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Smartscope M5 manual

1. Power on your camera 8 Take some images and wait for the images to transfer Take photos with your Mobi card Looking for card Connecting to card Waiting for transfer Cancel 9 Select Done 10 Set up is completed and Wi Fi transfer is enabled to your computer IE Activate Eyefi Mobi ca Take photos with your Mobi card Card found Connected Activation complete Page 57 of 58 Problem solving A Computer cannot connect to Smartscope Verify that your computer s Wi Fi is enabled Instructions can be found from your Operating system help Select Back and select Next again Take more images Wait for images to transfer gt Activate Eyefi Mobi carc Take photos with your Mobi card eyefi Looking for card Connecting to card Waiting for transfer Can t find Mobi card 1 Make sure your Eyefi Mobi card is in your camera with the power on 2 Move your camera closer to your computer 3 Adjust your camera s power settings See instructions 4 Still not working Please visit Eyefi Customer Care B Computer is connected to camera but images don t transfer Goto your computers Network and Sharing Center Verify that Network type is Work instead of Public Change Network type by clicking blue Public Network text Page 58 of 58
2. side is always marked only to the file name When marking side is enabled camera verifies side after each captured image Identifiers used for normal eye images are OS for left and OD for right Identifiers used for red free images are SG for left and DG for right Identifiers used for save IR images are SI for left and DI for right Identifiers used for color corrected images are SC for left and DC for right Zoom cropping With zoom cropping on the camera will save the zoomed area instead of the whole image area By default zoom cropping is turned off and camera will save the whole image area instead of the area that is visible on the camera screen when user has zoomed in Instant review Instant review can be ON OFF according to user need as available in ES Optics menu When the reviewing zoom level is 1x user can change the image to be reviewed with left and right arrow keys Images are in showing order Normal Low red Red free IR NOTE Camera stores selected menu settings when it is powered off Page 28 of 58 10 Ear imaging using otoscopic lens Smartscope OT1 Optomed Smartscope OT1 digital otoscopic module is intended to capture digital images and video of the ear canal and tympanic membrane Device set for otoscopic imaging consists of e Camera handset M5 e Attachable otoscopic lens OT1 e Otoscopic specula e Air pump Otoscope can be used with widely available type beta Heine allspec speculas Step
3. ES settings tab for anterior eye imaging Setting Values default bolded Purpose Capture mode Still Video Use left and right arrow keys to choose between still capture and video capture Half press capture On Off Enable capture by pressing shutter button half way Focus windows Visible Hidden Use left and right arrow keys to choose between having focus window visible or hidden Mark side 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 Instant Review On Off Instant review can be ON OFF according to user need as available in ES Optics menu Instant review image can be changed from left and right arrow keys Page 27 of 58 Capture mode Both still images and video can be taken with the Smartscope M5 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 Half press capture It is possible to take images and video by pressing shutter button half way Focus Window Focus Window helps user position the image Focus Window can be moved on the screen by using Left soft key and then using the arrow keys when aiming 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
4. Ene d EA RO RUE Ud EUR TEA DD d a ena Cox ad eu eR 41 16 Technical descriptor zai doen iro eru e Nee kk oe de pd Er Tu SENE deo pce md e p eru EE RES 42 LA Waray asssnosisstei iesus es UD eh RD dE AR edi esa usse ME RP dn METER 48 Appendixes Appendix A Electromagnetic compatibility information Appendix B Battery replacement Appendix C WIFI installation guide Page 4 of 58 1 Indications for use Smartscope M5 is a medical digital camera that is used with dedicated optics lens intended to take images of the eye fundus surface of the eye ear canal and tympanic membrane and skin Supported optics lenses and their intended uses are Description Smartscope EY3 Optomed Smartscope M5 digital camera with EY3 optics module is intended to capture digital images and video of the fundus of the human eye Smartscope ES2 amp ES1 Optomed Smartscope M5 digital camera with ES2 amp ES1 optics module is intended to capture images and video of the surface of the human eye and surrounding areas Smartscope SK1 Optomed Smartscope M5 digital camera with SK1 optics module is intended to capture images and video of the surface of the human skin Smartscope OT1 Optomed Smartscope M5 digital camera with OT1 optics module is intended to capture images and video of the human ear Page 5 of 58 2 Contraindications for use of the eye optics module EY3 and ES2 Because prolonged intense light exposure can damage the retina the use of the devi
5. MB of free disk space and a minimum 2GB of RAM Previous versions of Eye Fi desktop software must be removed before installing the Mobile Desktop Transfer Page 53 of 58 Installation 1 Install Eyefi Mobi Desktop Transfer for Windows from USB memory stick provided by Optomed Oy 2 Runsetup 1 1 ENU exe Enclosed pop up window will open 3 Select Next Transfer InstallShield Wizar Welcome to the Installshield Wizard for Eyefi Mobi Desktop Transfer The Install5hield R Wizard will install Eyefi Mobi Desktop Transfer on your computer To continue click Next 4 Accept license agreement 5 Select Next License Agreement Please read the following license agreement carefully Eye Fi End User License Agreement and Terms of Service This Eye Fi End User License Agreement and Terms of Service the Agreement is made between you the end user of the Eye Fi software and services described herein and Eye Fi Inc a California corporation with its principal place of business at 967 North Shoreline Blvd Mountain View CA 94043 Eye Fi we or us You agree that this Agreement is legally binding upon you and equivalent to any written negotiated agreement signed by you Your use of any software product including any mobile application provided by Eye Fi to you and any accompanying services provided by Eye Fi to you is subject to the terms of this Agreement Certain _ features maw he enhierct to additinnal ouid
6. a 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 theoretically 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 the Smartscope M5 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 the Smartscope M5 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 50 of 58 Manufacturer s declaration electromagnetic emissions SMARTSCOPE M5 is intended for use in the electromagnetic environment specified below The customer or the user of the Smartscope M5 should assure that it is used in such an environment Emissionstest Compliance level Electromagnetic environment guidance M5 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 equipment RF emissions CISPR 11 RF emissions Harmonic emissions IEC Not applicable 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 M5 is suitable for use in all esta
7. information usage can be enabled disabled There can be maximum 500 patients on the list Name of the patient is shown in low right hand side above right soft key if current folder is linked to a patient 7 6 1 Adding new patient User can add new patient from Device menu by selecting Edit Patient list User can add Patient ID and Patient name after choosing New patient New patient can be added also after creating new folder 7 6 2 Patient folder linking User can link or unlink patient to from current folder not earlier ones It is possible to link 5 folders to each patient Linking can be done 1 Answering yes when powering on or lifting device from cradle 2 Selecting erasing image memory from menu 3 Choosing Link in image browser when folders and files are visible Link key is grey and unresponsive if current folder is not chosen After folder is linked to a patient folder is named by the patient 4 Creating new folder by long pressing middle key or from menu Linking can be done 1 Choosing Link in image browser when folders and files are visible Link key is grey and unresponsive if current folder is not chosen NOTE Exiting from image browser is done by pressing left key 7 6 3 Patient list exporting User can export patient list via WIFI New file is created containing patient list with 16 kBytes of padding bytes added to the end of file File is named pehhmmss jpg hh is current hours mm minutes and ss
8. normal humidity Do not use Smartscope in an environment where there is possibility that water condenses to or inside the Smartscope Type of the power source is indicated in Chapter 16 Technical description CAUTION It is only allowed to attach USB cable and Power source provided in the sales package into the cradle If you need replacement to the USB cable or Power source please contact Manufacturer or your own Retailer USB Cable must be connected only to the USB port of a PC computer that complies with the IEC 60950 standard Avoid using excessive power or twisting the connector when connecting the USB cord to a PC To transfer patient image data the device must be used together with a PC Personal Computer running either Microsoft Window Vista Windows 79 and Windows 8 The device does not need any drivers to be installed on a PC Optomed recommends to use the memory card which is supplied with the device In case device has WIFI functionality memory card is permanently installed Writing to the memory card from PC is not enabled by default Device shall be used according to this manual quick reference guide and or information found on Optomed website www optomed com Electromagnetic compatibility information and recommended separation distances between portable and mobile RF communications equipment and the Optomed Smartscope are given in the Appendix A Page 12 of 58 7 Operating instructions This chapter g
9. on by default Autofocus range is Right soft key 11 to 3 diopters longer than 1s 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 Middle key 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 Left Right arrow 7 Change brightness Use left and right arrow keys to adjust capture light 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 i P j myopia Press arrow key down when patient has hyperopia Table below includes explanations of the EY settings tab for retinal imaging Setting Values default bolded Purpose Capture mode Still Video Use left and right arrow keys to move between still capture and video capture Page 22 of 58 On Off Mark side of the eye to the image data IR brightness Low High Aiming light brightness Red free On Off Saves a copy of an eye image using green color channel e rn image when turned on image Half press capture On Off Enable capture by pressing shutter button half way Illumination mode IR Wh IR IR Wh Wh Use left and right arrow keys to select aiming and capt
10. products as unsorted municipal waste Prepare Optomed Smartscope products 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 Optomed Oy or your local retailer Page 46 of 58 CONTACT For after sales services please contact your local distributor If you need to contact Optomed Oy additional information can be obtained Optomed Oy Customer Service number 358 20 741 3380 Optomed Oy Customer Service email service optomed com Latest version of User Manual can be found www optomed com Page 47 of 58 17 Warranty Optomed Oy 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 be submitted in writing before the end of warranty period to Optomed Oy The claim must include a written description of the failure that the device have 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 caus
11. s declaration electromagnetic immunity The Smartscope M5 is intended for use in the electromagnetic environment specified below The customer or the user of the Smartscope M5 should assure 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 the Smartscope M5 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted gate RF d 1 2VP 150 kHz IEC 61000 g0 MHz d 1 2 P 80 MHz to 800 MHz d 2 3 P800 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 distance in metres m Radiated 3 V m RF Field strengths from fixed RF transmitters as determined by an 80 MHz to T IEC 61000 electromagnetic site survey a should be less than the compliance level 2 5 GHz 4 3 in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol R 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
12. 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 If half press capture is enabled still image can be captured by pressing shutter button half way Taken image is displayed on screen until user clears the image by pressing shutter button left or right soft key Instant review can be enabled disabled in the Smartscope ES1 ES2 optics menu Page 25 of 58 8 Image can be zoomed in instant preview by pressing middle key There are four zoom levels 1 2 4 8 Pressing middle key activates the next level Move around the image by using arrow keys Scroll between images by using left and right arrow keys 9 Video is captured by keeping shutter button down If half press capture is enabled video image can be captured by pressing shutter button half way Video capturing is finished by pressing shutter button all the way down 10 If multiple patients are examined during one session new file folder is created for each patient by pressi
13. 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 By default zoom cropping is on and camera will save visible area on the camera screen Instant review Instant review can be ON OFF according to user need as available in EY Optics menu When the reviewing zoom level is 1x user can change the image to be reviewed with left and right arrow keys Images are in showing order Normal Low red Red free IR Camera stores selected menu settings when it is powered off Page 36 of 58 12 General imaging without optics module It is possible to take pictures using Smartscope M5 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 manually Zoom in Move focus window Short Zoom Focus window Short Auto Manual Long Power On Off Long Menu Decrease Brightness Increase brightness Move focus window Move focus window Short Video Still Long New patient folder Focus manually Zoom out Move focus window Table below provides explanations for the key functions Press Funct
14. used with Optomed Smartscope M5 must include text SMARTSCOPE It is not allowed to attach other objects to the bayonet connector Optics is attached by placing it in front of the bayonet area of the device Three bayonet legs are placed on the holes and optics is pressed firmly to the device BAYONET LEGS BAYONET __HOLES Optics is released by sliding release button that is located in front of the device above the dual action shutter Page 14 of 58 OPTICS RELEASE BUTTON 7 5 Device Menu Menu is opened by pressing right soft key XX for 1s Device EY FA ES OT sk DF W Start study Menu has seven tabs settings page One is for device settings such as language selection There is one tab for Mark side retinal imaging EY fundus angiogram imaging FA anterior eye imaging ES ear imaging OT skin imaging IR brightness High SK and general imaging DF select settings page with left and right arrow keys Arrow keys are used to move between tabs use arrow key up until tab is active and use left and right arrow keys to an e change active tab Light blue color indicates active tab 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 confirmed by pressing the Middle key Table below includes explanations of the Device settings t
15. PC Connect power unit to the wall plug mains Place Optomed Smartscope M5 to the cradle Battery starts to 22 12 Ed charge Charge battery for four hours before the first use When device is not used it may be stored in the Cradle A A Guideline for placing the camera to the cradle Camera will fit to the cradle when it s hold straight while placing it Excessive force shall be avoided in order to prevent the camera and cradle connectors form breaking Guideline for battery and device storage If battery is stored out of the camera for longer period of time ensure that battery is fully charged before storage During storage battery shall be re charged occasionally e g every 3 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 Page 3 of 58 Table of contents ese 5 rs I gia lt 8 e sees erento AE I UU e Pm 3 Fable OF COH tents scit ota EET Eten era TO Bett t a ec eres 4 1 JnaicatioHs TOF USB acea is pedidos tiit endetan Mun das endi cuentas edet eroe dtu ee eee 5 2 Contraindications for use of the eye optics module EY3 and ES2 eeseeeeee 6 3 Warnings and CUON S cst oxa ion uto Dv i Cn evan a rudis qu d cesi Land ete Kor cruel 7 d WV ONS IG subs asmmeietouav ON acae ac awe coat ee PIU IM OE 8 5 PALS Ol LING CO VICE eL 9 6 Usage environment requiremieliES fa
16. SMARTSC PE USER S MANUAL Optomed Smartscope M5 Medical Camera Optomed SMARTSCOPE is manufactured by Optomed Oy Place of Business Optomed Oy Hallituskatu 13 17 D FI 90100 Oulu Finland Manual version Rev 3 0 SW 3 2 Date 2015 03 27 CE Page 1 of 58 This manual describes guidelines for the following modules Smartscope M5 camera with optics lenses and accessories Model Description Accessories Smartscope EY3 module for retinal imaging eye cup quick user guide Smartscope ES1 ES2 module for anterior ophthalmic imaging MEME Smartscope SK1 module for dermatoscopic imaging m air pump Power unit If not all optics modules were purchased then the sales case does not include them or the accessories related to that optics module In addition the sales case includes Batteries 2 pcs Cleaning cloth User manual USB memory stick Includes training material WIFI SW amp guide and Workstation SW amp guide The following accessories can be purchased separately Optomed Slit Lamp Adapter that enables the camera to be used as stationary imaging tool Page 2 of 58 Quick start guide WHAT TO DO BEFORE THE FIRST USE 1 Remove Optomed Smartscope M5 from the sales package and check that all parts are undamaged 2 Install Battery as instructed in the Appendix B last page of this manual Place Cradle on a desk next to the PC Personal Computer Connect the other end of the USB cable to the
17. ab Setting Values default bolded Purpose LCD e HENENNNEEN To preview the images on camera press middle button New patient folder To create a new patient folder press middle button New patient folder can also be created in live view by long pressing the middle key Erase image memory Ok Select middle button to erase images and videos from camera SD card Edit patient list Press middle key to edit patient list On Off Enable or disable patient information linking Display brightness Low Med High Use left and right arrow keys to adjust display brightness 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 Select language ENG FIN FRA GER ITA Use left and right arrow keys to select camera language JPN POR SPA ZHO Page 15 of 58 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 PC to the camera Note that if device contains WIFI card during its setup or updating of its firmware USB write protection need to be temporarily set off Video file format MPEG4 MPEG1 Use left and right arrow keys to select video file format Image transfer UMS WIA Use WIA for automatic and UMS for end user activated method image transfer UMS can be used in most cases DD MM YYYY Use up and down arrow keys to set date HH MM Use u
18. attery is at end of its 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 Optomed or Optomed certified service facilities and service personnel Optomed Oy will make available work instructions to repair those parts of medical electrical equipment that Optomed Oy has designated as repairable by service personnel CAUTION If there are breaks in the device covers or other visual defects contact Optomed Customer Service or Optomed certified service facility Page 41 of 58 16 Technical description CAMERA Type OPTOMED SMARTSCOPE M5 Image sensor CMOS 5 0 Megapixels Image memory type 2 GB micro SD card or WIFI SDHC card Display 2 4 TFT LCD 262 000 colors antireflective coating Image format JPEG file extension jpg Video format MPEG 4 and MPEG 1 Connectivity PC with USB port Operating systems Windows XP Windows Vista Windows 7 Windows 8 No driver installation needed Dimensions 82 30 w x166 50 h x 66 50 d mm Weight 400 g Battery Rechargeable Ni MH Cylinder cell HRAU 700 AAA 4 8 V 1 0 Ah User can change battery Batteries provided by Optomed Usage time 1h 30min with full battery CHARGING CRADLE Type OPTOMED SMARTSCOPE CRADLE V1 Dimensions 170 w x 35 h x 150 d mm W
19. blishments 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 Optomed Smartscope M5 Optomed Smartscope M5 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of Optomed Smartscope M5 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and Optomed Smartscope M5 as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter ES distance according to frequency of transmitter W Ei kHz to 80 MHz 150 kHz to 80 MHz 800 MHz to 2 5 GHz d 1 2 MEN d 1 d 2 EB 902 O02 02 a l a La LLL 23 12 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 transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propaga
20. c cacsescasinseiaccduisedexsasalveceassanecinsetVansedeecarnasalvetanierweanmataciens 12 Je Operatie INS EVICTIONS ioi a a ule du bus a d iustos nda a e cu Np taut 13 Tod PrEP AON S RETE LT EPA 13 72e SCOMMECUON LO ae mr M E 13 7 3 Basic use starting up shutting down and taking an image eere 13 7 4 Attaching and detaching optics MOCUIE ccccccesscccessececesececeececeeseeeeeseceeseecesseeeseees 14 ra MERI iia ER I m 15 7 6 Adjusting FOCUS and automatic focus ccccccesececessccceenececeececeeececseseecsuecessueceseueetsees 19 Zl ResebtbUbtOD esses tate tin tebiu d Endo tus edoctus e oan eae acidum itai quss aua eet hari 19 8 Retinal imaging using optics module EY3 ecccccssecccessceceeseceeeeececeeeceseuseeeeeeceseecesseeeeees 20 9 Eye imaging using anterior ophthalmic module Smartscope ES1 ES2 eese 25 10 Ear imaging using otoscopic lens Smartscope OT1 seeeseeeeeennem eene 29 11 Skin Imaging using dermatoscopic optics module SK1 eeeeeeeenne 33 12 General imaging without optics module sees 37 13 MENTO TNS SS AOS accession cadence wn ea antis eade apo bb wnciecsesni ws en iO sei esto nema tea tutta E toda a t tabs 39 14 Cleaning IstP ctlOfiS eisdem cal sa de en etes dts de dad De eee led eee alas doe i aa Suds Db et 40 15 DEVICE malntenalle B rase oo
21. ce for ocular examination should not be unnecessarily prolonged and the brightness setting should not exceed what is needed 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 Smartscope EY3 and ES2 are classified as Class 2 based on standard 1S015004 2 2007 The daily usage time and maximum allowed number of pulses is calculated based on optical classification results according to standard IS015004 2 2007 CAUTION The light emitted from this instrument is potentially hazardous The longer the duration of exposure and the greater the number of pulses the greater the risk of ocular damage Exposure to light from this instrument when op
22. choose between still capture and video capture Half press capture On Off Enable capture by pressing shutter button half way Focus window Visible Hidden Use left and right arrow keys to choose between having focus window visible or hidden Zoom cropping On Off When turned on camera will save the zoomed area only When turned on camera will save the whole image area even when zoom is used Instant Review On Off Instant review can be ON OFF according to user need as available in EY Optics menu Instant review image can be changed from left and right arrow keys Capture mode Both still images and video can be taken with Smartscope M5 camera Capture mode can be chosen in DF menu Shutter button must be held down while taking the video Video recording will stop once shutter button is released Half press capture It is possible to take images and video by pressing shutter button half way Focus Window Focus Window helps user position the image Focus Window can be moved on the screen by first pressing left soft key and then using the arrow keys when aiming Zoom cropping By default zoom cropping is on and camera will save the zoomed area instead of the whole image area When zoom cropping is off camera will save the whole image area Instant review Instant review can be ON OFF according to user need as available in EY Optics menu When the reviewing zoom level is 1x user can change the image to be reviewed with left and right arr
23. companying 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 Smartscope 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 Optomed s address integrated general imaging optics focal length and F number WARNING Indicates a hazardous situation which could result in patient injury harm or death if the appropriate safety precautions are not followed CAUTION Indicates a situation which could result in device harm damage or mal function if the appropriate cautions precautions are not followed Page 8 of 58 5 Parts of the device BAYONET CONNECTOR n BAYONET HOLE OPTICS RELEASE BUTTON DUALACTION SHUTTER A SNAP FOR SYSTEM CONNECTOR OPENING BATTERY COVER Page 9 of 58 CONNECTION LED RESET BUTTON 3 RIGHT SOFT POWER LED G KEY MIDDLE KEY LEFT SOFT KEY ARROW KEYS Cradle P SYSTEM CONNEC TOR C Cla zx SMARTSCOPE oe O Cradle v1 rria Hio MET S N 1110212000068 Page 10 of 58 Soft key indicators Position Indicator Purpose To power on the device Left soft key To power off the device with lo
24. deo players MPEG1 format is more widely supported by different SW applications Image transfer method There are three options for the image transfer method UMS USB Mass Storage WIA Windows Image Acquisition and WIFI NOTE WIFI supported only if device has WIFI functionality Restore factory settings Press middle key to restore factory defaults selection Date Press middle key to change date settings Date can be set using the up and down arrow keys Move between day month and year by pressing the left and right keys Date format is DD MM YYYY for Finnish German French Italian Spanish and Portuguese Date format is MM DD YYYY for Japanese and Chinese Time Press middle key to change time settings Time can be set using the up and down arrow keys Move between hours and minutes by pressing the left and right arrow keys Camera SW version This item in Device menu tells the camera SW version Page 17 of 58 Start query User can choose start up query between erasing images creating new patient folder or no query at all When erasing images is chosen as the query the camera will prompt user on start up whether all images and videos shall be deleted When new patient folder query 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 query is selected then camera will go directly to live view upon start up 7 6 Patient editor Patient
25. e of the skin close up use Skin mode When taking an image of larger area use Portrait mode Long New patient folder If multiple patients are examined during a same Middle key 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 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 Move focus window Move focus window left and right after pressing Left soft key to activate Window returns to original position when camera is put to cradle turned off or optics module detached a 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 Up Down arrow value is saved to camera memory Move focus window Move focus window up and down after pressing Left soft key to activate Left Right arrow Table below includes explanations of the SK settings tab for skin imaging Setting Values default bolded Purpose Capture mode Still Video Use left and right arrow keys to choose between still capture and video capture Half press capture On Off Enable capture by pressing shutter button half way Focus window Visible Hidden Use left and right a
26. e s 2 kV line s to earth 5 Ut 595 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 96 dip in Ur for 25 cycles 5 96 Ur gt 95 96 dip in Ur for 5 sec 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 1 kV 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 NOTE Ur is the a c mains voltage prior to application of the test level IEC 60601 test level Compliance Electromagnetic level environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 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 typical commercial or hospital environment If the user of the Smartscope M5 requires continued operation during power mains interruptions it is recommended that the Smartscope M5 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 Page 49 of 58 Guidance and manufacturer
27. ed by dropping the device or damage caused by 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 Optomed certified service facility is not covered by warranty Page 48 of 58 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 equipment can affect MEDICAL ELECTRICAL SYSTEM Optomed Smartscope M5 should not be used adjacent to or stacked with other equipment 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 SMARTSCOPE M5 is intended for use in the electromagnetic environment specified below The customer or the user of the M5 should assure 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 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to lin
28. eight 380g Switching power supply connected to cradle Type CINCON TR10RO90 Input 100 240 V 0 4A 47 63 Hz Output 9V 1 1A 10 W USB cable Type A to mini B high speed unshielded length 1 8 m CAUTION It is only allowed to attach Battery and Power source provided in the sales package into the Cradle If you need replacement to the Battery or Power source please contact Optomed Customer Service or your local Retailer Page 42 of 58 NON MYDRIATIC OPHTHALMIC MODULE CONNECTED TO SMARTSCOPE M5 CAMERA Type Intended use Illumination Maximum Luminance output level towards eye Field of view Dioptre compensation Image resolution Dimensions Weight Smartscope EY3 Digital ophthalmoscope Intended to capture digital images and video of the fundus of the human eye Infrared LED for targeting Visible white LED for photographing 10 illumination brightness levels 0 0613 cd cm 459 20 D to 20D 1920x1440 px 132 1x55 2 mm 180 g EXTERNAL OPHTHALMIC MODULE CONNECTED TO THE SMARTSCOPE M5 CAMERA Type Intended use Illumination Maximum Luminance output level towards eye Image resolution Dimensions Weight Smartscope ES1 ES2 Digital eye anterior optics module Intended to capture digital images and video of the surface of the human eye and surrounding areas Visible white and cobalt blue LED for photographing 10 illumination brightness levels 192 cd c
29. elinee terme nr rules I accept the terms in the license agreement Ido not accept the terms in the license agreement InstallShield 6 Select Install Page 54 of 58 Ready to Install the Program The wizard is ready to begin installation If you want to review or change any of your installation settings click Back Click Cancel to exit the wizard Current Settings Setup Type Typical Destination Folder C Program Files x86 Eye Fi User Information Name optomed Company InstallShield lt Back pl Install 7 Select Finish InstallShield Wizard Completed The InstallShield Wizard has successfully installed Eyefi Mobi Desktop Transfer Click Finish to exit the wizard Launch the program Back Finish Cancel 8 Your Windows Firewall may ask depending on your computer setting Allowance for Eye Fi helper gt Select Allow access e Windows Firewall has blocked some features of this program Windows Firewall has blocked some features of Eye Fi Helper on all public private and domain networks CN Name Eye Fi Helper e Publisher Eye Fi Inc Path C program files x86 eye fi helper eyefihelper exe This program has already been blocked or unblocked for a different network location Allow Eye Fi Helper to communicate on these networks Domain networks such as a workplace network Private networks such as my home or work network The fir
30. erated at maximum output will exceed the safety guideline after Maximum number of pulses still images allowed daily EY3 5000 pulses still images eye ES2 250 pulses still images eye Or alternatively Total daily usage time for continuous light video usage time aiming light duration shall be limited to EY3 1h30 min video usage eye ES2 8 min video usage eye Page 6 of 58 3 Warnings and cautions Place PC and cradle outside the patient environment at least 1 5 meters distance from the patient Use only accessories and battery provided by Optomed with this product Connection between camera and workstation is USB and or WIFI Any authorization procedures should be carried out in workstation Images and videos can be copied from camera to workstation via USB and or WIFI and then viewed in workstation USB write protection is on by default When protection is on this feature will prevent writing to camera memory card from PC when connected to the cradle In case device has WIFI functionality USB write protection must be turned off No modification of this equipment is allowed Page 7 of 58 4 Important symbols Symbol 1KO p9urojg 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 Directive CE mark with notified body identification number indicates a class lla product Read ac
31. ewall is already configured for this network location Public networks such as those in airports and coffee shops not recommended because these networks often have little or no security The firewall is already configured for this network location What are the risks of allowing a program through a firewall ie aiaaion SE Page 55 of 58 Set up 1 Enter 10 digit activation code Activation code can be found under camera battery cover 2 Type activation code 3 Select Next B Activate Eyehi Mobi can Activate Eyefi Mobi card PTVAC ar ir4 71 XXXXXXXXXX Where is my activation code The 10 digit activation code is located on the membership card or plastic case that came with your Eyefi Mobi card Cancel Next 4 Select folder where to transfer images and videos t is recommended to use folder C Optomedworkstation wifi with Optomed Workstation viewing software f you are not using Optomed Workstation viewing software you can use any folder in your computer 5 Create subfolders are selected by default Please remove selection from check boxes at the right side 6 Select Next Page 56 of 58 Choose destination folders Eyefi will automatically transfer photos and videos from camera to the following folders Create subfolders by date taken e g 2012 06 28 Photos CAVISUSCOUT Viewing SW Browse v Videos CAVISUSCOUT Viewing SW Browse v 7
32. ging illumination brightness affects only the white capturing flash If using IR IR or White White both aiming and capturing light are changed 6 Approaching the eye is started from 10 centimeters 4 inch distance Patient is asked to look at a target in a wall 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 2 cm 0 8 inch Silicone support must be compressed approximately half way down Page 20 of 58 10 11 12 13 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 Still image is captured by pressing the shutter button all the way down If half press capture is enabled still image can be captured by pressing shutter button half way Taken image is displayed on screen until user clears the image by pressing shutter button left or right soft key Instant review can be enabled disabled in the Smartscope EY3 optics menu Image can be zoomed in instant preview by pressing middle key There are four zoom levels 1 2 4 8 Pressing middle key activates the next level Move around the image by using arrow keys Scroll between images by using left and right arrow keys Video is captured by keeping shutter button down If half press capture is enabled video image can be captured by press
33. he 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 Instant review can be enabled disabled in the Smartscope OT1 optics menu 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 Page 29 of 58 9 Transfer images to a PC after capturing images Images are transferred to the PC when camera is placed to the cradle or if a WIFI connection is active Smartscope works as any other digital camera Camera keys function as shown in image below when OT1 optics module is attached Focus manually Zoom in Move capture area Move focus window Short Zoom Capture area Focus win Long Power On Off Short Auto Manual Long Menu Decrease Brightness Increase brightness Move capture area Move capture area Move focus window Move focus window Short Still Video Long New patient folder Focus manually Zoom out Move capture area Move focus window Below table provides explanations for the key functions Press Function Explanation Short Zoom Press Left soft key to activate zoom function Digital zoom can be used for close up of features and image focus Icon Zoom displayed in lower left corner of Left soft key display when active Edit capture a
34. ht can changed to constant to help focus on the target light Capture setting in image It is possible to write brightness and diopter settings to image Instant review Instant review can be ON OFF according to user need as available in EY Optics menu When the reviewing zoom level is 1x user can change the image to be reviewed with left and right arrow keys Images are in showing order Normal Low red Red free IR NOTE Camera stores selected menu settings when it is powered off Page 24 of 58 9 Eyeimaging using anterior ophthalmic module Smartscope ES1 ES2 Optomed Smartscope ES1 ES2 is intended to capture images and video of the surface of the human eye and surrounding areas The device set for anterior ophthalmic imaging consists of e Camera handset M5 e Attachable anterior ophthalmic lens ES1 ES2 e Cradle for charging and image transfer Smartscope ES1 ES2 optics module has two light sources white and cobalt blue light User can choose between the light sources by pressing middle key when ES1 ES2 module is attached Cobalt blue light enables taking fluorescent pictures of the surface of the eye to reveal any cuts or defects STEPS FOR EYE SURFACE IMAGING 1 After ES1 ES2 optics module is attached the light source is chosen by pressing middle key 2 Still or video image is selected Selection is made in ES menu 3 It is recommended to use autofocus 4 Aiming light is turned on by pressing the shutter key in front of
35. ice 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 optics specific tab that opens by pressing right soft key for 1s 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 Page 13 of 58 To transfer images to a PC place device to the cradle The image transfer and charging is indicated with green and blue LED lights and text on LCD screen In case the WIFI connection is active images are transferred to the PC automatically Smartscope 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 NOTE When device is powered on powered off or goes to standby mode the camera focus motor may make a sound This sound is normal and is not a sign of any damage or problem 7 4 Attaching and detaching optics module NOTE Optic modules
36. ient by pressing middle key for over 3 seconds 9 Transfer images to a PC after capturing images Images are transferred to the PC when camera is placed to the cradle or if a WIFI connection is active Smartscope works as any other digital camera Page 33 of 58 Camera keys function as shown in image below when SK1 optics module is attached Focus manually Zoom in Move focus window Short Zoom Focus win Long Power On Off Short Auto Manual Long Menu Decrease Brightness Move focus window Increase brightness Move focus window Short Skin Portrait Long New patient folder Focus manually Zoom out Move focus window Below table provides explanations for the key functions Ke Press Function Explanation 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 Zoom displayed in lower left corner of display when active Zoom value is saved to camera Left soft key memory o uet SSnearo haystobecer capture the waned using arrow keys to better capture the wanted area key for longer than 2s Short Auto Manual focus Switch between Auto and Manual focus by pressing CENE 50 NE ns Nene fanis by presse Page 34 of 58 I Open Menu Enter camera menu by pressing Right soft key for longer than 1s LO Skin Portrait Press left soft key to switch between Skin and Portrait modes When taking an imag
37. image taken with white light Low red It is possible to capture red reduced image Page 23 of 58 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 Camera stores selected menu settings when it is powered off Automatic IR contrast Automatically adjust infrared live view brightness and contrast according to image content Improves visibility of fundus features during aiming Same contrast and brightness settings are applied to IR still captures NOTE In IR IR mode IR brightness adjustment does not always directly affect brightness on screen when automatic contrast is enabled This happens because automatic contrast feature always tries to adjust screen brightness to same level IR brightness setting still works but the effect is only visible when adjustment range of automatic contrast adjustment runs out It is advisable to use highest brightness that does not cause image saturation pink or white washed out effect Target blinking By default the fixation target light is on with blinking illumination If patient cannot keep their eye targeted well the lig
38. ing shutter button half way Video capturing is finished by pressing shutter button all the way down If multiple patients are examined during one session new file folder is created for each patient by pressing middle key for over 3 seconds Transfer images to a PC after capturing images Images are transferred to the PC when camera is placed to the cradle or if a WIFI connection is active Smartscope works as any other digital camera To erase the image video manually choose Menu then Preview Images There will be an option to erase a specific image or a specific folder When camera is removed from the cradle it verifies image data storage erase lt 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 EY3 optics module is attached Page 21 of 58 Focus manually Short AF MF Long Menu Increase Brightness Short Light On Off Long Power On Off Decrease Brightness Long New patient folder Focus manually Below table provides explanations for the key functions Press Function Explanation Key Short IR On Off 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 Short Auto Manual focus Switch between focus modes by pressing Right soft key Manual focus is
39. ion Explanation Short Edit focus window When focus window is visible it is possible to move it Activate Zoom using arrow keys to better capture the wanted area Digital zoom can be used for close up of features and image focus Long Power On Off Camera is powered on and off by pressing the Left soft key for longer than 2s Auto Manual focus Switch between Auto and Manual focus by pressing Right soft key Right soft key CILE Left soft key longer than 1s pressing Middle key key Long New patient folder If multiple patients are examined during a same Middle key 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 current patient Page 37 of 58 e e ee in it a new folder cannot be created a aa brightness Move AF window Move focus window left and right after pressing Middle Left Right arrow i E key to activate 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 EN LN nn enererne ie key to activate Table below includes explanations of the DF settings tab for general imaging Setting Values default bolded Purpose Capture mode Still Video Use left and right arrow keys to
40. ives instructions for using the device More specific instructions for using optics lenses are given in the optics lens specific chapters 7 1 Preparations Smartscope is both charged and connected to PC Personal Computer using the provided cradle When Smartscope is not used it may be stored in the cradle Storing device in the cradle is not harmful for the battery Device can be connected to the cradle with optics attached 7 2 Connection to a PC Smartscope E Always do this for pictures Image data transfer method to PC is similar as with a digital camera Pictures options ai Import pictures eJ in findo S When connected to a PC running Microsoft Window Vista Windows 7 or fg te Windows 8 operating system displays query for AutoPlay It is possible to select appropriate image viewing program or simply open the folder to view and then store files to the hard disk of the PC ee ere General options Writing to the memory card from PC is not enabled by default In case device has WIFI functionality USB write protection must be turned off WIFI enables wireless image transfer from camera to PC For WIFI installation instructions refer to Appendix C 7 2 1 Pay per study In case camera is in pay per study mode images can be viewed only with Optomed Workstation Software There are no other changes in camera functionality 7 3 Basic use starting up shutting down and taking an image Dev
41. m 2560x1920 px 79x70 mm 90 g Page 43 of 58 DIGITAL DERMATOSCOPE SK1 CONNECTED TO THE M5 CAMERA Type Smartscope SK1 Intended use Digital dermatoscope Intended to capture images of the skin Illumination Light ring of 24 LEDs Image resolution 2560 1920 px Image size on skin 30 22 mm Dimensions 60x77mm Weight 150g OTOSCOPIC LENS OT1 CONNECTED TO THE M5 CAMERA Type Smartscope OT1 Intended use Imaging of ear canal and tympanic membrane Image resolution 2560 x 1920 pixels Dimensions 49 2x45 5 mm Weight 80g Main features Integrated LED illumination Insufflation port for pneumatic otoscopy Disposable and reusable speculum diameter range 2 9 5 Page 44 of 58 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 96 to 80 96 Atmospheric pressure 800 hPa to 1060 hPa Please note also EMC information given in Annex A Temperature storage 10 C to 40 C Relative humidity storage 10 96 to 95 96 Atmospheric pressure 500 hPa to 1060 hPa NOTE If stored over 1 month it is recommended to remove battery Appendix B gives instructions for removing the battery Transported in protective aluminum carrying case Temperature 40 C to 70 C Relative humidity 10 96 to 95 96 Atmospheric pressure 500 hPa to 1060 hPa Si
42. nation 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 left soft key to activate Zoom lower left corner shows Zoom 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 middle key when taking an image of a larger area such as head whole arm or the whole body The icon on the upper right corner of screen now says P Portrait instead of S Skin 7 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 Instant review can be enabled disabled in the Smartscope SK1 optics menu 8 If multiple patients are examined during one session create a new file folder for each pat
43. ng and image transfer EY3 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 RETINAL 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 in a wall 2 3 meters 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 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 up 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 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 Capturing light is adjusted using left and right arrow key There are brightness levels from O to 10 default value is 5 and typical levels are from 2 to 8 When using IR White capture mode chan
44. ng middle key for over 3 seconds 11 Transfer images to a PC after capturing images Images are transferred to the PC when camera is placed to the cradle or if a WIFI connection is active Smartscope works as any other digital camera 12 Erase manually image video by choosing Menu Preview images There can be chosen either the specific image or the specific folder to be erased 13 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 Camera keys function as shown in image below when ES1 ES2 optics module is attached Focus manually Short Focus window Zoom Zoom in Short Auto Manual Move between tabs Move focus window Move between tabs Long Power On Off Long Menu Short White Cobalt blue illumination Long New patient folder Focus manually Zoom out Move focus window Below table provides explanations for the key functions Pres Function Explanation Short Edit focus window When focus window is visible it is possible to move it Left soft key Activate Zoom using arrow keys to better capture the wanted area Page 26 of 58 NENNEN I image focus Zoom value is saved to camera memory soft key for longer than 2s Short Auto Manual focus Switch between Auto and Manual focus by pressing Activate Zoom Right soft key Press Right sof
45. ng press Right soft key om Open menu with long press LED indicators The recharging and connection to PC is indicated with green charging and blue connection LED lights Position Indicator Purpose Left LED indicator Active when device is powered on blinking when charging in Green cradle Active when devices is placed to the cradle and connected to a Right LED indicator Blue PC Graphical indicators These indicators are displayed on the top row of the display during imaging Optics EY eye optics FA angiogram optics SK skin optics This indicator ES eye surface changes with optics Battery optics modules S Still i i i according to middle Patient1 OT ear optics 100 Time g V Video DF no lens key function S B E W Esz optics atiacnea W White light B Blue light Zoom indicator Diopter compensation indicator in manual focus mode when using EY4 Brightness indicator 10 steps This indicator changes with optics modules according to left soft key function EY4 optics attached Autofocus Target high low off Manual focus AF Assist with EY4 Page 11 of 58 6 Usage environment requirements WARNING Smartscope is not suitable for use in the presence of flammable anesthetics WARNING Place PC and cradle outside the patient environment at least 1 5 meters distance from the patient CAUTION Smartscope is intended to be used inside in a normal room temperature and
46. nusoidal vibration 10 Hz to 500Hz 0 5g Shock 30 g duration 6 ms Bump 10 g duration 6 ms WARNING Do not leave the eye cup in direct sunlight as it may warm up and burn patients head when taking image Page 45 of 58 SERIAL NUMBERING Year of manufacture can be found from the serial number digits 3 to 4 Serial number of the cradle is in a sticker attached to the underside of the cradle Serial numbers of the attachable optics modules are attached to the modules SW version is displayed in the device menu EXPECTED USAGE LIFE OF THE SMARTSCOPE There are no strict limitations about expected usage life of the Smartscope Usage life is approximately five years INTELLECTUAL PROPERTY RIGHT INFORMATION Microsoft Window Vista Windows 7 and Windows 8 are trademarks of Microsoft Corporation Hama Pro Optic is a trademark of Hama GmbH amp Co KG Erisan OXY is a trademark of Farmos Ltd PATENT NOTICE This product is protected by the following patent numbers and their corresponding national rights 122533 107120 119531 120958 2200498 5171845 5561130 5658371 1468147 2L200880101934 7 ZL200880112052 0 US 8 078 667 B2 Additional patent applications are pending TRADEMARK Optomed Smartscope its logos and other Optomed Smartscope brand trademarks and made names are registered or unregistered trademarks of Optomed Oy All rights are reserved DISPOSING THE OPTOMED SMARTSCOPE M5 Do not dispose Optomed Smartscope
47. ow keys Images are in showing order Normal Low red Red free IR NOTE Camera stores selected menu settings when it is powered off Page 38 of 58 13 Error messages Optomed Smartscope M5 will display error messages for the limitations of the usage Error message is always displayed with explanatory message providing information about possible actions List of error messages Error message What to do Autofocus calibration needed Please hold camera horizontal and press OK to calibrate Battery failure Remove battery completely from camera Re install or replace Charging failure Please remove and reconnect device to cradle Copy images to safe location and then choose Erase image memory from device Image counter full menu Image storage not found Please contact service for more information Light source temperature too Please wait for camera to cool down Cooling may take several minutes high Optic communication failed Please re attach optic Optic control failed Please detach optic and restart camera Patient list upload failed Please verify list against instructions System flash memory not available Please contact service for more information Memory full Memory is full store images and erase memory card Memory erasing failed Please contact service for more information Optic type not detected Please re attach optic Page 39 of 58 14 Cleaning instructions Optomed Smartscope M5 is a precision optics in
48. p and down arrow keys to set time 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 This feature is currently not available Remote trigger On Off This feature is currently not available Restore factory Ok To restore all settings menus to factory defaults Activate Setting using the middle key 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 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 Patient ID information can be edited in image browser 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 Edi
49. r position the image Focus Window can be moved on the screen by first pressing Left soft key until text Focus win appears in lower left corner of display and then using the arrow keys when aiming Marking side It is possible to mark which ear was imaged Marking side is enabled from the menu When enabled side is marked to the file name and to the image When marking side is enabled camera verifies side after each captured image Identifiers used for ear images are LE left and RI right Zoom cropping By default zoom cropping is on and camera will save the zoomed area instead of the whole image area When zoom cropping is off camera will save the whole image area Instant review Instant review can be ON OFF according to user need as available in EY Optics menu When the reviewing zoom level is 1x user can change the image to be reviewed with left and right arrow keys Images are in showing order Normal Low red Red free IR Camera stores selected menu settings when it is powered off Page 32 of 58 11 Skin Imaging using dermatoscopic optics module SK1 With attachable skin optics module SK1 camera can be used for capturing 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 illumi
50. rea Due to differences between specula the image area can be tilted to the side of the screen when using small specula Press Left soft key to enter Capture area Page 30 of 58 NENNEN d If capture area is moved the location is saved Move focus window When focus window is visible it is possible to move it E inl al Long Power On Off Camera is powered on and off by pressing the Left soft fens Pwr md Right soft key Rie aE OE KEY Long Open Menu Enter camera menu by pressing Right soft key for A lin n pressing Middle key Middle key 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 Move focus window Move focus window left and right after pressing Left soft key to activate Window returns to original position when camera is put to cradle turned off or optics module detached Move capture area Use left and right arrow keys to adjust capture area to center of screen after activating with Left soft key Focus manually Use up and down arrows to focus manually Zoom In Out Zoom in using arrow key up Zoom out using arrow key p men down There are four zoom levels 1 2 4 and 6 Zoom ip Dawn aitow value is saved to camera memory Move focus window Move focus window up and down after pressing Left o quete Eeee nn ees ee o remet chee sre aRer activating with tete ep 8d center of screen af
51. rrow keys to choose between having focus window visible or hidden Skin body map On Off Mark body part to image and image name 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 Instant Review On Off Instant review can be ON OFF according to user need as available in FA Optics menu Capture mode Both still images and video can be taken with the Smartscope M5 camera Capture mode can be chosen in SK menu When taking video the shutter button must be held down while taking the video Video recording will stop once the shutter button is released Half press capture It is possible to take images and video by pressing shutter button half way Page 35 of 58 Focus Window Focus Window helps user position the image Focus Window can be moved on the screen by first pressing left soft key until icon Focus win appears in lower left corner of display and then using the arrow keys when aiming Skin body map Skin body mapping can be used when taking dermatoscopic images to mark on the image and image name the body part number 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
52. s for capturing ear images are 1 Attach otoscopic lens Press firmly until you hear a clicking sound to make sure module connects properly 2 Attach specula 3 Start illumination by pressing shutter half way down 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 lower right corner of the display shows text Auto If pressing shutter button 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 left soft key to activate Zoom lower left corner shows text Zoom 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 6 Dueto slight differences between individual specula the image area may not be completely visible or tilted to the side when using zoom Press left key to access Capture area function Then you can move the image area to the centre of the screen If capture area is edited this setting is saved The centring can be reset by restoring factory settings 7 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 t
53. seconds File is written under DCIM folder in SD card File is exported over WIFI Patient list can be exported also via USB Patient list is written as text file patexp txt to SD card root If patient list is modified in camera new patient created or SD card is erased patient list is updated Page 18 of 58 7 7 Adjusting focus and automatic focus Camera has an autofocus function where camera finds correct focus place automatically For EY3 square indicator appears when focusing is finished For ES2 OT1 and SK1 focus window turns green when focusing is finished Automatic focusing start when shutter button is pressed half way down Focus mode 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 a diopter scale is visible on the screen 7 8 Reset button Reset button can be used if device behavior is abnormal Reset button is located in a small opening under display Button is marked with circle O Reset button can be pressed with a thin object such as a paper clip Button needs to be pressed for over 7 seconds Page 19 of 58 8 Retinal imaging using optics module EY3 Optomed Smartscope M5 EY3 digital ophthalmic camera is intended to capture digital images and video of the fundus of the human eye The device set for retinal imaging consists of e Camera handset M5 Attachable ophthalmic lens EY3 Eye cup for EY3 Cradle for chargi
54. strument that should be handled with care Please note following cleaning instructions for camera and optics modules e Shut down device before cleaning it e Remove cradle from mains before cleaning it e Disinfect housing with soft cloth moistened with alcohol e g 7096 ethanol Avoid touching System connectors in the handset and cradle e Lenses may be cleaned with cleaning cloth Also moist cleaning tissue such as Hama Pro Optic cleaning tissue can be used Optomed Smartscope is not intended to be sterilized Clean Eye optics EY3 and Eye surface optics ES1 ES2 eye cup before each use on a new patient e disinfect eye cup with soft cloth moistened with alcohol e g 70 ethanol or e soak eye cup in glutaraldehyde based solution or hydrogen peroxide and peracetic acid solution such as Erisan OXY e rinse the eye cup under running water e dry the eye cup e g with clean paper towel before subsequent use If replacement for eye cup EY3 is needed please contact Optomed or your own retailer Eye cup should be replaced if when e eye cup is discolored e eye cup form is deteriorated e eye cup is shattered cracked or disintegrated WARNING Clean eye cup before each use on a new patient to avoid contamination Page 40 of 58 15 Device maintenance Optomed Smartscope contains rechargeable Ni MH battery pack Service life of the battery is approximately 1 2 years Battery needs to be replaced on planned intervals When b
55. t key to activate zoom function Digital zoom can be used for close up of Right soft key features and image focus Zoom value is saved to camera memory Long Open Menu Enter camera menu by pressing Right soft key for longer than 1s 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 Long New patient folder If multiple patients are examined during a same Middle key 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 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 Move AF window Move focus window left and right after pressing Left Right arrow m Middle key to activate Window returns to original position when camera is put to cradle turned off or optics module detached FEN 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 Up Down arrow Zoom value is saved to camera memory Move AF window Move focus window left and right after pressing Middle key to activate Table below includes explanations of the
56. t patient list User can add or remove patients from patient list Patient information Enable or disable patient information linking 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 Page 16 of 58 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 Keyboard 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 Camera has nine 9 different languages the user can choose from Default language is English and the language selection is always shown in English in menu If language is changed camera has to be re started USB write protection USB write protection is on by default When protection is on this feature will prevent any virus from entering the camera from a PC when connected to the cradle In case device has WIFI functionality USB write protection must be turned off Video file format 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 vi
57. ter activating with Left soft key Table below includes explanations of OT settings tab for ear imaging 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 current patient Left Right arrow Setting Values default bolded Purpose Capture mode Still Video Use left and right arrow keys to choose between still capture and video capture Half press capture On Off Enable capture by pressing shutter button half way Focus window Visible Hidden Use left and right arrow keys to choose between having focus window visible or hidden 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 available in OT Optics menu Page 31 of 58 Capture mode Both still images and video can be taken with the Smartscope M5 camera Capture mode can be chosen in OT menu and when using OT1 otoscopic module from Middle key When taking video shutter button must be held down while taking the video Video recording will stop once the shutter button is released Half press capture It is possible to take images and video by pressing shutter button half way Focus Window Focus Window helps use
58. tion is affected by absorption and reflection from structures objects and people Page 51 of 58 Appendix B Replacing the battery Battery pack is specially designed and manufactured for this device Optomed and Optomed retailers provide suitable battery packs Labels in the battery and label inside the battery cover display following information NiMH battery 4 HR 4U AAA 4 8V 1000 mAh Procedure for replacing the battery is 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 screw driver or similar pointy small 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 Page 52 of 58 Appendix C WIFI Installation Guide e Information about WIFI functionality e Installation e Setup e Problem solving Information about WIFI functionality Wi Fi feature is implemented by using Eye Fi card More information about the card can be found in Eye Fi internet pages http www eyefi com products System requirements Smartscope with WIFI card Computer running Windows 7 or 8 Pro with Wi Fi capability 10
59. ure light source Automatic IR contrast On Off Enable automatic IR contrast Target blinking On Off Fixation target light can be set to constant if needed On Off Enable or disable writing of capture settings to image image Instant Review On Off Instant review can be ON OFF according to user need as available in EY Optics menu Instant review image can be changed from left and right arrow keys Capture mode Both still images and video can be taken with the Smartscope M5 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 Half press capture It is possible to take images and video by pressing shutter button half way 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 It is possible to set the aiming light brightness Save 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 Save IR image If Save IR image is enabled from menu the camera will save an image taken with IR image in addition to saving a colour

Smartscope M5 manual

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