 mm Fig 65 Undisturbed measurement signal with secondary maxima 000000 1322 734_GA_GB US_120608 108 Evaluation of ALM results 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 display of Evaluation in place of the mean value composite reading or display of multiple peaks Examples ee 22 76 mm 22 74 mm 22 72 mm o N 7 Ne 22 74 mm NS 22 74 mm 22 74 mm or o
18. e File Services e Print Services e Internet Information Services and e Internet Connection Sharing and Telephony Services LT_XP_PRO_embedded_080807 1 The ten connection limit applies to devices that access the software indirectly through multiplexing or other software or hardware that pools connections You may use unlimited inbound connections at any time via TCP IP SCOPE OF LICENSE The software is licensed not sold This agreement only gives you some rights to use the software CZM and Microsoft reserve all other rights Unless applicable law gives you more rights despite this limitation you may use the software only as expressly permitted in this agreement In doing so you must comply with any technical limitations in the software that allow you to use it only in certain ways For more information see the software documentation or contact CZM Except and only to the extent permitted by applicable law despite these limitations you may not e work around any technical limitations in the software e reverse engineer decompile or disassemble the software e make more copies of the software than specified in this agreement e publish the software for others to copy e rent lease or lend the software or e use the software for commercial software hosting services Except as expressly provided in this agreement rights to access the software on this device do not give you any right to implement Microsoft patents or
19. 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 corneal K s radii in the Program settings submenu page 35 the keratometer readings are displayed in either Corneal K values D or Radii mm 000000 1322 734_GA_GB US_ 120608 Operation 77 Calculation of corneal refraction after corneal refractive surgery Select an eye optional IOL Calculation Select eye surgeon s name Select the lens types Fig 47 IOL calculation window SRK T Click on the appropriate tab to select the desired formula The Haigis HofferQ Holladay SRK ll and SRK T formulae are implemented as standards After refractive corneal surgery the Haigis L or Prior refractive surgery tabs may be selected Selected phakic implants may be calculated with the Phakic IOL tab Select the eye surgeon s name This gives the surgeon access to lens types saved to his database The measured values may be edited if desired Warning Edited readings appear with an asterisk in the printout of the lens AN 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 0 D plano Select suitable lenses from the lens types shown After you have entered the necessary
20. eye If the readings in the case of the keratometer the radius are within the tolerances stated on the holder 6 Fig 91 the device is properly calibrated Anterior chamber depth measurements The larger test eye 2 Fig 91 on the side of the test eye holder 1 Fig 91 marked with the VKT ACD set value and tolerance is for checking the anterior chamber depth measuring device The surface structure simulates the cornea Before 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 69 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 91 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 91 is positioned exactly vertically in front of the device res Note The
21. hospital information system The data of patients manually entered into the OLMaster has to be assigned manually after the export Qi 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 re 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 processed in the appropriate form 000000 1322 734_GA_GB US_ 120608 96 Operation is 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 34 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 36
22. lt ENTER gt key If you have selected the display Refractive index 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 35 Depending on the setting selected under Program settings Program a traffic light display is provided as an aid for optimum measurement setting see page 35 When the optimum measurement position has been reached the traffic light will change from red to yellow to green Arrows will show how the joystick must be moved in order to reach the optimum measurement position In Automatic mode the measurement is triggered by pressing the knob on the joystick Automatic activated as soon as the optimum measurement adjustment green traffic light has been achieved L Note By clicking on the VIDEO HELP button in the upper right corner of the program window for ACD measurement you can play a video showing the steps required to set the optimum measurement position 000000 1322 734_GA_GB US_ 120608 Operation 3 Note In some cases it is possible that the green traffic light display for an optimum measurement setting cannot be reached 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
23. now pay attention to the correct setting as described above Press the lt M gt key once again to reactivate Automatic Automatic will always be switched back on for a new patient Unfavourable room illumination will be indicated by a sun symbol If necessary the slit lamp is additionally switched on and off flashing This shows that additional dark exposures will be taken in order to expand the evaluation possibilities Direct and lateral light incidence to the front of the device or eye being examined should be avoided The best results will be obtained when the examination room is slightly darkened Five internal individual measurements are taken for a single anterior chamber depth measurement within 0 5 seconds Subsequently the anterior chamber depth will be determined for each individual measurement A blue progress bar in the status bar will indicate the progress of computation Five ACD readings will be listed in the display field next to the video image together with the calculated mean value If the setting is not optimum the images of the anterior lens and or cornea cannot be evaluated In this case the message Measuring error and a reference to the lack of or not correctly recognised image details is displayed In addition the image of the first measuring error is displayed With SHOW SEQUENCE all five images are displayed in succession Upon examining the error cause the calculated median value can be accepted despit
24. 1911 PatientL 01 01 1911 Patient M 01 01 1911 Remiks amp Patient N 01 01 1911 amp Patient 0 01 01 1911 window optional o Cel T Database window Fig 33 New patient dialog box 000000 1322 734_GA_GB US_ 120608 54 Patient Options Erase Del Rename lt Ctrl gt R H 8 Karlo Primus 13 07 1996 Query waiting room Operation Patients who have been imported via the EMR or DICOM interface from the waiting room into the database are indicated by the person on network symbol in the database field The person is shown in blue if measurements are already available The colour is grey if no measurements exist yet Import of patient data via DICOM interface optional For hospital operation patient data in DICOM format can be imported directly from the DICOM modality worklist of the hospital network server To call up patient data from the waiting room via the DICOM interface the DICOM option must be activated in the menu Options gt Setup gt Program settings Network see page 36 f and the Network Broker must be configured accordingly see section Network Broker configuration on page 43 ff e Select Patient gt Query waiting room in the New Patient input window Network Broker EIEI Broad Query Patient ID ch g Accession Number ob g C e L ERER ea lil Patient s Name d g Requested Procedure ID dh g vy Reset fields gt Modality
25. 734_GA_GB US_ 120608 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 Error Fig 77 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 fluctuations or measuring errors may occur Remedy Fig 78 Condition following keratoplasty I Note In this case keratometer measurements cannot be taken with the lOLMaster 000000 1322 734_GA_GB US_120608 117 118 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 133 howev
26. DO Narrow holding bracket for securing the IOLMaster 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 Oooocovoo Connecting cable for coupling with PC 000000 1322 734_GA_GB US_ 120608 Description Power isolation transformer for external devices A 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 000000 1322 734_GA_GB US_120608 19
27. Franz 07 07 1977 05 2 Mustermann g 01 401 1911 05 31 20 Mustermann g 01 207 1977 05 24 2C Mustermann Haigis L 01 401 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 jj 05 25 2005 amp Erase 2 Mustermann j 07 07 1977 05 25 2C Mustermann John 05 23 2005 Mustemar Jon 1 87 7377 05 2 wf Fig 55 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 Select the eye to be used for the optimisation calculation The fields OD fright _OS left below show the measurement data of the OLMaster e f you wish the data of the other eye to be kept in the data table for further optimisation activate keep other side in table in the check box 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 eleven data records into the left hand table in this way lt lt 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
28. Name first name identified by D Number u 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 Number 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 000000 1322 734_GA_GB US_ 120608 Operation Keratometer Display For displaying during IOL calculation the specification may be as a Radius or Corneal K s or 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 Adjustment aid Keratometer Anterior chamber depth Adjustment aid KER If the ADJUSTMENT AID is activated for the Keratometer a traffic light display will appear on measurement of the corneal curvature When the optinum measurement position for the patient has been reached the traffic light will change from red to yellow to green If the AU
29. Piggy back Silicone SLM 2 Primary Piggy back Hydrophobic Acrylate IOL centre thickness 0 2mm 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 material used and the centre thickness 000000 1322 734_GA_GB US_120608 Fig 39 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 66 Fig 40 Setting for keratometer measurement Operation 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 100 It is expedient to measure at a number of different points Warning Use the psph pseudophakic button to calculate secondary piggy back IOLs For this purpose the ACD should be measured by a method other than the lOLMaster and the readings thus obtained entered into the appropriate boxes Me
30. a SUCCESS IL Note After backed up data has been restored the Lens Database 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 L Note Download IOL data using a PC connected to the Internet and a CD RW recorder or USB flash drive Caution Do not use a network connected OLMaster for the download Log into www meditec zeiss com iolmaster Select Optimized lens constants from More information 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 1322 734_GA_GB US_ 120608 Operation 33 Importing IOL data from the storage medium to the l OLMaster e Inthe Lens Database activate Administrator e Click on the IMPORT button Import Import of lens data X Please insert the USB stick CD containing the lens data base for import e Insert the CD RW or USB flash drive with the database to be imported and confirm with OK Import of lens constant data Lens constants in the import databas
31. and date of birth or an ID Number 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 L 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 34 Up to 255 characters may be entered in the Remark field comments diagnoses etc 3 Note Refer to page 91 for working with the database field In Program Settings you can set the number of days after which a data record is automatically deleted 5 to 365 days e To close after entering the date of birth click on the NEW button or press the ENTER key 000000 1322 734_GA_GB US_ 120608 57 H L Test T 01 01 1911 The following special characters are permitted for entering patient data Minus Dot Apostrophe Underline 58 1 2 Circle of light spots for focusing Cross hairs Fig 36 Video image with correctly set device Operation 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 six 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 Pa
32. calculation Select EMMETROPY IOL if desired 000000 1322 734_GA_GB US_ 120608 35 36 Operation QO Program settings Export requires Option A plus Select export settings Under Identification select the patient identification categories under Measurement Values the values to be exported and under File output the corresponding output 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 using other applications e g MS Excel Program Export Network View User management Identification gt m Measurement Values IV Last Name M Axial Length JV First Name IV Composite Value V Date of Birth I List of Values V Exam Date IV Keratometer I ID Number Mean Value List of Values J Anterior Chamber Depth V White To White Active Value C List of Values m File output Field separator Semicolon gt Decimal separator Comma M Output path CD RW USB stick File name amp xport csv Fig 18 Program settings Export dialog box QO Program settings Network Warning Configuration and changes to the network settings should only be carried out by an experienced network administrator Network information Here you will find all the key network information such as Computer Name Working Group IP and MAC address Use the CHANGE NETWO
33. data click on the IOL Calculation IOL 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 To change the display select the other eye under Surgical Eye The lenses calculated for the other eye will now be displayed 000000 1322 734_GA_GB US_ 120608 78 Operation IOL Calculation x Haigis SRK II Hoffer Holladay SRK T Muti Formula Haigis L phakic IOL Prior Refractive Surgery Mustermann Max 01 01 1911 Axial Length mm 23 81 23 67 Eye Surgeon Dr Mustermann X Corneal K s mm A ra 9 B 35 47 33 Target Refraction D 1 0 5 Optical ACD Imm f Surgical Eve C OD Cos i OL Calculation i Print IOL Calculation Data Jens 1 7 Lens 2 7 fens 3 7 Lens 4 7 IOL D REF D lOL D REF D 1OL D REF D lOL D REF D 185 188 185 1 88 EA m30 223 e ps pa fzo fiz E po pre 17 0 0 87 ps pose a 0 82 160 023 w0 023 10 5 0 09 105 0 09 a m e C wo fose E 0 41 15 0 0 41 3 5 0 98 g5 0 98 fias 0 72 14 5 0 72 3 0 1 42 l 3 0 1 42 Fig 48 Calculated IOL data in IOL calculation window SRK T In the columns below each specified lens you will find the calculated refractive powers and target refractions for those lenses The middle line appearing in bold type indicates which refraction of the corresponding IOL comes closest t
34. 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 91 into the holes adjacent to the chin rest the holding pins for the paper pads 4 Fig 91 may need to be removed beforehand The test eye holder 2 Fig 91 is secured by a locking screw and mounted on a mandrel which allows it to rotate 7 Fig 91 The respective set value and tolerance 3 and 6 Fig 91 for checking the calibration status are marked on the test eye holder 1 Fig 91 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 e Highlight the patient CHECK DEVICE and click on NEW 000000 1322 734_GA_GB US_ 120608 Servicing and maintenance Axial length measurement and keratometer The test eye 8 Fig 91 marked with AL R the respective set values and tolerances 6 Fig 91 is used for checking the axial length AL and keratometer R The measurements should be taken in the same way as for a human
35. has the greater amplitude The measuring cursor may not be moved rs 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 66 It may be advisable to perform further individual measurements Up to 20 measurements may be taken on one day 000000 1322 734_GA_GB US_120608 111 112 Tips for keratometer measurement How to adjust the measuring marks Ask the patient to relax and look at the yellow fixation light If the patient cannot see the fixation light he or she should look straight ahead into the device L 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 six 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 reflecti
36. hospital information system The person is shown in blue if measurements are already available The colour is grey if no measurements exist yet see also section Patient Manager New patient on page 53 Measurements are indicated by a clock Measurements already transferred to the hospital information system are additionally indicated by a red arrow 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 by last name Use the Search textbox to quickly access a data record Place the cursor in this box and type in the desired last name to list all relevant data records The following letters of the name can also be entered this ensures fast access to the desired data record On repeat visits data can be instantly transferred to the input area by clicking on the patient s name To take a new measurement click the NEW button or use the keyboard shortcut lt ALT gt lt N gt 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 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 d
37. 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 1322 734_GA_GB US_120608 Tips for anterior chamber depth measurement 125 Irregularities of the corneal surface scars Fig 87 Condition after keratoplasty same eye as shown in Section Tips for keratometer measurement Fig 78 page 117 Scars and local irregularities of the anterior cornea impair the image Error 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 Remedy impossible to improve the adjustment If apparently plausible anterior chamber depth results are nevertheless displayed they can only be regarded as reference points To obtain reliable data all the other known facts and findings of this eye should be included in the evaluation 000000 1322 734_GA_GB US_120608 126 Tips for WTW measurement optional How to adjust the device Ask the patient to relax and look at the yellow fixation light Focus on the iris not on the light spots Adequate room lighting will facilitate the detection of iri
38. its affiliates only direct damages up to two hundred fifty U S Dollars U S 250 00 or equivalent in local currency You cannot recover any other damages including consequential lost profits special indirect or incidental damages This limitation applies to e anything related to the software services content including code on third party internet sites or third party programs and e claims for breach of contract breach of warranty guarantee or condition strict liability negligence or other tort to the extent permitted by applicable law It also applies even if Microsoft should have been aware of the possibility of the damages The above limitation may not apply to you because your country may not allow the exclusion or limitation of incidental consequential or other damages EXPORT RESTRICTIONS The software is subject to United States export laws and regulations You must comply with all domestic and international export laws and regulations that apply to the software These laws include restrictions on destinations end users and end use For additional information see www microsoft com exporting LT_XP_PRO_embedded_080807 3 Content User manual l OLMaster with Advanced Technology Software Version 5 4 000000 1322 734_GA_GB US_ 120608 Microsoft Software License Terms LT_XP_PRO_embedded_080807 Installation of a Network Printer on the OLMaster Network Printer on IOLMaster_180707 Notes on an
39. lt lt 19 3 SRK II Data Records 15715 A Const P195 _ lt lt 195 SRKe T 14 22mm B ad 425 lt lt 4235 Haigis 22 25mm E pACD 577 lt lt 577 Hoffer 25 40mm 0 SF 208 _ lt lt 208 Holladay Ave AL mm 2203 eo Last Optimize 06 03 2005 Load New Optimize Erase OK Cancel SRK is a trademark of CTI Computational Technology Inc Fig 59 New data record has been added e Click on OK to return to the Lens 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 OLMaster main module 000000 1322 734_GA_GB US_ 120608 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 lt N gt button The readings of the previous patient to the left and or right will be stored and removed from the display The patient manager appears and new patients can be entered or be imported from via the DICOM or EMR interface from the waiting room optional rg Note Data is available in the internal database for the period preset in under Program settings Program see page 34 After importing the new patient data and selecting a patient or manually entering the new patient data switch to Overview mode OVM by clicking lt ENTER gt or NEW
40. 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 optimisation 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 8 4mm Indicates possibility of a very flat corneal curvature R lt 7 2mm Indicates possibility of a very steep corneal curvature R1 R2 gt 0 5mm Indicates 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 000000 1322 734_GA_GB US_ 120608 Operation Measurement of ant
41. such a case the automatic algorithm finds the correct axial length cr Note 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 Fig 67 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 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 1322 734_GA_GB US_120608 109 110 Evaluation of ALM results Signals from the choroid Triple peaks In rare cases the measuring beam may also be reflected by the vessels of the choroid Signal from 1 secondary Yo N maximum f choroid f i inner limiting pigment membran epithelium 150 250 pm ca 800 um Fig 68 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 pea
42. the Application Entity Title field The address and port via which the provider is contacted must be entered in the Host IP and Port fields respectively I Note To register a name contact the DICOM network administrator e A maximum timeout period for the provider can be entered in the Timeout field e The CONNECTION TEST button allows you to check the connection to the specified host e The MODALITY WORKLIST DIALOG check box allows you to determine whether a dialog is displayed for the modality worklist e You can decide whether you wish to select single or multiple entries in this dialog box e f you have selected the MULTI SELECTION option enter the maximum number of selection possibilities in the Maximum box e Then click on CONTINUE rR Note By default the maximum is set to N This means you can select the entire list 000000 1322 734_GA_GB US_ 120608 47 48 Operation Network Broker Configuration Tool x loj x DICOM Storage Provider Set up step 5 Application Entity Title STORESCP Host IP localhost Port e104 Timeout zo s Connection test Used DICOM IOD No compression Muti frame True Color Secondary Capture JPEGb Activate SC scaling Factor Scaling Factor J 4 T G Help Q Back Continue Y Ok Cancel Fig 28 Network Broker Configuration Tool step 5 e Enter the name of the DICOM Storage Provider in the Applicatio
43. the installation of the software update has been completed 000000 1322 734_GA_GB US_ 120608 41 42 Operation Carl Ceiss Meditec Teleservice requires Option T Used for remote maintenance of OLMaster by Carl Zeiss Service see section Remote maintenance optional page 127 QO Service For servicing purposes and password protected Warning Unauthorised persons may under no circumstances use the service password The safety warranty for the medical device will otherwise become invalid 000000 1322 734_GA_GB US_ 120608 Operation Network Broker configuration optional IL Note The Network Broker configuration described on the following pages should only be performed by experienced network administrators x Network Broker Configuration Tool o x Welcome Welcome to the Network Broker configuration tool Select language for the installation instructions English _ O Hep sad Continue yO Q comei Fig 23 Network Broker Configuration Tool start screen e Start the Network Broker Configuration Tool by clicking on the BROKER CONFIGURATION button in the Program setting Network menu see page 37 e Select the desired language for the configuration instructions and click CONTINUE I Note Click the HELP button in all of the configuration tool windows to obtain assistance at each configuration step Use the CONTINUE and BACK buttons to navigate between the individual conf
44. traffic light will change from red to yellow to green In Automatic mode Automatic activated three consecutive measurements will be triggered automatically once the knob on the joystick has been pressed and the optimum measurement setting green traffic light has been reached and remains constant for all three 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 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 principal meridians 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 re Note The OLMaster requires
45. 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 1322 734_GA_GB US_ 120608 138 CE 0297 Manufacturer s Declaration The device meets the requirements of the Medical Device Directive 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 1322 734_GA_GB US_ 120608 ACD AE ALM CD RW COM csv DICOM DICOM Modality Worklist DIN EMR EN Fig HIPAA KER LC display LED mm MS um MMLD Network Broker OVM PC PCI SRK USB VGA WTW Abbreviations Glossary Anterior chamber depth Application Entity Name of a DICOM node 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 Digital Imaging and Communications in Medicine open standard for the exchan
46. with the lOLMaster and its database after logging on again with the password Screen Saver IV Activate Idle Time Eg min Password Protection Fig 21 Program settings User management dialog box 000000 1322 734_GA_GB US_ 120608 39 40 Operation 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 CHANGE PASSWORD or users to be deleted DELETE x User Management User Membership dministrator New Delete Change password Add Remove User Group Management Under User Groups you will find an overview of all user groups with their privileges Here you can change the privileges of the groups User Groups Fig 22 Program settings User management User manager dialog box 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 Lens database see page 29 and the Setup menu The Surgeon only has an access right to the respective tab in the Lens database This tab is created automatically w
47. 08 Evaluation of ALM results 103 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 98 The manipulations described here can be performed on the individual measurements but have no influence on the composite signal Manipulations are therefore only expedient on the composite signal For simplification reasons the illustrations below do not show the video image ee 4 dp dt fp dt 14 40 rum Fig 63 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 1 ere Ces COD DAAD haan D 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 cs 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 1322 734_GA_GB US_120608
48. 10 to 95 no condensation 500 to 1060 hPa 000000 1322 734_GA_GB US_120608 133 134 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 Comparison 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 ae 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 1322 734_GA_GB US_ 120608 Technical specifications Optical radiation Light spots WTW determination Source Wavelength Delivered power Axial l
49. 101 continuous positioning of the measuring cursor while dragging see page 104 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 28 and Overview of buttons and shortcut keys on page 25 ff 000000 1322 734_GA_GB US_ 120608 23 24 Operation Screen layout Carl Zeiss IOLMaster Advanced 7echnology Oo ON DU RPWDN o 1 Superimpose 2 Focus 3 Push iS 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 1322 734_GA_GB US_120608 Operation Overview of buttons and shortcut keys Icon Key Function Explanations lt N gt Activates patient data For new patients input of entry screen patient data is essential lt O gt Activates overview Functions in all modes and mode and light spots for every measurement A lt A gt Activates axial length measurement mode 8 lt K gt Activates keratometer corneal curvature measuremen
50. 34_GA_GB US_120608 122 Tips for anterior chamber depth measurement Fig 83 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 Error Remedy Fig 84 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 1322 734_GA_GB US_120608 Tips for anterior chamber depth measurement 123 Reflections in the corneal image Fig 85 Reflection in corneal image due to lateral misadjustment The lateral adjustment of the device is not correct Illumination Error reflections can be seen in the corneal image slit and the fixation point lies within the lens image Adjust the device laterally until the corneal image is undisturbed As a Remedy rule the fixation point will then be between the image of the anterior lens and that of the cornea Repeat the measurement 000000 1322 734_GA_GB US_120608 124 Tips for anterior chamber depth measurement Pathological findings Dry eye Error Remedy Fig 86 Optical sections of dry eyes A locally
51. 80707 Notes on and conditions of use for the remote maintenance tool 000000 1305 000_AddGA_GB_ 150807 Enclosure lOLMaster Quick Instructions Version 5 4 000000 1322 734_KurzGA_GB_ 110608 000000 1322 734_Inhalt2_GB_160608 MICROSOFT SOFTWARE LICENSE TERMS FOR MICROSOFT WINDOWS 2000 PROFESSIONAL FOR EMBEDDED SYSTEMS 1 2 CPU VERSION MICROSOFT WINDOWS XP PROFESSIONAL 64 BIT EDITION FOR EMBEDDED SYSTEMS 1 2 CPU MICROSOFT WINDOWS XP PROFESSIONAL FOR EMBEDDED SYSTEMS 1 2 CPU VERSION MICROSOFT WINDOWS XP PROFESSIONAL FOR EMBEDDED SYSTEMS RUSSIAN VERSION 1 2 CPU VERSION MICROSOFT WINDOWS XP PROFESSIONAL FOR EMBEDDED SYSTEMS SIMPLIFIED CHINESE VERSION 1 2 CPU VERSION These license terms are an agreement between you and Carl Zeiss Meditec AG CZM Please read them They apply to the software included on this device The software also includes any separate media on which you received the software The software on this device includes software licensed from Microsoft Corporation or its affiliate The terms also apply to any Microsoft e updates e supplements e Internet based services and e support services for this software unless other terms accompany those items If so those terms apply If you obtain updates or supplements directly from Microsoft then Microsoft and not CZM licenses those to you As described below using some features also operates as your consent to the tra
52. 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 1322 734_GA_GB US_ 120608 89 Basis lt lt New A Const 1191 _ lt lt 193 SRK A Const 1186 _ lt lt M195 sRKe T a faz EE 25 Haigis pACD 53 _ lt 577 Hoffen sF 56 _ lt lt 208 Holladay Fig 58 Optimised lens constants Operation John Q Public 0 D Actimed Actriflex 45C Mustermann Egon 07 07 1977 05 23 2005 Last Name Mustermann Surgical Eye 0S left Mustermann Erhard 11 11 1888 05 08 2008 Mustermann Ema 11 11 1866 05 08 2005 First Name Egon AL mm 24 23 Mustermann Ema 11 11 1866 05 08 2005 ith Mustermann Franz 07 07 1977 05 23 2005 Date of Bith JO7 07 1977 Koa efo Mustermann g 01 0171911 05 3172005 Exam Date 0572372005 K2 or 43 49 Mustermann Haigis L 01 01 1911 05 30 201 Mustermann Hemine 02 02 1911 05 07 20 1D Number l Opt ACD mm 3 8 Mustermann John 05 23 2005 Mustermann John 05 23 201 Impl IOL pif23 Mustermann John 01 407 1977 05 23 2005 Mustermann mein 05 26 2005 Post Op Ret Dii M afso Mustermann Mo 07 07 1977 05 23 2005 Mustermann test 01 401 1911 05 03 2005 supe Bete Mustermann Userinterface 04 22 2005 gt Post Op Date f Basis New A Const 1193 _
53. Following this call Carl Zeiss Service 000000 1322 734_GA_GB US_120608 10 4 Safety instructions Important when using the device Q Always enter the patient data last and first name date of birth or ID Number depending on setting in Setup menu Q Pull the power supply cable immediately if damage or unspecified problems occur Q 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 Warning Internal components are still under voltage while the switch lamp is lit 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 O The device contains a computer Please follow the instructions for the Switching off the device on page 97 Disposal The device s internal control computer contains electronic components and a lithium battery type CR 2032 At the end of its useful life it must be properly disposed of in compliance with local regulations Disposal of the product within the EU In acco
54. 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 Warning Ensure that the device permits no more than 20 measurements per eye and day Do not delete any single measurements e g because they have a very low SNR or no axial length measurement could be determined from the single signal alone SNR with or Even a noisy signal may contain usable information on axial length that can be used for calculating the composite signal The new technology of the IOLMaster Advanced Technology is based precisely on the evaluation and use of information from all single measuring signals This eliminates the need for post run editing of the single signals They should only be consulted if the composite signal has multiple peaks In this case post run editing may be advisable taking into account the single signals and axial length of the other eye The overall axial length measurement is post run edited as described on page 103 onwards 000000 1322 734_GA_GB US_ 120608 Operation Axial length measurement ALM Activate the ALM mode by e clicking on the ALM icon or e pr
55. Meditec AG or a company authorised by them by telephone if there are other people in the room in which the instrument is located during a remote maintenance session 6 The user is solely responsible for the safe operation of the instrument during a remote maintenance session 7 No guarantee is entered into for advice given during a remote maintenance session Carl Zeiss Meditec AG in particular does not guarantee that they or a company authorised by them will be able to diagnose or remedy a fault using remote maintenance mode If it is not possible to diagnose or remedy the fault in remote maintenance mode the user will need to request that a service technician attend the installation This will incur further costs Notes on and conditions of use for the remote maintenance tool Carl Zeiss Meditec AG 000000 1305 000_AddGA_GB_ 150807 Page 1 2 8 The user may only permit the use of remote maintenance mode if the currently logged on user s privileges do not permit unauthorised access to protected data 9 The user may only permit the use of remote maintenance mode if no danger can arise to patients or other persons through the operation of the instrument in remote maintenance mode 10 Except in cases of intent or gross negligence Carl Zeiss Meditec AG accepts no liability on any legal basis for damages arising during fault diagnosis or maintenance in remote maintenance mode 11 Place of jurisdiction is for commercial custome
56. O1 1 Alle Felder HERR pre suf a AA AN O Abel Andreas Aa Bb Cc xc Invert selection Clear selection OK Cancel Fig 35 Network Broker Broad query dialog box On the left side of the Broad Query tab you can use the gt Modality search box to search for patients for a specific device modality The options on the right can be used to restrict the query period If you leave these boxes empty the entire patient list will be shown In both tabs start the query by clicking EXECUTE or cancel by clicking CANCEL Use RESET FIELDS to reset all query boxes to their standard values e Enter the desired search criteria in the appropriate boxes and start the query by clicking EXECUTE e Select the patients to be imported from the patient list shown 000000 1322 734_GA_GB US_ 120608 55 56 Patient Options Erase Del Rename lt Ctrl gt R Query waiting room Operation Use the SELECT ALL button to select the entire patient list INVERT SELECTION to invert the selection and CLEAR SELECTION to deselect entries e Click OK to confirm the import of the selected data The patient data from the waiting room will now be imported into the local database of the device Import of patient data from a practice administration system EMR system optional Data of patients to be examined with the device can also be imported directly from the patient list in the practice management system To cal
57. Op Date is optional When l entered however the data will be checked for plausibility Post Op Date I 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 Mustermann E gon 07 07 1977 05 23 2005 Last Name Mustermann Surgical Eye 0S left Mustermann Ethard 11 11 1888 05 08 2008 gt Mustermann Ema 11 11 1866 05 08 2005 FirstName Egon AL Imm 2423 Mustermann Ema 11 11 1866 05 08 2005 pets ozana Mustermann Franz 07 07 1977 05 23 2006 Date of Bith J07 07 1977 Koza efo Mustermann g 01 01 1911 05 31 42005 Exam Date 0572372005 K2 or 4a 4g Mustermann Haigis L 01 401 1911 05 30 201 Mustermann Hermine 02 02 1911 05 07 20 1D Number Opt ACD mm 38 Mustermann John 05 23 2005 Mustermann John 05 23 2005 Impl IOL pr 23 MustermannJohn 01 407 1977 05 23 2005 Mustermann mein 05 26 2005 Post Op Ret pifi f xf50 Mustermann Mo 07 07 1977 05 23 2005 Dat J Mustermann test 01 01 1911 05 03 2005 at ees Mustermann Userinterface 04 22 2005 y Post Op Date Basis lt lt New A Const 1193 _ lt __ SRK II Data Records 15715 A Const 1195 lt lt SRK T 14 22mm B ad 425 IT Hagis 22 25mm E pacn 577 lt lt Hotte 25 40mm 0 sr 208 lt lt J Holladay Ave AL mm 2203 Iree ea Last Optimize 0670372005 Load New Optimize Erase Of Cancel SRK is
58. RK SETTINGS BUTTON to configure the IP address 000000 1322 734_GA_GB US_ 120608 Operation 37 Serial Port Use the Serial Port to exchange data with another PC or the Serial Port practice administration system installed on it activate Choose old if the connected office management system only old allows import of data of interface software versions 1 01 to 2 02 C new with IOL calc table patient data measured values Choose new with IOL calc table requires option A plus if aay PET e200 Stender E 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 Baud DICOM requires Option N Activate the option box under DICOM Digital Imaging and Pico Communications in Medicine to exchange DICOM standard data ah with the information system of your hospital For example with eee the help of the DICOM Modality Worklist you can automatically transfer jobs including all relevant patient data from the hospital s information system to the OLMaster You need to configure the Network Broker to be able to use this option Access the Network Broker Configuration Tool by clicking the BROKER CONFIGURATION button Warning A Configuration and changes to the network settings should only be carried out by an experienced network administrator EMR requires Option N If you act
59. TOMATIC KER is also activated upon pressing the joystick knob three measurements will be automatically and consecutively triggered after the best possible setting for the patient has been made and the traffic light has changed to green Adjustment aid ACD If the ADJUSTMENT AID is activated for the anterior chamber depth ACD a traffic light display will appear on measurement of the ACD When the optimum measurement position for the patient has been reached the traffic light will change from red to yellow to green If the AUTOMATIC ACD is also activated upon pressing the joystick knob the measurement will be automatically triggered after the best possible setting for the patient has been made and the traffic light has changed to green r Keratometer Display Radius C Comeal K s Cylinder Cylinder has x Caution Keratometer indices affect corneal power for a given Refractive Index 1 3375 XJ radius of curvature Adjustment aid Keratometer Anterior Chamber Depth Adjustment aid KER Automatic KER JV Adjustment aid ACD M Automatic ACD Fig 17 Dialog box Program settings Program Keratometer and Keratometer Anterior chamber depth adjustment aid Printing of IOL calculation data Choose whether you wish to have the calculated IOL data 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
60. The device may not be stored or operated in environmental conditions other than those prescribed see Technical specifications on page 133 QO 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 QO Do not store or use this device in damp rooms Do not expose the device to water splashes dripping water or sprayed water QO 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 Q 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 Q 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 Q The device may only be operated by instructed and trained personnel Q In USA this device may only be purchased or ordered by physicians and ophthalmologists Q The user manual should always be kept at hand for reference Q It is also important to comply with the instructions supplied with accessories 000000 1322 734_GA_GB US_ 120608 Safety instructions Q Use only printers approved by Carl Zeiss Meditec Use only the CD supplied by the printer manufacturer to install the print
61. The device may only be used in combination with accessories delivered by Carl Zeiss Meditec see Section Optional accessories on page 18 Please consult Carl Zeiss Service regarding the use of other accessories Functional description The 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 session axial length corneal curvature anterior chamber depth and optionally white to white All measurements are non contact providing excellent patient comfort The axial length measurement is based on a patented interference optical method known as partial coherence interferometry PCI The displayed results of the axial length measurements are compatible with the ultrasonic immersion measurements of axial length via the use of an internal statistically verified calculation algorithm The familiar formulae for IOL calculation can thus be used 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
62. U 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 1322 734_GA_GB US_120608 Description Overall view 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 Fig 2 View from doctor s side 000000 1322 734_GA_GB US_ 120608 18 Description 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 mount alignment aid test eye 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 DOO
63. 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 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 1322 734_GA_GB US_ 120608 15 16 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 LASIK PRK LASEK The refractive history or contact lens method may be used to correct the measured corneal radii refraction following refractive corneal surgery Selected phakic implants may be calculated by the calculation of u 1 phakic implants An IOL d
64. XP_PRO_embedded_080807 e NOTICES ABOUT THE MPEG 4 VISUAL STANDARD The software may include MPEG 4 visual decoding technology This technology is a format for data compression of video information MPEG LA L L C requires this notice USE OF THIS PRODUCT IN ANY MANNER THAT COMPLIES WITH THE MPEG 4 VISUAL STANDARD IS PROHIBITED EXCEPT FOR USE DIRECTLY RELATED TO A DATA OR INFORMATION i GENERATED BY AND OBTAINED WITHOUT CHARGE FROM A CONSUMER NOT THEREBY ENGAGED IN A BUSINESS ENTERPRISE AND ii FOR PERSONAL USE ONLY AND B OTHER USES SPECIFICALLY AND SEPARATELY LICENSED BY MPEG LA L L C If you have questions about the MPEG 4 visual standard please contact MPEG LA L L C 250 Steele Street Suite 300 Denver CO 80206 www mpegla com PRODUCT SUPPORT Contact CZM for support options Refer to the support number provided with the device BACKUP COPY You may make one backup copy of the software You may use it only to reinstall the software on the device PROOF OF LICENSE If you acquired the software on the device or on a disc or other media a genuine Certificate of Authenticity label with a genuine copy of the software identifies licensed software To be valid this label must be affixed to the device or included on or in CZM s software packaging If you receive the label separately it is not valid You should keep the label on the device or packaging to prove that you are licensed to use the software To identify genuine M
65. a trademark of CTI Computational Technology Inc Fig 57 Assign data records dialog box 000000 1322 734_GA_GB US_ 120608 88 Operation 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 Once all IOL and post op data has been entered the requirements for the optimisation calculation have been met O 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 Q If a data record is highlighted in yellow no ACD values exist as yet a0 Haigis formula will not be optimised with such data records Q Patient data records appearing on a white background contain all the data required for optimisation L Note Only the aO 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 1322 734_GA_GB US_ 120608 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 const
66. ants will now be displayed in the New column te Note Data records with an IOL power of 0 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 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 inter or postoperative complications which could affect the refraction state should be excluded L 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
67. asurement 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 individual measurement and an axial length calculated therefrom Should a reading deviate from another by more than 0 05mm 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 103 ff 000000 1322 734_GA_GB US_ 120608 63 64 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 This warning will also be issued if a significant axial length could be determined from a single measurement but this information is not contained in any further single measurement If the warning Multiple peaks appears certain axial lengths from the single measurements deviate from each other by more than 50 um In this case the axial length from the composite signal blue should be viewed with the axial lengths from the single measuring signals red in conjunction with the values for corneal refraction and checked for plausibility It is also advisabl
68. asurement of corneal curvature KER Keratometer measurement Activate the KER measurement mode by clicking on the KER icon or 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 crosshair and appear optimally focused The central point is usually not focused and is not evaluated for keratometer measurement The lOLMaster with Advanced Technology indicates the optimum measurement setting by means of a green traffic light IL Note Ensure that all six peripheral points are visible and located in the field between the two auxiliary circles on the display It is recommended that the patient blink his her eye shortly before the measurement to produce a continuous tear film This will improve the reflectivity of the cornea The measuring points should be circular or ellipsoid If the measuring points are irregular i e corneal scar measurement is not possible Precise measurements are possible only if the six peripheral measuring points appear optimally focused on the display e Trigger the measurement by pressing the knob on the joystick 000000 1322 734_GA_GB US_ 120608 Operation Depending on the setting under Program settings Program see page 35 a traffic light will assist in finding the optimum measurement setting When the optimum measurement position has been reached the
69. at these manipulations be carried out in a zoom view of the measurement curve 1 Automatic positioning over a distant peak e Move the arrow cursor to the white point when the mouse pointer approaches the white point the cursor changes from an arrow pointing diagonally upwards into a horizontal double arrow hold the left button depressed and move the measuring cursor over the other peak For easier orientation a vertical blue line will appear below the white dot This line can be dragged with the cursor e When the button is released the measuring cursor automatically snaps in over the desired peak The display will show the corresponding axial length and SNR always smaller than the maximum SNR found automatically and the recalculated value will appear in the display field denoted by an asterisk 000000 1322 734_GA_GB US_ 120608 Evaluation of ALM results Example hold left mouse button depressed drag line is moving with the cursor release mouse button Fig 64 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
70. atabase 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 Hoffer Q formula A comparison of theoretic and regression formulas J Cataract Refract Surg 19 700 712 1993 ERRATA 20 677 1994 e Holladay HOLLADAY JT PRAGER TC CHANDLER TY MUSGROVE KH LEWIS JW RUIZ RS A three part system for refining intraocular lens power calculations J Cataract Refract Surg 14 17 24 1988 e SRKII RETZLAFF J A new intraocular lens calculation formula Am Intra Ocular Implant Soc J 6 148 152 1980 e SRK T RETZLAFF J SANDERS DR KRAFF MC Development of the SRK T intraocular lens implant power calculation formula J Cataract Refract Surg 16 3 333 340 1990 e Haigis L HAIGIS W Publication in preparation e Correction of corneal radii corneal refraction after corneal refractive surgery HOLLADAY JT IOL calculations following RK Refract Corneal Surg 5 3 203 1989 HOFFER KJ Intraocular lens power calculation for eyes after refractive keratotomy J Refract Surg 11 490 493 1995 e Calculation of phakic implants vd HEIJDE GL FECHNER P
71. ation Print IOL Calculation Data Ophtec Artisan IOLTECH PRL x r Important safety warning IOL D REF D 10L D REF D Please refer to the manufacturer s guidelines regarding fex 6 50 ka 0 52 g oo 1 21 lens type and critical distances to the endothelium 7 50 0 69 5 50 aE 33 7 00 0 16 OS D 0 0 Ma Emm IOL a OK Cancel Fig 52 Calculation of phakic implants 000000 1322 734_GA_GB US_120608 84 Basis lt lt New AConst 18 lt lt srRken A Const 118 _ saket ad 1 273 lt lt Haigis paco 496 lt lt Hofferd SF TEN JEES al Holladay Load New Wptimze Erase Fig 53 Lens data in dialog box for selected lens Operation 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 IOL CALCULATION to display the results To print out the page with the results press PRINT Optimisation of lens constants Selecting lens data The lens data available in the following procedure database may be optimised by the e In the Options menu open Lens database Select the respective eye surgeon and confirm your choice with OK Fig 54 e Choose a lens The input mask contains constants calculated from A Constant Manufacturer or previously optimised constants e Click on the OPTIMIZE button The dialog box for the select
72. automatic method unless the curve adjoining them drops down below a value which is less than half the amplitude of their maxima cs 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 1322 734_GA_GB US_ 120608 105 106 Evaluation of ALM results 2 Fine shifting the measuring cursor L Note This manipulation should always be performed in a zoomed view e Proceed as described above under item 1 but use the right button to drag the measuring cursor This way the automatic peak detection is deactivated and the white dot can be positioned at any point over the measuring curve e When the button is released the current axial length and the new SNR will be calculated and displayed This kind of manipulation is advisable with closely adjacent double or triple peaks Here again the recalculated axial length is shown in the display field with an asterisk 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 a
73. ber field and click on on Dorr OK A connection will be established and the remote maintenance module control window will be disolayed on your screen see Fig 90 The service team is now able to view the user interface of your device and resolve the problem by telephone Fig 90 Online remote maintenance module control window e f it is necessary to activate the remote control function click on the ON button in the remote control panel e Closing the control window will terminate the remote maintenance session 000000 1322 734_GA_GB US_ 120608 128 ON OU 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 91 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 2 and 8 Fig 91 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
74. ce Type B medical device conforming to DIN EN 60601 1 gt E gt 5 f Disconnect the device from the power gt lt caliion supply before servicing Information and notes for a better under cS Note 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 1322 734_GA_GB US_ 120608 Safety instructions Compliance with standards and regulations O This device is a Class lla medical instrument as defined by the European Medical Device Directive MDD Q 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 MPA see Manufacturer s Declaration on page 138 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 Q
75. ched 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 device s control software This does not present a hazard to patients or the operator 38 gt Note The procedure described below does not apply in the case of breakdowns see page 126 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 1322 734_GA_GB US_ 120608 4 97 98 Evaluation of ALM results Signal curves of axial length measurements re Note The following notes refer mainly to the composite signal displayed in blue Valid signal curves Secondary maxima system specific distance about 0 8 mm maximal peak _t_4 4 4 4 4 4 4 4 sopip 4 4 4 4 4 4 4 4 4 4 4 4 fg 14 40 mm Very good signals signal to noise ratio gt 10 Several secondary maxima may be visible system specific Clear media patient correctly fixating Slight ametropia Clear signal SNR display GREEN Secondary maxima visible Relatively clear media 000000 1322 734_GA_GB US_120608 Evaluation of ALM results Cc j AN j PA fh ka y fbn J fred r i nt ur Aly lj ih nbs f i mA Wi ANI AVY j 1 dah T W T iF ay ih A 1
76. ctions from the IOL are fainter and lack definition Try moving the device approximately 1 mm away from the patient s Remedy eye defocusing and take the measurement The images produced at the cornea will now be slightly larger while the artefacts of the IOL become fainter such that the evaluation process may not identify them as measuring points a measurement is then possible If this procedure does not succeed the corneal curvature cannot be measured 000000 1322 734_GA_GB US_120608 116 Tips for keratometer measurement Dry eye Fig 75 Multiple reflections produced by a dry eye Error Remedy Fig 76 Light trail bottom due to a dry eye 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 1322
77. d conditions of use for the remote maintenance tool 000000 1305 000_AddGA_GB_ 150807 Enclosure lOLMaster Quick Instructions Version 5 4 000000 1322 734_KurzGA_GB_ 110608 000000 1322 734_Inhalt3_GB_160608 Installation of a Network Printer on the OLMaster Ask your network administrator for correct IP ad dress or DNS and exact type model of the network printer used Keep printer installation CD ready To open the Printers and Faxes dialog box click Printer which can be found in the Option Setup menu If other printers exist delete them here to avoid trouble Click on the ADD PRINTER icon and follow Select Local printer attached to this computer option Deactivate the checkbox Automatically detect and install my Plug and Play printer Confirm with NEXT ii Click the Create a new port option and select Standard TCP IP Port in the drop down list Continue with NEXT the instructions The Add Standard TCP IP Printer Port Wizard opens Continue with the Next button Type the correct IP address or DNS name of your network printer Change the Port Name if you like Confirm with NEXT If your specified printer was found in the network a dialog appears with the appropriate details Confirm with FINISH Select manufacturer printer from those listed in the Add Printer dialog Confirm with Next If your printer is not listed insert the printer ins
78. d 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 Inthe Lens 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 t may be necessary to delete existing data on the CD RW conform with YES Answering with No will abort the backup process The data will now be copied to the CD RW A progress bar will show the status of the copying process e Finally you will be informed that data backup was successful 000000 1322 734_GA_GB US_ 120608 Backup 31 32 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 Lens 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 lOLMaster 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 inform you if the restore action was
79. de at any time by closing the remote maintenance dialog box It is not possible for the service technician to start or restart observation mode without the user s consent 3 In observation mode a service technician from Carl Zeiss Meditec AG or a company authorised by them is able to continuously view a copy of the current program interface Service personnel may therefore be able to view patient details if they are displayed in the visible program interface It is entirely the responsibility of the user to take all necessary measures to ensure that confidential data is protected during the remote maintenance session and that all legal regulations are adhered to 4 In remote control mode a service technician from Carl Zeiss Meditec AG or an authorised company is able to operate the instrument s user interface with the privileges of the currently logged in user Remote control mode can be terminated at any time by pressing F5 The program will then switch to observation mode It is solely the user s responsibility to take all necessary measures to ensure that confidential data is protected during the remote maintenance session and that all legal regulations are adhered to 5 The user may not leave the instrument unsupervised in observation or remote maintenance mode Under no circumstances is the remote maintenance tool to be used for fault diagnosis while treatment is being carried out The user must alert the service technician from Carl Zeiss
80. djustments on the graph 99 Measuring errors with pseudophakic eyes 0008 100 Zooming the graph display es o0hesccleidscattsacnietigescebee Maen 101 Post run editing of axial length measurements 0008 103 SNR categori eS oionn arcs tova Ute tetuaedswartonndese Wwe detiaeasegeht 103 Shifting the measuring CUISOF cccceeeeeeeeeeeeeeeeeeeees 104 Interpretation of axial length measurements 0 00e 107 Signals from the inner limiting membrane ILM 109 Signals from the choroid ccceceeeeeteeeeeeeeeeteeeteees 110 Tips for keratometer measurement ccceeeceeeeeeeeeeeeeeseeeeeeeeees 112 How to adjust the measuring Marks cceeeeeeeeeeeteeees 112 Measuring CONG sah ce eas a cede cates ana a SMtacuitn tecasoon 113 Misadj stmMerts i aseeni renn niea aiani 113 Other findings Aren aen aa eoe EIO 115 Tips for anterior chamber depth measurement 1 ceeeee 118 How to adjust the device cecccceeeeeeeeeeeeeeeeeeeeeeneeeeeeeeneees 118 M as ring GIT ORS iaraa ea a ea ai Mua detuaua bates 120 Incorrect settings eee eae hhh Gente 120 Pathological PINGIAGS 05 13 s02ccucsevscreetetnedahcaeescderaresevacnmeett 124 Tips for WTW measurement optional cccssssseeeessseeeeeeees 126 How to adjust the device vc5 5 5 fae eek ela cere eae ah ns 126 Troubleshooting seer oe Conia odie Gatch it la ees 126 Servici
81. e measurement The fixation point must be optimally focused 000000 1322 734_GA_GB US_120608 Tips for anterior chamber depth measurement 121 I 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 Error lateral misalignment may make the lens invisible This problem may also appear with patients who are restless or fixate poorly L Fig 82 Slit image on the iris invisible lens In such a case the slit image on the iris is almost continuously visible Error The automatic evaluation software does not recognise this kind of misadjustment The system will display values that are too short These values do not correspond to the actual anterior chamber depth A but represent the distance between the anterior cornea and the iris The value displayed is not the exact reading for the anterior chamber depth Adjust the device laterally until the anterior lens becomes visible If Remedy necessary ask the patient to look steadily at the fixation light Then repeat the measurement I Note It suffices if a relatively small section of the lens is visible The picture below shows an alignment which permits accurate measurement 000000 1322 7
82. e Surgeons of the current user data base Dr Schmidt MP2125 John Q Public 0 D Dr Schmidt MS612 Gen Innov 310 Gen Innov xP 55 Hoya AF 1 UV VABOBB HumanOptics 1CU lOLtech Haptibag lOLtech Stabibag lOLtech XL Stabi Lenstec LS 106 OIl Aqua Sense III Ophtec PC265 Ophtec PC410 Ophtec PC420 Ophtec PC430 Ophtec REF510 Pharm Tecnis 29000 Pharm Upj 808C Pharm Upj CeeOn 9114 Polytech Polylens A460 Polytech Polylens AG Fig 15 Import of lens constant data dialog box 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 OK 000000 1322 734_GA_GB US_120608 34 Program Settings Regional Settings Printer SW Option Update Operation Setup The Setup submenu contains the following entries Date Time Opens the Windows routine for setting the system clock QO Program settings Program Language OLMaster dialogs in German English or other Fig 16 Setup submenu r Database Erase records after fi OO Days Patients willbe gt
83. e is optimally aligned re Note The image of the fixation point should be near but not in the image of the lens Fig 80 Optimally adjusted optical section lens with cataract Fig 79 and Fig 80 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 Depending on the lighting conditions in the examination room the front side of the lOLMaster as reflected by the cornea may also be visible These artefacts do not affect the measurement of anterior chamber depth unless the significant image details images of cornea and crystalline lens and the image of the fixation point are eclipsed by this extraneous light This may be alleviated by slightly darkening the examination room Warning Failing to satisfy the above requirements for the measurement of the anterior chamber depth will either result in measuring errors or the measured values shown will be incorrect Because of the complexity of the images measured measuring errors may under certain circumstances not be recognised as such The OLMaster must be adjusted very carefully for anterior chamber d
84. e to include the axial length of the other eye in the consideration If no reading can be determined from the composite signal no value will be transferred to the IOL calculation and database for constant optimisation 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 TN In this way the signal curves of the individual measurements can be displayed Deleted individual measurements can be restored with Functions Recover The composite signal can be displayed by clicking on the composite reading in the display field denotes readings with an SNR smaller than 1 6 The following plausibility tests are performed with the axial length measurement AL from the composite signal AL lt 22 mm indication of short ocular axis AL gt 25mm indication of long ocular axis 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 conf
85. e warnings by pressing OK The anterior chamber depth measurement may be repeated as often as desired If additional measurements are taken of anterior chamber depth the previous readings will be overwritten To restore the last just overwritten readings press shortcut keys lt CTR gt lt Z gt UNDO function rR Note This UNDO function itself is irrevocable 000000 1322 734_GA_GB US_ 120608 71 72 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 six 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 j Patient Functions Options y 0 3 mm WTW 12 4 mm fix point x 0 4 mm y 0 3 mm
86. ed lens will appear and the lens constants can be seen in the BASIS column Fig 53 Administrator Dr Test Lenses Nana Lens 2 A Const ACD A Const Const al al a2 pACD SF Power Steps OK ens 1 PE Manufacturer Manufacturer SAK II SRK T 273 Haigis Hoffer Holladay C 1 40 Erase Optimize SRK is a trademark of CTI Computational Technology Inc 2 z N amp dd Set Fig 54 Lens data in the Lens Database dialog box 000000 1322 734_GA_GB US_120608 Operation Loading existing data records e Click on the LOAD button to load the data records of all patients available for optimisation John Q Public O D Actimed Acriflex 3 Measurement Table Fiter Search Mustermann Auge 01 07 1977 05 2 a z _ 5 fe Mustermann Auge 01 07 1977 05 2 Last Name Mustermann Auge 01 07 1977 05 2 5 C Mustermann Auge 01707 1977 05 2 manane 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 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 Mustermann Augek 01 07 1 977 057 Mustermann Augek 01 07 1977 05 Mustermann Augekh 01 07 1977 05 Mustermann Auger 01 07 1977 05 2 Mustermann D250505 01 01 1990 0 Mustermann Erhard 11 11 1888 05 1 Mustermann
87. ed when the examination room is slightly darkened WTW measurement may be repeated as often as desired 000000 1322 734_GA_GB US_120608 A 73 74 i Ul Operation Measuring the other eye The system automatically registers which eye is being measured OD or OS All past readings of this patient are still stored and may be retrieved as necessary Measurements of the other eye must be performed analogously to the previous eye L 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 21 re 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 is 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 IL Note In ALM mode the printout of
88. eeeeeeeeees 7 SEO IA E OEE cana Ae eel eo EE 9 Electrical satetes San e EE 9 Light emission from the deVICC ceeceeeteeeteeeeteeeseeees 9 Requirements for operation ccccceeeeeeeeeeeeeeeeeeteeeeseees 9 Important when using the device cceceeeeeeeeeeees 10 DUIS O Sell atl n59 9 2 ois a a ST ett LR 10 Disposal of the product within the EU cece 10 Package COMLON Sst caus acento msec augue it ee Sela a E EES 11 Warning and information labels on the device ccceceee 12 Customer s safety obligations cccccccceeeeeeeeeeteeetteeeeeeeees 14 Description nr ee en meee ane near en one etn 15 Intended use of the device 00 2 eee ceeeeeeeeeeeeetteeeeteeeetteeeees 15 Functional description su suse coer nate Lait of Saat Baht eS DL 15 Overall VEW neinn enea ated e A ATN ON 17 8 e illo wrel bre alel css 0 g iene mere eT oon Renae te Lee ET ON PE on nee 18 Power isolation transformer for external devices 19 Setting up the device for USC ceeceeeeeeeeeeeteeeeteeeeeteeeeenteeees 20 A iSteal LATION sieve cette acted ohenweesiters e r Sa EASA 20 Electrical COMMECTION 2 c cscnsctsi Sele ia ste del decdeesceeland Seles 21 000000 1322 734_GA_GB US_120608 Contents OD GV atiOn oseane aanne aae aeren aeaa esaera EKE En EEE aaa Saa AEE 22 General notes on control ssssessseseessseeirersirrereerrrsrrtrrrrrrrrrrren 22 Operation by touchpad and keyboard
89. ength 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 Delivered power Slit illumination for anterior chamber depth measurement integral irradiance UV 300 to 400 nm IR 700 to 1100 nm L phakic eye L aphakic eye LED 880 nm lt 100 uw 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 1322 734_GA_GB US_ 120608 135 136 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 0 corresponds to the direct v
90. epth measurements 000000 1322 734_GA_GB US_120608 119 120 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 tre Note It is advisable to measure accommodating patients under cycloplegia Measuring errors The Error message may have two basic causes O The results of the five internal individual measurements vary by more than 0 15 mm very rare or Q 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 Error Remedy Fig 81 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 th
91. er 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 79 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 QO the image of the fixation point appears optimally focused in the green square on the display O 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 O the image of the anterior crystalline lens is visible in the pupil I Note The image of the fixation point may not lie in the image of the lens or cornea 000000 1322 734_GA_GB US_120608 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 devic
92. er 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 the 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 21 000000 1322 734_GA_GB US_120608 131 132 A E a Servicing and maintenance Care of the device Warning Before cleaning the device switch it off and pull the power supply plug Caution When cleaning the greatest care must be taken to prevent moisture from penetrating the device or keyboard as this may cause damage Q 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 ha
93. er 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 19 is connected into the printer power supply cable If a Protection Class printer with protective earth terminal is used make sure that it is connected to its own stationary wall socket of the room s electrical installation or that a power isolation transformer see page 19 is connected into the printer power line The required isolation transformer can be obtained from our sales 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 protective earth terminal whose wattage power consumption exceeds the permissible connected load of the power isolation transformer may not be used Q Additional portable multiple
94. erior 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 re Note The keratometer measurement must be performed before anterior chamber depth measurement Activate the ACD mode by e clicking on the ACD icon or e pressing the lt D 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 bright 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 43 Setting for anterior chamber depth ia 69 000000 1322 734_GA_GB US_120608
95. ess lt CTRL gt lt R gt or select Rename lt Ctrl gt R Rename in the Patient menu The patient data can be edited in the dialog box which now appears 9 1OLMaster H ICHECK DEVICEL01 01 1911 Once the renaming has been confirmed patient data for all Moe Karlo Primus 13 07 1996 measurements will be changed Measurement results cannot be 13 08 2007 renamed e Confirm the changes with RENAME Rename record Last Name fret o First Name cr Date of Bith VOI Exam Date fal ID number ooo0033 Rename Cancel Fig 60 Rename record dialog box 000000 1322 734_GA_GB US_120608 Operation Transmitting exporting data optional Patient data can be exported to connected hospital information systems EMR DICOM or personal computers aUSB storage medium or a CD RW The data is then available for further processing I Note Transmitting exporting does not work in the Patient Manager only in measurement modes Exporting data to another system O After measurement depending on the configuration the data can be exported by Program settings Network on page 36 to the connection hospital information system DICOM or EMR interface or transferred to a connected PC with appropriate additional software installed on it tre Note Measurement data of patients whose data was imported from the hospital information system DICOM EMR before the measurement are automatically assigned correctly within the
96. essing key A or e pressing 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 37 e The patient should look at the red fixation point in the centre A crosshair 3 Fig 37 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 37 appears within the circle AN 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 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 axial length of the single measuring signal will be shown in the respective display panel next to the video image A red graph will be superimposed on the video image similar to that familiar from ultrasonic devices 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 with an exclamation mark after the reading and the message Borderline value uncertain value will appear Readings in the series o
97. etection is deactivated To select a side click the cursor on the appropriate display or press the lt R gt or lt L gt key 000000 1322 734_GA_GB US_ 120608 Operation 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 e Confirm the delete action with YES Personal data and individual measurements for this patient will be irrevocably deleted in the Patient Manager The numerical measurement data will still be available in the database for optimisation of lens constants ks Note If you are working with the option Operator login with password you may only delete patient data if you have the appropriate rights see User Manager on page 40 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 css 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 000000 1322 734_GA_GB US_120608 Patient Options Erase Del Rename lt Ctrl gt R 5 8 1OLMaster ICHECK DEVICE 01 01 1911 a e Karlo Primus 13 07 1996 13 08 2007 94 Operation Renaming a patient To edit the last name first name date of birth or ID Number of a Patient Options patient follow this procedure Erase Del e Highlight the patient s name and pr
98. f measured values that deviate from the internally calculated composite value by more than 50 um are shown in red and marked multiple peaks If the SNR is below 1 6 no reliable axis length can be determined from the single measuring signal In this case dashes are shown 000000 1322 734_GA_GB US_120608 61 1 Vertical line 2 Reflection of alignment light 3 Cross hairs Fig 37 View prior to axial length measurement Operation is Note Borderline value does not necessarily mean that the reading is incorrect and must be rejected It rather means that all axial length measurements for the eye should be checked for plausibility and consistency and compared with the reading 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 Do not delete any single measurements e g only because they have a very low SNR or no axial length measurement could be determined SNR with or Such signals can also contain usable information on axial length for use in the calculation of the composite signal 000000 1322 734_GA_GB US_ 120608 Operation 38 gt 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 fol
99. figuration Tool step 7 e Enter the name of the IOLMaster in the CZM XML environmanet in the CZM XML Application Entity Title text box e Then click on CONTINUE 000000 1322 734_GA_GB US_ 120608 Operation 51 Network Broker Configuration Tool mE HotKey Set up step 8 Storage Dialog HotKey F12 Show Storage Dialog ONLY on pressing HotKey wo EJ Cancel Fig 31 Network Broker Configuration Tool step 8 e Define the HotKey button to activate the Storage dialog e Activate the SHOW STORAGE DIALOG ONLY ON PRESSING HOTKEY check box if the Storage window appears only after pressing the Hotkeys and not after every storage request 000000 1322 734_GA_GB US_120608 52 Operation s Network Broker Configuration Tool loj xj Language selection step 9 Network Broker language Jen X pi wo EJ Cancel Fig 32 Network Broker Configuration Tool step 9 e Select the language for the Network Broker application from the Network Broker language list e Then click on CONTINUE e In this last step click on OK to save the configuration settings made to the configuration file If the configuration has been correctly concluded the Network Broker Configuration Tool will automatically end at this point 000000 1322 734_GA_GB US_120608 Operation 53 Preparing for measurements Switching the device on e Turn the device on at the power switch 1 Fig 9 The dev
100. ge of digital medical images and the data linked to them Service enabling the automatic import of jobs including pertinent patient data from an information system Deutsches Institut f r Normung German Technical Standards Institute Electronic medical record Practice management system European standard Figure American Health Insurance Portability and Accountability Act Identification Intraocular lens Internet protocol Keratometer Liquid crystal display Light emitting diode millimetres Microsoft micrometre Multi mode laser diode Broker service for the communication with a DICOM server 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 1322 734_GA_GB US_120608 139 CARL ZEISS MEDITEC AG Goeschwitzer Str 51 52 07745 Jena Germany Phone 49 3641 220 333 Fax 49 3641 220 282 Email info meditec zeiss com Internet www meditec zeiss com 000000 1322 734_GA_GB US_120608 OLMaster Specifications subject to change Content User manual l OLMaster with Advanced Technology Software Version 5 4 000000 1322 734_GA_GB US_ 120608 Microsoft Software License Terms LT_XP_PRO_embedded_080807 Installation of a Network Printer on the OLMaster Network Printer on OLMaster_1
101. guage code of the device where the software was installed Examples of these features are clip art templates online training online assistance and Appshelp You may choose not to use these web content features e Windows Media Digital Rights Management Content owners use Windows Media Digital Rights Management technology WMDRM to protect their intellectual property including copyrights This software and third party software use WMDRM to play and copy WMDRM protected content If the software fails to protect the content content owners may ask Microsoft to revoke the software s ability to use WMDRM to play or copy protected content Revocation does not affect other content When you download licenses for protected content you agree that Microsoft may include a revocation list with the licenses Content owners may require you to upgrade WMDRM to access their content Microsoft software that includes WMDRM will ask for your consent prior to the upgrade If you decline an upgrade you will not be able to access content that requires the upgrade You may switch off WMDRM features that access the Internet When these features are off you can still play content for which you have a valid license Misuse of Internet based Services You may not use these services in any way that could harm them or impair anyone else s use of them You may not use the services to try to gain unauthorized access to any service data account or network by any means LT_
102. he device The limit values as specified for Class 1 laser devices to EN 60825 1 will be observed if the device is operated as intended Requirements for operation Please take care that the following operational requirements are met when using the lOLMaster QO Use the power cable supplied with the device If the device is mounted on an IT 3L instrument table it will receive its power supply through the table 0 The power supply plug must be inserted into a power outlet that has an intact protective conductor connection O 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 O 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 0 Do not cover obstruct ventilation slots in the computer casing right and left Q 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 OY A network isolator must be inserted for connection to an external network NET O If either of the error messages laser fixation power too strong or laser power too strong measurement interrupted appears the device must be shut down
103. he list Only in ALM KER and WTW mode with acknowledgment lt M gt Briefly inactivates automatic function Briefly interrupts adjustment aid automatic function in KER mode lt CTRL gt lt Z gt Restores the last measurement Effective only in KER ACD and WTW mode lt CTRL gt lt P 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 1322 734_GA_GB US_ 120608 Summary of result displays Operation Display Meaning Notes 22 73 mm 22 72 mm 3 axial length measurement 22 55 mm selected Displays measurement curve of this measurement 3 c6 mm 23 21 mm 23 27 mm Unreliable value SNR displays YELLOW SNR signal to noise ratio Borderline SNR uncertain value appears above graph Result should be examined by the user for validity 2U 66 mm ae mm Measuring error SNR display RED Error appears above axial length graph Result has been manipulated remains displayed even if manipulation has been undone SNR display and SNR signal to noise ratio beside signal curve Values for the peak below the measuring cursor Measuring cursor is positioned above signal peak 000000 1322 734_GA_GB US_120608 27 28 Operation Menu overview Patient
104. hen the user account Is established in the User Manager The Assistant has no right of access to the Lens database 000000 1322 734_GA_GB US_ 120608 Operation 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 rs 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 Regional settings Opens the Windows routine for regional settings Q 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 21 QO SW option Installing or de installing a software option QO 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 Remove update CD from the drive If the IOLMaster reappears in New patient mode after restarting
105. ic eyes double peaks with certain IOL Source W Hill Mesa Arizona 000000 1322 734_GA_GB US_120608 Evaluation of ALM results Zooming the graph display The system allows zooming the graphs in 4 steps to improve the presentation of signal curves e Move the cursor on the longitudinal axis x axis to the desired centre of the zoomed image and press the left mouse button When the mouse pointer approaches the X axis the cursor changes from an arrow pointing diagonally upwards into a magnifying glass Then press the left button This procedure may be repeated four times e To return to the original view zooming out place the cursor at any position on the longitudinal axis and press the right mouse button IB Note In zoomed views the axial length scale is not visible 000000 1322 734_GA_GB US_120608 101 102 Evaluation of ALM results left mouse button left mouse button left mouse button x right mouse button right mouse button left mouse button right mouse button n right mouse button Fig 62 Zooming the graph display The arrow symbols show the respective position of the left mouse button for creating the next zoom stage or the right mouse button for returning to the original status 000000 1322 734_GA_GB US_ 1206
106. ice will start automatically and perform a self test after which the Patient manager screen will appear Fig 33 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 128 Warning A 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 33 for working with existing patients see page 91 New patients can be entered manually in the patient manager or be imported from via the DICOM or EMR interface from the waiting room New Patient Search line LastName HA 5 4 10LMaster First Name details ICHECK DEVICE 01 01 1911 ee i i a z l Date of Birth i j 319 local Patient C 01 01 1911 a my mand amp PatientA 01 01 1911 ID Number 4 Patient B 01 01 1911 1 le nena een 3 9 Patient D local 01 01 1911 peli dee eiaeia fo e o Enter amp Patient E 01 01 1911 OS D 0 0 0o g refraction a Patient F 01 01 1911 and visual PatientG local 01 01 1911 i Visuel Acuity OD acuity data amp PatientH 01 01 1911 a Patient1 01 01 1911 optional Patient J 01 01 1911 PatientK local 01 01
107. icrosoft software see http www howtotell com TRANSFER TO A THIRD PARTY You may transfer the software only with the device the Certificate of Authenticity label and these license terms directly to a third party Before the transfer that party must agree that these license terms apply to the transfer and use of the software You may not retain any copies of the software including the backup copy NOT FAULT TOLERANT The software is not fault tolerant CZM installed the software on the device and is responsible for how it operates on the device RESTRICTED USE The Microsoft software was designed for systems that do not require fail safe performance You may not use the Microsoft software in any device or system in which a malfunction of the software would result in foreseeable risk of injury or death to any person This includes operation of nuclear facilities aircraft navigation or communication systems and air traffic control NO WARRANTIES FOR THE SOFTWARE The software is provided as is You bear all risks of using it Microsoft gives no express warranties guarantees or conditions Any warranties you receive regarding the device or the software do not originate from and are not binding on Microsoft or its affiliates When allowed by your local laws CZM and Microsoft exclude implied warranties of merchantability fitness for a particular purpose and non infringement LIABILITY LIMITATIONS You can recover from Microsoft and
108. iew 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 1322 734_GA_GB US_ 120608 Technical specifications 137 Photochemical 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
109. iguration steps Click CANCEL to cancel the configuration dialog 000000 1322 734_GA_GB US_120608 44 Operation Network Broker Configuration Tool 5 xi Selection of the configuration assistant step 1 What do you want to do Create a new configuration Edit an existing configuration Fig 24 Network Broker Configuration Tool step 1 You can create a new configuration using the Network Broker Configuration Tool or edit an existing configuration It is only possible to edit an existing configuration if such a configuration has already been created for the configuration tool to call up When adapting an existing configuration a backup of the old configuration is automatically made meaning that configuration can be cancelled at any time without loss of data e Once you have selected a task click on CONTINUE 000000 1322 734_GA_GB US_120608 Operation Network Broker Configuration Tool 5 xj Select device step 2 y Preset iOLmaster v VISUCAM Humphrey Field Analyzer Socket Communication FEP Communication T Help Q Back Continue Ww of Cancel Fig 25 Network Broker Configuration Tool step 2 e Select the lOLMaster from the list of devices e Activate the SOCKET COMMUNICATION option The FEP COMMUNICATION option is not permitted e Click On CONTINUE 000000 1322 734_GA_GB US_120608 45 Operation
110. irm 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 000000 1322 734_GA_GB US_ 120608 Operation The number of measurements of the respective eye taken on this particular day is displayed in the Mode field of the status bar next to ALM If the count reaches 20 no further measurements of this eye can be taken on this day The counter cannot be reset Deleted readings see above do not affect the measurement counter Fig 38 Video image after axial length measurement ALM 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 Wurzburg University Clinic Germany should be used Aphakic 65 Pseudophakic Silicone Pseudophakic Memory Pseudophakic PMMA Pseudophakic Acrylate Silicone Filled Eye Silicone Filled Eye Aphakic Silicone Filled EYE Pseudophakic Phakic IOL PMMA 0 2mm Primary
111. ivate the option button EMR Electronic Medical Record you can exchange data with the EMR system of your clinic or practice To do this the IP address the port of the EMR server the rot p Application Entity Title IOLMaster free choice of device name ae for the OLMaster but must be unique within the network and ra ices ns the Application Entity Title EMR this name must correspond EERE to the one given in the EMR system must be entered in the relevant text boxes Server IP 000000 1322 734_GA_GB US_120608 38 m 2nd level patient tree C Date Accession No Date Requested Procedure ID Date Operation Program settings View Depending on how your EMR or DICOM system is configured you can adjust the display of the patient measurements in the 2nd level of the patient tree patient manager list in database field Select Accession No Date if your system issues a process number Select Requested ProcedurelD Date if your system uses the examination method assigned IDs Otherwise select the Date option Q Program settings User management System login lOLMaster and the patient database can be protected by means of a password acc to HIPAA For this purpose activate the option Operator login with password A password must contain at least one character Program Export User management r System login J Operator login with password User manager Fig 19 Prog
112. k of the pigmented epithelium In the above example the signal from the pigment epithelium middle peak has the highest amplitude The automatic peak detection system has correctly recognised this measured value as the axial length so that the measuring cursor may not be moved This type of rare triple peak clearly differs from the secondary maxima produced through the light source by the distance from the RPE reflected peak 000000 1322 734_GA_GB US_ 120608 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 Fig 69 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 70 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
113. l up patient data from the waiting room via the EMR interface the EMR option must be activated in the menu Options gt Setup gt Program settings Network see page 36 f and correctly configured e Select Patient gt Query waiting room in the New Patient input window The patient data from the waiting room will now be imported into the local database of the device I amp Note The patient list will be combined with the patient data to be imported in the office management system No search criteria or queries are possible with the device software 000000 1322 734_GA_GB US_ 120608 Operation Manual patient input If you cannot import the data of a new patient from an existing information system via the DICOM or EMR interface you must enter this patient s data manually Patients entered manually in the database are labelled in the patient manager list with a symbol showing a blue man on an index card To register a new patient manually proceed as follows The personal data of patients not yet listed in the database New patient must be entered into the text boxes on the right hand side of the New patient dialog box via the keyboard No special nou nou nsn u characters other than _ _ are permitted To move the text cursor to the next dialog box press the TAB or ENTER key or click the mouse L Note Depending on the program setting see page 34 the entry of either the last and first name case sensitive
114. l1OLMaster with Advanced Technology Software Version 5 4 Documentation set 809091 a9 S39Q vet ZZE t 000000 Content User manual l OLMaster with Advanced Technology Software Version 5 4 000000 1322 734_GA_GB US_ 120608 Microsoft Software License Terms LT_XP_PRO_embedded_080807 Installation of a Network Printer on the OLMaster Network Printer on OLMaster_180707 Notes on and conditions of use for the remote maintenance tool 000000 1305 000_AddGA_GB_ 150807 Enclosure lOLMaster Quick Instructions Version 5 4 000000 1322 734_KurzGA_GB_ 110608 000000 1322 734_Inhalt1_GB_160608 lOLMaster with Advanced Technology Software Version 5 4 User manual Copyright Knowledge of this user manual is required for operation of the device You should therefore familiarise yourself with its contents 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 1322 734_GA_GB US_120608 Trademarks All names of companies and
115. later use e Click on the ERASE button to irrevocably delete the data record to Erase 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 54 e Further patient records can be added to the left hand list for subsequent additional optimisations 000000 1322 734_GA_GB US_ 120608 86 Operation gt 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 table click on the NEW button This 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 lect Nome e r Pre Op Values First Name DR AL mm Date of Birth SZ R1 mm ia E Exam Date sy R2 mm z ez ID Number rn Opt ACD mm ibaa Remark Surgical Eye OD right C OS left m Post Op Values Implant IOL D PostOp Ref D Surgery Date zz Post Op Date Pi Cancel Fig 56 Input new data record dialog box Warning
116. lowing 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 checking the individual axial length measurements and carrying out further measurements if necessary With stronger lens opacities it may be advisable to defocus the device You may choose a reflection 2 Fig 37 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 rs 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 me
117. ly 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 53 onwards In rare cases Windows error messages may appear on the LC display This might be the case for instance if the program running 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 O using the icons by cursor touchpad or Q keyboard or LJ menus Measurements are initiated by pressing the button on the joystick 000000 1322 734_GA_GB US_ 120608 Operation Operation by touchpad and keyboard 1 Touchpad Left button 3 Right button Fig 10 Touchpad control QO Move the cursor by touching the touchpad with your finger and moving it as desired O Single and double clicks are possible by tapping a finger on the touchpad or pressing the left button Q To drag the cursor hold the left mouse button depressed while moving the finger across the touchpad Q The right button is only functional for resetting the zoom function page
118. ministrator 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 1322 734_GA_GB US_ 120608 Operation Data store 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 L Note If you wish to export data 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 Only the Nero InCD is suitable for formatting in UDF format Alternatively use one of the formatted CD RWs as supplied Warning A compressed and password protected file is created in the CD RW Do not attempt to read or manipulate this file using other programs The respective 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 L Note In this way all critical patient and IOL data can be saved together with the data require
119. n Entity Title field e The address and port via of the provider must be entered in the Host IP and Port fields respectively L Note To register a name contact the DICOM network administrator e A maximum timeout period for the provider can be entered in the Timeout field e The CONNECTION TEST button allows you to check the connection to the specified host e Use the SC Scaling Factor to specify whether the image output should be scaled down not for PDF Activation of this option is not recommended for the lOLMaster e Then click on CONTINUE 000000 1322 734_GA_GB US_ 120608 Operation Network Broker Configuration Tool k ioj xj CZM XML Application Entity Title of Network Broker step 6 CZM XML Application Entity Title NB Port 1 30999 1042 Q Back Continue Ww OF EJ Cancel Fig 29 Network Broker Configuration Tool step 6 e Enter the name of the Network Broker in the CZM XML environment in the CZM XML Application Entity Title text box e Under Port enter the port number through which the Network Broker can be addressed for socket communication The standard value 1042 can generally be used e Then click on CONTINUE 000000 1322 734_GA_GB US_120608 49 50 Operation Network Broker Configuration Tool MEE Device configuration step 7 C2M XML Application Entity Title fest Q Back Continue Y ok EJ Cancel Fig 30 Network Broker Con
120. n rer eerie oe nee ee nein oer T a 76 IOL calculation after corneal refractive surgery optional 79 Calculation of phakic implants optional 0 0 83 AI Call QUO aoe saelete su ap aid arn aie neared eerie 84 Optimisation of lens CONStANHS 0 ccceeeeeeeeeeeeeeeeeeeteeeetteeees 84 Selecting lens data scs ccscisecteee ss aes sce asdaeeeeeteawesent 84 Loading existing data recordS icin stcoielccensieeednailend 85 Entering new data records ccceeeeseeeeeeeeeeeeeeeeeeees 86 Starting Optimisation ge vices cdntanl gcaare elon ereenn 89 New Da CION Casares es cine cerd toe cecal Real EEE T ECEE 91 Working with the Patient managet cccceerteeee 91 Retrieving a reading from previous measurements 92 Deleting a patient measurement ceeeeeeeeeeeeeeeees 93 Renaming a patient es ecnetunateainanid date 94 Transmitting exporting data optional c ceeeeeeeeeteeees 95 Exporting data to another system cccseeeeeeeeeeeeees 95 Exporting data to a storage MedIUM cceeeeeeeees 96 Switching off the device 0 eee cece eeeeee tenet eeseeeeteteeeeneeeeees 97 000000 1322 734_GA_GB US_ 120608 Contents Evaluation of ALM reSullts cccccccccssseeeeneeeeeeeeeeeeeneeeeeseeeeeeseenees 98 Signal curves of axial length measurements 00 eeeeeees 98 Valid signal CUrVeS fat bee a sieu iad oi Me alta cad nied ats 98 Recognition of misa
121. ng ANd maintenance cccceeeeeeeeeeenneeeeeeeneeeeeeeeneeeeeeeeeeeeees 127 Remote maintenance Optional c cccccscccesssseesessseeeeenteees 127 Operating the online remote maintenance module 127 Checking the measurement fUNCTIONS ceeeeeeteeeeeteeeeeees 128 Axial length measurement and keratometer 5 129 Anterior chamber depth measurements 0 c c0ee 129 Verifying WTW measurements optional 0 cceee 130 Printer troubleshooting wai kiaitclontetele WMS ile cheered Mede 131 Care Otte device ee eee ae ee cone ee See eee 132 Safety INSPECHOMNG 2x wie siete shan ate cese trait eioul Aas EE 132 Technical Specifications u0 ccvenicecencicessseessevesiceveveiwevensitecacteeesnuere 133 Manufacturer s Declaration c cccssceseeeeeeseeeeeneeeeseeeeeeeeeeeeees 138 Abbreviations GlOSSary cccccceeseeeeeeeeeeeeeeeeeeeeeeeneeeeseeeeeeeeeeenes 139 Important for your safety Safety instructions Servicing and maintenance 000000 1322 734_GA_GB US_120608 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 against possible health risks or fatal injury 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 devi
122. nsmission of certain standard computer information for Internet based services By using the software you accept these terms If you do not accept them do not use the software Instead contact CZM to determine its return policy for a refund or credit If you comply with these license terms you have the rights below 1 USE RIGHTS You may use the software on the device with which you acquired the software Processor Limit You may use the software with no more than two 2 processors at any one time 2 ADDITIONAL LICENSING REQUIREMENTS AND OR USE RIGHTS a Specific Use CZM designed this device for a specific use You may only use the software for that use b Other Software You may use other programs with the software as long as the other programs e directly support the manufacturer s specific use for the device or e provide system utilities resource management or anti virus or similar protection Software that provides consumer or business tasks or processes may not run on the device This includes email word processing spreadsheet database scheduling and personal finance software The device may use terminal services protocols to access such software running on a server c Device Connections You may not use the software as server software In other words more than one device may not access display run share or use the software at the same time You may allow up to ten other devices to access the software to use
123. o 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 optimised for the specific application The data calculated for the IOL to be implanted can be printed out e For this purpose click on the PRINT button The IOL data of both eyes or of one eye and emmetropic IOL will be printed out either on a single page or on separate pages depending on the option selected in the Program settings menu page 34 e Click on OK to finish IOL calculation 000000 1322 734_GA_GB US_ 120608 Operation IOL calculation after corneal refractive surgery optional Corneal refraction is an important quantitative 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 O Refractive history method Contact lens method Q 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 e clicking on OL or pressing the lt gt button e selecting Prior Refractive Surgery tab Warning
124. orrect operation of the lOLMaster is essential to ensure its safe functioning Please familiarise yourself thoroughly with the contents of the complete user manual before using the device Network Printer on IOLMaster_180707 CARL ZEISS MEDITEC AG Goeschwitzer Str 51 52 07745 Jena GERMANY Phone 49 3641 220 333 Fax 49 3641 220 282 Email info meditec zeiss com Internet www meditec zeiss com Network Printer on OLMaster_180707 Specifications subject to change Content User manual l OLMaster with Advanced Technology Software Version 5 4 000000 1322 734_GA_GB US_ 120608 Microsoft Software License Terms LT_XP_PRO_embedded_080807 Installation of a Network Printer on the OLMaster Network Printer on OLMaster_180707 Notes on and conditions of use for the remote maintenance tool 000000 1305 000_AddGA_GB_ 150807 Enclosure lOLMaster Quick Instructions Version 5 4 000000 1322 734_KurzGA_GB_ 110608 000000 1322 734_Inhalt4_GB_160608 Notes on and conditions of use for the remote maintenance tool 1 Use of the remote maintenance tool requires that the Carl Zeiss Meditec AG service team or a company authorised by them be contacted beforehand 2 The remote maintenance function can be activated by the user only This requires the entry of an activation code The user can then switch between observation mode and remote control mode The user can abort the selected remote maintenance mo
125. other Microsoft intellectual property in software or devices that access this device e INTERNET BASED SERVICES Microsoft provides Internet based services with the software Microsoft may change or cancel them at any time a C Consent for Internet Based Services The software features described below connect to Microsoft or service provider computer systems over the Internet In some cases you will not receive a separate notice when they connect You may switch off these features or not use them For more information about these features visit http www microsoft com windowsxp downloads updates so2 docs privacy mspXx By using these features you consent to the transmission of this information Microsoft does not use the information to identify or contact you Computer Information The following feature uses Internet protocols which send to the appropriate systems computer information such as your Internet protocol address the type of operating system browser and name and version of the software you are using and the language code of the device where you installed the software Microsoft uses this information to make the Internet based services available to you e Web Content Features Features in the software can retrieve related content from Microsoft and provide it to you To provide the content these features send to Microsoft the type of operating system name and version of the software you are using type of browser and lan
126. pective data for the manufacturer from catalogues or package inserts 000000 1322 734_GA_GB US_ 120608 Fig 45 Please enter password dialog box 76 Operation Warning If the ACD constant is not available you may click the ADD button after entering the A constant All parameters will automatically be calculated from the A constant according to standard formulae However the manufacturer s A constants are not optimal for optic biometry and may result in refractive deviations e Your IOL constants which have been optimised for various calculation formulae for optical biometry or your personally determined constants must be entered changed in the A Const SRK II A Const SRK T a0 a1 a2 pACD and SF boxes L Note Only constants optimised for optical biometry should be used for calculating the suggested strength of the intraocular lens to be implanted with the IOL Master not the manufacturer s IOL constants see also pages 84 and 107 e f you use lenses graded in 0 25 D intervals in future activate the Power steps 1 4 D radio button e To add data to the database click the ADD button e To delete the data of the lens type selected in the 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 Lens database by clicking on OK IOL calculation Start the calculation by
127. previously treated by myopic LASIK myopic PRK or myopic LASEK press the MYOP button prior to calculation Warning The formula may only be used for eyes with myopic LASIK myopic PRK and myopic LASEK Lenses by hyperopic LASIK LASEK PRK or myopic hyperopic RK should never be calculated The corneal radii and axial lengths measured by the lOLMaster are required for the formula The measured values cannot be edited here 000000 1322 734_GA_GB US_120608 81 Operation IOL Calculation 9 xj Haigis SRK II Hoffer Holaday SRK T Multi Formula Haigis L phakic IOL Prior Refractive Surgery Muster 1 01 01 1911 Myop Hyperop Axial Length mm Eye Surgeon Dr Mustermann x Comealk s mm f Target Refraction D 0 5 Optical ACD mm Surgical Eye OD Cos IOL Calculation Print IOL Calculation Data Lens 1 x JLens 2 z JLens 3 x JLens 4 x 1OL D REF D 1OL D REF D lOL D REF D 1OL D REF D Be GE EE Ee e eee SS a hy ee es Se a T a a aT ef Valid for myopic LASIK LASEK PRK only Do not use after RK or hyperopic treatments OK Abbrechen Fig 50 IOL calculation window Haigis L If you wish to perform the calculations for eyes that were previously treated by hyperopic LASIK hyperopic PRK or hyperopic LASEK press the HYPEROP button prior to calculation Warning The formula may only be used for eyes with hyperopic LASIK hyperopic PRK and hyperopic LASEK Lense
128. 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 O Windows XP is a registered trademark of Microsoft Corporation Inc O SRK is a trademark of CTI Computational Technology Inc Q Nero is a registered trademark Nero InCD is a trademark of Nero AG 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 purposes only and does not constitute a trademark misuse 000000 1322 734_GA_GB US_ 120608 Contents Page CODY ONIN rs soc sass esac cece Gi eeetaceies aes aii a eat ee ena eteeets 1 TAGE IMAIKS E E E 2 Contents a e aE a paa r e a aa aa aa a ontiadentetedeeceteadvierdidetex 3 Notes on the user manual ccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneeeeeeeees 6 SNAN 6 0 EEE AEE E E E Senet 6 Purpose of this doctimentatiOnan aca wale iad 6 Accessibility of the user Manual ccccceeeeeeeeteeeeeeeeteeeeneees 6 Safety IIS EEUCTIONNS oii stecerinievicneiicceictetiunet Santd dan ideann kopai inani deini denaii 7 Compliance with standards and regulations c ceeeeeee 7 Instructions for installation and USC eeeeeeeeteeeeteeeeeee
129. r or 2 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 L Note The resolution of fine retinal structures is clearly distinguishable from the previously mentioned secondary maxima which are further away from the multiple peaks and symmetrical to them The distance between the maximum peak and internal limiting membrane or choroid is 350 um whereas the secondary maxima are about 800 um from the maximum peak 000000 1322 734_GA_GB US_ 120608 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 66 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
130. ram settings User management dialog box IL Note The option OPERATOR LOGIN WITH PASSWORD and screen saver together with password protection should not be activated until 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 000000 1322 734_GA_GB US_ 120608 Operation As soon as you have confirmed the new program settings with OK a login dialog will appear From now on the OLMaster can only be used by logging in with password The default setting is user Admin with the password 0000 4x zero in the User manager To change the password select the option Change password enter your user name and old password and confirm with OK User name Password F Change password Shutdown Fig 20 Login dialog box In addition a screen saver with a freely adjustable interval can be activated The screen saver appears if the OLMaster 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
131. rdance 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 1322 734_GA_GB US_ 120608 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 000000 1322 734_GA_GB US_120608 11 Safety instructions 12 Warning and information labels on the device The device casing carries the following warning and information labels Fig 1 Warning and information labels on the device 000000 1322 734_GA_GB US_ 120608 Safety instructions
132. ring to the keyboard support 2 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 2 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 1322 734_GA_GB US_120608 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 Printer
133. rs the registered place of business of the Carl Zeiss Group company making use of these conditions of use We are however also entitled to pursue claims against you at your official place of business 12 The law of the Federal Republic of Germany applies with the exclusion of UN sales law and the referral provisions of German private international law 13 In addition the currently applicable version of the general terms and conditions for service agreements apply to all remote maintenance procedures Users can view the current version of the general terms and conditions for service agreements on the internet at http Awww meditec zeiss de AGB 14 Should any individual provisions of these conditions be in part or in full invalid the validity of the remaining provisions or the remaining parts of such provisions shall not be affected Carl Zeiss Meditec AG Notes on and conditions of use for the remote maintenance tool Page 2 2 000000 1305 000_AddGA_GB_ 150807
134. rve D ie Refr with CL D sph f etf Refr without CL D sh et Corneal K s D Radius mm Apply T m Contact Lens Method CL power D 025 Vertex mm J 12 CL base curve D 41 50 Refr with CL D sph 1 75 cyl 0 50 Refr without CL D sph 3 25 cyl 1 25 Corneal K s D 46 98 Radius mm 7 18 Apply M Cancel Fig 49 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 000000 1322 734_GA_GB US_ 120608 Operation 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 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 The Haigis L formula offers two alternatives for IOL calculation The correct choice of alternative is important otherwise the calculation will be incorrect If you wish to perform the calculations for eyes that were
135. s been added Never use aggressive or abrasive cleaning agents Use conventional cleaning cloths for wiping off the display and keyboard of computers and monitors QI Contaminated parts with which the patient has come into contact during the examination chin rest forehead rest should be cleaned with a disinfectant approved for the purpose These parts are resistant to wiping off with low toxic agents e g suds quaternary ammonium compounds and intermediate agents e g alcohol Javel water iodine classification pursuant to Disinfectants and activity spectrum according to the Center for Disease Control and Prevention Atlanta USA QO Remove dust from optical surfaces by means of a fine brush Q 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 O To protect from dust cover the system using the dust cover provided when not in use Q 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 mu
136. s by myopic 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 000000 1322 734_GA_GB US_ 120608 Operation 83 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 Only spherical lenses can be calculated In addition to the anterior ae Ophtec Arti chamber depth and corneal radii corneal refraction measured with the AMO Vetisyse lOLMaster the refraction for the appropriate corneal vertex CVD and Staar ICL lens model must be entered IOLTECH PRL The manufacturer s IOL constants are used for calculating lens power Fin ai 2 ened Warning Please observe the manufacturer s recommendations for the phakic IOL employed with regard to choice of lens type and critical distance to the endothelium IOL Calculation Haigis SAK II Hoffer Holladay SRK T Multi Formula HaigisL phakic IOL Prior Refractive Surgery m EIfE 01 01 1911 Axial Length mm 2410 2412 Eye SugsonfDr Mustermann El Corneal K s rom 7 88 47 75 7 93 47 86 Target Refraction Optical ACD mm 3 26 f3 50 OD D 0 50 Refr sph cyl p f 4 50 4A75 6 75 4 50 Vertex mm fi 2 fi 2 phak psph phak psph Surgical Eye JV OD Vv os IOL Calcul
137. s structures Avoid direct exposure of the eye and device front panel to extraneous light In particular ensure that the visible right and left edge of the iris is not disturbed by reflections from lamps and windows If the iris structure is not discernible focus on the edge of either iris or pupil Serious defocusing will result in incorrect data After the image has been taken the operator should check if the software has correctly detected the edge of the iris If the circle segments drawn in the image do not define the iris correctly the result must be discarded Click on OK to confirm the results 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 1322 734_GA_GB US_ 120608 Servicing and maintenance 127 Remote maintenance optional Operating the online remote maintenance module The lOLMaster is equipped with a remote maintenance module so that if a problem arises the user can establish con
138. sockets or extension cords may not to be used Q 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 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 O With the exception of compatible printer drivers the installation of other software on the system is not permitted A software routine prevents external 3 party software from being installed on the system QO The IOLMaster may only be connected to private networks which are protected from public networks Internet by firewalls conforming to the latest technical standards 000000 1322 734_GA_GB US_ 120608 Safety instructions Safe operation Electrical safety Q The built in power supply unit is short circuit proof and does not contain any fuses which are accessible from the outside Q Provided the device is properly used no electrical hazards exist to either patients or operators Q The device may be opened only by persons authorised by the manufacturer Light emission from t
139. st be carried out by an authorised specialist Please observe national safety regulations 000000 1322 734_GA_GB US_120608 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 Protection 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 condensation 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
140. t mode O lt D gt Activates anterior chamber depth measurement mode lt w gt Activates WTW WTW white to white determination optional o lt I gt Activates IOL Calculation already possible calculation after measurement of one eye lt P gt Prints results obtained hitherto lt S gt Sends data Requirement A suitable ee computer must be connected to the serial interface or the IOLMaster must be connected to a network fo lt X gt Transfers data to CD Requirement CD RW has a 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 1322 734_GA_GB US_ 120608 25 Warning If connecting external devices e g an external PC monitor or an external network the operator must ensure the safety requirements are met as per DIN EN 60601 1 1 medical electrical systems Operation Key functions without icons Key Function Notes Space bar Cyclic change of modes ALM KER ACD WTW ALM gt KER gt ACD gt WTW Joystick button Program continuation Activates measurement In overview mode change to ALM mode In ALM KER ACD and WTW mode lt DEL gt Deletes the selected ALM or KER measurement from t
141. t be properly used Only adjusted IOL constants may be used 0 the device is only used in a perfect operating condition without functional impairment Q the user manual and all accompanying documents are maintained in good condition and kept on or in the immediate vicinity of the device Q only sufficiently trained and authorised personnel is permitted to operate maintain and repair the device Q all operating personnel receives regular instruction on all issues concerning the device and its components that such persons are familiar with the user manual and in particular the safety precautions Q none of the warning signs on the system are removed or rendered illegible Q the device is inspected daily according to Checking the measurement functions on page 128 before any patient measurements are taken each day no more than 20 axial length measurements are taken on each patient s eye QO a safety inspection is performed on the device each year see page 132 in order to guarantee its perfect operating condition 000000 1322 734_GA_GB US_ 120608 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
142. tact to the Carl Zeiss service team via the internet for fault diagnosis and resolution The online remote maintenance module offers two problem resolution options Q The OLMaster user interface is made visible to a service technician The operator carries out actions himself under instruction from the service technician Fig 88 Conditions of use dialog box O The user interface is visible to a service technician who is able to operate or configure the OLMaster directly using the remote control function Carl Zeiss Meditec Teleservice To start remote maintenance proceed as follows cg E e Select Carl Zeiss Meditec Teleservice from the Tools menu A EE dialog box asking you to confirm the conditions of use will be j Please enter the session number your displayed see Fig 88 consultant gives you on the phone Session number hm lt gt Note Cancel The OLMaster document set includes complete conditions of use for the remote maintenance function as a separate document Fig 89 Login screen for online e If you do not accept the conditions of use terminate the remote maintenance procedure e f you accept the conditions of use select YES I AGREE and click on OK The online remote maintenance login window will be displayed see Fig 89 e Call the service team who will provide you with a 6 figure access 5 show WATCH code remote control e Enter the access code in the Session num
143. tallation CD and click Have Disk y Now you can type a name for the network printer and continue with NEXT Select Do not share this printer option and confirm with NEXT If you want print a test page and confirm with NEXT The installation is now completed and you will see a dialog containing all the information on the network printer Finalize the installation with FINISH The flow chart on the left should help you with the installation of a network printer on the IOLMaster Make sure that the OLMaster is connected to the network with a network cable using a network isolator Q00000 0448 931 Caution The IOLMaster may only be connected to private networks which are protected from public networks internet by firewalls conforming to the latest technical stan dards A network isolator must be used for connection to an external network NET This can be ordered from Carl Zeiss The platform of the IOLMaster is the English version of Windows XP Usually the default paper size will be legal or any other American paper size Be sure the setting is for the paper size used in the printer Otherwise the printer will show an error message instead of printing If during the installation an error message A port with that name already exists Choose another name occurs an earlier installation was interrupted and the port name is already in use Choose a different port name instead Warning C
144. test eyes are ideally suited to practising the operation of the lOLMaster The status of the Test eye is also reset each time a new patient lt N gt or icon is admitted Warning If the test eye readings are not within the given tolerances the device must be shut down Notify Carl Zeiss Service 000000 1322 734_GA_GB US_120608 AN 129 130 Servicing and maintenance Verifying WTW measurements optional The WTW scale optional 2 Fig 92 is for verifying the WTW reading WTW calibration 7 1 Please mount the AWT calibration scale on OLMaster see manual 2 Center WT calibration scale Scale must fill whole video window 3 Focus on the black lines in the scale 4 Push joystick button performs calibration Fig 92 WTW scale Cancel Fig 93 WTW calibration e Take a measurement If the reading is within the tolerances WTW determination has been properly calibrated is Note The WTW scale must completely fill the video window The scale black lines must appear in focus 000000 1322 734_GA_GB US_ 120608 Servicing and maintenance Printer troubleshooting Please use only printers recommended by Carl Zeiss Meditec The printers currently recommended can be found at http Awww meditec zeiss com iolmaster The printer models listed there have been tested in conjunction with the lOLMaster and provided the instructions for setting up see page 21 are observed the OLMast
145. the graph with the blue highlighted reading can be enlarged by pressing lt CTRL gt lt P gt For enlarging the display of the graph see page 101 In WTW mode the current reading can be printed out using lt CTRL gt lt P gt 000000 1322 734_GA_GB US_ 120608 Operation Generation of IOL options Once all measurements have been taken depending on the IOL calculation formula options can be generated for intraocular lenses to be implanted Filling the IOL database Before the system can calculate IOL options the available lens types must be entered into the database e In Options Lens 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 29 liens Database UUU x Administrator Dr Test Lenses Name flens 1 Lens 2 A Const fis Manufacturer ACD 4 96 Manufacturer A Const fire SRK II A Const IE SRK T al 1 273 al fo 4 Haigis a2 fot pACD 4 96 HofferQ SF 1 22 Holladay Power Steps 1 2D 1 4D Add Erase Set Optimize SRK is a trademark of CTI Computational Technology Inc ai OK 75 x w Password Cancel I Change password New password S Confirmation SS Fig 46 Database window for the input of lens data e In the lines Name A Const Manufacturer and ACD Manu facturer enter the res
146. 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 te Note In some cases keratoconus keratoglobus corneal lesions etc it may not be possible to reach the green traffic light for optimum measurement setting 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 Automatic will always be switched back on for a new patient 000000 1322 734_GA_GB US_ 120608 67 Fig 41 Measurement point not identified 68 Fig 42 Three keratometer readings A 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 more than 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 mm 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
147. tie 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 re Note The file is not designed for archiving patient and measurement data The database field is structured similar to Windows Explorer see Fig 33 left side A sign at the branch indicates that the database already contains measurement results for this patient 000000 1322 734_GA_GB US_ 120608 91 92 9 1OLMaster D 0 4 Ee amp ICHECK DEVICE 01 01 1911 amp 13 08 2007 amp Klever Dorette 26 03 1965 Maus Gustav 21 07 1962 amp Meyer Karl 01 01 1940 amp Muster F 01 01 1911 gt 01 07 2007 13 08 2007 New Patient Patient Options ae Y OLMaster H ICHECK DEYICE 01 01 1911 a local Patient C 01 01 1911 3 10 10 2005 Patient F 01 01 1911 ai Patient G local 01 01 1911 H 8 PatientH 01 01 1911 Patient 01 01 1911 Open Operation The person on index card symbol in front of the patient signifies that this patient has only been registered locally on this PC The person on network symbol means that this patient has been imported from a
148. tient dialog box in the measurement mode e Press the EXIT icon in Patient Manager to quit the program and Windows Adjusting the device to the patient The two red ring marks 3 Fig 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 36 appear focused If possible the 6 light spots should be centred on the cross hairs and the edge of the pupil iris structure should appear in focus The position of the device in relation to the patient s eye thus found serves as a Starting point for fine adjustments to be made in the respective measurement mode 000000 1322 734_GA_GB US_120608 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 lOLMaster 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 98 In some cases the axial length can even be determined
149. tient is displayed r 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 ee ee Insert installation CD for printer driver and wait for language selection to appear in selection window y Select appropriate language and confirm with NEXT v If a dialog box for the installation of additional printer software is displayed close this box without installing another printer y The windows installation routine will confirm that installation of the selected printer is finished Exit with FINISH Fig 8 Installing the printer 22 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 Warning 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 IL Note The system does not support all key combinations of Windows The special Windows keys that exist on some keyboards are ineffective The software uses on
150. up Adjusts various settings Date time Sets system clock Program settings Adjusts prograrm export network view settings User management User manager Regional settings Windows routine Printer Opens system folder SW option Installs de installs Carl Zeiss Meditec Teleservice Opens remote maintenance dialog box Service Only for service password protected About lOLMaster Displays and prints information on program version 000000 1322 734_GA_GB US_ 120608 Operation 29 Options menu Test eye The calibration of the device can be checked with this function see Section Checking the measurement functions on page 128 Lens database Since the device may be used for the preparation of eye surgery by a Test Eye number of surgeons surgeon specific records may be created This is Lens Database performed using the Lens database in the Options menu Setup gt e Click On LENS DATABASE in the Options pull down menu The dialog Service box for entering surgeon specific data will appear Fig 12 Options menu Please enter password E x Password Cancel I Change password New password Confirmation Fig 13 Please enter password dialog box 38 gt Note When the device is delivered the Lens database only contains the administrator without any password specifications Only the administrator is entitled to add or delete users and edit their databases L Note Individual
151. users may edit their databases only if password protection has been set If no password protection was set the databases are accessible to all users If Change password is checked the administrator may assign himself a password in this dialog box e Type in the password in the New password and Confirmation text boxes e Confirm your entry with OK 000000 1322 734_GA_GB US_120608 30 bw Administrator t Operation To create a new lens 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 xi Administrator Name Eo oo Password OoOO O Confirmation DOO O Sa m Data store Backup Restore Import Fig 14 Lens 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 75 f L Note Should a user forget his or her password the ad
152. vity 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 mea surements Fig 71 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 or not visible at all This is irrelevant for the calculation of the corneal curvature as the position of the fixation point will not be evaluated 000000 1322 734_GA_GB US_ 120608 Tips for keratometer measurement 113 Measuring errors The Error message may have two basic causes O The results of the internal individual measurements vary by more than 0 05 mm very rare defocused device LJ 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 Fig 72 Image of a defocused device The images of the measuring marks are too large because the device is Error defocused The system cannot calculate a measured value and Error
153. 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 61 Take at least five individual measurements The axial length measurement signal 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 SNR SNR SNR f N bai A Measuring Uncertain Value with error value good SNR 59 000000 1322 734_GA_GB US_120608 60 Operation
154. xial length measurement mode after the current individual measurement and in post run editing mode 000000 1322 734_GA_GB US_ 120608 107 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 css Note Ultrasonic biometrical instruments measure the axial length as the distance between the cornea and the inner limiting membrane because the sound waves are reflected at this membrane To ensure that the measured values obtained with the OLMaster are compatible with those obtained through acoustic axial length measurement the system automatically adjusts for the distance difference between the inner limiting membrane and the pigmented epithelium The displayed axial length values are thus directly comparable to those obtained by immersion ultrasound and no re calculation or correction factors are necessary 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

IOLMaster Manual V.5.4

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