USER MANUAL. Version 2.2. English Português Deutsch Nederlands Türkçe Français اللغة العربية. 日本語 한국어 Español Italiano 0318

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1 USER MANUAL Version 2.2 English Português Deutsch Nederlands Türkçe Français اللغة العربية 日本語 한국어 Español Italiano 0318

2 MODEL: TRADE MARK: OQAS HDA Optical Quality Analysis System High Definition Analyzer HD Analyzer APLICABLE PARTS: Chin rest (Type B) CODE: 2 REVISION: /06 PRINTED IN SPAIN

3 Table of Contents Warnings... 5 Precautions INTRODUCTION GENERAL DESCRIPTION Double-pass technique What is OSI? What is MTF? FEATURES APPLICATIONS HD ANALYZER SPECIFICATIONS Hardware Specifications Software Specifications Accessories Computer (PC or laptop) Manufacturing compliance PRODUCT LIFESPAN USER MANUAL S ACCURACY HD Analyzer installation and maintenance HD ANALYZER INSTALLATION MAINTENANCE HD Analyzer Functions USING THE SOFTWARE WITHOUT THE HARDWARE PAY-PER-PATIENT MODE GETTING STARTED HOME MENU DATABASE New Modify Delete: patient/acquisition Results Compare MEASUREMENTS How to carry out an acquisition Objective Refraction Types of measurement Scatter Meter and Optical Quality Pseudo Accommodation Tear Film Analysis... 40

4 3.6.4 Monitoring results Scatter Meter and Optical Quality Pseudo Accommodation Tear Film Analysis Result comparison screens Purkinje Measurement Typing in subjective refraction Selecting the Purkinje option Positioning the device Select desired option Focus using indicator arrows Automatic capture of images Validating an image Acquiring and validating four more images Validating final results Printing and exporting a results report LICENSE MANAGER SETUP Tear Film Options User visible parameters Setup buttons Hardware setup BACKUP Examples of measurements NORMAL EYE CATARACT EYE POST-LASIK EYE Error solving ERROR MESSAGES WARNING MESSAGES Manufacturer Regulatory information Appendix A PATIENTS_TABLE ACQUISITIONS_TABLE STRUCT SYMBOLS Electromagnetic immunity

5 WARNINGS READ THE USER MANUAL BEFORE PERFORMING ANY OPERATION WITH THIS EQUIPMENT. ONLY STAFF FAMILIARIZED WITH OPHTHALMOLOGY DIAGNOSTIC AND CONTROL EQUIPMENT MUST OPERATE THIS INSTRUMENT (OPHTHALMOLOGIST, OPTOMETRIST, ETC ). THIS EQUIPMENT MUST BE OPERATED WITH THE POWER SUPPLY UNIT PROVIDED. THE EQUIPMENT MUST NOT BE POSITIONED IN SUCH WAY THAT HINDERS ACCESS TO THE POWER CONNECTION JACK. SWITCH OFF AND UNPLUG THE INSTRUMENT WHILE NOT USING IT. TO PREVENT FIRE OR ELECTRIC SHOCK HAZARD, DO NOT EXPOSE THE HD ANALYZER UNIT TO RAIN OR MOISTURE. THIS INSTRUMENT IS NOT WATER OR SPLASH PROOF. IF ANY HUMIDITY, WATER OR LIQUID ENTERS THE INSTRUMENT, UNPLUG IT IMMEDIATELY AND CONTACT TECHNICAL SUPPORT BEFORE USING IT AGAIN. KEEP THIS INSTRUMENT DRY. FOR INDOOR USE ONLY. NOT INTENDED FOR OUTDOOR USE. DO NOT ATTEMPT TO REMOVE UNIT COVER AND/OR MODIFY THE UNIT, OR WARRANTY WILL BE VOID. THIS INSTRUMENT REQUIRES ANNUAL CALIBRATION TO GUARANTEE PROPER PERFORMANCE. NOT SUITABLE FOR USE IN FLAMMABLE ENVIRONMENTS

6 THERE ARE NO PARTS INSIDE THE UNIT THAT MAY BE REPAIRED BY THE USER. PLEASE CONTACT TECHNICAL SUPPORT. SHOULD SOME OUTER PIECE SUFFER DAMAGE, PLEASE CONTACT TECHNICAL SUPPORT BEFORE USING THE DEVICE AGAIN. DO NOT TOUCH THE LENS ON THE OUTPUT WINDOW OF THE DEVICE

7 PRECAUTIONS Do not attempt to disassemble, modify or repair the HD Analyzer instrument. There is a class 3R laser device inside the HD Analyzer instrument. Avoid direct exposure to the human eye. Contact VISIOMETRICS for help. Do not expose the instrument to bright light, such as sunlight, for long periods of time. Do not operate the HD Analyzer instrument beyond the recommended temperature range. This instrument must be plugged in to the electrical power network. Take standard domestic precautions. If the instrument stops working normally, several error messages may be shown on the computer screen. In this case, do not try to repair the instrument. Contact technical support. If the instrument stops working normally (showing error messages on the computer screen) due to exposure (in reasonable foreseeable environmental conditions) to magnetic fields, external electrical influences, electrostatic discharges, pressure or pressure variations, acceleration, thermal sources of ignition, etc., do not try to repair the instrument. Contact technical support. Contact VISIOMETRICS if you require any help

8 Chapter 1: Introduction 1 INTRODUCTION 1.1 GENERAL DESCRIPTION Due to the importance of and necessity for objectively measuring visual quality, VISIOMETRICS has developed HD Analyzer, a new instrument based on the double-pass technique that provides an objective clinical evaluation of the eye s optical quality. A single light source is sent from the HD Analyzer and is imaged on the retina. Light then passes back through ocular media. HD Analyzer then analyses the size and the shape of the reflected light spot. HD Analyzer images contain all of the information about the optical quality of the eye including all of the higher order aberrations and scattered light, both of which are generally missed by most aberrometric techniques. These higher order aberrations may have an important impact on refractive surgery. HD Analyzer allows performing measurements in a wide range of clinical situations. The most promising application areas for HD Analyzer is cataract detection and classification, as well as refractive surgery. Furthermore, its functionalities for the evaluation of pseudo accommodation and the tear film degradation with time, have become very useful tools for the study of presbyopia and dry eye syndrome. HD Analyzer provides a control and acquisition software. Additional advantages are that it is easy to work with, provides an intuitive user interface and has real-time control Double-pass technique Figure 1 shows an image of a double-pass system, similar to the HD Analyzer one. The light source is a 780-nm laser diode. The light beam is filtered and collimated at L1. After reflecting through a beam splitter (BS), the beam passes through two achromatic doublet lenses L2 and L3, and through the mobile Focus Corrector (FC), with two mirrors attached to it. Spherical refraction of the patient s eye is corrected - 8 -

9 Chapter 1: Introduction by modifying the optical paths between L2 and L3. Figure 1. Scheme of the double-pass The eye forms the image of the punctual source on the retina. The optical pathway from the laser source to the retina constitutes the first-pass of this system. The double-pass is determined by the light traveling from the retina to the CCD camera (aerial image or double-pass). This pathway begins with light being reflected on the retina in a set pattern due to the retina s diffusing behavior. The reflected light passes through the two doublet lenses and through the BS. Light transmitted through the BS encounters the second artificial pupil (AP2), which is conjugated with the eye s pupil plane. This pupil is variable and works as an effective exit pupil when AP2 is smaller than the natural pupil. The effective exit pupil will be whichever is smaller; AP2 or the natural pupil. Since the natural pupil is not static it dilates and contracts- it is advised to set AP2 slightly smaller than the natural pupil. An optical objective focuses the aerial image on a CCD camera. Measurements may be taken using different AP2 diameters

10 Chapter 1: Introduction What is OSI? OSI = Objective Scatter Index OSI is a parameter which objectively evaluates the intraocular scattered light. It is computed by evaluating the amount of light on the periphery of the double-pass image in relation to the amount of light on the center of it. In this way, the higher the OSI value, the higher the level of intraocular scatter. It is the only parameter which allows the objective quantification of intraocular scattered light. It is useful in all clinical situations when scattered light may be important (e.g. cataract development and surgery, refractive surgery, aging, dry eye syndrome, etc.). OSI is being used for a new objective classification of cataract development. For eyes with a normal degree of scatter (young eyes) OSI value is lower than 0.5. For eyes which are developing a cataract, OSI value stands between 1.5 and 4. For eyes with a mature cataract OSI is higher than What is MTF? MTF = Modulation Transfer Function The MTF of an optical system is a function which allows us to evaluate the degree of image detail that the system is able to distinguish, i.e. it evaluates the ratio between the contrast in the original scene and the contrast in the image formed by the system. As the eye is an optical system, it too has a MTF, which represents the loss of contrast of the image formed in the retina in relation to the real scene. In any optical system, contrast reduction is higher for high spatial frequencies (fine details and contours on an image). In the following example of barcodes, the codes on the right are seen as greyer (less contrast) than those on the left, although all have the same definition. This is consistent with the fact that the more details and contours (greater spatial frequency) are found, the lower the contrast between these

11 Chapter 1: Introduction details and contours in the image formed in the retina will be. Figure 2. Bar patterns with distinct spatial frequencies. Thus, MTF is a function that relates spatial frequency (measured in cycles per degree) to the contrast loss observed at each frequency on the image in the optical system in this particular case, the image formed in the retina. In the figure below, each bracket represents a distance that corresponds to one degree. The number of complete spatial cycles (the pattern formed by one black bar and one white bar) within the space of one degree varies as a function of frequency. The first bar code has a spatial frequency of 1, whereas the subsequent patterns have frequencies of 2, 4, 8, and 16, respectively. The higher the spatial frequency, the lower the contrast of the image formed in the retina. Figure 3. Bar patterns with distinct spatial frequencies. Each bracket representing one degree. If the contrast of the image in the optical system were the same as in the real scene, MTF would equal 1 (the highest possible value). As the frequency increases, MTF decreases because the contrast in the system image is lower and lower than in the real scene. This ratio can be expressed mathematically as follows: Contrast of image in optical system Contrast of real scene

12 Chapter 1: Introduction Figure 4. Comparison of contrast (C) in a real scene (A) and contrast (D) in the resulting image formed by an optical system (B). Finally, plotting the MTF curve will yield a graph that resembles the following: Figure 5. MTF plot. The X-axis corresponds to frequencies, and the Y-axis, the MTF associated with each frequency. MTF also changes with pupil diameter. In this way, it is important to consider the pupil diameter of a measurement before comparing it to another measurement. This

13 Chapter 1: Introduction value will be the one set as artificial pupil before performing the measurement, if it is smaller than the patient s pupil. Since a patient s pupil dilates and contracts, we advise the user to carry out measurements with a set artificial pupil slightly smaller than the natural pupil, so that measurements can be reproduced. 1.2 FEATURES Quantitative and objective evaluation of intraocular scattered light. Quantitative and objective evaluation of the eye s optical quality. Quantitative and objective evaluation of the loss of optical quality due to tear film degradation. Quantitative and objective evaluation of pseudo accommodation. Qualitative evaluation of the eye s optical quality by means of two and three dimensional maps of the double pass retinal image. A simulation of the image of a scene projected onto the retina is also provided. Optical axis position assessment with respect to the pupil center. When a KAMRA TM inlay is implanted, inlay position assessment with respect to pupil center and to optical axis. Tools for optimal visualization and quantification of the images, such as zoom, rotation, profiles and measurements. A useful and user-friendly patient database. Printable reports of the measurement parameters and results. Easy acquisition and manipulation of the images 1.3 APPLICATIONS Evaluation of the level of intraocular objective scatter index (OSI) for early detection of cataracts or for the determination of its degree of maturity. Objective measurement of halos and glare. Comparing pre and post cataract and refractive surgery measurements. Evaluation of tear film quality, especially on patients suffering from dry eye

14 Chapter 1: Introduction Objective measurement of the amplitude of pseudo accommodation range. Diagnosis of pathologies. Precise measurements of the ocular MTF (Modulation Transfer Function) in all situations (overestimated by aberrometers when scattering exists, like in cataract patients). Showing the effect of ocular aberrations in visual acuity (including higher order aberrations, which are not usually measured by standard aberrometers). Showing the effect of the tear film degradation on the quality of the retinal image. Purkinje image assessment of an eye with no KAMRA TM inlay implanted, detecting exact position of its optical axis with respect to the pupil center and allowing the required correct position for KAMRA TM inlay implantation. Purkinje image assessment of an eye with a KAMRA TM inlay implanted, detecting exact position of implanted inlay with respect to the eye s optical axis, allowing the user to quantify how close the inlay is from its optimal position (eye s optical axis). 1.4 HD ANALYZER SPECIFICATIONS Hardware Specifications Type B Measurement range: Min. +5 D to -8 D S.E. (higher ammetropias including astigmatism can be neutralized with an additional lens) o Reproducibility: +/ D o Accuracy: +/ D Best focus dioptric value: ± D of average Natural pupil diameter measurement: Automatic o Accuracy: +/- 0.5 mm (for an 8 mm pupil) Artificial pupil diameter: 2 to 7 mm Image capture time: 240 ms

15 Chapter 1: Introduction Laser diode wavelength: 780 nm Laser power selection: Automatic Maximum laser power at the pupil plane: 45.39μW Best focus position: Automatic Fixation target: Landscape with house XY translation: Joystick Size: 415 (L) x 350 (W) x 530 (H) mm Recommended working space: 2.5 m² Weight: 20 Kg External Power supply: o Input: VAC, Hz, max. 0.9 A o Output: 12 V DC, 3.0 A, 40 W Operating temperature and relative humidity: +10 ºC to +35 ºC (50ºF to 95ºF), and 30% to 90%. Storage temperature and relative humidity: -10 ºC to +55 ºC (14ºF to 131ºF), and 10% to 95%. Transport temperature and relative humidity: -40 ºC to +70 ºC (-40ºF to 158ºF), and 10% to 95%. Class II Class II double insulated equipment has the double square symbol indicating the equipment is double insulated and therefore has no earth wire. With respect to Purkinje measurement: Optimal distance between the patient s eye and HD Analyzer is achieved by following the arrow directions shown by the software when starting the measurement. Purkinje detection o Error below 142μm in more than 95% of measurements

16 Chapter 1: Introduction Purkinje offset detection KAMRA inlay o Error below 142μm in more than 95% of measurements. Pupil offset detection KAMRA inlay o Error below 142μm in more than 95% of measurements Software Specifications 1.6 MHz or higher Pentium-compatible CPU 512 megabytes (MB) of RAM recommended minimum; more memory generally improves performance USB 2.0 port Screen resolution: recommended 1366 x 768; minimum 1280 x 768 Windows XP, Windows Vista & Windows 7 (32 bits) compatible Accessories Computer (PC or laptop) It is used to run the instrument control software. Minimum requirements: Processor: 2.10 GHz, 3 MB Screen resolution: Minimum 1280 x 768; recommended 1366 x 768 Memory: 4 GB 1600 MHz DDR3 Hard disk: 320 GB Operating system: Windows XP, Windows Vista and Windows 7 (32 and 64 bits) Ports: Minimum 1x USB 2.0 (recommended 2x) Manufacturing compliance Electrical Safety: Designed and manufactured to comply with EN : ERR: Electromagnetic Compatibility (EMC): Designed and manufactured to comply with EN : ERR:

17 Chapter 1: Introduction 1.5 PRODUCT LIFESPAN The power source supplied with the HD Analyzer equipment has a useful life of 3 years and should be replaced after such time has passed. This equipment must be operated with the power supply unit provided. VISIOMETRICS estimates that the useful life of the equipment, having duly replaced the power supply, is 5 years. Habitual use of the HD Analyzer over 5 years places the useful life of the dynamic elements of the equipment at 15% below its useful life. 1.6 USER MANUAL S ACCURACY It may happen that some of the screens shown on this user s manual are not exactly the screens shown on your software. Small differences will be due only to different setup options

18 Chapter 2: Hardware setup 2 HD ANALYZER INSTALLATION AND MAINTENANCE 2.1 HD ANALYZER INSTALLATION The HD Analyzer system should only be installed by authorized personnel. This equipment is not designed to be portable. Once the system has been installed, moving it to another location is discouraged. If transport to a nearby location is unavoidable, we recommend that two people lift and move the instrument by securely holding it from its base, with one person on each side of the instrument. Never lift the HD Analyzer instrument unless holding it from its base. The device s mobile part is very fragile and interior elements could get damaged. If the equipment is to be moved to a remote location, contact the distributor or manufacturer to schedule proper repackaging of the instrument and installation at its new location. 2.2 MAINTENANCE The only maintenance task which the user must carry out is periodical cleaning. We recommend carrying out cleaning quarterly. Cleaning Always unplug your HD Analyzer instrument before cleaning it. Clean plastic surfaces with a soft and humid cloth. Do not use solvents or abrasive cleaners. The HD Analyzer has a low infection risk derived from its usage, which can be classified as non-critical and therefore will need a low level of disinfection. The

19 Chapter 2: Hardware setup patient comes in contact with the instrument through intact skin of the chin and front areas, which rest on the chinrest, and with their hands, which they may use to hold the chinrest. These applicable parts may be periodically disinfected by using a low-level disinfectant, such as quaternary ammonium compounds. Keep this device dry. For indoor use only. Not designed for outdoor use. Professional use only. Turn off or unplug when not in use. This machine is not water or splash-proof. If moisture, water, or liquid gets inside the housing, immediately unplug the unit and contact a service technician or your dealer before using it again. In case of technical issues, do not attempt to remove the side unit covers. There are no user-serviceable parts inside. Refer to your dealer or other accredited service personnel Calibration User must not carry out any calibration tasks on the equipment. It is recommended to contact your distributor to have a calibration carried out on annual basis

20 3 HD ANALYZER FUNCTIONS 3.1 USING THE SOFTWARE WITHOUT THE HARDWARE The user-friendly software allows access to the database without needing the HD Analyzer instrument to be switched on or even connected to the computer. All of the utilities related to the database can be performed without the instrument (see section 3.5). The database will also be accessible if the software is running in pay-per-patient mode and there are no more available measurement credits. It will not be possible to perform new measurements until buying new credits. 3.2 PAY-PER-PATIENT MODE Depending on the service that you have contracted, the HD Analyzer instrument can work in free mode or in pay-per-patient mode. In free mode, you can perform unlimited measurements, with no limitation. In pay-per-patient mode, you have a limited number of measurement credits. Once a patient is measured with the instrument, a credit is subtracted from the counter. Please, carefully read section 3.6.3, where we explain in which cases a credit is subtracted, for each measurement type. If you run out of credits, the software will allow you to review the results of previously saved measurements, but it will not allow you to perform new ones. In order to get new measurement credits, you have to purchase them at Visiometrics website ( Once you have entered the web site, click on Client Access, and enter your username and password. This will allow you to access your private account, where you can check your personal data (User Profile) and a list of your previous purchases. In the section Buy measurements, select the center where the HD Analyzer is installed, its serial number, and the number of credits you would like to buy. After clicking on Buy, type in all of the required data in order to complete the purchase process. The result of this process

21 will be a 16-character code (activation code) with this format: XXXX XXXX XXXX XXXX (For example: ABCD efgh) In order to have these new measurements available for use in the HD Analyzer instrument, please follow these simple steps: 1. Write down the activation code. 2. Go to the computer connected to the HD Analyzer instrument and run the software. 3. In the home menu of the software (Home), click on License Manager. This will open the application for managing the activation codes. See section 3.7 for more information. 4. Click on Enter New Code. Enter the new code and click on Validate Code. 5. The new measurement credits will be added to the previously available ones. 6. Close the License Manager. The HD Analyzer software will restart with the new number of available measurement credits. NOTES: Activation codes do not expire. Each activation code can only be used once. Each activation code can only be used for the device selected during the purchase process. If you have any questions, please contact Visiometrics. 3.3 GETTING STARTED Instructions for use The HD Analyzer instrument allows the user to take measurements of the eye with or without neutralizations (glasses, contact lenses or intraocular lenses). When using conventional lenses (patient glasses or a trial frame) these should be slightly tilted to avoid reflections. We recommend the use of the instrument s lens frame

22 instead, which is already tilted. When a patient has more than 0.5 D of astigmatism, measurements must be taken with the corresponding correction in order to avoid incorrect results. General directions to patients It is important to place the patient properly and in a comfortable position before beginning to take any measurements. To do this, make sure that the hygienic protectors are correctly placed on the chinrest of the HD Analyzer instrument. The patient will be requested to sit down and place his chin on the hygienic protector, on the chin rest. In addition, it is also recommended that all measurements are taken in rooms with low and constant lighting, to aid the dilation of the pupils and to avoid direct air currents to the patient, so as not to affect the patient s blinking rhythm. Using the HD Analyzer joystick, bring back the mobile part of the HD Analyzer instrument to the farthest point from the patient and then push it forward until the patient s pupil appears well focused on the screen, paying special attention to avoid touching the patient s nose. The patient should feel comfortable and at ease. Directions to the patient during the objective refraction During the objective refraction sequence, the patient should be warned that during the sequence, the target will appear, at times, unfocused, and that they should not attempt to focus on it, but to casually look at the target throughout the whole sequence. Directions to the patient during the measurement of scattering and optical quality During the scattering or optical quality sequence, the patient should be requested to try to focus on the target as much as possible during the process. Directions to the patient during pseudoaccommodation The pseudoaccomodation sequence (Pseudo Accommodation) is intended only for those patients who have, to a great extent or even completely, lost their accommodation ability. Nonetheless, the patient should be instructed to try to focus on the target as much as possible during the process

23 Directions to the patient during Tear Film Analysis During the tear film analysis sequence (Tear Film Analysis), the patient should be requested to casually look at the target. If the measurement is carried out following a sound pattern, patient should be requested to only blink when hearing the sound signals. If no sound pattern is followed, patient should be requested to try hard not to blink during the entire process (20 seconds). Directions to the patient during the Purkinje sequence Lastly, while performing the Purkinje sequence (Purkinje), the patient should be requested to always look at the laser light (red light), focusing the eyes on it. Moreover, during the first moments when the software is acquiring images, the patient should be requested to try hard not to blink. 3.4 HOME MENU After double-clicking the HD Analyzer icon, the program will start and will ask for the unit s Serial Number: Figure 6. Serial number confirmation This request will be asked for, at most, once every 24 hours. If the introduced number does not agree with the one registered in the software, it will not be possible to proceed with measurements

24 After providing the unit s Serial Number and clicking OK, the Home screen will appear, as shown below. Figure 7. Home screen This screen gives access to the following sections: Database: Gives access to the patient database in order to edit, view, compare, print or delete previously saved results. The database will always be accessible through this button; even when running the software without having the HD Analyzer instrument connected, or if there are no available measurement credits in pay-per-patient mode. Measurement: When the HD Analyzer instrument is connected to the computer, switched on and the serial number is correct, this button will be enabled and will activate the screen which allows measurements to be taken. In pay-per-patient mode, this option will be enabled only if there are measurement credits available. License Manager: Gives access to the application for the system s license management. In that application, the user will be able to enter the purchase codes obtained from his account from the Visiometrics web page. This will allow the new measurement credits bought by the user to be activated. Setup: This button activates the setup screen. The user will be able to modify some of the parameters of the system. The rest of parameters are

25 protected with a password, which the manufacturer will provide only in case that the device requires maintenance. The password is not provided by default in order to avoid any unintended modification of the configuration parameters of the instrument. Backup: Allows carrying out a backup of patient database and associated images onto the desired directory. 3.5 DATABASE HD Analyzer provides an easy to use patient database, which can be accessed by clicking the Database button. Saved data can also be accessed directly by using Microsoft Access TM (if you have installed it). See Appendix A for further information about the data stored in the database file. Database You can either take a measurement first and select a patient later or select the patient first and then carry out the measurements. In this case, enter the database screen by clicking the Database button. In this screen, you can add new patients and modify or delete the existing ones. You can also select a patient for performing new measurements

26 Figure 8. Patient database The Patient field allows you to quickly find a patients name. Type the first letter of the patient s last name and a drop-down list will appear, with all of the patients whose last name starts with that letter. A patient s record can also be recalled by typing an Id. Number in the corresponding field. To select a patient, click over their name or press Enter. All of the data fields will be filled in with the selected patient s data, as well as the list of the measurements performed on him. New acquisitions can now begin (Measure) or recorded data can be analyzed (Results or Compare). The data shown in this screen is not editable. For any data modification, proceed using the button Modify (see section 3.5.2) New Click the New button to add a new patient record to the database. All of the data fields are now editable. It is mandatory to fill out the fields Patient s Id, Name and Surname. The fields Gender, Date of birth, Address, City, Zip code, Country, Phone number, and Comments are optional. Click OK to validate new record or Cancel to return. Confirmation will be required before saving the new data

27 3.5.2 Modify Select a patient and then click the Modify button in order to modify a patient s record in the database. Figure 9 Data modification Make the desired changes and then click OK to validate the new data or click Cancel to return without saving the changes. Confirmation will be required before changing the data Delete: patient/acquisition Select a patient and then click the Delete button in order to remove a patient s record from the database. Confirmation is required before deleting a patient record. Deleting a patient record will delete all data and images related to that patient. Make sure you have chosen the right patient and that you really want to delete it

28 If you want to remove just one single measurement from a patient s history, select an acquisition from the list and click on Delete acq Results Once the patient has been selected, all of the measurements performed on him are shown in the list below (see Figure 10), and are now available for analysis, printing, comparison, etc. The full list is shown by default. Different types of filters can be applied, using the buttons at the right of the list. The list can also be sorted by any of the available columns, by clicking on the column title. Figure 10. Open a measurement These are the different parameters shown on the list to identify the measurements: Date/Time Type: SCT (Scatter Meter), Opt. Qlt. (Optical Quality), Pseudo Acc. (Pseudo Accommodation), Tear Film (Tear Film Analysis) and PKJ (Purkinje). Some of these features may not be available in your system. OS/OD: Left/Right eye Pat. Refrac. Subjective patient s refraction (Sph, Cyl and Axis values), typed by the user before performing the measurement

29 Sph. Refrac. Corr.: Defocus (spherical refraction) correction applied by the instrument during the measurement. NP.: Natural pupil diameter (in mm) determined by the instrument while performing the measurement. A 0 value indicates that this diameter was not measured. AP.: Artificial pupil diameter (in mm) used for performing the measurement. Notes: Acquisition notes, if any. Select one acquisition by clicking on it and then click on Results to continue Compare This option allows the user to load two measurements of the same type and compare them. In order to do this, click on Compare. You will be requested to select the first measurement to be compared and then click OK. Then, select the second measurement. It can belong to the same patient or to a different one, but it must always be of the same type. Again, click OK. See section for more information about the comparison screens. It is important to clarify that it is not possible to load and compare Purkinje measurements. 3.6 MEASUREMENTS There are two ways for accessing the main measurement screen. The first is to click on the Measurement button of the Home menu, without selecting a patient. The other option is to enter the database by clicking on Database, select a patient and click on Measure. In both cases, the user will be required to enter the values of the subjective refraction of the patient (see Figure 11). This information is needed by the HD Analyzer instrument to look for the best spherical correction around a dioptric range, thus resulting in a more reliable and exact measurement and will require less time. The fields Sph (sphere), Cyl (cylinder) and Axis (axis) are required, for both eyes. The

30 instrument is able to perform measurements in the range of spherical refractions between +5 D a -8 D, and the range of astigmatism between +0.5 D and -0.5 D. Out of these ranges, the refraction of the patient must be corrected by means of trial lenses (only for the astigmatism, or for both sphere and c ylinder). For this purpose, use the lens holder placed in the front part of the instrument. The user will need to choose the proper option in the field Correction of the measurement s main screen (see section 3.6.1). The subjective refraction is needed for the process of determination of the best spherical correction to be applied in the measurements. If a patient s refraction is ± 3D over the input values, this process will have a wrong result. Figure 11. Subjective refraction (compacted view) You can also enter the best corrected visual acuity (BCVA) and the uncorrected visual acuity (UCVA), as additional information that will be included in the printing reports of the measurement results. To do that, access the enlarged view with button >>

31 Figure 12. Subjective refraction (enlarged view) Once all the refraction data has been entered, click on OK to access the measurement s main screen

32 3.6.1 How to carry out an acquisition The measurement s main screen is divided into six areas (see Figure 13): Figure 13. Measurements main screen A. System information: The information shown at the top of the screen can be customized to include the name of the center and person who operates the HD Analyzer instrument. This information can be accessed and modified through the Setup button at the Home menu (see section 3.8). If the software is running in pay-per-patient mode, the system also shows the number of available measurement credits. B. Main functions: These buttons allow the user to perform common actions with the data, such as accessing the database (see section 3.5), and saving or printing the results. C. Measurement processes: Some of the buttons become available only when Objective Refraction has been carried out. See the following sections for more information. (Note: not all of the measurement options may be available in your system) D. Live image: This window shows the patient eye in real time, allowing the user to center and focus the image

33 E. Input data: This section shows the selected patient s data, and allows the setting and changing of the input parameters used in the measurement (further information shown later in this section). F. This section shows two different types of information: o o Visualization of the Objective Refraction process: This section shows the progress and results of the process for the determination of the best spherical refraction correction. Measurement Results: Once the measurement process has finished, results are shown for: Scatter Meter, Optical Quality, Pseudo Accommodation and Tear Film Analysis, as well as parameters typed in by the user (see section 3.6.4) If a patient has been selected, his data appears on the main screen. The eye that is going to be measured OD/OS (Right Eye / Left Eye respectively) is automatically detected by the instrument. The eye s spherical refraction (Sph), Cylinder (Cyl) and astigmatism axis (Axis) that have been entered previously are shown in the corresponding fields. Please check if those values are correct. If they are not, change the values by clicking on Change subjective refraction, as seen in red on Figure 14. Figure 14. Eye and refraction data

34 It is important to enter correct values for the subjective refraction of the patient. In the Objective Refraction process (the determination of the best spherical correction for the patient), the HD Analyzer searches for corrections within a ± 3D range around the spherical equivalent of the subjective refraction typed in by the user. If the entered values are not correct, the instrument will find a wrong spherical correction, and the results may be wrong. The subjective refraction is needed for the process of determination of the best spherical correction to be applied in the measurements. If a patient s refraction is ± 3D over the input values, this process will have a wrong result. The instrument is able to perform measurements in the range of spherical refractions between +5 D a -8 D. If the eye to be measured is out of that range, the subject s refraction must be corrected externally by means of trial lenses. Regarding a patient s astigmatism, the system is able to perform measurements in the range between +0.5 D and -0.5 D. Larger astigmatisms seriously affect the retinal image registered by the instrument, so any underlying problem may be hidden by this effect. Furthermore, the results of the OSI can be affected by astigmatism. Because of this, cylindrical refractions out of that range must be corrected by means of trial lenses. In these out of range cases, the software will remind you to enter the proper external correction. The instrument has a trial lens holder placed in its front part. We strongly recommend using this holder, although it is possible to use a trial frame or even the patient s spectacles (see section 3.3). In case of correcting externally the spherical and/or cylindrical refractions, that must be indicated to the instrument. In this way, select the proper option in the drop down list of the field Correction. The different options are: No correction: The user has not corrected the patient s refraction by means of trial lenses. Astig. correction: The user has corrected the patient s astigmatism by means of a trial lens

35 Total correction: The user has corrected both the patient s spherical refraction and astigmatism by means of trial lenses. Again, it is important to select the correct option of the field Correction. The spherical equivalent used for the Objective Refraction process may depend strongly on the applied correction. If an incorrect option is selected, the instrument will find a wrong spherical correction, and so the rest of results may be wrong. You must select the correct option in the field Correction. If an incorrect option is selected, the process of determination of the best spherical correction may come out with a wrong result Objective Refraction See section 3.3 for patients directions. Click Objective Refraction to begin the process of determination of the optimal spherical refraction correction. This process is necessary in order to avoid the presence of defocus on the registered images, which effect may hide other underlying problems. Consequently, the optimal spherical correction must be determined before performing any other measurement. The HD Analyzer, using a 5-mm artificial pupil, performs a sweep looking for the best double-pass image at different spherical corrections, so as to compensate for defocus. While this process is running, the user can see the images that the HD Analyzer stores. When this process is completed, the system automatically selects the best correction. HD Analyzer will show this value as Objective spherical refraction and Selected spherical refraction. This last value can be modified, if wanted, by clicking on the desired image. It should be taken into account that the measurements will be carried out considering the Selected spherical refraction value. It should be taken into account that modifying the value of Selected spherical correction, may cause a wrong or unexpected result. Only change this value when you are absolutely sure

36 Figure 15. Objective Refraction process HD Analyzer is now ready to start the measurement processes, and the buttons Scatter Meter, Optical Quality, Pseudo Accommodation and Tear Film Analysis are enabled. (Note: not all of the measurement options may be available in your system) Types of measurement Scatter Meter and Optical Quality See section 3.3 for patients directions. Once the Objective Refraction process has been carried out, measurements may begin. In the case of Optical Quality, you must establish the artificial pupil diameter that will be used for the measurement. Select the desired value in the field Artificial pupil diameter. In the case of Scatter Meter, there is no need for setting the parameter. According to the definition of OSI parameter, the measurement will be performed using a 4-mm artificial pupil, no matter what the entered value may be. If, when capturing the images, the software detects that the patient s pupil is inferior to the artificial pupil used, a warning will be shown at the end of the process. Click Scatter Meter or Optical Quality to begin the corresponding measurement process (intraocular scattered light quantification, or optical quality evaluation for far

37 vision). Both processes consist of capturing six double-pass images in conditions of best spherical correction (far vision), and their processing. The system outlines in green the images considered to be correct. Once the capture has finished, the user can select any undesired image by clicking it with the mouse. Checked out images will appear outlined in red and will be excluded from the processing and analysis. Images outlined in green are processed and analyzed by clicking Results, and results are shown with different visualization options (see section ). Figure 16. Scatter Meter measurement If a measurement does not satisfy you, it can be repeated it by clicking Return

38 If you are running the software in pay-per-patient mode and you click on Results, the system will consider that you have completed the measurement. A measurement credit allows you to complete two consecutive measurements on the same patient. A measurement credit will be subtracted from your counter as you complete the first measurement on a patient, but you will not be charged if you perform a second measurement directly after the first one. If you perform a third measurement you will be charged again and the fourth one would be free, and so on. Please, take into account that if you access the database and select a patient, it will always be considered as a new patient, no matter if you have selected the same one Pseudo Accommodation See section 3.3 for patients directions. Once the Objective Refraction process has been carried out, measurements may begin. In the case of Pseudo Accommodation, you must establish the artificial pupil diameter that will be used for the measurement. Select the desired value in the field Artificial pupil diameter. Click Pseudo Accommodation to begin the measurement process of pseudo accommodative range. This process makes a sweep of 4 diopters [BF + 1 diopters, BF - 3 diopters] from the best correction (BF) value measured during the Objective Refraction process or the one designated by the user. The system makes -0.5 D steps, registering images at each vergence, until reaching the final position. The recorded images are shown in real time

39 Figure 17. Pseudo Accommodation measurement It must be taken into account that when measuring at BF + 1 D and BF D, a patient will not be able to see the target clearly, no matter how much he tries to accommodate. In the range between BF and BF - 3 D, patient should always try to accommodate with the purpose of seeing the target clearly. When carrying out a Pseudo Accommodation sequence, patient will be requested to try and focus on the target, through all the process. Otherwise, the measurement may come out with a wrong result If you consider the process to be correct, click Results to view the final calculations. Otherwise, you can repeat the test by clicking Return

40 If you are running the software in pay-per-patient mode and you click on Results, the system will consider that you have completed the measurement. A measurement credit allows you to complete two consecutive measurements on the same patient. So, a measurement credit will be subtracted from your counter as you complete the first measurement on a patient, but you will not be charged if you perform a second measurement directly after the first one. If you perform a third measurement you will be charged again and the fourth one would be free, and so on. Please, take into account that if you access the database and select a patient, it will always be considered a new patient, no matter if you have selected the same one Tear Film Analysis See section 3.3 for patients directions. Note: This measurement type may not be available in your system. Once the Objective Refraction process has been carried out, measurements may begin. In the case of Tear Film Analysis, you do not need to set the artificial pupil diameter. In order to assure that any tear degradation is detected, including the periphery of the patient s pupil, this process is performed using the maximum size of the artificial pupil (7 mm), no matter what the entered value may be. The Tear Film Analysis sequence can be guided, or not, by a sound pattern. The results obtained will show different information according to whether it has been guided, or not, by a sound pattern. To configure the default mode in which the Tear Film Analysis sequences will be carried out, go to the Setup screen (see chapter 3.8.1). To begin the Tear Film Analysis sequence, following the default setup, click on Tear Film Analysis. If you want to occasionally carry out a sequence using a different pattern, you can do it by clicking on the button Tear Film Analysis while holding down the Control key. In addition, doing it this way will allow you to quickly change the default pattern used without having to go to the Setup screen

41 Click Tear Film Analysis to begin the process of evaluation of tear film dynamics. It consists of recording double-pass images every 0.5 seconds, until a 20-second capture has been completed. The system records 40 images, showing the optical quality evolution during those 20 seconds. These images are shown in real time. It is strongly recommended to keep the eye that is not being measured closed, in order to avoid the stimulation of the tear glands and the production of extra tear. The user should try to keep the patient s eye centered on the image in order to assure that any variation between images is due to a tear film change. If the patient blinks during the process, a red frame will be shown around the live image of the eye, and the corresponding image will be labeled as Blink. Figure 18 shows the result of a Tear Film Analysis process. Figure 18. Tear Film Analysis measurement At the end of the 20 seconds, you can see all 40 captured images. Below each one, you can find the exact second when the image was captured. Some of them may be labeled as Blink. In addition, those considered as blinks will be marked with a red square, whereas the rest will be marked with a green square. You can change the state of any image, from Blink to normal, or from normal to Blink, by clicking on the image

42 If you consider the process to be correct, click Results to view the final calculations. Otherwise, you can repeat the test by clicking Return. If you are running the software in pay-per-patient mode and you click on Results, the system will consider that you have completed the measurement. A measurement credit allows you to complete two consecutive measurements on the same patient. So, a measurement credit will be subtracted from your counter as you complete the first measurement on a patient, but you will not be charged if you perform a second measurement directly after the first one. If you perform a third measurement you will be charged again and the fourth one would be free, and so on. Please, take into account that if you access the database and select a patient, it will always be considered as a new patient, no matter if you have selected the same one Monitoring results The results screens for the different types of measurements have a common area, which includes the parameters used during the measurement. Those parameters are: OD/OS: Measured eye (Right / Left). Sph, Cyl, Axis: Subjective refraction values entered by the user before performing the measurement. Comments: Comments related to the patient typed in by the user in the patient s data on Database. Artificial pupil diameter: Artificial pupil diameter used to take measurements, entered by the user. Measured pupil diameter: Patient s pupil diameter measured by the instrument. A value of 0.0 will indicate that the patient s pupil size could not be measured. Objective spherical refraction: Best spherical correction obtained during the Objective Refraction process

43 Selected spherical refraction: Spherical correction used in the measurement. Correction: Shows if the measurement was performed without external refraction correction, with astigmatism correction or with total correction, as entered by the user. Acquisition notes: Comments related to the measurement, entered by the user. These notes can be modified by the user in any subsequent viewing. The numerical results and the different available visualizations will depend on the particular type of measurement. In the next pages, you will find the description of the different elements shown for each type Scatter Meter and Optical Quality Once the Scatter Meter or Optical Quality measurement processes have finished, click on Results. Results are shown as per Figure 19 and Figure 20 respectively. Figure 19. Scatter Meter results

44 Figure 20. Optical Quality results The results given by the system for both types of measurement are basically the same, excepting the parameter OSI (Objective Scatter Index) computed only for Scatter Meter (see section 1.1.2). The results screen is divided into three areas, clearly separated, as seen below: Figure 21. Areas of the results screen

45 A. Image visualization area: Depending on selection made using buttons in section C, this area will show one of the visualization options available in normal mode (VA simulation, 2D) or for expert users (3D, Profile, MTF). (See below for more information). B. Input/Output data: This section shows the most representative numerical results obtained in the measurement, as well as the input parameter values. The most representative results are: OSI: Only for Scatter Meter. It is the Objective Scatter Index, that quantifies the level of intraocular scatter of the eye. For more clarity, the OSI value is also represented in a color scale. This shows in a graphical way if that value corresponds to a low, medium or high level of scatter. Values within the green range of the scale represent eyes with low scatter level. Values within the yellow range of the scale represent cases where scatter begins to be remarkable (first stages of a cataract, lens starting to get opacified, etc). Values within the red range of the scale represent eyes with an important scatter level (mature cataract, etc). Predicted Visual Acuity: It is the value of the visual acuity estimated from the actual eye s optical quality (MTF). It can be understood as the monocular visual acuity that the patient would have, if that magnitude depended only on optical factors. It does not take into account the retinal sampling and the neural processing performed afterwards. The result is shown in both decimal and Snellen notations. Figure 22. Input / Output data

46 C. Buttons area: It consists of the buttons which give access to the different visualization options of the results obtained for the measurements. By default, two options are shown (VA simulation and 2D). By means of the button More options, it is possible to access the visualizations for expert users (3D, Profile and MTF, apart from the two default ones). We will now describe what the user can find in each of the different visualization options. VA Simulation visualization Click on the button VA in the results button area in order to access the VA Simulation screen. It is the default option that is shown just after the results are processed. The goal of this screen (Figure 23) is to show what an image of a common scene looks like projected on to the retina of the patient. In particular, the software shows the image of a baby placed at a distance of 1 meter from the viewer. On the left side of the screen, you can see the original scene. On the right side you can find a simulation of how that scene would be imaged on the retina. That simulation is achieved by means of the convolution of the original scene with the eye s PSF measured by the instrument. In this way, it will show how aberrations and intraocular scatter of the patient s optical system are affecting the image formation. This does not mean that the patient is seeing in the exact way that is shown on the screen, because the only factor that is being considered is the optical quality, not the neural processing performed to the retinal image

47 Figure 23 VA Simulation visualization For a normal and healthy eye, both images (original and retinal) will be very similar. For aberrated eyes, you will notice a blurring of the image, so it will be harder to distinguish details. For eyes with a high level of intraocular scatter, you will notice a clear overall loss of contrast on the image. It should be taken into account that other effects such as glare or halos are not simulated on this image, so their presence must not be expected to be shown. The images can be exported by double-clicking over them and selecting the desired destination. You can export them as bmp or jpeg image files. 2D visualization Click on the 2D button in the results button area in order to access the 2D screen. Two retinal image representations are shown in this screen, as seen in Figure 24. The 2D retinal image is displayed, on the left side of the screen with its original size while on the right side it is zoomed. Zoom in and zoom out can be performed by clicking the In or Out buttons (the maximum zoom in factor is 16 and the minimum zoom factor is 2). The different energy levels are represented with a color scale. You can select a particular area of the image by clicking and dragging the mouse

48 over the left image. That area will be shown with the corresponding zoom in the right image. The scale of both images is shown below each one, in minutes of arc. You can measure distances on the retinal image by right clicking and dragging the mouse over either image. The measured distance appears over the cursor of the mouse. The images can be exported by double-clicking over them and selecting the desired destination. You can export them as bmp or jpeg image files. Figure 24. 2D visualization 3D visualization This option is only available after clicking on the button More options. It is intended for expert users. Click on the button 3D of the results button area in order to access the 3D screen. The 3D retinal image representation is displayed on the right side of the screen (Figure 25). Zoom in and zoom out can be performed by clicking the In or Out buttons. The retinal image can be rotated, moved and scaled just dragging the mouse over it

49 The images can be exported by double-clicking over them and selecting the desired destination. You can export them as bmp or jpeg image files. Figure 25. 3D visualization Profile visualization This option is only available after clicking on the button More options. It is intended for expert users. Click on the button Profile of the results button area in order to access the Profile screen. The right side of screen shows the retinal image intensity distribution profile. You can select a specific area with the mouse and then zoom in and out. To zoom in, you must start selecting the desired area from the left top. To zoom out, you must start by selecting the desired area from bottom right. The radial profile shows the average profile. To see the profile at a desired angle, choose Angular. Slide the bar that will appear below the image in order to modify the desired angle

50 Figure 26. Profile visualization The software also shows the values of the widths of the profile at 50% and 10% of its maximum value. With these values the user can obtain information about the size and shape of the image profile. The profile plot can be exported by double-clicking over it and selecting the desired destination. You can export it as an image file (bmp or jpeg), or save the plot data as a text file (txt). MTF visualization This option is only available after clicking on the button More options. It is intended for expert users. Click on the button MTF of the results button area in order to access the MTF screen. The MTF describes the performance of an optical system. MTF values represent the quotient between the image s contrast and the object s contrast for each spatial frequency (see section 1.1.3). From this function, the system can estimate visual acuity due to the optics of the eye, for different contrasts (Predicted VA 100%, 20%

51 and 9%). This information shows similar measurements of those obtained with subjective techniques, such as Snellen chart exams. It is important to note that this information is only affected by optical defects, while in subjective measurements it is greatly affected by neural processing tasks. The estimated visual acuity is shown in both decimal and Snellen scales. The MTF cut off value is also provided. The higher cut off values, the better the retinal image (see section 1.1.3). Another parameter given by the system is the Strehl ratio. This ratio is a qualitative measurement of the optical quality of the eye and can be calculated as the ratio of the eye s MTF and that of a system limited by diffraction. Thus, it will be a figure between 0 and 1. Again, the higher its value, the better optical quality. As a reference, a normal young eye with a pupil diameter of 4 mm will have a Strehl ratio around 0.3. Figure 27. MTF visualization Two representations of MTF are provided: Linear (Linear) is the default option when you select the MTF plot for the first time. Spatial frequency is shown in a lineal scale. Logarithmic (Log) is where the spatial frequency axis is shown in a logarithmic scale, which allows the user to clearly appreciate the cut off frequency (MTF Cut off)

52 This plot is shown on the right side of screen. You can select a specific area with the mouse and then zoom in and out. To zoom in, you must start by selecting the desired area from the top left. To zoom out, you must start by selecting the desired area from bottom right. The MTF plot can be exported by double-clicking over it and selecting the desired destination. You can export it as an image file (bmp or jpeg), or save the plot data as a text file (txt) Pseudo Accommodation Once the user has finished the Pseudo Accommodation measurement process, the user may click on Results, and will obtain the results as shown in Figure 28. Figure 28. Pseudo Accommodation results The results screen shows all nine images recorded during the process (see section ). In addition, it includes a plot of an image quality index for each vergence. These image quality values are normalized. Thus, for the best spherical correction (BF), it should have a value of 1. That plot is shown on the bottom right side of the screen. You can select a specific area with the mouse and then zoom in and out. To zoom in, you must start by selecting the desired area from the top left. To zoom out, you must start by selecting the desired area from bottom right

53 OQAS Accommodative Range is considered to be the dioptric range between BF and the point at which quality decreases to a 50% of its maximum. The value on the top left corner of each image corresponds to the profile width at 50% in minutes of arc. The system also provides a simulation of the image projected on to the retina of an optotype (Snellen E letter), for each vergence, as in VA simulation visualization for Scatter Meter and Optical Quality. It is important to note that this does not mean that the patient is seeing in the way that is shown on the screen, because the only factor that is being considered is the optical quality, not the neural processing performed to the retinal image. The images can be exported by double-clicking over them and selecting the desired destination. You can export them as bmp or jpeg image files. The plot can be exported by double-clicking over it and selecting the desired destination. You can export it as an image file (bmp or jpeg), or save the plot data as a text file (txt) Tear Film Analysis Note: This measurement type may not be available in your system. Once the Tear Film Analysis measurement process is complete, the user may click on Results, and will obtain the results as shown on Figure 29. According to whether the sequence has followed a sound pattern or not, the information shown on the results screen will be different

54 Results screen without sound pattern Figure 29. Tear Film Analysis without sound pattern results The results screen shows all of the 40 images recorded during the process (see section ). In the top of each image you will find two numbers. The left one corresponds with the moment when the image was recorded. The right one corresponds to the OSI value for that image. A plot is also provided, representing the evolution of the OSI with time. An increment in the OSI may indicate a double-pass image degradation caused by the tear film break-up. This plot is shown on the right bottom side of the screen. You can select a specific area with the mouse and then zoom in and out. To zoom in, you must start by selecting the desired area from the top left. To zoom out, you must start by selecting the desired area from bottom right. If any blink has been detected during the measurement, the corresponding image will be labeled as Blink and the point in the graph will be missed. If you want to modify the category of any of the images, select it by clicking on it to show the software how it should be categorized. By doing this you will be able to select other images before showing the software to recalculate to results considering the corrections made

55 Figure 30. Modifying the categorization of the images The images can be exported by double-clicking over them and selecting the desired destination. You can export them as bmp or jpeg image files. The plot can be exported by double-clicking over it and selecting the desired destination. You can export it as an image file (bmp or jpeg), or save the plot data as a text file (txt). These data will be exported in several columns, the first 3 being the most representative: time, OSI values and whether there has been a blink or not. Notice that, even if the point is missed in the graph because of a blink, the corresponding OSI value will not be missed in the exported data

56 Results screen with sound pattern This screen is divided into 3 different areas, as shown in the following figure: Figure 31. Results screen for Tear Film Analysis with sound pattern A. Patient history Each time a measurement is made guided by a sound pattern it is classified in one of the 5 following groups, conveniently defined and identified using an associated color and number: o Plateau --- Intense green o Plateau/Seesaw --- Olive green o Seesaw --- Yellow o Seesaw/Ladder --- Orange o Ladder --- Red Some measurements, whose characteristics do not permit an accurate classification are associated to a sixth group, and identified with a zero and the color black. The aim of this graph is to show the evolution of a specific eye over time. You can move horizontally across it by dragging the mouse while holding the right button. By clicking on any marker on the graph, you will be taken to the associated measurement details

57 B. Detail of a specific measurement In the upper left portion of the screen you will see the graph that shows the evolution of the OSI in the 20 seconds that a specific measurement is taken, giving it the color associated to the group that the measurement belongs to, according to its characteristics. On the upper right portion of the screen, you will clearly see the group to which the studied measurement belongs, as well as the studied eye. On the lower right portion of the screen, you will see the notes assigned to the measurement, as well as the date it was made. These notes can be modified by the user when finalizing the measurement, or during any subsequent viewing. C. Button area Formed by the buttons that change the information shown between: - The double-pass images, explained in section 0. - The classification in groups, explained in A & B of this section Result comparison screens As explained in section 3.5.5, the system provides a results comparison screen for each type of measurement, excluding Purkinje measurements. The next figures show an example of each of these comparison screens. All of them have the same structure. The bottom part corresponds with the parameters used for each of the measurements, while in the upper part you can find the results that were obtained. You will find the same numerical results as if you viewed each measurement individually. In the same way as in the results screens that were explained previously for Scatter Meter and Optical Quality, you can click on More options in order to access the results intended for expert users (as well as MTF and Profile views)

58 Figure 32. Comparison of Scatter Meter measurements Figure 33. Comparison of Optical Quality measurements

59 Figure 34. Comparison of Pseudo Accommodation measurements Figure 35. Comparison of Tear Film Analysis measurements A report of the comparison can be printed out. Simply click on Print to access the report. See section for more information. For any of the screens, all of the images can be exported by double-clicking over them and selecting the desired destination. You can export them as bmp or jpeg image files. You can also export the plots by double-clicking over them and selecting

60 the desired destination. You can export them as an image file (bmp or jpeg), or save the plot data as a text file (txt) Purkinje Measurement Typing in subjective refraction To access the Purkinje measurement screen, you must select Measurement and type in the patient s subjective refraction. Patient must remain uncorrected for this measurement. You must not use trial lenses nor the patient s own correction means. Figure 36. Subjective refraction (enlarged view) The typed in subjective refraction will be used, with respect to Purkinje measurement, to place the target at the proper distance from patient s eye, allowing the patient to see the target clearly and comfortably

61 Selecting the Purkinje option Once you have typed in the patient s subjective refraction, click on Purkinje. Figure 37. Purkinje option Positioning the device While the patient is looking at the target, use the joystick to bring the device to the furthest distance from the patient s eye, while centering the patient s pupil in the coordinate axis overprinted on the live image. While doing this: You should not take into account whether the patient s eye appears well focused or not on the live image. The patient can blink as often as they like, since no image is being captured

62 Figure 38. Live image showing centered eye, not well focused Select desired option Once the device is as far as possible from the patient s eye and the patient s eye is centered on the axis, you should select the desired option according to the type of task you will carry out: Pre-Without inlay for those patients who do not have a KAMRA TM inlay implanted. Post-With inlay for those patients who already have a KAMRA TM inlay implanted. When you select one of either option, the laser diode will be activated and it will be visible to the patient. The patient must look at the laser beam (red light). The Automatic and Manual options specify if the acquired images have to be studied automatically by the software, or if the operator must manually select the exact location and size of: In Pre-Without inlay acquirements, the pupil. In Post-With inlay acquirement, the KAMRA TM inlay. At this stage, the patient can still blink as much as needed in order to feel comfortable

63 Focus using indicator arrows During this step, the software will use 2 arrows, a blue one pointing at the patient s eye, and another yellow arrow pointing at the operator. These arrows will guide the movements of the operator. Keep in mind that the indicator arrows will be shown only when the eye is well centered in the crosshairs. At the beginning, the blue arrow indicates that the operator must move the instrument closer to the patient. Figure 39. Blue arrow when beginning

64 When approaching the patient, it is important to always keep the eye well centered. During this process, a green circle will appear around the laser reflection. The operator must keep the green circle as centered as possible, until he has reached the best focus point. The operator should slightly surpass this point. Figure 40. Blue arrow with green circle near laser reflection

65 After surpassing it, the software will recognize that the best focus point has been reached and surpassed, and blue arrow will be replaced by the yellow arrow, pointing in the opposite direction. The operator must change the direction of the instrument, moving it away from the patient. Figure 41. Yellow arrow just before losing the detection of laser reflection

66 At this point, the software will continue using the arrows to indicate the correct direction the user should be moving in to reach the best focus point. Furthermore, the sizes of the arrows will fluctuate, to indicate how far the instrument is to the correct point (the larger the arrow, the farther it is to the best focus point). Figure 42. Yellow arrow when getting close to the best focus point

67 Once the best focus is reached, the arrows will be replaced by a green tick or check mark (as shown below). Once this position has been reached, do not move the instrument. Figure 43. Green tick indicating the best focus point has been reached. The patient can now blink freely at this point. During the focus process it is recommended to ask the patient NOT to blink. Blinking can cause the software to restart calculating the result

68 Automatic capture of images Once at this point, the software will begin to capture images automatically. There are two modes of image capture and below are the parameters they detect: Automatic mode: software will try to detect: o In Pre-Without inlay acquirements: the laser reflection, and the pupil. o In Post-With inlay acquirements: the laser reflection and the KAMRA inlay. In some cases, the pupil parameters may also be detected. Manual mode: The software will try to detect the laser reflection and the operator will manually mark the location of the pupil (pre-op) or the inlay (post-op). If for some reason the best focus point is lost (the tick/check mark and green circle disappear), move the instrument again in the direction of the indicator arrows to center and obtain better focus. This can happen due to involuntary movement of the instrument by the operator or movement of the patient s head. It is recommended that the patient blinks as little as possible during this step of automatic capture of images Automatic mode The software will try to capture 3 consecutive and similar images. Once complete, the software will automatically choose the best of these 3 images, and will display it on the screen for the operator Manual mode Once the software captures an image where the laser reflection is detected, the patient can blink normally again. The captured image is displayed for the operator, zoomed and with incremented contrasts

69 Figure 44. Zoomed and contrasted image, with a wrong mark for center and diameter pupil. On the zoomed image, the operator must mark: Pre-Without inlay acquirements: pupil s center and border. Post-With inlay acquirements: KAMRA inlay s center and borders. In order to mark the center, simply move the mouse to the center of the circle over the pupil (pre-op) or inlay (post-op). To adjust the diameter, simply use the mouse wheel, or keys + and

70 Figure 45. Zoomed and contrasted image with correct mark for center and diameter pupil. Once the operator finds the correct center and diameter, he must click, and the software will show the results of this partial acquirement

71 Validating an image The user should then assess how good the suggested image is based on how well borders and detected points adjust to patient s eye reality. While the decision is made, the patient may again blink comfortably, since the image has already been captured Invalid image If you believe that the pupil border has not been properly detected, you should click on Discard image and the program will take you back to section Figure 46. Wrong pupil detection on pre-op image

72 Valid image If you consider the suggested image to be sufficient, you should then click on the Valid image! button. The program will keep the image and proceed to the next step. Figure 47. Valid pupil detection on pre-op image

73 Acquiring and validating four more images In Manual mode, this step is not required and therefore the software will move on to the next step (section ). If in Automatic mode, you have managed to acquire and validate one image but in order to guarantee accurate results, the program requires five images and it will choose the one which best reflects the patient s eye reality. Therefore, once you have validated one image, the program will take you back to section , in order to continue with the process of acquiring and validating images until reaching five valid images. When going back to section you should take into account that since the patient s position should not have changed (nor the device s position), the patient s eye should still be well focused, but small corrections of the machine s position will be needed. For the second, successive image, the program will automatically discard those images that are different from the initially validated image. In this way, the five validated images will be very similar to one another. Once you validate the fifth image, the program will take you to the next step. Figure 48. Fifth pre-op measurement

74 Validating final results At this stage, the patient can move away from the device since the measurement process has finalized. Once you validate the last captured image, the program will show you the final resulting image. This final image is automatically chosen by the program from the set of previously validated and accepted images by the operator (1 in Manual mode, or 5 in Automatic mode), and it is, statistically, the one closest to reality. For result images of pre-op measurements, the following parameters are shown: Yellow: Green: Red: Pupil and pupil center. Optical axis. Position where the KAMRA TM inlay should be implanted. Figure 49. Final result of a pre-op measurement

75 For result images of post-op measurements, the following parameters are shown: Green: Optical axis. Red: KAMRA TM inlay and its center. Figure 50. Final result of a post-op measurement Printing and exporting a results report For any of the measurement types, click the Print button to print a complete report of the measurement results and parameters. You will be shown a menu where you can choose to print the report, access a preview or export the report to a file. The report can be exported to bmp, jpeg and pdf files. It can also be exported from the preview screen (click on Save as). Figure 51 and the following figures provide an example of a report for each type of measurement. They include the most relevant information of the measurement, including the parameters that were used and the results that were obtained

76 Figure 51 Example of a report for Scatter Meter

77 Figure 52. Example of a report for Optical Quality

78 Figure 53. Example of a report for Pseudo Accommodation

79 Figure 54. Example of a report for Tear Film Analysis

80 Figure 55. Example of a print report for Tear Film Analysis (sound pattern)

81 Figure 56. Example of a report for a pre-op Purkinje

82 Figure 57. Example of a report for a post-op Purkinje For Scatter Meter and Optical Quality, more complete reports are also available, which include all of the results (also those intended for expert users). These reports are only accessible after clicking the More options button of the visualization options. Click on Print complete report in order to get those reports

83 Lastly, you can also generate reports for each of the result comparison screens (accessible from the option Compare in Database). Click on Print complete report in order to get those reports. 3.7 LICENSE MANAGER Click on the License Manager button in the home menu (Home) in order to access the application for the system s license management. That application manages the measurement credits that are available for the HD Analyzer user, when the software runs in pay-per-patient mode. Carefully read section 3.2 for more information about the different operation modes of the software. After clicking on the License Manager button, the HD Analyzer software shuts down, after user confirmation. The license managing application will run immediately. Figure 58 shows the home screen of that application. Figure 58. License Manager Home menu

84 The field Running mode indicates the HD Analyzer software running mode. It can be in Pay-Per-Patient or Free mode. The field Available credits indicates the number of available measurement credits in pay-per-patient mode. If you have purchased new credits and you want to activate them in the device, click on Enter New Code. You will be shown the screen represented in Figure 59. Figure 59. Validation of the activation code You must type in the activation code you obtained after your purchase at the Visiometrics web page (see section 3.2). In the example, the code ABCD a-lkjh has been typed. Then click on Validate Code. If the code you have entered is not valid, you will be asked to check if the 16 digits have been typed correctly. If the code you have entered is valid, the new credits will be added to the previously available ones, and a summary screen will be shown (Figure 60)

85 Figure 60. Summary of the activation code validation In the home menu of the application (Figure 58), there is also an Options button. That button gives access to the option screen, as seen in Figure 61. The only parameter that can be modified by the user is the language of the license managing application (English and Spanish are available). The button Administrative tools activates a section of administrative parameters, which cannot be accessed by the user. In this way, this section is protected with a password that is not provided to the user. Figure 61. License Manager options

86 The application can be closed at any time by clicking on the red cross on the right top corner of the screen. The license managing application will be shut down. The HD Analyzer software will then restart with the updated number of available measurement credits (if it has been modified). 3.8 SETUP Click on the Setup button in the home menu (Home) in order to access the system s setup screen. Figure 62 shows an example of the setup screen. It is clearly divided into four sections: Figure 62. Setup screen Tear Film Options This refers to the sound pattern that will be used by default to carry out the Tear Film Analysis sequences. Click on Modify to apply changes. The program will restart with the new values, with prior confirmation from the user

87 3.8.2 User visible parameters There are three data fields that are visible to the user: Serial number refers to the serial number of the HD Analyzer unit that is being operated and cannot be modified by the user. Company refers to the name of the clinic, hospital, company, etc. where the equipment is installed, and it can be modified by the user. User refers to the user s name that operates the HD Analyzer, and it can be modified by the user. The data entered in the fields Company and User is shown in the header of all software screens. None of the editable fields is mandatory and can be left blank, if desired. By clicking on Modify, the software will restart with the new values, after the user s confirmation Setup buttons In this section, you will find three buttons. The actual configuration is stored in a file, which can be imported/exported by means of the buttons Load Config File and Export Config File, respectively. Both actions are only necessary in case of an error in the system or due to maintenance tasks. The user should never manipulate the configuration file unless proper instructions were given by Visiometrics or an authorized person. An incorrect manipulation of that file will result in the system malfunctioning. The user must never perform import/export operations of the configuration file of HD Analyzer (Load Config File / Export Config File), unless the user has the express consent of Visiometrics. An incorrect manipulation of that file will result in the system malfunctioning. The other button that is included, Upgrade, is used for performing upgrades of the software version of the HD Analyzer. In case that an upgrade is available for the equipment, Visiometrics will send the user the setup file, along with proper instructions. Please, follow those instructions carefully. In general, the upgrade is

88 performed by clicking on Upgrade and choosing the upgrade file in its location. A password will be required, which will be previously provided by Visiometrics. After password validation, the upgrade is performed. You must always follow the instructions that are provided with the upgrade file Hardware setup This section is protected with a password, which Visiometrics will provide only in the case that the device needs a maintenance task. The password is not provided by default, in order to avoid any unintended modification of the configuration parameters of the instrument. Access to the Hardware setup section is restricted to qualified staff. Some parameters, if changed, can cause the equipment to malfunction. 3.9 BACKUP Click on the Backup button in the home menu (Home) in order to perform a backup copy of the database. You must select the desired location and name of the folder where the copy of the data will be stored. The system backups all of the files with patients data and the measurements performed on them. This includes the Microsoft Access TM database file, as well as all of the registered images. You should make a backup copy regularly. It should be noted that the copy may take up a large amount of disk space (it could reach up to several gigabytes). Therefore, before performing the backup, verify that there is enough free disk space in the folder where the copy will be stored

89 Chapter 4: Examples of measurements 4 EXAMPLES OF MEASUREMENTS 4.1 NORMAL EYE Figure 63 shows a report of the results for a young and healthy eye measurement. Figure 63. Normal eye Notice that the double-pass image is sharp and round. This indicates that the optical degradation, due to both aberrations and intraocular scatter, is very small. This is also confirmed with the high value of Predicted VA (few aberrations) and the low value of OSI (low level of scatter), as expected. Regarding the simulation of the image projected on to the retina, it can be seen that there is no remarkable degradation compared with the original image

90 Chapter 4: Examples of measurements 4.2 CATARACT EYE Figure 64 is an example of a results report of an eye with a cataract. Figure 64. Eye with a cataract It can be noticed that the double-pass image is much larger than in the case of a normal eye. This means that the energy (light) is spread on the retina. That is the effect of the intraocular scatter (light spreading in all directions). In this case, a high value of OSI should be expected. Furthermore, the Predicted VA value should be low. The simulation of the image projected on to the retina shows an important degradation caused by the ocular media, comparing it with the original image. The scatter generates an overall loss of contrast in the retinal image. This is the wellknown veil effect caused by cataracts. It should be taken into account that other effects such as glare or halos are not simulated on this image, so their presence must not be expected

91 Chapter 4: Examples of measurements 4.3 POST-LASIK EYE After a LASIK procedure, there is some uncertainty about the real state of the eye. Although the patient sees properly, new aberrations or a slight level of scatter on the cornea may appear. To verify the success of the procedure, the user may take a measurement on the patient. Figure 65 shows an example of a report of the results of an eye after LASIK surgery. In this case, quality of vision is very satisfactory, since the double-pass image is round and its size is acceptable. The OSI value is low and the Predicted VA value is high, as it should be for a successful procedure. Figure 65. Eye after a successful LASIK surgery

92 Chapter 4: Examples of measurements On the other hand, Figure 66 shows an example of a surgery where the expected results have not been achieved. The double-pass image is larger, due to the presence of aberrations and a certain level of scatter. The OSI value is larger than in the previous case (more scatter), and Predicted VA is lower. Lastly, the simulations of the image projected on to the retina show a more noticeable blurring in the second case. Figure 66. Eye after a non-successful LASIK surgery

93 Chapter 5: Error solving 5 ERROR SOLVING HD Analyzer software shows several error messages when an error occurs. These are the possible messages the system can show: 5.1 ERROR MESSAGES Code Error message Cause 5 6 The program requires a screen resolution of 1366x768, 1366x800, 1280x768 or 1280x800. The current resolution is not valid, so the program must shut down. Try to change your screen resolution. The program initialization has failed. The program will shut down. 21 The acquisition has failed 22 25, 26, 27, 28, 29, 30 The self-focusing process has failed. Please check if the subjective refraction you have entered is correct and try again 32 Error in the video signal 33 The images could not be opened 34 Error while processing the images 36 The program has not captured enough images for their process. Please try again The program requires a screen resolution of 1366x768, 1366x800, 1280x768 or 1280x800. This error shows up when a different screen resolution is being used. User should change screen resolution. For some reason (memory shortage, not enough free space on disk, etc.) software cannot initialize. Contact Visiometrics. Measurement could not be completed. Try again. The Objective Refraction process could not be completed. Check subjective refraction typed in and try again A hardware error has occurred in the spherical refraction compensation internal system, in the artificial pupil internal system, in the system s shutter, in the system s laser, in the vibration internal system or in the system s LEDs User should switch the device off and then on again to check if the error happens again. If it does, contact Visiometrics Signal coming from the system cameras has been lost. User should switch the device off and then on again to check if error happens again. If it does, contact Visiometrics. Images for that selected acquisition were not found in disk. Contact Visiometrics if this error becomes repetitive. An error has occurred when processing the images. Contact Visiometrics if this error becomes repetitive. For some reason, measurement could not be completed. (Some images were not registered). Try again. 39 There is no patient selected. No patient was selected. Select one. 40 There is no acquisition selected No acquisition was selected. Select one.

94 Chapter 5: Error solving Code Error message Cause There is more than one acquisition Too many acquisitions have been selected. 41 selected. Select only one The system s cameras could not be detected. Check the connections. One of the system s cameras could not be detected. Check the connections. Software is not detecting the device s cameras. User should check the connection between computer and device. Software is not detecting one of the device s cameras. User should switch the device off and then on again in order to check if the error occurs again. If it does, contact Visiometrics. 49 Communication failure with camera A communication problem has occurred with the system cameras. User should switch the device off and then on again to check if error occurs again. If it does, contact Visiometrics There is not enough energy reaching the camera. The images could not be recorded. Error while updating the credit count. The program will shut down. The License Manager software was not found. The system has reached the maximum laser power, but it is still not enough to measure patent. Try again. Credit could not be deducted. Contact Visiometrics. The License Manager software could not be found. Contact Visiometrics. 5.2 WARNING MESSAGES Message The device has not been detected so the software will run in read only mode. Cause Hardware is not connected or is not working. It will not be possible to take any new measurements. To run it in normal mode, check the connection cables and restart the software. The program has detected a problem with the hardware and will shut down. You can t perform new measurements. Visit our website if you want to get more credits. To take new measurements make sure that the device is correctly plugged into the main power source and to the computer. Once everything is checked, restart the software. A hardware error has occurred and the program shuts down. User should switch the device off and then on again to check if error occurs again. If it does, contact Visiometrics. User does not have any credits left. User must buy and activate new credits through the License Manager tool

95 Chapter 5: Error solving Message The MTF could not be computed. The pupil diameter of the patient could not be measured during the process. This value will be set to zero. At least one of the spherical refractions is out of range. In case of measuring that eye, please correct it with trial lenses and choose Total correction in the Correction field in the measurement screen. At least one of the cylindrical refractions is out of range. In case of measuring that eye, please correct it with trial lenses and choose Astig. correction or Total correction in the Correction field in the measurement screen. You have typed an incorrect password Cause Images have such poor quality that MTF function could not be processed. Contact Visiometrics if this error becomes repetitive. Because of lighting conditions not being optimal, the patient s pupil diameter could not be measured. Try again. Spherical refraction typed in is out of range. It must be compensated by means of trial lenses or patients own correction devices (contact lenses or glasses). Cylindrical refraction typed in is out of range. It must be compensated by means of trial lenses or patients own correction devices (contact lenses or glasses). A wrong password has been typed in to enter setup. Try again. Error listing is registered in the file C:/Program Files (x86)/visiometrics/hd_ Analyzer/log/error.log. If an error occurs, exit the application; switch off the instrument and restart PC and HD Analyzer. If repetitive error occurs, verify the connections between the computer and hardware and contact VISIOMETRICS. If error persists, please contact Visiometrics technical support

96 Chapter 6: Manufacturer 6 MANUFACTURER VISIOMETRICS, S.L. c/ Argenters, 8 - Edifici nº 3 Parc Tecnològic del Vallès Cerdanyola del Vallès Barcelona (Spain) Tel.: (+34) Manufacturer nr: PS Our Website: Sales Inquiries: Technical Support: customerservice@visiometrics.com technicalservice@visiometrics.com

97 Chapter 7: Regulatory Information 7 REGULATORY INFORMATION Australian sponsor Emergo Australia Level 20 Tower II, Darling Park 201 Sussex Street Sydney, NSW 2000 Australia

98 Chapter 8: Appendix A 8 APPENDIX A If MS Access TM is installed on your computer, you can access the HD Analyzer database directly. You will find a copy of the database file in this folder C:/Program Files (x86)/ Visiometrics/HD_Analyzer / PATIENTS BD. Using this folder, there is no danger of harming or deleting existing data. This copy of the database file (BD_PATIENTS. mdb) is regenerated every time the HD Analyzer software is closed. We strongly recommend not accessing it while running the software. When you open BD_PATIENTS.mdb you will find three tables: Patients_Table Acquisitions_Table Struct 8.1 PATIENTS_TABLE This table shows the patients personal data, which was typed in at the time of adding a new patient file. These are the available fields: Id: Automatically generated exclusive identifier for each patient. For internal use of the system. NAME: Patient s name. SURNAME1: Patient s surname. REFERENCE: Patient s Id number on patient s file. It is a compulsory field. DATE_OF_BIRTH SEX ADDRESS CITY ZIP COUNTRY PHONE E_MAIL

99 Chapter 8: Appendix A OBSERVATIONS: Comments OD_Sph, OD_Cyl, OD_Axis, OS_Sph, OS_Cyl, OS_Axis: Unused obsolete fields 8.2 ACQUISITIONS_TABLE Fields on this table are related to acquisitions. Each record corresponds to one measurement of any of the available types (Purkinje, Scatter Meter, Optical Quality, Pseudo Accommodation or Tear Film Analysis). Id_Acq: Automatically generated exclusive identifier for each measurement. For internal use of the system. FK_Id_Patient: Patient s identifier to whom the measurement belongs to. It is the same value as Id on the Patients_Table and it allows us to relate this table to the patients table. DATE, HOUR: When the measurement was taken OS, OD: Left eye, right eye, respectively. SPH, CYL, AXIS: These are spherical and cylindrical refraction values and astigmatic axis introduced by user in the Sph, Cyl and Axis fields on the main screen, before carrying out the measurement. BCVA, UCVA: These are the visual acuities for best correction (Best Corrected Visual Acuity) and no correction (Uncorrected Visual Acuity), respectively. They are entered by the user before carrying out the measurement. REFERENCE_SPH_REFRAC: Spherical refraction correction applied during the measurement. AP, NP: Diameter in millimeters of the artificial (diaphragm) and natural pupil, respectively. NOTES: These are the comments written under the field Acquisition notes on the results screen. BESTFOCUS: It is the value of optimal spherical correction obtained in the Objective Refraction process. WIDTH_PROFILE_1/2: Profile width at half height. WIDTH_PROFILE_1/10: Profile width at 10% height. MTF_CUT_OFF: MTF cut off frequency

100 Chapter 8: Appendix A STREHL RATIO: Calculated Strehl Ratio. VA_100, VA_20 and VA_9: Estimated decimal VA at different contrast situations, 100%, 20% and 9%. OQAS_Value_100, OQAS_Value_20 and OQAS_Value_9: OQAS value at different contrast situations, 100%, 20% and 9%. Type_Num: 1, 2, 3, 4 or 5. It relates to the following field. Type: Measurement type 1 = Opt. Qlt (Optical Quality) 2 = SCT (Scatter Meter) 3 = Pseudo Acc (Pseudo Accommodation) 4 = Not in use 5 = Tear Film (Tear Film Analysis) 6 = Purkinje Corr_Type_Num: 0, 1 or 2. It relates to the following field Corr_Type: Indicates the correction type applied during the measurement. 0 = No correction 1 = Astig. correction 2 = Total correction NImag: Number of captured images. NImag_Acc_Each: Number of images processed for each pseudo accommodative stage (Pseudo Accommodation). COMPUTED_IMAGES: It records which of the six available images were used to carry out calculations the last time that acquisition was shown. OAR: OQAS Accommodative Range. OSI: Objective Scatter Index. Refrac_Acc_Per_1: Not in use. Refrac_Acc_Per_2: Not in use. AR: Not in use. Time_Each_Image_TearFilm: Time between images for the Tear Film Analysis process. TearFilm_Time: Stores the moment when each image was recorded in the Tear Film Analysis process. TearFilm_OSI: Stores the OSI value for each image that was recorded in the Tear Film Analysis process. TearFilm_Central_Energy: Stores the energy at the center of each image that was recorded in the Tear Film Analysis process. TearFilm_Peripheral_Energy: Stores the energy at the periphery of each

101 Chapter 8: Appendix A image that was recorded in the Tear Film Analysis process. TearFilm_VA: Stores the estimated VA for each image that was recorded in the Tear Film Analysis process. TearFilm_MTFCutoff: Stores the MTF cut off frequency for each image that was recorded in the Tear Film Analysis process. TearFilm_MeanOSI: Stores the mean OSI value for the Tear Film Analysis process. TearFilm_StdevOSI: Stores the standard deviation of the OSI for the Tear Film Analysis process. PKJ_IsPreOperation: It only applies for Purkinje acquirements. It stores if the acquirement is pre-operation or post-operation. PKJ_MicrasPerPixel: It only applies for Purkinje acquirements. It stores the relation pixel-microns in the associated image. PKJ_PupilDiameter: It only applies for Purkinje acquirements. It stores the pupil s diameter. PKJ_PkjVsPupil_Length: It only applies for Purkinje acquirements. It stores the distance, in pixels, between the Purkinje and the pupil s center. PKJ_PkjVsPupil_Angle: It only applies for Purkinje acquirements. It stores the angle between Purkinje and pupil s center. PKJ_PkjVsPupil_X: It only applies for Purkinje acquirements. It stores the existent distance, in microns, on the X axis, between Purkinje and pupil s center. PKJ_PkjVsPupil_Y: It only applies for Purkinje acquirements. It stores the existent distance, in microns, on Y axis, between Purkinje and pupil s center. PKJ_InlayVsPupil_X: It only applies for Purkinje post-operations acquirements. It stores the existent distance, in microns, on X axis, between inlay KAMRA s center and pupil s center. PKJ_InlayVsPupil_Y: It only applies for Purkinje post-operations acquirements. It stores the existent distance, in microns, on Y axis, between inlay KAMRA s center and pupil s center. PKJ_InlayVsPkj_X: It only applies for Purkinje post-operations acquirements. It stores the existent distance, in microns, on X axis, between inlay KAMRA s center and Purkinje. PKJ_InlayVsPkj_Y: It only applies for Purkinje post-operations acquirements. It stores the existent distance, in microns, on Y axis, between inlay KAMRA s center and Purkinje

102 Chapter 8: Appendix A PKJ_Pupil_PixelCentroX: It only applies for Purkinje acquirements. It stores the pixel, on X axis, where the pupil s center is. PKJ_Pupil_PixelCentroY: It only applies for Purkinje acquirements. It stores the pixel, on Y axis, where the pupil s center is. PKJ_Pupil_PixelRadio: It only applies for Purkinje acquirements. It stores the pupil s radius, in pixels. PKJ_Laser_PixelCentroX: It only applies for Purkinje acquirements. It stores the pixel, on X axis, where the Purkinje s center is. PKJ_Laser_PixelCentroY: It only applies for Purkinje acquirements. It stores the pixel, on Y axis, where the Purkinje s center is. PKJ_Inlay_PixelCentroX: It only applies for Purkinje post-operation acquirements. It stores the pixel, on X axis, where the inlay KAMRA s center is. PKJ_Inlay_PixelCentroY: It only applies for Purkinje post-operation acquirements. It stores the pixel, on Y axis, where the inlay KAMRA s center is. PKJ_Inlay_PixelRadio: It only applies for Purkinje post-operation acquirements. It stores the inlay KAMRA s radius in pixels. TearFilm_Pattern: Only applies in measuring Tear Film, and indicates the following sound pattern: 0: Without sound patter 1: Baseline pattern 2: Stress Condition pattern TearFilm_Group: Only applies in measuring Tear Film that has followed a type of sound pattern, and indicated the group to which the measurement belongs: 0: Not possible to determine a specific group 1: Plateau 2: Plateau/Seesaw 3: Seesaw 4: Seesaw/Ladder 5: Ladder

103 Chapter 8: Appendix A 8.3 STRUCT The fields of this table contain no useful information for the final user. 8.4 SYMBOLS Warning Electrical products recycling. Do not dispose of this product with your other household waste. It must go to a designated collection point for the recycling of electrical and electronic equipment waste. CE Mark Serial number Applicable part Laser radiation Class II device Fragile Keep dry Keep in upright position Read user manual