Topcon ALADDIN User Manual
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Topcon ALADDIN User Manual

Intended for biometric determination of the following ocular measurements: axial length, corneal radius, corneal cylinder axis, anterior chamber depth, white-to-white wtw and pupil diameter of the human eye. aladdin also measures corneal topography
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ALADDIN
- User manual
Rev. 23 of 08/07/2016
ALADDIN
User manual
0123
Product cod. 1240211
ALADDIN HW2.0
Rev. 23 - 2016
1

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  • Page 1 ALADDIN - User manual Rev. 23 of 08/07/2016 ALADDIN User manual 0123 Product cod. 1240211 ALADDIN HW2.0 Rev. 23 - 2016...
  • Page 2 The manufacturer also reserves the right to make any changes to this manual without notice. The original text of this manual is in English. SW v.: 1.5.x Manufacturer Distributor VISIA imaging S.r.l. Topcon Europe Medical B.V. Via Martiri della Libertà 95/e Essebaan 11 52027 San Giovanni Valdarno (AR) 2908 LJ Capelle a/d IJssel Italy The Netherlands www.topcon.eu...
  • Page 3 Components ............................23 Main Body ............................23 Other components .......................... 24 Installation /uninstallation of the system ....................25 10.1 Installing the system ........................25 10.2 Uninstalling the system ........................28 ALADDIN accessories and equipment ..................... 31 11.1 Standard equipment ........................31...
  • Page 4 ALADDIN - User manual Rev. 23 of 08/07/2016 Setting up the instrument ........................32 12.1 Connection modes ........................... 32 OPERATING INSTRUCTIONS ........................33 13.1 General description of functionalities ..................... 33 13.1.1 General instructions ........................ 34 13.2 Checking the calibration ........................34 13.3...
  • Page 5 ALADDIN - User manual Rev. 23 of 08/07/2016 13.12.3 Toric IOL calculation ......................73 13.12.4 Post Refractive IOL calculation .................... 76 13.13 MEASUREMENTS ......................... 79 13.13.1 TOPOGRAPHIC MAP (KER) ....................79 Topographic map indices ....................... 80 Keratometry ........................... 80 Keratorefractive indices ......................... 80 Keratoconus ...........................
  • Page 6 Other Specifications: Onboard PC component specifications ............140 Declaration of conformity ........................141 Appendix: Installing an external printer ....................142 17.1 Getting drivers and transferring them to ALADDIN ..............142 17.2 Disabling the Write Filter ....................... 142 17.3 Installing a local printer (USB) ....................... 143 17.4...

  • Page 7: Intended Use

    Aladdin 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 millimetres from the patient's eye. The position of the device in relation to the patient’s eye serves as the starting point to make adjustments in the respective...
  • Page 8 The ACD measurement is the distance between corneal epithelium and the crystalline lens surface. Aladdin has an onboard PC with the dedicated software that provides all the functionalities described. The information obtained from the measurements can be used for various applications, for example: Cataract...

  • Page 9: Users

    ALADDIN - User manual Rev. 23 of 08/07/2016 • HOLLADAY, JT: International intraocular lens implant registry 2003. J Cataract Refract Surg (2003) 29:176-197 • HAIGIS W: Relations between optimized IOL constants. Symposium on Cataract, IOL and Refractive Surgery of the American Society of Cataract and Refractive Surgery (ASCRS), Philadelphia, PA, USA, June 1-5, 2002, Abstracts, p.112, 2002...

  • Page 10: Positioning The Patient

    ALADDIN - User manual Rev. 23 of 08/07/2016 1.3 Positioning the patient The patient must be positioned in such a way that the distance from the device to the eye is 80 mm. A steady head position and the correct device-to -patient distance is promoted by resting the patient’s head well against the chin rest and forehead band.

  • Page 11: Accessibility And Scope Of The Manual

    ALADDIN - User manual Rev. 23 of 08/07/2016 2 Accessibility and scope of the manual Keep these instructions in a safe place close to the device. The manual must be at hand at all times. For best use of the instrument, read the instructions carefully.

  • Page 12: Introduction

    3 Introduction 3.1 Main characteristics ALADDIN is a multifunction medical device used for the detection of various biometric parameters, particularly useful for the calculation of spherical, toric or personalized intraocular lenses. It records a wide range of parameters, which are acquired by using different techniques.

  • Page 13: Precautions

    ALADDIN - User manual Rev. 23 of 08/07/2016 4 Precautions This electronic instrument is a precision tool. Make sure to use it and keep it in a suitable place, at a normal temperature, humidity and atmospheric pressure out of direct sunlight.

  • Page 14: Emc Table

    - User manual Rev. 23 of 08/07/2016 4.1 EMC table Emission issues ALADDIN is intended for use in the electromagnetic environment specified below. The customer or user must ensure that it is used only in such an environment. Emission test Compliance Electromagnetic environment - guide ALADDIN uses RF energy only for its internal function.
  • Page 15 ALADDIN device ALADDIN is intended for use in an electromagnetic environment in which radiated RF disturbances are under control. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between mobile and portable RF communication devices (transmitters) and the ALADDIN device as recommended below, according to the maximum output power of the radio communication devices.

  • Page 16: Symbols

    ALADDIN - User manual Rev. 23 of 08/07/2016 5 Symbols Symbols Description publications IEC 60417- CLASS I DEVICE ACCORDING TO EN 60601-1 5840 APPLIED PART TYPE B PRODUCT COMPLIANT WITH DIRECTIVE 93/42/EC EN ISO CORNEAL TOPOGRAPHY ACCORDING TO ISO 19980:2005...

  • Page 17: Labeling On The Device

    ALADDIN - User manual Rev. 23 of 08/07/2016 KEEP DRY EN ISO Indicates a medical device that needs to be protected from 15223-1 moisture. HANDLE WITH CARE THIS WAY UP ISO 780 Indicates correct upright position of the transport package.

  • Page 18: Safety Instructions

    Rev. 23 of 08/07/2016 6 Safety instructions 6.1 General  ALADDIN should be used only for its intended purposes as detailed in this manual.  It must be installed by qualified personnel.  The device must be used in the environmental conditions as specified in this document.

  • Page 19: Electrical Safety

    6.3 LED emission safety The light emitted from this instrument is not potentially hazardous. ALADDIN has a series of LEDs of various types and powers installed. All the characteristics are detailed in the Technical Specifications section in this manual. The LED groups comply with the emission limits for the Group 1 instruments of the standard UNI EN ISO 15004-2.

  • Page 20: Transport And Packaging

    Be careful not to get the device wet and clean it only as indicated to prevent damaging it. Never use solvents or other abrasive agents.  The device comes with a dust cover to be used to protect it. Cover ALADDIN if it is not going to be used for a long period of time. ...

  • Page 21: Cybersecurity

    ALADDIN - User manual Rev. 23 of 08/07/2016  Check the measurements every day when turning on the device using the instrument provided.  The user of the device must check that the measurements provided by the device are plausible.

  • Page 22: Product Warranty And Reliability

    ALADDIN - User manual Rev. 23 of 08/07/2016 7 Product warranty and reliability  The product warranty is valid only if all the instructions detailed in this document are followed.  The product warranty is forfeited in the event of loss or damage due to improper or incorrect use of the device.

  • Page 23: Components

    ALADDIN - User manual Rev. 23 of 08/07/2016 9 Components 9.1 Main Body Placido disk Figure 2 LCD display with touchscreen Joystick with acquisition button Semi-lock Figure 3 Instrument locking devices for transportation...

  • Page 24: Other Components

    ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 4 Power connector LAN port USB ports (2) ON/OFF button (with fuse carrier) 9.2 Other components Forehead rest Chin rest Wheel for adjusting Locking pins for the rest position chin rest papers...

  • Page 25: Installation /Uninstallation Of The System

    Rev. 23 of 08/07/2016 10 Installation /uninstallation of the system ALADDIN is packed for shipping in a double cardboard box on a dedicated pallet with specially shaped cardboard parts inside to guarantee instrument safety during shipment. Two special warning labels are applied on the outside of the cardboard box. Please check them as described below before accepting the instrument consignment, or accept it only with reserve.
  • Page 26 (see Figure 8). Figure 8 The accessories are:  “Topcon” box: o calibration checking device o chin rest paper o chin rest pins o touchscreen pen o silicon cloth  Power cable  “Topcon” ALADDIN dust cover  ALADDIN user manual...
  • Page 27 The steps are illustrated in Figure 9. Figure 9 Be careful when taking ALADDIN HW3.0 out of the box gripping it by the chin rest arch and the base beside the joystick.

  • Page 28: Uninstalling The System

    ALADDIN - User manual Rev. 23 of 08/07/2016 Semi-lock Instrument locking devices for transportation Figure 10 10.2 Uninstalling the system 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 “instrument locking devices”...
  • Page 29 ALADDIN - User manual Rev. 23 of 08/07/2016...
  • Page 30 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 12 Put the accessories in the dedicated spaces. Position the wood panel with the shock absorbers in the lower part. Close the external box with strong packing tape or use extensible film and packing straps.

  • Page 31: Aladdin Accessories And Equipment

    ALADDIN - User manual Rev. 23 of 08/07/2016 11 ALADDIN accessories and equipment 11.1 Standard equipment  Calibration checking device The calibration checking device shows the serial number of the instrument with which it is associated. To properly check calibration, the calibrator provided with the instrument must always be used.

  • Page 32: Setting Up The Instrument

    ALADDIN - User manual Rev. 23 of 08/07/2016 12 Setting up the instrument 12.1 Connection modes Figure 13...

  • Page 33: Operating Instructions

    Rev. 23 of 08/07/2016 13 OPERATING INSTRUCTIONS ALADDIN is designed to work in stand-alone mode. For this reason, all the software functions are automatically loaded when the device is turned on, enabling the user to control the device and guiding him...

  • Page 34: General Instructions

    ALADDIN - User manual Rev. 23 of 08/07/2016 • Shammas No-history: Shammas H.J., Shammas M.C., Garabet A., Kim J.H., Shammas A. , LaBree L.: Correcting the Corneal Power Measurements for Intraocular Lens Power Calculations After Myopic Laser In Situ Keratomileusis” - American Journal of Ophthalmology (Impact Factor: 4.02).
  • Page 35 ALADDIN - User manual Rev. 23 of 08/07/2016 WRONG alignment CORRECT alignment Figure 15 To check the calibration, turn on the instrument, and when asked to check the calibration, press Start (Figure 16) and then press Close (Figure 17). Figure 16...
  • Page 36 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 17 To check the calibration, turn on the instrument and, when asked to check the calibration, press OK. By pressing ok, the test patient is automatically created. Now check and several times acquire the calibration checking device using the complete acquisition (AL-ACD-K), in check calibration is not possible to acquire the single measurements.
  • Page 37  make sure that the calibration tool is position correctly. If the calibration check is still not valid, do not take any patient measurement and contact Topcon Technical Support to have the Aladdin instrument checked. To complete the measurements, check that all the measurements are valid, click on “Main” to start a new...

  • Page 38: Patient Entry/Selection

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.3 Patient entry/selection When the instrument is turned on, the software displays the following screen. To continue the examination, you always need to enter a patient or select one from those on file.

  • Page 39: Creating A New Patient

    ALADDIN - User manual Rev. 23 of 08/07/2016 fields (Gender and ID are optional). You can set from the settings environment to have only the ID as required field. 13.3.1 Creating a new patient To create a new patient, select the “New” tab and enter the data using the on-screen keyboard. Once you have entered the new patient data, click on the “Ok”...
  • Page 40 The measured axial eye length depends on the measuring mode selected. Depending on the measuring mode selected, Aladdin corrects the measurement with a constant defined as follows. Aladdin device takes into consideration two conditions of the eye that can alter the measurement of axial length:...
  • Page 41 ALADDIN - User manual Rev. 23 of 08/07/2016 The correction values (in mm) of the natural vitreous body Phakic APhakic 0.21 Pseudophakic Unknown material 0.11 Pseudophakic Silicone IOL 0.12 Pseudophakic PMMA IOL 0.11 Pseudophakic Acrylic IOL Pseudophakic Memory IOL 0.11 For the vitreous body you can choose between: ...
  • Page 42 ALADDIN - User manual Rev. 23 of 08/07/2016...

  • Page 43: Selecting Or Modifying A Patient

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.3.2 Selecting or modifying a patient On the input screen, click on the "List" tab to access all the patients included in the database (see Errore. L'origine riferimento non è stata trovata.).

  • Page 44: Insert The Post-Op (After Surgery) Refraction Data

    ALADDIN - User manual Rev. 23 of 08/07/2016 Press "Edit" to change the name, surname or date of birth. This takes you back to the initial "New" tab. From here, you can edit the information you need to change and press “Ok” or “Cancel” to confirm or cancel the changes.

  • Page 45: Selecting A Patient From Server

    Once enabled, Aladdin IMAGEnet i-base’s integration from Aladdin’s settings panel (refer to IMAGEnet i- base configuration), it’s possible to select a new patient from the patient list retrieved from IMAGEnet i-base (Figure 25). In the same way, Aladdin can be activated to search patients from DICOM services (refer to DICOM configuration section): ...
  • Page 46 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 26 Figure 27...

  • Page 47: Start An Exam From The Waiting Room

    Start an exam from the Waiting Room If DICOM Modality Worklist service is configured, Aladdin is able to search for pending patient’s examinations in the waiting room. Pressing on the “Waiting Room…” button (Figure 26) shows a list of the pending worklists for the current day.

  • Page 48: Acquisition Environment: General Instructions

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.4 Acquisition environment: general instructions Figure 29 Figure 29 shows the acquisition screen. The joystick illustrated in Figure 30 is the only part the user has to physically control during acquisition. The button on the top marked "Acquisition button"...
  • Page 49 ALADDIN - User manual Rev. 23 of 08/07/2016 Make sure the patient's forehead is well up against the Figure 30 forehead rest. Wheel for adjusting the The position of the chin rest chinrest height. must be both comfortable and correct, i.e. it must allow the...

  • Page 50: Description Of The Acquisition Screen

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.4.1 Description of the Acquisition screen Figure 31 Figure 31 shows the acquisition screen from where all the operations to acquire the required measurements are performed. The acquisition window has the following commands: ...

  • Page 51: Errors In Measurements

    ALADDIN - User manual Rev. 23 of 08/07/2016 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 sign appears above the measurement.

  • Page 52: Biometry

    ALADDIN - User manual Rev. 23 of 08/07/2016 If a warning sign is shown above a measurement, it is recommended to make further acquisitions until reliable data is obtained. It is very important that the main types of measurement (KER-AL-ACD) taken are shown without a warning sign, otherwise it will not be possible to proceed to IOL Calculation with the current data (valid ACD is needed only if using Haigis formula).

  • Page 53: Pupillometry

    ALADDIN - User manual Rev. 23 of 08/07/2016 To perform the measurements individually, simply click on one of the “AL” (axial length), “ACD” (anterior chamber depth) or “KER” (keratometry) buttons. WARNING: a correct ACD measurement cannot be made without acquiring the patient's keratometry.

  • Page 54: Acquisition Procedure

    ALADDIN - User manual Rev. 23 of 08/07/2016 Acquisition of the topographic map with all associated measurements Identification of Mesopic and Photopic pupil 13.5.1 Acquisition procedure Backlighting 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;...
  • Page 55 ALADDIN - User manual Rev. 23 of 08/07/2016 The blue arrows indicate to move the instrument backwards away from the patient. In this situation the centering aims assume different tones of blue color, as follows: The centering condition is out of tolerance(Ideal Centering Marker and...

  • Page 56: Further Adjustments For The Anterior Chamber Depth

    To ensure that the measured values obtained with the Aladdin are compatible with those obtained through acoustic axial length measurement, the system automatically adjusts for the distance difference between the inner limiting...

  • Page 57: Acquisition Of The Anterior Chamber Measurement (Acd)

    ALADDIN - User manual Rev. 23 of 08/07/2016 membrane and the pigmented epithelium. The displayed axial length values are thus directly comparable to those obtained by immersion ultrasound, and no re-calculation or correction factors are necessary. Deviations may nevertheless occur between the displayed axial lengths and ultrasonic readings (particularly in the applanation procedure).
  • Page 58 ALADDIN - User manual Rev. 23 of 08/07/2016  the fixation point is displayed in optimum focus in the square on the screen (only the fixation point should be within the square, not the other image details),  no reflections must be in the image of the cornea (can cause interference), otherwise the reading will be incorrect, ...

  • Page 59: Keratometry Acquisition (Ker)

    Aladdin 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. The position of the device, in relation to the patient’s eye thus found, serves as a starting point for fine adjustments to be...
  • Page 60 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 39 In this mode, the topographic map of the cornea is acquired. Knowing the distance of the corneal apex, with a precision of microns, at the time of acquisition of the topographical image, the software applies to each of the 256 zero crossing, identified for each of the 24 RINGS, a correction factor given by the ratio between correct mean value and mean radius of the ring.

  • Page 61: Acquisition Of The Dynamic, Photopic, Mesopic Pupillometry

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.9 Acquisition of the dynamic, photopic, mesopic pupillometry Figure 40 By selecting this mode, the acquisition environment shown in Figure 40 appears on the screen. In order to acquire the pupillometry, first of all you need to center the blue rectangle, which is overlaid in the image on the reflection of the four LEDs, as shown in Figure 41.
  • Page 62 ALADDIN - User manual Rev. 23 of 08/07/2016 Acquisition in photopic controlled light conditions Figure 41 Acquisition in mesopic controlled light conditions Figure 42...

  • Page 63: Report Printing

    In addition to these two options you can select a network folder as destination of report to print. For network folder settings, see 13.15.5.1. The “Aladdin Report Options” allow to define which overlay will be printed in the topography maps images of the “Aladdin”. Refer to sections 13.13.1 and to 13.15.2 for details about this options.

  • Page 64: Available Printers

    ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 44 Available Printers 13.10.1 The printing form is showing a list of available printers. The available printers are the one installed on the Operating System. Refer to “Appendix: Installing an external printer” or ask to your technical support in order to have the desired printer installed.

  • Page 65: Custom Reports

    ALADDIN - User manual Rev. 23 of 08/07/2016 Custom Reports 13.10.2 If the unit has been provided with Customized Reports they will be available to be selected for printing or exporting in the Printing form. In order to obtain custom reports contact you technical assistance.

  • Page 66: Data Exportation

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.11 Data Exportation After every measurement, you can export the corresponding reports or xml date made in the current exam. In the top-right corner of the screen, press on the button. The popup of Figure 45 is show where you can select one or more destinations for exportation.
  • Page 67 ALADDIN - User manual Rev. 23 of 08/07/2016 If Storage Commitment is configured you will receive the confirmation message in case of successful or unsuccessful transfer.  IMAGEnet 6/IMAGEnet i-base, the selected reports and data are sent to IMAGEnet i-base or IMAGEnet 6 if activated and configured from the settings.

  • Page 68: Iol Calculation

    Rev. 23 of 08/07/2016 13.12 IOL CALCULATION ALADDIN also includes a section for calculation of the intraocular lenses (IOL Calculation). In order to perform the intraocular lens power calculation, the available power interval, the increments and the calculation constants must be provided for each type of formula and lens. These, however, do not depend solely on the type of lens and the calculation formula, but are also closely linked to the measuring technology and the surgical techniques used.

  • Page 69: Data

    From the “Source” field (present in both the Biometry and Keratometry sections, Figure 46), you can choose to use the measurements of the “Aladdin” instrument as source, or to enter them manually by pressing the “Manual” button. In this case, a panel opens (Figure 48) where you can enter the data manually using the...
  • Page 70 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 48 In Figure 48 (Manual Keratometry tab), you can enter values both in Diopters or Millimeters. The values will be automatically recognized according to a specific range. This range goes from 6.75mm to 9.64mm, (from 35Diopters to 50Diopters).

  • Page 71: Spherical Iol Calculation

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.12.2 Spherical IOL calculation The section where you process the data collected for the calculation of the best intraocular lens is divided into three main parts: The IOL Calculation section is fundamental in calculating the total spherical power that will compensate the removal of the crystalline in cataract surgery.
  • Page 72 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 49 above shows the SW environment for entering data for the “IOL Calculation”. In the “Surgeon” field, you can choose which surgeon will perform the IOL implant and any customization of the constants or presetting of the preferred lenses and formulae will be applied on this basis.

  • Page 73: Toric Iol Calculation

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.12.3 Toric IOL calculation Toric IOL calculation is divided into two main steps. The first one consists on the calculation of the Spherical Equivalent Power; in the second one you can select the toric IOL that produce the best correction.
  • Page 74 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 51 “Measures” and “Surgical Pre Op Data” frames summarize the values used in the first-step calculation. “Expected Post Op Cornea” frame gives information about the post surgery patient eye Keratometry, taking into account the aforementioned SIA and IL.
  • Page 75 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 52 This simulation shows the impact of a wrong axis placement that can occur during surgery and how it affects the residual sphere and cylinder refraction of the patient. The simulator starts at the correct axis placement and displays in the left bottom table a series of misalignment angles close to the ideal one.

  • Page 76: Post Refractive Iol Calculation

    ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 53 13.12.4 Post Refractive IOL calculation In this section, you can calculate intraocular lenses also for patients who have undergone refractive surgery to correct myopia or hyperopia by using the Camellin-Calossi formula and the Shammas no-history formula (Figure 54).
  • Page 77 ALADDIN - User manual Rev. 23 of 08/07/2016 If the correction type is myopic or hyperopic, you have to select the surgery type performed on the patient from those listed: 1. Radial Keratotomy (RK) 2. Photo Refractive Keratectomy (PRK) 3. Lasik 4.
  • Page 78 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 56 The final result of the Post-Op calculation is shown in Figure 56 with the suggested lens highlighted in yellow.

  • Page 79: Measurements

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.13 MEASUREMENTS All measurements performed during the examination can be reviewed in detail in the "Measurements" section. There are four types of measurement. KER: Keratometry o ZER: Zernike Analysis AL: Axial length...

  • Page 80: Topographic Map Indices

    ALADDIN - User manual Rev. 23 of 08/07/2016  Diopters (D)  Radius (r)  Meridians (θ)  Altimetry (z) The Scale buttons allow to switch between Absolute and Normalized (adjustable) scale color steps. When Normalized is pressed the button is replaced with controls that allows to adjust the color step for the current topography map.

  • Page 81: Keratoconus

    ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 58  Astigmatism: Astigmatism at 3 and 5 mm (or 2 and 4 mm)  Pupil Avg: Average pupil power for a pupil of 4.5 mm  Asphericity: Asphericity of the cornea at 8 mm diameter ...

  • Page 82: Pupil

    ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 59  AK: Apical curvature. Represents the power of the cornea in its apex  AGC: apical gradient of curvature. Represents the average variations per unit of length of the corneal power, taking the apical power as reference.
  • Page 83 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 60  KC: KC represents the central keratometry in diopters  Avg Pupil Power: Average pupil power for a pupil of 4.5 mm and 3.0 mm  Photopic o Pupil Dec.: Pupil decentralization from optical axis o Avg Pupil Ø: Mean diameter of the pupil...

  • Page 84: Profile

    ALADDIN - User manual Rev. 23 of 08/07/2016 Profile Press the "Profile" button to view the curvature profile along the most curved meridian and the flattest meridian (red and blue). The difference is displayed in green (Figure 61). By pressing the arrow buttons, you can vary the flattest and the most curved meridians.

  • Page 85: Zernike

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.13.2 Zernike The Zernike module provides a comprehensive view of the wavefront aberrations generated by the front surface of the cornea. The results of the Zernike axis are illustrated by means of numerical indices and graphic representations (Figure 62).
  • Page 86 ALADDIN - User manual Rev. 23 of 08/07/2016  Spot Diagram: represents the spatial distribution of the wavefront over the retina.  Visus/Visus Low Contrast: represent the patient's real vision at high and low contrast. Figure 63 The data displayed refers only to the component induced by the anterior surface of the cornea, not by the eye's entire optical system.
  • Page 87 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 64 It is possible to switch between ETDRS and Landolt C Visus simulation view.

  • Page 88: Axial Length (Al)

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.13.3 AXIAL LENGTH (AL) Figure 65 Figure 65 shows an axial length measurement. In this screen you can select and display the interferometric graph for each measurement and from the left and right columns the measurements performed for the right eye and left eye, respectively. The measurements highlighted in yellow are the ones used to calculate the average axial length and are acceptable with respect to signal/noise.

  • Page 89: Anterior Chamber Depth (Acd)

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.13.4 ANTERIOR CHAMBER DEPTH (ACD) Figure 66 Figure 66 gives an example of ACD (Anterior Chamber Depth) measurement. Looking at the image in the centre of the screen, you can see that three different reflections are present.

  • Page 90: Display

    ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 67 Click on “OD” or “OS” to display the pupillometry of the right or left eye, respectively. With the patient's eye in view, buttons are located below the home screen. These buttons are used to navigate between the acquired frames.

  • Page 91: Photopic, Mesopic

    ALADDIN - User manual Rev. 23 of 08/07/2016  Diameter: Pupil diameter for the frame selected  Pupil Center (frame): Cartesian coordinates of the center of the pupil for the frame selected Photopic, Mesopic By clicking on the “Photopic”, “Mesopic” buttons static pupillometry acquisitions will be displayed, with the following information: ...
  • Page 92 ALADDIN - User manual Rev. 23 of 08/07/2016 Decentralization Figure 68 The green concentric circles identify the decentralization of the pupil center with respect to the fixation point. The red dots, on the other hand, represent the coordinate variations during acquisition of the dynamic pupillometry.
  • Page 93 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 69 The graph shows the time in seconds on the abscissa and the pupil diameter in mm on the ordinate, in a scale standardized on the maximum and minimum value recorded. Next the progression of the pupil’s diameter over time is represented.

  • Page 94: White To White

    ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 70 The graph represents the static value of the percentile of the sample for each acquisition in controlled light conditions. As indicated in the key on the right-hand side and by the values detailed on the left, the red line represents...
  • Page 95 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 71 Clicking on the Open button in the Edit menu, the user can manually reposition positional indicators in order to refine the diameter measurements. Figure 72 Next to the image, obtained by automatic white to white calculation, you can see: ...
  • Page 96 ALADDIN - User manual Rev. 23 of 08/07/2016  Decentralisation: deviation from the center of the iris with respect to the fixation point. By changing the indicators position also values of corneal diameter and offset of the visual axis x and y are updated.

  • Page 97: Examination Data Saving

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.14 EXAMINATION DATA SAVING After performing some acquisitions and eventual IOL calculations, in order to save the data from the examination, click on the home button. As shown in Figure 73, the software will ask the user to confirm the action.

  • Page 98: Settings

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.15 SETTINGS To access the “Settings” section, press the button. Figure 74 The settings screen is divided into the following categories.

  • Page 99: General

    ALADDIN - User manual Rev. 23 of 08/07/2016  General  Measurements  Surgeons   Report  Admin From each settings environment you can close and return to the previous activity by selecting the "Close" button. 13.15.1 General Refer to Figure 74: Language: The first time the program is started, the default language set is English and the keyboard layout is "QWERTY".
  • Page 100 ALADDIN - User manual Rev. 23 of 08/07/2016 Select a scale type:  Absolute  Normalized Select a scale color map:  Classic   ISO 2005 Cylinder Notation Select the type of cylinder notation:  Positive  Negative Figure 75 Refractive Index Select the refractive index to work with.
  • Page 101 ALADDIN - User manual Rev. 23 of 08/07/2016 Be careful because changing the index will result in a differently calculated Keratometry and Topographic Map. Change this value at your discretion. Asphericity Select an asphericity unit of measure:   ...

  • Page 102: Topography Map Color Scale

    ISO2005 color scale, by going to Measures section of the settings. The color scale option selected affects any topographic map drawing in the Aladdin application and in the printed reports (also the custom ones). The Classic and ISO absolute color scale are shown in the following figure for the same topography map.

  • Page 103: Map Option

    ALADDIN - User manual Rev. 23 of 08/07/2016 2005 Map Option Map Design Select one or more items with which to personalise the map display:  Meridians  3 Zones  Ruler  Grid Keratometry Select one of the keratometric indices: ...

  • Page 104: Surgeons

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.15.3 Surgeons The “Surgeons” panel allows you to create different user profiles. Figure 76 Select the surgeon in the left column to display the data. Press the “Edit” button to modify the data entered.

  • Page 105: General

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.15.4 Figure 77 Here you can configure various options and presets for the IOL environment (Errore. L'origine riferimento non è stata trovata.) associated with the surgeon selected in the “Last Name” section, divided into three different environments described in detail below: ...

  • Page 106: Preset

    ALADDIN - User manual Rev. 23 of 08/07/2016 Preset Figure 78 The screen presented is as shown in Errore. L'origine riferimento non è stata trovata.. Each surgeon can set: Under “IOL” the preset for the IOL Calculation Under “Toric” the preset for the Toric IOL Calculation Under “Post Refractive”...
  • Page 107 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 79 Toric preset uses a different set of lenses (with only toric ones) and requires some additional settings with respect to “IOL” and “Post Refractive IOL” sections. In particular, you can specify the “Surgical Induced Astigmatism (SIA)” induced by the surgeon and the “Incision Location”...

  • Page 108: Iol List

    ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 80 IOL list In this section (Figure 81) you can manage IOL spherical and torical lenses list. You can change the available manufacturers and models by adding, deleting or editing them.
  • Page 109 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 81 List of functions for IOL manufacturer column: Add: add a new manufacturer not present in the current list o Insert the manufacturer name o Insert the model name o Insert the kind of formula and constant o Insert the value of the constant, “Hoffer Q pACD”...
  • Page 110 ALADDIN - User manual Rev. 23 of 08/07/2016 Delete: delete a manufacturer. Please note that this function will also delete every IOL associated to the current manufacturer. List of functions for IOL model column: Add: add a new IOL model to the current manufacturer:...
  • Page 111 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 84...
  • Page 112 With the “Ulib” button you can import .zip files of ULIB (User Group for Laser Interference Biometry) format. Download the file and copy it to the root (main card) of an empty FAT32-formatted USB pen 1. Insert the USB pen in the Aladdin device. 2. Click on the “Ulib” button on the “IOL list” panel.
  • Page 113 ALADDIN - User manual Rev. 23 of 08/07/2016 o Insert the kind of formula and constant o Insert the value of the constant, “Hoffer Q pACD” in the case below (other constants will automatically be converted) o Define the “Sphere Power Range”, inserting the minimum, the maximum and the step of the spherical power of the lens o Choose the “Cylinder Definition”...
  • Page 114 ALADDIN - User manual Rev. 23 of 08/07/2016 Edit: edit the name of the current manufacturer in the list Delete: delete a manufacturer. Please note that this function will also delete every IOL associated to the current manufacturer. List of functions for IOL model column: Add: add a new IOL model to the current manufacturer, with the same procedure described in the “Add Toric Manufacturer”...

  • Page 115: Connectivity

    That resource will then become selectable as a destination in the report’s print form. In order for Aladdin to be able to connect to the remote network folder, you must configure Aladdin setting the correct access credentials for the remote resource.

  • Page 116: Xml Export

    IMAGEnet i-base software Aladdin can receive and transfer data to Topcon IMAGEnet i-base through a wireless or LAN network. IMAGEnet i-base is activated by clicking on the Enabled Option and by providing the IP address of the machine we want to connect to. By clicking on the Configure button (Figure 88) the user is presented with a list of IP Addresses of the machines running IMAGEnet i-base software that are reachable from Aladdin.

  • Page 117: Imagenet 6 Server Software

    IMAGEnet 6 Server is activated by clicking on the Enabled Option and by providing the IP address of the external server we want to connect to. Once we have selected the proper IP, Aladdin is ready to exchange data with the IMAGEnet 6 Server machine (Figure 91).
  • Page 118 In order to get exam data to exported to PhacoOptics® software, running on an external PC, it is necessary to configure a network path and access credentials for the target of exportation. Refer to PhacoOptics® manuals on how to get the data exported from Aladdin inside the application.

  • Page 119: Dicom

    ALADDIN - User manual Rev. 23 of 08/07/2016 DICOM The DICOM panel of Connectivity section allows to set the needed parameters for the connections to the available DICOM services. The available services are:  Modality Worklist, The DICOM Modality Worklist service provides a list of imaging procedures that have been scheduled for performance by the acquisition device.
  • Page 120 In order to configure properly the full DICOM workflow 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 Aladdin is describe in detail in its DICOM Conformance Statement. Visit http://www.topconmedical.com/conformance.cfm...

  • Page 121: Admin

    ALADDIN - User manual Rev. 23 of 08/07/2016 13.15.6 Admin Figure 92 This is the instrument's administration panel (Figure 92). It provides certain information on the system: serial number (S/N) and software version (S/V). The “Check” button starts the calibration check procedure ...

  • Page 122: Remote Assistance

    The password is masked, the operator knows it already To turn off manually the Remote Assistance you can close the Teamviewer window or press “Remote Ass. OFF” If you get one of the following windows please check your internet connection to Aladdin or contact your IT staff.

  • Page 123: Updating The Integrated Software

    In this section is described the software upgrade procedure from one version to the following version. To update the software, perform the following operations: 1. Unpack the update packet in the root (main card) of an empty FAT32-formatted USB external drive. 2. Switch on the Aladdin. 3. Cancel the calibration check (Figure 93). Figure 93...
  • Page 124 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 94 5. Click on the “Admin” tab (Figure 95). Figure 95 6. Insert the USB stick with the “Aladdin upgrade” files in one of the USB ports (Figure 96).
  • Page 125 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 96 7. Click on the “Upgrade” button (Figure 97). Figure 97 8. Click on “Ok” to reboot the system and start the upgrade (Figure 98).
  • Page 126 9. After the upgrade you will see the message of Figure 99 on the screen. Figure 99 10. The system will reboot and starts the “Aladdin application”. 11. After restart, the software updates the system; this operations could take some minutes please...
  • Page 127 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 100 12. If you see the message of Figure 101, please switch off your Aladdin and turn it on again. Your Aladdin should now works fine. Figure 101...

  • Page 128: Backup & Restore

    ALADDIN - User manual Rev. 23 of 08/07/2016 13. Your Aladdin is upgraded. Please check in the settings, “Admin” tab if the S/V is now the new one (Figure 102). Figure 102 Backup & Restore It’s recommended to perform a backup to have a safety copy of every patient stored data. Depending on the expected size of the entire archive, we suggest to use an external USB drive or have available enough space on a designed network shared folder.
  • Page 129 ALADDIN - User manual Rev. 23 of 08/07/2016 Backup Procedure To perform the backup connect the desired USB external storage device or switch to Network Folder option. 1. Select the desired destination:  USB, select the desired partition from the list of the available ...
  • Page 130 ALADDIN - User manual Rev. 23 of 08/07/2016 2. Press “Backup” button, wait for the procedure to complete. Press “OK” to confirm the operation or “No” to do not perform the backup. Do not turn off the device or unplug the power supply and ethernet cable while performing this operation.
  • Page 131 ALADDIN - User manual Rev. 23 of 08/07/2016 Restore Procedure The machine calibration backup CANNOT be restored to a different machine from the original one. If attempting to restore a different machine backup to the current machine the calibration restore is skipped. Ask to technical assistance in order to restore the calibration.

  • Page 132: Closing The Software

    ALADDIN - User manual Rev. 23 of 08/07/2016 4. In sequence, it is prompted to confirm if restoring or not each kind of backup content. Press “OK” if you want to restore the content or press “No” to skip the restore of the mentioned content.

  • Page 133: Operating Voltage And Fuse Change

    ALADDIN - User manual Rev. 23 of 08/07/2016 14 Operating voltage and fuse change 14.1 Changing the operating voltage Step 1 Open the fuse box cover using a screwdriver Step 2 Take out the red fuse box (use a screwdriver to release...

  • Page 134: Changing The Fuse

    ALADDIN - User manual Rev. 23 of 08/07/2016 Step 6 Close the black cover again and check if 115V is displayed in the opening 14.2 Changing the fuse It is mandatory to use fuses only with the indicated characteristics The use of undersized fuses can cause the interruption of power to the device during normal working conditions.

  • Page 135: Technical Specifications

    ALADDIN - User manual Rev. 23 of 08/07/2016 15 Technical specifications No modification of this equipment is allowed NOTE: the manufacturer shall provide, upon request, circuit diagrams. the 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 136: Optical Radiation

    ALADDIN - User manual Rev. 23 of 08/07/2016 Device Class for EN 60601-1 Class I 15.3 Optical radiation 1) Axial length measurement Source: Sled Wavelength 830 nm Power on patient's eye: < 0.6 mW Source: IR LED (crown) Wavelength: 770 nm Power on patient's eye: <...

  • Page 137: Performance Testing

    ALADDIN and IOLMaster separately using a factorial ANOVA models for repeated measures within subject including the subsequent term: device identifier (A1, A2, A3 for ALADDIN and I1, I2, I3 for IOLMaster), operator identifier (1, 2 and 3), subject identifier (1 to 63) and every two-way interactions;...
  • Page 138 Repeatability % COV = (Repeatability SD / abs(overall mean))*100; Reproducibility % COV = (Reproducibility SD / abs(overall mean))*100. The result of the repeatability and reproducibility study demonstrate that ALADDIN is substantially equivalent for both repeatability and reproducibility to the predicate device.

  • Page 139: Information On Measurements

    ALADDIN - User manual Rev. 23 of 08/07/2016 15.5 Information on measurements 1) Anterior chamber depth Measuring range 1.5 – 5.5 mm Display resolution 0.01 mm Repeatability in live mode ±0.1 mm 2) Axial length Measuring range 15 - 38 mm Display resolution 0.01 mm...

  • Page 140: Mechanical Specifications

    ALADDIN - User manual Rev. 23 of 08/07/2016 15.7 Mechanical Specifications Device: Packaged Width 320mm 600mm product: Height 490mm 800mm Length 470mm 710mm Weight 18 kg 29kg 15.8 Other Specifications: Onboard PC component specifications Hardware 1.0 Hardware 2.0 Operating system...

  • Page 141: Declaration Of Conformity

    ALADDIN - User manual Rev. 23 of 08/07/2016 16 Declaration of conformity DECLARATION OF CONFORMITY/ Dichiarazione di conformità: Manufacturer/Fabbricante : Name/Nome : VISIA imaging S.r.l. Via C.E. Gadda, 15 – 52027 San Giovanni Valdarno (AR) – ITALY Address/Indirizzo : Name of device/Nome del dispositivo :...

  • Page 142: Appendix: Installing An External Printer

    (for example “C:\Drivers”). Copy them to the root directory of an USB FAT32 formatted pen driver that will later be connected to the ALADDIN USB port. Now go back to ALADDIN and disable the “Write Filter” carrying out the following steps: 17.2 Disabling the Write Filter 1.

  • Page 143: Installing A Local Printer (Usb)

    17.3 Installing a local printer (USB) The following instructions are for a Windows XP system. On Windows 7 machines follow similar steps. Close the software using the procedure explained before in step 2. From the ALADDIN Windows Start menu, select Settings then Printers and Faxes.
  • Page 144 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 105 Select “Local printer attached to this computer” and make sure that the Automatically detect and install my Plug and Play printer checkbox is not checked. Click Next. Figure 106 You now need to identify the make and model of the printer. Click on the Have Disk... button.
  • Page 145 ALADDIN - User manual Rev. 23 of 08/07/2016 Figure 107 Click the Browse button and select the folder where you extracted the drivers (.inf file) for this printer. Once you've done that, click OK. Figure 108 Select your printer model from the Printers list and then click the Next button Figure 109 Select if you want to make this printer the default.

  • Page 146: Installing A Network Printer (Lan)

    Filter”, otherwise there is the risk of damaging the device. 17.4 Installing a network printer (LAN) Connect ALADDIN to an external network through the LAN port using an Ethernet cable. Figure 110 This time, select “A network printer, or a printer attached to another computer”...

  • Page 147: Re-Enabling The Write Filter

    From here on, follow the same procedure as described for “Installing a local printer (USB)” 17.5 Re-Enabling the Write Filter 1. Open the Aladdin application. 2. The system will warn about the unsafe state. 3. Wait for the automatic restart or press OK.

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