USER`S MANUAL Volk Pictor Digital Imaging Device
Contents
1. Reset button can be pressed with a thin object such as a paper clip Button needs to be pressed for over 7 seconds Page 20 of 51 IM 052 Rev D 8 Eye Fundus imaging using module VP1RET Pictor VP1RET is intended to capture digital images and video of the fundus of the human eye The device set for ophthalmic imaging consists of e Camera handset VP1HAND Attachable ophthalmic module VP1RET Silicone support for VP1RET Cradle for charging and image transfer VPIRET is intended for non mydriatic imaging This means that infrared is used for targeting image to the eye fundus and visible light is flashed when image is taken Pupil does not respond to the infrared light so examination is convenient for the patient Constant illumination can be selected from device menu if mydriatic drops are used Pictures can also be taken using infrared light for both aiming and capturing STEPS FOR FUNDUS IMAGING 1 The examination room should be as dark as possible 2 Both the patient and the examiner shall be seated while taking the images Patient is asked to look at a target on a wall 6 9 feet behind the operator patient s eye targets to infinity and stays still 3 Either autofocus or manual focus can be used Autofocus range is 11 to 3 diopters manual focus range is 20 to 20 diopters If patient has a refractive error and autofocus is off focus need to be adjusted e Hyperopia camera is focused to distance by pressing arrow key u2. CAUTION When device is powered on powered off or goes to standby mode the handset issues noise This noise is normal and is not a sign of any damage or problem 7 4 Attaching and detaching optics module CAUTION Imaging modules used with Pictor must include text Pictor It is not allowed to attach other objects to the bayonet connector Module is attached by placing it in front of the BAYONET 3 bayonet area of the device Three bayonet legs are placed in the holes and the module is pressed firmly into the handset Module is released by sliding release button that is located in front of the device above the dual action shutter IM 052 Rev D Page 13 of 51 7 5 Device Menu Menu is opened by pressing a right soft key for 1s ME GNT OTO Preview images Menu has six tabs One is for device settings such as language selection There is one tab for retinal imaging RET anterior eye New patient folder imaging ANT ear imaging OTO skin imaging DER and general imaging DF Erase image memory Arrow keys are used to move between tabs use arrow key up A irae until tab is active and use left and right arrow keys to change active tab Light blue color indicates active tab ve Siesta Arrow keys change values in the menu Active value is indicated with light blue color Changed values are saved by using left soft key OK and cancelled by pressing right soft key Cancel Some values are confi
3. If Save IR image is enabled from menu the camera will save an image taken with IR image in addition to saving a color image taken with white light Illumination mode Illumination mode can be set to IR White IR IR or White White In IR White mode aiming is done using infrared light and image is captured using white light The pupil does not react to infrared light and thus it is recommended to use IR White mode whenever possible In IR IR mode both aiming and image capture are done with infrared light In White White mode aiming and image capture are done with white light Aim help Aim help feature indicates to user when the aim on retina is good for taking an image If the rectangle is red the aim is not good and retina does not fully cover the image area Ifthe rectangle is green the aim is good and image can be taken IM 052 Rev D Page 24 of 51 9 Eye imaging using external ophthalmic module VP1ANT Volk Pictor VP1ANT is intended to capture images and video of the surface of the human eye and surrounding areas The device set for external ophthalmic imaging consists of e Camera handset VP1HAND e Attachable external ophthalmic lens VP1ANT e Cradle for charging and image transfer VP1ANT optics module has two light sources white and cobalt blue light User can choose between the light sources by pressing left soft key when VP1ANT module is attached Cobalt blue light enables taking fluorescent pictures of the surface of the eye to reve
4. recommended to create a new file folder for each patient s images New folder is created by pressing middle key for 3 seconds Icon P at the top of the screen indicates number of the current patient folder If the current folder does not have any images in it a new folder cannot be created m TT Use left and right arrow keys to adjust capture light brightness Aiming light brightness is adjusted in menu Move AF window Move focus window left and right after pressing Middle key to KIN HAAA activate The Window returns to original position when camera is putto cradle turned off or optics module detached Focus manually Use up and down arrows to focus manually Zoom In Out Zoom in using arrow key up Zoom out using arrow key down There are four zoom levels 1 2 4 and 6 Zoom value is saved to camera memory A A a activate Page 26 of 51 Table below includes explanations of the ANT settings tab for anterior eye imaging Setting EHE default bolded Purpose video capture window visible or hidden mode Normal Auto In Auto mode camera takes picture automatically after focusing In Normal mode user must press shutter button to second position to take picture after focusing On Off Mark side of the eye to the image data Zoom cropping On Off When turned on camera will save the zoomed area only When turned off camera will save the whole image area even when zoom is used Capture mode Both still images an
5. Visible white and cobalt blue LED for imaging 10 illumination brightness levels 2560 x 1920 px 79x 70 mm 80g Page 41 of 51 DIGITAL DERMATOSCOPE VP1DERM CONNECTED TO THE PICTOR HANDSET VP1HAND Type Pictor VP1DERM Intended use Digital dermatoscope Intended to capture images of the skin Illumination Light ring of 24 LEDs Image resolution 2560 x 1920 px Image size on skin 30 x 22 mm Dimensions 60 x 77mm Weight 150g OTOSCOPIC MODULE VP10TO CONNECTED TO THE PICTOR HANDSET VP1HAND Type Pictor VPLOTO Intended use Imaging of ear canal and tympanic membrane Image resolution 2560 x 1920 pixels Dimensions 49 2 x 45 5 mm Weight 80 g Main features Integrated LED illumination Insufflation port for pneumatic otoscopy Disposable and reusable speculum diameter range 2 5 5 IM 052 Rev D Page 42 of 51 ENVIRONMENTAL CONDITIONS FOR USE STORAGE AND TRANSPORTATION IP Code IPXO Equipment not protected against the ingress of water Intended to be use indoors Temperature use 10 C to 35 C Relative humidity use 10 to 80 Please note also EMC information given in Annex A Temperature storage 10 C to 40 C Relative humidity storage 10 to 95 NOTE If stored over 1 month it is recommended to remove battery Appendix B gives instructions for removing the battery Transported in protective aluminium carrying case Temperature 40 C to 70 C Relative humidity 10
6. be submitted in writing before the end of warranty period to Volk Optical The claim must include a written description of the problem 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 by normal wear and tear Any issue related to the labels attached to the device coming off are not covered by warranty Repair or service done by non Volk certified service facility is not covered by warranty IM 052 Rev D Page 45 of 51 Appendix A Electromagnetic compatibility information MEDICAL ELECTRICAL SYSTEM needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided Portable and mobile RF communications eguipment can affect MEDICAL ELECTRICAL SYSTEM Pictor should not be used adjacent to or stacked with other eguipment and that if adjacent or stacked use is necessary the EQUIPMENT or SYSTEM should be observed to verify normal operation in the configuration in which it will be used Manufacturer s declaration electromagnetic immunity Pictor is intended for use in the electromagnetic environment spe
7. key There are four zoom levels Pressing middle key activates the next level Move around the image by using arrow keys 8 If multiple patients are examined during one session new file folder is created for each patient by pressing middle key for over 3 seconds 9 Transfer images to a computer after capturing images Images are transferred to the computer when camera is placed to the cradle VPIHAND works as any other digital camera 10 When camera is removed from the cradle it verifies image data storage erase It is recommended that image data storage is always erased before images are captured of a new patient The camera keys function as shown in image below when VP1RET optics module is attached Focus manually Short Light On Off Short AF MF Long Power On Off Long Menu Decrease Brightness Increase Brightness Long New patient folder Focus manually IM 052 Rev D Page 22 of 51 Below table provides explanations for the key functions Press Function Explanation Key The aiming light can be turned on and off by pressing Left soft key The aiming light IR or white can also be Left soft key turned on by half pressing the shutter button key for longer than 2s Auto Manual focus Switch between Auto and Manual focus by pressing Right soft key Autofocus range is 11 to 3 diopters Right soft key manual focus range is 20 to 20 diopters than 1s Long New patient folder If multiple patients are examined durin
8. settings when it is powered off IM 052 Rev D Page 27 of 51 10 Ear imaging using otoscopic lens Pictor VPLHAND VP10TO Volk Pictor VP1HAND VP10TO digital otoscope is intended to capture digital images and video of the ear canal and tympanic membrane The device set for otoscopic imaging consists of e Camera handset VP1HAND Attachable otoscopic lens VP1OTO e Otoscopic specula type beta Heine air pump Otoscope can be used with widely available type beta Heine allspec speculas Steps for capturing ear images are 1 Attach otoscopic lens Press firmly until you hear a clicking sound to make sure module connects properly Attach specula Start illumination by pressing shutter half way down Adjust illumination by using left and right arrow keys Adjust focus if needed by pressing arrow keys up and down It is recommended to use autofocus Automatic focusing starts when shutter is pressed half way down top right corner of the display shows icon A If pressing shutter does not activate automatic focusing autofocus needs to be activated from right soft key Use digital zoom for close up of features if needed press right soft key to activate Zoom upper right corner shows Z and arrow key up or down to adjust zoom There are four zoom levels 1 2 4 and 6 Press right soft key to re activate focus if needed Due to slight differences between individual specula the image area may not be completely v
9. still images and video can be taken with the Pictor VP1HAND camera Capture mode can be chosen in OTO menu and when using VP1OTO otoscopic module from left soft key When taking video the shutter button must be held down while taking the video The video recording will stop once the shutter button is released Focus Window Focus Window help user position the image The Focus Window can be moved on the screen by first pressing Middle key until icon F appears in up right corner of display and then using the arrow keys when aiming Shoot mode Shoot mode function can be used when autofocus is enabled There are two shoot modes to choose from normal and auto In normal mode the camera will focus when shutter button is pressed half way down and take a picture when shutter button is pressed all the way down In auto mode when shutter button is pressed the camera will focus and take a picture automatically Marking side It is possible to mark which ear was imaged Marking side is enabled from the menu When On side is marked to the file name and to the image For video files side is always marked only to the file name When marking side is enabled camera verifies side after each captured image Identifiers used for ear images are Left LE and Right RI Zoom cropping With zoom cropping on the camera will save the zoomed area instead of the whole image area When zoom cropping is turned off then camera will save the whole image area instead
10. to 95 Atmospheric pressure 500 hPa to 1060 hPa Sinusoidal vibration 10 Hz to 500 Hz 0 5 g Shock 30 g duration 6 ms Bump 10 g duration 6 ms IM 052 Rev D Page 43 of 51 SERIAL NUMBERING Label indicating serial number of the Handset is attached to the Warranty certificate and in the sticker next to system connector Warranty certificate is part of this user s manual Serial number of the cradle is in a sticker attached to the underside of the cradle Serial numbers of the attachable modules are attached to the modules and also to the Warranty certificate Year of manufacture is can be found from the serial number digits 3 to 4 SW version is displayed in the device menu EXPECTED USAGE LIFE OF PICTOR There are no strict limitations about expected usage life of Pictor Usage life is approximately five years DISPOSING OF PICTOR Do not dispose Pictor as unsorted municipal waste Prepare Pictor 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 Volk or your authorized Volk distributor IM 052 Rev D Page 44 of 51 17 Warranty Volk Optical gives device a 1 year warranty for the parts and labor Warranty for battery is 6 months Submitting claim Any claim under this warranty must
11. transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher freguency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people IM 052 Rev D Page 48 of 51 Appendix B Replacing the battery Battery pack is specially designed and manufactured for this device Volk and authorized Volk distributors provide suitable battery packs Labels on the battery and inside the battery cover display following information NiMH battery 4 HR 4U AAA 4 8V 1000 mAh Procedure for replacing battery Open the battery compartment cover by pushing and tilting the snap through the hole next to the connector in the bottom of the device A pen screwdriver or similar device can be used to assist in opening the cover Remove the battery compartment cover by lifting it up Remove old battery Squeeze battery wires with fingers and pull the connector out from its socket Put the new battery in the same position and attach the connector to its socket Replace the battery compartment cover and secure it in place by snapping it firmly to place IM 052 Rev D Page 49 of 51 Ordering Information Orders may be placed with the Authorized Volk Distributor in your region Authorized Distributor contact information is available directly from Volk Volk Optical
12. uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic eguipment RF emissions CISPR 11 RF emissions Harmonic emissions IEC Not applicable 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Pictor is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Complies Recommended separation distances between portable and mobile RF communications equipment and Pictor Pictor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and Pictor as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter Separation distance according to frequency of transmitter W m 150 kHz to 80 MHz 150 kHz to 80 MHz 800 MHz to 2 5 GHz d 1 2 VP d 1 2VP d 2 3VP 100 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the
13. will open the Patient Information editor screen o The Patient Information editor screen includes a simple on screen keyboard in ABC 123 order as well as the special characters mentioned above It also includes a white editing field at the top of the screen The 4 arrow keys are used to navigate to the desired character or up to the white editing field The middle key is used to select that character which will then appear at the top of the Patient Information editor screen in the editing field o Toggle between upper or lower case characters by using the left soft key below the A a icon o Exit the editor screen by using the right soft key below the Exit icon This saves the entered Patient Information o To delete a character Arrow up to the white editor field at the top of the screen Use the left or right arrow keys to navigate the blinking cursor to the position AT THE IMMEDIATE RIGHT of the character you want to delete Press the middle button to delete the character In the Patient Information screen e Use the left soft key under the OK icon to save the Patient Information settings and exit the Patient Information screen OR e Use the right soft key under the Cancel icon to discard any changes and exit the Patient Information screen How To Access The Patient Information Screen When powering on the Pictor Plus e When the Pictor Plus starts up after being powered on or being removed from its charging cradle it au
14. with module attached 7 2 Connection to a Computer Image data transfer method to a computer is similar as in a digital camera When connected to a computer it is possible to simply open the folder to view and then store files to the hard disk of the computer 7 3 Basic use starting up shutting down and taking an image Device is powered on by pressing left soft key It is possible to capture both still images and video Image capture mode is changed from camera menu that opens by pressing right soft key for 15 Still image is captured using the dual action shutter to the second position Video is captured by keeping the dual action shutter pressed down in the second position Taken image will stay on display until it is cleared by pressing right or left soft key Image can be zoomed in instant preview by pressing middle key There are four zoom levels Pressing middle key activates the next level Move around the image by using arrow keys To transfer images to a computer place device to the cradle The image transfer and charging is indicated with green and blue LED lights and text on LCD screen Pictor verifies if image data is erased when e Device is powered on from power off mode or power save mode e Device is removed from the cradle It is recommended that image data storage is always erased with a new patient Device is powered off by keeping left soft key pressed down over 1 second IM 052 Rev D Page 12 of 51
15. 0 d mm 400 g Rechargeable Ni MH Cylindar cell HR4U 700 AAA 4 8 V 1 0 Ah User can change battery Batteries provided by Volk 1h 30min with full battery Pictor Cradle 170 w x 35 h x 150 d mm 380 g Switching power supply connected to cradle Type CINCON TR10RO90 Input 100 240 V 0 4A 47 63 Hz Output 9V 1 14 10 W USB cable CAUTION Type Ato mini B high speed unshielded length 1 8 m It is only allowed to attach Battery and Power source provided into the Cradle If you need replacement to the Battery or Power source please contact Volk or authorized Volk distributor IM 052 Rev D Page 40 of 51 NON MYDRIATIC OPHTHALMIC MODULE VPIRET CONNECTED TO THE PICTOR HANDSET VP1HAND Type Intended use Illumination Field of view Diopter compensation Image resolution Dimensions Weight Pictor VPLRET Digital ophthalmoscope Intended to capture digital images and video of the fundus of the human eye Infrared LED for targeting Visible white LED for imaging 10 illumination brightness levels 45 20Dto 20D 1920 x 1440 px 132 1 x 55 2 mm 180 g EXTERNAL OPHTHALMIC MODULE VP1ANT CONNECTED TO THE PICTOR HANDSET VP1HAND Type Intended use Illumination Image resolution Dimensions Weight IM 052 Rev D Pictor VPIANT Digital external ocular optics module Intended to capture digital images and video of the surface of the human eye and surrounding areas
16. 052 Rev D Page 3 of 51 Table of contents CUICK start je a aaah eee aneeesat 3 Fale OCONEE araa AE aunt AA 4 t Mmadicaton Tor isa m t 5 2 Contraindications for use of the posterior segment module VPLRET ccccesscccessecceeneceeeeceeeeeees 6 Oe Wanne aDC MOMS ia e a A 7 Ao MOONS yD aaner E ee ee ee ee 8 Ds Parts OF ENG GOV ICC daa gata hace nce aaa aaa 9 6 Usage environment requirements ssssessessessesessessesresrrsressrsseseosesseosesressesseseeseeseeseeressesseseeseesee 11 Ze Operaine ASTUDA norena E N 12 Pode dE MeO ele ONS eon ana E O E E Gease nan aes 12 42 CONNECCION tTO a COMMS UU CM aena n AN T AT 12 7 3 Basic use starting up shutting down and taking an IMAaEe ceccccssscccesseceeeseceeeeeceseeeeeees 12 7 4 Attaching and detaching optics module 6 nrrsvenennnenennnnenenenenennnenen noore nene nen nenea 13 Fes WDOCVICSIVICI IU a E A E A A SAS RAAD SADE Ea ME 14 76 Adjusting TOCUS and automatic ToCUS iii tet vaas aaa laiku amaan lahati al aalaa 16 7 7 Patient Information Editor sitaks Santana aaa taak kud Vava kaa aaa 17 Toa ARES 2155 01010 Oea AN ee erage At t a i ea ie 20 8 Eye Fundus imaging using module VPIRET 066rrenenenenenenennenene ne nene nn neneannene n nene enne 21 9 Eye imaging using external ophthalmic module VP1ANT vveennerennneneanenene nene ne nne 25 10 Ear imaging using otoscopic lens Pictor
17. Inc 7893 Enterprise Drive Mentor Ohio 44060 USA Toll free within the United States 1 800 345 8655 Phone 440 942 6161 Fax 440 942 2257 Email volk volk com Website www volk com EU REPRESENTATIVE The Volk authorized representative based in the European Union EU is Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA U K Tel 44 0 1753 857177 C Eos Note This product complies with current required standards for electromagnetic interferences and should not present problems to other equipment or be affected by other devices As a precaution avoid using this device in close proximity to other equipment Members of the European Union should contact their authorized Volk Distributor for disposal of this unit Certificate FM 71461 IM 052 Rev D Page 50 of 51 HUIK 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 O 2011 Volk Optical Inc Part No IM 052 Effective February 07 2014 Revision D IM 052 Rev D Page 51 of 51
18. PICTOR USER S MANUAL Volk Pictor Digital Imaging Device The system component options are Pictor digital imager with optics lenses and accessories Component Description Accessories a a Otoscopic module VP1OTO module for otoscopic imaging ear specula pack air Imaging handset VP1HAND handset for general imaging Cradle VPCRADLE for data transmission and battery charging USB aa Power unit The following accessory can be purchased separately Pictor Slit Lamp Adapter VPSLM that enables the camera to be used as stationary imaging tool IM 052 Rev D Page 2 of 51 Auick start guide WHAT TO DO BEFORE THE FIRST USE 1 Remove Pictor from the packaging and check that all parts are undamaged 2 Install Battery as instructed in the Appendix B end of this manual Place Cradle on a desk next to the computer Connect the other end of the USB cable to the computer Connect power unit to the wall plug mains Place Pictor handset in the cradle Battery starts to charge Charge battery for four hours before the first use When device is not used it may be stored in the Cradle 17 BA Guideline for device storage If battery is stored out of the camera for longer period of time battery shall be charged every 9 months If battery is stored in the camera camera shall be placed in the cradle with cradle power cable connected Normal battery life time is expected to be 1 2 years IM
19. VPIHAND VPIOTO ccccccccecccccccseeeeeeeeeeeeeeeesseeeeees 28 11 Skin Imaging using dermatoscopic optics module VP1HAND and VP1DERM 31 12 General imaging without optics module cc ceeccccssecccesececeesceceesececeuececsueceseueeeseuecesenecesseaeeesees 34 Ts EIA MESS AS ini ce snes T T isaisa aata 37 T4 Cleaning instructions anomena aata nirki ast E A A NEA 38 154 Device maintemaneemtk samas a E E N ow dase pe sign E usa 39 TGs Technical ASSEFIDLION yates esata asaya as Sion cach cla Ta a Daa ance de Salon ge els E t le jaala 40 17 WVAGGAIIEY etesbcacatetcoced ncheecanatsesamte che Sas via Senne ealaetianasaenamause auc aea ne oases rele beinaaaaee venawiem E sooner vals 45 Appendixes Appendix A Electromagnetic compatibility information Appendix B Battery replacement IM 052 Rev D Page 4 of 51 1 Indications for use Pictor is a medical digital camera that is used with dedicated optics modules intended to take images of the eye fundus surface of the eye ear canal and tympanic membrane and skin Image and video data is intended for documentation and consultation Supported optics modules and their intended uses are Component Description VP1RET module for fundus imaging VP1ANT module for exterior ophthalmic imaging VP1DERM module for dermatoscopic imaging VP10TO module for otoscopic imaging VP1HAND handset for general imaging IM 052 Rev D Page 5of 51 2 Contr
20. aindications for use of the posterior segment module VP1RET Because prolonged intense light exposure can damage the retina the use of the device for ocular examination should not be unnecessarily prolonged and the brightness setting should not exceed necessary illumination to provide clear visualization of the target structures The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time If the value of radiance were reduced in half twice the time would be needed to reach the maximum exposure limit While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes it is recommended that the intensity of light directed into the patient s eye be limited to the minimum level which is necessary for diagnosis Infants aphakes and persons with diseased eyes will be at greater risk The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours This will apply particularly if the eye has been exposed to retinal photography IM 052 Rev D Page 6of 51 3 Warnings and cautions BH Use only accessories and battery provided by Volk with this product Place computer and cradle outside the patient environment at least 4 feet distance from the patient IM 052 Rev D Page 7 of 51 4 Important symbols Symbol Description The CE mark
21. al any cuts or defects STEPS FOR EYE SURFACE IMAGING 1 After VP1ANT optics module is attached the light source is chosen by pressing left soft key 2 Still or video image is selected Selection is made in ANT menu 3 Itis recommended to use autofocus 4 Ophthalmic aiming light is turned on by pressing the shutter key in front of the device half way down 5 Light is adjusted using left and right arrow key There are altogether 10 brightness levels Default value is 5 Suitable illumination is typically 2 to 8 6 Place the optics module cup on patient s eye Patient can be asked to look at different directions depending on what area of the eye needs to be captured Camera is stabilised by keeping the outer side of the hand against the patient s forehead Example of the correct usage position is shown below 7 Still image is captured by pressing the shutter key all the way down Video is captured by keeping shutter down Taken image is displayed on screen until user clears the image by pressing shutter left or right soft key Image can be zoomed in instant preview by pressing middle key There are four zoom levels Pressing middle key activates the next level Move around the image by using arrow keys 8 If multiple patients are examined during one session new file folder is created for each patient by pressing middle key for over 3 seconds 9 Transfer images to a computer after capturing images Images are transfer
22. an 3 characters the remaining characters are defaulted to underscore marks _ The last character of the jpeg filename is reserved for the type of image IR illuminated Normal color N Red free R Color corrected C The middle 4 characters are reserved as a counter for the number of images taken 0000 to 9999 then rolling over to 0000 again For example if John Doe 123 were entered for the patient information as per the above example then the jpeg filename would be JOHxxxxC JPG Page 17 of 51 How Is Patient Information Entered Patient information is entered in the Patient Information screen The Patient Information screen allows setting of which eye will be imaged left or right It also allows access to the Patient Information editing screen The current Patient Information entered will be displayed to the right of the Patient ID icon The default value is ABC12345 e Selecting patient side left or right o Inthe Patient Information entry screen use the arrow keys to navigate to the Patient Side ICON o Select the Patient Side icon using the middle key o Use the left or right arrow keys OR the middle key to toggle between the Left or Right side ICONS o Use the up or down arrow keys to navigate out of the Patient Side setting which saves your selection e Editing the Patient Information o Use the up and down arrows to navigate to the Patient ID icon and select it using the middle key This
23. anually Short Still Video Zoom in Long Power Move AF window On Off Edit capture area Decrease Brightness Move AF window Edit capture area Short Edit focus window Long New patient folder Focus manually Zoom out Move AF window Edit capture area IM 052 Rev D Short AF MF Zoom Long Menu Increase Brightness Move AF window Edit capture area Page 34 of 51 Key Press Function Explanation k ike key pressing left soft key Long Power On Off Camera is powered on and off by pressing the Left soft fos KASAI JAA Right soft key Short Activate Zoom Press Right soft key to activate zoom function Digital zoom can be used for close up of features and image Right soft key focus Icon Z displayed in up right corner of display when active Press Middle key to enter Edit capture area function and move image area to center of the screen than 1s using arrow keys to better capture the wanted area New patient folder If multiple patients are examined during a same session it is recommended to create a new file folder for each Middle key patient s images New folder is created by pressing middle key for 3 seconds Icon P at the top of the screen indicates number of the current patient folder If the current folder does not have any images in it a new folder cannot be created Change brightness Use left and right arrow keys to adjust capture light brightness Aiming light brightness is adjusted in
24. ard backlight By default the camera keys have a backlight lit up when the camera is turned on This light can be turned off from Device menu if it disturbs the user while taking images Language The camera has six different languages the user can choose from Default language is English and the language selection is always shown in English in menu USB write protection USB write protection is recommended to be turned on by user When protection is on this feature will prevent any virus from entering the camera from a computer when connected to the cradle Video file format The camera has two file formats that user can choose for videos MPEG4 and MPEG1 MPEG4 is a higher quality file format but may not be viewed with all video players MPEG1 format is more widely supported by different SW applications Image transfer method There are two options for the image transfer method UMS USB Mass Storage or WIA Windows Image Acquisition IM 052 Rev D Page 15 of 51 Restore factory settings By selecting Activate in Device menu and pressing middle key Restore factory defaults selection the original factory settings will be returned Date Date can be set using the left and right arrow keys Enable editing by using the Middle key Move between day month and year by pressing the middle key Time Time can be set using the left and right arrow keys Enable editing by using the Middle key Move between hours and minutes by pressin
25. be zoomed while previewing by pressing middle key Move around the image by pressing arrow keys Change between the four zoom levels by pressing middle key Resolution of the image preview is rather small Preview is intended only for the quick check that all necessary information is captured and for showing pathologies for the patient It is recommended always to study full resolution pictures on a computer screen New Patient Folder A new patient folder is created by pressing middle key when the New patient folder selection is active in Device menu A new patient folder can also be created by pressing Middle key for 3 seconds when in live view If the current patient folder is empty a new folder cannot be created Erase Image Memory Image memory can be erased by selecting Erase Image Memory in Device menu This selection is activated by pressing middle key The camera also prompts the question Erase image memory when camera is powered on or removed from cradle Display brightness The Display brightness selection has three options low medium and high Choose the suitable level of display brightness according to for example how the examination room is lit up Icons The icons shown on camera screen can be enabled or disabled to the user s liking The most essential icons such as Menu icon are always visible Sounds By default the camera makes a sound during image capture This sound can be turned off from Device menu Keybo
26. cified below The user should ensure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 U7 gt 95 dip in U7 for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in UT for 25 cycles lt 5 U gt 95 dip in U for 5 sec 3 A m Compliance level 2kV 4kV 6 kV indirect contact 2kV 4kV 6 kV contact 2kV 4kV 8 kV air 2 kV for AC power supply 1 kV for serial cable 1kV for AC power supply 1 Phase without Protective Earth Manufacturer s test shows conformance to the requirements of the IEC 61000 4 11 EN 61000 4 11 3 A m Electromagnetic 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 quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a ty
27. d video can be taken with the Pictor VPLHAND camera When taking video the shutter button must be held down while taking the video The video recording will stop once the shutter button is released Focus Window Focus Window help user position the image The Focus Window can be moved on the screen by first pressing Middle key until icon F appears in up right corner of display and then using the arrow keys when aiming Shoot mode Shoot mode function can be used when autofocus is enabled There are two shoot modes to choose from normal and auto In normal mode the camera will focus when shutter button is pressed half way down and take a picture when shutter button is pressed all the way down In auto mode when shutter button is pressed the camera will focus and take a picture automatically Marking side It is possible to mark which eye was imaged Marking side is enabled from the menu When On side is marked to the file name and to the image For video files side is always marked only to the file name When marking side is enabled camera verifies side after each captured image Identifiers used for eye images are OS for left and OD for right Zoom cropping With zoom cropping on the camera will save the zoomed area instead of the whole image area When zoom cropping is turned off then camera will save the whole image area instead of the area that is visible on the camera screen when user has zoomed in Camera stores selected menu
28. ed on the screen by first pressing Middle key until icon F appears in up right corner of display and then using the arrow keys when aiming Shoot mode Shoot mode function can be used when autofocus is enabled There are two shoot modes to choose from normal and auto In normal mode the camera will focus when shutter button is pressed half way down and take a picture when shutter button is pressed all the way down In auto mode when shutter button is pressed the camera will focus and take a picture automatically Zoom cropping With zoom cropping on the camera will save the zoomed area instead of the whole image area When zoom cropping is turned off then camera will save the whole image area instead of the area that is visible on the camera screen when user has zoomed in Camera stores selected menu settings when it is powered off IM 052 Rev D Page 36 of 51 13 Error messages Volk Pictor VPI1HAND will display error messages about the limitations of the usage Error message is always displayed with explanatory message providing information about possible actions Following image is an example of an error message displaying information about recharging the device List of the all possible error messages Error message What to do Optic failure Please detach Restart camera and reconnect optics lens Contact maintenance if lens does not the optic and restart the camera connect Please reattach battery or change Battery i
29. er than 2s Auto Manual Switch between Auto and Manual focus by pressing Right soft focus key Short Activate Zoom Press Right soft key to activate zoom function Digital zoom can Right soft key ugn be used for close up of features and image focus Icon Z pm pan displayed in up right corner of display when active Short Edit focus window When focus window is visible it is possible to move it using arrow keys to better capture the wanted area Middle key current patient folder If the current folder does not have any Long New patient folder If multiple patients are examined during a same session it is recommended to create a new file folder for each patient s images New folder is created by pressing middle key for 3 seconds Icon P at the top of the screen indicates number of the images in it a new folder cannot be created E n Use left and right arrow keys to adjust capture light brightness Aiming light brightness is adjusted in menu Left Right arrow Move AF window Move focus window left and right after pressing Middle key to activate The Window returns to original position when camera is put to cradle turned off or optics module detached Focus manually Use up and down arrows to focus manually Zoom In Out Zoom in using arrow key up Zoom out using arrow key down A AA ESG 1 6 0 activate Zoom value is saved to camera memory IM 052 Rev D Page 32 of 51 Up Down arrow Table below includes explanations o
30. f the DER settings tab for skin imaging Setting Values default bolded Purpose video capture window visible or hidden Shoot mode Normal Auto In Auto mode camera takes picture automatically after focusing In Normal mode user must press shutter button to second position to take picture after focusing Skin body map On Off Mark body part to image and image name Skin Portrait Skin Portrait Select skin when taking close up pictures of skin Select Portrait when taking portrait pictures Zoom cropping On Off When turned on camera will save the zoomed area only When turned off camera will save the whole image area even when zoom is used Capture mode Both still images and video can be taken with the Pictor VP1HAND camera Capture mode can be chosen in OTO menu and when using VP1OTO otoscopic module from left soft key When taking video the shutter button must be held down while taking the video The video recording will stop once the shutter button is released Focus Window Focus Window help user position the image The Focus Window can be moved on the screen by first pressing Middle key until icon F appears in up right corner of display and then using the arrow keys when aiming Shoot mode Shoot mode function can be used when autofocus is enabled There are two shoot modes to choose from normal and auto In normal mode the camera will focus when shutter button is pressed half way down and take a picture when shutte
31. g a same session it is recommended to create a new file folder for each patient s images New folder is created by pressing Middle key middle key for 3 seconds Icon P at the top of the screen indicates number of the current patient folder If the current folder does not have any images in it a new folder cannot be created Change brightness Use left and right arrow keys to adjust capture light Left Right arrow brightness Aiming light brightness is adjusted in menu Focus manually When manual focus is active use up and down arrow keys to focus Press arrow key up when patient has Up Down arrow myopia Press arrow key down when patient has hyperopia Table below includes explanations of the RET settings tab for retinal imaging Setting Values default bolded Purpose video capture In Auto mode camera takes picture automatically after focusing In Normal mode user must press shutter button to second position to take picture after focusing On Off Mark side of the eye to the image data IR brightness Low Med High Use left and right arrow keys to set infrared brightness for VP1RET eye fundus lens Red free On Off Saves a copy of an eye image using green color channel only Can Rees 907 aetcuwrnvrunctopies TOOTEST Save IR image On Off Saves an image taken with IR light in addition to white light image Seen source Aim help On Off When enabled the camera indicates with a red green rectangle if aim on the retina is good enou
32. g the middle key Camera SW version This item in Device menu tells the camera SW version Start guery User can choose start up guery between erasing images creating new patient folder or no guery at all When erasing images is chosen as the guery the camera will prompt user on start up whether all images and videos shall be deleted When new patient folder guery is chosen the camera will ask if a new patient folder shall be created upon start up to prevent from mixing images with previous patient If no guery is selected then camera will go directly to live view upon start up 7 6 Adjusting focus and automatic focus The camera has an autofocus function where camera finds correct focus place automatically Automatic focusing start when shutter is pressed half way down icon at the top right corner of the display shows icon A The focus mode Auto Manual can be changed by pressing right soft key Image focus can be adjusted manually by pressing arrow keys up and down When focus mode is set to manual and VP1RET module is attached a dioptre scale is visible on the screen IM 052 Rev D Page 16 of 51 7 7 Patient Information Editor What Is Patient Information Entry The Pictor Plus has a feature that allows entry and editing of patient information e g patient name ID number or other identifier information e The patientinformation can contain a maximum of 32 characters including letters upper or lower case numbers and so
33. gh for image capturing When Auto is chosen the camera takes image automatically once rectangle turns green aim on retina is good IM 052 Rev D Page 23 of 51 Capture mode Both still images and video can be taken with the Pictor VPLHAND camera When taking video the shutter button must be held down while taking the video The video recording will stop once the shutter button is released Shoot mode Shoot mode function can be used when autofocus is enabled There are two shoot modes to choose from normal and auto In normal mode the camera will focus when shutter button is pressed half way down and take a picture when shutter button is pressed all the way down In auto mode when shutter button is pressed the camera will focus and take a picture automatically Marking side It is possible to mark which eye was imaged Marking side is enabled from the menu When On side is marked to the file name and to the image For video files side is always marked only to the file name When marking side is enabled camera verifies side after each captured image Identifiers used for eye images are OS for left and OD for right IR brightness Infrared illumination brightness has three levels low medium and high Red free If red free image is enabled from menu then camera will save a picture using only green channel at the same time when saving original picture Camera stores selected menu settings when it is powered off Save IR image
34. icon to access the Patient Information entry screen and edit the Patient Information per the above instructions REMEMBER IF YOU ARE EDITING PATIENT INFORMATION FOR A FOLDER ALL OF THE IMAGE FILES IN THAT FOLDER WILL BE CHANGED TO THE NEW PATIENT INFORMATION IF YOU ARE EDITING A SINGLE IMAGE FILE ONLY THAT IMAGE FILE WILL BE CHANGED TO THE NEW PATIENT INFORMATION e From the New patient folder icon you can use the Patient Information entry screen to set Patient Information for images that you are going to take next o Arrow to the New patient folder icon and select with the middle key o The device will prompt Create a new patient folder for new patient images Select Yes left soft key if you also wish to create a new patient folder in which to Save your next images Select No right soft key if you do not want a new patient folder o Next the device will prompt Edit current patient information Select Yes left soft key to enter the Patient Information entry screen e Proceed to edit Patient Information per the above instructions e Your next images will have the new Patient Information Select No right soft key to return to the Device tab without editing Patient Information IM 052 Rev D Page 19 of 51 7 8 Reset button Reset button can be used if device behavior is abnormal this should not happen too often Reset button is located in a small opening under display Button is marked with circle O
35. isible or tilted to the side when using zoom Press Middle key to access Edit capture area function Then you can move the image area to the center of the screen Capture image by pressing shutter button all the way down Still image is captured by pressing the shutter key all the way down Video is captured by keeping shutter down Taken image is displayed on screen until user clears the image by pressing shutter left or right soft key Image can be zoomed in instant preview by pressing middle key There are four zoom levels Pressing middle key activates the next level Move around the image by using arrow keys If multiple patients are examined during one session create a new file folder for each patient by pressing middle key for over 3 seconds When imaging is ready store images on a computer Place camera to the cradle and image transfer starts VPLHAND works as any other digital camera connected to a computer IM 052 Rev D Page 28 of 51 The camera keys function as shown in image below when VP1OTO optics module is attached Focus manually Short Still Video Zoom in Short AF MF Long Power Move AF window Zoom On Off Edit capture area Long Menu Decrease Increase Brightness Brightness Move AF window Move AF window Edit capture area Edit capture area Short Edit focus window Edit capture area Focus manually Long New patient folder Zoom out Move AF window Edit capture area Below table provides ex
36. mage by pressing shutter button all the way down Still image is captured by pressing the shutter key all the way down Video is captured by keeping shutter down Taken image is displayed on screen until user clears the image by pressing shutter left or right soft key Image can be zoomed in instant preview by pressing middle key There are four zoom levels Pressing middle key activates the next level Move around the image by using arrow keys 8 If multiple patients are examined during one session create a new file folder for each patient by pressing middle key for over 3 seconds 9 After taking pictures store images on a computer Place camera to the cradle and image transfer starts VP1HAND works as any other digital camera connected to a computer IM 052 Rev D Page 31 of 51 The camera keys function as shown in image below when VP1DERM optics module is attached Focus manually Zoom in Short Skin Portrait Move AF window Short AF MF Zoom Long Power On Off Long Menu Decrease Increase Brightness Brightness Move AF window Move AF window Short Edit focus window Long New patient Focus manually Zoom out Move AF window Below table provides explanations for the key functions Function Explanation Key Skin Portrait Press left soft key to switch between Skin and Portrait modes When taking an image of the skin close up use Skin mode When Left soft key taking an image of larger area use Portrait mode long
37. me special characters and space e Which patient eye being imaged left or right can also be set e Additionally they type of image saved IR illuminated normal color red free or color corrected is also saved automatically IR illuminated IR Normal color Co Red free RF Color corrected CC Where Is The Patient Information Saved The patient information is saved as part of the jpeg image file in two different locations e Location 1 the Exif data field Exif exchangeable image file format O The Exif data field is embedded inside the jpeg image file It can be accessed using typical EMR software that is set up to read the Exif field or by using Exif viewing software e g Exif Pilot For example if John Doe 123 were entered for the patient information then the Exif field would contain Patient ID John Doe 123 If the Left setting were selected for John Doe then the Exif field would also contain Side Left If the particular image for John Doe were a color corrected image then the Exif field would also contain Image type CC The entire Exif data field would be Patient ID John Doe 123 Side Left lmage type CC e Location 2 the jpeg filename O O IM 052 Rev D The jpeg filename has 8 characters with a jpg extension The first 3 characters of the jpeg filename are reserved for the first 3 characters of the patient information If the Patient Information is shorter th
38. menu Move AF window Move focus window left and right after pressing Middle Left Right arrow E ai key to activate The Window returns to original position when camera is put to cradle turned off or optics module detached EE Focus manually Use up and down arrows to focus manually KA kai In Out Zoom in using arrow key up Zoom out using arrow key Up Down arrow down There are four zoom levels 1 2 4 and 6 po AF window Move focus window left and right after pressing Middle key to activate Table below includes explanations of the DF settings tab for general imaging Setting Values default bolded Purpose video capture window visible or hidden Shoot mode Normal Auto In Auto mode camera takes picture automatically after focusing In Normal mode user must press shutter button to second position to take picture after focusing Zoom cropping On Off When turned on camera will save the zoomed area only When turned off camera will save the whole image area even when zoom is used IM 052 Rev D Page 35 of 51 Capture mode Both still images and video can be taken with the Pictor VP1HAND camera Capture mode can be chosen in OTO menu and when using VP1OTO otoscopic module from left soft key When taking video the shutter button must be held down while taking the video The video recording will stop once the shutter button is released Focus Window Focus Window help user position the image The Focus Window can be mov
39. of the area that is visible on the camera screen when user has zoomed in Camera stores selected menu settings when it is powered off IM 052 Rev D Page 30 of 51 11 Skin Imaging using dermatoscopic optics module VP1HAND and VP1DERM With attachable skin optics module VP1DERM camera can be used for storing digital images and video of the Skin Steps for capturing skin images are 1 Attach skin optics module Press firmly until you hear a clicking sound to make module connect properly 2 Press module gently to the skin You may use immersion fluids such as aqueous disinfectant 3 Adjust illumination by using left and right arrow keys 4 Adjust focus if needed by pressing arrow keys up and down It is recommended to use autofocus Automatic focusing starts when shutter is pressed half way down If pressing shutter does not activate automatic focusing autofocus needs to be activated from right soft key 5 Use digital zoom for close up of features if needed press right soft key to activate Zoom upper right corner shows Z and arrow key up or down to adjust zoom There are four zoom levels 1 2 4 and 6 Press right soft key to re activate focus if needed Zoom value is saved to camera memory 6 Activate portrait mode by pressing left soft key when taking an image of a larger area such as head whole arm or the whole body The icon on the bottom left corner of screen now says Portrait instead of Skin 7 Capture i
40. omagnetic 4 3 site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which Pictor is used exceeds the applicable RF compliance level above the Model 006 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating Pictor Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m IM 052 Rev D Page 47 of 51 Manufacturer s declaration electromagnetic emissions Pictor is intended for use in the electromagnetic environment specified below The user should ensure that it is used in such an environment Emissions test Compliance level Electromagnetic environment guidance Pictor
41. onnected only to the USB port of a computer that complies with the IEC 60950 standard Avoid using excessive power or twisting the connector when connecting the USB cord to a computer Place computer and cradle outside the patient environment at least 4 feet distance from the patient To transfer patient image data the device must be used together with a computer The device does not need any drivers to be installed on a computer Device can be used with all major patient database application supporting both textual and image data recording The device must be used according to this manual guick reference guide and or information found on the Volk com website Electromagnetic compatibility information and recommended separation distances between portable and mobile RF communications eguipment and Pictor are given in the Appendix A IM 052 Rev D Page 11 of 51 7 Operating instructions This chapter gives instructions for using the device More specific instructions for using modules are given in the modules chapters 7 1 Preparations Pictor is both charged and connected to a computer using the provided cradle When Pictor is not use it may be stored in the cradle Storing device in the cradle is not harmful for the battery because the battery is charged only when the charge drops below a certain limit To connect Pictor to the cradle gently connect it to the connector hole The device can be connected to the cradle
42. onthis product indicates it has been tested and conforms to the provisions noted within the 93 42 EEC Medical Device Directive CE mark with notified body identification number indicates a class lla product Read accompanying user documentation indicates that important operating instructions are included in this User s and Maintenance Manual Failure to follow these instructions could place the patient or operator at risk Type BF applied parts Applied part is a part of Pictor that in normal use necessarily comes into physical contact with the patient Charger polarity symbol voltage and power Sticker at the front of the device indicating integrated general imaging optics focal length and F number IM 052 Rev D Page 8 of 51 5 Parts ofthe device Connector Cradle SYSTEM CONNEC TOR IM 052 Rev D Dual Action Shutter Bayonet Hole Left Soft Key Battery Cover Opening E TAM System Connector C PICTOR VPCRADLE Volk Optical 7883 Enterprise Dr Mantor OH 44060 USA Left Right Connection Page 9 of 51 Soft key indicators Position Indicator Purpose To power on the device Left soft key To power off the device with long press Open menu with long press Right soft key LED indicators The recharging and connection to the computer is indicated with green charging and blue connection LED lights Position Indicator Purpose Left LED indica
43. p One click of the key is approximately 2 Dioptres e Myopia camera is focused closer by pressing arrow key down One click of the key is approximately 2 Dioptres 4 Ophthalmoscope aiming light is turned on by pressing the shutter key in front of the device half way down or by pressing the left soft key 5 Light is adjusted using left and right arrow key There are altogether 10 brightness levels Default value is 5 Suitable illumination is typically 2 to 8 Infrared used for targeting can be adjusted from menu Usually there is no need to adjust infrared 6 Approaching the eye is started from 4 inches 10 centimeters distance Patient is asked to look at a target on a wall 6 9 feet 2 3 meters behind the operator patient s eye targets to infinity and stays still Pupil is approached until the reflection from the eye fundus can be seen The right imaging distance is about 0 8 inch 2 cm Silicone support must be compressed approximately half way down IM 052 Rev D Page 21 of 51 Camera is stabilised by keeping the outer side of the hand against the patient s forehead Example of the correct usage position is shown below 14 sas gt i 1 A 7 Still image is captured by pressing the shutter key all the way down Video is captured by keeping shutter down Taken image is displayed on screen until user clears the image by pressing shutter left or right soft key Image can be zoomed in instant preview by pressing middle
44. pical commercial or hospital environment If the user of Pictor requires continued operation during power mains interruptions it is recommended that Pictor be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level IM 052 Rev D Page 46 of 51 Guidance and manufacturer s declaration electromagnetic immunity Pictor is intended for use in the electromagnetic environment specified below The user should ensure that it is used in such an environment Immunity IEC 60601 Compliance test test level level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of Pictor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted Sae RF d 1 2 P 150 kHz to IEC 61000 4 6 80 MHz d 1 2 P 80 MHz to 800 MHz d 2 3 WF 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation Radiated distance in metres m RF IEC 61000 Field strengths from fixed RF transmitters as determined by an electr
45. planations for the key functions Press Function Explanation Key Still Video Choose between still image and video shooting by pressing left soft key Left soft key Long Power On Off Camera is powered on and off by pressing the Left soft key for longer than 2s Short Auto Manual Switch between Auto and Manual focus by pressing Right soft key focus Short Activate Zoom Press Right soft key to activate zoom function Digital zoom can be used Right soft key pear de for close up of features and image focus Icon Z displayed in up right corner of display when active Enter camera menu by pressing Right soft key for longer than 1s Edit focus When focus window is visible it is possible to move it using arrow keys to window better capture the wanted area Short Edit capture area Due to differences between specula the image area can be tilted to the side of the screen when using small specula Press Middle key to enter Edit capture area function and move image area to center of the screen New patient If multiple patients are examined during a same session it is folder recommended to create a new file folder for each patient s images New folder is created by pressing middle key for 3 seconds Icon P at the top of the screen indicates number of the current patient folder If the current folder does not have any images in it a new folder cannot be created Use left and right arrow keys to adjust capture light brightne
46. r button is pressed all the way down In auto mode when shutter button is pressed the camera will focus and take a picture automatically Skin body map Skin body mapping can be used when taking dermatoscopic images to mark on the image and image name the body part which was imaged Camera will display options of body parts after an image is captured Choose the correct body part by using arrow keys and soft keys Skin Portrait This feature allows taking images from close up and from further away with the skin module To take a close up image choose Skin mode this is on by default To take an image of larger area such as the head choose Portrait Zoom cropping With zoom cropping on the camera will save the zoomed area instead of the whole image area When zoom cropping is turned off then camera will save the whole image area instead of the area that is visible on the camera screen when user has zoomed in Camera stores selected menu settings when it is powered off IM 052 Rev D Page 33 of 51 12 General imaging without optics module It is possible to take pictures using Pictor VPI1HAND without any optics module When taking images without additional optics integration time that corresponds to the brightness of the image is adjusted using left and right arrow key Indicator for integration time is shown at the bottom of the display Below picture shows the functions of camera keys when no optics is attached Focus m
47. red to the computer when camera is placed to the cradle VP1HAND works as any other digital camera 10 When camera is removed from the cradle it verifies image data storage erase It is recommended that image data storage is always erased before images are captured of a new patient IM 052 Rev D Page 25 of 51 The camera keys function as shown in image below when VP1ANT optics module is attached Focus manually Zoom in Short White Blue Move AF window Short AF MF Zoom Long Power On Off Long Menu Decrease Brightness Move AF window Increase Brightness Move AF window Short Edit focus window Long New patient folder Focus manually Zoom out Move AF window Below table provides explanations for the key functions Key Left soft key Right soft key Middle key Left Right arrow Up Down arrow IM 052 Rev D Press Function Explanation Short White Blue Choose between white and blue illumination by pressing left soft key Blue light can be used with fluorescent applied on the eye to reveal any cuts or defects longer than 2s key Short Activate Zoom Press Right soft key to activate zoom function Digital zoom can be used for close up of features and image focus Icon Z displayed in up right corner of display when active Zoom value is saved to camera memory arrow keys to better capture the wanted area New patient folder If multiple patients are examined during a same session it is
48. rmed by pressing the Middle key Table below includes explanations of the Device settings tab Setting Values default bolded Purpose To preview the images on camera press Ok also be created in live view by long pressing the middle key On Off Show graphical icons when imaging On Off When enabled sound is played during image capture Keyboard backlight On Off When enabled keyboard illumination is on POR SPA USB write protection On Off When enabled writing to SD card is not allowed when device is in cradle This feature helps prevent any viruses getting from the computer to the camera Image transfer method UMS WIA Use WIA for automatic and UMS for end user activated image olite Restore factory Setting Ok To restore all settings menus to factory defaults Activate using teese a RRO OO Aaa ens next field Time HH MM Use left and right arrow keys to set time Use Middle key to select next field Show camera SW version Browse version information with left and right arrow key Start query Era Fol None Choose the startup query between memory erase new patient folder or no query at all Set Data Cable Type CRA SLI Feature Not yet Available Remote Trigger On Off Feature Not yet Available IM 052 Rev D Page 14 of 51 Preview images Image preview is opened by selecting Preview files with a middle key Images are browsed by using arrow keys Display gives information about usage of the image preview Image can
49. s either not well in place or has been damaged Try to reattach battery or Optics error detected IM 052 Rev D Page 37 of 51 14 Cleaning instructions Pictor is a precision optical instrument that should be handled with care Please note following cleaning instructions e Shut down device before cleaning it e Remove cradle from mains before cleaning it e Disinfect housing with soft cloth moistened with alcohol Avoid touching system connectors in the handset and cradle e If acetone based products are used wait for cleaning agent to dissolve before starting up the device or connecting cradle to the mains e Lenses may be cleaned with cleaning cloth Pictor is not intended to be sterilized Clean optics and silicon support before each use on a new patient e Disinfect silicon support with soft cloth moistened with alcohol 70 ethyl alcohol or e Soak silicon support in glutaraldehyde based solution If replacement for silicon support is needed please contact Volk or authorized Volk distributor Clean dermatoscope glass before each use on a new patient e Disinfect glass with soft cloth moistened with alcohol 70 ethyl alcohol or e Remove glass and soak it in glutaraldehyde based solution If replacement for the dermatoscope glass is needed please contact Volk or authorized Volk distributor IM 052 Rev D Page 38 of 51 15 Device maintenance Pictor contains rechargeable Ni MH battery pack Service life of the batter
50. ss Aiming light brightness is adjusted in menu Move focus window left and right after pressing Middle key to activate The Window returns to original position when camera is put to cradle turned off or optics module detached Edit capture area Use left and right arrow keys to adjust capture area to center of screen after activating with Middle key Focus manually Use up and down arrows to focus manually Up Down arrow Middle key Left Right arrow Move AF window Move focus window left and right after pressing Middle key to activate Edit capture area Use up and down arrow keys to adjust capture area to center of screen after activating with Middle key Zoom In Out Zoom in using arrow key up Zoom out using arrow key down There are four zoom levels 1 2 4 and 6 Zoom value is saved to camera memory Table below includes explanations of the OT settings tab for ear imaging IM 052 Rev D Page 29 of 51 setting 007090 ENEB Values defaultbolded bolded Purpose 00909000 video capture window visible or hidden Shoot mode Normal Auto In Auto mode camera takes picture automatically after focusing In Normal mode user must press shutter button to second position to take picture after focusing On Off Mark side of the ear to the image data Zoom cropping On Off When turned on camera will save the zoomed area only When turned off camera will save the whole image area even when zoom is used Capture mode Both
51. tomatically presents an option to Edit current patient information in the startup screen o Select Yes left soft button to proceed to the Patient Information entry screen o Select No right soft button to proceed to the live view screen e This will set the Patient Information for the next images taken IM 052 Rev D Page 18 of 51 When in the camera live view screen using the Menu button right soft key long press e Use the right soft key long press to access the Menu screen e Under the Device tab the Patient Information entry screen can be accessed from either the Preview images icon or the New patient folder icon e From the Preview images icon you can use the Patient Information entry screen to edit Patient Information on images you have already taken You can edit Patient Information for ALL of the images in a selected folder OR You can edit Patient Information for a single selected image file o Arrow to the Preview images icon and select with the middle key to access the Image Browser screen o Inthe Image Browser screen use the arrow keys to navigate to a specific folder or a specific image file When only a folder is selected the folder name will be highlighted with white text the filenames will be dark When an image file is selected that filename AND its folder name will be highlighted with white text o When your selected folder or image file is highlighted press the right soft key under the Edit
52. tor Green Active when device is powered on Right LED indicator Blue eo Active when devices is placed to the cradle and connected to a computer Graphical indicators These indicators are displayed on the top row of the display during imaging Optics A Autofocus RET Posterior M Manual focus ANT External mics Z Zoom Stil DER Dermascopic attery ve fdi E f s A ika ga Patient 1 A Time C Edit capture area DF no lens fe Z I Zoom indicator Pi Diopter compensation This indicator indicator in manual changes with focus mode when using optics modules RET according to left optics attached Brightness indicator Autofocus soft key Light ON Aiming lighton 10 steps Manual focus function Light OFF Aiming light off Zoom Light ON st IM 052 Rev D Page 10 of 51 6 Usage environment reguirements Pictor is designed for use in a medical environment CAUTION Pictor is not suitable for use in the presence of flammable anaesthetics Pictor is intended to be use inside in a normal room temperature and normal humidity Do not use Pictor in an environment where there is possibility that water condenses to or inside Pictor The type of power source is indicated in Chapter 15 Technical description CAUTION It is only allowed to attach USB cable and Power source provided into the cradle If you need replacement to the USB cable or Power source please contact Volk USB Cable must be c
53. y is approximately 1 2 years When battery is at end ofits service life usage time of the device goes down Appendix B gives instructions for battery replacement There are no other maintenance procedures that can be carried out by the user All servicing and repairs other than replacing the battery must be carried out by Volk or Volk certified service facilities and service personnel Volk will make available work instructions to repair those parts of medical electrical eguipment that Volk has designated as repairable by service personnel CAUTION No modification of this eguipment is allowed CLASS 1 LASER PRODUCT Caution Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure CAUTION If there are breaks in the device covers or other visual defects contact Volk or authorized Volk distributor IM 052 Rev D Page 39 of 51 16 Technical description CAMERA Type Image sensor Image memory type Display Image format Video format Connectivity Operating systems Dimensions Weight Battery Usage time CHARGING CRADLE Type Dimensions Weight Pictor Handset VPLHAND CMOS 5 0 Megapixels 1 2 GB micro SD card 2 4 TFT LCD 262 000 million colors antireflective coating JPEG file extension jpg MPEG 4 and MPEG 1 Computer with USB port No driver installation needed 82 30 w x 166 50 h x 66 5
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