Page 1 SPECULAR MICROSCOPE CEM-530 OPERATOR’S MANUAL Be sure to read the SOFTWARE LICENSE AGREEMENT (page 2) before using this product.
Page 2 Original instructions NIDEK CO., LTD. : 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, JAPAN (Manufacturer) Telephone: +81-533-67-6611 URL: https://www.nidek.com/ NIDEK INC. : 2040 Corporate Court, San Jose, CA 95131, U.S.A. (United States Agent) Telephone: +1-800-223-9044 (USA Only) URL: https://usa.nidek.com/ NIDEK S.A. : Ecoparc, rue Benjamin Franklin, 94370 Sucy En Brie, FRANCE (EU Authorized Representative) 2023-03-31...
Page 3 Before Use This operator's manual includes information such as the operating procedure, safety precautions, maintenance, and specifications. Be sure to read this operator's manual before using this product. Keep this manual handy for reference. If you encounter any problems or have questions about this prod- uct, please contact NIDEK or your authorized distributor.
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Page 7 Table of Contents 1. SAFETY PRECAUTIONS ......9 1.1 For Safe Use ............9 1.2 Usage Precautions .
Page 8 3.7 Detail Analysis Screen Operation ........89 3.8 Manual Analysis .
Page 9 6. APPENDIX ........137 6.1 Glossary .
Page 11 SAFETY PRECAUTIONS For Safe Use BEFORE USE, READ THIS MANUAL. Be sure to read the operator’s manual before operating the device to understand the safety precautions and operating procedures thoroughly. Keep this manual handy for reference. There are no parts within the device that require servicing by the user other than printer paper.
Page 12 SAFETY PRECAUTIONS: Usage Precautions Usage Precautions Before use • If any serious device-related incident occurs, report it to NIDEK and the competent WARNING authority in the country where the user or patient, or both reside. • Connect the power plug to a grounded power outlet or the grounding wire to a ground terminal.
Page 13 SAFETY PRECAUTIONS: Usage Precautions • Do not use the device immediately after it has been exposed to radical temperature CAUTION differences because condensation may occur inside the device. Wait until the device is at room temperature (1 to 2 hours). If the device is used with condensation present, satisfactory capture images may not be obtained.
Page 14 SAFETY PRECAUTIONS: Usage Precautions • When carrying the device to another CAUTION location, its base should be held by two hands from both sides by two persons as indicated by (A) and (B) in the figure shown to the right. Never hold any parts other than the base such as the forehead rest, main unit or capturing unit.
Page 15 SAFETY PRECAUTIONS: Usage Precautions During use • Do not perform servicing or maintenance on the device during use. CAUTION • Perform visual and operational checks before using the device. Do not use the device if any error is found. Use of a malfunctioning device may cause harm or produce improper results that lead to inappropriate diagnoses resulting in health hazards.
Page 16 SAFETY PRECAUTIONS: Usage Precautions • Never touch the screen touch panel with wet hands. CAUTION If the inside of the device is exposed to water, malfunction may occur. • There may be a few defective pixels in the screen which are a characteristic of any LCD monitor.
Page 17 SAFETY PRECAUTIONS: Usage Precautions • Use devices that comply with IEC 60601-1 in CAUTION the patient environment. If any device that 1.5 m does not comply with IEC 60601-1 is to be used, install the device outside the patient environment. For a generalized information system, use the device that complies with IEC 60950-1 or IEC 62368-1.
Page 18 SAFETY PRECAUTIONS: Usage Precautions After use • This device uses a heat-sensitive printer paper. The paper degrades over time and the CAUTION printed characters may become illegible. If glue containing organic solvents or adhesives such as on adhesive tape comes in contact with the printer paper, the printed characters may become illegible.
Page 19 SAFETY PRECAUTIONS: Usage Precautions Maintenance and check • Only service personnel trained by NIDEK are allowed to repair the device or update CAUTION the software. NIDEK assumes no responsibility for any adverse events resulting from improper ser- vicing. • When performing maintenance work, secure a sufficient maintenance space. Maintenance work in an insufficient space may result in injury.
Page 20 SAFETY PRECAUTIONS: Usage Precautions Connection to network • If the medical system is to be configured using an IT network, implement IT security CAUTION measures with the network administrator, and check that the system operates properly. Virus infection, unauthorized access, or data tampering may result. •...
Page 21 INTRODUCTION Device Outline The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.
Page 22 INTRODUCTION: Intended User Profile Intended User Profile Doctors or persons qualified by the law of each country Intended use environment Medical facility • If the device is used outside the specified use location, intended performance and CAUTION security level cannot be maintained.
Page 23 INTRODUCTION: Principles Principles Endothelial image capture This device captures endothelial images in a non-contact method using the principle of specular reflection. A slit of light is projected diagonally onto the endothelium of the patient, and the specular reflected light from the surface of the endothelium at the border of the anterior chamber is captured by a CCD camera positioned at the same angle of incidence as the light source.
Page 24 INTRODUCTION: Device Configuration Device Configuration  Front view Capturing unit Main unit Base unit 1. Screen touch panel Displays various operation screens and captured results. The device can be operated by touching the buttons on the screen.
Page 25 INTRODUCTION: Device Configuration The screen touch panel is a 8.4-inch color LCD. It can be tilted by pulling its bottom and fixed at various angles. If the operator uses the device in a standing posture, tilt the screen at a suitable angle. To return the screen to the original position, raise it to the horizontal position, then slowly lower it.
Page 26 INTRODUCTION: Device Configuration  Rear view 9. Forehead rest Used to rest the patient’s forehead to restrict head movement during image capture. Clean it for each patient. 10. Capturing windows Check the window cleanliness before image capture. There are three windows for image capture: anterior segment observation / alignment, endothelium illumination, and endothelium focus/capture.
Page 27 INTRODUCTION: Device Configuration  Bottom view Provides the connectors for the video printer, barcode reader, and magnetic card reader. • Equipment connected to the analog or digital interfaces must be certified according CAUTION to the representative appropriate national standards (such as EN 60601-1 and IEC 60601-1).
Page 28 Cable connection Connect the end of the plug with the ferrite core attached to the CEM-530 connector. With the groove in the plug aligned with the connector pin, insert the plug straight and then turn the ring clockwise until it stops and Ferrite core is locked.
Page 29 INTRODUCTION: Device Configuration  Ferrite core attachment Attach the supplied ferrite core near the plug of the LAN cable. Loop the cord around the ferrite core as shown in the figure below. Ferrite core...
Page 30 INTRODUCTION: Screen Configuration Screen Configuration 2.8.1 Capture screen This is the screen for capturing endothelial images and observing the anterior segment. Image capture method settings such as fixation lamp, auto tracking, and auto shot are also performed here. 1. [Fixation] button Used to display the Fixation window that allows setting of the illumination position of the fixation lamp.
Page 31 INTRODUCTION: Screen Configuration Displays the patient eye (right eye / left eye) shown on the screen in blue. 3. Auto shot button Used to toggle use of the auto shot function (automatically starting image capture when proper vertical and horizontal alignment and focus is achieved). The auto shot function is disabled.
Page 32 INTRODUCTION: Screen Configuration •Page change button for captured image display A maximum of 10 captured images may be displayed on the same page for one eye. When more than 10 images are captured, the page change button appears and the images are divided into three pages. Pressing the button changes the display page.
Page 33 INTRODUCTION: Screen Configuration 12. Capture area marks Indicate the area where image capture is possible. If the pupil is smaller than this circle or eyelashes cover this circle, image capture may not be possible. 13. Alignment target Used as a guide to center the patient’s eye on the screen. 14.
Page 34 INTRODUCTION: Screen Configuration 2.8.2 Patient Information screen Patient information can be newly created as desired. Pressing the patient data field in the capture screen displays this screen. 1. [ID] button/box Press this button to display the on-screen keyboard and enter the For patient information, patient ID entry is required.
Page 35 INTRODUCTION: Screen Configuration 5. [Memo] button/box Press this button to display the on-screen keyboard and take notes. 6. [OK] button Press this button to confirm the entered patient data and return to the capture screen. 7. [Cancel] button Press this button to cancel the entered patient data and return to the capture screen. 2.8.3 Image select screen This is the screen for selecting the most suitable image for analysis from the 16 images captured in...
Page 36 INTRODUCTION: Screen Configuration 4. Thumbnail images The 16 captured images are displayed in thumbnail view. Pressing a thumbnail selects its image. Thumbnails are displayed in order of image quality. The displayed thumbnail images are switched by the [Page] button. 5. Enlarged image The currently selected thumbnail image is displayed in enlarged view.
Page 37 INTRODUCTION: Screen Configuration 2.8.4 Capture results screen This is the screen for displaying each analysis value based on the captured endothelial images. This screen is displayed when image capture is complete. In this screen, printing of the analysis results and display of the detail analysis screen are performed. In single mode, the capture results screen is always shown as a single display.
Page 38 INTRODUCTION: Screen Configuration 2. [Detail] button Used to display the selected data in the detail analysis screen. 3. Endothelial image An image selected in the image select screen for analysis is displayed. An orange border indicates the image selected to be initially displayed in the detail analysis screen by pressing the [Detail] button.
Page 39 INTRODUCTION: Screen Configuration 8. [Delete] button Used to delete the capture data (patient information, image data, and analysis data). After data is deleted, the capture screen appears automatically. The confirmation message “Delete all data? [OK]/[Cancel]” appears. Pressing the [OK] button deletes the capture data and displays the capture screen.
Page 40 INTRODUCTION: Screen Configuration  Paracentral mode In paracentral mode, pressing the [Result] button after images have been captured displays the capture results screen as a multiple display. In multiple display of paracentral mode, the [Paracentral] button is added to the multiple mode screen. Pressing the [Result] button after the right and left eye images have been captured only once each displays the capture results screen as a single display with the [Paracentral] button displayed.
Page 41 INTRODUCTION: Screen Configuration Paracentral screen 12. R/L indication Displays the patient eye (right eye / left eye) shown on the screen. 13. R/L button Used to display the captured image results of the other eye. When only one eye has been captured, this button is disabled (grayed out). 14.
Page 42 INTRODUCTION: Screen Configuration • Total value is the recalculation result of Number of Cells (NUM), Cell Density (CD), Coefficient of Variation (CV), and Hexagonal Cells (HEX) taken from all the cells of the images displayed in the paracentral screen. 2.8.5 Detail analysis screen This is the screen for displaying and confirming the details of capture data.
Page 43 INTRODUCTION: Screen Configuration Area The identified endothelium is distinguished by area and displayed in different colors. Apex The identified endothelium is distinguished by apex and displayed in different colors. When the analysis range is set, display according to Trace, Area, or Apex is performed only within the analysis range.
Page 44 INTRODUCTION: Screen Configuration  Detail screen after manual analysis When manual analysis is performed, the analysis values are displayed in the detail analysis screen. The screen display changes as follows. • The [Range] button changes to [Reanalysis]. • When manual analysis is performed, an indication mark appears on the upper left corner of the endothelial image.
Page 45 INTRODUCTION: Screen Configuration 2.8.6 Maintenance screen The Maintenance screen allows selection and execution of the desired maintenance operations. Maintenance menu buttons The software version and the serial number of the device are displayed. Maintenance menu buttons Used to display the corresponding maintenance screen. LAN Settings Sets the IP address and other settings for LAN and file sharing Reader Settings...
Page 46 INTRODUCTION: Screen Configuration 2.8.7 Settings screen The Settings screen allows setting of various parameters: “Take”, “Print”, “Network”, and “Other”. 1. Item buttons Used to select one from four parameters: “Take”, “Print”, “Network” and “Other”. Item button Options Take Fixation, Capturing/Display Mode, Min. Cell Number, Cell Image Display, Check Data Clear Print Printer, Printer Mode, Patient No.
Page 47 INTRODUCTION: Symbols Symbols To call attention to users, labels and indications are provided on the device. If labels are peeling off, characters are fading, or otherwise becoming illegible, contact NIDEK or your authorized distributor. Indicates that the operator is advised to refer to the related instructions in the operator’s manual.
Page 48 INTRODUCTION: Checking Contents 2.10 Checking Contents Standard accessories are as follows. Unpack and confirm contents from the shipping. Part name Qty. Appearance Part name Qty. Appearance Magnetic forehead rest pad (The magnetic forehead rest pad does Main body not come attached to the device and is included in the packed contents.) Printer paper...
Page 49 INTRODUCTION: Before First Use 2.11 Before First Use Place the device on a stable table and connect the power cord to it. Place the device on a stable table. Pull the main unit fully to a side, then gently lay down the device on the same side. Connect the power cord to the power inlet.
Page 50 INTRODUCTION: Before First Use Attach the magnetic forehead rest pad to the device. The magnetic forehead rest pad does not come attached to the device and is included in the packed contents. The magnetic fore- head rest pad is attachable in the orientation as shown to the right.
Page 51 INTRODUCTION: Before First Use Confirm that the capture screen is displayed. Capture screen Set the printer paper. See “4.3 Replacing Printer Paper” (page 106) for details on the printer paper setting proce- dure. The setup procedure is complete. • Set the parameters in the Settings screen as desired. See “4.7 Parameter Settings”...
Page 52 INTRODUCTION: Automatic Analysis Results Considerations 2.12 Automatic Analysis Results Considerations Depending on the patient's condition, there may be cases where detection of endothelial cells by auto- matic analysis is difficult. Case where there is extensive deficiency of Case where cell recognition requires careful endothelial cell visual observation Case where visual cell recognition is difficult and...
Page 53 OPERATING PROCEDURE Operation Flow Turning on the device 3.2.1 Start up (see page 53) Turn on power to the device, and change the parameter settings of the device if necessary. Entering patient names 3.3 Entering Patient Information (see page 57) Enter patient information if necessary.
Page 54 OPERATING PROCEDURE: Operation Flow  Screen and operation flow Start-up: Turn on power. Fixation lamp illumina- Patient information tion position setting entry Fixation window (2) Patient Information screen* See page 57. Return Return To next patient (after printing or outputting) To next patient Image determination (after printing or...
Page 55 Wait for until the screen to switch to the capture screen. When power to the CEM-530 is turned on, the capturing unit makes up/down, right/left, and forward/backward movements to determine the initial position for auto tracking. It is not a failure of the device.
Page 56 OPERATING PROCEDURE: Start Up and Shut Down Perform checks before use. Perform the following checks before use.  No error message appears.  The main unit moves smoothly using the joystick.  The capturing window is clean.  The chinrest moves up and down by pressing the chinrest up/down button. ...
Page 57 OPERATING PROCEDURE: Start Up and Shut Down 3.2.3 Normal shut down • Before packing the device, turn off power to the device in packing mode. For details of packing mode, see “3.2.4 Shutoff before transporting the device” (page 56). Return to the capture screen. Turn off ( ) the power switch.
Page 58 OPERATING PROCEDURE: Start Up and Shut Down 3.2.4 Shutoff before transporting the device Before the device is transported, put the device in packing mode. In packing mode, the capturing unit and chinrest are automatically set in preparation for transportation. • Before transporting, set the mode to packing mode and pack the device in the CAUTION provided packing material with the locking lever for the main unit unlocked.
Page 59 OPERATING PROCEDURE: Entering Patient Information Entering Patient Information Enter patient information if necessary. (Patient information entry is not necessarily needed.) • Data can be identified with patient number (automatically provided 4-digit number) in addition to capture data. Patient information number is enabled or disabled by the Print parameter in the Settings screen. See “4.7.3 Print parameter”...
Page 60 OPERATING PROCEDURE: Entering Patient Information The various patient information is presented as in the following accordingly.  The “ ” indication means the patient information is not presented. For example, even if data is entered for DOB or Memo as patient information, it is not displayed in the screen (patient informa- tion field).
Page 61 OPERATING PROCEDURE: Entering Patient Information • If an improper date is entered in the DOB entry window, the date is not reflected in the Patient Information screen. In such a case, reenter the data in the DOB entry window. 4) Press [First], [Last], [MI.] or [Memo] to display the on-screen keyboard and enter each con- tent.
Page 62 OPERATING PROCEDURE: Entering Patient Information Moves the cursor to right or left by one position. Other keys can be used as a usual keyboard. Symbols that are not displayed on the on-screen keyboard cannot be entered. • When the on-screen keyboard is displayed to edit the entered contents, all the contents are selected (highlighted).
Page 63 OPERATING PROCEDURE: Setting Capture Conditions Setting Capture Conditions Set the capture conditions (Capturing/ Display Mode, illumination position of fixation lamp, auto shot, auto tracking) in advance.  Capturing/ Display Mode Set the capture count (one time only / 1 to 15 times) and whether to perform paracentral image capture.
Page 64 OPERATING PROCEDURE: Setting Capture Conditions Regardless of the capture count, the capture results screen is always shown as a single display. After completion of each image capture for both eyes, the capture results screen Single mode appears. When image capture is performed more than once for one eye, after each capture, the previous data is overwritten.
Page 65 OPERATING PROCEDURE: Setting Capture Conditions Single mode / Multiple mode Select one point from among C (corneal center), Paracentral (paracentral eight points, 5° visual angle), and Peripheral (peripheral six points, 27° visual angle). The fixation lamp of the selected point lights up. When capturing images of various points in multiple mode, set the illumination point of the fixation lamp before capturing images.
Page 66 OPERATING PROCEDURE: Setting Capture Conditions • After setting the capture order in the Fixation window, when the capture screen is displayed either by pressing the [Delete] button to delete the captured data or the [Print] button to print the captured data, the fixation lamp saved as No.1 will light up. The arrangement of the fixation lamps shown in the Fixation window is as viewed from the patient’s side.
Page 67 OPERATING PROCEDURE: Setting Capture Conditions  Auto tracking function Press the button to select the auto tracking function. The auto tracking function in the forward and back, right and left, and up and down directions is enabled. When endothelium observation is selected, the auto tracking function in the forward and back direction is disabled.
Page 68 OPERATING PROCEDURE: Image Capture Procedure Image Capture Procedure Start endothelial image capture after alignment with the image toggle button at “Anterior” in the screen display. Turn on power to the device. The device starts up, and the capture screen appears. Capture screen Enter the patient information as necessary.
Page 69 OPERATING PROCEDURE: Image Capture Procedure Prepare the patient. • Be careful not to get fingers of the patient or operator caught in the moving parts CAUTION during image capture. 1) Clean the forehead rest and chinrest that come into contact with the patient with clean gauze or absorbent cotton dampened with rubbing alcohol.
Page 70 OPERATING PROCEDURE: Image Capture Procedure Instruct the patient to look into the capturing window and stare at the green spot with eyes wide open. • Instruct the patient not to blink during image capture. For successful capture, it is recommended to have the patient blink once then open their eyes wide just before image capture.
Page 71 OPERATING PROCEDURE: Image Capture Procedure 2D auto tracking 1) Perform rough alignment focus Up, down, right, left alignment: Auto adjustment to the working range of the auto tracking function. 2) When the capturing unit is brought into the working range of the auto tracking func- tion, fine alignment automatically starts.
Page 72 OPERATING PROCEDURE: Image Capture Procedure Move the capturing unit up. Move the capturing unit down. Tilt the joystick slightly to the right. Tilt the joystick slightly to the left.  Focus indicator display If the focus is outside the working range of the auto tracking function, the limit indicator appears.
Page 73 OPERATING PROCEDURE: Image Capture Procedure When image capture starts, an endothelium observation image is displayed. After the endo- thelium position is detected, 16 images are successively captured as the focus is moved around the endothelium. Do not manipulate the joystick during image capture (about 2 seconds from the start). •...
Page 74 OPERATING PROCEDURE: Image Capture Procedure • The captured images are displayed by quality as determined by automatic calculation (that is, the number of cells that can be widely seen). However, this may not be the optimum image. The image to select should be determined by the operator according to their expertise.
Page 75 OPERATING PROCEDURE: Image Capture Procedure  Capture screen operation • Setting for entering patient information, auto shot, and auto tracking can be performed after image capturing is started. Single mode Multiple image capture for one eye Start image capture. (The previous image data is deleted.) Finish image capture for one eye and Perform alignment for the other eye by operating the joy perform image capture for the other eye...
Page 76 OPERATING PROCEDURE: Image Capture Procedure • In paracentral mode, the “Image capture at the selected fixation point has been completed.” message appears after the set image capture is complete. Press the [OK] button to proceed to next operation. • After starting image capture, press the [Fixation] button to display the fixation lamp screen, and then press the [OK] button to reset the fixation lamp to its No.1 point and begin illumination.
Page 77 OPERATING PROCEDURE: Image Capture Procedure When either eye image is captured more than once, the capture results screen is shown as a multiple display. (This applies to multiple mode and paracentral mode.) Select one image to display analysis values from the thumbnails.
Page 78 OPERATING PROCEDURE: Image Capture Procedure • If there are images that are not analyzed yet, printing or outputting is not possible. Pressing the [Print] button displays the message “Un-analyzed data exist. Analyze all data”. Perform manual analysis on the detail analysis screen. •...
Page 79 OPERATING PROCEDURE: Image Capture Procedure • When the “Check Data Clear” parameter is set to “OFF”, pressing the [Take] button displays the capture screen without displaying a confirmation message. 2) Press the [OK] button. The capture screen is displayed. The previous capture data is preserved at this time. Starting the next image capture deletes the previous capture data.
Page 80 OPERATING PROCEDURE: Image Capture Procedure • Patient information or image data cannot be stored in the device. Print out or output all necessary data before deleting in preparation for the next patient. • Patient information and image data can be cleared by pressing the [Delete] button in the capture screen.
Page 81 OPERATING PROCEDURE: Image Capture Procedure 4) Manipulate the joystick to bring the endothelial cell in focus for observation. The tracking function is deactivated. Change the observation range by moving the position up, down, right and left. Pressing the start button performs image capture at the position. Image capture is performed without eye tracking.
Page 82 OPERATING PROCEDURE: Capture Results Screen Operation Capture Results Screen Operation The capture results screen displays each analysis value based on the captured endothelial images. The capture results screen is displayed as a single display or multiple display that is set by the “Cap- turing/ Display mode”...
Page 83 OPERATING PROCEDURE: Capture Results Screen Operation  Capture results screen (single mode) In single mode, one capture data set is displayed for each eye. Analysis image select button [Detail] button Endothelial image Captured eye display Analysis values [Take] button [Print] button [Delete] button...
Page 84 OPERATING PROCEDURE: Capture Results Screen Operation  Capture results screen (multiple mode) In multiple mode, select the data for analysis from the multiple display of two or more captured images. Image select fields [Page] button...
Page 85 OPERATING PROCEDURE: Capture Results Screen Operation  Capture results screen (paracentral mode) In multiple display (or single display) of paracentral mode, the [Paracentral] button is added to the mul- tiple mode screen. [Paracentral] button  Confirming analysis values Analysis results and corneal thickness of the displayed endothelial image are shown. In multiple display, select the image whose analysis values are displayed from the image select field.
Page 86 OPERATING PROCEDURE: Capture Results Screen Operation Abbreviation Analysis item Unit Details Max Area Largest area of endothelium analyzed µm Min Area Smallest area of endothelium analyzed µm Proportion of hexagonal cells found in the analyzed Hexagonal Cells endothelium Corneal Thickness µm Corneal thickness obtained through capture procedure •...
Page 87 OPERATING PROCEDURE: Capture Results Screen Operation  Performing additional image capture Press the [Take] button. The previous capture data is preserved and the capture screen is displayed. The newly captured data is then added to the currently captured data. • Additional image capture is only possible before printing or outputting. If the [Take] button is pressed after printing or outputting, a confirmation message for deleting data appears.
Page 88 OPERATING PROCEDURE: Capture Results Screen Operation  Image display in paracentral screen (in paracentral mode only) Press the [Paracentral] button to display the paracentral screen. In the paracentral screen, the images are displayed in graphical layout. The total values of the analysis values are calculated from the entire captured data.
Page 89 OPERATING PROCEDURE: Capture Results Screen Operation In paracentral image capture, the endothelial cells are 0.25 × 0.55 mm captured at a 5° visual angle in the center and at 45° surrounding paracentral points. These images are displayed in graphical layout, and the cells in the paracentral area can be observed in a wider range than the central image capture range.
Page 90 OPERATING PROCEDURE: Capture Results Screen Operation  Capturing images of new patient Before image capture of a new patient, follow the procedure below to delete the capture data (patient information, image data, and analysis data) of the previous patient. The deleted capture data cannot be restored. Print out or output all necessary data before following the procedure below.
Page 91 OPERATING PROCEDURE: Detail Analysis Screen Operation Detail Analysis Screen Operation The detail analysis screen displays the distribution of endothelial apex and area as histograms in addi- tion to analysis values. Reanalysis can be also performed with the changed analysis conditions. The detail analysis screen is displayed by pressing the [Detail] button in the capture results screen.
Page 92 OPERATING PROCEDURE: Detail Analysis Screen Operation  Changing the endothelial image display The endothelial image may be changed to be displayed as Photo, Trace, Area, or Apex. When Area or Apex is selected, the corresponding histogram is displayed by the corresponding color as Pleomorphism or Polymegathism.
Page 93 OPERATING PROCEDURE: Detail Analysis Screen Operation 5) After “Reanalysis - Analyzing” is displayed, the image specified in the Set Analysis Range window is displayed in the detail anal- ysis screen. The red frame indicating the analysis range is dis- played. Cells are displayed according to Trace, Area, or Apex within the frame only.
Page 94 OPERATING PROCEDURE: Detail Analysis Screen Operation  Manual analysis If cells cannot be identified automatically due to image quality, the operator selects the cells for analy- sis. Manual analysis of auto analyzed images is possible. Display the Manual Analysis window by pressing the [Manual Analysis] button to perform manual analysis.
Page 95 OPERATING PROCEDURE: Manual Analysis Manual Analysis The following methods are available. Select the center of a cell. The outlines of the cells to be analyzed are Center point method applied according to the point distribution. Trace the outlines of the cells to be analyzed by selecting the corners of Corner point method each cell (polygon).
Page 96 OPERATING PROCEDURE: Manual Analysis Other operation Clears the selected points in reverse order. 4) Touch the screen again to enter additional points. A maximum of 300 points can be entered. Take the general distance between cell centers into consideration when selecting points. •...
Page 97 OPERATING PROCEDURE: Manual Analysis Other operation Clears the selected corners in reverse order. (Undo) Clears entire cell patterns in reverse order. • A maximum of 15 corners can be selected for a single cell pattern. When the 16th corner is selected, the message “You have already entered 15 apex points.
Page 98 OPERATING PROCEDURE: Manual Analysis 4) Press the cell to be analyzed on the endothelial image with the touch-screen pen. The selected cell is indicated by an orange hexagon on the endothelial image. The number of the created cell patterns is dis- played in the Pattern field.
Page 99 OPERATING PROCEDURE: Manual Analysis 3.8.4 Detail screen after manual analysis When manual analysis is performed, the analysis values are displayed in the detail analysis screen. The screen display changes as follows. • The [Range] button changes to the [Reanalysis] button. •...
Page 100 OPERATING PROCEDURE: Printing Printing 3.9.1 Printing captured results (built-in printer) After image capture, pressing the [Print] button prints the endothelial image and analysis values on the built-in printer. • Do not touch the printer paper while the printer is in operation. Printed characters may become blurred or obscured.
Page 101 OPERATING PROCEDURE: Printing Printed when the “Built-in Printer Option” - “Patient No.” parameter check box is selected “Patient No.” increases in 1 increments automatically from 0001 to 9999. The number can be reset or the desired number can be specified by the “Patient No.” - “Set No.” parameter.
Page 102 OPERATING PROCEDURE: Printing  Printing in multiple mode / paracentral mode When the “Capturing/ Display Mode” parameter is set to “Multi Mode”/ “Paracentral”, one image for each eye is selected from the multiple image data sets as indicated below and printed. One image for each eye selected in the capture results screen Printing in capture results screen (multiple display)
Page 103 OPERATING PROCEDURE: Printing 3.9.2 Printing captured results (video printer) When the optional video printer is set, pressing the [Print] button prints the endothelial image and analysis values on the video printer. Ensure that necessary information is displayed on the screen (whether selected in multiple mode / paracentral mode) before printing.
Page 104 OPERATING PROCEDURE: Printing Capture results screen (multiple mode / paracentral mode) Patient information ID, patient number, patient name, sex, print date and time, print page Print page “1/2” indicates the first page when two pages are printed in total. Two pages are printed when more than four im- ages are captured for one eye.
Page 105 MAINTENANCE Troubleshooting In the event that the device does not work correctly, correct the problem according to the following table before contacting NIDEK or your authorized distributor. Symptom Remedy • The power cord may not be correctly connected. The LCD monitor does not turn on. Reconnect it securely.
Page 106 MAINTENANCE: Error Messages and Remedies Error Messages and Remedies If one of the following error codes is displayed on the screen, follow the suggestions in the cause and remedy column. The error code, detailed indications and serial number of your device are helpful for proper servicing. Error code and message Cause and remedy •...
Page 107 MAINTENANCE: Error Messages and Remedies Error code and message Cause and remedy • Error related to network writing Write-protection is enabled or no free space is available. No.751 Unable to write files to the PC. • Check whether write permission is granted to the destination folder in the PC and sufficient free space is available.
Page 108 MAINTENANCE: Replacing Printer Paper Replacing Printer Paper When a red line appears on the side of the printer paper, it means that paper is running short. In such a case, stop using the printer and replace the roll with a new one. •...
Page 109 MAINTENANCE: Replacing Printer Paper Set new printer paper. Set paper as shown in the picture to the right. Leave the end of paper out from the cover. • If the roll is set upside down, printing will not occur. • Make sure that the printer paper roll is not tilted or the shaft misaligned. The paper will not be properly fed.
Page 110 MAINTENANCE: Attaching a Stack of Chinrest Paper Attaching a Stack of Chinrest Paper Pull out the two fixing pins from the chinrest. To attach the stack of chinrest paper at first, remove the fixing pins from the accessory pack- age. Take out the proper amount of chinrest papers from a whole stack.
Page 111 MAINTENANCE: Replacing the Forehead Rest Pad Replacing the Forehead Rest Pad Magnetic forehead rest pad (30611-1520) (*A) The forehead rest pad (made of ABS resin) included in the standard configuration is magnet- ically attachable. Attach or remove it in the orien- tation as shown to the right.
Page 112 When connecting the device to the external PC via LAN connection, set the IP address, subnet mask, and account. If the CEM-530 and external PC belong to the different domain in the network, set the account so that access between each other become possible.
Page 113 MAINTENANCE: Maintenance Screen Operation While the device is turned off, connect the LAN cable to the LAN connector. Turn on the power switch to activate the device. Press the [LAN Settings] button in the Mainte- nance screen to display the LAN Settings screen.
Page 114 Specify necessary parameters for the shared folders. Up to three shared folders can be set as out- put destination of data. When data output from the CEM-530 is used by two or more devices, set the shared folders for each device.
Page 115 MAINTENANCE: Maintenance Screen Operation Folder Name Enter the folder name of up to three shared folders as output destination of data. Test Performs connection testing. Before connection testing, check the LAN cable connection. If an error occurs, check the setting contents. 1) Press the [Folder1] button, then enter the shared folder name in the Folder1 box.
Page 116 MAINTENANCE: Maintenance Screen Operation 4.6.2 Setting the barcode reader or magnetic card reader The barcode reader or magnetic card reader to be used for entering the patient ID is set. • Do not connect any device other than the optional barcode reader or magnetic card CAUTION reader.
Page 117 • Use a magnetic card utilizing a magnetic stripe format compliant with ISO 7811, AAMVA, CA DMV. • For the patient ID, only alphanumeric characters, “_” and “-” symbols can be used. Other symbols are not recognized by the CEM-530. All the unrecognized symbols are converted to “~”.
Page 118 MAINTENANCE: Maintenance Screen Operation 4.6.3 Screen touch panel calibration If the response does not correspond to the position touched on the screen touch panel, perform cali- bration of the screen. Prepare the provided touch-screen pen. Press the [Touch Panel] button to start the calibration. The screen is switched, the message “Touch Panel Calibration”...
Page 119 MAINTENANCE: Maintenance Screen Operation 4.6.4 Setting date and time The date and time displayed on the output image or print can be set. • If the device has been left off for about a month, the date and time may have become inaccurate.
Page 120 4.7.1 Changing parameter settings The CEM-530 is provided with parameters that set various functions according to the needs of the operator. The procedures for checking and changing the parameter settings are as follows. Press the [Settings] button from the menu dis- played by pressing the [Menu] button in the cap- ture screen to display the Settings screen.
Page 121 MAINTENANCE: Parameter Settings Set options to be changed. Setting options are set using check boxes, radio buttons, or text boxes. For the setting contents, see “4.7.2 Take parameter” (page 121) - “4.7.5 Other parameter” (page 128). • Underlined options indicate factory settings. After changing settings, press the [OK] button to save the settings and return to the cap- ture screen.
Page 122 MAINTENANCE: Parameter Settings  Printing parameters The set contents in the Maintenance screen and Settings screen are printed from the built-in printer by pressing the [Print] button. Settings in Maintenance screen LAN settings TCP/IP settings File sharing settings Reader settings Date and time (current time) Settings in Settings screen Capture...
Page 123 MAINTENANCE: Parameter Settings 4.7.2 Take parameter Fixation: Blink (This parameter check box is selected in the factory setting.) Sets to blink the internal fixation lamp or peripheral fixation lamp. Select Analysis Image: Auto, Manual Sets whether to select the image for analysis automatically or manually. The most suitable image is automatically selected for analysis.
Page 124 MAINTENANCE: Parameter Settings Multi Mode Depending on the capture count, the capture results screen is automatically shown as a single display or multiple display. When image capture is performed only once for either eye, the capture results screen is shown as a single display for that eye. In other cases, it is shown as a multiple display.The capture results screen is displayed by pressing the [Result] button.
Page 125 MAINTENANCE: Parameter Settings Cell Image Display: Captured Image, Enhanced Image Select the endothelial image to be displayed in the capture results screen or detail analysis screen from either “Captured Image (live image)” or “Enhanced Image (sharp image pro- cessed image)”. This setting is also reflected in the endothelial image of the LAN output or video printer output.
Page 126 MAINTENANCE: Parameter Settings • When the “Print&Clear” check box of the “Data Clear” parameter is selected, the “Check Data Clear” parameter setting is disabled. When the “Print&Clear” parameter check box is selected, a confirmation message for data dele- tion does not appear. 4.7.3 Print parameter Printer: OFF, ON...
Page 127 The image to be printed is the central part (approx. 0.2 × 0.4 mm) of the original endothelial image. Comment Print “NIDEK CEM-530” is printed at the end of each print. Video Printer Options Sets the printing contents of the optional video printer.
Page 128 MAINTENANCE: Parameter Settings 4.7.4 Network parameter Output Item: Sets output items to be output to folders on the destination PC. The following settings are available for each output destination (Folder1 to Folder3). No parameter check box selected for any folder is the factory setting. Set “ACK”...
Page 129 MAINTENANCE: Parameter Settings The contents of the capture results screen and patient information (ID, name, patient No., and output date and time) are output in a report for printing (JPEG) over a LAN. A maximum of 10 images can be printed for each eye. When more than 10 images Results are captured, the latest 10 images are printed out.
Page 130 MAINTENANCE: Parameter Settings 4.7.5 Other parameter Language: Japanese, English Selects the language displayed on the screen. Beep: OFF, Normal, High Sets whether to sound a beep when operations are performed and sets its tone. LCD Backlight: Low, Middle, High Sets the LCD brightness. Name: L, F MI., F L MI., L F MI.
Page 131 MAINTENANCE: Cleaning Cleaning When the cover or screen touch panel of the device becomes dirty, clean it with a soft cloth before use. For persistent stains, soak the cloth in a neutral detergent, wring well, and wipe. Finally dry with a soft, dry cloth.
Page 132 MAINTENANCE: Cleaning Check if the windows are cleaned using a penlight. If not, clean them again with a fresh cleaning paper. Apply light with a penlight and change the view angle to check the clearness. Light receiving window Endothelium illumination for endothelium focus window or image capture...
Page 133 MAINTENANCE: List of Replacement Parts List of Replacement Parts Part name Part number Note For built-in printer, Width 58 mm, Printer paper 80620-00001 Length 25 m Chinrest paper 32903-M047 Pack of chinrest paper Magnetic forehead rest pad 30611-1520 Made of ABS resin Forehead rest pad 15411-M752 Made of polyester elastomer...
Page 134 MAINTENANCE: List of Replacement Parts...
Page 135 SPECIFICATIONS AND ACCESSORIES Classifications Protection against electrical shock: Class I ME equipment Protection against electrical shock (applied parts): Type B applied part Protection against harmful ingress of water or particulate matter: IPX0 Suitability for use in an oxygen rich environment: ME equipment that is not intended for use in an oxygen rich environment Method(s) of sterilization: ME equipment that does not contain any part that needs sterilization Mode of operation: Continuous operation...
Page 136 SPECIFICATIONS AND ACCESSORIES: Specifications Specifications  Endothelial image capture • Capture field 0.25 × 0.55 mm (W × H) • Fixation lamp (center) ° ° Nine-point fixation lamp: Central one point + Central eight points visual angle, 45 spacing) • Fixation lamp (peripheral) °...
Page 137 SPECIFICATIONS AND ACCESSORIES: Specifications  Dimensions and mass • Dimensions 291 (W) × 495 (D) × 457 mm (H) • Mass 20 kg  Environmental conditions (during use) ° ° • Temperature 10 to 35 C (50 to 95 • Humidity 30 to 90% •...
Page 138 SPECIFICATIONS AND ACCESSORIES: Accessories Accessories 5.3.1 Standard accessories • Printer paper 3 rolls • Power cord 1 unit • Dust cover 1 unit • Pack of chinrest paper 1 unit • Fixing pins for chinrest paper 2 units • Operator’s manual 1 volume •...
Page 139 APPENDIX Glossary  Auto shot A function to automatically start image capture as soon as the eye is best aligned and focused.  Auto tracking A function to automatically control the up, down, right, and left movements and focus direc- tion of the capturing unit.
Page 140 APPENDIX: Glossary  Specular reflection Reflection of light entering from one direction exiting to another one-way without diffusion. If a boundary surface exists which causes a difference of the optical reflectivity in the optical path, part of light is reflected. The specular microscope captures images of light reflected at the border between the cornea and anterior chamber.
Page 141 APPENDIX: List of Abbreviations List of Abbreviations This device and operator’s manual use the abbreviations below. General AAMVA American Association of Motor Vehicle Administrators Acrylonitrile Butadiene Styrene ACGIH American Conference of Industrial Hygienists Bayonet Neill Concelman CA DMV California Department of Motor Vehicles DHCP Dynamic Host Configuration Protocol Electromagnetic Compatibility...
Page 142 APPENDIX: List of Abbreviations Analysis parameters Abbreviation Analysis item Details Number of Cells Number of endothelial cells analyzed Cell Density Number of endothelial cells per unit area (1 mm Average Area Average area of endothelium analyzed Standard Deviation Standard deviation of the endothelium area analyzed Coefficient of Variation Standard deviation (SD) divided by the calculated average (AVG) Max Area...
Page 143 APPENDIX: EMC (ELECTROMAGNETIC COMPATIBILITY) EMC (ELECTROMAGNETIC COMPATIBILITY) The device is suitable for use in stores and hospitals except for near active HF surgical equipment and RF shielded rooms with an ME system for magnetic resonance imaging, where the intensity of electro- magnetic disturbances is high, electrophysiology laboratories, or areas where short-wave therapy equipment is used.
Page 144 APPENDIX: EMC (ELECTROMAGNETIC COMPATIBILITY) Compliance for Emission Standard Phenomenon Product family standard Compliance Group 1 Conducted and radiated RF emissions CISPR 11 Class B Harmonic distortion IEC 61000-3-2 Voltage fluctuations and flicker IEC 61000-3-3 For the regions where the rated voltage is 220 V to 240 V, this device complies with this standard. For the regions where the rated voltage (line to neutral) is 220 V to 250 V, this device complies with this standard.
Page 145 APPENDIX: EMC (ELECTROMAGNETIC COMPATIBILITY) Compliance for Standard Immunity Phenomenon Basic EMC standard Immunity test levels ±8 kV contact Electrostatic discharge IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV, ±15 kV air 10 V/m Radiated RF IEC 61000-4-3 80 MHz - 2.7 GHz electromagnetic field 80% AM at 1 kHz Proximity fields from...
Page 146 APPENDIX: EMC (ELECTROMAGNETIC COMPATIBILITY)
Page 147 INDEX LCD touch screen ......22 Limit indicator ......67 Alignment target .
Page 148 INDEX:...

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Summary of Contents for Nidek Medical CEM-530