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ONTENTS

I. I

NTRODUCTION

II. S

AFETY

1. Documentation

2. Definitions

3. Symbols

4. Classification

a. Technical features

b. Environmental conditions

5. Indication for use

6. Safety requirements

a. Contraindications

b. Warnings

7. Precautions

a. Special patient populations

b. Adverse reactions

c. Prescription devices

8. Disclaimer of liability

III. S

UPPLY

PACKAGE

1. Packaging and transport

2. Unpacking and storage

3. Package contents

IV. I

NSTALLATION

THE

DEVICE

1. Installation

2. Initial powering ON

3. First login

4. Change password

5. Recover a lost password through the PUK code

6. Turn ON/OFF the tablet

a. Switch ON the tablet and activate the APP

b. Switch OFF

V. U

THE

DEVICE

1. Enter patient

2. Perform an exam

3. Applicable features

a. [Actions]

b. [Filters]

c. [Compare images]

4. Consult patient records

VI. S

ETTINGS

1. Date and time

SER

MANUAL

> C

ONTENTS

Содержание Retina 800

Страница 1: ...User manual...

Страница 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...

Страница 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...

Страница 4: ...I INTRODUCTION...

Страница 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...

Страница 6: ...II SAFETY...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 14: ...III SUPPLY PACKAGE...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 58: ...VI SETTINGS...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 101: ...VII MAINTENANCE...

Страница 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...

Страница 103: ...VIII TROUBLESHOOTING...

Страница 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...

Страница 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...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 112: ...XI QR CODE...

Страница 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...

Страница 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...

Страница 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...

Страница 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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