Mobile Vision Screener plusoptiX S12 User Manual
Contents
1. This error is typically caused by sunlight in the examination room But infrared ambiance light can be emitted by incandescent light sources e g light bulbs and halogen spots too To avoid this error shade examination room and switch all heat emitting light sources off A measurement is aborted if no pupils are detected within 20 seconds after pressing the orange color shutter The corresponding error message reads Camera did not detect pupils o There are three causes for this error pupils themselves measurement distance and eye device alignment Both pupil diameters need to be in between 4 and 8 mm and pupils must not be covered by eye lids eye lashes or long hair Check if both pupils are displayed with a round shape on screen Measurement distance needs to be in between 95 and 105 cm i e 3 1 and 3 5 feet Check if camera picture is displayed pin sharp on screen i e each single hair of eye lashes is displayed Both eyes and camera need to be aligned with each other A patient needs to focus the nose of the smiley face and the camera needs to capture a picture of both eyes Check if green dots are plotted in both gaze charts Page 37 40 plus 5 Maintenance calibration service and warranty Mobile Vision Screener plusoptiX S12 is an opto electronic measurement device Mechanical construction and mode of operation can be compared to a video camera If you treat your Mobile Vision Screener plusoptiX S122. plus Mobile Vision Screener plusoptiX S12 User Manual Release August 1 2013 Plusoptix GmbH Neumeyerstrasse 48 90411 Nuremberg Germany www plusoptix com Read this user manual prior to initial operation This user manual explains the basic functions of the device Once the device is switched on supplementary information can be accessed by touching the blue i button on screen This Supplementary information describes on screen displays in more detail Page 1 40 Content 1 Intended use and responsibility Of the OWNET ccccseecceeeeceeeeseeeeeeeeseeeeeeeseeeeneeesaeeens 4 2 Putting the device into operation ccccceeccsececeeeeceeeeeeeeceueeseeeceeeseueesaeessueesseeeseeesaneesanes 6 2 1 Checking scope Of CElIVELY ccccccseccceececeeeceeeceeeeseeeseueeseueeseeeseueeseeeeseeesaueeseeeeaes 6 22 Getting TO know TIN CO Ce saisoimuiseinaisaom t E n 7 2 3 Inserting and charging batteries ccceeccceeccsececeseeceeeceucecsueeceeceusesseeeeeeseueeseeesags 9 2 4 Switching device on and Off cccccccsseceeseeccecesseeccenecoecesseecceeeseeeseneseeeeseeeseesess 10 2 5 Screen display and help screen ccccccsecccseeeeceeeeeeeeeeseeeeseeeeeseueeeseeeseeeesseeeesaes 11 3 Performing a measurement cccccceecceeeceeeceeeceeeceeeceeceeeseeeseeseeeteeeeeeteeeseeeseeeseeetnees 12 Oils Consider Ne environmen erse i a E E E E 12 re AAR a IMIS AS UN i EE E E E
3. Page 28 40 plus 4 7 Activating WLAN to connect wireless printer The device is equipped with WLAN WLAN access is needed to establish an ad hoc connection i e no wireless router is needed with a wireless ZEBRA printer see chapter 4 15 Compatible printers or to connect with a wireless DHCP server for EMR integration To save battery power WLAN is disabled as default and needs to be activated in settings Make sure that ZEBRA printer or wireless DHCP server are up and running prior to opening WLAN activation screen WLAN activation screen is opened by pressing WLAN button 1 in settings Activate WLAN i Password Screenshot 15 Activate WLAN screen Touch WLAN activation button 2 to search for available WLAN After one minute a listing is displayed Use arrow down button 3 to scroll down in the listing and touch refresh button 4 to search for wireless networks again Activate WLAN t I plusoptix I Cisco_WPS_8247 I zebra Ad Hoc Password Screenshot 16 Listing of available WLAN Oe AN Page 29 40 plus A warning sign 1 indicates that no wireless network is selected Choose the zebra Ad Hoc network 2 by touching the listing Entering a password is not necessary to set up an ad hoc connection to a Zebra printer Activate WLAN a A plusoptix a Cisco WPS_8247 E Password screenshot 17 Choosing Zebra printer Confirm zebra Ad Hoc network s
4. GA 30339 ge Do not discard the device as household garbage Please return your device to for environmentally responsible disposal Plusoptix will reimburse shipping cost Page 4 40 plus Intended use The purpose of Mobile Vision Screener plusoptix S12 is to detect vision disorders early vision screening Vision disorders can cause permanent loss of vision in one eye amblyopia if they are not detected and treated within the first years of life To detect vision disorders Mobile Vision Screener plusoptiX S12 measures sphere cylinder axis gaze and pupil size of both eyes simultaneously Based on these readings spherical equivalent gaze symmetry and inter pupillary distance are calculated Patients who should see an eye care professional are identified by comparing these measurement values to age dependent referral criteria These patients show refer as vision screening result automatically Measurement results don t replace a comprehensive eye exam by an eye care professional They can t be used to prescribe glasses or contact lenses All children who are not treated by an eye care professional should be subject to vision screening The first vision screening should be performed at one year of age After that it should be repeated regularly because the eyes keep changing with growth of the child and new vision disorders can occur anytime All children with a refer screening result should be presented to an eye care pr
5. EE EE EEEE EEE REE ai e ninenin 10 SCEN MOr 2 FOME AC aaa E E E E E O 13 Screenshot 3 Enter patient date of birth 2 0 0 ccccccececseeeeceeeeeeeeeeseeesseeeeseesesseesseeesaaees 14 Screenshot 4 Enter patient first NAMEC ccccccseccceeeeceeeeeeeeceeeeseeseueeseeesaeeeseueeseeeseeeeseeesaes 15 Screenshot 5 Check screening result SCLEN cccccceecceeeceeeeseeeseueeceeeeeeesaueeseeeseeeeseeeeaes 18 Screenshot 6 Review video SCIEEN ccccceececseececeeeeceeceeseeeeceucessueeeceueessueeeseueesseeesseeesaaees 19 Screenshot 7 Save screening result SCFEEN ccceccccsecccseeeeceeeeseeeeeceeeeseaeeeseueesseesseeeeseaees 20 Screenshot 8 Review database entries screen ccccccseececeececeeeeeceecesseeeeseesessueesseeeseaees 21 Screenshot 9 Home screen with last patient pre selected cccccccseecseeeceeeeeeeeeeeeeseeeeaes 22 Screenshot 10 Select patient from short liSt cee cccecccseeeeceeceseeeeeeeeeeseeeeeseeeesseeeesaeeeeaaees 24 Screenshot 11 Select age group 19 30 month for a 2 click measurement 0ccee ee 25 SCFEENSNOL 1 22 SC UNOS ICM orae a E EEES 26 Screenshot 19r SET UD SCHOO Ci sisas AAEE AA 27 Screenshot 14 Generate a report ccccccceecccseececeeeeceeeeeceeeeseecessueeeseusesseeeseusesseeesseeeeseaees 28 Screenshot 15 Activate WLAN SCION cccccsccccceececeeceeseeeeseecesseeeeseeessueeeseueessneetseeeesaaees 29 Screenshot 16 Listing of avai
6. as energy saving lamps or neon tubes do not disturo measurement results Picture 6 Illustration of a measurement A child needs to focus the device in order to take a measurement Make sure that the child sits straight and does not turn its head over the shoulder Knees and nose of the child should point at the device An especially developed warble sound attracts attention of infants to the device This works well as long as infant s attention is not diverted to other objects or persons in the exam room Close the door and avoid all distracting activities such as clicking one s fingers for example Do not use additional fixation targets Attention span of infants is very limited Take advantage of the fact that the exam room is all new to the infant An exotic warble sound in an unknown environment is always attractive to look at Therefore enter patient data prior to inviting the infant to enter the exam room or enter patient data after the measurement Avoid long explanations to the parents prior to taking a reading Page 12 40 plus 3 2 Start a measurement After switching the device on you will see this home page on screen Select age or Enter data Screenshot 2 Home page In order to enter patient data touch button 1 lf patient data was entered previously it can be retrieved comfortably see chapter 4 2 Retrieving editing and deleting a patient from the database A measurement can be perfor
7. as date of birth with first and family names or ID number is entered a measurement can be started by pressing the orange shutter Results are splayed on screen immediately after the measurement Pr amp as the orange shutter to exit measurement result screens and to return to this Ame page After a measurement the previous age group 1 or patient 3 is pre selected Re screen the same patient by pressing the orange shutter a second time Age group buttons on the left side of the screen will adjust automatically based on referral criteria 4 selected in settings 5 1 5 240 2 2 a ik 5 Ai ve Picture 5 Toggle in between screen display and help screen Title bar provides date and time on the left hand side as well as WLAN 1 and battery status 2 on the right hand side WLAN information 1 is displayed only if WLAN is activated in settings A warning symbol 3 shows up as soon as WLAN reception is down or batteries need to be charged A battery charging symbol 4 shows up once 12 V power cord is connected and batteries are charging In the navigation menu active touch buttons are displayed in color and inactive touch buttons are shown grayed out Touch the tools button 5 to access settings Lock screen button 6 is only displayed if screen lock is activated in settings Touch it to lock screen and prevent unauthorized access to patient data Green checkmark button 7 confirms and saves whereas cancel button 8
8. as thoughtful as your personal video camera it will be operational for many years Maintenance and calibration The device is maintenance and calibration free Put it in its carrying case if not in use This will protect it from dirt and damage Only use a moist microfiber cloth to clean the device Service If the device is not working flawlessly read chapter 4 Handling clues first and then contact your authorized Plusoptix dealer for support Warranty The device comes with a 12 Month warranty from the date of purchase A warranty extension is available Please contact Plusoptix or your authorized Plusoptix dealer if you want to purchase a warranty extension Warranty expires in case of external damage improper use wrong cleaning or transportation without carrying case Warranty expires if device was opened too Please note that warranty does not cover rechargeable batteries SD card and auxiliaries such as printers keyboard mice etc Sending a device in For service or warranty repair we kindly ask you to put your device in its carrying case into a covering box and to ship it at your expenses to our nearest service center We will return it to you at our expenses Shipping addresses of our service centers are in Europe in North and South America Plusoptix GmbH Plusoptix Inc Neumeyerstrasse 46 2850 Paces Ferry Road 90411 Nuremberg Suite 440 Germany Atlanta GA 30339 Tel 49 911 59 83 99 10 USA Tel 1 800 488 6436
9. in the right sequence gt Vv Vv VV V V WV Generate a report see chapter 4 6 Saving database backup restoring database and generating reports and save it to your USB Stick Connect this USB Stick to your computer and open the report with your spreadsheet software e g Microsoft Excel Open Office Calc etc Copy and paste your patient data into the corresponding data columns within this report file Delete all data rows that were exported initially patient data that is already saved within the database can t be imported a second time After adding all your patient data to the report file save it to your USB Stick Make sure file format is csv and list separators are semicolons Connect your USB Stick to Mobile Vision Screener plusoptiX S12 and choose Import data in the settings menu 1 A listing of all csv files that are available on your USB stick will be shown on screen Choose the csv file to be imported and confirm by touching the green checkmark button in the navigation menu Prior to importing patient data the device checks if datasets are unique and if data entries are correct e g no dates in name fields automatically However interchanged data e g first names instead of last names can t be detected automatically Therefore check if patient data is presented in the right sequence and acknowledge patient data import by touching the green checkmark button in the navigation menu database entries are
10. lt John q Screenshot 4 Enter patient first name Use on screen keyboard to enter patient information Touch shift button 1 to change from lower to upper case and vice versa and backspace button 2 to delete a letter Please read chapter 4 16 Using a stylus mouse or keyboard in case manipulation of on screen keyboard is cumbersome Once data is entered a green checkmark is displayed on the left hand side of the tab 3 After all data is entered press orange shutter to start a measurement needed is either date of birth first name family name or date of birth ID Orange shutter will only start a measurement once all data is entered Data number Location and contact information is optional EA E o Page 15 40 plus 3 4 Start and align camera Hold device in 4 feet distance and at eye level of the patient Measurement distance is 3 3 feet but it takes some training to estimate this distance in the open room It is easier to start further away and to sweep toward the patient with the device running Picture 7 Aligning the camera Press the orange shutter to start the camera A warble sound is played back This warble sound attracts patient attention to the camera A picture of the patient is displayed on screen Align camera so as to see both eyes of the patient on screen Then sweep toward the patient At first white squares are plotted around both pupils These whit
11. not deleted by importing patient data Imported patient data is always added to the existing patient database Existing n Ea Page 31 40 plus 4 9 Touch screen is off i e black Touch screen illumination is switched off automatically to save power Simply touch the screen to re activate illumination If the screen doesn t illuminate after touching it the device has switched off automatically Press On Off button to switch it on again A N In settings a time span until automatic power shut off can be defined If the device doesn t switch on after pressing the On Off button batteries are empty Connect the medical power adapter and check if power is available green LED on top of the medical power adapter is on The device can be operated while batteries are charging Simply switch it on by pressing the On Off button with the medical power adapter connected 4 10 Touch screen is inactive i e buttons don t work Every time the touch screen is touched a little mouse pointer indicates where the touch was located Check positioning of this mouse pointer if a touch button can t be activated Make sure the mouse pointer is superposing the touch button to be activated Remember that touch buttons that are shown grayed out are in active A stylus can be used instead of a finger for greater precision in operating the touch screen 4 11 A date of birth can t be entered There are two reasons why a date of birth can t be ent
12. operate the touch screen more comfortably Mouse or keyboard can be wired or wireless Simply connect the USB connector or USB receiver to the in built USB port of the device USB port within the device is positioned upside down i e USB connector or USB receiver of mouse keyboard need to be turned upside down prior to connecting them to the device lf an USB mouse or USB keyboard is not working check if batteries are inserted first Make sure mouse or keyboard are switched on Try an USB mouse or USB keyboard of another manufacturer Logitech Microsoft in case mouse or keyboard still don t work Not working USB mice or USB keyboards are neither a service nor a warranty claim 4 17 EMR integration The device is equipped with a WLAN interface and can be connected to an Electronic Medical Record EMR system This integration allows to import patient data and to export readings wirelessly There is a separate EMR integration manual available Please contact Plusoptix or your distributor in case you want to connect your device to your EMR system Please note that EMR integration can t be used to connect the device to network printers EMR integration exchanges data electronically only Page 36 40 plus 4 18 Aborted measurements What is the meaning of error messages A measurement is aborted if there is too much infrared ambiance light The corresponding error message reads o Too much infrared ambiance light
13. work cccceecceceseeceeeeeeseeeeeeeeeeaeeees 32 4 11 A date of birth can t be entered ccc ccccccccceecaeeceecaeeceecaeecuecaeeseesaueceeseueseeeseeees 32 4 12 SD Card and USB Memory Interface cccccccsecceseeeeceeeeeeeeeeseeeesseeeeseesesseeeeees 33 Aoa MOUSE MONICE a a E 33 4 14 Screening report and information COLUMN cccccccccseeceeeeeeceeeeeeeeeseeeeeeeeeeseeeenaaees 34 4 15 Compatible ORNS US sac ecceceesoscnctsasnctesepesusecnescesceapeuetonsssebesapccuedceanaesasecscedemnsseneeneooss 35 4 16 Using a stylus MOUSE OF KEYDOAIC cccceecceeeeceeeeeeeeceeeeseeeseueeseeeeseeesaeeeseeesaeeess 36 A17 EMR MC ONANOMN eeii ae aa aa aia aiaa 36 4 18 Aborted measurements What is the meaning of error messages 0010010n 37 5 Maintenance calibration Service ANd warranty cccccceececceeeceeceeeeeeeeeseeeeeeseeeeeesees 38 6 Technical Spe cifiCations ccccccceecceeccseeeseeceeeceeeeeeeseeeeeeeeeeteesseeseeesseeseeeseeeseeeseeeseeees 39 6 1 Measurements cccc ccc ecceeceeeeeece ees eceeeseeeeeeseeeaeesaeeeeeseeeeeeceeeseeseeseeseeeseeseeeseees 39 6 2 Interfaces and StANAAMAS ccccceeceeeeceeeceeeceeeceeeeseeeceeeeseeeeseeeseueeseeesaeeeseeesseeess 39 6 3 Power supply and rechargeable batteries ccccccceceeeeceeeeeeeeseeeeseeeseeeeseeeeseeees 39 6 4 Ambient conditions for Operation and StOraGe cccceecceccseeceeeeee
14. E EEEE 13 Ioe EMD aa O 14 3 4 Start and align camera 2 0 e ce eccccecccceececceeeeeeeeeeseeeeceeeesseeeeseeeessueeeseueessaeeeseueessneeesees 16 3 5 Check and document measurement results ccceeeeceeeeeeeeceeeeceeeeseeeseeeeseeeseeeens 17 3 6 Perform next measurement ccccccecceeeceeeeeeceeeeeeceeeseeseeeaeeceeeseesaeeseeseeeseeseeeseeees 22 Be Aanding CICS yc rrpetxcteccetaccenned etaceetemt acceded actelant neaedactaxtelacinqedactictelact e aiao ia 23 4 1 Holding camera and USING NECK strap cee ceecceecceeeeceeeeseeeseeeeseeeeseeeseeeeseeeeseeees 23 4 2 Retrieving editing and deleting a patient from the database cceeeeseeeeeeeees 24 4 3 Performing a Two Click Measurement cccceecceeeeeseeeeeeteeeeeeteeeeeeteeeeeeteeeeetes 25 4 4 Adjusting settings cc cccccccecccceeeceeeeceeeeceeeeeeeeseueeeeeeseueeseeeesaeeseueeseeeseeeseeeseeesaeeess 26 4 5 Activating screen IOCK cccccecccecccecccecccseccseccsceceeccseecaeecaeeceeecseecaeseueeeeeseaeseanenaes 27 4 6 Saving database backup restoring database and generating reports 0 28 4 7 Activating WLAN to connect wireless printer ccccceceeeeeeeeeeeseeeeeeeeseeeeeeeeeaeeees 29 48 IMIPOMTING patent dala aAA EEEE 31 4 9 Touch screen is off i e DIACK cccccccecceceseeeeeeeneeeseeeseeeseeeneeeseeeseeeneeeneeeneeenaeenaes 32 4 10 Touch screen is inactive i e buttons don t
15. Page 38 40 plus 6 Technical specifications 6 1 Measurements Metered value Measurement range and tolerance 7 to 5 dot in 0 25 dpt increments 0 25 dpt Cylinder 7 to 5 dpt in 0 25 dpt increments 0 25 dpt 1 to 180 in 1 increments 15 0 1 to 180 in 1 increments 15 4 to 8 mm in 0 1 mm increments 10 6 2 Interfaces and standards e po WLANand Bluetooth SSS O Screen size 5 7 640 x 480 Pixel Ratio 4 3 6 3 Power supply and rechargeable batteries Only use medical power adapter type MES30B 3P1J which is included in the delivery Medical power adapter 110 to 240 VAC 50 to 60 Hz 0 8 A Type MES30B 3P1J 12 VDC 2 5A Rechargeable batteries Type Size Nickel metal hydride NiMH AA HR6 Sanyo HR 3UTGA 1 2V Wattage Number 1900 mAh 6 pieces 6 4 Ambient conditions for operation and storage The device can be stored in its carrying case Don t store carrying case close to heat sources radiators heater blowers etc If device is taken out of carrying case don t place it in direct sunlight Temperature Oto 50 Humidity 10 to 80 noncondensing Operation 10 to 50 C i Humidity 20 to 80 noncondensing 6 5 Size and weight with and without carrying case Percent 250 x 150 x 140 mm 10 x 6 x 51 1 1 Kg 38 8 oz DECENTE 430 x 185 x 370 mm 17 x 74 x 141 Weight 3 4 Kg 119 9 oz Page 39 40 plus 6 6 Guidance and manufacturers declaration electr
16. aborts without saving Touching blue information button 9 opens a help screen Touch cancel button 8 to close help screen Help screen explains touch buttons that are used in screen display To save space these touch buttons are replaced by a consecutive number within the text same as here Numbers and touch buttons that are replaced are illustrated on the bottom of the help screen All touch buttons that are illustrated on help screens are inactive They are shown in color for better visualization only 1an as AAE Page 11 40 plus 3 Performing a measurement Mobile Vision Screener plusoptiX S12 measures both eyes simultaneously in less than 1 second from 3 3 feet away Patients with a very limited attention span such as infants 6 months and older can be measured this way In addition simultaneous binocular readings provide reliable values for a left and right eye comparison 3 1 Consider the environment The device uses infrared light to perform measurements The same infrared light is part of sunlight and emitted by all incandescent light sources such as light bulbs and halogen spots Infrared light is invisible to the human eye and nonhazardous To obtain accurate measurements it is important to avoid disturbing infrared ambiance light in the examination room Close curtains or shutters to keep sunlight out and switch off all incandescent light sources However examination room does not need to be dark Cold light sources such
17. aders can be measured without entering individual patient data This measurement mode is called Two Click Measurement because all it takes to perform measurements is to press the shutter twice At first define the age group of the children to be measured by touching the corresponding age group button on the home page see screen shot below Then press the orange shutter first Click to measure the first patient At the end of the measurement a screening result is displayed on screen automatically Press the orange shutter again second Click to return to the home screen The initially selected age group is pre selected and the touch screen doesn t need to be touched Simply press the orange shutter again to start the next measurement first Click of the second measurement Select age or Enter data 9 13 Repeat 50 240 Screenshot 11 Select age group 19 30 month for a 2 click measurement Numbers on the age group buttons indicate the age of the children in months A N From the first day of the first month to the first day of the last month Age group buttons adjust to the selected set of referral criteria automatically In order to document measurement results patient data can be entered after a measurement was performed This is useful if only refer screening results are to be documented In this case data of all patients that receive a pass screening result doesn t need to be entered and time i
18. arranty Page 7 40 plus A 5 7 capacitive touch screen is located at the rear of the camera Simply touch the screen with one finger to activate a function that is displayed Screen and touch sensor are protected by a thin glass panel This glass panel can scratch in case of improper use or break in case the device falls down rear side e g to insert or exchange batteries Use neck strap to protect the Place a soft cloth underneath the glass panel if you have to turn the device on its device from falling down ba Picture 3 Device in rear view There are two orange color buttons the On Off button on the right hand side underneath the touch screen and the Shutter on the handle to the right of the touch screen The functioning of these buttons is explained in chapter 2 4 Switching device on and off and 3 4 Start and align camera The device has 3 interfaces USB micro USB and SD card All are located in the center underneath the touch screen How to use these interfaces is explained in chapters 4 12 SD Card and USB Memory Interfaces and chapter 4 13 Micro USB Interface All interfaces are positioned upside down Therefore all media to be connected need to be turned upside down prior to connecting them to the device A 12 V female power input connector is located at the left hand side underneath the touch screen Page 8 40 plus 2 3 Inserting and charging batteries Place t
19. button will be inactive as long as no USB Stick is connected 2 To save a backup copy of the patient database don t select any filters and touch the green checkmark button in the navigation menu 3 The entire database will be saved as db file to the USB Stick A backup copy of the patient database can be used to restore it To restore a patient database connect an USB Stick with the db file in its main directory The patient database will be restored automatically When restoring a database a backup copy of the existing database is automatically saved to the USB Stick Select filters to generate a report and then touch green checkmark button 3 so save report as csv file Csv files can be manipulated with all current soreadsheet software tools SALE ELE M E 2008 03 01 2012 05 01 _ V 4 kY egs _ V d _ Y d _ V 4 Detmold Hamburg N rnberg Screenshot 14 Generate a report Selecting these filters will save a csv file including all patients who obtained a refer screening result 5 at the screening location Berlin 10 and who were born 7 in between 9 March 1 2008 and May 1 2012 Touching button 4 will add all pass screening results and button 6 all inconclusive screening results Touching button 8 will replace date of birth selection by date of screening and de selecting button 9 will only include those screenings that took place March 1 2008 precisely N Av 3 4 5 6 E fee 8 p 9 10
20. ce from damage it is delivered in a carrying case with foam insert Please contact your vendor immediately if the carrying case shows any signs of damage at delivery Picture 1 Device in carrying case Please check at delivery if the carrying case contains all components Scope of delivery includes Mobile Vision Screener plusoptix S12 Neck strap Power adapter medical Power cord 6x AA batteries rechargeable SD Card in the device Please contact your vendor immediately if something is missing Page 6 40 plus 2 2 Getting to know the device The device takes a series of pictures during a measurement To assure that patients focus at the camera while pictures are taken a warble sound is played back The loud speaker is located behind vertical slats located in front of the camera Picture 2 Direct viewing of device Camera lens and infrared LEDs to illuminate pictures are located behind a protective filter A smiley face is printed on top of this filter and acts as additional visual fixation target Do not use additional external fixation targets A measurement can be aborted or provide wrong eye alignment results if a child doesn t fixate the camera lens behind the hexagonal nose in the middle of the smiley face Do not touch the protective filter to avoid stains on its surface If the protective filter is dirty read cleaning instructions provided in chapter 5 Maintenance calibration service and w
21. deleted All measurements showing a trash can will be deleted once checkmark button 3 is touched Press cancel button 4 to abort if Page 21 40 plus 3 6 Perform next measurement After reviewing measurement results orange shutter needs to be pressed in order to return to home screen Returning to home screen previous patient is pre selected see button 1 This very same patient can be measured again by pressing the shutter a second time A To measure the same patient over and over touch screen doesn t need to be touched Hold on to the camera and keep pressing orange shutter Every second push will start a new measurement Select age or Enter data 12 36 Repeat 72 300 m John Smith Screenshot 9 Home screen with last patient pre selected To measure another patient camera needs to be released and next patient button 2 on screen needs to be touched This will open the enter patient data screen see chapter 3 3 Enter patient data a John Smith Page 22 40 plus 4 Handling clues Handling clues are sorted by keywords Paragraphs can be read entirely or be consulted if relevant only 4 1 Holding camera and using neck strap Hold camera the same way as a tablet PC Press orange shutter with the thumb of your right hand Picture 9 Holding the camera and pressing the shutter Adjust length of neck strap to put the weight of the camera onto your neck In this case one hand ca
22. e squares turn into red circles and green circles as correct measurement distance of 3 3 feet approaches As soon as both pupils are circled in green the plotted line in between both pupils turns green too The device is now located at 3 3 feet distance and the measurement starts automatically Another warble sound is played This second warble sound assures that patient keeps looking at the camera during measurement Stop moving camera and wait for the completion of the measurement A ping sound indicates completion of a measurement At this moment measurement results are displayed on screen instead of patient eyes Page 16 40 plus 3 5 Check and document measurement results Screen size is limited and therefore measurement results are presented on 4 screens for better readability These 4 measurement result screens are Check screening result screen Review video screen Save screening result screen Review database entries screen Touch orange arrows 1 and 2 located in navigation menu to toggle in between measurement result screens An orange color dot in between these arrows indicates which of the 4 measurement result screens is displayed at present Database entries of John Smith Picture 8 Overview of measurement result screens The only way to exit measurement result screens and to return to home screen i e to start a new measurement is to press the orange shutter n lt EA Page 17 40 pl
23. e the following home page is displayed Select age or Enter data 12 36 72 300 Screenshot 1 Home page If touch screen does not illuminate after switching device on check if battery contacts are inserted correctly and switch the device on again If touch screen still does not illuminate after pressing On Off button although battery contacts are inserted correctly connect 12 V power cord and switch it on again The device can be operated while batteries are charging Press On Off button shortly to switch device off The touch screen illumination turns off immediately and device shuts down If touch screen illumination doesn t turn off immediately keep On Off button pressed for 10 seconds until touch screen illumination turns off Device switches off automatically if not used Timespan for automated power off can be defined in settings A Device switches off automatically if batteries are empty regardless of settings In this case it can only be switched on with 12 V power cord connected Page 10 40 plus 2 5 Screen display and help screen All screen displays are structured identically A title bar is located on the top an information area in the center and a navigation menu on the bottom Select age or Enter data Repeat Home page A date of birth needs to be entered prior to a measurement Choose an age group on the left side 1 or open the patient database 2 on the right side of the screen As soon
24. eded All print jobs in print spooler will be deleted once the device is shut off on purpose or shuts off automatically for power saving Instead of using a wired DYMO printer a wireless ZEBRA printer can be used see chapter 4 15 Compatible printers Once a wireless ZEBRA printer is installed button 2 will be replaced by button 3 Pressing button 3 will then print a self adhesive label immediately Page 20 40 plus Review database entries screen Each measurement of a patient is added to his record in the database automatically All previous measurements are displayed in chronological order This listing of previous measurements shows at a glance if and how measurements and screening results changed over time Yellow entries indicate inconclusive measurements green entries indicate pass and red entries refer screening results Database entries of John Smith OD Right eye OS Left eye Date Sph Cyl A 8 Sph Cyt A PD 2013 05 14 14 49 09 1 75 0 00 n a 4 4 1 75 0 00 n a 4 4 55 Screenshot 8 Review database entries screen single or multiple measurements can be deleted from the database First select a measurement to be deleted by touching it on screen The entry is highlighted with orange color and a delete symbol is displayed 1 Confirm selection by touching the delete symbol and a trash can 2 will be displayed instead Then move on to the next measurements that need to be
25. ee www dymo com In order to generate a printout this printer needs to be connected to the Plusoptix device with an USB cable and the printer needs to be connected to the mains for power supply To use a DYMO printer the following genuine Dymo printing labels are needed gt LabelWriter Labels White 3 5 Disk 2 1 8 x 2 3 4 320 labels per roll These labels can be ordered online from DYMO search at www dymo com for SKU 30324 or at www dymo de for SKU S0722440 Optional printer is a ZEBRA QLn 220 see zebra com This printer has a WLAN interface and is battery powered A wireless ad hoc connection to the Plusoptix device can be established i e a wireless router is not needed To use a Zebra printer the following genuine Zebra printing labels are needed gt Label Paper 50 8 x 38 1 mm Direct Thermal Z Select 2000D 250 labels per roll These labels can be ordered from ZEBRA search at www zebra com for part 3003060 Please refer to chapter 4 7 Activating WLAN to connect wireless printer for instructions on how to replace default DYMO printer with optional ZEBRA printer driver software Attempting to install printer driver software will end medical Other printers are not compatible and it s impossible to install aftermarket printer device registration as well as warranty coverage Page 35 40 plus 4 16 Using a stylus mouse or keyboard A stylus USB mouse or USB keyboard can be used to
26. eeeeeeeceeeseeeeeeaees 39 6 5 Size and weight with and without carrying CASEC cccceeeeeeecseeeceeeeseeeseeeeseeeeeeeens 39 6 6 Guidance and manufacturer s declaration electromagnetic emissions immunity 40 Page 2 40 Index of Pictures Pic re 1 DEVICC IT Call WING Case wissisusenresanscnumesusonamsanctaimeduenapsancearcaneracancsnsnnerantaaanans 6 Picture 2 Direct VIEWING Of COVICE cccccccceecceeeeceeeseeeceeeeseeeeeeeeseeeesaeeseuseseeesseeeteneeseeesaeeens 7 Picture 3 Device IN FEAL VIEW ccccccecceeccecceeecuecaeecuecaeecuecauecuecaeeceesauecueseeecaesaeeseesaeesensaeenaes 8 Picture 4 Device battery compartment VIEW ccecceeccseeceeceeeeeeeeeeeeeeeeeeeeneeeaeeeeeeeaeeeaeeenees 9 Picture 5 Toggle in between screen display and help SCreeN cccceceeeeeeeeeeeeeeeeeeeeeeseees 11 Picture 6 Illustration Of a measurement cccceccceccceeecececeeeceeecseeceeecseecseecseecseeteeeneeeseeenes 12 Picture Fs Aligning Ne CANON cl sncusandannah tnd ameatiduaunrianeansatiannn S Teme a 16 Picture 8 Overview of measurement result SCFEENS cccecceeeeeeeeeceeeeseeesaeeeceeeeseeeseneesaees 17 Picture 9 Holding the camera and pressing the SNUtter ccccccseceseeeeeeeneeeneeeseeeneeeneeenes 23 Picture 10 Screening EDOM sosccacccssnsccasecesanccoaneccasoeesenccoansecosactsoneearsaiesnenoeemensaiesemeuencsace 34 Index of screenshots Seen MOr 1s FOME Da anar EREE EE E
27. election with green checkmark button 3 This will close WLAN activation screen and settings main page will be displayed Opening activate WLAN screen with WLAN already active will look as follows A checkmark icon 3 instead of the warning sign 1 indicates an established connection The network name is highlighted in orange color Network IP address is displayed next to password 4 Activate WLAN a wl plusoptix ail Cisco_WPS_8247 Password Screenshot 18 Reviewing network connection WN wl zebra Ad Hoc A 192 168 12 12 1 2 Page 30 40 plus 4 8 Importing patient data lf a patient roster is available patient data can be imported but the existing patient roster needs to be adjusted Necessary adjustments include conversion of patient roster in a csv file with semicolons as list separators and presenting patient data in the right sequence Proceed as follows in order to use semicolons as list separators on your computer VVVVV V Open Control Panel on your computer Windows operating system Select Clock Language and Region followed by Region and Laguage Choose Formats tab and click on Additional setting Choose Numbers tab and go down to List separator Enter a semicolon in the field for List separator Click on Apply followed by OK Your computer is now set up to write csv files in the right format Now sort patient data
28. ered First date and time are not set correctly in settings And second the age of the child is younger than 5 Months or older than 300 Months Page 32 40 plus 4 12 SD Card and USB Memory Interfaces Two storage media can be connected a SD Card and a USB Stick Pay attention to enter these storage media with connectors facing up i e upside down media from another manufacturer instead Not working storage media are Some storage media may not be identified by the device In this case use storage neither a service nor a warranty claim All storage media have to be formatted in FAT 32 format If a storage media with another format is entered the device will offer to format it in FAT 32 If storage media is formatted all data will be lost No backup copy will be saved The advantage of a SD Card is that it doesn t stick out of the device body Therefore it can remain within the device during measurements All screening reports see chapter 4 14 Screening report and information column are saved onto a SD Card exclusively Database backup copies and reports are saved onto USB Sticks exclusively see chapter 4 6 Saving database backup restoring database and generating reports A USB Stick is used to import an info column see chapter 4 14 Screening report and information column too Info columns can be imported from USB sticks only All USB Sticks poke out of the device body and should be connected temporari
29. hapes within one or both pupils Refer patient to an eye care professional if you detect different brightness levels or shapes Mild or de central media opacities may not cause a referral to an eye care nono Page 19 40 plus Save screening result screen A screening report is saved as pdf file to the SD card at the end of each measurement automatically The name of the pdf file is displayed on screen It combines patient name measurement date and time If a patient ID number is available patient name is substituted by patient ID number See chapter 4 14 Screening report and information column for a screening report sample and instructions on how to insert your information column 04 08 2013 si John Smith 02 43 pm Save screening result Screening report was saved as pdf file 0900 20130408 14440 7 certiaad pdf Label was printed to Dymo Printer Screenshot 7 Save screening result screen lf automated saving failed because of a lack of the SD card a SD card can be connected after the measurement and a screening report can be saved manually by touching button 1 In addition a self adhesive label can be printed manually by touching button 2 These printouts are saved in the print spooler and will be printed once a compatible DYMO printer is connected see chapter 4 15 Compatible printers Compatible DYMO printer is set as default printer and neither an installation nor any changes to settings are ne
30. he device on an even surface and turn it on the touch screen Remember to place a soft cloth underneath the touch screen to avoid scratches Use a 1 cent coin to open the battery compartment lid and insert provided rechargeable batteries Picture 4 Device battery compartment view Pay attention to insert battery contacts correctly The device will not switch on if one or more batteries are inserted the wrong way If connected to power it will switch on and a error message will be displayed A type label with serial number S N 1201S xxx xxxx xxxx is located underneath the battery compartment Remember to include this serial number in all service or warranty inquiries The serial number helps in speeding up response time Once batteries are inserted close battery compartment lid and turn the device upside up Use power cord to connect the medical power adapter with an electrical outlet and check if power is available green LED on medical power adapter is on Insert male connector of 12 V power cord to female power input connector in the device Batteries are charged automatically once 12 V power cord is connected Battery charging time depends on how full or empty they are Maximal charging time is 3 hours Page 9 40 plus 2 4 Switching device on and off Press On Off button shortly to switch device on Touch screen will illuminate immediately and device is booting Device will be operational after approximately 25 seconds onc
31. herical equivalent 2 1 00 dpt Gaze asymmetry Asymmetry gt 5 0 Asymmetric corneal reflexes are caused either by strabismus true positive referral or by fixation to an object other than the camera false positive referral Anisocoria Pupil size 21 0 mm No Vision Screening does not replace a complete eye examination by an ophthalmologist or optometrist Vision Screening must be conducted regularly as eyes may change over time Customize this column with your logo and contact information ROC 4 Version 6 0 0 0 www plusoptix com Refer Picture 10 Screening report The column to the left is called info column This info column can be designed freely and adjusted anytime Generate your graphic file with 583 x 3 300 width x hight pixels in png format Name your graphic file info png and save it to the main directory of your USB Stick Connect your USB Stick to the running device and your graphic file will be uploaded automatically Page 34 40 plus 4 15 Compatible printers A self adhesive label can be printed if a paper record of the measurement is needed on site Information provided on a self adhesive label is OD Refer OS 0 75 dpt Sphere 0 25 dpt 0 75 dpt Cylinder 2 25 dpt EE e 5 8 mm pupil 4 5 mm Interpupillary distance 56 mm Gaze asymmetry 7 6 www plusoptix com Default printer is a DYMO LabelWriter 450 s
32. lable WLAN c cccccccsccceeeeeceeeeeseeeeceeeeseeeeeseesessaeeeseeeesaaees 29 Screenshot 17 Choosing Zebra printer ccccecccceececeeeeeeeeeeceeeeseeeeeseueeseeeeeseeeesseeeeseeeesaaes 30 Screenshot 18 Reviewing network CONNECTION ccecccseeeeceeceeeeeeceeeeseaeeeseeeesseeeseeesaaees 30 Page 3 40 plus 1 Intended use and responsibility of the owner Please follow instructions provided in this user manual They avert danger and assure correct measurement results Symbols used have the following meaning Read this user manual A N Warning notices are marked with this warning symbol C 4 Mobile Vision Screener plusoptiX S12 meets requirements set by council 0123 directive 2007 47 EG for medical devices Mobile Vision Screener plusoptix S12 meets requirements according to type B T applied part EN 60601 1 12V Connect Mobile Vision Screener plusoptixX S12 exclusively to included medical power adapter MES30B 3P1J Use AA NimH batteries with a capacity of min 1900 mAh only e g Sanyo HR SUTGA 1 2V On Off Button push button 50 C The device can be stored and transported in temperatures ranging from 0 C to 50 C i e 32 F to 122 F Please note that temperature for operation of the oe device needs to be in between 10 C to 50 C i e 50 F to 122 F with humidity in between 20 to 80 noncondensing Plusoptix Plusoptix Inc 2850 Paces Ferry Road Suite 440 Atlanta
33. ly only Remove USB Sticks prior to performing measurements Instead of an USB Stick an USB keyboard or an USB mouse can be connected to the USB interface alternatively see chapter 4 16 Using a stylus mouse or keyboard 4 13 Micro USB Interface The device has a micro USB interface This interface is used in production and for service and warranty inspections During operation this micro USB interface is not in use Don t connect any external devices to the micro USB interface to avoid damaging the device Page 33 40 plus 4 14 Screening report and information column A screening report can be used to inform parents and an eye care professional in case of a referral A screening report is saved as pdf file to the SD card at the end of each measurement automatically Vision Screening Result Name Stephen Reinschmidt Patient ID Date of birth 05 08 2010 Contact information Date of measurement 27 04 2013 amp Y Right eye Refraction dpt Left eye rens 0 50 0 25 110 0 00 1 7572 Spherical equivalent dpt Clinic aire A Gaze asymmetry The Children s Clinic 1 9 4001 Dale Street Suite 213 Pupil size Anchorage AK 99508 6 2 6 7 Phone 907 562 2944 Fax 907 562 6321 Email info tccpeds com Website www tccpeds com Pupil distance 61 Pass Refer critena Anisometropia Spherical equivalent 2 1 00 dpt Astigmatism Cylinder 2 1 00 dpt Hyperopia Spherical equivalent 2 1 00 dpt Myopia Sp
34. med anonymously if patient data is not needed because of privacy protection or to save time Simply assign the patient to an age group on the left hand side of the screen see chapter 4 3 Performing a wo Click Measurement and press the shutter to start the measurement ns Page 13 40 plus 3 3 Enter patient data A patient s date of birth needs to be entered prior to a measurement This information is needed in order to compare measurement values with appropriate referral criteria Enter patient data 10 07 2011 VY Firstname f Family name ID Locatii lt Screenshot 3 Enter patient date of birth Use up 1 and down 2 arrows to enter a date of birth Date format can be adjusted in settings Touching the up arrow once day count is 31 will start day count over at 1 and vice versa This way it takes a maximum of 16 touches to set day correctly Once a date of birth is entered first and family name or a patient ID number need to be entered additionally This additional information is used as unique identifier of this patient within the database Location and contact information can be entered optionally This information is not necessary to perform a measurement Touch right 3 and left 4 buttons to navigate to these tabs A EN gt o K Page 14 40 plus Touch the tab of the next data to be entered to move on Enter patient data John 10 07 2010 a Date of birth A VW Familyname ID Locati
35. ment range Gaze charts are displayed on left and right hand side of the screen Red dots are plotted if an eye is aligned more than 10 degrees off camera axis i e outside the inner circle In this case a measurement is aborted inconclusively Make sure patient looks at the camera when repeating the measurement Avoid distractions within the examination room EE Page 18 40 plus Review video screen Use white video control buttons in navigation menu to play back measurement video file 1 or to scroll through measurement video picture by picture 2 Touch button 2 several times 4 to 7 times to see a test picture This test picture is taken without any infrared light emitted by the camera As a consequence this test picture should be pitch black i e not illuminated If the patient s face can be seen despite camera infrared lights being shut off infrared ambiance light is present Make sure to avoid sunlight and switch off all incandescent light sources e g light bulbs and halogen spots 04 08 2013 02 43 pm John Smith Screenshot 6 Review video screen Pay attention to both pupils They have to be visible entirely and must not be covered or partly covered by hair eye lashes or eye lids for example Partly covered pupils may lead to wrong measurements or cause a measurement to abort professional automatically Therefore check after each measurement if both pupils have the same brightness and if there are s
36. n be used to hold camera off the body and the other hand to operate the touch screen Touch screen is mounted in a 45 degrees angle to camera axis Tilt hand wrist down for proper alignment Page 23 40 plus 4 2 Retrieving editing and deleting a patient from the database When entering patient data a short list of matching entries is offered automatically Short lists are generated in any data field as soon as there are less than 5 matching entries left to choose from Enter patient data J mre h VY Date of birth VY Familyname 1D Locati lt J i J John Doe 0610612006 i J John Smith 10 07 2010 Ea Screenshot 10 Select patient from short list To select a patient right away simply touch the matching patient data in the short list 1 The name respectively ID number of this patient will then be displayed in the title bar and a measurement can be started by pressing the orange shutter right away Use backspace button 2 if there is a misspelling and add button 3 if the patient is new and needs to be added to the short list If patient information within the database is wrong it can be edited by touching the edit button 4 A patient can be deleted from the database including all measurement results by pressing the trash can button 5 B E A 1 2 3 4 Ral 5 Page 24 40 plus 4 3 Performing a Two Click Measurement To save time children with the same age e g first gr
37. n lock icon in settings 1 to open screen lock set up screen Set up screen lock SSS Enter PIN Confirm PIN Screenshot 13 Set up screen lock Once screen lock is enabled and a PIN is defined it can be activated by touching the lock symbol button 1 in the navigation menu Once screen is locked a 6 digit hexadecimal code has to be entered to unlock The lock symbol button in the navigation menu is displayed only if screen lock is activated in settings Screen lock is activated automatically only if device is switched off or switches off for power saving The screen turning black for power saving will not activate screen lock Screen locks permanently if wrong PIN is entered three times In this case a Master PIN is needed to unlock screen You need to contact Plusoptix and provide your Master PIN number in order to obtain a matching Master PIN nO gt gt b gt Page 27 40 plus 4 6 Saving database backup restoring database and generating reports All patient data is saved in the internal memory of the device This patient database is used to retrieve previously entered patient data comfortably without the need to re type all data It can also be used to generate reports for analysis To avoid a loss of patient data it s recommended to save backup copies of patient database regularly Touch export data button 1 in settings to open the export data screen and connect an USB Stick Please note that checkmark
38. ofessional for a comprehensive eye exam False positive and false negative screening results may occur in any type of heath care screening Responsibility of the owner The owner has to assure that Mobile Vision Screener plusoptiX S12 is operated by trained users only Minimum user training requirements are to read this user manual and to participate in a hands on training in manipulating the device Hands on training can be provided by a previously trained user Hands on training is offered by Plusoptix and authorized distributors alternatively The owner is responsible for assuring that Mobile Vision Screener plusoptiX S12 is not opened in case of service or warranty The device must not be opened by anyone other than Plusoptix or an authorized distributor Opening the device exposes you to the risk of an electric shock In addition the device loses its medical device certification and warranty coverage The owner is responsible for external devices connected to Mobile Vision Screener plusoptiX S12 comply with standards EN 60601 1 and EN 60601 1 1 Page 5 40 plus 2 Putting the device into operation Thank you for purchasing Mobile Vision Screener plusoptiX S12 Plusoptix is world market leader in developing manufacturing and distributing medical devices for vision screening in infants We are happy to assist you if you have any further questions after reading this user manual 2 1 Checking scope of delivery To protect the devi
39. oltage Dips short interruptions and 0 0 5 periods 0 0 0 5 periods 0 Mains power supply voltage variations on 40 5 periods 0 40 5 periods 0 should be that of a power supply input 70 25 periods 0 70 25 periods 0 typical commercial or lines IEC 61000 4 0 250 periods 0 0 250 periods 0 hospital environment 11 Power frequency magnetic fields should Power Frequency be at levels 50 60 Hz magnetic characteristic of a field IEC 61000 4 8 typical location in a typical commercial or hospital environment Page 40 40
40. omagnetic emissions immunity The device is intended for use in electromagnetic environments as specified below Owner and user of the device are responsible that these assure that it is in such an environment Emissions Test Compliance Electromagnetic environment Guidance RF emissions are very low and are not likely to RF Emission CISPR 11 Group 1 cause any interference in nearby electronic equipment RF Emission CISPR 11 Class B The device is suitable for use in all establishments including domestic establishments Harmonic Emissions IEC and those directly connected to the public low 61000 3 2 voltage power supply network that supplies Voltage fluctuations flicker Class B buildings used for domestic purposes emissions IEC 61000 3 3 Electromagnetic Immunity test IEC 60601 test level Compliance level environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power supply 2 kV for power supply 2 kV for power supply should be that of a lines lines typical commercial or hospital environment Mains power supply Surge 1 kV differential mode 1 kV differential mode should be that of a IEC 61000 4 5 2 kV common mode 2 kV common mode typical commercial or hospital environment 6 kV contact 6 kV contact ESD IEC 61000 4 2 8 kV air 8 kV air Electric fast transient burst IEC 61000 4 4 V
41. s saved To enter patient data after a measurement is completed navigate to the Save screening result screen how to get there is described in chapter 3 5 Check and document measurement results Choose the document to be created by touching the PDF DYMO or ZEBRA icon on screen This will open the Enter patient data screen see chapter 3 3 Enter all patient data and confirm by touching the green checkmark button The document is now saved to SD card PDF saved to print spooler DYMO or printed directly ZEBRA Page 25 40 plus 4 4 Adjusting settings Settings can be used to customize the device Touch the tool button 1 in the navigation bar to access the settings menu and touch the abort button in the navigation bar to exit settings menu 2 Settings Screenshot 12 Settings menu Available settings are Customize basic settings 3 Set date amp time 4 Choose language 5 Set up screen lock 6 Configure software 7 Choose referral criteria 8 Activate WLAN 9 Set up EMR 10 Export data 11 Import data 12 ad Rd ES ES 7 i gt Le gt Ca oy Lal o el io ll Page 26 40 plus 4 5 Activating screen lock A screen lock can be activated to protect patient data that is saved within the device from unauthorized access To activate screen lock it needs to be enabled and a PIN needs to be defined in settings first Touch scree
42. us Check screening result screen A pass or refer screening result is displayed on screen immediately after a measurement was performed Inconclusive measurement attempts return a Refer or try again screening result 1 Read chapter 4 18 Aborted measurements What is the meaning of error messages in case an error message is displayed on screen additionally Repeat the measurement by pressing the orange shutter twice one time to return to home screen and a second time to start the next measurement of the same patient if Refer or try again is displayed Refer patient to an eye care professional if a pass or refer screening result can t be obtained within three measurement attempts 04 08 2013 John Smith Screenshot 5 Check screening result screen Measurement values are displayed above the screening result They are displayed for right eye OD and left eye OS individually Measurement values are Spherical Equivalent SE Cylinder CYL Pupil Size PS and gaze Asymmetry Measurement values are displayed in green color as long as they are smaller than the referral criteria i e they are without pathological findings Once a measurement value is equal or greater than its referral criteria it is highlighted in red color In these cases screening result is refer automatically Hyperopia HYP or Myopia MYO are displayed instead of a reading if Spherical Equivalent is beyond measure
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