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Tomey OA-2000 Operation Manual

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Tomey
OA-2000
Operation Guide
Tomey Corporation
OA-2000_OG_V4D5B_EN

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Summary of Contents for Tomey OA-2000

  • Page 1 Tomey OA-2000 Operation Guide Tomey Corporation OA-2000_OG_V4D5B_EN...

  • Page 2: Table Of Contents

    Table of Contents 1. NAMES AND FUNCTIONS ..............................4 Physician's side ................................4 Patient side .................................. 5 Sides of the main unit .............................. 6 Basic structure and common items ........................7 Screens in optical mode ............................8 a) Measurement screen ............................8 b) Axial length view screen ..........................
  • Page 3 3.2.2 Measurement ............................50 3.2.3 Checking waveforms after measurement .................. 52 Ultrasound corneal thickness measurement mode ................. 58 3.3.1 Setting the data type to be displayed ..................58 3.3.2 Setting measurement conditions ....................58 3.3.3 Displaying and setting measurement points ................60 3.3.4 Measurement ............................
  • Page 4 a) Registering IOL data ............................ 112 b) Selecting IOL power formula ........................115 c) Setting IOP formula ............................116 d) IOL Formula Install/Update function ....................117 Connection & Print ............................. 120 a) Setting functions of save, export, and print buttons ..............120 b) Selecting and setting printer ........................

  • Page 5: Names And Functions

    1. NAMES AND FUNCTIONS Physician's side (1) LCD and touch panel Displays data or is used to perform operations. The display angle can be adjusted. (2) Power lamp (3) Chin rest up/down button (4) Joystick Moves the head in all directions. A measurement button is incorporated at the top of the joystick.

  • Page 6: Patient Side

    Patient side (1) Measurement window (2) Chin rest (3) Forehead pad (4) Touch pen The touch pen holder is a magnet type. 5 / 153...

  • Page 7: Sides Of The Main Unit

    Connector for measurement unit, USB flash memory, and external ID input device. (6) USB-D connector (PC) Connect a personal computer, etc. here. (7) LAN connector (8) Maintenance switch Tomey service personnel use this switch for maintenance. Do not change the setting. 6 / 153...

  • Page 8: Basic Structure And Common Items

    Basic structure and common items (1) Eye display field (eye selection button) (2) AL-4000 communication status field The status of communication with AL-4000 is displayed with the following icons. Communicating via Communicating Communication COMMUNICATION wireless access via USB stopped NOT POSSIBLE * * Operation not possible.

  • Page 9: Screens In Optical Mode

    Screens in optical mode a) Measurement screen (1) Measured eye display field (2) Measurement data display (3) Measuring head position limit Appears when the measuring head is near the limit of its movable range. The bar appears at the top, bottom, right, or left of the screen according to the position of the measuring head.t (4) Auto Alignment ring Indicates the effective range of Auto Alignment.
  • Page 10 (9) Auto/Manual Measurement modes (Auto or Manual) for keratometer measurement data and axial length measurement data are displayed. The first letter represents the alignment mode and the second letter represents the measurement mode. A.A: Auto Alignment / Auto Measurement A.M: Auto Alignment / Manual Measurement M.A: Manual Alignment / Auto Measurement M.M: Manual Alignment / Manual Measurement (10) Low reliability mark...

  • Page 11: B) Axial Length View Screen

    b) Axial length view screen (1) Display area selection button Enlarges and displays the image of the selected section. Axial length / anterior chamber depth, lens / corneal thickness / All. (2) Axial length measurement data display (3) Scanned image / waveform display area (4) View screen switch button (5) Measurement data display Lists measurement data of axial length, anterior chamber depth, lens, and corneal...

  • Page 12: C) Keratometer Measurement View Screen

    c) Keratometer measurement view screen (1) Ring projection image display field An image with rings projected is displayed. (2) View screen switch button (3) ”Toric” button Displays the toric auxiliary functions. (4) Measurement position display selector Select the measurement position to be displayed. φ2.0mean / φ2.5 / φ3.0 When “φ2.0mean”...

  • Page 13: D) Pupil Diameter And Corneal Diameter View Screen

    Displays the R/L alignment display screen. (12) KAI/KRI KAI represents asymmetry of the corneal shape and KRI represents regularity / irregularity of the corneal shape. (13) Axial error Displays errors that have occurred during axial length measurement by the subject currently in choice.

  • Page 14: Screens In Each Ultrasound Mode

    Screens in each ultrasound mode a) Axial length measurement screen (1) Gain display/adjustment field (2) Mode display – Contact/Immersion (3) Waveform display area (4) Corneal gate cursor (only in immersion mode) The waveform on the right of this cursor position is measured as the waveform of the cornea.

  • Page 15: B) Axial Length View Screen

    b) Axial length view screen (1) Axial length measurement data display Displays measurement conditions and measured axial length. (2) Measurement data display The axial length, anterior chamber depth, lens, and their average values are listed. (3) "Delete/Restore" button Deletes or recovers the measurement data. (4) "Select"...

  • Page 16: C) Corneal Thickness Measurement Screen

    c) Corneal thickness measurement screen (1) Real-time data display field Displays the actual measurements of the uploaded measurement points. The latest uploaded data are displayed during the measurement process. (2) Corneal thickness data display (3) Measurement data display (4) "Delete/Restore" button (5) ”Caliper”...

  • Page 17: Iol Power Calculation Screen

    IOL power calculation screen (1) Parameter field Enter the following parameters used for calculating IOL power. Average Axial (axial length / ACD (anterior chamber depth) / K1 / K2 / WTW / Lens / Target Ref. (expected refractive power). (2) Clinical History Method parameter input field (3) Measurement mode display/measurement data type button Switches the display between optical measurement data and ultrasound measurement data.
  • Page 18 (10) Implanted IOL [D] (IOL power) input field (11) Date of Surgery input field (12) Post Op. Ref (post-operation eye refractive power) input field (13) "Personal Constant" screen display button (14) ”Statistics” screen display button (15) ”Page” button Touch the “Page” button to change the pages. (16) ”Clear”...

  • Page 19: Operating Procedures

    2. OPERATING PROCEDURES Connections 2.1.1 Connections for accessory a) Power code Insert the connector of the power cord into the power socket on the side of the main unit in the correct direction. Connect all three pins of the plug. b) Connect the axial length and corneal thickness measurement instrument AL-4000 Check that either or both of connected devices is in new patient mode before starting to communicate the patient information and measurement data.
  • Page 20 c) External digital printer [Video printer] 1) Insert the cable plug A(1) of the USB-H cable into the USB connector (2) on the side of the main unit in the correct orientation. 2) Connect the other cable plug B (3) of the USB cable to a video printer. Follow the instruction manual of the video printer for details on how to connect the printer.
  • Page 21 Prepare the following items. - LAN cables (straight type, category 5 or higher): 2 - A network hub (A 100MHz switching hub recommended): 1 - A computer with TOMEY Link or DATA Transfer installed: 1 20 / 153...
  • Page 22 g) AL-100 measurement data review screen (1) Waveform display field (2) Mode display field – Contact / Immersion (3) Axial length measurement data field (4) Measurement condition display field (5) AL-100 version h) Connection with Biometer AL-100 The following settings are required in Biometer AL-100. Refer to the Biometer AL-100 instruction manual for the settings.

  • Page 23: Connecting The Al-4000

    2.1.2 Connecting the AL-4000 a) Wireless communication setting Refer to “6.4 f) AL-4000 wireless settings” to make the settings. b) Connection for wireless communication Check that either or both connected devices are in new patient mode before starting to communicate the patient information and measurement data. Communication cannot be started while both devices have information and measurement data for the last patient.

  • Page 24: Preparation

    [Resuming communication from the no communication state] 1) Click the “New” button (1) to clear the existing data. 2) Select the same measurement mode as that of the AL-4000 using the “Setup” button (2). 3) Click the “AL-4000 communication check” button (3) to resume communication. Preparation 2.2.1 Turning the power on and adjustment after turning the power on...

  • Page 25: Switching Between Optical (Opt) Mode And Ultrasound (Us) Mode

    b) Pre-use inspection If the inspection result is unsuccessful, accurate measurement or measurement itself may not be possible. Contact your local distributor. Align the model eye by placing it on the chin rest according to the installation guide displayed on the measurement screen. Perform a pre-use inspection using the model eye c) Login screen When using the instrument for the first time, change the admin user’s password (admin).

  • Page 26: Entering Patient Data

    The result will be displayed. 3) If TOMEY Link or database is selected as the query source in the device settings, the ID query starts as soon as ID is entered. If DICOM is selected, DICOM Worklist Inquiry screen (fig.3) will be displayed.
  • Page 27 4) Touch the "Internal Memory Patient Search" button (4) to display the patient list (Fig. 4) saved in the memory. A search can be performed in the internal memory of the instrument or the connected external memory. The memory subject to search can be set according to “3.9.4 c) Media options / Data output format.”...

  • Page 28: Clear All Measurement Data (Preparation For Measuring A New Patient)

    6) Touch the “No” button (8) on the confirmation screen (Fig. 5) or the “No” button on the Patient Information screen (Fig. 2) to ignore the entered data and return to the previous screen (Fig. 1) Entry of the patient ID from an external ID input device (barcode reader etc.) is accepted on the following screens.

  • Page 29: Selecting An Eye

    2) Select an eye and start new measurements. 2.2.5 Selecting an eye Touch either eye selection button (1) to select “R (right)” or “L (left)." 2.2.6 Patient's eye height adjustment 1) Have the patient place their face on the chin rest (1). Adjust the chin rest height so that the height of the corner of the eye is aligned with the eye level mark (2).

  • Page 30: Measurement Mode

    3. MEASUREMENT MODE Optical measurement mode Refer to “2.2.2 Switching between optical (OPT) mode and ultrasound (US) mode” for the method to switch to optical measurement mode. Calibration may be conducted automatically in optical measurement mode in order to smoothly perform measurement. No operation is available during calibration. Restart the operation after the message “Calibrating…”...
  • Page 31 a) Selecting measurement items The following 6 items can be measured simultaneously in optical measurement mode. * Axial length * Pupil/corneal diameter * Kerato * Anterior chamber depth, lens * Corneal thickness * M-Scope Select the item to be measured. Touch the “All”...

  • Page 32: Alignment

    d) Setting Auto Alignment and Auto Measurement - Use Manual mode only when measurement must be performed even though the sight- fixing condition is unstable. Correct alignment is difficult in Manual mode and measurement errors easily occur. Follow the procedures below to make settings for Auto Alignment and Auto Measurement. 3.1.2 Alignment Measurement results may be affected if the patient’s eyelid and/or eyelashes cover the...
  • Page 33 Perform alignment in the Y axis. Pressing the center of the screen (3), advances the measuring head towards the patient. Touch the measuring head retract button (4) to retract the measuring head towards the physician. When the focus indicator (5) appears while Auto Alignment is activated, focusing in the Y axis starts automatically.
  • Page 34 [General operation] Moving the joystick moves the measuring head back, forth, left, and right. Slide the up/down ring vertically to move the head up and down. (Fig. 1) [Fine operation] Tilting the joystick moves the measuring head in the tilting direction. Rotate the up/down ring to move the head up and down.

  • Page 35: Measurement

    3.1.3 Measurement Be sure to touch the “New” button to delete all the measurement data of the previous patient before measuring another patient. If new measurement is started without deleting the previous data, the measurement data of the previous patient may be included. When an attention message pertaining to the measurement is displayed after measurement, follow the directions in the message to check the measurement data.
  • Page 36 1) Adjust the patient’s eye height and ask the patient to look at the red lamp in the measurement window. (Refer to “2.2.6 Patient's eye height adjustment") When capturing an image immediately after having the patient blink and open their eye widely, partial gaps in the color code map due to breakage of the tear film or insufficient opening of the eye can be reduced.

  • Page 37: Browsing And Editing Axial Length Measurement

    3.1.4 Browsing and editing axial length measurement Touch the "View" button (1) at the lower left of the measurement screen (Fig. 1) to open the axial length view screen (Fig. 2). Touch the “Measure" button (2) on the view screen (Fig. 2) to return to the measurement screen (Fig.
  • Page 38 b) Deleting and recovering measurement values 1) Touch the “Delete” button (1) to delete the data selected with the cursor and the data color changes to gray. The data deleted here is excluded from the integral calculus value and average. 2) To recover the deleted data, move the cursor to the data.
  • Page 39 1) Use the selection cursor movement buttons (1) to move the selection cursor (2) to the data which is to be measured. 2) Touch the "Caliper" button (3) to open the caliper screen (Fig. 2). 3) Select the display area (4). The following caliper lines will be displayed. Axial length : Front of cornea, retina Anterior chamber depth / lens :...

  • Page 40: Browsing Corneal Thickness Measurement Values And Correcting Iop

    d) Selecting specific measurement data to be used for calculating IOL power The average value is normally adopted for the measurement data to be used in calculating the IOL power, but specific measurement data can also be selected. 1) Use the selection cursor movement buttons (1) to move the selection cursor (2) to the measurement data which is to be used in calculating the IOL power.

  • Page 41: Browsing And Editing Keratometer Measurement

    3) The input fields of parameter 1 (4) and parameter 2 (5) for the intraocular pressure correction formula become active when touched, and the keypad appears. Also, when a formula selection button (6) is touched, the parameters already set are displayed in the intraocular pressure correction formula.
  • Page 42 1) Touch the "Kerato" button (1) on each view screen to open the kerato view screen (Fig. 2). The default view for measurement position is determined by the fitting formula used in the measurement. Immersion shows φ2.5 mm. Other fitting fomulae show φ3.0 mm. 2) Touch the measurement position display button (2) to select the section to be displayed.
  • Page 43 A (Green) B (Yellow) C (Red) 0.0 - 23.4 23.5 - 29.0 29.1 - 0.0 - 4.4 4.5 - 5.2 5.3 - (Refer to “7.5 Corneal irregular astigmatism index”) 3) Touch the “mm/D” button (4) to change the unit for display. 4) “*”...
  • Page 44 2) Measurement values (2) selected on the kerato view screen appear. In addition, the axis angle line for the characteristic point (green) and the IOL axis angle icon (yellow) are shown on the camera image (3). 3) Enter an angle to the input field of the axis angle line for the characteristic point (green) (4) to change the displayed position on the camera image.
  • Page 45 d) Topography function 1) Touch the “Topo” button (1) on the Topo view screen to open the view screen (Fig. 2). 2) Measurement values (2) selected on the kerato view screen, and the astigmatism axis angle and corneal eccentricity (3) are shown. The single map and scale are shown in the image display field (4).
  • Page 46 e) Topo Fourier function 1) Touch the “Fourier Map” button (1) on the Topo view screen to open the Topo Fourier screen (Fig. 2). 2) On the Topo Fourier analysis screen, the constant term is displayed as “Spherical equ.” the first order term as “Asymmetry” the second order term as “Regular astigmatism” and higher order terms as “Higher order irregularity”...

  • Page 47: Browsing And Editing Pupil Diameter And Corneal Diameter Measurement Values

    3.1.7 Browsing and editing pupil diameter and corneal diameter measurement values 1) Touch the "DIA" button (1) on each view screen to open the pupil/corneal diameter view screen (Fig. 2). 2) Measured pupil diameter (2) and corneal diameter (3) are shown. The fitting circle and center point for analyzing the pupil diameter, and measurement lines for analyzing the corneal diameter are shown on the CCD image.

  • Page 48: Ultrasound Axial Length Measurement Mode

    Ultrasound axial length measurement mode Refer to “2.2.2 Switching between optical (OPT) mode and ultrasound (US) mode” for the method to switch to ultrasound measurement mode. 3.2.1 Setting measurement conditions Settings made here are only effective for the eye currently selected. Settings cannot be made for both eyes simultaneously.
  • Page 49 * User Setting Select this when registering optional materials for IOL eyes. Register the settings on the converted acoustic velocity setting screen. (Refer to “Setting converted acoustic velocity.”) “Anterior Chamber Depth” and “Lens” are not measured for an aphakic eye and “Lens” is not measured for an IOL eye.
  • Page 50 2) After entry, touch the “Enter” key (4) to move to the next entry box. Also, by touching the “Incorporate in L” button (5) or the “Incorporate in R” button (6), the data entered will be applied to the other eye. 3) Touch the “Initial Setting”...

  • Page 51: Measurement

    c) Measurement mode Set the measurement mode. * Auto Select this for normal measurements. * Auto quick Select this when measurement is difficult. * Manual Select this when measurement is difficult in Auto and Auto quick modes. d) Setting contact/immersion mode Complete the settings for contact mode and immersion mode referring to “6.2 c) Settings for various...
  • Page 52 a) Setting gain - Settings made here are only effective for the eye currently selected. Settings cannot be made for both eyes simultaneously. Complete necessary settings for each eye. Adjust the waveform height according to the gain settings. The gain and the waveform height increases as the gain value increases.

  • Page 53: Checking Waveforms After Measurement

    c) Re-measurement of the same patient Retain the patient information and delete only the measurement data for each eye. Delete all data while referring to “2.2.4 Clear all measurement data (preparation for measuring a patient)” when the patient is changed. Hold the “Retake”...
  • Page 54 2) The waveform measured at the selected cursor (2) is displayed in the waveform display field (3). Touch the selection cursor movement buttons (4) to move the selection cursor (2) up or down. The following marks are assigned to the measurement data. * : Data used for calculating IOL power ! : Data with low reliability L : Longest axial length...
  • Page 55 1) 1) Use the selection cursor movement buttons (1) to move the selection cursor (2) to the data to be changed. Touch the “Gate” button (3) to open the gate change screen (Fig. 2). 2) Touch the gate cursor selection buttons (4) to select the gate cursor to be changed. The selected and active gate cursor is displayed in red but the other cursors are displayed in white.
  • Page 56 1) Use the selection cursor movement buttons (1) to move the selection cursor (2) to the data to be measured. Touch the “Caliper” button (3) to open the caliper screen (Fig. 2). 2) Touch the “Switch” button (4) of the active caliper line to select the caliper line to be changed.
  • Page 57 * In Contact Lens mode (Fig. 3) The distance between the start line of the waveform (0 mm point) (10) and the retina caliper line (13) is shown in the axial length field, the distance between the start line of the waveform (10) and the caliper line for the front of the crystalline lens (11) is shown in the ACD (anterior chamber depth) field, and the distance between the caliper lines for the front of the crystalline lens (11) and for the back of the crystalline lens (12) is shown...
  • Page 58 e) Selecting specific measurement data to be used for calculating IOL power The average value is normally adopted for the measurement data to be used in calculating the IOL power, but specific data can also be selected. 1) Use the selection cursor movement buttons (1) to move the selection cursor (2) to the data which is to be used in calculating the IOL power.

  • Page 59: Ultrasound Corneal Thickness Measurement Mode

    Ultrasound corneal thickness measurement mode Refer to “2.2.2 Switching between optical (OPT) mode and ultrasound (US) mode” for the method to switch to ultrasound corneal thickness measurement mode. 3.3.1 Setting the data type to be displayed Select the measurement data type to be displayed from the following three options. * Latest : Displays the last measurement data taken.
  • Page 60 b) Selecting measurement values to be displayed Select measurement values to be displayed from the following 2 options. * Actual measurement * Bias value c) How to display converted acoustic velocity and bias values Select how to display the bias value from the following two options. * Percentage bias: Converts the actual measurement using the preset bias rate (percentage) and displays the result.

  • Page 61: Displaying And Setting Measurement Points

    d) Measurement mode Set the measurement mode. * Auto * Manual Select manual measurement when it is difficult to measure in Auto mode or when measurement values are captured while not intentionally performing a measurement. Refer to the AL-4000 Operation Guid. 3.3.3 Displaying and setting measurement points This function displays and sets the location of measurement points.
  • Page 62 1) Touch the "Meas. Point" button (1) to display measurement points in the measurement data display field (2). 2) Touch the “Change Meas. Point” button (3) to open the measurement point change screen (Fig. 3) to change the measurement point. 3) When the desired input field on the measurement point change screen (Fig.

  • Page 63: Measurement

    3.3.4 Measurement See the user manual of the AL-4000 for the actual procedure of measurement. This section describes the operations that can be performed with this instrument during measurement. The converted acoustic velocity directly affects the measurement data. Check that the desired value is set before starting measurement.

  • Page 64: Checking The Measurement Data

    3.3.5 Checking the measurement data a) Intraocular pressure correction This instrument automatically starts calculation and displays the result when all items required for calculating the intraocular pressure correction are set. 1) Touch the “IOP” button (1) to open the intraocular pressure correction screen (Fig. 2). When a measurement has already been completed at this point, the measured value is displayed in the CCT field (2).
  • Page 65 3) Enter the intraocular pressure data. The keypad appears when the entry field (6) is touched. [Input range] * Intraocular pressure data : 1 - 60.0 (mmHg) : 1.33 - 79.99 (hPa) 4) Touch the “Back” button (7) to close the intraocular pressure correction screen (Fig. 2) and return to the previous screen.
  • Page 66 c) Caliper function The caliper function is for temporary reference and cannot store the calipered data. 1) Touch the "Caliper" button (1) to display the caliper screen (Fig. 2). 2) Touch the “Switch” button (2) to select a caliper line to be adjusted. The active caliper line is displayed in red and the other caliper line in yellow.
  • Page 67 d) Subtraction display function This function displays the value difference between the 2 selected measurement data. 1) Touch the “Differential” button (1) to open the subtraction display screen (Fig. 2). When a measurement has already been completed at this point, the measured values are displayed in the data 1 display field (2).
  • Page 68 3) Touch the “Data Display” button (4) to display the selected measurement data in the subtraction display screen. 4) When measurement data are selected in Data 1 and Data 2, the value difference between Data 1 and Data 2 is displayed in the subtraction display field (5). If measurement points have been selected, however, only the difference values of the memory numbers whose measurement points match in both data are displayed.

  • Page 69: Iol Power Calculation

    4. IOL POWER CALCULATION When using biometry results for calculation of the IOL power, the physician must assess the measurement result beforehand. This instrument’s limited capacity to display the volume of digits generated in internal calculations in their entirety, may cause some errors. Complex numbers may be generated for the SRK/T formula.

  • Page 70: Setting The Eye To Be Measured

    Setting the eye to be measured Refer to “2.2.5 Selecting an eye”. IOL power calculation 4.2.1 Entering calculation parameters a) Axial length, anterior chamber depth or lens When measurement of an axial length, anterior chamber depth or lens is completed, the measurement data is automatically present and cannot be entered manually.
  • Page 71 1) Touch the K1 input field (1) or the K2 input field (2) to activate it. The keypad (3) appears. Touch the “Enter” key (4) to apply the data. [Input range] Corneal refractive power : 30.00 - 60.00D Radius of corneal curvature : 5.00 - 11.00 mm 2) Touch the keratometer value display switch button (5) to change between the K1/K2 display and the AvgK display.
  • Page 72 c) Target Ref. 1) Touch the Target Ref. input field (1) to activate it. The keypad (2) appears. Touch the “Enter” key (3) to enter the data. [Input range] Angle : -30.00 - +10.00 2) The entered value is stored in the main unit, and is not cleared even when the power is turned off.
  • Page 73 * Entering using keypad The lens constants a0, a1, and a2 in the Haigis optimized formula cannot be entered directly using the keypad. Refer to “Entering through IOL data list” below. 1) Touch an input field (1) to activate it. The keypad (2) appears. Touch the “Enter” key (3) to apply the data.
  • Page 74 1) Touch an input field (1) to activate it. The IOL data list (2) appears. 2) You can check the registration content by sliding the IOL data list being displayed with the scroll bar (3). 3) Select data using the “IOL data selection” buttons (4). 4) Touch the "Edit"...
  • Page 75 5) Select the distance between the verticies (V.D.) (5), History (6) from the pulldown menu. CL / 12.0 / 13.5 / 14.0 / 15.5 / 16.0 History: ML / HL / RK ML: Myopic Lasik (Myopic correction LASIK) HL: Hyperopic Lasik (Hyperopic correction LASIK) RK: Radial Keratotomy (Radial keratotomy) f) WTW When measurement of the corneal diameter is completed, the measurement data is...

  • Page 76: Setting A Calculation Formula

    4.2.2 Setting a calculation formula Touch the calculation formula pull-down button (1) and select a formula. (When selecting OKULIX, use the IOL select button on the lower part of the screen.) The following 11 types of IOL power calculation formulae are provided with this instrument. IOL calculation formulae listed in the pull-down menu can be set according to “6.3.b) Selecting IOL power...

  • Page 77: Entering Data After Surgery

    4.2.3 Entering data after surgery Select the name of the IOL type that was actually implanted in the surgery. 1) Select the type of implanted IOL. When the entry field (1) is touched, it is activated. Select the name of the IOL type that was actually implanted in the surgery from the IOL list. 2) Enter the implanted IOL power (2), date of surgery (3), and refractive power post-surgery (4).

  • Page 78: Okulix

    OKULIX When using the OKULIX calculation result to select IOL, accurately determine the selection by also examining cataract surgery methods, other inspections and other IOL power calculation formulas. In particular, in the case of the cornea of a sound eye without having had surgery to correct refractive power of the cornea such as LASIK, carefully compare the OKULIX calculation result with the result of SRK/T formula etc.
  • Page 79 b) Entering ultrasound data on OKULIX screen When an axial length and anterior chamber depth, and lens measurement is completed, the data in the Axial, ACD(Epi.), or Lens fields are automatically present and cannot be entered manually. When entering Pachy data manually, the ACD (Endo.) is automatically calculated.
  • Page 80 d) Selecting IOL 1) Touch the IOL data field (1). The IOL List screen (Fig. 2) appears and allows you to select the desired IOL data. Select the data and touch the “Apply” key (2) to apply the data. The entered value is stored in the main unit, and is not cleared even when the power is turned off.

  • Page 81: Toric Iol Calculation

    Toric IOL calculation This function is available only after purchasing the license of the Barrett formula and performing installation. a) IOL power calculation Toric IOL calculation uses the calculation results shown on the IOL calculation screen. First, calculate the IOL power on the IOL calculation screen. When IOL power calculation has been executed, the “Toric Calc”...
  • Page 82 2) Enter the incision data. Values for the incision axis and SIA (surgically induced astigmatism) can be set on each page. [Input parameters] Incision axis : 0 - 359° SIA : 0.00 - 2.00 D 3) The IOL power values calculated on the IOL calculation screen are shown in the IOL calculation result list (3).Select the IOL power value to be used for Toric IOL calculation.
  • Page 83 c) Toric Planning screen 1) Toric IOL calculation results are used on the Toric Planning screen. Complete calculation on the Toric IOL calculation screen first. 2) Select calculated values to be used on the Toric Planning screen. Touch the IOL Model input field (1) to activate it. Select a model for which the calculation results are shown.

  • Page 84: Statistics Processing

    Statistics processing The lens constant registered on this screen will be used for the next IOL calculation. Carefully check the data before registration. Statistics processing can be performed on this screen using the examination data accumulated by the clinic of facility. Predictive errors when using the registered lens constant are calculated and a histogram is displayed.
  • Page 85 Surgeon : The registered physician IDs are displayed in the pull-down menu. “All” includes all physicians. 2) After all the conditions are set, touch the “OK” button (2). Statistics processing is performed and the result appears on the right side of the screen. The histogram (3) in the upper section shows registered lens constants and the statistics processing results of those lens constants.

  • Page 86: Export, Print, And Save

    5. EXPORT, PRINT, AND SAVE Assign functions to 2 buttons for export, print, and save provided on the operation screen before executing the export, print, and save functions. [Refer to “6.4 a) Setting functions of save, export, and print buttons”] The print and export buttons work according to the preset functions when touched after measurement.

  • Page 87: Printing

    2) The transfer confirmation screen (Fig. 2) displays patient ID, patient name, and sex. Touch the "Send" button (2) to start sending data. Touching the "Cancel" button (3) returns you to the previous screen without sending data. 3) When data transfer is completed, the message “Complete” appears. If an error is displayed, refer to “9.

  • Page 88: A) Common Items

    a) Common items (1) Measurement date and time (2) Physician name (3) Surgeon name (4) Patient ID (5) Patient name (6) Sex (7) Printed date and time (8) Product Name 87 / 153...

  • Page 89: B) Example Of Printout For Optical (Axial Length, Acd, Lens, Corneal Thickness)

    b) Example of printout for optical (axial length, ACD, lens, corneal thickness) (1) Measurement eye (right eye/left eye) (2) Measurement method (3) Measurement eye (4) Measurement mode Auto (A) / Manual (M) (5) Fitting Immersion / Contact / Optical length (6) Average axial length (7) Average optical distance (8) Standard deviation of axial length...

  • Page 90: C) Example Of Printout For Optical Measurement (Kerato)

    c) Example of printout for optical measurement (kerato) (1) Measurement eye (right eye/left eye) (2) Kerato measurement position (3) Selected measurement value (4) Keratometer average value (5) Corneal astigmatism (6) Measurement value (7) Low reliability mark (8) Memory number of representative value (9) Corneal irregular astigmatism index (10) Corneal irregular astigmatism angle Example of printout for optical measurement (pupil/corneal diameter)

  • Page 91: E) Example Of Printout For Ultrasound Measurement (Axial Length)

    Example of printout for ultrasound measurement (axial length) (1) Measurement eye (right eye/left eye) (2) Measurement method (3) Patient’s eye (4) Converted sonic velocity (5) Gain (6) Average axial length (7) Standard deviation of axial length (8) Difference between shortest axial length and longest axial length (9) Average anterior chamber depth (10) Average lens thickness...

  • Page 92: F) Example Of Printout For Ultrasound Measurement (Corneal Thickness)

    Example of printout for ultrasound measurement (corneal thickness) (1) Measurement eye (right eye/left eye) (2) Model of measuring instrument (3) Measurement mode / Type of displayed data (4) Converted acoustic velocity (5) Actual measurement in each memory slot (6) Measurement point of measurement data (7) Average of actual measurements (8) Standard deviation of actual measurements (9) Bias value display method and bias rate or...

  • Page 93: G) Printout Of Iol Power Calculation

    g) Printout of IOL power calculation (1) Measurement eye (right eye/left eye) (2) US/OPT display (3) Axial length (4) ACD (anterior chamber depth) (5) Corneal refractive power or radius of corneal curvature (6) Cornea equivalent refractive index (7) Target Ref. post-surgery (8) WTW (Corneal diameter) (9) Lens thickness (10) Parameters printed when SRK/T Double K is...

  • Page 94: H) Printout Of Personal Constants

    h) Printout of personal constants (1) Measurement eye (right eye/left eye) (2) Eye refractive power postsurgery (3) Power of the implanted IOL (4) Axial length (5) ACD (anterior chamber depth) (6) Corneal refractive power or radius of corneal curvature (7) Lens constant (8) Parameters for SRK/T Double K (9) Parameters for Barrett formula (10) Calculation result...

  • Page 95: I) Printout Of Toric Iol Calculation

    Printout of toric IOL calculation (1) Measurement eye (right eye/left eye) (2) US/OPT display (3) Axial length (4) ACD (anterior chamber depth) (5) Corneal refractive power or radius of corneal curvature (6) Axial angle of flat meridian (7) Axial angle of steep meridian (8) Cornea equivalent refractive index (9) Expected refractive power (10) Surgically induced astigmatism...

  • Page 96: Saved Data Management

    Saved data management a) Selecting storage The internal memory of this instrument or external memory connected to this instrument can be selected. Set the storage referring to “6.4 c) Media options / Data output format” When the internal memory is selected for storage, the used storage capacity is shown as a % on the button. If the used storage capacity exceeds 90%, the value turns red.
  • Page 97 3) When characters are entered in the search field (3), the patient ID and name are retrieved and the result appears. Touch the title of the line (4) to change the order of the list. Touching this button sorts the data in ascending order or descending order. 4) Touch the “Measurement List”...
  • Page 98 6) Touch the “Over Write” button (7) to overwrite the existing data with the edited contents. 7) Touch the “Meas. List” button (8) to return to the Preservation Data List screen (Fig. 4). Touch the “Patient List” button (9) to return to the Patient List screen (Fig. 3). 8) Touch the “Measure”...
  • Page 99 e) Transferring saved data - Some USB flash memorie is not recognized when connected to this instrument. When an external memory is connected to this instrument, the data saved in the internal memory can be transferred to the external memory. Touch the “Export”...
  • Page 100 g) Changing ID - Examination data are saved or deleted when changing ID. Do not turn off the power when ID is being changed. Otherwise, the data may be damaged. Backup the data as necessary. - Be sure to confirm the modification before saving the changed ID. 1) Hold the grayed out patient information button (1) briefly on the view screen to open the patient information entry screen (Fig.

  • Page 101: System Setup

    6. SYSTEM SETUP Touch the “System Setup” button (1) on the Setup screen (Fig. 1) in each mode to open the System Setup screen (Fig. 2). 1) The system setup consists of 4 major categories. - General ……… Language, time, version information, etc. - Measurement …...

  • Page 102: General

    General Set general functions here. Select the General tab. (1) System Ver. Displays the version information. The version information of the ultrasound measurement unit AL-4000 is also displayed. (2) Language Selects the language. (3) Date & Time Set the display format of the date and the date and time. The key pad appears when the input field is touched.
  • Page 103 (12) Save/Export if no ID entered Set how the patient ID must be handled when saving and sending examination data to TOMEY Link. Not Available: Select this when ID numbers are always required. Data cannot be saved or sent when the ID is not entered.

  • Page 104: [Login Settings]

    ID number. (15) Confirmation Use this field to display the Patient information confirmation screen when saving the inspection data or sending the inspection data to TOMEY Link. [Login settings] Login users of the instrument are managed here.
  • Page 105 a) Adding users Press the [Add] button (1), and the user registration screen appears. Enter “user name” and “password”, and press the [Add] button. b) Editing user information/password Select the target user, and press the [Edit] button (2). The Login screen appears. Enter the target user’s password.

  • Page 106: Measurement

    Measurement Make settings related to measurement on this screen. Select the Measurement tab. a) Optical Measurement Mode - Selection Select measurements to be performed in optical mode. Touch the “Selection” button (1) to open the measurement mode setup screen (Fig. 2). 3 patterns can be prepared.

  • Page 107: B) Starting Condition

    b) Starting Condition Set the measurement mode when power is turned on and when the measurement mode is switched. [Mode Selection] Favorite The system starts with measurement contents Settings selected on the mode selection screen. Latest The system starts with measurement contents Settings active when power was turned off last time.

  • Page 108: C) Settings For Various Measurements

    c) Settings for various measurements [Optical] Axial Pachy / Opens the setup screen for optical measurement of Kerato axial length and corneal thickness. Kerato Opens the setup screen for keratometer measurement. [Ultrasound] Axial Opens the setup screen for ultrasound measurement of axial length. Pachy Opens the setup screen for ultrasound measurement of corneal thickness.
  • Page 109 (1) SNR Assigns a low reliability mark to data with an SNR smaller than the preset value. Input Default range setting Axial SNR SNR of retina waveform 2 - 99 ACD SNR SNR of waveform on the front of 2 - 99 crystalline lens LENS SNR SNR of waveform on the back of...
  • Page 110 [Optical – Kerato] (1) Default Measure Range Set a normal measurement position. φ2.5 mm /φ3.0 mm (2) Unit of Indication Set the unit normally used for indications. mm / D (3) Kerato Step (D) (unit for measurement – diopter) Sets the indication units for the measurement value of corneal refractive power. 0.25 / 0.01 (4) AXIS Step (unit for angle) Sets the display units for the corneal astigmatism axial angle.
  • Page 111 Input range: 10 - 60 (s) (7) Measurement Display Area Average / Typical (8) Cylinder Notation Cyl is displayed with a set sign + or -. [Ultrasound – Axial] (1) Default fitting formula Set the fitting formula for normal operation. Contact / Immersion (2) Fix light Select whether the fix light in the biometry probe is turned on or off.
  • Page 112 [Ultrasound – Pachy] (1) Data Selection Method Select the measurement data type to be displayed. Latest / Minimum / Average (2) Measure Point Opens the measurement setup screen (Fig. 2). (3) PreSet1 / PreSet2 Changes the selected preset measurement point. (4) Eye selection Changes the preset measurement point of the selected eye.

  • Page 113: Application

    Application Make settings related to measurement of calculation, correction, etc. Select the Application tab. a) Registering IOL data Registers the IOL data to each measurement method. Touch each button to open the corresponding registration screen (Fig. 2). [Surgeon List] (1) Surgeon List The registered surgeons are displayed.
  • Page 114 [Surgeon Record] (1) Surgeon input field Edit the surgeon name other than Common. (2) Mode button The IOL data list of the selected mode. (3) Delete button Delete the selected IOL data list. (4) Add button Add the IOL data list. Newly Add: Newly add the IOL data list.
  • Page 115 [IOL Constant] (1) Surgeon display field (2) IOL data input field Enter each item. The software keyboard appears when the entry field is touched. (3) “Calculated from A-Const”/“Calculated from SRK/T” button Calculates the values corresponding to SF, ACD constants and LF. The calculated values are displayed in the respective input boxes.

  • Page 116: B) Selecting Iol Power Formula

    b) Selecting IOL power formula Select the IOL formula to be used on the IOL power calculation screen. The selected formulae will be displayed in the pull-down menu on the IOL power calculation screen. Touch the “Selection” button to open the IOL Formula Selection screen (Fig. 2). When Haigis standard is selected, setting items for a1 and a2 appear.

  • Page 117: C) Setting Iop Formula

    c) Setting IOP formula Register the intraocular pressure correction formula to be used for the intraocular pressure correction. The formula set here can be selected on the intraocular pressure correction screen. Touch the “Settings” button to open the selection screen (Fig. 2). (1) Intraocular pressure correction formulas Register the intraocular pressure correction formula to be used for the intraocular pressure correction.

  • Page 118: D) Iol Formula Install/Update Function

    d) IOL Formula Install/Update function The current specific IOL formula version can be checked, updated and installed. [Confirming installation of each formula] 1) Touch the IOL formula Install/Update “Settings” button (1). 2) Installation and update status of IOL formulae can be confirmed. (Fig. 2)n 117 / 153...
  • Page 119 [Updating OKULIX] 1) Create a folder named OKULIX on the USB flash memory (top level). Copy the updated file into this folder. 2) Connect the prepared USB flash memory to the instrument. The current version and new versions of OKULIX available are displayed. 3) Touch the “Update - OKULIX”...
  • Page 120 [Installing Barrett formula] The Barrett formula becomes available after entering the license key. 1) Hold the “Install - Barrett” button (4) for 1 or 2 seconds. The Serial number/License key entry field (5) appears. Enter the Serial number/License key and touch the “OK” button (6). 2) When the correct License Key is entered, the following message appears on the side of the button: * If the Barrett formula is not shown on the IOL calculation screen after installation,...

  • Page 121: Connection & Print

    Connection & Print Make settings related to connection, saving, export, and printing on this screen. Select the Connection & Print tab. a) Setting functions of save, export, and print buttons Assign functions to 2 buttons for saving, export, and print provided on each screen (Fig. Touch the “Function settings of button”...

  • Page 122: B) Selecting And Setting Printer

    b) Selecting and setting printer The printer used for printing can be selected here. The built-in printer, video monochrome printer, video color printer, or network printer can be selected. Touch the “Setting” button to open the Setup screen for each printer. There are no setting items for the video color printer.
  • Page 123 (1) Single Eye / Both Eyes Set whether to print the data of the displayed eye only or the data of both eyes. Single Eye / Both Eyes (2) Print Form Select the display form of printing. Standard / Simple (3) Header Info.
  • Page 124 [Video monochrome printer setting] (1) B/W Reverse (black/white reverse printing) ON / OFF (2) Print Size Small / Large [Network printer setting] (1) IP Address Set the IP address of the printer to be connected. Touch the input field to display the keyboard. (2) Paper Size L / A4 / B5 (3) IP Check...
  • Page 125 [Setting Data Transfer printer] (1) Connection permission and selection of cable type (2) Login Tomey Link (3) Host IP address (4) "Connection Test" button (5) Port number (6) Paper Size L / A4 / B5 Set this to the appropriate setting for the printer.

  • Page 126: C) Media Options / Data Output Format

    Selects whether to reverse a waveform image (black and white) to be exported to Data Transfer/Tomey Link. Select ON to display the waveform in black on the white background. Select OFF to display the waveform in white on the black background.

  • Page 127: D) Pc (Pc Connection)

    Select the communication destination according to the tool being used on the PC. (4) Login TOMEY Link Set the user ID and password to log in to the TOMEY Link. Maximum number of characters to be entered for the user ID or password is 16.
  • Page 128 (5) Host IP address Set the IP address of the PC to be connected. Touch the “DNS” button to specify the PC name. A DNS server must be running in the LAN environment to enable connection using the DNS. Touch the input field to display the keyboard. (6) Port number A port number can be set.

  • Page 129: E) Casia2 Communication Setting

    e) CASIA2 communication setting Select the ultrasound biometer and make settings for wireless communication with the ultrasound measurement unit AL-4000. Connection can be established automatically upon startup of the instrument when the information of the AL-4000 to be connected is registered in the connection location list and “Permit”...
  • Page 130 Select the model of the ultrasound biometer. When AL-4000 is selected, settings for wireless communication can be made. (1) Connection permission Enable / Disable (2) My BD Address The BD address of this instrument is displayed. (3) Connecting Place Name; Connecting BD Address The connecting location name and BD address currently connected are displayed.

  • Page 131: G) Database

    g) Database Delete all data in the memory and initialize the memory. Touch the “Setting” button to open the System Setup screen (Fig. 2). (1) Internal Memory (SD Card) All Delete (2) External Memory All Delete / Format (3) Patient name in database CSV export ON: The output of the patient's name is performed during CSV en bloc output.

  • Page 132: H) My Ip Address Setting

    h) My IP Address setting (1) My IP Address Setting Selects either of DHCP (dynamic IP) or MANUAL (static IP) in the IP Setting Type. When “Manual” is selected, set My IP Address, Sub Net Mask, and Default Gateway. (2) “IP Check” button Performs a duplicate IP address check.

  • Page 133: I) Extension Export

    i) Extension Export (1) KV Output ON: When the ultrasonic measurement data is output, the product information is also output. OFF: Product information is not output at the same time when ultrasonic measurement data is output. (2) Clinic Output ON: Outputs clinic information. OFF: Does not output clinic information (3) Clinic ID/Name Set the clinic ID and name.

  • Page 134: Technical Information

    7. TECHNICAL INFORMATION IOL power calculation formula 7.1.1 SRK/T formula 133 / 153...
  • Page 135 134 / 153...

  • Page 136: Holladay 1

    7.1.2 Holladay 1 135 / 153...
  • Page 137 136 / 153...

  • Page 138: Hoffer® Q Formula

    7.1.3 Hoffer® Q formula 137 / 153...

  • Page 139: Haigis Standard / Haigis Optimized

    7.1.4 Haigis Standard / Haigis optimized 138 / 153...

  • Page 140: Srk/T Double K

    7.1.5 SRK/T Double K 139 / 153...
  • Page 141 140 / 153...

  • Page 142: Shammas-Pl Formula

    7.1.6 Shammas-PL formula 141 / 153...

  • Page 143: Verification When Measuring Axial Length

    Verification when measuring axial length OA-2000 measures the distance from the lacrimal fluid on the corneal surface to the retinal pigment epithelium (RPE) as the axial length. Normally, the waveform height and width of the internal limiting membrane and choroid are smaller than those of the retinal pigment epithelium.

  • Page 144: Ultrasound Conversion Formula

    Ultrasound conversion formula The axial length measurement displayed in Contact mode or Immersion mode of the OA-2000 is the value calculated by converting the optically obtained axial length to an ultrasound axial length value, using a correction formula developed based on clinical results. Therefore, the...

  • Page 145: Verification When Measuring Anterior Chamber Depth And Crystalline Lens Thickness

    Verification when measuring anterior chamber depth and crystalline lens thickness Since there are many waveforms of the cortex etc. of the crystalline lens when measuring an eye with cataracts, the front and rear of the crystalline lens may not be captured. In this case, adjust the waveform display line on the scanned image up and down, find and display the position where the largest waveforms are shown, and move the caliper line to the point of the front of the crystalline lens.

  • Page 146: Corneal Irregular Astigmatism Index

    Corneal irregular astigmatism index Corneal irregular astigmatism index This is the index that simply quantitates the data of the corneal irregular astigmatism which cannot be found by ordinary keratometer measurements (K1, K2, and AX) according the keratometory image. There are 2 indices (KAI and KRI) as shown below, and each of them shows the level of irregular astigmatism.

  • Page 147: Troubleshooting

    8. TROUBLESHOOTING Check the following first when you encounter any problems. If the problem is not solved even after checking the applicable item listed below, contact your local distributor to request inspection and/or repair. Do not remove the cover of the instrument. You may be directly exposed to high voltage sections.
  • Page 148 - Nothing appears on the monitor screen. Cause1: The auto power off function, which automatically turns off the screen when the instrument is not operated for the specified time, has been activated. 1) Touch the Monitor screen. Cause2: The maintenance switch on the side is in the P (up) position.
  • Page 149 Cause3: Setting the output printer 3) Set "Video Monochrome" to select a monochrome printer as the output destination when pressing the PRINT button; set “Video Color” when the output destination is a color printer. Refer to “6.4 b) Selecting and setting printer”...
  • Page 150 - A different button to the one touched on the touch panel becomes active. Cause1: The touch panel is not calibrated correctly. 1) Turn on the power, touching the touch panel. When startup of the instrument is completed while your finger is in contact with the touch panel, calibration of the touch panel will complete.

  • Page 151: Optical Measurement

    Cause2: There is not enough space available in the internal memory. (The confirmation screen appears when attempting to save the data.). 2) Delete unnecessary data in the internal memory and save the data again. Cause3: An external memory is not connected even though the storage is set to an external memory.

  • Page 152: Ultrasound Measurement

    Ultrasound measurement - Measurement cannot be performed in Auto mode. Cause1: The mode is set to Manual. 1) Set to auto measurement (Auto or Auto quick). (Refer to “3.2.1 Setting measurement conditions"). Cause2: Noise is generated in the peripheral area. 2) If there is any source of noise (devices such as a motor, laser surgical equipment, etc.) near the instrument, move it away from the instrument.
  • Page 153 Cause2: The retina waveform gate cursor is not set in an appropriate position 2) Set the retina waveform gate cursor on the immediate left of the actual retina waveform. Make sure that there are no unnecessary waveforms between the retina gate cursor and retina waveform. - Monitoring sound does not go off.

  • Page 154: Consumables And Optional Equipment

    The following spare parts and accessories are available from your local distributor of this instrument. Contact your local distributor to order them. Printer paper Specify the paper type as "Built-in printer paper for OA-2000 (58 mm)." Chin rest paper (100 sheets/set) Fuse Specify the fuse type as "Fuse for OA-2000."...

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