Volk Eye Check Instructions for Use
Contents
1. Height 63 5mm Depth 27 25mm lens retracted Depth 37 25mm lens extended 242g 1x Rechargeable Li ion 3 7v 1020mAh 2x AAA Alkaline pH If you need a replacement Lithium lon battery or power adapter please contact Volk Optical or your local retailer distributor IM 078 Rev C Page 26 of 31 VOLK Q Environmental Conditions for Use Storage and Transportation IP Code IPXO Equipment not protected against the ingress of water The Volk Eye Check is intended to be used in a controlled lighting environment There is no need for special storage of the device No specialized handling conditions required Usage Temperature use 10 C to 35 C Relative humidity use 10 to 80 Atmospheric pressure 800 hPa to 1060 hPa Please note also EMC information given in Annex A Storage Temperature storage 10 C to 40 C Relative humidity storage 10 to 95 Atmospheric pressure 500 hPa to 1060 hPa Serial numbering Volk Eye Check is a serialized product A label indicating the serial number is attached to the base of the device 8652560009602311 4 0 0 1 151 First screen of the regulatory label sequence The software version and the serial number are both displayed on the device s display during start up and are accessible via the user interface IM 078 Rev C Page 27 of 31 VOLK Q Intellectual Property Rights Information Copyright IRISS Medical Technologies Ltd Disposi2. NOLK INSTRUCTIONS FOR USE Volk Eye Check Ophthalmic Measurement Device VOLK Q Shipping Contents Part Item Number Description Volk Eye Check 18343 US Ophthalmic measurement device USB Cord 18338 For charging and data transmission Power Adaptors 18339 US For charging Volk Eye Check in a wall outlet Formats Supplied USA For precise interaction with touch screen Case for Volk Eye Check Microfiber Pouch for Volk Eye Check NOTE Instructions for Use IFU available at http volk com eyecheck literature Preparation for First Use Remove Volk Eye Check from the package and check that all parts present are undamaged Sterilization or calibration prior to first use is not required Connect Volk Eye Check to the mains using the USB cord and the appropriate power adaptor The battery will start to charge Safely place Volk Eye Check on a flat surface Charge battery for at least 3 hours before the first use et Se eS IM 078 Rev C Page 2 of 31 WOK Table of Contents SNM CON rE E A E 2 PCD AARON Tor Fr E U Creaire E EE EE EEEE 2 meende d U Gerr E E E E tee ecee 4 MACON TO U a E E E E 4 Recommendations Pror to USE xc aiedenazacecscancusst searanamesueanneaavwcaevansmess seawabctesanannesnenensaeaessartonsanbearanuatsees 4 Co ntraindicati ons Tor USE seisena ne aO E OE ENE 4 NAY E E AE E EE E E A E E E E EE E E T A EER 4 CO S ota ests rec E E E E E E E E E E NE 4 WMO OE SIN 51 OS eei E E EEE E
3. OO E EO E TO 5 Device Display amp Interlace ciawissicscsdacascrnacecusucasasduaacscawaiadesswenlscinsuaiagonal yxtdes ouwatacesanadadssuauedeeatavtnorousandaaatess 6 FENU COI ONS oenen rini erR EE ENER EE E N EEE N E EEEN O 6 OIU BU ON anaE A E E E E TAE E 7 Environment amp Photo Taking INGICAtOIS ccceccccssscccesseccceseceeeesceceesceceeeceeeuecessuecesseeceseaecesseesessgaeetes 8 PCAN ACOs a cnn ncernteasice sani E tein nen ence uotier EAE E nen encour secbanaianasiantwanarcn A A T E 8 WII UN SOULS Secs are E toga amt cree E E cera gett ee acer o aureus se E EE E 9 PO St SS IANS E E E E A Goacnu e dom aeatane E E EE E E E E ines 9 7AVo 0 Cer 400 gio lt 1 NE E a E E EOE T eee 10 Basic Use Start Up Shut Down and Capturing an IMage ccccssccccssecccesececeeeeeceeneceeeecesseeceesenees 12 Capturing a Patient SSS SO Macs sec suc ssestieneacsctantaecetienonane sant a Er cecum AA E 12 Measurements Provided by Volk Eye Check ccccccsssecccesececensceeeescccseseceeeuececeecesseaeceseecessencesseaess 14 Reviewing Patient Measurement Data cccccsccsscccsccesccesccssccseccsecesccesecasesseetsecesecesecessssetseeeseceaes 16 MV UFO OAC serrin ee EE E EE E teedacpessoundeavastoaverssanien eadaenesaauteussecees 16 Data Transter via PC CONNECHON serias memionreren eenn ia a aaan 17 PCO AGI Pen de I nr AE EA EE A ahienaacteeeesnes 18 Andine Paea CDa DaS a a E E e e a a 18 Starting a new session for a patient
4. already in the database ccccecccsseccesecceeeceeeceeeneeteneeeeeeeeeeess 20 FSCS MOOG gn ics cats aeec antares naseec ae rE saute sisenazocesynnctaiichaveeactbanaindes scneneissaceseearctasmibararateesneesstnecseets 20 HOW toupdate Volk Eye Check SOTEWANC siccccccsiccpacseurcacectorisadvascssnasannensaseumenancturiaatenucesoeraerensateeaeccdures 22 NV MO E a E E E E E E sere 23 cenne N acO esna r A E E sone sesnceeweuevae 24 Device Maintenance and ServiCing ccccssccccssecccessccccesccccesececseceeeescceseneceeeuecessusceseeeceseaecesseecetseaees 24 COF O e E E E E EE A E E A 25 EN OAZO e E E E E 25 OG NIC DESCA D ON eanne E A E E E E E E EEEE 26 Environmental Conditions for Use Storage and Transportation cccccccssscccesseeceeseceeeecetseeceeseaees 27 SU ed ev INN DE NE aaa ate ip circa acme desecrate eneeres ences eee actos aes ceneun ee aeuesars een tiaciandanaeracceus 27 Intellectual Property Rights Information ccccccesscccessecceesececeececeeseeeceececenecessecesseaeceseaecesseeeesseaees 28 Disposing OF VON EC C16 Ci acai aa ce caste cecsnenosaiinndsgarndouaacrennctseaducicaianontuansneevaaatonaraseednolsnnnietuanseansacdennteserse 28 contactor Prod ct SUN DOIG ace racsctossnwcecoiseuscace E E E O E 28 Wy Tera cect E E E E E E A E T A E A T E A A 28 Appendix A FCC Statement Seen en ee ne eee iE TOERE eer 29 Appendix B Replacing the AAA Batteries ccccccssscccssseccesececescecsesceseeeceeenc
5. during the manufacture of the camera This calibration process will last the lifetime of the product No further calibration by the user is required EN 62479 Volk Eye Check has been tested to EN 62479 RF Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic fields and has been found to be safe The manufacturer does not foresee any precautions or measures that are required to be undertaken with regard to risk of interference or external environmental influences IM 078 Rev C Page 25 of 31 Technical Description Volk Eye Check Ophthalmic measurements Measurement accuracy Operating subject distance Average pictures per session Average session time HIPAA Compliant Image Resolution Touchscreen Lens Exposure Subject Illumination Fixation target Storage Connectivity Dimensions Weight With batteries Batteries NOTE WOLK Left and right pupil size Pupil size difference Deviation Inter pupillary distance IPD Left and right horizontal visible iris diameter HVID HVID difference Palpebral aperture difference Left and right top and bottom MRD Left and right vertical and horizontal pupil eccentricity 5 Based on the results of clinical trials see page 16 500mm to 650mm 30 45sec 16Mp 4608x3440 pixels 3 USB 2 microUSB WiFi 802 11 b g n Bluetooth v2 1 EDR Width 162 75mm
6. indicators are displayed on the interactive touch screen while taking pictures Indicator Purpose of Good photos Indicates number of valid photos in current session Poor photos Indicates number of poor photos in current session Correct distance Optimal patient practitioner distance Distance too far Face too small move closer to patient Distance too close Too close to patient move back Brightness level Optimum level is between 70 80 Zoom Pre set zoom level Battery Indicated percentage left of battery life Preparation Volk Eye Check can be charged by connecting the supplied USB cable to either a PC Personal Computer or the appropriate mains power adaptor When not using Volk Eye Check it is recommended that the device is completely shut down The device will not function if the remaining battery power falls below a 15 IM 078 Rev C Page 8 of 31 VOLK check Initial Settings Power the device on with a long press on the power button After completing a short self test the Volk Eye Check Home Screen will appear o aia OIE Home Screen Device Settings From the Home Screen touch the Device Settings icon This will display a menu of items relating to the Volk Eye Check hardware as shown below Scroll the screen to locate the wireless and date time settings Wireless amp networks l HH Privacy Call settings 6 Storage 45 Audio profiles Language amp keyboard Displa
7. inferiorly located Centre of the left pupil relative to the center of the left iris in the horizontal axis Negative measurement indicates temporally located IM 078 Rev C Page 15 of 31 VOLK Launch Volk Eye Check by touching the Eye Check icon on the Home Screen Open the patient database using the review icon on the left side The database is organized in numerical alphabetical patient ID order Scroll though the database to locate the desired patient Select the patient then select the required session if there s more than one The measurement data for the chosen session will be displayed Scroll through as required To re generate the local report file touch the report icon Note the report icon will be visible only if the report for this session is not already present on the device Reviewing Patient Measurement Data The high resolution images taken by the device are required only for the analysis stages of each Volk Eye Check session in order to produce the measurement data These images are not stored on the device and will not be available to the practitioner WiFi Upload If the settings described in the nitial Settings section have been configured correctly then on the successful completion of each session a PDF document containing the results will automatically be emailed to the address specified in the WiFi connectivity permitting To check if the upload has been successful Launch Volk Eye Check using the E
8. pay Voice input amp output Location Accessibility fm Security Date amp time Applications Schedule power on off IM 078 Rev C Page 9 of 31 VOLK Device Settings Menu Enable WiFi functionality eS Sa Select wireless amp networks from the device settings menu In the next screen check the WiFi box to turn on WiFi Select WiFi Settings Scroll down to select your preferred wireless network Input the password if required and then choose connect Press the physical back button to return to the Device Settings Menu Set the Date Time and Time Zone ee a Ye Select Date amp Time from the Device Settings Menu In the following screen ensure Automatic is un checked Touch set date Spin the wheels to the correct date then touch set Choose select time zone and scroll the list up or down to select your location Touch set time spin the wheels to the correct time and touch set Set the 24 hour check box Touch select date format to select the desired date format Press the physical back button to return to the Device Settings Menu From the Device Settings Menu press the physical back button to return to the Home Screen Application Settings From the Home Screen touch the Eye Check icon to start the Eye Check application The first screen to be displayed is Patient Details IM 078 Rev C Patient Ref Date of Birth Gender IPD if known Page 10 of 31 VOLK chec
9. top left side of the device The fixation LEDs will be activated all the time this button is pressed The patient is required to look at this target throughout the photo capture session 8 Frame the subject s face aiming for 2 3 of the face to appear on the screen from forehead to mouth Half press the shutter button to achieve correct focus The white focus squares will turn green if this is the case Fully press the shutter button to take a photo Do not linger after focus is achieved NOTE All parameters distance brightness and focus lock must be green to validate a picture If the focus squares are red completely release the shutter button and half press again Repeat until correct focus achieved Zoom on face Include both eyes 9 2 to 4 green check photos are required to complete a session and report the measurements The lens may automatically recalibrate after 4 photos If a photo is invalid please adjust your position the patient s position or the surroundings to account for the factor that is not optimum See System Message for error messages and what to do Please do read these messages and follow their instructions IM 078 Rev C Page 13 of 31 WOLK check 10 Once a session analysis has been completed the measurements report will be displayed on screen Scroll up and down to review all data 11 Touch the review icon to view thumbnails of the pictures for that session Touch back to return to the r
10. Delete e New session e Cancel Select new session This will populate the patient details screen with the details of the chosen patient Now touch the start icon and use as directed in the Capturing a Patient Session section Patient ABC12345 Export Delete or New Session Options for existing patient details Freestyle Mode Follow the steps below to successfully complete a free style mode patient session 1 Select the Eye Check icon from the Home Screen 2 Enter the patient data correctly Patient ID date of birth and gender Long press the start icon and select Freestyle to start a free style mode patient session IM 078 Rev C Page 20 of 31 WOK check Select Analyze or Freestyle Options from long press on the start control 3 The lens will extend and automatically be set to the correct zoom setting There is a short lag as the lens extends out and the device prepares the new session 4 Hold the camera comfortably but firmly with two hands to avoid shaking Frame the area of interest on the subject s face Half press the shutter button to achieve correct focus The white focus squares will appear green if this is the case Fully press the shutter button to take a photo Do not linger after focus is achieved 5 The photograph will be saved in the database Continue to take as many freestyle photographs as required Once the practitioner has completed a session press the physical back button to retu
11. age to turn off this functionality Safely eject the device from the physical PC connection 6 Return to the Eye Check Home Screen select the Eye Check icon to start a session 7 Long press the PatientID field this will display the contents of the uploaded csv file Scroll through the database to select the required patient Once selected the user will be returned to the patient details screen with the other data fields now populated from the chosen record AVNO6 14Dec06 F Kathy Kirby AVN19 17May06 F Lois Lane AVN14 13Jan08 F Maggie May AVN13 18Sep09 M Noddy Holder Selecting a patient from an uploaded file Note If there is more than one valid csv file loaded onto the device the user is required to select the correct database to be used Select a CSV file AcmeSchool csv Pre load csv Choosing a patient database file 8 Select the start icon to start the patient session Use as directed in the section Capturing a patient session steps 3 11 IM 078 Rev C WOK Q Starting a new session for a patient already in the database Access the patient database by launching Volk Eye Check using the Eye Check icon on the Home Screen Select patient database using the review icon on the left hand side The database is organized in numerical alphabetical patient ID order Scroll though the database to locate the desired patient Long press on the patient entry will activate a menu with the following options e Export e
12. al aperture O nil Difference between the right and left palpebral apertures IM 078 Rev C Page 14 of 31 Maximum horizontal white to white measurement of the right iris WOLK check Measurement Abbreviation Definition M ar i Upper margin reflex distance right MRD R top easurement from the purkinje image to the margin of the right upper eyelid MI a l i Lower margin reflex distance right MRD R bottom easurement from the purkinje image to the right lower eyelid margin MI aa Upper macimnreiesdi i anelen MRD L top easurement from the purkinje image to the margin of the left upper eyelid MI BER Lower margin reflex distance left MRD L bottom a from the purkinje image to the left lower eyelid Right pupil nasal Right pupil eccentricity nasal or ecc or temporal Right pupil temporal ecc Centre of the right pupil relative to the center of the right iris in the horizontal axis Negative measurement indicates temporally located Centre of the right pupil relative to the center of the right iris in the vertical axis Negative measurement indicates inferiorly located Right pupil Right pupil eccentricity vertical ARAR y vertical ecc Left pupil nasal Left pupil eccentricity nasal or ecc or temporal Left pupil temporal ecc _ Left pupil Centre of the left pupil relative to the center of the left iris in the Left pupil eccentricity vertical sods vertical ecc vertical axis Negative measurement indicates
13. cel the data will not be deleted Check clinical setting procedures for Personal Data Directive If this complies touch yes If this does not comply touch no The data will not be sent via WiFi upload feature Sending data may breach the Personal Data Directive Including a picture may breach the Personal Data Directive Check clinical setting procedures for Personal Data Directive If this complies touch yes If this does not comply touch no The report will not contain the patient picture Messages from the Eye Check hardware Error message What to do Eye Check has stopped Choose the Force Close option unexpectedly This will reset the application and return to Eye Check Home Screen IM 078 Rev C Page 23 of 31 WOLK check Cleaning Instructions Volk Eye Check is a precision instrument that should be handled with care Please note the following cleaning instructions e Shut down the device before cleaning except when cleaning the camera s lens element e Clean the housing and display with a soft lint free cloth moistened with alcohol Avoid touching electrical connectors etc e The lens may be cleaned with a clean cloth or moist lens tissue such as Volk s Precision Optical Lens Cleaner CAUTION Do not allow Volk Eye Check to become wet Do not irrigate with liquids CAUTION Volk Eye Check is not intended to be disinfected or sterilized Device Maintenance and Servicing Volk Eye Check
14. contains a Lithium ion Li ion battery that operates the camera The service life of the battery is approximately 2 years depending on usage The battery should only be replaced by the Volk Optical or a Volk Optical certified service facility when the battery is approaching the end of its service life or when it ceases electrical functionality Cease using and return for service if any of the following occur e The device does not power up e The battery does not retain its charge e The application no longer behaves as expected e The device no longer operates as expected e The case is cracked or broken Volk Eye Check contains two AAA Alkaline batteries that operate the fixation target s LEDs Do not recharge the alkaline batteries Both alkaline batteries should be replaced at the same time when required It is advised that the batteries should be removed from the device if it is to be stored for an extended period of time See Appendix B for instructions on replacement of the AAA batteries All servicing and repairs other than replacing the AAA batteries must be carried out by Volk Optical or a Volk Optical certified service facilities and service personnel CAUTION If there is damage to the device s display buttons or surfaces or other visual defects please contact Volk Optical or a Volk Optical certified service facility IM 078 Rev C Page 24 of 31 VOLK check Calibration Volk Eye Check is factory calibrated
15. couraged to try to correct the interference by one of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help FCC Caution Any changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate this equipment This transmitter must not be co located or operating in conjunction with any other antenna or transmitter Radiation Exposure Statement This device meets the government s requirements for exposure to radio waves This device is designed and manufactured not to exceed the emission limits for exposure to radio frequency RF energy set by the Federal Communications Commission of the U S Government The exposure standard for wireless device employs a unit of measurement known as the Specific Absorption Rate or SAR The SAR limit set by the FCC is 1 6W kg Tests for SAR are conducted using standard operating positions accepted by the FCC with the device transmitting at its highest certified power level in all tested frequency bands The highest SAR value for the device as reported to the FCC is 1 492 W kg when placed next to the body IM 078 Rev C Page 29 of 31 VOLK Appendix B Replacing the AAA Batteries Tw
16. esseacesseneceseaecessueeessees 30 IM 078 Rev C Page 3 of 31 VOLK Q Intended Use Volk Eye Check is standalone ophthalmic software loaded on a mobile electronic platform that is intended to measure ophthalmic characteristics and to aid in the diagnosis of ophthalmic abnormalities Indications for Use To be used by Ophthalmologists Optometrists and other trained health care professionals Clinical support staff can also use Volk Eye Check Recommendations Prior to Use It is highly recommended that all persons eye care specialists and healthcare professionals or clinical support staff thoroughly review this document prior to patient usage Interpretation of the measurement data generated is advised for eye care specialists and healthcare professionals only There are no special facilities or qualifications required relating to the device Contraindications for Use Some patients may experience momentary discomfort when exposed to flash photography Use of Volk Eye Check on patients with photosensitive epilepsy is at the discretion and professional judgement of the healthcare professional Warnings There are no medicinal substances or biological materials incorporated within this device No personal protective equipment is required to be worn by the user or the patient when using this device Cautions Use only accessories and Li ion batteries provided by Volk Optical with this product Any good quality Alkaline AAA batterie
17. esults screen The upload icon on the right side will indicate the session upload status See WiFi Upload section Measurements Provided by Volk Eye Check ay Me ae yy ABC12345 7 4 19 3 2014 Right pupil size 4 32 mm Left pupil size 3 85 mm Diff pupil size 0 47 mm No manifest deviation IPD 69 6 mm Right HVID RRJETE Left HVID 11 66 HVID difference 0 04 mm Ete Eye Check Scrollable Measurements Screen The table below lists all of the ocular measurements provided in the Volk Eye Check session analysis Measurement Abbreviation Definition il si Diameter of the right pupil Left pupil size Diameter of the left pupil Difference in pupil size Diff pupil size Difference between right and left pupil sizes Right pupil size No Deviation Strabismus deviation in prism diopters if detected Reports no manifest deviation if no misalignment is detected Distance between the centers of the right and left corneas in Inter pupillary distance primary gaze Distance IPD is given If IPD was input by the user then this will be indicated on the report Richt hori I visible iri ig t horizontal visible iris Right HVID diameter Left horizontal visible iris diameter Left HVID Maximum horizontal white to white measurement of the left iris Hori visible iris di E onan ASE aE HVID difference Difference in right and left visible iris horizontal distances difference Diff palpebral Difference in palpebr
18. half press and takes photo full press F FIXATION TARGET Activates the fixation target s flashing LEDs J MICRO USB CONNECTOR For charging and data transfer IM 078 Rev C Page 6 of 31 Soft Buttons WOLK check These controls will be found on the interactive touch screen and will change depending on mode Icon Purpose Fa vE Home kT Start Attract Review Upload Application Settings Session Report Help Back IM 078 Rev C Displays the regulatory labels when in the Patient Details screen Returns to Patient Details screen when in any other screen Short press Initiates a new session and enters capture mode Long press Choose normal or freestyle session or save patient details Plays random MP3 when in picture capture mode Note Audio needs to be enabled in Application Settings for icon to be visible Initiates patient data review mode from home or capture screen Indicates the upload status of the current session Red not uploaded Amber upload in progress Green upload complete Opens the Eye Check settings screen where upload reporting and audio features can be configured When pressed will generate and save a report file for the current session Note This control is only visible if the report file does not exist Long press to activate help dialog Go back to the previous screen Page 7 of 31 WOLK Q Environment amp Photo Taking Indicators These
19. k Patient Details Screen Touch the gear wheel icon on the right side of the screen to access the Application Settings Sound Off Orr User prefix _ n Session data Upload Report Include picture Show warning dialogs Clear Database Application Settings Screen Setting Purpose Upload Set if you wish to upload patient data automatically on completion of a patient session Email address Enter the address where the PDF report should be sent Note Upload must be set for the email PDF to be enabled Report Set if you wish to generate a data report at the end of a patient session If you do not check this option no report for reference will be generated on the device at the end of each patient session Include picture Set if you wish to include the patient photo on session reports Note this setting applies to both local and uploaded report content Please be aware of HIPAA regulations within your clinical setting for this feature Prefix A prefix can be added to all patient IDs Sound Set to ON if you wish to activate the audio attract feature This helps to attract the attention of younger patients Show warning Unset if you wish to disable the warning dialogs that may pop up during a photo taking dialogs session It is highly recommended that this option remains set in order to direct the user during the photo taking process for maximum efficiency Generally both Device Settings and Applicatio
20. ng lt USB connected Select to copy files to from your computer USR debugging connected Swipe down to access USB connection control 4 Touch USB Connected Select to copy files to from your computer 5 Touch Turn on USB Storage Select OK when USB advice message appears USB connected You have connected your phone to your computer via USB Select the button below if you want to copy files between your computer and your Android s SD card Turn on USB storage 6 Touch Turn on USB Storage Select OK when USB advice message appears 7 On your computer locate the device in Finder Mac or Windows Explorer Windows Click on the device to open the root folder IM 078 Rev C Page 17 of 31 WOLK check 8 Open the folder IRISSReports and begin managing the patient records You can a Copy reports to a local drive b Print via PC printer c Delete reports from the device d Rename files Pre loading Patient details To pre load and save patient details to the Eye Check database prior to use follow the instructions below 1 Enter the patient ID screen via the Eye Check icon on the Home Screen 2 Input all patient details correctly as required including date of birth and gender 3 Long press the start icon An options menu will appear giving the following options e Analyze e Freestyle e Save details e Cancel Select Save Details These details have now been saved for later use 4 Continue to input as man
21. ng of Volk Eye check Do not dispose Volk Eye Check as unsorted municipal waste Prepare Volk Eye Check for reuse or separate collection as specified by Directive 2002 96 EC of the European Parliament and Council of the European Union on Waste Electronic and Electrical Equipment WEEE If this product is contaminated this directive does not apply For more specific information please contact IRISS Medical Technologies or your local retailer distributor Contact for Product Support If you wish to contact Volk for product support gt Direct 440 942 6161 gt Tollfree in the United States 1 800 345 8655 gt Fax 440 942 2257 gt e mail sales volk com or service volk com Warranty Volk Optical provides a 1 year warranty for the parts and labor Warranty for the Lithium lon battery is 6 months Submitting claim Any claim under this warranty must be submitted in writing before the end of warranty period to Volk Optical The claim must include a written description of any failure s experienced with the device Warranty does not cover Products that have been subjected to abuse accident alternation modification tampering misuse faulty installation lack of reasonable care repair or service in any way that is not contemplated in the documentation of the product or if the model or serial number has been altered tampered with defaced or removed Warranty does not cover damage caused by dropping the device or damage caused b
22. ns Settings only require attention once during initial setup However they can be changed at any time if desired When finished touch the back button to return to the Patient Details screen then again to return to the Home Screen IM 078 Rev C Page 11 of 31 VOLK Q Basic Use Start Up Shut Down and Capturing an Image An image is captured using the dual action shutter button At the first detent half press the camera will focus on the subject and lock in its exposure settings Pressing the shutter further to its second detent full press the image is captured and analyzed Don t wait too long between half press and full press because of camera shake and subject movement The device may be powered off or put to sleep by returning to the Home Screen and touching the power sleep soft key Choose either shut down or sleep The device may also be placed into sleep mode by a short press on the power button To wake the device from sleep mode short press the power button or the back button If a device is left in sleep standby overnight it will power itself down at approximately 2 00am Capturing a Patient Session Follow the steps below to successfully complete a patient session 1 Select the Eye Check icon from the Home Screen 2 Enter the patient data correctly Patient ID date of birth gender and IPD if known Touch the start icon to start a patient session NOTE The use of IPD is recommended in order to facilita
23. o AAA batteries are included within the device to operate the flashing LED on the front of the camera The user can follow the instructions below to replace the batteries Alternatively Volk Optical and or Volk Optical s retailers will provide battery replacement service Replacing the Fixation Target batteries 1 Open the battery compartment cover by removing four screws at the back Put the screws somewhere safe so they don t get lost 2 Gently pry the back cover away from the front of the Eye Check device starting at the groove on the right hand end of the case 3 Insert 2 fresh AAA Alkaline batteries after first making note of the proper orientation Please dispose properly of the old batteries 4 Replace the back cover by snapping it in to position all around the edges Finish by replacing the four screws saved from step 1 IM 078 Rev C Page 30 of 31 WOK Q OLK the leader in aspheric optics A HALMA COMPANY Volk Optical Inc 7893 Enterprise Drive Mentor Ohio 44060 USA Phone 440 942 6161 Toll free within the United States 1 800 345 8655 Fax 440 942 2257 Email volk volk com Website www volk com Copyright 2014 Volk Optical Inc Part No IM 078 Effective August 22 2014 Revision C Instructions for Use IFU available at http volk com eyecheck literature IM 078 Rev C Page 31 of 31
24. put Zoom on face Correct zoom setting already pre set Z5 Move to correct distance 50 65cm from Analysis in progress Valid photo achieved Eye Check requires another valid photo to complete analysis another picture required Continue to take valid photos until session completed Lift finger from dual action shutter button Re frame patient Half press shutter button to Picture not quite in focus achieve green focus lock Repeat half press process if red focus lock appears to achieve a green focus lock Face may be tilted Readjust patient head position until straight in primary position The memory card is full Subject too bright or 6 Either reduce lighting or move closer to patient too far away Too close move away unwanted reflections large windows and extra reflections Return to Eye Check settings via the settings icon on the patient ID input page If you wish to clear database touch clear database This is an irreversible process If you do not wish to delete database and require more storage space contact Volk Optical Check WiFi settings are correct section 7 2 and WiFi set up within clinical environment Picture not valid Retake photo ensuring correct distance good lighting level and green focus lock Clear Database No WiFi or SIM connection Please try later are correct Warning If you wish to delete data click delete This is an irreversible process To go back click This will delete all data can
25. rn to the patient entry page 6 Select the review icon to access the database Scroll down to select correct patient Select the correct session if there is more than one and select review icon on the left hand side to review thumbnails of the photographs taken Note There will be no analysis or data measurements on the first screen when reviewing data This will present as a black screen until the review icon is selected to view thumbnails Freestyle sessions are not uploaded and reports are not generated Data and pictures may be copied from the internal memory after exporting the session IM 078 Rev C Page 21 of 31 WOLK check How to update Volk Eye Check Software To update your Volk Eye Check to the latest software when available follow the steps below 1 Refer to the section titled Data Transfer via PC connection and connect the Volk Eye Check to the PC using the steps 1 6 2 Download the new version of the software from your e mail account to a remembered location on your PC 3 Goto the saved location of the software right click the icon data field to select the copy option 4 Return to locate the device in Finder Mac or Windows Explorer Windows Click on the device to open the root folder Select the R SSApps folder Right click within this folder to select the paste option to paste the new software package to the device 5 On the device select turn off USB storage to turn off this functionality Safel
26. s may be used in the Fixation Target No modification of this equipment is allowed No files may be copied to from the device except as described later in this document IM 078 Rev C Page 4 of 31 Important Symbols IM 078 Rev C WOLK Q Description The CE mark on this product indicates it has been tested and conforms to the provisions noted within the 93 42 EEC Medical Device Directives The CE mark with notified body identification number indicates a Class measuring product The FCC Declaration of Conformity or the FCC label or the FCC mark is a certification mark employed on electronic products manufactured or sold in the United States which certifies that the electromagnetic interference from the device is under limits approved by the Federal Communications Commission Do not dispose of Volk Eye Check or Volk Eye Check s battery Lithium lon as unsorted municipal waste Recycle Volk Eye Check s Lithium lon battery Read accompanying user documentation Indicates that important operating instructions are included in this User Manual Failure to follow these instructions could place the patient or operator at risk Page 5 of 31 VOLK Device Display amp Interface Features amp Controls Number Name Purpose Display Screen Home screen for the Volk Eye Check application POWER i bruins the dev Turns the device on and off with a long press SHUTTER 3 G Locks the focus and exposure
27. te an easier photo taking session particularly in sub optimal conditions The IPD can be input in one of two ways as the full IPD or as right and left PD respectively both to the nearest 0 5mm Enter left amp right PDs or full IPD in mm Right PD or full IPD Left PD or zero IPD Input Screen 3 The lens will extend and automatically be set to the correct zoom setting There is a short lag as this takes place and the device prepares the new session IM 078 Rev C Page 12 of 31 WOLK check NOTE When capture mode is initiated the camera focus motor makes a sound This sound is normal and is not a sign of any damage or problem 4 The attract icon on the left hand side will only appear if the sound feature has been enabled in application settings Press this icon to hear the sound as required 5 The optimum light level is between 70 80 for light skinned patients and around 60 for darker skinned patients A patient practitioner distance of 50 60cm is required Check the brightness level and distance on the panel to the right side of the screen 6 Ensure that the patient is sitting comfortably in front of a neutral background The practitioner should be at eye level with the subject Avoid large windows mirrors and strong reflections 7 Hold the camera comfortably but firmly with two hands to avoid shaking Use the index finger of the left hand to activate the fixation target button This is located on the
28. y eject the device from the physical PC connection 6 Press the physical back key to return to the Eye Check Home Screen A message will automatically be generated on detection of the new software Software update found do you want to install Touch yes This will automatically initiate the installation of the latest version of the Eye Check software Follow the prompts to accept the replacement of the current version and to proceed with the installation Touch the done control on the final screen and the update is completed 7 To verify that the new software update has been correctly installed touch the home icon when in the Home Screen This will display the details of the software currently running on the device Cross reference these details with the details of the software update that was received 8 At this point you can continue to use the device as directed IM 078 Rev C Page 22 of 31 WOLK check System Messages The Volk Eye Check device will display messages for many reasons The messages usually include an explanation and details of possible corrective actions List of messages displayed by the Volk Eye Check application Error message What to do es A capture session will not be possible unless all fields are filled in on the patient Patient details field label p p p information page Ensure correct date of birth and gender are input Future dates are not allowed Check correct date of birth has been in
29. y normal wearing Any issue related to the stickers attached to the device coming off are not covered by warranty Repair or service done by non Volk Optical certified service facility is not covered by warranty For customer support contact service volk com IM 078 Rev C Page 28 of 31 WOLK check Appendix A FCC Statement Electromagnetic compatibility information US notice Wireless LAN frequency range 2412 MHz 2462 MHz Federal Communication Commission Interference Statement This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is en
30. y patient entries as required 5 To access the preloaded patient details when starting a new patient session long press the empty Patient Ref field in the patient ID screen The preloaded patient entries will appear here 6 Scroll down and select the correct patient Once selected the patient information will automatically populate the necessary data fields 7 Touch the start icon to start a session for the selected patient following the instructions as per the Capturing a Patient Session section of this instruction manual Adding a Patient Database To use this pre load patient database feature Microsoft Excel or similar is required to create a data list of the patient details to be saved to the device database 1 Create a spreadsheet with the following data column headings in bold PatientID DoB date of birth Gender Name Input all of required information to complete the spreadsheet database Note The Name column is not mandatory and is not retained by the Eye Check database It is useful for validation of patient identity by the practitioner 2 Save this spreadsheet in a remembered file location using a designated file name and save it as a csv format comma separated value file 3 Use steps 1 6 in the section Data transfer via PC connection to successfully connect the device to a PC 4 Once in the root folder copy the csv file created here IM 078 Rev C Page 18 of 31 5 On the device select turn off USB stor
31. ye Check icon on the Home Screen Open the patient database using the review icon on the left side The database is organized in numerical alphabetical patient ID order Scroll though the database until the desired patient is located Select the patient and the session if there is more than one This upload icon will appear green if the upload has been successful If the upload is in progress the icon will be amber If the upload had not been successful the icon will be red To manually initiate an upload or to get the PDF re sent touch the red icon ae ABC12330 aE 19 3 2014 Session 1 Inconclusive 19 3 2014 Session 2 Completed 2x Sessions One uploaded the other not Please be aware that a successful session upload and subsequent receipt of the PDF email is dependent on entering the correct email address in the application settings and properly setting the WiFi connection in the device settings If the upload fails please check all the settings and ensure the device is within the coverage of the specified WiFi service IM 078 Rev C Page 16 of 31 VOLK check Data Transfer via PC Connection 1 Connect the Volk Eye Check device to a personal computer using the supplied USB cable 2 Once the connection is complete return to the device and click device settings 3 From the device settings menu drag down from the top of the screen to open Connectivity menu March 19 2014 gt Bluetooth No service Ongoi
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