Optomed M5 Instructions for Use
Contents
1. Move between tabs Long Power On Off Decrease Brightness Move fixation target Long New patient folder Focus manually Move fixation target Below table provides explanations for the key functions Press Function Explanation Key Short Control Fixation target Fixation target is off by default and can be turned on level and selection by pressing left soft key Fixation target light has two levels Low and High If the patient cannot see the ight on low level turn it up to high Long Power On Off Camera is powered on and off by pressing the Left soft key for longer than 2s Short Manual Auto Switch between focus modes by pressing Right soft key Manual focus is on by default Autofocus range is 11 to 3 diopters manual focus range is 20 to PIGNE SON KEY 20 diopters i Long Open Menu Enter camera menu by pressing Right soft key for 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 Change brightness Use left and right arrow keys to adjust capture light brightness Icon above left soft key must be selected lighter color to change brightness Sel2. Page 37 of 49 12 13 Cleaning instructions Optomed Smartscope M5 is a precision optics 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 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 and Eye surface optics eye cup before each use on a new patient e disinfect eye cup with soft cloth moistened with alcohol e g 7096 ethanol or e soak eye cup in glutaraldehyde based solution or hydrogen peroxide and peracetic acid solution such as Erisan 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 is needed please contact Optomed or your own retailer Eye cup should be replaced if when e the eye cup is discolored e the eye form is deteriorated e the eye cup is shattered cracked or disintegrated BA CAUTION Clean eye cup before each use on a new patient to avoid contamination Page 38 of 49 13 14 Device maintenance Optomed Smartscope contains rechargeable Ni MH battery pack Service life of the battery is approximately 1
3. changes with optics modules 54 according to left soft key function EY4 optics attached Autofocus Target high low off Manual focus AF Assist with EY4 Page 11 of 49 6 Usage environment requirements CAUTION Smartscope is not suitable for use in the presence of flammable anaesthetics Smartscope is intended to be used inside in a normal room temperature and 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 Place PC and cradle outside the patient environment at least 1 5 meters distance from the patient To transfer patient image data the device must be used together with a PC Personal Computer running either Microsoft Windows XP Window Vista Windows 7 The device does not need any drivers to be installed on a PC Optomed recommends to use the 2 GB SD 4 GB SDHC card which is supplied with the device In case device has WIFI funct
4. 1h 30min with full battery OPTOMED SMARTSCOPE CRADLE V1 170 w x 35 h x 150 d mm 380g Switching power supply connected to cradle Type CINCON TR10RO9O0 Input 100 240 V 0 4A 47 63 Hz Output 9V 1 1A 10 W USB cable CAUTION Type A to mini B high speed unshielded length 1 8 m 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 Oy or your own Retailer Page 40 of 49 NON MYDRIATIC OPHTHALMIC MODULE CONNECTED THE SMARTSCOPE M5 CAMERA Type Intended use Illumination Maximum Luminance output level towards eye Field of view Dioptre compensation Image resolution Dimensions Weight Smartscope EY4 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 9 red Internal fixation target LEDs 95 8 cd cm 409 20 D to 20D 1536x1152 px total 1 8 Mpix informational area 1 41 Mpix 160x73mm 310g FUNDUS ANGIOGRAPHY MODULE CONNECTED TO THE SMARTSCOPE M5 CAMERA Type Intended use Illumination Maximum Luminance output level towards eye Field of view Dioptre compensation Image resolution Dimensions Weight Smartscope FA Intended to capture digital images of the fundus angiograms of t
5. 2 years Battery needs to be replaced on planned intervals When battery 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 BA CAUTION If there are breaks in the device covers or other visual defects contact Optomed Oy or Optomed certified service facility Page 39 of 49 14 15 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 OPTOMED SMARTSCOPE M5 CMOS 5 0 Megapixels 2 GB micro SD card 2 4 TFT LCD 262 000 colors antireflective coating JPEG file extension jpg MPEG 4 and MPEG 1 PC with USB port Windows XP Windows Vista Windows 7 Windows 8 No driver installation needed 82 30 w x166 50 h x 66 50 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 Optomed
6. 40 C to 70 Relative humidity 10 to 95 96 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 BA CAUTION Do not leave the eye cup in direct sunlight as it may warm up and burn patients head when taking image Page 43 of 49 SERIAL NUMBERING Sticker 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 optics 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 THE SMARTSCOPE There are no Strict limitations on expected usage life of the Smartscope Usage life is approximately five years INTELLECTUAL PROPERTY RIGHT INFORMATION Windows XP Windows 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 DISPOSING THE OPTOMED SMARTSCOPE M5 Do not dispose Optomed Smartscope M5 as unsorted municipal waste Prepare Optomed Smartscope M5 for reuse or separate collection as specified by Directive 2002 96 EC of the European
7. 8 minm operating system displays query for AutoPlay It is possible to select enter ete appropriate image viewing program or simply open the folder to view and E then store files to the hard disk of the PC oa acacia N 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 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 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 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 Smartscope verifies if image data is erased when e Device is powered on from power off mode or power save mode Page 13 of 49 e Device is removed from the cradle It is recomm
8. 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 own retailer CONTACT If you wish to contact your local support personnel please call to 358 20 741 3380 or email to us at service optomed com Page 44 of 49 15 16 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 caused 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 For customer support contact service optomed com Page 45 of 49 Appendix Electromagnetic compatib
9. There are altogether 10 brightness levels Default value is 5 Suitable illumination is typically 2 to 8 When using IR White capture mode changing illumination brightness affects only the white capturing flash If using IR IR or White White both aiming and capturing light are changed Page 19 of 49 10 11 12 13 Aim help circle on the screen guides user when to take image When retina is not fully in view the circle is red Once the aim is good and retina fully appears on screen the circle turns green indicating a good moment for capturing the image Approaching the eye is started from 10 centimetres 4 inch distance If internal fixation target is not used 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 Eye cup must be compressed approximately half way down Aim help circle on the display guides to take image once it turns from red to green 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 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 zoom
10. 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 Short Zoom Focus window Zoom in Short AF MF Long Power On Off Move AF window Long Menu Decrease Brightness I lt C u Increase Brightness Move AF window Move AF window Short Video Still Long New patient folder Focus manually Zoom out Move AF window Below table provides explanations for the key functions Press Function 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 Left soft key image focus Icon Z displayed in up right corner of display when active key for longer than 2s Right soft key Long Open Menu Enter camera menu by pressing Right soft key for longer than 1s Short Still Video Choose between still image and video shooting by pressing left soft key Middle key 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
11. 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 tab Setting Values default bolded Purpose New patient folder Device EY z Start study Mark side IR brightness Select settings page with left and right arrow keys Cancel To preview the images on camera press middle button Ok 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 Display brightness Low Med High Use left and right arrow keys to adjust display brightness On Off Show graphical icons when imaging Sounds 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 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 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
12. 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 AF assist 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 EY4 optics is attached a dioptre scale is visible on the screen 7 7 Reset button Reset button can be used if device behaviour 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 18 of 49 8 Retinal imaging using optics module Smartscope EY4 Optomed Smartscope EY4 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 e Attachable ophthalmic lens EY4 e Eye cup for EYA e Cradle for charging and image transfer Smartscope EY4 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 co
13. 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 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 Focus Window Focus Window helps user position the image The Focus Window can be moved on the screen by first pressing Left soft key until icon F appears in up right corner of display 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 side is always marked only to the file name When marking side is enabled camera verifies side after each captured image dentifiers used for normal eye images are OS for left and OD for right dentifiers used for red free images are SG for left and DG for right dentifiers used for save IR images are SI for left and DI for right dentifiers 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 Camera
14. can be used in most cases Restore factory Ok To restore all settings menus to factory defaults Activate Setting using the middle key Date DD MM YYYY Use left and right arrow keys to set date Use Middle key to select 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 This feature is currently not available Remote trigger On Off This feature is currently not available Page 15 of 49 Formatted Font Not Bold 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 Patient ID information ca
15. 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 Page 24 of 49 10 11 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 Smartscope works as any other digital camera Erase manually image video by choosing Menu Preview images There can be chosen either the specific image or the specific folder to be erased 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 ES2 optics module is attached Short Focus window Zoom Move between tabs Long Power On Off Focus manually Zoom in Move focus window Short Auto Manual Move between tabs Long Menu Decrease Brightness lt gt o Increase brightness Move focus window p Move focus window Short White Cobalt blue illumination Long New patient folder Focus manually Zoom
16. out Move focus window Focus manually Short White Blue Zoom in Short AF MF Zoom Long Power On Off Move AF window Long Menu Decrease Brightness Increase Brightness Move AF window Move AF window Short Edit focus window Long New patient folder Focus manually Zoom out Move AF window Page 25 of 49 Below table provides explanations for the key functions Press Function 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 Icon Z displayed in up right corner of display when active Zoom value is saved to camera memory Long Power On Off ene 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 Activate Zoom Right soft key Press Right soft key to activate zoom function Digital zoom can be used for close up of Right soft features and image focus Icon Z displayed in up keyRiehtset key right corner of display when active 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 New patient fo
17. stores selected menu settings when it is powered off Page 27 of 49 Formatted Normal M Formatted Font Calibri 12 pt English United Kingdom Formatted Justified 10 Fluorescein Angiography imaging using optics module Smartscope FA Optomed Smartscope FA digital ophthalmic camera is intended to capture digital images of the fundus angiography of the human eye The device set for fundus angiography imaging consists of e Camera handset M5 e Attachable Smartscope FA e Eye cup for EY4 e Cradle for charging and image transfer Infrared is used for targeting image to the eye fundus and blue light is flashed when image is taken Pupil does not respond to the infrared light so examination is convenient for the patient Smartscope FA has 9 internal fixation targets for the patient to fixate at while imaging Below section will guide how to control the fixation lights 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 3 When using Smartscope FA optics the device should be mounted on a slit lamp base using Slit lamp Adapter its mandatory to achieve good images 4 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 distanc
18. Mode You can adjust the dioptre scale according to patient diopter manually Image can be taken when shutter button pressed long way op FA gt Optics recognized as FA for fundus angiography imaging S Mio donde 3 Default Display window when FA optics is attached using AF Assist mode Diopter scale is automatically adjusted Image can be captured when shutter button is pressed half a way Page 33 of 49 4 Default Display window when FA optics is attached using MF Assist mode Diopter scale is manually adjusted Image can be captured when shutter button is pressed half a way S Bio 5 When Right Arrow key is long pressed Menu table appears on display Default Device tab will be ON By using left and right arrow keys you slide to the next tab Here FA tab is chosen Time Counter Start study is selected from the FA optics menu After pressing shutter button half a way for one time during the live view screen Time counter will be ready appearing on the upper right pointed with arrow on the image Time counter will be printed on the final images Time counter will guide you through out through the all phases of Angiography To stop the time counter after finishing the study user need to switch to FA optics menu and press the STOP STUDY button Page 34 of 49 4 Formatted Heading 1 11 General imaging without optics module It is possible to take pictures using Smartscope M5 without
19. PENING SYSTEM BATTERY CONNECTOR COVER Page 9 of 49 CONNECTION LED RESET BUTTON S POWER LED LEFT SOFT KEY RIGHT SOFT KEY MIDDLE KEY ARROW KEYS Cradle P SYSTEM B 4 CONNEC TOR C Ii Sz SMARTSCOPE Cradle v1 me er om SN 111021200300 2 Lx Page 10 of 49 Soft key indicators Position Indicator Purpose To power on the device Left soft key To power off the device with long press Right soft key En 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 Active when device is powered on blinking when charging in Left LED indicator Green cradle Right LED indicator Blue Active when devices is placed to the cradle and connected to a 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 S Still optics Battery optics modules Vj Patient1 ear optics 100 Time according to middle V Video DF n lens key function Ey Es optics atached W White light B Blue light Zoom indicator Diopter compensation indicator in manual focus mode when using EY4 Brightness indicator 10 steps This indicator
20. SMARTSC PE USER S MANUAL Optomed Smartscope PRO amp Smartscope FA Optomed SMARTSCOPE PRO and SMARTSCOPE FA are manufactured by Optomed Oy Place of Business Optomed Oy Hallituskatu 13 17 D FI 90100 Oulu Finland Manual version 2014 02 14 Rev 5 0 SW 3 2 Page 1 of 49 This sales package includes Smartscope M5 camera with optics lenses and accessories Model Description Accessories Smartscope EY4 module for retinal imaging eye cup quick user guide Smartscope FA module for fundus fluorescein angiography eye cup quick user guide imaging Smartscope ES2 module for anterior ophthalmic imaging ee Smartscope Cradle V1 for data transmission and battery charging USB cord 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 Page 2 of 49 Quick start guide WHAT TO DO BEFORE THE FIRST USE Remove Optomed Smartscope M5 from the sales package and check that all parts are undamaged 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 USB cable to the PC Connect power unit to the wall plug mains Place Op
21. age with left and right arrow keys Cancel Start Study This enables the study to start For every new study user needs to go into the menu and start study to enable the study or Time counter 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 IR brightness values are Low Med High This can be chosen by user by using left and right arrow keys Always high is recommended Page 31 of 49 amp Device EY OT SK DF R amp D Instant review CHT Calibration frequency Cancel Instant review Instant review can be ON OFF according to user need as available in FA Optics menu Target blinking By default the fixation target light is on with constant illumination If patient cannot keep their eye targeted well the light can changed to blink to help focus on the target light Calibration Frequency User can manually set calibration frequency of the optics For Example User selects 5 the device won t calibrate until next five consecutive images taken Camera stores selected menu settings when it is powered off Page 32 of 49 1 Default Display window when FA optics is attached using Manual
22. 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 Page 35 of 49 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 Middle 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 p Mmmm SS ne Middle 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 choose between still capture and video capture 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 Capture mode Both still images and video can be taken with the Smartscope M5 camera Capture mode can be chosen in DF menu and left soft key when in live view When taking video the shutter button must be held down while taking the video The video recording will stop once the shutter bu
23. 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 EY4 FA and ES2 are classified as Class 2 based on standard 15015004 2 2007 The daily usage time and maximum allowed number of pulses is calculated based on optical classification results according to standard 15015004 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 operated at maximum output will exceed the safety guideline after Maximum number of pulses still images allowed daily 4 6300 pulses still images eye 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 EY4 1h30 min video usage eye ES2 8 min video usage eye Page 6 of 49 3 Warnings and cautions Use only accessories and battery provided by Optomed with this product Place PC and cradle outside the patient environment at least 1 5 meters distance from the patient Connection between camera and workstation is USB and or WIFI Any autho
24. brightness Left Right arrow Rig Move fixation target Move between 9 internal fixation targets Icon above left soft key turns to lighter color when fixation target selection mode is active Focus manually When manual focus is active use up and down arrow keys to focus Press arrow key up when patient has myopia Press arrow key down when patient has Up Down arrow hyperopia Move fixation target Move between 9 internal fixation targets Icon above left soft key turns to lighter color when fixation target selection mode is active 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 choose between still capture and video capture On Off Mark side of the eye to the image data IR brightness Low High Aiming light brightness Red free free On Off Saves a copy of an eye image using green color channel only image when turned on image light source Target blinking On Off Fixation target light can be set to constant if needed 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 Marking side It is possible to mark which eye was imaged Marking side is enabled from the menu When side is marked t
25. e 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 5 Aiming light is automatically turned on when camera enters live view 6 The middle fixation target is lit when pressing left soft key and it by default providesing a macula centred image To change the fixation target press Left Soft Key and use arrow keys to navigate between the 9 targets as shown in the graphics in lower left corner of the display If fixation target is turned off ask patient to look at a target in a wall 2 3 meters behind the operator 7 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 Changing illumination brightness affects only the blue capturing flash Page 28 of 49 8 Aim help square on the screen guides user when to take image When retina is not fully in view the square is red Once the aim is good and retina fully appears on screen the Square turn s green indicating a good moment for capturing the image 9 Approaching the eye is started from 10 centimetres 4 inch distance 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 Aim help square on the display guides to take image o
26. ect fixation target Move between 9 internal fixation targets Icon above left soft key turns to lighter color when fixation target selection mode is active Left Right arrow Focus manually When manual focus is active use up and down arrow keys to focus Press arrow key up when patient has myopia Press arrow key down when patient has hyperopia Select fixation target Move between 9 internal fixation targets Icon above left soft key turns to lighter color when fixation target selection mode is active Up Down arrow Page 30 of 49 Table below includes explanations of the FA settings tab for fundus Angiography imaging Setting Values default bolded Purpose Start Study This enables the study to start For every new study user needs to go into the menu and start study to enable the study or Time counter On Off Mark side of the POI e to the image data IR brightness Low High Aiming Aiming light brightness brightness Instant Review On Off Instant review can be ON OFF according to user need as available in FA Optics menu Target Blinking By default the fixation target light is on with constant illumination If patient cannot keep their eye targeted well the light can changed to blink to help focus on the target light Calibration Frequency pen User can manually set calibration frequency of the optics Device EY FA 3 OT SK DF R amp D i Start study Mark side IR brightness High Select settings p
27. ed 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 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 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 It is recommended that image data storage is always erased before images are captured of a new patient Page 20 of 49 The camera keys function as shown in image below when Smartscope EY4 optics module is attached Focus manually Select fixation target Formatted Font 11 pt Short Level 1 2 3 Target off Long Power On Off Decrease Brightness Increase Brightness Select fixation target Select fixation target Short Light Dark eye Long New patient folder Short AF MF Long Menu Focus manually Select fixation target Focus manually Move fixation target Short Target low high off Move between tabs Long Power On Off Decrease Brightness Move fixation target Long New patient folder Short Auto MF AF assist M
28. ended 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 BA CAUTION Optic modules 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 OPTICS RELEASE BUTTON 7 5 Device Menu Page 14 of 49 Menu is opened by pressing right soft key XX for 1s Menu has six tabs One is for device settings such as language selection There is one tab for retinal imaging EY fundus angiogram imaging FA anterior eye imaging ES ear imaging OT skin imaging SK and general imaging DF Arrow keys are used to move between tabs use arrow key up until tab is active and use left and right arrow keys to change active tab Light blue color indicates active tab Arrow keys change values in the menu Active value is indicated with light
29. he human eye Infrared LED for targeting Blue LED for photographing 10 illumination brightness levels 9 red internal fixation target LEDs 8 07 TY 409 20 D to 20D 1536x1152 px total 1 8 Mpix informational area 1 41 Mpix 160x73mm 310g Page 41 of 49 Comment IJ1 8 07 cd cm EXTERNAL OPHTHALMIC MODULE CONNECTED TO THE SMARTSCOPE M5 CAMERA Type Intended use Illumination Maximum Luminance output level towards eye Image resolution Dimensions Weight Smartscope 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 cm 2560x1920 px 79x70 mm 90 g Page 42 of 49 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 to 35 Relative humidity use 10 to 80 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 to 95 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 aluminium carrying case Temperature
30. hutting down and taking an image 13 7 4 Attaching and detaching optics MOCUIE cccccsesccsssccce cece ceceeeeeeeecesaecesaeseeseesaenss 14 MEN m x 14 7 6 Adjusting focus and automatic FOCUS cceccccsececeeeeceeecceeecceeccaeceseucessueessueeaseeesanes 17 Zu Ree DUO 17 8 Retinal imaging using optics module Smartscope 19 9 Eye imaging using anterior ophthalmic module Smartscope 2 24 10 Fluorescein Angiography imaging using optics module Smartscope FA 28 11 General imaging without optics module 35 12 WEILOUIDeSSdBOS scientes ssm nho Aen 37 T3 38 T4 Device IIT ESI ING hospes pe 39 15 gt PASSED TION is De deae nds 40 16 Warnan uso as ae ee eee 45 Appendixes Appendix A Electromagnetic compatibility information Appendix B Battery replacement Page 4 of 49 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 and surface of the eye Supported optics len
31. iMH battery 4 HR 4U AAA 4 8V 1000 mAh Procedure for replacing the battery is 1 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 2 Remove the battery compartment cover by lifting it up 3 Remove old battery Squeeze battery wires with fingers and pull the connector out from its socket 4 Put the new battery in the same position and attach the connector to its socket 5 Replace the battery compartment cover and secure it in place by snapping it firmly to place Page 49 of 49
32. ility 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 IEC 60601 test level Compliance Electromagnetic level environment guidance Electrostatic discharge ESD 6 kV contact 2kV 4kV Floors should be wood IEC 61000 4 2 8 kV air 6 kV indirect concrete or ceramic tile If contact floors are covered with 2kV 4kV synthetic material the 6 kV contact relative humidity should be 2kV 4kV at least 30 96 8 kV air Electrical fast transient burst 2 kV for power supply 2 kV for AC Mains power quality should IEC 61000 4 4 lines power supply be that of a typical 1 kV for input output 1 kV for serial commercial or hospital lines cable environment Surge IEC 61000 4 5 1 kV line s to line s 1 kV for AC Mains power quality
33. ionality memory card is permanently installed Writing to the memory card from PC is not enabled by default Device can be used with all major patient database applications supporting both textual and image data recording The device must be used according to this manual quick reference guide and or information found on Optomed s 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 49 7 Operating instructions This chapter gives 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 because battery is charged only when charge is dropped below certain limit To connect Smartscope to the cradle gently place it to the connector hole The device can be connected to the cradle with optics attached 7 2 Connection to a PC J Smartscope Always do this for pictures Image data transfer method to PC is similar as with a digital camera Pictures options O When connected to a PC running Microsoft Windows XP Vista 7 or
34. ld 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 47 of 49 Manufacturer s declaration electromagnetic emissions SMARTSCOPE 5 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 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 the Optomed Smartscope M5 The Optomed Smartscope M5 is inte
35. lder 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 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 ui Middle key to activate Window returns to original position when camera is put to cradle turned off or optics module detached pm x 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 ES settings tab for anterior eye imaging Left soft key Middle key Setting Values default bolded Purpose Capture mode Still Video Use left and right arrow keys to choose between still capture and video capture Focus windows Visible Hidden Use left and right arrow keys to choose between having focus window visible or hidden On Off Mark side of the eye to the image data Page 26 of 49 Zoom cropping When turned on
36. n be edited after creating new patient folder 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 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 The camera has nine 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 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 The camera has two file formats that use
37. nce it turns from red to green 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 10 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 This Instant Preview can be enabled disabled in the Smartscope FA optics menu 11 If multiple patients are examined during one session new file folder is created for each patient by pressing middle key for over 3 seconds 12 Transfer images to a PC after capturing images Images are transferred to the PC when camera is placed to the cradle Smartscope works as any other digital camera 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 The camera keys function as shown in image below when Smartscope FA optics module is attached Page 29 of 49 Focus manually Move fixation target Short Auto MF AF assist Move between tabs Long Menu Increase brightness Move fixation target Short Target low high off
38. nded for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Optomed Smartscope M5 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Optomed Smartscope M5 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 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 propagation is affected by absorption and reflection from structures objects and people Page 48 of 49 Appendix Replacing the battery Battery pack is specially designed and manufactured for this device Optomed and Optomed s retailers provide suitable battery packs Labels in the battery and label inside the battery cover display following information N
39. nvenient 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 Smartscope EY4 has 9 internal fixation targets for the patient to fixate at while imaging Below section will guide how to control the fixation lights 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 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 up One click of the key is approximately 1 Dioptre e Myopia camera is focused closer by pressing arrow key down One click of the key is approximately 1 Dioptre 4 Aiming light is automatically turned on when camera enters live view 5 The middle fixation target is lit when pressing left soft key and it by default providesing a macula centred image To change the fixation target press Left Soft Key and use arrow keys to navigate between the 9 targets as shown in the graphics in lower left corner of the display If fixation target is turned off ask patient to look at a target in a wall 2 3 meters behind the operator 6 Light is adjusted using left and right arrow key
40. o 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 Page 22 of 49 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 image taken with white light Color correction It is possible to capture color corrected image 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 Target blinking By default the fixation target light is on with blinking illumination If patient cannot keep their eye targeted well the light can changed to constant to help focus on the target light Page 23 of 49 9 Eye imaging using anterior oph
41. ove between tabs Long Menu Increase brightness Move fixation target Focus manually Move fixation target Below table provides explanations for the key functions Key Press Function Explanation A3 Formatted Table Short Control Fixation target Fixation target is off by default and can be turned on level and selection by pressing left soft key Fixation target light has two levels Low and High If the patient cannot see the light on low level turn it up to high E Power On Off Camera is powered on and off by pressing the Left soft key for longer than 2s i Manual Auto AF Switch between focus modes by pressing Right soft assist key Manual focus is on by default Autofocus range is 11 to 3 di rs manual focus range is 20 to Right soft key nis i B Long Open Menu Enter camera menu by pressing Right soft key for longer than 1s Page 21 of 49 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 new folder cannot be created Change brightness Use left and right arrow keys to adjust capture light brightness Icon above left soft key must be selected lighter color to change
42. r 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 Page 16 of 49 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 By selecting Activate in Device menu Restore factory defaults selection the original factory settings will be returned Date Date can be set using the left and right arrow keys Move between day month and year by pressing the middle key Date format is DD MM YYYY for Finnish German French Italian Spanish Portuguese Date format is MM DD YYYY for Japanese and Chinese Time Time can be set using the left and right arrow keys Move between hours and minutes by pressing the middle key Camera SW version This item in Device menu tells the camera SW version 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
43. rization 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 49 4 Important symbols 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 Ila 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 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 ho 8 of 49 5 Parts of the device BAYONET CONNECTOR BAYONET HOLE OPTICS RELEASE BUTTON DUALACTION SHUTTER n _ SNAP FOR O
44. ses and their intended uses are Description Smartscope EY4 Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye Smartscope FA Optomed Smartscope 5 digital camera with FA optics module is intended to capture digital images of the fundus angiograms of the human eye Smartscope ES2 Optomed Smartscope M5 digital camera with ES2 optics module is intended to capture images and video of the surface of the human eye and surrounding areas Page 5 of 49 2 Contraindications for use of the optics modules EY4 FA ES2 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 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
45. should 2 kV line s to earth power supply 1 be that of a typical Phase without commercial or hospital Protective Earth environment Voltage dips short interruptions and 5 96 gt 95 96 dip in Manufacturer s Mains power quality should voltage variations on power supply for 0 5 cycle test shows be that of a typical input lines IEC 61000 4 11 40 96 6096 dip in conformance to commercial or hospital for 5 cycles the environment If the user of 70 U 3096 dip in requirements of the Smartscope M5 requires for 25 cycles the IEC 61000 4 continued operation during 5 96 gt 95 dip U 11 EN 61000 4 power mains interruptions it for 5 sec 11 is recommended that the Smartscope M5 be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic Power frequency magnetic field IEC 61000 4 8 fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE is the a c mains voltage prior to application of the test level Page 46 of 49 Guidance manufacturer s declaration electromagnetic immunity The Smartscope 5 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 testlevel level Electromagnetic environment g
46. thalmic module Smartscope ES2 Optomed Smartscope 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 ES2 e Cradle for charging and image transfer Smartscope ES2 optics module has two light sources white and cobalt blue light User can choose between the light sources by pressing middle key when 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 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 Itis recommended to use autofocus 4 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
47. tomed Smartscope M5 to the cradle Battery starts to charge Charge battery for 4 hours before the first use When device is not used it may be stored in the Cradle 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 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 Page 3 of 49 Table of contents QUICK 3 Tabl e ot CONTEN S osa re EA FORD 4 1 WGC AMOS TOP USC 5 2 Contraindications for use of the optics module Smartscope EY4 and Smartscope ES2 6 3 Warnings and 7 4 IMPONE 8 5 Pats a ec 9 6 Usage environment requirements 12 7 Operating INSUUCHIONS ear ee 13 T Prepara UON 13 72 CONMECHON xa pbi Neb 13 7 3 Basic use starting up s
48. tton is released Focus Window Focus Window helps 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 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 Camera stores selected menu settings when it is powered off Page 36 of 49 11 12 Error messages Optomed Smartscope M5 will display error messages about the limitations of the usage Error message is always displayed with explanatory message providing information about possible actions List of the all possible error messages Error message What to do Memory full Memory is full and you must empty memory card Optics type not detected Reconnect optic lens Contact maintenance if lens does not connect Optic failure Restart camera and reconnect optics lens Contact maintenance if lens does not Please detach the optic connect The number after text Optic failure is an error code that can be needed and restart the camera by Optomed service team inem Iban Image storage not found In case device has WIFI functionality contact Customer Service ee inate v Battery error change it to a new one too high
49. uidance 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 RF d 1 2 VP IEC 61000 150 kHz to 3 Vrms 4 6 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 RF 80 MHz to 3 V M Field strengths from fixed RF transmitters as determined by an IEC 61000 electromagnetic site survey a should be less than the compliance level in 4 3 each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Q 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 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 shou
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