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ALADDIN

- User manual

Rev. 19 EN of 10/07/2019

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:



EMC

ISO 15004-2:



Group 2

UNI EN ISO 19980



Type A

ETL Standards:



Medical Electrical Equipment – Part 1: General Requirements For
Basic Safety and Essential Performance [AAMI ES60601-
1:2005+A1]



Medical Electrical Equipment – Part 1: General Requirements For
Basic Safety and Essential Performance [CSA C22.2#60601-1:2014
Ed.3]

Содержание ALADDIN HW3.0

Страница 1: ...ALADDIN User manual Rev 19 EN of 10 07 2019 1 ALADDIN HW3 0 User manual Rev 19 EN 2019...

Страница 2: ...you for choosing this product Please read the information in this manual carefully You must be familiar with its contents in order to work with the device Keep these instructions in a safe place clos...

Страница 3: ...ETY INSTRUCTIONS 14 4 1 General 14 4 2 Electrical safety 15 4 3 LED emission safety 15 4 4 Installation with external devices or IT Network 15 4 5 Transport and packaging 16 4 6 Cleaning 16 4 7 Checki...

Страница 4: ...scription of the Acquisition screen 47 11 6 Biometry acquisition procedure 50 11 7 Full biometry acquisition K AL CCT ACD LT 52 11 8 Acquisition of axial length measurements AL 53 11 9 Acquisition of...

Страница 5: ...CT ACD LT 108 12 5 Pupillometry PUP 109 12 5 1 Graphs 110 12 6 White To White WTW 114 13 SETTINGS 116 13 1 General 116 13 2 Measurements 117 13 2 1 Map 117 13 2 2 Acquisition 118 13 2 3 Pupillometry 1...

Страница 6: ...4 Anonymize filenames of exported reports and exam packages 152 13 7 5 Password protect exported PDF reports 152 13 7 6 Hide Patient Names and Disable Actions when in assistance mode 152 14 CHANGING...

Страница 7: ...inutes 1 4 Description of functionalities The ALADDIN HW3 0 is a combined device for the biometric measurements of ocular structures The measurements assist in the determination of the appropriate pow...

Страница 8: ...traocular lens to be implanted Toric IOL calculation Calculating the spherical equivalent power cylinder power and placement axis for a toric intraocular lens to be implanted Post refractive IOL calcu...

Страница 9: ...acked use is inevitable the equipment should be observed to verify normal operation in the configuration in which it will be used Portable RF communications equipment should be used no closer than 30...

Страница 10: ...h Edition Immunity test Standard Test level Electrostatic discharge ESD IEC 61000 4 2 8kV contact 15kV air Electrical fast transient Burst IEC 61000 4 4 2kV 100kHz repetition frequency Surges IEC 6100...

Страница 11: ...ded below according to the maximum output power of the communication equipment Rated maximum output of transmitter W Separation distance according to transmitter frequency m 150kHz to 80MHz d 1 2 P 80...

Страница 12: ...ERAL WARNING TO AVOID INJURY CAUSED BY ELECTRIC SHOCK DO NOT OPEN THE COVER ASK YOUR DEALER FOR SERVICE ISO 7010 W001 GENERAL WARNING BE CAREFUL NOT TO HIT THE PATIENT S EYES OR NOSE WITH THE INSTRUME...

Страница 13: ...5009 STAND BY SWITCH This symbol is solely applicable for EC member countries To avoid potential negative consequences for the environment and possibly human health this instrument should be disposed...

Страница 14: ...f the cables supplied with the device Position the unit so that it is not difficult to disconnect the plug for connection to the supply main Perform all the control functions detailed in the relative...

Страница 15: ...in the Technical Specifications section in this manual The LED groups comply with the emission limits for the Group 2 instruments according to the standard ISO 15004 2 4 4 Installation with external...

Страница 16: ...responds to the term network data coupling in IEC 60601 1 2005 Do not change the Ethernet settings Local Area Connection 2 adapter If specific configuration for LAN network is needed in the settings c...

Страница 17: ...ided The user of the device must check that the measurements provided by the device are plausible It is advisable to visually check all the light sources before examining patients to make sure that th...

Страница 18: ...l person data subject an identifiable natural person is one who can be identified directly or indirectly in particular by reference to an identifier such as a name an identification number location da...

Страница 19: ...ler and processor have access to data related to the subject which can be stored on the device and can make the data available to the subject in the normal operating mode The data can be also accessed...

Страница 20: ...4 8 2 Privacy Security options When the on board application is booted the following prompt is shown By pressing the OK button you get access to the Privacy Security settings of the application where...

Страница 21: ...due to improper or incorrect use of the device The product warranty is valid only if it is equipped with its original accessories If the device is opened by unauthorized personnel the manufacturer is...

Страница 22: ...inuous operation IEC 60601 1 2 EMC ISO 15004 2 Group 2 UNI EN ISO 19980 Type A ETL Standards Medical Electrical Equipment Part 1 General Requirements For Basic Safety and Essential Performance AAMI ES...

Страница 23: ...of 10 07 2019 23 7 MAIN COMPONENTS Figure 1 Patient s side Figure 2 User s side NB The parts in contact with the patient applied parts are the forehead rest in Teflon and the chin rest in acrylonitril...

Страница 24: ...ystem must always be moved shipped in its original packaging which is specifically designed for damage protection 8 1 Installing the system Before installing the system read the Safety Instructions in...

Страница 25: ...o chin rest paper o chin rest pins o touchscreen pen o silicon cloth Power cable Topcon ALADDIN HW3 0 dust cover ALADDIN HW3 0 user manual Open the internal box and remove the specially shaped cardboa...

Страница 26: ...ing screws and the semi lock Figure 2 Connect the power cable provided The instrument is now ready for use 8 2 Uninstalling the system Take the original packaging Set the instrument to the minimum hei...

Страница 27: ...ALADDIN User manual Rev 19 EN of 10 07 2019 27...

Страница 28: ...N of 10 07 2019 28 Figure 8 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 extens...

Страница 29: ...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 Power c...

Страница 30: ...des Before connect device to external devices or IT Network please read paragraph 4 4 Figure 9 10 2 Power on procedure Make sure the power cord provided is connected to the mains Press the stand by bu...

Страница 31: ...he screen close to the command The screen is highly sensitive Minimum pressure is required indeed advised 11 1 User Login Logout The user MUST configure the login password to access the device operati...

Страница 32: ...ill be prompted again 11 1 2 Auto LogOFF Screen Saver The device locks automatically if no user actions occurs for a configurable amount of time The Aladdin screen saver is then shown To unlock the to...

Страница 33: ...ing the calibration The calibration must be checked every day before starting patient examinations when the device has been transported from one place to another when it has suffered an impact or ther...

Страница 34: ...plains how to check calibration Figure 12 Set the calibration tool supplied with the device in the special holes in the chin rest and press until the tool is blocked on the device Check that the calib...

Страница 35: ...ee table below for instructions MESSAGE MEANING WHAT TO DO VALID Good calibration Click on Main to start a new examination When asked press Yes to save the Calibration Check NB the Valid word must be...

Страница 36: ...ALADDIN User manual Rev 19 EN of 10 07 2019 36 Figure 14 Figure 15...

Страница 37: ...d the new patient data click on the Ok button or select the Acquisition tab to confirm the information and continue with the examination If you want to empty all the fields click on the Clear button B...

Страница 38: ...to select the type of cristallyne and vitreous body for each patient s eye by pressing the Acquisition button please see the following Figure 18 Figure 18 For each eye select the type of crystalline c...

Страница 39: ...ions has been elaborated as follows The correction values in mm of the natural vitreous body Phakic 0 Aphakic 0 21 Pseudophakic Unknown material 0 11 Pseudophakic Silicone IOL 0 12 Pseudophakic PMMA I...

Страница 40: ...details on the acquisition environment see the dedicated section The vitreous body nature is expressed if different from natural in the acquisition view as well as in the output reports as shown in t...

Страница 41: ...st is ordered alphabetically A to Z or by last exam date most recent first Open an examination or acquire data for the selected patient In the left column clicking on a patient in the Exam List frame...

Страница 42: ...ent This means that if the patient has already undergone surgery the new refractive status can be recorded as a main factor to personalize constants of the implanted IOL Figure 20 Opening the Post Op...

Страница 43: ...Patient Root Query search patient s details on enable patient s archive server DICOM Modality Worklist get the list of patients and tasks in the waiting room The user can search for a patient either...

Страница 44: ...ALADDIN User manual Rev 19 EN of 10 07 2019 44 Figure 22 Figure 23...

Страница 45: ...ding worklists for the current day The list can filtered by one or more of the other criteria Patient Name Patient ID Examination date range Scheduled Station Name default is Aladdin Modality default...

Страница 46: ...ing distance from the device to the eye is 80 0 mm The software guides the operator in order to reach the ideal focus condition see paragraph 11 6 The joystick illustrated in Figure 26 is the only par...

Страница 47: ...hich you move the instrument Biometry gives access to the biometric measurement section Pupillometry gives access to the pupillometry section The buttons at the bottom of the data frame for each eye s...

Страница 48: ...d 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 ATTENTION When the symbol i...

Страница 49: ...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 Calculati...

Страница 50: ...ements in general whatever mode you are in simply proceed as follows 1 Align the live image in the center and focus then press the joystick button to start the acquisition you need to perform this ste...

Страница 51: ...assume different colors as follows The centering condition is out of tolerance and a better center alignment is required The centering condition is displayed in green color press the joystick button...

Страница 52: ...al focus and achieve the central alignment as described in paragraph 11 6 3 Press the joystick button to perform the Keratometry acquisition 4 Next the system will automatically perform also the Axial...

Страница 53: ...istance difference between the inner limiting membrane and the pigmented epithelium The displayed axial length values are thus directly comparable to those obtained by immersion ultrasound and no re c...

Страница 54: ...tomatic guidance system red blue arrows and centering aims until ideal conditions have been reached green icons and centered aims Figure 34 11 10 Keratometry acquisition KER Keratometry is used to mea...

Страница 55: ...ncerning the calculation the software performs the standard calculation of 6 144 zero crossing points identified at the 24 RINGS along the 256 semi meridian In order to increase the measurement precis...

Страница 56: ...itions Mesopic In the case of the dynamic pupillometry recording of the state of the pupil is started first in mesopic conditions then photopic and then mesopic again The data on the diameters measure...

Страница 57: ...ALADDIN User manual Rev 19 EN of 10 07 2019 57 Figure 37 Acquisition in photopic controlled light conditions Acquisition in mesopic controlled light conditions Figure 38...

Страница 58: ...directly to an external printer or a USB drive and also print to both simultaneously Both option Figure 39 In addition to these two options you can select a network folder as destination of report to...

Страница 59: ...orm 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 or...

Страница 60: ...2019 60 11 12 2 Custom Reports 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 rep...

Страница 61: ...e 41 is show where you can select one or more destinations for exportation Figure 41 Currently available destinations are DICOM Storage SCP Server the selected reports are sent to the designed DICOM s...

Страница 62: ...IMAGEnet 6 PhacoOptics http www phacooptics net export biometry data in xml format to a network shared folder to be imported in PhacoOptics software Refer to section 13 5 and to PhacoOptics software...

Страница 63: ...IOL constants in clinical practice and the type of device used for acquisition of the biometric data Figure 42 The screen has various sections which we will explore in detail below Data IOL Calculati...

Страница 64: ...as two sections Biometry detailing the data on the ocular biometry Keratometry detailing the patient s keratometric data From the Source field present in both the Biometry and Keratometry sections Fig...

Страница 65: ...of the current index in this section In Figure 44 you can manually enter biometry data knowing that an external instrument does not always work in Optical mode you can also select acoustic measuremen...

Страница 66: ...ulation section a surgeon who has established by means of topography the need for an astigmatic correction can use toric lens calculation The calculation is made on the basis of the ideal spherical IO...

Страница 67: ...ents field summarizes the measurement data From the drop down menu select the IOL manufacturer and model as well as the preferred formula with which to calculate the best lens Once this data has been...

Страница 68: ...constants have been published by their manufacturer The user can in case insert new toric manufacturers and or models inside toric IOL settings section see 13 4 3 In addition to choosing the Target y...

Страница 69: ...IOL calculation is performed using the Abulafia Koch Correction it is reported in the corresponding Toric IOL report As a result the Toric IOL frame immediately below details the best toric lens compu...

Страница 70: ...ction 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 Selecting a different row you can s...

Страница 71: ...tal data Figure 50 The first is the surgeon who performs the operation As in IOL calculation the constants may differ from one surgeon to another The second data is the LT i e the crystalline lens thi...

Страница 72: ...ter of the optical zone to improve the accuracy of the final calculation Figure 51 The Unknown option must be selected every time that you don t know the type of surgery or one of the associated infor...

Страница 73: ...sal Formula II Barrett Universal II Formula v1 05 for alle yes regardless of axial length Toric Calculator Barrett Toric Calculator v1 05 for correction of pre existing corneal astigmatism with Toric...

Страница 74: ...a II Barrett Barrett Universal II Formula v1 05 for all yes regardless of axial length In the Surgeon field you can choose which surgeon will perform the IOL implant and any customization of the const...

Страница 75: ...xisting corneal astigmatism with Toric IOLs Figure 54 Toric Calculator Barrett is divided into two main steps The first one consists on the calculation of the Spherical Equivalent Power in the second...

Страница 76: ...matically by the system for the manufacturer and model selected previously in the first step From Available Toric Lenses table you can choose also a different cylinder value for the lens based on the...

Страница 77: ...y Myopic Lasik Hyperopic Lasik Radial Keratotomy Insert the measured Refraction Pre Lasik Ref in diopters before the Refractive Surgery and the measured Refraction Post Lasik Ref in diopters after the...

Страница 78: ...teps 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 Figure 57 shows the first step interfac...

Страница 79: ...an estimate of the correction amount based on the correction type and the eye biometry data After having selected the toric IOL model a values table from which the Spherical Equivalent Power is obtai...

Страница 80: ...taract surgery RX Formula Barrett is divided into two main steps The first one consists in inserting all the information regarding the current situation of the patient s eye The Measurements field sum...

Страница 81: ...rmed to select the power of the IOL implanted in the first cataract surgery are filled automatically if the lens model is selected from the on board archive or must be inserted manually for manually i...

Страница 82: ...mplanted IOL described in the Implanted IOL data was applied All the mentioned values are required to proceed in the second step of the RX Formula Then it s possible to proceed to the second step usin...

Страница 83: ...tor is an optional module ask your distributor for details The Dr Olsen s formula is based on standard paraxial ray tracing using standard keratometry of the anterior surface of the cornea and optical...

Страница 84: ...ptical parameters have been validated The user can in case insert new manufacturers and or models inside IOL settings section see 13 4 3 Once this data has been entered the most appropriate lens can b...

Страница 85: ...nd or models inside toric IOL settings section see 13 4 3 In addition to choosing the Target you need to specify also the Surgical Induced Astigmatism SIA and Incision Location IL The former identify...

Страница 86: ...table you can choose also a different cylinder value for the lens based on the Residual Astigmatism you want to achieve under correction overcorrection In particular the best toric lens value is shown...

Страница 87: ...ta from the examination click on the Main button As shown in Figure 59 the software will ask the user to confirm the action Figure 59 If you want to save the data of the patients without doing an acqu...

Страница 88: ...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 you access the two main actions for the selected patient Data...

Страница 89: ...current refraction measurement data before performing the biometry acquisitions The data is not compulsory to proceed with acquisition you can update them afterward in Data Review section If you sele...

Страница 90: ...present in the Data Review section is provided by examinations directly performed with Aladdin and stored onboard together with manual data eventually imported or added BASELINE Starting condition of...

Страница 91: ...ALADDIN User manual Rev 19 EN of 10 07 2019 91...

Страница 92: ...d Combined trend view with Refraction error S E and Axial Length RX Refraction trend Refraction S E absolute value at reference Vertex Distance trend and yearly variation on 3 6 12 months basis AL Axi...

Страница 93: ...ata and refraction data if available Ortho K section View to compare Topography map between two different examinations Available only for examination performed directly with Aladdin Compare variations...

Страница 94: ...d management edit delete Import Button Import data from template sheet for the current patient only Add Button Add data manually by filling the form ROW Buttons Edit Button Edit data of the selected r...

Страница 95: ...nt view Available output destinations o Printer as in the main printing form of the Aladdin application o USB drive export o Network Shared folder 11 16 4 RX AL Trend Option By pressing on the setting...

Страница 96: ...connected USB pen drive will be shown In this action can be imported data for o The currently active patient will be matched by ID o Another patient already existing in Aladdin archive will be matche...

Страница 97: ...ry data is not provided the single sheet row will be ignored Patients not already present in the archive The Dates patient DoB and Exam Date will be parsed according to the Date Format selected in the...

Страница 98: ...ective or Objective o Eye status condition at the moment of refraction measurement Cycloplegia or Normal o Contact Lens data in case of Over Refaction measurement Lens Power SE in Diopters Base Curve...

Страница 99: ...tions 12 1 Topographic map KER Figure 60 The environment displayed is shown in Figure 60 Click on the OD or OS buttons to display the map of the right or left eye The R and L buttons are only active i...

Страница 100: ...screen top show the topographic map indices see following paragraphs for details K Keratometry I Keratorefractive indices KC Keratoconus P Pupil 12 1 1 Keratometry Press the K button to display the ke...

Страница 101: ...s reference SI difference between the average power of two circular zones centered in the vertical axis of the ruler and placed in the lower hemisphere and in the upper hemisphere of the cornea respec...

Страница 102: ...rs Avg Pupil Power Average pupil power for a pupil of 4 5 mm and 3 0 mm Photopic red outline o Pupil Dec Pupil decentration in polar and cartesian coordinates from the cornea vertex o Avg Pupil Mean d...

Страница 103: ...ile along the most curved meridian and the flattest meridian red and blue The difference is displayed in green Figure 64 By pressing the arrow buttons you can vary the flattest and the most curved mer...

Страница 104: ...tion Histograms of the Zernike expansion coefficients each histogram represents the weight of the corresponding polynomial Primary aberrations map Astigmatism the map the magnitude in diopters the axi...

Страница 105: ...refers only to the component induced by the anterior surface of the cornea not by the eye s entire optical system Press the Maps button to return to the maps display The Pupil button opens a panel Fi...

Страница 106: ...ALADDIN User manual Rev 19 EN of 10 07 2019 106 Figure 67 It is possible to switch between ETDRS and Landolt C Visus simulation view...

Страница 107: ...rement 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 axia...

Страница 108: ...s the measurements performed for the right eye and left eye respectively As for the axial length if the instrument does not record good quality signal or if the data is inconsistent the acquisition is...

Страница 109: ...ttons are located below the home screen These buttons are used to navigate between the acquired frames The current frame is shown next to the buttons Below a summary of the functions available on this...

Страница 110: ...of the average pupil diameter measured in all the images acquired during the sequence The other information is the same as that already described for the dynamic pupillometry The active buttons are t...

Страница 111: ...Decentration Figure 71 The green concentric circles identify the decentration of the pupil center with respect to the fixation point The red dots on the other hand represent the coordinate variations...

Страница 112: ...ious images in variable light conditions from mesopic to photopic and back to mesopic on the Settings screen you can set the acquisition times for each mode explained later The left column shows the k...

Страница 113: ...ey on the right hand side and by the values detailed on the left the red line represents the average value of the sample the blue frame the value interval between the 25 and 75 percentiles the green l...

Страница 114: ...W The White to White section allows you to view the value of the corneal diameter calculated from limbus Figure 74 Clicking on the Open button in the Edit menu the user can manually reposition positio...

Страница 115: ...see Corneal diameter Decentration 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...

Страница 116: ...13 1 General Refer to Figure 76 Language The first time the program is started the default language set is English and the keyboard layout is QWERTY To change the language settings select the desired...

Страница 117: ...for left and right Patient Required Fields Toggles between two different options of required fields for creation of new patient s details With ID only the ID is the only required field to insert when...

Страница 118: ...hericity unit of measure e SF p Q 13 2 2 Acquisition Select the default Biometry sequence acquisition K AL ANT the default acquisition sequence is Keratometry Axial Length Anterior Segment CCT ACD LT...

Страница 119: ...pography Map Color scale description Previous software versions have always used the same color scale for Topography maps absolute and normalized this is called Classic color scale This software versi...

Страница 120: ...er manual Rev 19 EN of 10 07 2019 120 Absolute scale Classic ISO ISO 2005 Normalized adjustable scale Classic ISO ISO 2005 13 3 Surgeons The Surgeons panel allows you to create different user profiles...

Страница 121: ...Here you can configure various options and presets for the IOL environment Figure 79 associated with the surgeon selected divided into three different environments described in detail below General P...

Страница 122: ...set for the Post Refractive IOL included the Barrett TrueK section of Barrett module Under Olsen Sph IOL the preset for Olsen Spherical IOL calculation section of Olsen module Under Olsen Toric IOL th...

Страница 123: ...nses preset from a fully customizable collection of models and manufacturers Oculentis Calculator that allows to limit the collection of available lenses to Oculentis manufacturer only In this case th...

Страница 124: ...odels by adding deleting or editing them For each lens you can display and edit the constants used in each formula The two main environments the Spherical and the Torical ones can be selected clicking...

Страница 125: ...rer name o Insert the model name 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 Figure 84...

Страница 126: ...he current IOL Delete delete the selected IOL Calculation Constants History gives information on any change of calculation constants or optical advanced parameters values as shown in Figure 86 The pos...

Страница 127: ...mong the list of source tables available in the downloaded package IOL Spherical model Advanced paremeters Olsen To use an IOL model with the Olsen formula advanced optical parameters for the IOL mode...

Страница 128: ...the following materials Acrylic Hydrophobic Acrylic PMMA Hydrophilic Acrylic Silicone Collamer HEMA It is recommended to obtain the exact value from the manufacturer this information is usually provi...

Страница 129: ...ndicate the relationship between the front IOL curvature and the back IOL curvature Available values in the list are Biconvex 1 1 front radius is positive back radius is negative Biconvex 2 1 front ra...

Страница 130: ...wer Range inserting the minimum the maximum and the step of the spherical power of the lens o Choose the Cylinder Definition of the lens with Sub models or Cylinder Range Based If you select Sub model...

Страница 131: ...Delete delete the selected IOL View Properties visualize properties calculation constants and list of sub models of the lens or cylinder range Calculation Constants History gives information on every...

Страница 132: ...eports That resource will then become selectable as a destination in the report s print form In order for ALADDIN HW3 0 to be able to connect to the remote network folder you must configure ALADDIN HW...

Страница 133: ...xporting XML data of the exam to the network folder by the export window 13 5 3 IMAGEnet i base software ALADDIN HW3 0 can receive and transfer data to Topcon IMAGEnet i base through a wireless or LAN...

Страница 134: ...to Topcon IMAGEnet 6 Server through a wireless or LAN network IMAGEnet 6 Server is activated by clicking on the Enabled Option and by providing the IP address of the external server we want to connec...

Страница 135: ...ortation form once saving a new or existing exam Don t ask for Confirmation when Exporting allows to skip the selection of targets when performing the exportation while saving or when pressing on the...

Страница 136: ...eeded 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 be...

Страница 137: ...r storage commitments default is 115 The connectivity to the defined server can be tested using the C ECHO function activated by the relative Connection Test button The result of connection test is sh...

Страница 138: ...libration when the device has been transported from one place to another and when it has suffered an impact or thermal shocks It is recommended to check the measurements every day when turning on the...

Страница 139: ...ientDoB _reportName _eyelabel _ExamD ateTime _progressiveNumbert extension Alternative patientID _patientDoB _Aladdin_eyelabel _progressiveNumber extension eyelabel is R right eye L left eye B both ey...

Страница 140: ...connection to ALADDIN HW3 0 or contact your IT staff 13 6 3 Updating the integrated software In this section is described the software upgrade procedure from one version to the following version To up...

Страница 141: ...ALADDIN User manual Rev 19 EN of 10 07 2019 141 Figure 95 4 Click on the settings icon Figure 96 Figure 96 5 Click on the Admin tab Figure 97...

Страница 142: ...ALADDIN User manual Rev 19 EN of 10 07 2019 142 Figure 97 6 Insert the USB stick with the Aladdin upgrade files in one of the USB ports Figure 98 Figure 98 7 Click on the Upgrade button Figure 99...

Страница 143: ...IN User manual Rev 19 EN of 10 07 2019 143 Figure 99 8 Click on Ok to reboot the system and start the upgrade Figure 100 Figure 100 9 After the upgrade you will see the message of Figure 101 on the sc...

Страница 144: ...tion 11 After restart the software updates the system this operations could take some minutes please don t restart machine during this procedure Figure 102 Figure 102 12 If you see the message of Figu...

Страница 145: ...ve or a network shared folder to backup and restore data Backup Contents With this utility it is possible to backup Local Exams archive the complete list of patients and exams that are currently store...

Страница 146: ...nect 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 Network folder define i...

Страница 147: ...vice or unplug the power supply and ethernet cable while performing this operation Do not unplug USB devices if USB is the backup destination This may take several minutes depending on the exam archiv...

Страница 148: ...e in order to restore the calibration 1 Select the source of the backup image to restore USB or Network Folder Navigate the list of detected backup images available at the selected source 2 Select fro...

Страница 149: ...ssistance The machine calibration restore is skipped if the procedure is performed by the user 2 Restore Application User Settings The current content on the machine will be overwritten 3 Restore Surg...

Страница 150: ...but requires the password to be configured When the option is enabled and the password configured the login is prompted when refer to section 11 1 the Aladdin on board application starts the auto log...

Страница 151: ...15 minutes When no interaction with the device is performed during the timeout the screen saver will be displayed When the screen saver is closed the login screen if enabled and configured will be dis...

Страница 152: ...d folder will be accessible only by typing the user password as defined to access the Aladdin on board application 13 7 6 Hide Patient Names and Disable Actions when in assistance mode The options use...

Страница 153: ...N of 10 07 2019 153 Technician Mode In technician Mode the patients details are not accessible and delete edit actions are not available When exporting exam packages in this mode the patient details a...

Страница 154: ...ith the indicated characteristics The use of undersized fuses can cause the interruption of power to the device during normal working conditions In this case there is no risk to the user nor for the p...

Страница 155: ...tometry conus 24 rings equally distributed in a 43D sphere Analysed points Over 100 000 points Measured points Over 6 000 points Corneal coverage Up to 9 8 mm on a sphere of 8mm radius 42 2 diopters w...

Страница 156: ...00 mm 0 01 mm 0 02 mm Curve Radius in Diopter D n 1 3375 28 00 67 50 D 0 01 D 0 12 D Axial Length 15 00 38 00 mm 0 01 mm 0 016 mm Anterior Chamber Depth 1 50 6 50 mm 0 01 mm 0 04 mm Central Corneal T...

Страница 157: ...anual Rev 19 EN of 10 07 2019 157 ON BOARD PC SPECIFICATIONS Operating system WINDOWS 10 64bit Processor Intel Celeron RAM 4GB Hard disk At least 500GB SATA mSATA SSD 32GB External connections LAN int...

Страница 158: ...ickness millimeters White to white distance millimeters Keratometry diopters Analysis of Agreement The measurements for the Agreement analysis arise from the first three acceptable measurement types a...

Страница 159: ...lysis of precision for each endpoint will be performed on ALADDIN and LENSTAR separately using a REML method for repeated measures within subject including the subsequent terms device identifier A1 A2...

Страница 160: ...R LS 900 AL mm 24 05 0 014 0 040 0 059 0 015 0 041 0 061 LENSTAR LS 900 AX 76 56 5 304 14 852 6 928 5 312 14 873 6 938 LENSTAR LS 900 ACD mm 3 67 0 036 0 100 0 974 0 036 0 102 0 991 LENSTAR LS 900 LT...

Страница 161: ...d hereby declare that the aforementioned devices comply with Directive 93 42 EEC implemented in Italy by Legislative Decree no 46 97 and subsequent amendments and additions Directive 2007 47 EC implem...

Страница 162: ...keep the inf file somewhere easily accessible 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 ba...

Страница 163: ...achine 6 Connect the USB pen with the downloaded drivers to Aladdin Figure 108 18 3 Installing a local printer USB The following instructions are for a Windows 10 system Close the software using the p...

Страница 164: ...The Add Printer Wizard will appear The printer could be automatically detected If yes follow the steps if not press on The printer that I want isn t listed Figure 111 Select Add a local printer or net...

Страница 165: ...select the folder where you extracted the drivers inf file for this printer Once you ve done that click OK Figure 114 Select your printer model from the Printers list and then click the Next button F...

Страница 166: ...Ethernet cable Go to control panel and select devices and printers refer to previous section The printer could be automatically detected If yes follow the steps if not press on The printer that I wan...

Страница 167: ...abling 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 4 The system will restart enabling the write filter 5...

Страница 168: ...sen Thomas et al C constant New concept for ray tracing assisted intraocular lens power calculation Journal of Cataract Refractive Surgery Volume 40 Issue 5 764 773 2014 Olsen Thomas United States Pat...

Страница 169: ...Intraocular Lens Power Calculations After Myopic Laser In Situ Keratomileusis American Journal of Ophthalmology Impact Factor 4 02 10 2003 136 3 426 32 Shammas No history SHAMMAS H J SHAMMAS M C HILL...

Страница 170: ...n HW3 0 Software version and Serial Number as written in Settings Admin section Period of use Please inform us of the date of installation Defective condition Please provide us with as much detail as...

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