Pentacam. Instruction Manual. Measurement and Evaluation System for the Anterior Chamber of the Eye

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1 Pentacam Instruction Manual Measurement and Evaluation System for the Anterior Chamber of the Eye Copyright by G/70700/0404/e

2 Page 2 Pentacam Instruction Manual Foreword We thank you for the trust you have put in this OCULUS-product. With the purchase of this instrument, you have chosen a modern, sophisticated product, which was manufactured and tested according to strict quality criteria. Ongoing research and development are of benefit to you but can result in changes in certain features of the product as well as in extent of supply. Therefore, in individual cases the diagrams shown in this instruction manual might not correspond completely with the features of the product you received. Our enterprise has been doing business for over 100 years. Today OCULUS is a medium-sized enterprise concentrating completely on helping ophthalmologists, optometrists and opticians to carry out their responsible work by supplying an optimal range of instruments for examinations and surgery on the eye. The Pentacam is the newest product in the Oculus line. It is based on the Scheimpflug principle, which generates precise, sharp images of the anterior eye segment. Our painstaking product development has produced an instrument that takes extremely accurate measurements and is easy to use. To assure safe operation, it is imperative that the instrument is used properly. Therefore, you should become thoroughly familiar with the content of the instruction manual before putting the instrument into operation. If you have questions or desire further information on this product, call, fax or us. Our service team will be glad to help you. OCULUS Optikgeräte Managing director and management team

3 Pentacam Instruction Manual Page 3 Table of Contents 1 Scope of supplies and optional accessories Safety precautions Description of unit Use in accordance with regulations Start-up Setting up and installing equipment Software Installation on separate PC s Transport and storage Patient data management Selecting patients Adding new patients Starting the examination program Deleting / reallocating examinations Patient data Renaming patients Deleting patient data Exporting patient data Importing patient data Backup Saving data Reconstructing data Automatic backup Loading previous examinations Changing settings The Pentacam program The Examination Program Setting up and performing measurements Important information on the acquisition of Scheimpflug images Settings Brightness/Contrast Changing Settings The evaluation programs Overview display Chamber Analysis Virtual Eye Colored maps, large Pachymetry Topography General Keratometer values Curvature radius Topography of the anterior surface Topography of the posterior surface Elevation data Reference bodies Applications of the elevation display method Anterior elevation map Posterior elevation map True Net Power Keratometric Deviation Anterior Chamber Depth Scheimpflug Images D-Scan large...49

4 Page 4 Pentacam Instruction Manual Manual measurement function Zoom function Densitometric quantification Tomography Artefacts Maintenance Care and maintenance Elimination of errors and malfunction Replacement of fuses Error detection Conditions of warranty and service Conditions of warranty Liability for malfunction and damages Address of manufacturer and service department Appendix Declaration of conformity Pentacam Calibration Data CD Installation of calibration files Formatting a CD-ROM for data protection Formatting procedure Example of how to to save a single examination Technical data Minimum PC-requirements Key words

5 Pentacam Instruction Manual Page 5 Scope of supplies and optional accessories Pentacam E: Including: Pentacam mounted on x-y-z moveable base Head and chin rest Power supply unit input Volt, output 5V, 1A Plate for mounting on refraction unit or table (size 28 x 36cm) USB hub License key Y-cable Testing protocol for electronic safety Instruction manual G / 70700/.../e Dust cover /1 Paper for chin rest Windows TM software package and manuals Mouse Software CD Calibration CD Optional applications: Software module for pachymetry Software module for densitometry Software module for 3D chamber analyzer Software module for corneal topography, front and rear surface Optional: Color printer Software module for separate working place Foot pedal option We reserve the right to make changes in extent of supply if called for by technical developments. 2

6 Page 6 Pentacam Instruction Manual Safety precautions The legislator expects the manufacturer to inform the user of safety precaution measures which should be taken when operating this instrument. The following chapter contains a summary of the most important information on technical safety features of the Pentacam. Further safety precautions are incorporated into the text of this instruction manual and are indicated by this symbol: Please heed these precautions. Please save this instruction manual and ensure that it is accessible to operating personnel at all times. This instrument must only be used for the Use in accordance with regulations as laid down in section 4 of this instruction manual and operated by persons who can assure that the instrument is used properly on the basis of their training, expertise or practical experience. Before using this instrument for the first time, you must be instructed on how to use it by our staff or an authorized dealer. Only operate the instrument with the original components supplied from OCULUS Optikgeraete GmbH and if the instrument is in good working condition. Should the instrument be defective, do not operate it; contact the supplier. Please observe the legally binding accident prevention regulations. The instrument may only be used in medical facilities, which comply with VDE regulations Before maintenance and cleaning the instrument, always pull out the plug of the Pentacam and all equipment attached to it, for example PC and printer. Do not connect cables if this proves difficult. If it is impossible to make a connection, check to see whether the plug fits into the socket. In case you ascertain a defect, have it repaired by our service team. When disconnecting electrical connections, always pull on the plugs, not on the cables. Supplementary equipment which is connected to the analog or digital interfaces of the instrument must comply with pertinent EN- / IEC specifications. All configurations must conform consistently to norm IEC If the Pentacam is coupled with non-medical electrical equipment (for ex. data processing equipment) this must not result in a decrease of patient safety beyond the tolerance levels laid down in IEC If the coupling of equipment causes the tolerance levels for leakage current to be exceeded, safety features, which include a disconnection device, must be provided for. Do not operate the delivered equipment ο in areas with risk of explosion, ο in the presence of flammable anesthetics or volatile solvents such as alcohol, benzene or similar substances. Do not use or store the instrument in damp rooms. Avoid placing the instrument in the vicinity of dripping, running or spraying water and ensure that no moisture can penetrate the instrument. For this reason, do not place any containers filled with fluids near the instrument. When cleaning the instrument with a damp cloth, be sure that no moisture enters it. Do not cover up ventilation holes. Important to note: this instrument is a highquality technical product. In order to assure faultless and safe operation, we recommend that our service team inspect the instrument every two years. If a defect arises which you cannot eliminate yourself, mark the instrument as defective and notify our service department. 3

7 Pentacam Instruction Manual Page 7 Description of unit The OCULUS Pentacam is a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions, with the dot matrix finemeshed in the center due to the rotation. It takes a maximum of 2 seconds to generate a complete image of the anterior eye segment. Any eye movement is detected by a second camera and corrected for in the process. The Pentacam calculates a 3-dimensional model of the anterior eye segment from as many as 25,000 true elevation points. The topography and pachymetry of the entire anterior and posterior surface of the cornea from limbus to limbus are calculated and depicted. The analysis of the anterior eye segment includes a calculation of the chamber angle, chamber volume and chamber height and a manual measuring function at any location in the anterior chamber of the eye. In a moveable virtual eye, images of the anterior and posterior surface of the cornea, the iris and the anterior and posterior surface of the lens are generated. The densitometry of the lens is automatically quantified. The Scheimpflug images taken during the examination are digitalized in the main unit and all image data are transferred to the PC. When the examination is finished, the PC calculates a 3D- virtual model of the anterior eye segment, from which all additional information is derived. The measurements are displayed on the monitor in the form of colored maps, diagrams and 3D images. When evaluating acquired images please keep in mind the possibility of artefacts arising, as described in chapter 8 Artefacts. The company OCULUS Optikgeräte GmbH emphasizes that the user bears the full responsibility for the correctness of data measured, calculated or displayed using the Pentacam. The manufacture will not accept claims based on erroneous data. 4 Use in accordance with regulations For the USA-Market only: Caution: Federal law restricts this device to sale by or on the order of a physician, or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of this device. The OCULUS Pentacam is a measuring device used to examine the anterior eye segment and must only be used for the purposes specified in this instruction manual. Therefore, only trained personnel capable of using it properly on the basis of their training, expertise and practical experience must use it. The OCULUS Pentacam is intended for use in clinics and ophthalmologists practices. It is to be used in connection with the examination station intended for it. It must only be operated with the original components supplied from us and in good technically condition. The special power supply unit (see instrument specification) must be used. Other forms of power supply must not be used. Observe the safety precautions stated on the previous page! 5

8 Page 8 Pentacam Instruction Manual Start-up 5.1 Setting up and installing equipment Before initial operation, the OCULUS Pentacam examination station must be set up and connected by our service department or your authorized dealer. Please keep the CD-ROMs, which include the Pentacam software and the calibration data, in a safe place. For installation on a PC or laptop, please contact our service department or your authorized dealer. Before installing the Pentacam please consider the transport, storage and current room temperature where the device is to be installed. The difference between the temperature of the installation room and the storage or transport temperature should not be more than 10 C to avoid fogging of the internal optics. If the difference in temperature is greater than 10 C, please leave the system at least for 6 hours until the temperature of the instrument has adapted to room temperature. The Pentacam must be placed in such a way as to prevent direct light from influencing the measurements. A reflex-free examination must be assured. Therefore, the Pentacam should be used in a darkened room. This is an optical device and should be handled with due care. Do not subject it to vibrations, jolts, contamination or high temperatures Software Installation on separate PC s The Pentacam software is network compatible. This makes it possible to install the Pentacam Software on several PCs connected in a network. A software protection tool is included in software versions V1.03 and higher. The Pentacam software shows only the demo examinations. To look at individual examinations on an external PC you will need to buy a software license from your authorized dealer. This license includes an operator s manual, an installation manual, a software CD-ROM and a hardware license key ( dongle ), which has to be connected to the serial or USB port of the PC where the Pentacam software is installed. Please be sure also to install the Calibration CD- ROM. For information that is more detailed please contact your authorized dealer or our Service department. 5.2 Transport and storage Should you ever transport the instrument to another place, do so with particular care. Avoid placing it near heating units or in a damp environment during operation as well as storage. Check the instrument for defects after any transport. Do not under any circumstances put a defective instrument into operation, but rather contact our service department. If you store the instrument in a cold room or in a vehicle in cold weather, the optical components of the instrument can become fogged up in the case of an extreme change of temperature from cold to warm. Give the instrument time to adapt to the new environmental conditions before putting it into operation. The transport and storage specifications required by IEC are: Ambient temperature: -40 C to +70 C Relative humidity including Condensation: 10% to 100% Air pressure: 500 hpa to 1060 hpa These tolerance levels are valid for packaged products for a period of no more than 15 weeks.

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10 Page 10 Pentacam Instruction Manual Patient data management First switch on the PC or Laptop and then the Pentacam. After power-on, the PC loads the operation system and then displays the OCULUS Logo. The patient data administration can be started by mouse click, by pressing down any key or by clicking on the OCULUS icon twice. In order to access the examination program, either a new patient must be entered in the first field or a patient must be selected from the directory of already existing patients.

11 Pentacam Instruction Manual Page Selecting patients On the left side of the monitor, all previously examined patients are listed alphabetically. If more patients are listed than can be displayed on the monitor, the list can be scrolled up or down with the help of the Windows scroll bar. To select more than one patient or more than one examination, move the mouse with pressed left mouse button or use the shift + arrow button of the keyboard. In order to find the desired patient in the list quickly it is advisable to enter the name of the patient in the patient field (upper left). After entry of each new letter, the entry in the directory is searched for and displayed. The patient can also be searched for via his ID number. If the patient s name has been found in the directory, it is transferred to the patient window by clicking on the entry. At the same time, the already existing examinations of the patient appear in the examination window (lower right). 6.2 Adding new patients To add a new patient to the patient administration first [Clear] should be activated in order to delete the previous patient from the patient window. Then the complete last name, first name and birth date must be entered into the patient window (upper left). An ID number for the patient can be entered, but this is not obligatory. When [File] is activated the following message appears: No patient data found! Should the patient be registered? Via [Register new patient] the patient is entered into the list of patients. 6.3 Starting the examination program After selecting the patient, the examination program can be started by activating [Pentacam]. If an examination is clicked on in the examination window as well, it is automatically loaded in the examination program. By double-clicking on the patient s name the examination program is started as well. It is also possible to start the examination program by double-clicking on previous examination. Then this examination is also automatically loaded in the examination program.

12 Page 12 Pentacam Instruction Manual 6.4 Deleting / reallocating examinations Underneath the list of examinations you will find two buttons. They can be used to activate functions, which always refer to the previously marked examination: [Delete exam] This function makes it possible to delete individual examinations from the patient data. After activating the button, one will be asked if one really wants to delete the examination. [Move examination] If the wrong patient s name was inadvertently selected when performing an examination, the results of the examination can be allocated to the proper patient afterwards. After activating [Move examination] in the patient data administration, the patient directory is displayed. The desired patient can now be selected from this directory (scroll down to correct line and click). If the correct patient name has been found and selected, the examination data is allocated to the patient by activating [Move examination].

13 Pentacam Instruction Manual Page 13 Patient data can be changed later by activating [Rename patient] (under the patient directory). 6.5 Patient data Renaming patients In the window, which now appears (on the top right) Change patient data patient data can be corrected. By activating the [Update] button the changes are recorded Deleting patient data Patient data can be deleted via [Delete patient]. Caution! Before data are actually deleted, one must confirm twice that all the examinations performed on the patient as well as all patient data from the patient data administration are to be removed Exporting patient data This function makes it possible to transfer patient and examination data to another file or from a PC to other types of data carriers (for example floppies). After activating the [Export] button in the patient data management, a window will appear which has two buttons. The upper field designates the data record, which is being exported, and the lower one serves to designate the target data carrier. In the field Directory the drive to which the data record is to be transferred (for ex. A:\ ) has to be entered. While clicking to the button with the three dots, a selection field opens to export the chosen patients and examinations directly to an existing file. A subdirectory can be created at the same time.

14 Page 14 Pentacam Instruction Manual Including CCD Images It is possible to extract the camera images from a data record, as data without camera images requires less memory space. Memory space The two memory space specifications show how much memory space is required and how much memory space is available on the target data carrier. Save all data in one file This field is a special function to export patient data and examinations in one file for an easy sending via . By activating the [Export] button the data record is transferred. [Cancel] deactivates the function without transferring data Importing patient data (For ex. from a floppy or CD-ROM to the hard disc or to a file of the PC) [Import] activates this function. Directory In this field the letter which designates the drive and, if it exists, the subdirectory of the source from which the data are being imported are entered. A patient directory shows which patients are registered on the data carrier. In the same way, the examinations performed on a patient are listed after the patient has been selected. Should only one examination be imported, click on the appropriate line in the list of examinations. Importing data is initiated by activating [Import data].

15 Pentacam Instruction Manual Page Backup Saving data [Backup] opens up the backup window. This consists of two fields: Save and Restore. reduce amount of memory space required. This is useful when saving data on floppies. In these fields, the directory can be marked in which the data are to be saved or from which it is to be loaded, for ex. F:\ for an external drive with exchangeable data carriers (replacement disc). Saving data can proceed according to various criteria: Save all data All patient and examination data are saved. Changed and new data only Only such data are saved which has been changed or added since data was last saved. Tip Saving data can be very time-consuming depending upon the amount of data. Therefore, you should perform this function when the PC (or the Pentacam) will not be needed for some time. To initiate data storage, activate [Save]. Including CCD image This function can be deactivated in order to Reconstructing data The reconstruction of saved data can also be carried out according to various criteria: Delete existing data first This function deletes all currently saved examination data of the patients before reconstructing the patient data on the data carrier. Thus after data reconstruction only the examinations are recorded which are also to be found on the backup data carrier. Add examinations This function adds the examination data of the data carrier to the already existing examination data of the patient. [Restore] activates the reloading of data from the backup data carrier into the system.

16 Page 16 Pentacam Instruction Manual Automatic backup It is also possible to save backup data automatically. When exiting an examination program the new examination data are always saved automatically. This function is activated in the Settings menu. This function should only be used if an additional drive with replaceable data carriers is available Loading previous examinations The saved examinations performed on selected patients can be reloaded with the help of the Load function in the Examination menu. The selection is made via a displayed list of examinations. Simply click on desired examination and confirm with [OK] (the displayed examination can also be reloaded by double-clicking on it).

17 Pentacam Instruction Manual Page Changing settings After [Settings] is activated, the menu Change settings appears. Here the patient data administration can be adjusted according to your individual wishes. Language To select the language, German or English, which the program should use. Date format To choose the order in which date is entered: Day/Month/Year (DMY), Month/Day/Year (MDY), Year/Month/Day (YMD), as well as to choose type of punctuation. Automatic backup This activates the automatic backup function (click on Enable ). The backup index in which the data are to be saved has to be entered. This index is also used in the normal backup function as backup index. It is also possible to designate whether camera images should be saved when data are saved automatically or not. Sort The patient directory can be sorted according to the name or ID number of the patient. If the patient s name is used to find the patient, then it is advisable to sort the directory according to name. If the patient s data are loaded according to the patient s ID number, then the directory should be sorted according to ID number.

18 Page 18 Pentacam Instruction Manual Date In this field the system time and date can be changed. Import / Export To enter the drive, and if applicable also the subdirectory from which or into which data are to be exported. Keyboard If simulate is clicked on, then [Keyboard] appears next to the field where the patient s name is entered. If this is activated, a virtual keyboard appears via which the patient s name can be entered. Size of keyboard The size of the virtual keyboard can be selected here. If [Use] is activated, the selected setting is used for all further steps of the program. When restarting the program the saved settings will be reloaded, however. By activating [Save] the selected setting can be saved. Then this setting will be loaded every time the program is restarted. [Cancel] deletes the selected alterations and deactivates the function.

19 Pentacam Instruction Manual Page 19 7 The Pentacam program To start the examination program first select the patient and an examination in the patient data management and confirm this via [Pentacam]. After loading the examination program of the Pentacam, the patient data (top left), as well as the menu bar for operating the program, appear. The menu bar consists of the following functions: Display This function is used to select the form in which the results of an examination should be displayed. Patient Ends the examination program and returns to patient administration. Examination Loads previous examinations or performs new ones. Settings Here various program settings can be selected.

20 Page 20 Pentacam Instruction Manual 7.1 The Examination Program Start the examination program and select the Scan function in the Examination menu. The eye to be examined is recognized by the automatic left/right detection and identified in the Eye field. The left, upper image is called the Orientation display. It contains information on the eye to be examined and the current position of the camera in the Enhanced Dynamic Scheimpflug image mode. The position of the camera can be selected by clicking on the small white rings. If Scheimpflug image is selected, only one Scheimpflug image will be generated. The desired camera position can be selected by clicking on the white rings in the orientation display. In the Enhanced Dynamic Scheimpflug image field one chooses whether 5, 10 or 15 Scheimpflug images should be taken from a single camera position. The mean value of the individual images is taken and represented as one single image. The camera position can be selected as desired by clicking on the white rings in the orientation display. This kind of imaging is suitable for a purely densitometric assessment of the lens. In the 3D Scan field 12, 25 or 50 images can be selected per scan. The scans then differ in the number of evaluated measuring points and the length of the examination. This type of examination must be selected to evaluate the pachymetry and topography and the 3D anterior chamber analysis. The Automatic Release button (lower right) enables or disables the automatic release. Please activate this function before starting the alignment. reached, a black cross is shown in the center of the alignment screen and the measurement starts. Instead of using the automatic release, you can also take the measurement by activating the foot pedal or the Scan button. Activating the Quit button interrupts the measurement. The Light button in the lower center switches the blue illumination of the eye on and off. It is used for screening purposes in order to get an impression of the condition of the eye s lens without dilating the pupil, thus enhancing the patient s comfort. The Pentacam is now set in the prescribed way, the blue light is switched off by clicking the Light button and in the pupil image one can see the patient s pupil becoming dilated. Then the measurement is initiated manually. This function is only useful when generating individual images, however. The live Scheimpflug image (lower left) describes the orientation of the measuring head in z-direction, i.e. the distance to the patient s eye. The image of the pupil (upper center) shows the orientation of the measuring head in vertical or horizontal direction. These two representations are for preadjustment. The small blue circle represents the center of the pupil; the big blue circle marks the pupil. The yellow circle marks the apex of the cornea. The measurement starts automatically when the Automatic Release button is activated. A black cross in the center of the alignment screen shows the point of automatic release. The alignment screen (lower center) provides information for the fine alignment. The arrows show the direction in which the instrument has to be moved to reach the point of automatic release. When this point is

21 Pentacam Instruction Manual Page 21 If automatic release is not activated, the measurement is initiated by activating the foot pedal or the Start Scan button. Before the measurement is initiated, or the point of automatic release is reached, the patient should be asked to open his eye as far as possible. After the measurement is initiated, the images are transferred to the PC digitally and displayed. The image processing procedure starts automatically. In the Enhanced Dynamic Scheimpflug Image mode, the mean values of all the recorded images are taken and one Scheimpflug image is displayed on the overview display (Overview). If the 3D-Scan mode was selected, the first Scheimpflug image, which was recorded, is shown on the overview display (Overview). All of the following images can be displayed and examined individually. From the recorded Scheimpflug images, the system calculates a Virtual Eye of the anterior eye segment. From this, all further information such as the anterior chamber analysis, the topography and the pachymetry are calculated. Areas, which are not measured and were obscured in some way, (eyebrows or eye lashes) are interpolated and marked with black points or whitened areas on the topographical and the pachymetry maps.

22 Page 22 Pentacam Instruction Manual Setting up and performing measurements Decide, which part of the anterior segment is Scheimpflug image. to be examined Ask the patient to open his eye wide. Select the settings in the examination program accordingly Perform the final adjustments according to the red arrows. Adjust the table height Ask the patient to put his head into the head and chin rest Adjust the height of the head and chin rest Align the Pentacam Adjust the Pentacam such that the pupil of the patient s comes into view. Adjust the Pentacam such that the live Scheimpflug image comes into view. Perform the final adjustments according to the arrows. The apex of the cornea is marked by the yellow circle in the pupil s image and by the red dot in the live The image is taken automatically. If you disable the automatic release, take the image manually by pressing the foot switch or clicking to the scan button. Ask the patient to take his head out of the head and chin rest. Check the results on the single Scheimpflug images. Please give particular attention to artefacts blinking of the eye whether the patient s eye was wide open

23 Pentacam Instruction Manual Page Important information on the acquisition of Scheimpflug images This chapter provides information, which should be of help in examining different parts of the anterior segment. The explanations are subdivided corresponded to the important segments: Examination Target Examination mode Images Auto Release Remarks Topography 3D-Scan 25 to 50 Yes No dilation of pupil required Pachymetry 3D-Scan 25 to 50 Yes No dilation of pupil required Anterior Chamber 3D-Scan 25 to 50 Yes No dilation of pupil Analysis required! Artificial lenses general Measurement function Densitometry 3D-Scan or Enhanced Dynamic 3D-Scan: 25 to 50 Enhanced dynamic: 5 Yes, for 3D-scan No, for Enhanced Dynamic, if special technique is used For Enhanced Dynamic Mode: If pupil is not wide enough, dilate pupil, For manual measurements, use 3D-scan 3D-Scan 25 to 50 Yes No dilation required 3D-Scan or Enhanced Dynamic 3D-Scan: 25 to 50 Enhanced Dynamic 5 to 15 x 3 Yes, for 3D-scan No, for Enhanced Dynamic, if special technique is used For Enhanced Dynamic Mode: If pupil does not become wide enough, dilate pupil; Use same number of images to track progress Techniques Place red line in anterior chamber x 1 For Enhanced Dynamic mode, move to nasal x 2 x 1 For locating an artificial lens it is sometimes helpful to place the red line in the live Scheimpflug image in the anterior chamber close to the iris if the lens is not sufficiently visible in the 3D-Scan. x 2 Especially if the pupil is not wide enough it is sometimes helpful to move the Pentacam towards the nose of the patient to get an image of the whole human lens. For better reproducibility, use the red circles in the pupil image as an alignment aid. If the pupil is large enough, the crystalline lens can be imaged entirely in 3D-scan mode. x 3 This depends on the patient. If the patient has difficulty fixating the target (the black ring), as is sometimes the case with older people, it is better to take only 5 images to get a sharp image. On the other hand, one should take as many images as possible in order to minimize noise.

24 Page 24 Pentacam Instruction Manual 7.2 Settings Clicking on the Settings button opens up two options: Brightness/Contrast The Brightness/Contrast field allows you to adjust the image settings. Please keep in mind that changes are only valid for the current examination and do not influence the densitometric evaluation of the Scheimpflug image. Contrast Catch the bar using the left mouse button. Pressing the left mouse button and dragging the bar to the right increases the contrast while dragging it to the left reduces the contrast of the Scheimpflug image(s). Brightness Catch the bar using the left mouse button. Pressing the left mouse button and dragging the bar to the right increases the brightness while dragging it to the left reduces the brightness of the Scheimpflug image(s). Clicking either the Reset or the Normal button causes contrast to return to its original setting, while brightness is set to 0. contrast. The Smooth X button smoothes the Scheimpflug image only in horizontal direction. This makes the important reference surfaces such as the anterior and posterior corneal surfaces and anterior surface of the lens less noisy and more sharp-edged in vertical direction. The Smooth More button smoothes the Scheimpflug Image(s) in vertical and horizontal direction. This gives better noise suppression, but at the cost of contrast. The Inverse button generates a negative representation of the Scheimpflug Image. Clicking on the Set Brightness button triggers a brightness calibration of the Scheimpflug image which sets the darkest point to zero to permit a better utilization of the grey scale. Clicking on the OK button can save changes. Clicking on the Cancel button cancels the changes. Clicking the Median button eliminates scattered pixels without influencing the

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26 Page 26 Pentacam Instruction Manual Changing Settings There are two ways of entering the settings menu of the Pentacam: By entering the Change Settings field By clicking on the color bar at the right. Curvature units permits switching Only one common Scheimpflug image between diopters (dpt) and curvature is taken and displayed. (mm). Color Map Scale permits switching the 5, 10,15 Pictures enhanced dynamic coordinate system between Diameter representation, which gives the usual 5, 10 or 15 Scheimpflug images are taken from one fixed camera position. topographic zones, and Radius, which Every Scheimpflug image has a facilitates evaluation of the distance from the origin, i.e. the apex position. certain noise level. If several images are taken, the resulting noise can be Mode provides the option of: minimized by generating and Online USB; this is mandatory if a displaying a single averaged image. Pentacam is connected to the PC. Demo mode ; this is mandatory if no 12,25, 50 pictures (3D-Scan) Pentacam is connected to the PC. 12, 25 or 50 single images are taken during one scan. The field on the right allows preadjustments to be made in the scan menu: 1 picture: The Automatic Release button activates automatic image acquisition.

27 Pentacam Instruction Manual Page 27 The Mirror Pupil Camera button switches between: the pupil image moving in the same direction as the Pentacam unit, the pupil image moving in the opposite direction of the Pentacam unit. Curvature Color Bar provides three color grades for the topography maps: diopter: 0.25D, 0.5D 1D, curvature: 0,05mm, 0,1mm, and 0,25mm. The Color table external button allows using an external color scale instead of the internal one. Pachy Color Bar provides three color grades for pachymetry map: 5µm, 10µm, 25µm. The Color table external button allows to use an external color scale instead of the internal one. Elevation Color Bar provides three color grades for the elevation maps: 5µm, 10µm, 25µm. The Color table external button allows to use an external color scale instead of the internal one. A. C. Depth Color Bar provides three color grades for the Anterior Chamber Depth map: 5µm, 10µm, 25µm. The Color table external button allows to use an external color scale instead of the internal one. The language can be set to English or German. Foot Switch allows setting the Com Port using the up/down keys. The message below shows whether the foot switch is connected to the Laptop / PC. Date Format provides country specific settings: D/M/Y: Day/Month/Year M/D/Y: Month/Day/Year Y/M/D: Year/Month/Day The Separator field provides a selection of country-specific separators. Normal level sets the contrast level for the Scheimpflug images to the standard value. The four buttons on the right are for presetting the representation of the Scheimpflug images. For more information about the effects of the individual buttons please refer to Brightness/Contrast Clicking on the Save button saves all changes. Clicking on the Cancel button cancels all changes. Test Screen button is for internal setting

28 Page 28 Pentacam Instruction Manual 7.3 The evaluation programs Overview display The overview display is a compilation of several evaluation representations which gives a quick overview of the anterior eye segment being measured. It contains the following data fields: Patient and Examination data (upper right) These data are displayed on the upper right. Camera/slit lamp position and individual images The display on the upper left shows the position of the camera and the cross-section of the eye as well as the corresponding Scheimpflug images. For better orientation in the individual Scheimpflug images one side of the image is marked with a white dot in the orientation display as well as in the current Scheimpflug image. All generated Scheimpflug images can be viewed individually by clicking on them. The images are numbered and the intersection angle of the individual images is displayed. The selected image is displayed below. Special keys assigned on the keyboard allow you to find important images more quickly: Pos1: selects the first Scheimpflug image taken End: selects the last Scheimpflug image taken Page up: selects the Scheimpflug image taken in the vertical axis (90 ) Page down: selects the Scheimpflug image taken in the horizontal axis (180 ).

29 Pentacam Instruction Manual Page 29 Comment At the top edge of the current Scheimpflug image is a place for adding comments. For this purpose click on the top edge of the Scheimpflug image with the left mouse button. A window appears saying Change info text, in which you can enter your comment or change one already entered. Clicking the [Ok] button closes the window, whereupon the comments appear in the camera image. Scheimpflug image and densitometry (left of center) The selected image is displayed. By clicking on any part of the lens with the left mouse button, its densitometry is displayed in a green bar on the right. The height of the green graph indicates how hazy the lens is. This entails evaluating the cross section, which is marked with dotted lines. By moving the mouse while holding down the left mouse button, the densitometry of any part of the lens can be evaluated. For more information about the Scheimpflug images, please refer to chapter Scheimpflug Images, page 49. Virtual Eye The Virtual Eye is shown in the lower half of the overview display. In this model the anterior and posterior surface of the cornea, iris and lens are depicted as planes. By clicking on the Show button on the left, they can be activated and deactivated. For more information, please refer to chapter Virtual Eye, page 31. Keratometer values (upper middle right) The anterior surface of the cornea is described in terms of central radii, astigmatism including axis, and eccentricity. The representation of the central radii can be chosen in diopters (dpt) or curvature (mm) values. The mean eccentricity (ecc) and the mean pupil diameter (mm) are depicted too. For more information, please refer to chapter Keratometer values, page 35. pachymetry map, calculated anterior chamber depth, lens thickness, chamber angle and chamber volume are depicted. For more detailed information, please refer to chapter Chamber Analysis, page 30. Colored maps In order to gain a first impression, the colored pachymetry, topography and elevation maps are displayed on the overview display in the lower right-hand corner. These maps of the cornea are shown in color and the depiction is dependent upon location, i.e. by clicking with the left mouse button on any part of the cornea the corneal thickness, curvature or elevation is represented numerically. By activating [Num] the values of 19 locations of the cornea are numerically represented, depending on the selected map. The pupil edge is depicted as a black and white line. The white cross marks the center of the pupil and the white dot marks the apex of the cornea. The apex is defined as that part of the cornea where the mathematical gradient is zero. This is comparable to the top of a mountain. For more information. Please refer to chapter Colored maps, large, page 33. Color bar The color bar is located on the right margin of the overview display. If one selects the pachymetry map, it describes which color is used to show the various thicknesses of the cornea in µm. If one employs the topography map, however, it describes which radius of curvature or equivalent of curvature in diopters corresponds to that bar, similar to the elevation maps. Clicking on it with the left mouse button causes the settings menu to automatically open to check or change the fundamental settings of the Pentacam. For more information, please refer to chapter Changing Settings, page 26. Chamber Analysis (middle right) In this field, the thinnest thickness in the

30 Page 30 Pentacam Instruction Manual Chamber Analysis necessity to dilate the pupil first. Pachy. Thinnest: Smallest thickness of the cornea A. Chamber depth: The true anterior chamber depth in the apex of the cornea, calculated in the 3-D model from the endothelium of the cornea to the lens. Lens Thickness: The thickness of the lens. Please keep in mind the Chamber Angle: The smallest of both chamber angles in the horizontal section, calculated in the 3-Dmodel. Please keep in mind; a dilated pupil influences the evaluation of the chamber analysis and supplies wrong results. Chamber Volume: The chamber volume of the anterior chamber. The borders are the posterior surface of the cornea, the iris and the lens-

31 Pentacam Instruction Manual Page Virtual Eye If one clicks on [Display] in the upper menu bar and then on [Virtual Eye (large)], the mode of representation shown above is displayed. The patient and examination data Underneath the keratometer values of the anterior surface of the cornea and the anterior chamber analysis are depicted. The Virtual Eye contains the anterior and posterior surface of the cornea, the iris and the anterior and posterior surface of the lens. This model is intended to help the doctor explain the examination and the results to the patient. The individual surfaces can be activated and deactivated by clicking on the [Show] button. By clicking on [Fill], the individual surfaces appear in the form of transparent lattices. In the control field [Cutout width] the cutout angle can be changed via arrow keys. This immediately gives a deeper view into the model. In the field [Cutout pos.] the model can be turned a certain number of degrees. Clicking on [Animate] causes the model to rotate until the button is activated again. If one clicks on the model with the left mouse button while holding it down, the model can be rotated in the desired direction by moving the mouse. If one clicks on the model with the right mouse button while holding it down and moving the mouse, the model can be zoomed. Moving deeper into the representation make the image become smaller while moving out of it makes them become bigger. Clicking on the [scale] field scales the Virtual Eye for better orientation. Clicking on the [fill] field generates more finely graded scales along the horizontal and vertical axes and concentric rings delimitating the 2mm,

32 Page 32 Pentacam Instruction Manual 4mm, 6mm, 8mm and 10mm zones of the cornea.

33 Pentacam Instruction Manual Page Colored maps, large If one clicks on [Display] in the upper menu bar and then [Maps (large)], the map mode of various representations is displayed. In each representation the: patient data, keratometer values of the anterior surface of the cornea results of the anterior chamber analysis are depicted. Each point can be selected individually by clicking on it with the help of the coordinate system and evaluated in terms of the specific selected map. The scale of the coordinate system can be selected in terms of diameter to generate topographic zones, or alternatively in terms of radii from the apex position. By clicking on [Num] a numerical representation of values specific to the selected map can be switched on and off. The values in the grid indicate the 2mm, 4mm, 6mm, 8mm and 10mm zone of the cornea. The pupil edge is depicted as a black and white line. The white cross marks the center of the pupil and the white dot marks the apex of the cornea. The apex is defined as that part of the cornea where the mathematical gradient is zero. Therefore the apex is not necessarily the thinnest part of the cornea. Refractivity calculations are generally based on the Gull stream eye. Because of the refractive index between the different materials, the refractive values for the anterior surface are therefore positive, while those for the posterior surface are negative. Surfaces, which were not measured, for example because they were covered up by the eyelid or eyelashes, are interpolated. They are marked by black dots. In the selection field in the lower left-hand corner the various modes of depicting the pachymetry, topography, elevation and anterior chamber depth maps are shown when clicked on.

34 Page 34 Pentacam Instruction Manual Pachymetry The varying thicknesses of the cornea are depicted in color across its entire surface from limbus to limbus. Any point can be selected and evaluated individually by clicking on it with the left mouse button. The thickness at the selected point is displayed in µm and the coordinate system gives its position. The pupil edge is depicted as a black and white line. The white cross marks the center of the pupil and the white dot marks the apex of the cornea. The color bar on the right shows the thickness color scale. The gradation of the color scale can be changed by clicking on the color bar, as is described in chapter Changing Settings, page 26

35 Pentacam Instruction Manual Page Topography General The topography of the anterior and posterior surfaces of the cornea is shown in color across the entire surface, from limbus to limbus. This depiction gives a good impression of the varying curvatures of the measured cornea Keratometer values The usual keratometer values are given in: Rh: Horizontal radius of curvature in the center of the cornea. The representation of the central radii can be switched between diopters (dpt) or curvature (mm) values by clicking on the color bar or the Display and Change settings buttons. For more information please refer to chapter Changing Settings, page 26. The two major meridians are determined on the 3mm ring of the cornea; by definition, these always lie at 90 to each other. The position of the major meridians is shown in the small diagram in the left part of the field. Rv: Asti.: Axis: Ecc.: Vertical radius of curvature in the center of the cornea. Corneal astigmatism in the center. Axis of corneal astigmatism Mean eccentricity (dropping out) of the cornea in 30. Pupil: Mean diameter of the pupil during the 3D-Scan.

36 Page 36 Pentacam Instruction Manual Curvature radius Tangential Curvature Sagittal Curvature The tangential curvature is the curvature of the cornea at the measuring point. In the tangential presentation mode irregularities in corneal geometry appear more pronounced. The sagittal curvature is equivalent to the distance between the measuring point and the point where the perpendicular to the tangent at the measuring point intersects the axis. In the sagittal presentation mode the curvature value depends on the slope of the measuring point. Furthermore, the position of the optical axis comes into play. The sagittal presentation mode is more representative of the influence of the cornea on the patient s visual acuity.

37 Pentacam Instruction Manual Page Topography of the anterior surface The topography of the anterior surface of the cornea is selected, depicted in the form of a sagittal curvature map in milimeters [mm] and described on the lower right in terms of [mm] and curvature. The same map can be represented in diopters by clicking on the mm button on the lower right. Here a case of regular astigmatism is shown. The central curvature values of the anterior surface of the cornea are described more accurately by the keratometer values in the middle left position of the image in terms of central radii, corneal astigmatism, the axis and eccentricity. The same map can be represented in tangential curvature radius as well. The color bar on the right gives the curvature or refractivity color scale. The color scale can be changed by clicking on the color bar with the left mouse button, as is described in chapter Changing Settings, page 26.

38 Page 38 Pentacam Instruction Manual Topography of the posterior surface The topography of the posterior surface of the cornea is depicted in the form of a sagittal curvature map in diopters (dpt) and described on the lower right in terms of D and curvature. The same map can be represented in diopters by clicking on the D button on the lower right. The calculation is based on the Gull stream eye. The values for the posterior surface have to be negative because of the negative refractive index between the tissue and aqueous. The same map can be represented in tangential curvature as well. The color bar gives the radii or refractivity color scale. The color scale can be changed by clicking on the color bar with the left mouse button, as is described in chapter Changing Settings, page 26. Here a keratoconus is shown. In combination with the height map it provides important information for treatments such as corneal refractive surgery.

39 Pentacam Instruction Manual Page Elevation data The Pentacam measures height data. It calculates an internal three-dimensional mathematical model on the basis of measured height data. All further information can be derived from this model. Therefore, height data are the basis for any calculation. Using height data from the outset offers important advantages: Height data give a more accurate representation of the true shape of the corneal surface because they are independent of axis, orientation and position. Height data represent the true shape of the cornea because they yield only one possible curvature map. In terms of practical evaluation and representation, the Pentacam offers clear advantages: It is far more accurate in locating the position of the apex in keratoconi than are curvature measurement systems such as Placido systems. Usually there is a difference in reference point location before and after a refractive treatment, and therefore postoperative measurements are sometimes of questionable value. Height data contain a wealth of information, which, however, only becomes accessible through further calculation. Height data can serve to define standards independent to the type of instrument being used. Height data are insusceptible to fixation artefacts, thus lessening the probability of pseudokeratoconi occurring. Height data serve as a starting point for analyzing various aberrations of the corneal surface. Height data can be shown either in absolute or in relative terms (in the latter case as differences in height between measurement and reference body). The Pentacam system generates relative height data. The difference in height P D between cornea and reference body may be either be positive or negative: negative: measurement below reference body, positive: measurement above reference body.

40 Page 40 Pentacam Instruction Manual Reference bodies The height data of the cornea can be displayed, using a reference shape or body. The Pentacam offers three different reference bodies, which are individual eligible. These reference bodies can be centered to the Apex of the cornea, or represented as a floatmap. The representation as a float-map means, the reference body has no fixed center, he floats. The distance between cornea and reference body is optimized, in summary to be as small as possible and as equal as possible. This representation has advantages and disadvantages: one advantage is the minimizing of the tilt, for instance if the topographic representation shows an regular astigmatism and the toric reference body is selected, possible irregularities on the cornea surface are depicted clearly. a disadvantage is for instance if the topographic map shows a keratoconus while using a float map, starting keratoconus are often hard to detect, because of the minimizing of the tilt. The Pentacam offers three selectable reference bodies: the rotation symmetric ellipsoid is activated, while clicking to the [Ellipsoid] button. It is calculated, using the mean value of central radii and the eccentricity of the keratometer measurement. The advantage of this reference shape is the good correlation to the true shape of normal corneas. Mathematical described: h v R + R Re_ Body = + exz 30 2 the toric reference body is activated, while clicking to the [toric ellips] button. The calculation is done, using the central radii and the eccentricity of the keratometer measurement. The flat radius is set automatic in the field rf, as well as the steep radius is set in the field rs. The advantage of the toric reference shape is the good approximation to astigmatic corneas. The Best Fit Sphere is activated while clicking to the [BF-Sphere] button. The calculation is done in a way to approximate the sphere as good as possible to the true shape of the cornea, in order to compare results easier to those of other topographic systems. The shape of the single reference bodies can be changed individually, too, while clicking to the up-/down arrows, or while inserting values manually. Usually, the eccentricity (flat out) of the cornea is positive, because the radii are steeper in the center as in the periphery. Sometimes the eccentricity of the posterior side of the cornea is negative, because the radii are more flat in the center as in the periphery. Each single point in the elevation map can evaluated individually, in the combination of: clicking on it with the left mouse pointer the 2mm, 4mm, 6mm, 8mm and 10mm zones (diameter), or alternative the 1mm, 2mm, 3mm, 4mm, 5mm radius.

41 Pentacam Instruction Manual Page Applications of the elevation display method The conventional method of imaging keratoconi by means of sagittal or tangential radii is prone to artificial distortion. For example, it not infrequently leads to an inaccurate location of the apex position. Clinical findings show that images based on height data yield results that are more accurate. The keratoconus apex is always located at the end of the loop-like bulge of the contour lines. Some examples below describes that theme: Representation based on Tangential radii The hourglass shape in the center is an artefact inherent to the display method. In the right eye the apex appears to be located inferior and nasal, while in the left eye it appears to be located inferior. Representation based on Sagittal radii Same problem as with tangential radii; nevertheless, often yields results that are more intuitive Representation based on Height data In both eyes, the apex position appears to be located temporally and shows a significant difference to the other images.

42 Page 42 Pentacam Instruction Manual Anterior elevation map The elevation map of the anterior surface is shown with a rotationally symmetric ellipsoid reference body. The topography map shows an regular astigmatism with a superior tilt, and the elevation map therefore shows the typical hourglass shape, with the superior tilt too. The eccentricity and the radii of the reference shape can be changed manually by clicking on the fields in the upper center and entering individual values. Clicking on the [toric ellips] button produces a toric reference shape, whose central radii filled automatically in the fields rf and rs. The color bar on the right gives the elevation scale. The color scale can be changed by clicking on it with the left mouse button, as is described in chapter Changing Settings, page 26.

43 Pentacam Instruction Manual Page Posterior elevation map The elevation map of the posterior surface is shown with a rotationally symmetric toric reference body. The topography shows an astigmatism and the elevation map therefore shows the typical hourglass shape. The eccentricity and the radii of the reference shape can be changed manually by clicking on the fields in the upper center and entering other values. For example, eccentricity can be set to zero to change the reference shape to a sphere. The color bar on the right gives the curvature or refractivity color scale. The color scale can be changed by clicking on the color bar with the left mouse button, as is described in chapter Changing Settings, page 26.

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45 Pentacam Instruction Manual Page True Net Power The True Net Power map considers the true optical conditions of the complete Cornea. Usually all topographers which are using a Placido system are working with an refractive index of to calculate the refractive power of the anterior surface of the cornea. That refractive index is an approximate value to consider the anterior and posterior surface, because usual topographers are not able to measure the posterior surface of the cornea. As long as the cornea has a regular shape, that approximate value supplies good results for the refractive power of the anterior surface of the cornea. For corneas with an abnormal shape like post Lasik, Keratoconus or high astigmatism the calculation has to be improved. The Pentacam measures both surfaces of the cornea and uses both curvature maps to calculate the true net power map. First, the refractive values for the anterior surface of the cornea is calculated, using the refractive index n=1,376 of the cornea. Afterwards the refractive index of the posterior surface is subtracted, using the refractive index of the anterior surface (n=1.376) and the refractive index of the aqueous (n=1.336). That builds the basis for a more correct calculation of the refractive power of the anterior surface, the true net power map. Please keep in mind; the curvature representation is independent of any refractive values.

46 Page 46 Pentacam Instruction Manual Keratometric Deviation The keratometric power deviation map is a difference representation between the true net power map and the sagittal power map of the anterior surface of the cornea. The keratometric power deviation map shows clearly the mistake, if only the curvature values of the anterior surface of the cornea would be used to calculate the refractive power.

47 Pentacam Instruction Manual Page Anterior Chamber Depth The anterior chamber depth is represented as a color scheme. The distance between posterior surface of the cornea and iris, res. lens is shown in milimeter [mm]. While clicking into the map, using the left mouse pointer, or the Num function the distance is depicted. For an easier orientation, the pupil frame and its center are implanted too. That representation gives an easy and quick overview about the real conditions in the anterior chamber. The color bar on the right shows, which distance in [mm] is represented by the different colors. While clicking into the color bar, using the left mouse button, the steps in the color scale can be changed, as it is described in chapter Changing Settings, page 26.

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49 Pentacam Instruction Manual Page Scheimpflug Images D-Scan large If one clicks on [Display] in the upper menu bar and then on [Image (large)], the mode of representation shown above is displayed if a 3D- Scan was taken. The patient and examination data are displayed in the upper right-hand corner. The orientation display on the top to the left shows which eye is being examined and which camera/cutting position was used to generate the current image. The brightness of the image can be altered via the slide control. This facilitates visualizing any edges found, which will be depicted in color, or artificial lenses which only produce a small degree of reflection. [Contrast Normal] resets the instrument to the original brightness; while [Adjust Image] offers the possibility to alter the image in terms of contrast, brightness and other parameters like it is described in chapter Brightness/Contrast, page. Clicking on [Set Brightness] saves the settings and applies them to the current image. By clicking on any part of the lens with the left mouse button its densitometry is shown in a green bar next to the image. The height of the green bars gives an indication of how hazy the lens is. The cross-section, which is represented by a dotted line, is evaluated. The values for the cloudiness of the lens is an objective one, based on the grey scale of the image, standardized from 0 to 100 for an objective observation. By moving the mouse, while holding down the left mouse button, the densitometry of any part of the lens can be evaluated. For more detailed information, please refer to chapter Densitometric quantification Densitometric quantification. When the Scheimpflug image is clicked on with the right mouse button, an additional window opens where the automatically found lines in the image are displayed. If Show edge pixel is activated, the anterior surface of the cornea is shown in red, the posterior surface in green and the anterior surface of the

50 Page 50 Pentacam Instruction Manual lens in yellow color. This depiction shows the discovered edges. If Show fitted curve is activated, all the edges found are represented in the form of a mathematical curve and shown in red. Thus, the two modes of representation can differ. Show milimeter grid fits a grid into the Scheimpflug image. The distance between two points is 1mm, independent of the visual impression. This distance represents the optical distortion. Show cursor marks the apex of the cornea in each single Scheimpflug image Manual measurement function The Pentacam is provided with a manual measurement function, which considers the optical distortion of the cornea and intraocular fluid when images are taken during a 3D-scan. In order to use the manual measurement function the 3D-scan mode must activated in the scan menu before taking the images.. The optical distortion is not corrected if the images are taken using the enhanced dynamic Scheimpflug image mode in the scan menu. A mm-grid is shown to provide a better overview and to define reference points in the Scheimpflug image. To start the manual measurement function, click on the current starting point in the Scheimpflug image with the mouse pointer using the left mouse button. On moving the mouse pointer in the Scheimpflug image the measurement arrow will follow as if suspended from the mouse pointer with a rubber band. The current distance is shown in µm. On reaching the target point press the left mouse button to have the distance between the two selected points written into the image. Pressing the right mouse button during the measurement stops the current measurement.

51 Pentacam Instruction Manual Page Zoom function The Zoom function is applied to the selected Scheimpflug image. The zoomed parts are displayed with due consideration to the viewing conditions to permit a better evaluation of the image. The Zoom + button enlarges the current Scheimpflug image, while the 1:1 button brings it to its original size and the Zoom - button makes it smaller. An enlarged Scheimpflug image can be scrolled up, down, left and right with the help of the windows slide bar. The above picture shows, as an example, the measurement of the distance between the posterior surface of the cornea and the iris in the chamber angle area. The distance between the iris and the posterior corneal surface is of importance for the implantation of anterior chamber lenses The zoom function considers the optical distortion of the cornea and of the intraocular fluid.

52 Page 52 Pentacam Instruction Manual Densitometric quantification If one clicks on [Display] in the upper menu bar and then on [Scheimpflug Images], the individual images can be viewed in a large representation. The densitometry of the lens becomes quantified and is scaled from 0 to 100. A cross marks the apex of the cornea in the current Scheimpflug image. Densitometric quantification starts automatically in the apex of the cornea. The white line marks the position. Two possibilities are given: Click on the line with the left mouse button and drag it around in the Scheimpflug image in order to evaluate different points and layers of the lens. click in the diagram in order to evaluate the current selected slit in the Scheimpflug Image. The density value is shown on the right in the densitogram. On positioning the line across the cornea, the upper value shows the maximum density value of the cornea, marked by a blue line. The yellow line marks the beginning of the lens in the densitogram. The height of the green bars gives an indication of how hazy the lens is. The program evaluates the cross-section in question, which is marked by a dotted line. By moving the mouse while holding down the left mouse button the density of any part of the lens can be evaluated. The density of the lens is standardized from 0 to 100. Therefore, 0 means the lens shows no clouding, 100 means the lens is completely opaque. The grey scale of the individual Scheimpflug image provides the basis for objective quantifications.

53 Pentacam Instruction Manual Page Tomography If one clicks on [Display] in the upper menu bar and then on [Tomography], a virtual model of the anterior segment of the eye is created. The virtual model, shown in the right image, provides a new representation of the anterior segment of the eye. The virtual model can be moved in space by clicking on it and moving it with the left mouse button depressed. Clicking in the model with the right mouse button depressed activates the zoom function. Moving deeper into the representation make the images becomes smaller, while moving out of it makes them become bigger. The slice function allows cutting the model, and the current slice is shown in the Scheimpflug image in the left image. The model provides a good overview of, e.g., the size of a cataract in the human lens, iris defects, corneal incisions etc. The three buttons on the lower left determine the orientation of the slices in space. To select a slice orientation click on the desired button. Clicking in the Scheimpflug image and moving the mouse with left button depressed brings the current slice into view in the virtual model as well as in the Scheimpflug image. The slicing buttons work as follows: o Upper button: slices in vertical direction. o Middle button: slices in the horizontal direction. o Lower button: slices along the visual axis. The seven buttons in the middle left are for viewing the surfaces in the virtual model. The Show field shows the current surface

54 Page 54 Pentacam Instruction Manual in the form of a grid, while the Fill button shows in the form of a plane. The two control bars below the virtual model have the following effects, whose combined use produces an optimal representation. o The Threshold control bar changes the cloudiness of the virtual model. This facilitates the detection and display of, e.g. a cataract in the crystalline lens. o The Transparency control bar changes the degree of transparency. The Normalize button changes the image back to an optimal view. The Default button resets the threshold and transparency to the default settings. On clicking on the High resolution button the system calculates the Scheimpflug image and the virtual eye with a higher resolution. It is advisable to click on this button after bringing the model into the desired position, since the system will otherwise require more time to calculate and generate the two images. The two selection fields Cutout Width and Cutout Pos. in the lower right change the cutout position of the virtual eye model. They are only active if the Cutout button on the lower right has been clicked. o Cutout Width: changes the size of the sector to allow a deeper view into the model. The size can be changed by pressing the up and down arrows. o Cutout Pos.: changes the orientation of the model. The orientation can be changed by pressing the up and down arrows. The seven buttons on the right allow showing different regions of the anterior segment of the eye. o Show Anterior displays the anterior regions. o Show Cornea displays the cornea. o Show Chamber displays the anterior chamber. o Show Lens displays the crystalline or the artificial lens. o Show Posterior displays the posterior surface of the crystalline or the artificial lens. o Clip Pupil displays the segment of the anterior segment of the eye, which is delimited by the pupil. o Cutout activates the Cutout width and Cutout pos. functions of the virtual model. 8

55 Pentacam Instruction Manual Page 55 Artefacts When performing a densitometric evaluation of the lens, one must note that reflexes produced by a ceiling lamp can cause haze or light coming through a window (sunlight), as is shown at the lower left picture. When in doubt the measurement should be retaken. The Pentacam must be set up in such a way so as to prevent incidence of direct light. Another type of artefact appears if the central slit or the lens in front of the camera is soiled, as is shown in the lower right picture. Please clean these parts as described in chapter 9.1 Care and maintenance, page 56. If the artefacts are not eliminated after cleaning the parts referred to and checking the ambient lighting conditions, contact the service team or your authorized distributor. 9

56 Page 56 Pentacam Instruction Manual When cleaning always pull out plug! Maintenance 9.1 Care and maintenance Casing Do not use any aggressive cleansers, which contain chlorine, solvents, abrasive or caustic substances! It is best to clean the surface of the casing with a soft cloth and an anti-static cleansing agent. Otherwise, wipe off outer surfaces with a damp cloth. In case of residue, remove with a mixture of equal parts of spirit and distilled water with a squirt of conventional detergent. Optical components The optical components of the slit illumination in the center of the unit and the lens in front of the camera are precision parts and sensitive to pressure. One should prevent the surface from being scratched. The lens in front of the camera must be cleaned with particular care. Use a lint-free dry cloth. The slit illumination in the center has to be cleaned by using cleaned compressed air only. Do not use cloths or detergents. 9.2 Elimination of errors and malfunction Pull out plug before replacing fuses! Replacement of fuses It is not necessary to replace the fuses, as the instrument is operated via a power supply unit with an integrated automatic overload switch Error detection Do not plug in or pull out any cables while the PC or the Pentacam is switched on! If an error occurs which you are not able to eliminate on the basis of the following instructions, designate the instrument as defective and notify our service department. ERROR: After starting the examination software the PC displays the message No Communication Check to see whether the pilot lamp on the power supply unit is illuminated. If not, plug in the power supply unit. Check to see whether the blue slit lamp in the examination program is illuminated. Check to see whether the USB-Connector is plugged into the Laptop or Standard PC properly. Switch off the Pentacam and restart the PC. As soon as the OCULUS patient data administration is active, switch on the Pentacam. The message Load boot loader should appear when the Pentacam software is being started. Contact our service department. Check to see whether the cable is plugged into the Pentacam properly.

57 Seite 57 Gebrauchsanweisung Pentacam 10

58 Page 58 Pentacam Instruction Manual Conditions of warranty and service 10.1 Conditions of warranty This OCULUS product is a high-quality instrument. It was manufactured with great care using high-quality materials and modern production technology. It is important for you to read the instruction manual before operation and to observe the safety precautions. You have a warranty on this instrument in accordance with legal warranty regulations Starting on the day of purchase. This warranty covers all kinds of malfunction caused by faulty material and manufacture. Malfunction caused by improper operation and external influences is not covered. Should you nevertheless have reason for legitimate complaint during the period of warranty, the malfunction will be eliminated at no cost to you. These warranty claims can be made if a receipt documenting date of purchase is presented. If unauthorized persons manipulate the instrument, all warranty claims become void, for improper alterations and handling can cause considerable damage to the user and patients. We request that complaints concerning damages which occur during transport or delivery be made to the shipping firm immediately and that the damage be documented on the consignment note so that the claim can be settled properly. Our terms of trade and delivery are valid as laid down at the time of purchase Liability for malfunction and damages OCULUS only considers itself responsible for the safety, reliability and proper function of the instrument if it is used in compliance with this instruction manual. There are no parts attached to or inside the instrument, which should be serviced or repaired by the user. If assembly work, expansions, adjustments, maintenance work, alterations or repairs are carried out by non-authorized personnel or if the unit is maintenanced or handled improperly, OCULUS is not liable for any damages which might occur. If authorized persons perform the kind of work described above, documentation of the nature and extent of the repair work must be demanded of them, if pertinent with a statement regarding changes made in specifications or application. The document must include date and particulars of services performed as well as name and address of firm and signature. If desired, OCULUS will put wiring diagrams, lists of replacement parts, additional descriptions and instructions for installation at the disposal of such authorized persons. In case of maintenance and repairs, only original OCULUS parts have to be used.

59 Pentacam Instruction Manual Page Address of manufacturer and service department You can receive additional information from our service department and authorized dealers. Address of manufacturer and service department: OCULUS Optikgeräte GmbH Münchholzhäuser Str Wetzlar Germany Tel.: / Fax: / We declare that this product complies with the following standards or normative documents: IEC IEC In accordance with the regulations of Directive 93 / 42 / EEC on medical products. We take sole responsibility for this declaration. Dipl d eng. Rainer Kirchhübel Managing Director of OCULUS Optikgeräte GmbH 11 Appendix 11.1 Declaration of conformity

60 Page 60 Pentacam Instruction Manual 11.2 Pentacam Calibration Data CD The Pentacam is calibrated in our factory. The calibration files are stored on a CD-ROM, which is included in each Pentacam delivery. The CD- ROM is called Pentacam Calibration Data and is valid only for the Pentacam with the same serial number as that of the Pentacam Calibration Data CD-ROM. The Calibration CD is Installation of calibration files therefore not valid for other systems. Please keep the Pentacam Calibration Data CD in a safe place. If you want to exchange your Laptop or PC, you will need to copy the calibration data to the new system, as, is described in the next chapter. Insert the Pentacam Calibration Data CD into the CD-ROM drive. Open the Windows Explorer. Mark the file calib-01 on the calibration data CD and copy it into the directory Pentacam. Confirm that you want to replace the old calib-01 by clicking on the OK button. Enter the Patient Data Management of the Pentacam program. Select or type in the drive letter of the CD- ROM drive. Click on the Import Data button. The calibration image is now copied into the Patient data management. You can compare the serial number of the imported examination with the serial number of the Pentacam in the patient data management. Click on the Import button Formatting a CD-ROM for data protection In order to store individual patient data records or run a backup of all the patient data, you first need to format the CD.ROM. We recommend using as a second backup medium, read and write able CD-ROMs, so called CD-RW s. Laptops and PC s delivered by Oculus are equipped with special software for data backup or for storing individual patient data records on a CD-RW. The following chapters describe how to prepare a CD-RW.

61 Pentacam Instruction Manual Page Formatting procedure Insert a CD-RW into the CD-ROM drive and close the drive. The program will start automatically. Select in the formatting program CD Formatieren The next image shows the progress of formatting. The system creates a new file for the formatted CD-RW. Please close the window by clicking on the cross in the upper right. In the next window you can give the CD-RW a name. Click on the Formatierung starten button to start the formatting procedure The next window confirms that the formatting has been completed successfully.

62 Page 62 Pentacam Instruction Manual Click on the OK button to exit the formatting program. Please close the next window by clicking on the cross on the upper right. Please close the next window by clicking on the cross on the upper right. The formatting of the CD-RW is now completed. The CD-RW is now prepared for the storage of single examinations or for a general backup.

63 Pentacam Instruction Manual Page Example of how to save a single examination Insert a CD-RW that has been formatted in the described way into the CD-ROM drive and close the drive. Start the Pentacam program and select a patient from the patient data management. Click on the Export button. Click on the button of the CD-ROM drive to open it. The next window shows the selected patient s name and the required memory to store the selected patient. Please check that the directory of the CD-ROM drive has been selected (?) and start clicking on the Export button. In the following window you can select the format in which you want the CD-ROM to be closed. After selecting the format click on the OK button. The CD-ROM is closed in the selected format and ejected automatically. 12

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