Essilor MYOPIA EXPERT 700 User Manual
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Essilor MYOPIA EXPERT 700 User Manual

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MYOPIA EXPERT
700
Biometer
USER MANUAL
Rev. 1 - 07/04/2021

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Summary of Contents for Essilor MYOPIA EXPERT 700

  • Page 1 MYOPIA EXPERT Biometer USER MANUAL Rev. 1 - 07/04/2021...
  • Page 2 The original text of this manual is in English. SW v.: 1.0.0 BMT1IV Distributor Manufacturer VISIA imaging S.r.l. ESSILOR INTERNATIONAL SAS Via Martiri della Libertà, 95/e 147 rue de Paris, 94220 Charenton-le-Pont France 52027 San Giovanni Valdarno (AR) USA: www.EssilorInstrumentsUSA.com Italy info@essilorinstrumentsusa.com...

  • Page 3: Table Of Contents

    CONTENT INTENDED USE ................6 Intended Users ....................... 6 Location of use ....................... 6 Patient Population ......................6 Contraindications ......................6 General Description of Functions ..................7 Interaction With the Patient ....................7 PRECAUTIONS ................8 Electromagnetic Compatibility ................... 9 2.1.1 EM Emission ........................
  • Page 4 STANDARD ACCESSORIES AND EQUIPMENT ........28 INSTALLING/UNISTALLING THE SYSTEM ........... 29 10.1 Installing the System ..................... 29 10.2 Uninstalling the System ....................31 11. SETTING UP THE INSTRUMENT ............33 11.1 General ........................... 33 11.2 Power-on Procedure ......................33 11.3 Power-off Procedure ......................33 12.
  • Page 5 13.1.1 Report & Screenshot ....................62 14. MEASUREMENTS ................63 14.1 MAP- TOPOGRAPHY MAP ....................64 14.1.1 Topographic map indexes ..................... 65 14.1.2 Keratometry ....................... 65 14.1.3 Keratorefractive indexes ....................65 14.1.4 Keratoconus ....................... 68 14.1.5 Pupil .......................... 69 14.1.6 Gallery ........................70 14.1.7 Full-screen mode ......................
  • Page 6 16.1 Contact Lenses ......................... 93 16.1.1 Gallery ........................94 16.1.2 Ref ..........................94 16.1.3 K/L ..........................96 16.1.4 T/D ........................... 97 16.1.5 Profile ........................98 17. SETTINGS..................99 17.1 General ......................... 100 17.2 Measurements ........................ 101 17.2.1 Scales ........................101 17.2.2 Fluorescein .......................
  • Page 7 17.8.6 Hide Patient Names and Disable Actions when in assistance mode ........119 18. MYOPIA EXPERT 700 TROUBLESHOOTING ......... 121 19. MYOPIA EXPERT 700 TECHNICAL SPECIFICATIONS ......123 20. DECLARATION OF CONFORMITY ............126 21. CHANGING THE FUSES ..............127...

  • Page 8: Intended Use

    1. INTENDED USE NTENDED SERS MYOPIA EXPERT 700 is a corneal analyser with an integrated pupillographer and optical biometer. The main applications are the following:  Corneal topography for diagnostic purposes  Measurement of Eye Axial thicknesses  Fluorescence imaging for contact lens fitting ...

  • Page 9: General Description Of Functions

    ENERAL ESCRIPTION OF UNCTIONS MYOPIA EXPERT 700 is a corneal analyser with integrated pupillographer and optical biometer with the following functions: • Cornea image acquisition and topographic analysis • Eye Axial Biometry • Dynamic pupillometry acquisition: recording of a sequence of pupil images as the light conditions change.

  • Page 10: Precautions

    2. PRECAUTIONS This electronic device is a precision unit, and it is intended to be used in a professional healthcare environment, including hospitals, physicians’ offices, surgical centres, and limited care facilities, where equipment and systems are managed by healthcare professionals. Use and store it in a suitable place at standard ambient temperature, humidity, and atmospheric pressure conditions and avoid exposure to direct sunlight.

  • Page 11: Electromagnetic Compatibility

    LECTROMAGNETIC OMPATIBILITY 2.1.1 EM Emission The MYOPIA EXPERT 700 device fulfills the requirements of IEC 60601-1-2 4 Edition: Emission limit Standard Compliance Conducted and radiated RF CISPR 11 Class B Harmonics distortion IEC 61000-3:2 Class A Voltage fluctuations/ flicker emissions...
  • Page 12 Recommended separation distances between portable and mobile RF communication equipment and the device The MYOPIA EXPERT 700 device is intended for use in an electromagnetic environment in which radiated RF interferences are controlled. The customer or the user of the device can help prevent electromagnetic...

  • Page 13: Symbols

    3. SYMBOLS Symbol IEC Publication Description CLASS I DEVICE IN ACCORDANCE WITH 60601-1 IEC 60417-5840 APPLIED PART TYPE B PRODUCT IN ACCORDANCE WITH DIRECTIVE 93/42/EEC CORNEAL TOPOGRAPHY ACCORDING TO ISO Type A EN ISO 19980 19980:2012 IEC 60417-5032 ALTERNATE CURRENT ISO 7010-M002 FOLLOW THE INSTRUCTIONS FOR USE ISO 7010-W001...
  • Page 14 EN ISO 15223-1 REFERENCE OR MODEL NUMBER PRODUCT CLASSIFIABLE AS GROUP 2 IN ACCORDANCE WITH Group 2 EN ISO 15004-2 EN ISO 15004-2 TEMPERATURE LIMITATION EN ISO 15223-1 Specifies the temperature limits to which the medical device can be safely exposed. HUMIDITY LIMITATION EN ISO 15223-1 Specifies the range of humidity to which the medical device...

  • Page 15: Device Sample Labeling

    EVICE AMPLE ABELING...

  • Page 16: Safety Instructions

    4. SAFETY INSTRUCTIONS ENERAL • MYOPIA EXPERT 700 should be used only for its intended purposes, as detailed in this manual. • Keep this manual handy and close to the device at all times. • The instrument can be used only by qualified personnel (eye specialists, ophthalmologists, opticians, and optometrists) after having read this user manual.

  • Page 17: Environment Of Use

    Exposure to the device light when using it at maximum intensity will infringe the safety requirements after 60-minutes of use. MYOPIA EXPERT 700 has a series of LEDs of various types and powers installed. All the characteristics are detailed in the Technical Specifications section in this manual.

  • Page 18: Installation With External Device Or It Network

    Every external device that has to be connected to MYOPIA EXPERT 700 must have a USB connection cable with a maximum length of 3 m. • The purpose of the MYOPIA EXPERT 700 connection to an IT network is to print reports and perform remote technical assistance. •...

  • Page 19: Transport And Packaging

    • The purpose of the MYOPIA EXPERT 700 connection is saving PDF reports on an external network folder or technical service intervention on the device. • Connection of the MYOPIA EXPERT 700 to a computer network that includes other equipment could result in previously unknown RISKS;...

  • Page 20: Cleaning

    • The device comes with a dust cover to be used to protect it. Cover the MYOPIA EXPERT 700 if it is not going to be used for an extended time.

  • Page 21: Privacy & Cybersecurity

    & C RIVACY YBERSECURITY • When installing a new unit, the user MUST set his credentials to prevent unauthorized physical access to the device. To set up the log in access to the instrument and on-board data, refer to section 17.8. •...
  • Page 22 Processor: means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the Controller. The processor is/are the person/s designed by the clinic or hospital to operate the device and use the results.

  • Page 23: Privacy & Security Options

    4.9.1.3 Privacy and Data Protection during assistance/support services The device provides functionalities to assure Data Protection also during assistance/support services, to avoid disclosure of Personal Data to unauthorized personnel and ensure data integrity and availability. Refer to section 17.8 for specific options Privacy &...

  • Page 25: Product Warranty And Reliability

    5. PRODUCT WARRANTY AND RELIABILITY The product warranty is valid only if all the instructions detailed in this document are followed. The product warranty is void in the event of loss or damage due to improper or incorrect use of the device. The product warranty is valid only if the device is equipped with its original accessories.

  • Page 26: Legal Provisions

    6. LEGAL PROVISIONS 93/42/EEC – 2007/47/EC Class IIa medical device IEC 60601-1 Class I type B continuous operation IEC 60601-1-2 see EMC Table ISO 15004-2 Group 2 UNI EN ISO 19980 Type A...

  • Page 27: Liability

    7. LIABILITY The manufacturer shall not be held liable for damages caused by fire, earthquakes, actions by third parties and other accidents, or negligence and misuse of the instrument by the user. The manufacturer shall in no way be liable for damages caused by the user or by the unavailability of the device, such as a loss of profits or suspension of business.

  • Page 28: Main Components

    8. MAIN COMPONENTS Fig. 1 Patient’s side 1. FOREHEAD REST 2. PLACIDO DISK 3. CHINREST 4. Locking pins for chinrest paper 5. Chinrest monitor...
  • Page 29 Fig.2 User’s side 1. LCD DISPLAY WITH TOUCHSCREEN 2. JOYSTICK 3. STAND-BY BUTTON Power connector (with fuse carrier) 2 x USB port 1x LAN port The parts in contact with the patient (applied parts) are the forehead rest and the chinrest in Acrylonitrile Butadiene Styrene resin (ABS).

  • Page 30: Standard Accessories And Equipment

    9. STANDARD ACCESSORIES AND EQUIPMENT Calibration checking device The calibration checking device shows serial number instrument with which it is associated. properly check calibration, calibrator provided with the instrument must always be used. Power cable User Manual (English) User Manual (English) Accessories box containing: ...

  • Page 31: Installing/Unistalling The System

    10. INSTALLING/UNISTALLING THE SYSTEM MYOPIA EXPERT 700 is packed for shipping in a double cardboard box on a dedicated pallet with specially shaped cardboard parts inside, to help ensure the instrument is safely handled and transported. Keep the original packaging for future use. The system must always be handled/shipped in its original packaging, which is specifically designed to protect it against damages.
  • Page 32 Open the internal box and remove the specially shaped part that holds the instrument. Remove the Nylon cover. Be careful when taking MYOPIA EXPERT 700 out of the box, gripping it by the chinrest arch and the base beside the joystick. The instrument can now be taken out of the package. The steps are illustrated in...

  • Page 33: Uninstalling The System

    Fig. 5 Place the instrument on a flat surface. Completely unscrew the two locking screws and the semi-lock. Connect the power cable provided. The instrument is now ready for use. 10.2 U NINSTALLING THE YSTEM Take the original packaging. Set the instrument to the minimum height using the joystick. Lock the device using the instrument semi-lock and the two locking screws for transportation.
  • Page 34 Follow the step sequence shown in Fig. 7. Fig. 7 Put the accessories in the dedicated spaces. Close the external box with strong packing tape or use extensible film and packing straps.

  • Page 35: Setting Up The Instrument

    11. SETTING UP THE INSTRUMENT 11.1 G ENERAL Before connecting the device to external devices or IT Networks, please read the SAFETY INSTRUCTIONS. Fig.8 1. STAND BY BUTTON 2. POWER CONNECTOR 3. LAN PORT 4. USB PORT (2) 11.2 P OWER ROCEDURE Make sure the power cord provided is connected to the supply mains.

  • Page 36: Operating Instructions

    Refer to section 17.8 on how to configure and manage the login access. If the user login password is configured and enabled, the login screen will be prompted at the start-up of the MYOPIA EXPERT 700 on- board application. The login screen is also prompted to allow access to the privacy and security settings...

  • Page 37: User Logout

    Type the user password as configured to access the operations and data of the device. If the password is forgotten or access problems are encountered, please contact assistance. It is possible to get remote support by pressing on the button “Remote Assistance” if the device is connected to the internet.

  • Page 38: Overview

    12.2 O VERVIEW Every working environment has the same screen layout. Below is shown a sample of the acquisition screen. Fig.9 1. The active working area is highlighted in orange. 2. Main Menu 3. Print 4. Settings 5. Left – Eye Data 6.

  • Page 39: Checking Calibration

    12.3 C HECKING ALIBRATION It is recommended to check the calibration of the device:  Every day before starting patient examinations;  When the device has been transported from one place to another;  When it has suffered an impact or thermal shocks. To check the calibration, turn on the device, and when asked to check the calibration, press START.
  • Page 40 Fig. 11 Set the calibration tool supplied with the device (Fig. 12) in the special holes in the chinrest and press until the tool is blocked on the device. Check that the calibration tool is perfectly aligned with the device. If the calibration tool is positioned correctly, all the rings of the Placido disk should be seen reflected in the center on the surface of the hemisphere (Fig.
  • Page 41 Fig.13 Now check and acquire several times the calibration checking device using the complete acquisition (Topography and Axial biometry). For details on this acquisition mode, see chapter 12.6. If the calibration is ok, the “Valid” word will be displayed for all the measurements. If the measurements are incorrect, the words “Repeat”...
  • Page 42 clean the sphere of the calibration tool; Incorrect make sure that the calibration tool is positioned correctly. ERROR calibration If the calibration check is still not valid, do not take any patient measurement and contact Technical Support. Fig. 14...

  • Page 43: Entering/ Selecting A Patient

    NTERING ELECTING A ATIENT When the MYOPIA EXPERT 700 instrument is turned on, the software displays the following screen. To continue the examination, you must always enter a patient or select one from the database or server (if enabled). Fig. 15 Fig.

  • Page 44: Creating A New Patient

    12.4.1 Creating a new patient To create a new patient, select the “New” tab and enter the data using the on-screen keyboard (MYOPIA EXPERT 700 only). Once you have entered the new patient data, tap on the “New Exam” button to confirm the information and continue with the examination.

  • Page 45: Patient Data Management

    the button on the right, the patient list is sorted alphabetically (A to Z) or by the last exam date (most recent first). 12.4.3 Patient data management When you create a new patient, edit an already existing patient, or select a patient from a server (to create a new exam), the software performs a search on the local archive to check if these data already exist.

  • Page 46: Managing The Selected Patient

    Fig. 18 12.4.6 Selecting a patient from Server MYOPIA EXPERT 700 can be enabled to search patients from DICOM services (refer to DICOM configuration section): DICOM Patient Root Query: search patient’s details on enabled patient’s archive server DICOM Worklist Mode: get the list of patients and tasks in the waiting room.
  • Page 47 12.4.6.1 Start an exam from the Waiting Room If DICOM Mode Worklist service is configured, MYOPIA EXPERT 700 can search for pending patient examinations in the waiting room. Pressing on the “Waiting Room…” button (Fig.19) shows a list of the pending worklists for the current day.

  • Page 48: Acquisition Environment: General Instructions

    12.5 A CQUISITION NVIRONMENT ENERAL NSTRUCTIONS 12.5.1 Positioning the patient The adequate positioning of the patient respect to the device is required to obtain correct measurements. A steady head position and the correct device-to-patient distance are obtained by resting the patient’s head well against the chinrest and forehead band.
  • Page 49 Fig. 21 The height of the chinrest can be regulated by the on-screen touch control if the joystick adjustment is not enough to achieve the correct position. Fig. 22 The position of the chinrest must be both comfortable and correct, i.e., it must allow the person measuring to focus on the fixation LED correctly.

  • Page 50: Description Of The Acquisition Screen

    12.5.2 Description of the acquisition screen Fig. 25 shows the acquisition screen: Fig. 23 The acquisition window (Fig.23 ) has the following commands:  OD and OS: these indicate the eye being acquired (the one highlighted in yellow); they are selected automatically, depending on the position to which you move the instrument.

  • Page 51: Acquisition Procedure

    12.5.3 Acquisition procedure The Back-lighting of the Placido disk is automatically activated when you enter the acquisition environment. If the instrument is not used for a few minutes, the cone turns off; to turn it on again, just press the joystick button.
  • Page 52 The red arrows indicate to move the instrument forwards towards the patient’s eye. The centering condition is displayed in red The blue arrows indicate to move the instrument backward away from the patient. The centering condition is displayed in blue The green signs indicate that the ideal focus has been reached.
  • Page 53 1: Total Result 2: Standard deviation of total results ERRORS IN MEASUREMENTS Sometimes the measurement is taken in one of these conditions: bad focus, closed eyelid, tear film irregularity, high standard deviation in multiple measurements, movement, measurement not in range; in this case, a warning appears above the measurement.

  • Page 54: Topography + Bio

    To ensure that the measured values obtained with the MYOPIA EXPERT 700 are compatible with those obtained through acoustic axial length measurement, the system automatically adjusts for the distance difference between the inner limiting membrane and the pigmented epithelium.

  • Page 55: Topography

    MYOPIA EXPERT 700 allows the user to acquire the corneal topography of the eye. The “Corneal Map” is obtained from the reflection of 24 rings of the Placido disk at a distance of 80 millimeters from the patient’s eye.

  • Page 56: Pupillometry

    12.8 P UPILLOMETRY Press the “PUPI” button to acquire the Pupillometry images. By selecting this mode, the acquisition environment shown in Fig. 26 appears on the screen. Press the joystick button to start the acquisition and press the button again to stop the acquisition; if the user does not interrupt the acquisition manually, the software automatically interrupts it when the sliding bar reaches the end.

  • Page 57: Fluorescein

    WARNING: With blue eyes, the acquisition of pupillometry in mesopic lighting conditions can be difficult to accomplish. 12.9 F LUORESCEIN Press the “FLUO” button to access the fluorescein analysis acquisition environment (Fig. 27). You can select between picture and movie acquisition. Fig.

  • Page 58: Rx/Al Trends Function

    13. RX/AL TRENDS FUNCTION The RX/AL Trend function allows reviewing the progression of the biometry value of the selected patient over time, based on the data present in the local archive, with the possibility to add further data manually. By pressing the RX/AL Trend button, it is possible to access the Data Review, the RX/AL Trend data overview section for the selected patient.

  • Page 59: Data Review

    13.1 D EVIEW The data present in the Data Review section is provided by examinations directly performed with MYOPIA EXPERT 700 and stored onboard together with manual data eventually imported or added. BASELINE Starting condition of the trend profiles. It can be changed on the fly to any examination date. MONTH BASE Window period for Variation profile calculation NOTES...
  • Page 60 RX/AL, Refraction & Axial Length trend: Combined trend view with Refraction error S.E. and Axial Length.
  • Page 61 RX, Refraction trend: Refraction S.E. absolute value (at reference Vertex Distance) trend and yearly variation (on 3,6,12 months’ basis). AL, Axial Length trend: Absolute Value trend and yearly variation (on 3,6,12 months’ basis).
  • Page 62 A.P.P., Average Pupillar Power: (calculated on a circle of 4.5mm diameter) Absolute Value trend and yearly variation (on 3,6,12 months’ basis). DATA Raw data table review and management (edit, delete). General action buttons:  Import Button: Import data from the template sheet for the current patient only. ...
  • Page 63  Delete Button: Delete the selected row...

  • Page 64: Report & Screenshot

    13.1.1 Report & Screenshot To create a report of the RX/AL Trend, press the print icon in the top main bar and check the RX/AL Trend report. A binocular report with:  Refraction and Axial Length absolute and yearly variation charts ...

  • Page 65: Measurements

    14. MEASUREMENTS All measurements performed during the examination can be reviewed in detail in the “Measurements” section. There are 12 types of measurement section.  MAP: Topography Map  OD/OS: (or R/L) Right to Left side by side Topography Map review ...

  • Page 66: Map- Topography Map

    14.1 MAP- TOPOGRAPHY MAP The environment displayed is shown in Fig. 28. Fig. 28 Tap on the “OD” or “OS” buttons to display the map of the right or left eye. The “OD” and “OS” buttons are only active if the keratometry of the eye in question has been acquired. In the right column, you can select the following options: ...

  • Page 67: Topographic Map Indexes

    14.1.1 Topographic map indexes The diagnostic indexes can be selected with the following buttons (at the top, above the map):  K: Keratometry  I: Keratorefractive indexes  KC: Keratoconus  P: Pupil 14.1.2 Keratometry Press the “K” button to display the keratometric data on the 3 mm, 5 mm, and 7 mm zones, as shown in Fig.
  • Page 68  Curvature Irregularity: Irregularity of curvature calculated on the standard deviation of the instantaneous readings for a 4.5mm diameter cornea area  Asymmetry + SAI: Asymmetry between the most curved hemisphere and the flattest one, calculated for a 4.5mm diameter cornea area and a SAI (Surface Asymmetry Index), which represents the surface asymmetry index of the 4.5mm diameter cornea area.
  • Page 69 The top right rectangle (Peripheral degrees) contains the same parameters as in the top left one, but the diameter of the circular area is 4.5mm. The bottom right rectangle contains two parameters: the corneal asphericity referred to the pupillary surface (4.5mm) and the surface irregularity (SD). The last parameter measures the difference between the current cornea curvature and the related aspherical best fit surface.

  • Page 70: Keratoconus

    14.1.4 Keratoconus Press the “AK” button to open Keratoconus screening; this section is divided into two tabs: KC and CLMI. The KC shows the following information (Fig. 32): Fig. 32  AK: Apical curvature Represents the power of the cornea at its apex ...

  • Page 71: Pupil

     A: area of the keratoconus (mm²)  D: average diameter of the keratoconus (mm)  r, ø: polar coordinates (mm, °) of the barycenter of the keratoconus in relation to the center of the  RND: circularity factor of the keratoconus The CLMI shows the following information (Fig.

  • Page 72: Gallery

     Pupil Dec.: Pupil decentration from the optical axis.  Avg Pupil Ø: Mean diameter of the pupil. Fig. 34 14.1.6 Gallery Press the icon at the top right of the map to enter the gallery (Fig.35). Fig. 35 From the gallery, you can change the default image for all the acquisitions made.

  • Page 73: Full-Screen Mode

    14.1.7 Full-screen mode From the map environment (Fig.38), you can access full-screen mode (Fig.36) by pressing the button positioned at the bottom right corner of the image. To close the environment, tap on the X button at the bottom right corner. Fig.

  • Page 74: Edit Rings

    14.1.9 3D Press the “3D” button to view the 3D map of the keratometric data (Fig.38): Fig. 38 14.1.10 Edit Rings In this section, the user can edit the 24 rings in order to improve the topographic map (Fig.39). Fig. 39...
  • Page 75 On the right, the navigation tools are available:  At the top, the thumbnail of the image with a red rectangle inside is displayed. This shows the current position within the image; it is possible to drag it and move it to see different parts of the image.

  • Page 76: Od/Os

    14.2 OD/OS In this section you can compare the OD and the OS data on the same screen (Fig 50): Fig. 40 As in the “Map” section, you can switch between the “K”, “I”, “KC” and “P” tabs. The “DIFF” button is disabled because the “difference map” is allowed only with the same eye.

  • Page 77: Zer-Zernike

    14.3 ZER-Z ERNIKE The Zernike module provides a comprehensive view of the wave front aberrations generated by the front surface of the cornea. The results of the Zernike axis are illustrated by means of numerical indexes and graphic representations. Fig. 41 Tap on the “OD”...
  • Page 78 Fig. 42 Tap on “Graphs” at the top left to display the vision quality summary (Fig.43). This section displays:  Zernike Coefficient pyramid: represents the numerical value of each coefficient by means of a grayscale; the greater the coefficient, the greater the color contrast with the pyramid background. ...
  • Page 79 Fig. 43 It is possible to switch between ETDRS and Landolt C Visus simulation view.

  • Page 80: Height

    14.4 H EIGHT “Height” environment allows the user to compare the patient’s cornea with a reference surface (Fig.44): Fig. 44 In the right column, it is possible to: Choose between the “Absolute” and “Normalized” scale, with the possibility to change the ...

  • Page 81: Profile

    Fig. 45 14.4.1 Profile Press the “Profile” button to view the curvature profile along the steep meridian or the flat meridian (Fig.56). It is possible to scale the graph with the “50μm”, “10μm” and “5μm” buttons found under the graph. Press the “Close”...
  • Page 82 Fig. 46 14.4.2 3D Press the “3D” button to view the 3D map of the altimetric data (Fig.47). Fig. 47...

  • Page 83: Comp- Comparison

    14.5 COMP- C OMPARISON Comparison mode allows the user to compare the current exam data with the data of another exam for the same patient (Fig.48). Fig. 48 When you select the “COMP” button, the interface shown in Fig.49 appears, and the software allows you to choose in a list of exams for the patient currently selected.
  • Page 84 Fig. 49 In comparison mode, it is still possible to see the “K”, “I”, “KC” and “P” tabs; in addition, it is possible to select the “DIFF” button (see the related paragraph). The user can also change:  MAP: it is possible to choose between axial and tangential. ...

  • Page 85: Diff-Differential

    14.5.1 DIFF-Differential By tapping the “DIFF” button in comparison mode, the user switches to differential mode (Fig.50). Fig. 50 In this section, it is possible to see the differential map between the current exam and the exam selected by the user. Under the maps found at the top left and top right, there are the main indexes of the respective maps.

  • Page 86: Pup-Pupillometry

    14.6 PUP-P UPILLOMETRY The pupillometry module allows the user to display and analyze the dynamic and static pupillometry (pupil images acquired in controlled light conditions). Normally, if pupillometry is acquired, the software switches to dynamic mode (Fig.51). Fig. 51 Tap on “OD” or “OS” to display the pupillometry of the right or left eye, respectively. With the patient’s eye in view, the buttons will be located below the home screen.

  • Page 87: Dynamic

     Mesopic  Scotopic The active buttons are those for which at least one acquisition is available. 14.6.3 Dynamic By tapping on the “Dynamic” button to display the dynamic pupillometry in the left column, the following information will also be displayed: ...
  • Page 88 Decentration: Fig. 52 The green concentric circles identify the decentration of the pupil center with respect to the fixation point. The red line, on the other hand, represents the coordinate variations during the acquisition of dynamic pupillometry. Latency: Fig. 53...
  • Page 89 The graph shows the time in seconds on the abscissa and the pupil diameter in mm on the ordinate, in a scale standardized based on the maximum and minimum value recorded. The progression of the pupil diameter over time is represented in the following. Taking into account that dynamic pupillometry consists of acquiring various images under variable light conditions, from scotopic to photopic and back to scotopic, on the “Settings”...

  • Page 90: Fluo-Fluorescein

    14.7 F LUORESCEIN The fluorescein module (Fig.55) allows you to assess the physical condition of the cornea and to verify the contact lens position and fitting towards the cornea. Fig. 55 The pictures and videos acquired can be viewed in the gallery. When the fluorescein module is started, the first acquisition in the gallery is displayed in the main window.

  • Page 91: Wtw - White To White

    14.8 WTW – W HITE HITE The White-to-White section allows you to view the value of the corneal diameter calculated from the limbus (Fig.56). Fig.56 Tapping on the Open button in the Edit menu (Fig.57), the user can manually reposition the positional indicators in order to refine the diameter measurements.
  • Page 92 Next to the image, obtained by automatic white to white calculation, you can see:  Corneal diameter.  Decentration: deviation from the center of the iris with respect to the fixation point By changing the position of the indicators also the values of corneal diameter and the offset of the visual axis x and y are updated.

  • Page 93: Report Printing & Saving

    15. REPORT PRINTING & SAVING 15.1 R EPORT RINTING  In the measurements section, the user can print all the measurements made in the current exam.  In the top-right corner of the screen, press on the button to open the report printing panel (Fig.58).
  • Page 94 Fig. 59...

  • Page 95: Lenses

    Note: This function calculates the difference between the patient’s corneal shape measured by MYOPIA EXPERT 700 and the shape of the contact lens provided by the lens manufacturer under the setting which you set up in advance, and visualizes the calculation results.

  • Page 96: Gallery

    16.1.1 Gallery From this section, it is possible to select the brand, the model, the diameter, and the base curve of the lenses (Fig.61) and to add the favourite ones to the gallery on the right. To add the favourite lenses, press the “Add” button. To cancel all the lenses shown in the gallery, press the “Reset”...
  • Page 97 In this section, it is also possible to edit these values by pressing the button found under the values: a tab will appear (Fig.62), and the user will be able to edit the values by pressing the related arrows found at the right of the value.

  • Page 98: K/L

    16.1.3 K/L This section displays information about the patient’s eye (Fig.63) and namely:  Keratometric data.  Corneal diameter Fig. 63 In this section, it is also possible to edit the limbus by tapping on the “Edit” button. By pressing this button, the user will be required to select three points of the limbus;...

  • Page 99: T/D

    16.1.4 T/D This section displays the tilting and decentration of the selected lens (Fig.64). Fig. 64 The user can edit the tilt values by tapping on the yellow squares found around the lens, and the decentration values by dragging (using their fingers) the lens to the desired position.

  • Page 100: Profile

    16.1.5 Profile In the profile section, the user can see the distance between the selected lens and the patient’s cornea in a graph (Fig.65). Fig. 65 The user can select the meridian where the distance is displayed by tapping on the arrows found above and under the meridian value.

  • Page 101: Settings

    17. SETTINGS To access the “Settings” section, press the button: Fig.66 The settings screen is divided into the following categories:  General  Measurements  RX/AL Trends  Lenses  Report  Connectivity  Admin From each setting environment, you can close and return to the previous activity by selecting the “Close” button.

  • Page 102: General

    17.1 G ENERAL Refer to Fig.66:  Language: The first time the program is started, the default language is set to English, and the keyboard layout is “QWERTY”. To change the language settings, select the desired language from  button, press “Set” to set the chosen language for automatic those that appear by tapping on the starting.

  • Page 103: Measurements

    17.2 M EASUREMENTS The acquisition settings panel allows you to set the parameters for displaying the corneal map and acquiring and displaying fluorescein and pupillometry (Fig.67). Fig. 67 17.2.1 Scales Select a unit of measure:  Diopters  Millimeters This option is activated both for the acquisition screen and for the topographic map. Type Select a scale type: ...

  • Page 104: Fluorescein

    Asphericity Select an asphericity unit of measure:     Cylinder Notation Select a notation for cylinder calculation:  Positive  Negative Scale Colors Select between two color scales options:  Color Mode 1 (Absolute scale)  Color Mode 2 (Absolute scale) Decentration Format Select a decentration format:...

  • Page 105: Pupillometry

    17.2.3 Pupillometry Display Select one or more items to customize the pupillometry display:  Grid  Ruler  Ring center  Pupil Time intervals Select the time intervals, in a range from 500ms to 5000ms, of the scotopic and the photopic phase during the pupillometry acquisition.

  • Page 106: Rx/Al Trend Options

    17.3 RX/AL T REND PTIONS By pressing on the settings icon, you get access to the RX/AL Trend related options. Time Axis Options The charts shown in the Data Review section can have the time axis visualized by:  Date, calendar date of examination data ...
  • Page 107 If the Age option is selected for the Time Axis, the Fixed age range can be enabled/disabled and configured. If the fixed age range is enabled, at least the age range defined by the two related values will be displayed in the time axis.
  • Page 108 REQUIRED DATA (for each row)  Patient ID: patients already present in the archive will be matched by this field  Patient Date of Birth: required to import patients who are not already existing in the archive  (if the DoB is not specified the patient will not be created and the related data ignored) ...
  • Page 109 Vertex Distance in mm relative to the refraction measurement Refraction measurement in preferred notation (positive cylinder notation or negative cylinder notation)  Rx type:  Subjective or Objective Eye status: condition at the moment of refraction measurement  Cycloplegia or Normal Contact Lens data (in case of Over Refraction measurement) ...

  • Page 110: Lenses

    17.4 L ENSES It allows you to manage your lens database (Fig.68). Fig.68 A brand list is displayed to the left. Tap on the “Import” button to add new manufacturers to the database. You can import new manufacturers using a USB pen-drive. Check the manufacturers you want to include in the list of available lenses for the contact lens fitting module.

  • Page 111: Report

    17.5 R EPORT Clinical Information It allows the user to edit the header and the logo that will be printed at the top of the report page (Fig.69). Fig.69 17.5.1 Report Settings It allows the user to set the default paper type and to choose whether the report will be for one eye or both.

  • Page 112: Network Folder

    17.5.2 Network Folder It allows the user to configure and use a remote network folder to store MYOPIA EXPERT 700 reports. This resource will then become selectable as the destination in the report print form. To allow MYOPIA EXPERT 700 to connect to the remote network folder, you must configure the MYOPIA EXPERT 700 settings with the correct access credentials for the remote resource.

  • Page 113: Connectivity

    17.6 C ONNECTIVITY 17.6.1 Server List 17.6.2 Export to External Software settings In this panel, it is possible to control two main aspects of the device behavior in relation to the exportation function. 17.6.3 XML Export Enables/Disables the XML option for exporting XML data of the exam to the network folder by the export window.
  • Page 114 In order to configure the full DICOM workflow properly, it could be necessary to perform some operations or configurations on the server’s side. In order to do this, contact the System Administrator. The DICOM module of MYOPIA EXPERT 700 is described in detail in its DICOM Conformance Statement. For more information, refer to your local distributor.

  • Page 115: Admin

    17.7 A DMIN This is the device administration panel (Fig. 72). Fig.72 It provides information on the system, such as a serial number (S/N) and software version (S/V). The “Check” button starts the calibration check procedure. Checking calibration See the section on the procedure. It is recommended to check the calibration when the device has been transported from one place to another and if it suffered an impact or thermal shocks.

  • Page 116: Remote Assistance

    17.7.1 Remote Assistance In case you need remote assistance, the MYOPIA EXPERT 700 application integrates Team Viewer QS (Quick Support) pre-installed. There is NO NEED to disable the Write Filter protection Ensure to have internet access available for your MYOPIA EXPERT 700 unit Go to Settings >...

  • Page 117: Updating The Integrated Software

    2. Switch on the MYOPIA EXPERT 700. 3. Click on the settings icon 4. Click on the “Admin” tab 5. Insert the USB stick with the “MYOPIA EXPERT 700 upgrade” files in one of the USB ports. 6. Click on the “Upgrade” button.
  • Page 118 8. After the upgrade completed, the system will reboot and starts the “MYOPIA EXPERT 700 application”. 9. If you see the message shown in Fig. 73, please switch off your MYOPIA EXPERT 700 and turn it on again. Your MYOPIA EXPERT 700 should now work fine.

  • Page 119: Patients Management

    USB drive. 1. System. This operation may take some minutes: do not restart the machine during this procedure. 2. Your MYOPIA EXPERT 700 is now upgraded. 17.7.4 Printer management and Network configuration The “Printer management” and the “Network configuration” buttons open, respectively, the printer management and the network configuration panels of Windows that allow to manage the printers and the network properties of the device.

  • Page 120: Password Protected Login

    17.8.1 Password protected Login The options allow protecting with a password the access to the MYOPIA EXPERT 700 on-board application operations and data. By default, the option is enabled but requires the password to be configured. When the option is enabled, and the password configured the login is prompted when: ...

  • Page 121: Hide Patient Details In Reports And Exported Exam Packages

    The options, used in combination with a password-protected login, allows making the patient details and related actions non-accessible when interacting with the MYOPIA EXPERT 700 on-board application in technician/service mode. To switch the application to technician mode, press on the lock button to lock the application.
  • Page 122 User Mode In standard user mode, the patient details and related actions are regularly accessible. Technician Mode In technician Mode, the patient details are not accessible, and delete/edit actions are not available. When exporting exam packages in this mode, the patient details are automatically anonymized.

  • Page 123: Myopia Expert 700 Troubleshooting

    18. MYOPIA EXPERT 700 TROUBLESHOOTING Problem Solution The external body of the MYOPIA EXPERT 700 is Contact Technical Service broken The MYOPIA EXPERT 700 display is broken Contact Technical Service The MYOPIA EXPERT 700 cannot be moved with the Completely unscrew the two locking screws and the joystick semi-lock.
  • Page 124 The MYOPIA EXPERT 700 restarts when clicking on Contact Technical Service. the joystick button Some lights in the MYOPIA EXPERT 700 do not turn Check that the proper acquisition type is selected. on when making the related acquisition. If the problem persists, contact Technical Service.

  • Page 125: Myopia Expert 700 Technical Specifications

    19. MYOPIA EXPERT 700 TECHNICAL SPECIFICATIONS No modification of this equipment is allowed. NOTE: The manufacturer shall provide, upon request, circuit diagrams, list of components, descriptions, calibration instructions, or other information that will assist the technical assistance personnel in the repair of parts of the device specified by the manufacturer as repairable by the technical support staff.
  • Page 126 Exposure to the device light when using it at maximum intensity will infringe the safety indication after a 60-minutes use. MYOPIA EXPERT 700 has a series of LEDs of various types and powers installed. All the characteristics are detailed in the Technical Specifications section in this manual.
  • Page 127 INFORMATION ON MEASUREMENTS MEASURING DISPLAY VIVO MEASUREMENTS RANGE RESOLUTION REPEATABILITY 5.00 – 12.00 mm Curve radius 0.01 mm ±0.02 mm Keratometry Curve Radius Diopter 28.00 - 67.50 D 0.01 D ±0.12 D (n=1.3375) 15.00 – 36.00 mm 0.01 mm ±0.027 mm Axial Length 0.50 –...

  • Page 128: Declaration Of Conformity

    Brand / ESSILOR Marca Model / MYOPIA EXPERT 700 Modello I, the undersigned, hereby declare under my sole responsibility that the aforementioned devices comply with the Directive 93/42/EEC (implemented in Italy by Legislative Decree n. 46/97) with Annex II excl. (4) and subsequent amendments and additions (Directive 2007/47/CE –...

  • Page 129: Changing The Fuses

    21. CHANGING THE FUSES WARNING: Do not perform the following operation in the presence of the patient. Step 1 Open the fuse box cover using a screwdriver Step 2 Take out the fuse box (use a screwdriver to release it) Step 3 Remove the blown fuse from its seat and replace...
  • Page 130 > QR C SER MANUAL The latest version of the user manual in the appropriate language is available on a web space. Upon request, a paper version can be provided for free. The complete user manual is available on a web space. To access it, please scan the QR code below using a dedicated application.
  • Page 131 > QR C SER MANUAL Manual pengguna yang lengkap boleh didapati di ruangan web. Untuk akses, sila imbas kod QR di bawah menggunakan aplikasi yang berkenaan. De volledige gebruikershandleiding is beschikbaar op een website. U kunt de handleiding bereiken door de QR- code hiernaast te scannen met een geschikte applicatie.
  • Page 132 Please specify the following when contacting your local supplier regarding questions about this product:  Product name: MYOPIA EXPERT 700  Software version: as written in the Settings > Admin section  Period of use: Please provide the date of installation ...

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