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Essilor Instruments Retina 800, User Manual, Page: 30 / 116

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Essilor Instruments Retina 800 User Manual Download Page 30

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OF

 

THE

 

DEVICE

Summary of Contents for Retina 800

Page 1: ...User manual...

Page 2: ...III SUPPLY PACKAGE 15 1 Packaging and transport 16 2 Unpacking and storage 16 3 Package contents 17 IV INSTALLATION OF THE DEVICE 19 1 Installation 20 2 Initial powering ON 21 3 First login 21 4 Chang...

Page 3: ...7 Retina800 adapter Optional accessory 96 a Overview 96 b Initial configuration 96 c Transfer of the image 99 VII MAINTENANCE 103 1 Cleaning the device 104 a Cleaning the lens 104 b Cleaning the chee...

Page 4: ...I INTRODUCTION...

Page 5: ...r manual is available on a web space To access other available languages please scan the QR code at the end of this user manual Chapter QR code F p 116 Retina800 Fundus camera V2 06 2019 6 USER MANUAL...

Page 6: ...II SAFETY...

Page 7: ...ions Any changes to the manufacturer s instructions that prove relevant for patient and or operator safety will be promptly communicated to the owners users of the product through all channels useful...

Page 8: ...ing a new piece of equivalent equipment The user is responsible for transporting the equipment to the appropriate collection facilities at the end of its life Proper collection for the subsequent deli...

Page 9: ...m Weight 14 7 kg Sensor resolution 2 1 mpixels b Environmental conditions Temperature Humidity Atmospheric pressure Use 10 C 40 C Maximum 90 without condensation 800hPa 1060hPa Storage 0 C 60 C Maximu...

Page 10: ...Annex IX to Directive 93 42 EEC amended by 2007 47 EC is built in compliance with national and international regulations concerning medical devices The Retina800 medical device takes color photographs...

Page 11: ...ns No contraindication b Warnings This device is to be used for its intended use according to the indicated instructions and directions for use Essilor does not assume responsibility for damage to per...

Page 12: ...tdoors It was designed and built for use in areas that are closed and protected from the elements Use the device only with the original spare parts supplied by the manufacturer Make sure that the feat...

Page 13: ...of a physician or a properly licensed practitioner The clinical interpretation of the images acquired by Retina800 is restricted to licensed eye care practitioners The process of making a diagnosis u...

Page 14: ...III SUPPLY PACKAGE...

Page 15: ...for an audit and revision of the device itself The user must be fully aware of the contents of the manual and symbols 2 UNPACKING AND STORAGE It is necessary that the person unpacking the box has been...

Page 16: ...g items Device Tablet Lenovo yoga with charger and micro USB cable The tablet can store about 50000 images Mean well AC DC adaptor GSM60A24 model Detachable power cord Lens cap User manual USER MANUAL...

Page 17: ...ter Head With 1 Forehead rest 2 Lens 3 Moveable head 4 Cheekbone rests Applied parts Socket panel 1 LAN port 2 USB port 3 Battery connection port 4 ON OFF button Retina800 Fundus camera V2 06 2019 18...

Page 18: ...IV INSTALLATION OF THE DEVICE...

Page 19: ...C DC adaptor into the socket on the base of Retina800 device Turn ON the tablet If it does not turn ON use the special charger and micro USB cable provided in its box Connect the AC DC adaptor plug to...

Page 20: ...provided during the description of the device 3 FIRST LOGIN Before you can use the device a first connection procedure must be performed It consists of creating an account username and password which...

Page 21: ...lows you to log in to your account and see patients and exams performed A PUK code is automatically generated Make sure to save this code This PUK code is required for all actions related to the accou...

Page 22: ...You are logged in your reserved area 4 CHANGE PASSWORD Go to the website https retina800 essilor com The following screen appears Fill in the fields Reminder Username username of your account Password...

Page 23: ...Click on LOGIN The following screen appears Go on PROFILE section and click on CHANGE PWD 3 4 Retina800 Fundus camera V2 06 2019 24 USER MANUAL IV INSTALLATION OF THE DEVICE...

Page 24: ...llowing screen appears Fill the fields current new and confirm new password and click on SAVE The password has been changed 5 USER MANUAL IV INSTALLATION OF THE DEVICE 25 Retina800 Fundus camera V2 06...

Page 25: ...o to the website https retina800 essilor com The following screen appears Click on forgot password recover with your PUK Insert your username and click on PROCEED 1 2 3 Retina800 Fundus camera V2 06 2...

Page 26: ...password has been changed 6 TURN ON OFF THE TABLET a Switch ON the tablet and activate the APP The Retina800 user interface consists of the appropriate APP pre installed in the supplied tablet the var...

Page 27: ...tom left Navigation icons Go back Go to the first page where you can set up Wifi APN Date and time System language Go to the first page where you can set up Wifi APN Date and time System language A sc...

Page 28: ...tina800 is ON or OFF 2 DEVICE OUT RANGE Indicates whether Bluetooth communication between the tablet and the device is ON or OFF If OFF switch ON the Bluetooth communication of the tablet and or bring...

Page 29: ...acquired images 6 BATTERY Indicates the charge level of the tablet battery b Switch OFF Switch OFF with the power button located at the bottom left of the screen A message appears Click on SHUTDOWN or...

Page 30: ...V USE OF THE DEVICE...

Page 31: ...atient click on DO EXAM by clicking on The HOME page or The side bar Home page Side bar The following screen appears From here click on ENTER NEW PATIENT 1 2 Retina800 Fundus camera V2 06 2019 32 USER...

Page 32: ...TRY To be used when complete patient information is not necessary 2 FULL ENTRY To be used when complete patient information is necessary 3 IMPORT Select the import mode 3 USER MANUAL V USE OF THE DEVI...

Page 33: ...ad and cheekbones resting on the silicon parts With 1 Forehead rest 2 Cheekbone rests The patient s eye must be positioned in the center of the cheekbone rests at the height of the blue bar To ensure...

Page 34: ...e HOME page click on PATIENTS A list of patients appears Then click on DO EXAM icon Select the eye left and or right and the type of fixation that you want to examine 1 2 3 USER MANUAL V USE OF THE DE...

Page 35: ...t s memory 3 APPLICABLE FEATURES Retinal images can be filtered in different ways depending on what needs to be highlighted most A more complete and detailed vision will thus allow to deepen the secti...

Page 36: ...a Actions On the ACTIONS tab you can choose between PATHOLOGIES REMOVE PRINT MOSAIC SEND EMAIL DRAW MANUAL CDR USER MANUAL V USE OF THE DEVICE 37 Retina800 Fundus camera V2 06 2019...

Page 37: ...nostic notes using the NOTE OD and NOTE OS Click on ACTIONS then PATHOLOGIES The following screen appears Select the pathologies by checking the boxes and click on UPDATE 1 2 Retina800 Fundus camera V...

Page 38: ...cted By clicking here you can enter the print format where you will be able to update the information on the patient or the doctor by entering the notes It is possible to insert additional images up t...

Page 39: ...The following screen appears Click on SELECT RETINAS 2 Retina800 Fundus camera V2 06 2019 40 USER MANUAL V USE OF THE DEVICE...

Page 40: ...The following screen appears Drag and drop the images of the exam performed 3 USER MANUAL V USE OF THE DEVICE 41 Retina800 Fundus camera V2 06 2019...

Page 41: ...nected to the same network of the tablet and compatible with the android print drivers Then the printer selection it is shown Select paper size A4 The choice of the correct paper size is mandatory The...

Page 42: ...ations previously acquired To perform the mosaic functionality is necessary to take at least 2 fixation images for each eye Click on ACTIONS then MOSAIC The following screen appears The mosaic can be...

Page 43: ...Drag and drop the chosen images to make the mosaic Then click on CREATE MOSAIC 2 3 Retina800 Fundus camera V2 06 2019 44 USER MANUAL V USE OF THE DEVICE...

Page 44: ...The mosaic creation starts At the end the mosaic appears You can reject or accept the image 4 USER MANUAL V USE OF THE DEVICE 45 Retina800 Fundus camera V2 06 2019...

Page 45: ...with VASCULAR filter Click on FILTERS VASCULAR Then click on UPDATE Mosaic image with CHOROIDAL filter Click on FILTERS CHOROIDAL Then click on UPDATE Mosaic image with NERVE FIBRE filter Click on FI...

Page 46: ...er Click on FILTERS RED FREE Then click on UPDATE Send email To configure the email address please go to the Settings chapter Click on ACTIONS then SEND EMAIL 1 USER MANUAL V USE OF THE DEVICE 47 Reti...

Page 47: ...The following screen appears Drag the images you want to send The maximum size allowed to send images is 5MB 2 Retina800 Fundus camera V2 06 2019 48 USER MANUAL V USE OF THE DEVICE...

Page 48: ...the configuration of your email the fields will be fill automatically You can still edit the fields and who will receive the email but the default settings described in the previous points will remai...

Page 49: ...ad This will open a default browser window with the password entry request the password is the phone number entered in the previous step before clicking SEND on the tablet and then click SEND The imag...

Page 50: ...hen DRAW MANUAL CDR For more information you can consult the filters section b Filters On the FILTERS tab you can choose to apply filters VASCULAR CHOROIDAL AUTOMATIC CDR MANUAL CDR NERVE FIBRE RED FR...

Page 51: ...ar Allows you to view images using a green filter Click on FILTERS VASCULAR Then click on UPDATE Choroidal Allows you to view images using a red filter Click on FILTERS CHOROIDAL Then click on UPDATE...

Page 52: ...the image of the two ellipses cup and disc 2 Manual CDR the user himself performs the sizing of the two ellipses cup and disc Automatic CDR Click on FILTERS AUTOMATIC CDR Then click on UPDATE Manual...

Page 53: ...d also to compare images with cup to disc and filters Please find below examples with the Manual CDR filter In both cases automatic or manual you just have to select the type of filter and click on UP...

Page 54: ...AL MANUAL CDR Then click on UPDATE Click on FILTERS MANUAL CDR NERVE FIBRE Then click on UPDATE Click on FILTERS MANUAL CDR RED FREE Then click on UPDATE USER MANUAL V USE OF THE DEVICE 55 Retina800 F...

Page 55: ...d free Allows you to view images using a 50 blue and 50 green filter Click on FILTERS RED FREE Then click on UPDATE c Compare images Allows comparisons of retinal images of the same patient Check the...

Page 56: ...The comparison of the two images is displayed It is also possible to combine the two functions shown above comparison of images and filters applicable For example Click on FILTERS VASCULAR Then click...

Page 57: ...nts list appears Click on a patient s name A screen appears where in the lower section all the exams carried out can be scrolled using the grey arrows To enter an individual exam click on it The image...

Page 58: ...VI SETTINGS...

Page 59: ...1 DATE AND TIME On the HOME page click on DATE AND TIME The user can set the date and time of the tablet Retina800 Fundus camera V2 06 2019 60 USER MANUAL VI SETTINGS...

Page 60: ...the HOME page click on SYSTEM LANGUAGE A list of available languages appears You can choose the desired system language from the list Click on it the language will change 1 2 USER MANUAL VI SETTINGS...

Page 61: ...e the desired system language from the list Click on it then on UPDATE The language will change c Change language on the tablet keyboard At login click either in the username field or in the password...

Page 62: ...on the keyboard The following window will appear To add a language to those shown click on LANGUAGE SETTINGS A window appears click on ADD KEYBOARD 2 3 USER MANUAL VI SETTINGS 63 Retina800 Fundus came...

Page 63: ...hoose the desired system language from the list The chosen language will then appear in the list Click on the icon to return to the App screen 4 5 Retina800 Fundus camera V2 06 2019 64 USER MANUAL VI...

Page 64: ...t field is inserted the chosen language will be retained If you want to change the keyboard language click on the icon once if you want to set a language already on the list or repeat the procedure de...

Page 65: ...se to set RETINAS SHARING PC SHARED FOLDER DICOM AI Artificial Intelligence Email Sending a Retinas sharing You can choose to Save images with patient information on the image file s name Save images...

Page 66: ...ol should be allowed if it isn t click the allow checkbox You can get more detailed OS specific instructions OS is for Operating System by googling for Windows your windows version share folder For Wi...

Page 67: ...name or A combination of jpg and json files the latter holding the patient s info By selecting the IMAGES WITH PATIENT INFO IN IMAGE FILE NAME checkbox you also get to choose what kind of information...

Page 68: ...owed If the DICOM server is set you can also transfer the images in DICOM format DCM in addition to the jpg png format By scrolling up a bit you will see a section titled PC SHARED FOLDER 7 USER MANUA...

Page 69: ...s of the PC that contains the shared folder i e laptopo 7gu05p3u or 192 168 1 100 FOLDER NAME refers to the name of the shared folder i e FolderName or Shared Click on UPDATE Log out and then log in u...

Page 70: ...ME page click on PATIENTS NEW PATIENTS You should see a column of checkboxes on the right one for every patient 2 Check the patients that you want to re send 3 Drop down the menu at the top right and...

Page 71: ...s Then click on UPDATE The settings are updated The active connections are shown in the HOME page If the status of the DICOM is ON the captured images are automatically sent to the DICOM server while...

Page 72: ...wait until the transfer is complete d AI Artificial Intelligence sharing images for software To perform the correct setting in order to transfer the images on a user PC to be processed by a third par...

Page 73: ...n the PC must have enabled the Advanced sharing Share folder setting to transfer the images Then click on PATIENTS NEW PATIENT Click on SEND TO AI to select the desired patients on the drop down menu...

Page 74: ...e website https retina800 essilor com The following screen appears Fill in the fields Reminder Username username of your account Password password of your account Click on LOGIN The following screen a...

Page 75: ...l Template A window appears Fill the fields SUBJECT subject of the email BODY body of the email SIGNATURE signature that you can attach ATTACHMENT file to be attached pdf 4 5 Retina800 Fundus camera V...

Page 76: ...AVE On the HOME page click on SETTINGS Go to EMAIL SENDING section From here you can edit the subject and text of the email Then click on UPDATE 6 7 8 9 USER MANUAL VI SETTINGS 77 Retina800 Fundus cam...

Page 77: ...dow will open showing the user s details Fill EMAIL and PHONE It is necessary that both e mail and phone number are inserted as they are essential to proceed with the following steps Then click on UPD...

Page 78: ...Example Select the desired image Click on ACTIONS then SEND EMAIL The following screen appears 1 USER MANUAL VI SETTINGS 79 Retina800 Fundus camera V2 06 2019...

Page 79: ...u want to send The maximum size allowed to send images is 5MB Then click on WRITE EMAIL It is possible to edit the fields Email Phone Subject Email text 2 3 Retina800 Fundus camera V2 06 2019 80 USER...

Page 80: ...nchanged Then click on SEND The user will then receive an e mail of the type In order to view and download the images it is necessary to click on Click here to download This will open a default browse...

Page 81: ...tributor in case it has been authorized by Essilor to perform remote support from a tablet In the event that the distributor takes care of the remote support he must have purchased the license of Team...

Page 82: ...Click on TEAMVIEWER The QuickSupport TeamViewer will open Wait for the ID number The ID must be communicated to the service personnel 2 3 USER MANUAL VI SETTINGS 83 Retina800 Fundus camera V2 06 2019...

Page 83: ...unicated the following screen appears Click on ALLOW A notification appears on the tablet The sharing of the screen between your device and the staff is activate 4 Retina800 Fundus camera V2 06 2019 8...

Page 84: ...ges from any web access Make save download and print picture and report You can t perform exam from this website Go to the website https retina800 essilor com The following screen appears Fill in the...

Page 85: ...ck on clicking Add new Patient The following screen appears Fill in the fields and click on SAVE It is possible to modify the patient informations by clicking on the PROFILE section 1 2 Retina800 Fund...

Page 86: ...e mouse over a patient line 2 icons appears Click on to modify patient data Then click on SAVE to update patient data to delete a patient Then enter your password and click on CONFIRM to delete the pa...

Page 87: ...reen appears Click on EDIT PATHOLOGIES to edit pathologies and proceed with the others images You can add only 2 pathologies maximum per eye The following screen appears The pathologies will appear on...

Page 88: ...m Click on the date of the exam The following screen appears You can also select pathologies from here by clicking on the drop drown menu on the right 1 USER MANUAL VI SETTINGS 89 Retina800 Fundus cam...

Page 89: ...clicking on FILTERS at the bottom of the retina image The list of the filters appears Select a filter and click on UPDATE To edit a report Click on REPORT 2 3 1 Retina800 Fundus camera V2 06 2019 90...

Page 90: ...reen appears Select each image you want to put on the report Only 1 image on the left and 1 image on the right image It is also possible to apply filter 2 USER MANUAL VI SETTINGS 91 Retina800 Fundus c...

Page 91: ...up a network made of several Retina800 units and one Eye Doctor which remotely makes the referrals on images taken with the device You need special credential to have telemedicine account Go to the we...

Page 92: ...by clicking on the corresponding line The exam datas appears Personal data are encrypted telemedicine accounts have no access to them Telemedicine account can see the patient s images by clicking on...

Page 93: ...ars Click on EDIT PATHOLOGIES to edit pathologies and proceed with the others images You can add only 2 pathologies maximum per eye The following screen appears 5 Retina800 Fundus camera V2 06 2019 94...

Page 94: ...con turns from grey to green On the HOME page click on PATIENTS A list of patients appears At the end on the column REPORTING STATUS the circle will be checked in green 6 USER MANUAL VI SETTINGS 95 Re...

Page 95: ...ey are acquired by the device as the tablet and adapter are within range If they are too far apart the images are put on hold until they are approached when this happens the transfer automatically pre...

Page 96: ...ut of range the actual image transfer will be put on hold The name of the jpg images is taken from the patient s data default is name last name NS code date of the exam If you want to change it On the...

Page 97: ...and in which order The only requirement is that you must enter the patient s first and last name and date of the exam The settings page will also show you an example of the name of the final file Reti...

Page 98: ...presence of the adapter does not change the way the device is normally used Each accepted image will be transferred to the adapter and will be displayed in the USB folder From the HOME page click on...

Page 99: ...you want to export You can choose one or more patients by selecting the appropriate check boxes You can also choose to select all the patients by clicking the checkboxes 2 Retina800 Fundus camera V2 0...

Page 100: ...ws may display an alert Recommendations 1 Always select Safely Remove hardware before disconnecting the adapter 2 The USB memory of the adapter must be considered temporary Once the transfer from the...

Page 101: ...VII MAINTENANCE...

Page 102: ...s exam performance Berkshire Bluesorb 750 cloth moistened with 96 neutral pure ethyl alcohol or moistened lens cleaning wipes can be used b Cleaning the cheekbone and forehead rests All parts in conta...

Page 103: ...VIII TROUBLESHOOTING...

Page 104: ...ands sent via tablet Wifi connection between tablet and the device failed Connect the product to the Wifi network via tablet The tablet is too far away from the device Move the tablet closer to the de...

Page 105: ...k your connection with the APP ERR 14 An error occurred while inserting the patient ERR 15 An error occurred while updating the patient ERR 18 Session expired Please log in again ERR 19 An error occur...

Page 106: ...IX ASSISTANCE NOTIFICATION ALERT AND LABEL...

Page 107: ...tics and performance of the device that has caused or may potentially be liable to cause harmful events for the operator patient must be promptly reported by contacting the manufacturer in order to ta...

Page 108: ...X GUIDANCE AND MANUFACTURER S DECLARATION...

Page 109: ...nergy only for its internal function Therefore its emissions are very low and are not likely to cause any interference in nearby electronic equipment Emission CISPR 11 Class B Retina800 is suitable fo...

Page 110: ...other devices are connected Surge IEC 61000 4 5 1 kV between phases 2 kV between the phase s and the ground 1 kV between phases 2 kV between the phase s and the ground The quality of the network volta...

Page 111: ...to 2 5 GHz 3 V m d 30 cm Immunity to proximity fields by wireless RF communication devices IEC 61000 4 3 TETRA 400 380 390 MHz 27 V m 27 V m d 30 cm GMRS 460 FRS 460 430 170 MHz 28 V m 28 V m LTE Ban...

Page 112: ...XI QR CODE...

Page 113: ...rea web do cliente Para acessar scanear o c digo QR abaixo usando a respetiva aplica o QR QR QR Potpuni korisni ki priru nik dostupan je na webu Da biste mu pristupili skenirajte QR kod u nastavku na...

Page 114: ...p boleh didapati di ruangan web Untuk akses sila imbas kod QR di bawah menggunakan aplikasi yang berkenaan Den komplette brukerh ndboken er tilgjengelig p et webomr de For f tilgang m du skanne QR kod...

Page 115: ...uporabni ki priro nik je na voljo na spletnem mestu Za dostop do njega skenirajte spodnjo kodo QR z uporabo namenske aplikacije Den fullst ndiga handboken finns p en plats p Internet Skanna QR koden n...

Page 116: ...Essilor Instruments USA 8600 W Catalpa Avenue Suite 703 Chicago IL 60656 Phone 855 393 4647 Email info essilorinstrumentsusa com www essilorinstrumentsusa com...

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