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USB ULTRASOUND PROBE SYSTEM USER MANUAL

1. The New button allows the user to create new doctor profiles and assign preferences to the newly created doctor Edt The Edit button allows the user to make changes to an existing doctor s preferences The user can change a doctor s preferences by clicking this button while the desired doctor s name is selected in the Name combo box The Delete button deletes a doctor from the system When clicked the user 1s prompted for confirmation prior to deleting the doctor s preferences Once deleted the doctor will still exist in the database but will be marked as inactive Delete The Name combo box selects an existing doctor from the database to view edit or delete their preferences The Default Doctor checkbox selects which doctor will be automatically placed on the Patient Data and IOL Calculator Screens If only one doctor exists that doctor is automatically set as the default doctor Default Preferences Default Doctor Notes The Notes text box is provided to allow the user to associate notes to a doctor s preferences Page 37 of 86 8000 INS UMENG Rev 2 14 The Patient Data Screen The Scanmate application will automatically open the Patient Data Screen upon startup The Patient Data Screen allows the user to Create Review and Edit patient records 7 gm DGH Scanmate File Edit Preferences Reports Help MMM Aso Sese 101 calc LastName
2. Save X 211 Y 605 0 0 fps The default settings for this page are dependent on the currently selected Operator The default settings can be changed by selecting Preferences Operator 16 1 Selecting the Probe Select the desired probe from the list of available probes in the Probe Type combo Probe Type DGH box The available Pulse Frequencies will eee IT T be displayed for the selected probe The Depth selection adjusts the depth of the Depth n l i cm 0 0 07 displayed B Scan image Note Pulse Frequency is the rate that the probe 1s electronically pulsed It 1s not the resonant frequency of the transducer crystal Page 42 of 86 8000 INS UMENG Rev 2 16 2 Adjusting Pulse Power z The Pulse Power slider adjusts the BLEE nori J 10 amount of energy used to pulse the transducer element in the probe Adjusting the pulse power allows the user to distinguish between tissues with different acoustic densities Exams are typically performed at the highest Pulse Power unless the image is saturated and better definition between tissue structures is desired 16 3 Selecting the Operator The name of the Operator performing the measurement can be selected using the Operator dropdown box at right If the operator is not listed in the drop down box add the new operattor by selecting Preferences gt Operator gt New 16 4 Selecting OD or OS The eye currently being examined OD or OS
3. File Action View Help e 4 0 iS i9 fa SQL Server Configuration Manager Local Protocol Name Status E SQL Server Services ccs ezi Y Shared Memory Enabled e t cm i eee Named Pipes Disabled Protocols for AE TCP IP Enabled l Protocols for DGH6000 E bem VIA Disabled He Protocols for DGHSERVER s SQL Native Client 10 0 Configuration 2 Right Click on TCP IP and select Properties 3 Select the IP Addresses Tab and Scroll down to IPAII 4 Delete the 0 from TCP Dynamic Ports field and enter 1433 in the TCP Port field Page 71 of 86 8000 INS UMENG Rev 2 TCP IP Properties El ips Active Yes Enabled Mo IP Address 127 0 0 1 TCP Dynamic Ports TCP Port IP Active Yes Enabled No IP Address FeSO 5efe192 168 0 45 15 TCP Dynamic Ports TCP Part IP All TCP Dynamic Ports TCP Part Active Indicates whether the selected IP Address is active 5 Select OK and Acknowledge the pop up message instructing you that the SQL server must be restarted for the changes to apply Warning 6 Left Click on SQL Server Services in the left hand console panel Page 72 of 86 8000 INS UMENG Rev 2 7 Right Click on SQL Server DGHServer in the right hand details pane and select Restart a Sql Server Configuration Manager File Action View Help 9 A2 a S O OO 3 SQL Server Configuration Manager Local E SQL Server Services 4 H SQL Server Network Configuration He Pro
4. First Name Comments By default this screen will open in Search Mode It is also possible to configure the Patient Data Screen to automatically open a new blank patient record each time the program is launched To change this setting select the Automatically Start with a New Patient preference in the System Preferences menu 14 1 Patient Data Screen Controls The Patient Data Screen operates in three distinct modes of operation Search and View Edit Save Data and New Patient The action buttons on the top right hand side of the screen change availability depending on the current mode of the Patient Data screen The patient data screen buttons include New Search Edit Save Undo Page 38 of 86 8000 INS UMENG Rev 2 The New button is used to enter new patients in the DGH Scanmate database When clicked the Last Name First Name and ID combo boxes change to plain text boxes and allow the user to enter a new patient The Search button is used to search for patients in the DGH Scanmate database When selected the Patient Info controls are closed for editing and all combo boxes become auto suggest fields The Edit button is used to edit patient records in the DGH Scanmate database When selected the Patient Info and Pre Operative controls become enabled for editing The Pre Operative and Post Operative data 1s only needed for performing IOL power calculatio
5. Note Please refer to the DGH 6000 Scanmate A User Guide for information on configuring A Scan related System Preferences The Automatically Start With New Patient checkbox allows the user to select if the program starts with a new patient or if the user is required to search for a patient upon program startup When the checkbox 1s enabled the program will begin a new patient file upon system startup The Automatic Login checkbox allows the user to select if login is required upon system startup or if the user is automatically logged in By default this checkbox is enabled indicating that the username and password will be entered automatically The Report PDF Export Location setting allows the user to specify the default directory that pdf reports will be exported The default directory can be any local or mapped network drive Page 33 of 86 8000 INS UMENG Rev 2 The Database Location textbox specifies the location of the DGH Database Server hosting the DGH Scanmate database To change the Database Server that the DGH Scanmate application connects to select the Change Configuration button and follow the steps described in section 10 13 The Database Name textbox displays the name of the DGH Scanmate database The default database name is created automatically when installing the system and is not user configurable The Username textbox displays the username that the Scanmate application uses to conn
6. 6 Data 01 30 2013 6 Data 01 31 2013 Data 02 08 2013 i faa Data 09 26 2012 C Program Files DGH Technology Inc Data D Database Files mdf M DGH Scanmate mdf 6 The Attach Databases dialog window will now show the DGH 6000 mdf Click OK S somt Ene Databases to attach DGH Scanmate database details Original File Name File Type Curent File Path Message Conne C Program Files DGH T xx agi C Program Files DGH T HPPROBOOK4520 DGHSERVEF Connection sa a View connection properties Ready Page 64 of 86 8000 INS UMENG Rev 2 19 6 Importing and Exporting Data B Scan Image and Video files can be imported or exported from the DGH Scanmate database to be consulted in other locations or by other practitioners If both locations have the Scanmate Software v3 0 0 or later installed the best way to exchange B Scan files is to use the bscan file format This format includes all the necessary information to completely identify the patient and to re create the record in the database It 1s also possible to export jpg images or avi movies to share with practitioners that do not have the Scanmate Software See section 16 for more details on exporting these file types To export a bscan file select File gt Export B Scan File The currently loaded B Scan Image or Video will be saved to the selected location To import
7. A N WARNING It is the responsibility of the user to remain current with the latest information from the relevant disinfectant manufacturer concerning instructions effects necessary concentrations immersion times and rinse requirements A N WARNING Using a non recommended disinfectant incorrect solution strength or immersing the probe tip deeper than described in step 4 above or for a period longer than recommended can damage or discolor the probe and will void the probe warranty Do not immerse the probe tip for longer than one hour The probe may be damaged by longer immersion times Disinfect the probe tip using only the liquid solutions Using autoclave gas EtO or other non DGH Technology approved methods will damage the probe and void the warranty Page 77 of 86 8000 INS UMENG Rev 2 22 Care and Maintenance 22 1 Care of the USB Probe The USB probe is a completely sealed unit The probe may be submersed in water up to the cable during normal use A N WARNING Do Not Attempt To Open the Probe Housing The probe should be cleaned after every use See the Cleaning and Disinfecting section for more details Regularly check the front face of the probe for cracks as this may cause a loss of fluid which would impair the performance of the probe Be sure to keep the USB connector dry at all times Regularly check the USB cables for cuts cracks and kinks The presence of these defects can impair the
8. Neo Selecting an Installation Folder Note If the computer or server being set up will only be used to host the database and will not perform scans this step will automatically be skipped by the installer By default the Scanmate software will be installed in the C Program Files DGH Technology Inc DGH Scanmate folder If a different location is desired it can be selected here On computers with multiple users the software can be made either available to all users or only available to the current user logged in during the installation Click Next to continue Page 22 of 86 i9 DGH Scanmate Select Installation Folder The installer will install DGH Scanmate to the following folder To install in this folder click Next To install to a different folder enter it below or click Browse Folder C Program Files DGH Technology Inch DGH Scanmate Browse Disk Cost Install DGH Scanmate for yourself or for anyone who uses this computer Everyone rE D Cancel lt Back Lo Nets 8000 INS UMENG Rev 2 10 12 Installation Note If the computer or server being set up will only be used to host the database and will not perform B scans this step will automatically be skipped by the installer During installation a progress bar will appear in the installation dialog box When the installation has finished successfully it will be replaced by an
9. A Mo USB Devices Detected Clicking OK will complete the log in and allow the Scanmate software to be used without the USB probe Although no scans can be completed the software can still be used to review B Scan images videos and reports If the Scanmate software is being used without the DGH 8000 probe attached the software will require probe key authentication before using and after every 20 hours of use Warnings will appear every hour after 15 hours of use To provide authentication plug a DGH 8000 probe into a USB port authentication will complete in a few seconds Page 32 of 86 8000 INS UMENG Rev 2 13 Configuring the Scanmate Software 13 1 System Preferences The System Preferences window provides controls to set various configuration items for the system The System Preferences window can be accessed by selecting Preferences gt System from the Menu Bar FP System Preferences aystem Options Login Configuration Database Location IP or Computer Name E Automatically Start With New Patient WINTPROXBA4 TESDDGHSERVER 7 Automatic Login Database Name DGH Scanmate Default Keratameter Index nc Username 1 3375 DGHUser Repot PDF Export Location Password IDGHTest1 Selected A Scan Transducer Hint Default Configure Transducer Change Configuration Caution Accepting changes ta System Preferences may alter currently loaded data Please review data on all farms Cancel
10. s last name in the Last Name field The software will automatically show all the results that match the letters that have been typed The desired Last Name can then be selected from this list If there is more than one patient in the database with the selected Last Name the desired patient can be selected using either the First Name and ID Number fields Only patients that have the currently selected Last Name will be available in these fields To search by ID Number type the desired ID number into the ID Number field Alternatively the ID Number can be selected from the dropdown list Once the desired ID Number has been selected the unique patient associated with that ID will appear on the screen Once a patient record has been loaded the Procedures associated with that record can be searched by selecting the Procedure list box 14 4 Editing a Patient Record Select the desired patient record to be edited following the steps described in section 14 3 Once the patient record has been loaded select the Edit button All of the editable fields will change from read only fields to white editable text boxes Once the desired changes have been made select the Save button to save the changed record Page 40 of 86 8000 INS UMENG Rev 2 15 The A Scan Screen The A Scan Screen allows the user to perform and review A Scan Measurements for the currently selected patient Please refer to the DGH 6000 Scanmate A User Guide for instr
11. DGH 8000 packing enclosure If the original package is not available pack in such a way that the DGH 8000 is protected 22 6 Disposal Contact DGH Technology Inc before disposing of the DGH 8000 Concerning the WEEE label the following information is for EU member states The use of this symbol indicates that this product should not be treated as household waste By ensuring that this product is disposed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product For more information concerning the return and recycling of this product please consult DGH Technology Inc Page 79 of 86 8000 INS UMENG Rev 2 23 Troubleshooting If a problem is experienced with the DGH 8000 try the suggestions listed below Error During Installation of Net Framework e In order to install the Net framework on Windows SBS Server 2008 the following steps are necessary 1 On the Start Menu select START gt Administrative Tools gt Server Manager 2 Click on Features in the left panel of the Server Manager dialog box 3 Click on Add Features in the Features panel of the Server Manager dialog box 4 Expand the NET Framework 3 5 1 Features in the Select Features dialog box 5 In the expanded NET Framework 3 5 1 Features list check ONLY NET Framework 3 5 1 and click the Next button 6 Click the Instal
12. KB to 20 fps Save Video On Stop Scan Bidirectional Scan The B Scan Video Buffer Frames slide bar adjusts the size of the buffer used when capturing B Scan video Moving the slide bar from left to right increases the number of frames stored in the buffer Increasing the number of frames that can be stored in the buffer allows the user to determine the amount of video that 1s captured before 1t begins to overwrite itself The video buffer can be configured to store from 16 to 256 frames Save Image On Stop Scan 7 Average Display Control Values I4 Interpolate When the Save Video On Stop Scan checkbox is selected the B Scan video will automatically be saved when the scan 1s stopped When the Save Image On Stop Scan checkbox is selected the last B Scan frame will automatically be saved when the scan is stopped The Display Control Values checkbox allows the user to select whether or not the Gain Intensity and Contrast control values are displayed in the B Scan image window When the Bidirectional Scan checkbox is selected the B Scan probe will acquire image information in both sweep directions The Average preference turns on the frame to frame B Scan averaging algorithm For slower processors averaging can be turned off to improve display performance at the expense of image quality The Interpolate preference enables or disables the linear interpolation algorithm For slower processors i
13. Post processing TGC control s near mid and far Contrast and Image Intensity controls Frame averaging Interpolation Signal processing Exam data Patient name and comments Video buffer range up to 512 frames or 34 seconds Open system architecture Archive functions 5 0 VDC 5 500mA maximum 2 5 watts maximum Power Requirements obtained from the USB2 port Max operating temperature 40 C 104 F Min operating temperature 10 C 50 F Operating humidity range 20 80 non condensing Environmental storage Temperature 10 C to 50C 14 F to 122 F Page 86 of 86 8000 INS UMENG Rev 2
14. Regularly Page 84 of 86 8000 INS UMENG Rev 2 APPENDIX B SUMMARY OF ACOUSTIC OUTPUT 12 0 MHz Probe Lm ome pm pm Mode Scanning Non scanning Acoustic working NA NA frequency MHz Bounded output power 173 0 173 0 173 NA NA mW Attenuated output 0 056 0 056 NA NA power mW Spatial peak temporal NA NA average intensity mW cm2 A Attenuated spatial peak N temporal average intensity mW cm2 Peak rarefactional acoustic pressure MPa Attenuated peak rarefactional acoustic pressure MPa 2 dB output beam NA NA area cm2 Equivalent aperture NA NA diameter cm Depth at max NA NA attenuated pulse intensity integral cm Supplementary information B Mode only with 60 degree scan angle 15 Hz scan rate and 256 lines per scan Page 85 of 86 8000 INS UMENG Rev 2 APPENDIX C SCANMATE B SPECIFICATIONS Imaging mode B Scan with Vector A mode Standard USB Port 2 0 connectivity Multiple freeze method button on probe keyboard or soft key on screen Zoom with enhanced resolution using 4 times over Sampling Auto Image saves on Freeze Functions Resolution Electronic 0 015 mm Clinical lt 0 1 mm Gray shades True 256 8 bits shades of gray Sector Size 60 degree sector Transducer High Bandwidth single element 12 MHz amp 15 MHz Depth selections 3 cm 6 cm 12 MHz 5 cm 10 cm 15 MHz Measurements 2 calibers for distance measurements Image
15. SQL ServerName HPPROBOOK4520 DGHSERVER HPPROBOOK4520 DGHSERVER SQL System Administrator Login sa SOL System Administrator Password IDGHTest1 Connect to the desired SQL Server 2008 instance to continue Connect to the desired SQL Server 2008 instance to continue Connection Status Connected Connection to SQL Server HPPROBOOK4520 DGHSERVER was successful _ Bk Ne Page 24 of 86 8000 INS UMENG Rev 2 Note When sharing the database over a network make sure the firewall on the computer hosting the database has been configured to allow access to SQL Server Client computers will be unable to connect to the database unless this is done See section 19 8 for details on firewall configuration Note In order to connect to the SQL database server over a network both the computer hosting the database and the client computer must be in the same Workgroup or Domain Once connected to the SQL Server click the Next button A database can now be created If a DGH Scanmate database already exists the installer will configure the DGH Scanmate application to connect to the existing database a Database Creation Update a a Database Creation Update Database Name DGH Scanmate Version 1 0 Click the Next button to continue A database is already installed on HPPROBOOK4520 DGHSERVER gt An instance of the DGH Scanmate database was not found Click the Create
16. amount of zoom is displayed in the top left corner of the display A single left click returns the image to normal resolution gm DGH Scanmate JZ m Open File Save Image Copy Image 9 oh Patient W A Scan gi TH IOL Calc Jane Doe 123 456 789 File Edit Preferences Reports Help Image Saved 04 10 2013 03 29 22 PM y Print Probe Type DGH 8000 Li B Scan Controls Position Map a a OS 1 30AX Scan 4 06 2009 11 45 00 AM Pulse Freq 15 MHz Freq 15 MHz Depth 5cm Depth 5 cm Zoom 250 Pulse Power 4 Calipers 4 Comments 9 A B THIS IS AN EXAMPLE OF A COMMENT Operator Smith Change Eye Near Gain J Mid Gain J Far Gain Intensity J Contrast Page 45 of 86 8000 INS UMENG Rev 2 16 13 Selecting Probe Orientation The position map allows the user to easily record the probe orientation along with the saved B Scan image or video T Eco een m VAX Cilary Body Pa eI Exi km O VAXO Ora f i ae m a ea E i T PX i quem Equator Anterior Yeu y AN Trans Equator H d 1 L3 j MAC Equator Posterior Lees Le 224 O HMAC Posterior to the Equator 2 NS 7 Xf LMAC Posterior Pole NA A TMAC Optic Nerve TN RIT me Macula cee RNC Lon The images produced by the DGH 8000 represent a 60 degree cross sectional slice of the globe
17. bak Do you want to continue 5 Select Yes if you wish to continue The Restore Process will attempt to restore the database from the backup file 19 3 Copying or Moving the Database If the database must be moved from its current computer or server location it can be transferred intact to a new location It is also possible to create a copy of the database which can be used as a Back Up 1 Launch SQL Server Management Studio on the computer hosting the database Management Studio can be found from the Windows Start Menu by selecting Programs gt Microsoft SQL Server 2008 R2 gt SQL Server Management Studio 2 Connect to DGHServer by entering the system administrator password that was created when the DGH Database Server was installed see section 10 6 for details Microsoft 4 SQL Server2008 m Server type Database Engine Server name HPPROBOOK4520 DGHSERVER Authentication SQL Server Authentication Login sa Password Remember password Cancel Help Options gt gt 3 It is necessary to Stop the DGH Database Server before the database can be copied or moved Right click on the DGHServer and Select Stop Note This will disconnect all active users from the database and should only be performed when the database is not being actively used Page 59 of 86 8000 INS UMENG Rev 2 4 Microsoft SQL Server Management Studio File Edit View Debug
18. can be selected by pressing the Change Eye button The currently selected eye is shown in the top left hand corner of the B Scan display 16 5 Starting Stopping the Scan Use the Blue Button on the Scanmate B probe to start Start Scan e and stop the scan The Space Bar or the Start Scan button can also be used 16 6 Adjusting Image Controls The three Gain Controls allow you to Hear Gain p 0 adjust the near middle or far field gain of the displayed image These sliders Mid Gain B 0 control gain in the imaging software not the probe itself Far Gain LJ 3 The Intensity Control adjusts the intensity g 3 overall intensity or brightness of the image Contrast 5 8 The Contrast Control adjusts the overall contrast of the image Adjust this control to increase or decrease the amount of contrast between light and dark areas of the 1mage Page 43 of 86 8000 INS UMENG Rev 2 16 7 Saving Operator Settings The current image control settings Gain Intensity Contrast can be saved to the active operator by selecting the Save Settings button Whenever the operator is selected the image controls will default to the saved settings 16 8 Video Controls Use the video controls to review the scan Save When paused use the slider bar to sweep Settings l through the video manually or use the keyboard arrow keys to move frame by frame 16 9 Diagnostic A Mode ue Sel
19. corner of the B Scan Screen This will also save all SaveVideo changes that have been made to the Patient Data since the last save Alternatively the currently loaded video can be saved using the toolbar at the top of the screen by selecting File gt Save B Scan Video Page 49 of 86 8000 INS UMENG Rev 2 16 13 Reviewing B Scan Exams Saved B scan files can be opened by clicking the Open File button This will open a window that shows all saved images and videos for the Open File current patient Open B Scan File leal Double clicking any image or video will open the file in the scan view window The Push Pin allows the user to pin the window to the desktop so that it remains visible even after a file has been loaded Alternatively the window can be configured so that it closes after a record is loaded The window can be configured to show saved records for both eyes OU or to only show records for the right OD or left OS eye Records can be deleted by Right clicking and selecting Delete from the context menu The Aspect Ratio of the window vertical vs horizontal can easily be changed The Scanmate program will remember the size and location of the window the next time it is opened Use the Check Box in the top right corner of each thumbnail to include the image in the B Scan Report 16 14 Saving B Scan Images as Jpegs It is possible to convert saved B Scan Files to jpg images so that they can
20. gigs cim do pn ER aee ene ead aires pn 209m Eds actin ead 55 19 DATABASE MANAGEMEN D 22 1 ERN ISI IE Ere NRI tabes 56 19 1 Backing Up the DGH Scanmate Database eese 56 19 2 Restoring the DGH Scanmate Database eeeeeesseeeeeee 57 19 3 Copying or Moymp the Database uii tni eoru eed reed curet edens 50 194 Dekne a DAL AD AS unetoetestu esame arua Cede oM dreht ars comedat ie eed 61 19 5 Attaching an Existing DGH Scanmate Database to a DGH Database SOLVED e 62 19 6 Importing and Exporting Data eeeeeeeeeseseeeeeeeennnneeeeeeen nnn 65 I9 7 importune Legacy Piles CDS Or SCITH a oi bedee re E bae bbs 66 19 8 Configuring Firewall for DGH Database Server seeeeeeessse 67 20 ELECTROMAGNETIC COMPATIBILITY eeeeeeeeeee eene 74 21 CLEANING AND DISINFECTION iet ette tea eS EHE S Rb NE 75 ZN Probe leas idest redeunt a a devia tute A diria 76 2k22 Probe DIS IMC hio Niicpos a a E E S 76 Page 4 of 86 8000 INS UMENG Rev 2 22 X XRESNDUVERINODEINAINGSE ristorante EH Ra POE a RE tUe ee Heat Mes 78 224 Care ofthe USB Pro we aue eru etnia a aero reb bea dadte 78 22 2 Maimtenance OF the USB Prope cette tco de adn o piede dace saeua 78 22 9 Operas COMCIMONS ea R E 78 PLGA O O eet eR ON ER LIT SEER COUR TINE TO eae OEE TTT AU cd UE 79 27 5 VAG porano uses yar cette cereale clin eei Orte uut Eu to uU np Pai a
21. or Video Page 48 of 86 8000 INS UMENG Rev 2 Macula Scans HMAC A horizontal macula scan HMAC is a horizontal axial scan where the probe has been aligned so that it 1s pointed directly at the macula The marker on the tip of the probe should be pointed nasally 3 00 OD or 9 00 OS The optic nerve shadow will be shifted towards the top of the display VMAC A vertical macula scan VMAC is a vertical axial scan where the probe has been aligned so that it is pointed directly at the macula The marker on the tip of the probe should be pointed in the superior 12 00 position LMAC A longitudinal macula scan LMAC is a longitudinal scan through the macula where the marker on the tip of the probe 1s pointed temporally 3 00 OS or 9 00 OD TMAC A transverse macula scan TMAC is a vertical transverse scan where the probe has been aligned so that it 1s pointed temporally 3 00 OS or 9 00 OD directly at the macula 16 11 Saving B Scan Images B Scan Images can be saved by selecting the Save Image Button on the e upper right hand corner of the B Scan Screen This will also save all Save Image changes that have been made to the Patient Data since the last save Alternatively the currently loaded image can be saved using the toolbar at the top of the screen by selecting File gt Save gt B Scan Image 16 12 Saving B Scan Videos B Scan Videos can be saved by selecting the Save Video Button on the E upper right hand
22. performance of the device A N WARNING Do Not Attempt to Disconnect or Remove USB Cable from the Probe 22 2 Maintenance of the USB Probe Periodic testing and maintenance of the USB Ultrasound Probe is NOT required 22 3 Operating Conditions The DGH 8000 Scanmate B should be operated within the following conditions e Max operating temperature 40 C 104 F e Min operating temperature 10 C 50 F e Operating humidity range 20 80 non condensing Page 78 of 86 8000 INS UMENG Rev 2 22 4 Storage When the DGH 8000 is not being used it should be stored in a clean dry area To prevent damage to the DGH 8000 do not store in areas where it might be exposed to Excessive vibration Excessive dust and dirt Liquids or condensation Impact Store the DGH 8000 under the following ambient conditions e Temperature 10 C to 50C 14 F to 122 F e Relative Humidity 20 to 80 no condensation e Atmospheric pressure 70 kPa to 106 kPa 22 5 Transportation Never carry the DGH 8000 by the USB cable Never bend the USB cable in a tight radius This could result in damage to the cable Transport the DGH 8000 under the following ambient conditions e Temperature 10 C to 50C 14 F to 122 F e Relative Humidity 20 to 80 no condensation e Atmospheric pressure 70 kPa to 106 kPa When transporting the DGH 8000 to a different field location or when returning it for repair or maintenance use the original
23. records added since the date of the last back up will be lost so regular back ups are essential 1 Open the Back Up Restore window by selecting File gt Database gt Back Up Restore Page 57 of 86 8000 INS UMENG Rev 2 2 Connect to the DGH Database Server by entering the system administrator password that was created when the DGH Database Server was installed see section 10 6 for details Configure Back Up Restore mm Server Connection Status Not Connected Server HPPROBOOK4520 DGHSERVER User Name sa Password IDGHTest1 Use Windows Authentication CL connect e Back Up Restore Last Back Up None Database 3 Select the desired database to Restore from the combo box and select the Restore button za Configure Back Up Restore Server Connection Status Connected Server HPPROBOOK4520 DGHSERVER User Name sa Password IDGHTest1 Use Windows Authentication Back Up Restore Last Back Up 4 4 2013 3 30 42 PM Database DGH Scanmate Backup Restore T Page 58 of 86 8000 INS UMENG Rev 2 4 A message box will appear to warn you that the Restore Process will delete the current database Any data that was saved since the last back up will be lost Warning le The restore process will delete the current database amp replace it with A the data from back up file C Program Files DGH Technology Inc Data Back Up DGH Scanmate DGH Scanmate
24. that the model number of this device is DGH 8000 GN This symbol indicates the serial number of the device YY YY indicates the year of manufacture and XXXX indicates the unit number F This symbol located on the DGH 8000 indicates that the equipment consists of electronic assemblies and other components that may be subject to Directives 2002 96 EC 2003 108 EC and 2002 95 EC of the European parliament which advises that electrical and electronic devices must not be disposed of as normal domestic refuse In order to prevent environmental risks or endangerments by non professional disposal the disposal of this product including any accessories must comply with valid practices as outlined in Directives 2002 96 EC 2003 108 EC and 2002 95 EC and local regulations All electronic components and systems should be returned to Original Manufacturer for disposal 4 4 General Cautions and Warnings A N CAUTION The probe must be cleaned after each use Cleaning the transducer is an essential step prior to effective disinfection Follow the manufacturer s instructions when using disinfectants A N WARNING Do not allow sharp objects such as scalpels or cauterizing knives to touch the probe or cables A N WARNING Equipment not suitable for use in the presence of flammable mixtures Page 9 of 86 8000 INS UMENG Rev 2 A N WARNING If the probe is used with other devices current leakage may increase and electric shock may be
25. tni Ree an tate hti mie DARE le Mun tesa editi tie Bau 42 HON Selecting tle PLOWS gx diss a E oo Dd uskE seed t dude 42 10 2 ZXNdjustie Pulse POWer arerin tee o re nbesiea eite Sot Ue tees 43 16 Selecting the Operalor edi E Ea oda OR ER beni aate cues EN E ed enis 43 t64 Selecting OD Ot OS seriinin e ETRS 43 16 5 Sta une y Stoppin NESC aiies a 43 160 zAdjustme Iniasc C onio acer E O ER 43 lO Savins Operator SCLUTITES mera N Asus A Rose anus 44 1S VIdeo CONTOS nocie in a a E mae A a lean PEU 44 16 9 DidenOstic A ModE centi E E E EE 44 1610 Adding Exam COMMEN senars en A 45 INN Caliper Eot Mr 45 IM Zwei 45 16 15 selectins Probe Orena JOD oot oda be ole honesto tdt bo dest edes 46 1O LI avis D scan Mates usce caedere ade oan in a v auc 49 LOZ Savins Bas Cam VAC OS iussum dida caceaua eda eeu eiui dt Eae recente 49 6 15 Reviewing B Scan Ex aMS aieia S 50 t614 Savine B Scan Images as JD6S9S ied itg do rae en aA S 50 6 15 Saving B Scan Videos as AVI PIS onis a reo eot ud 51 16 16 Creatin Repor 2 gilt eta E 5l 16 17 Performing a B Scan EX ain iiio rre ire tti eina leone Pk ead a ore oc eius 52 13 THE OL CALCULATOR S CREE Nigar teta te ve edente Rut Lu on dnte 53 I5S CREATING ROR Saeco et Onde inva ute nium oap dd quin RE apu ed datu 54 S L JescandBebOLbexsestteudm oco cP PRTC ehe iu n en do ot M DA S Dd 54 15 2 Usma Repon oosetoodiet eot ertum aut toh duce tales ether a Dd anne 35 5 5 ODOIUne REPONS ooo eoe onini cnd
26. will ensure correct installation of the DGH Scanmate drivers Note The following steps may vary depending on the version of the Windows Operating System being used 11 1 Connecting USB Interface Module Connect the DGH 8000 Probe to an available USB 2 0 port 11 2 Found New Hardware Wizard Once plugged in the Found New Hardware Wizard should appear automatically If the Found New Hardware Wizard does not appear launch the Add New Hardware Wizard manually The Add New Hardware Wizard can be launched in Control Panel or by typing hdwwiz into the search box in the start menu Do not use Windows Update to search for software Select the No not this time option and press the Next button Found New Hardware Wizard Welcome to the Found New Hardware Wizard Windows will search for current and updated software by looking an Your computer on the hardware installation CD or an the Windows Update Web site with your permission Read our privacy policy Can Windows connect to Windows Update to search for software CO Yes this time only yand every time connect a device Click Next ta continue Page 28 of 86 8000 INS UMENG Rev 2 11 3 Automatically Install Drivers Select the Install the software automatically Recommended option Click the Next button to continue with the installation Found New Hardware Wizard This wizard helps you install software for Intersan Corporati
27. will not perform B scans this step will automatically be skipped by the installer Crystal Reports 2008 1s a pre requisite used by the Scanmate software to create and view reports Install Crystal Reports 2008 Crystal Reports 2008 Click start to begin the installation of Crystal Reports 2008 ex cms C sb Page 18 of 86 8000 INS UMENG Rev 2 Click Start to begin installation The installer will provide a notification when finished click Next to continue Install Crystal Reports 2008 Crystal Reports 2008 Crystal Reports 2008 has finished installing Click next to continue to the next step Back Cancel 10 8 DGH Scanmate Drivers Note If the computer or server being set up will only be used to host the database and will not perform B scans this step will automatically be skipped by the installer Install DGH Scanmate Drivers DGH Scanmate Drivers Click start to begin the installation of the DGH Scanmate Drivers coe c T sw T Click Start to install the DGH Scanmate drivers The installer will now install the drivers to operate the DGH 8000 All DGH devices must be disconnected from the USB port s during the driver installation process A warning window will appear as a reminder UNPLUG USB DEVICES BEFORE CONTINUING mim All DGH devices must be disconnected from the USB port s before proceeding Please disconnect all DGH devices and select OK
28. 0 INS UMENG Rev 2 3 Select Port and then Next Rule Type Select the type of firewall rule to create Steps What type of rule would you like to create Rule Type Protocol and Ports Action Program e Profile Rule that controls connections for a program Name Port Rule that controls connections for a TCP or UDP port Predefined Connect to a Network Projector Rule that controls connections for a Windows experience Custom Custom rule 4 Select TCP and Specific Local Ports Enter port number 1433 and then select Next Protocol and Ports Specify the protocols and ports ta which this rule applies Steps Rule Type Protocol and Ports amp TCP Action UDP Profile Does this rule apply to TCP or UDP Name Does this rule apply to all local ports or specific local ports All local ports e H Example 80 443 5000 5010 Leam more about protocol and ports Page 68 of 86 8000 INS UMENG Rev 2 5 Select Allow the connection and then select Next a New Inbound Rule Wizard Action Specify the action to be taken when a connection matches the conditions specified in the rule Steps Rule Type What action should be taken when a connection matches the specified conditions Protocol and Ports iQ Allow the connection ded This includes connections that are protected with Psec as well as those are not Profile T O Allow the connection if it is secure aii Thi
29. A S10 Cidex Gluteraldenyde K934434 Cidex Plus Gluteraldehyde K923744 1 Wear protective gloves when performing the disinfecting procedure 2 Check the expiration date on the solution that is being used Use only solutions that are within the expiration date 3 Mix the disinfection solution compatible with the probe according to label instructions for solution strength A disinfectant qualified by the FDA 510 k process 1s recommended 4 Immerse the tip of the probe approximately 1 5 cm in the disinfection solution Avoid immersion beyond the membrane probe interface 5 Follow the instructions on the disinfection label for the duration of probe immersion 6 Using the instructions on the disinfectant or sterilization label rinse the probe up to the point of immersion and then air dry or towel dry with a clean cloth 7 Examine the probe for damage such as cracks splitting fluid leaks or sharp edges or projections If damage 1s evident discontinue use of the probe and contact a customer service representative Page 76 of 86 8000 INS UMENG Rev 2 A N WARNING DGH makes no claims about the biological effectiveness as a disinfectant of any of the products listed above Furthermore DGH makes no claims regarding the effectiveness of any of these products for killing any known or unknown bacteria virus or other micro organisms DGH only claims that these products when used properly will not harm the probe tip
30. Aa fy Connection Security Rules O rgen me Prete Yes Allow Ne M New Rute E Monitoring O ngee Private Yes Afiow No ell NP Firer by Profile o avgupd exe Prevate Yes Afow Ne i Bonjour Private Yes Atow No V Paty Ree Beoryour Prate Yes Allow Ne V iter by Group d Dropbox Private Yei Allow No View gt o Dropbux Prate Yes Allow No lich Retreat O dropboxexe Public Yes Allow No M y dropbox exe Public Yes Auw No Export Lis FileMaker Pro Private Yes Allow No H Hep o FileMaker Pro Public Yes Aliaw No Q FileMaker Pre Public Yes Allow Ne v FileMaker Pro Prate Yes Allow No E Google Fanh Private Yes Allow Ne o Google Earth Prate Yes Allow Nu uo McAfee Shared Service Host Prevate Yes Allow No v McAfee Shared Service Host Prate Yes Allow No Q Microsoft Office Groove Private Yes Allow No Q wet Office Groove Prate Yes Allow No Q Microsoft Office OneNote Public Yes Allow No o Microsoft Office OneNote Private e Allow No E Microsoft Office OneNote Prevate Yes Allow No amp Microsoft Office OneNote Public es Allow No E Microsoft Office Outlook Prevate Yes Allaw No amp NAVBrowser Private es Astow No E NAVErowser Prevate Yes Allow No E Quick Play Au Yes Allow No E Quick Play Resident Program A Yes Allow No o Skype A3 Yes Aow No a SQL Server Windows NT Prevate Yes ASnw Ne G SQL Server Windows NT Domain No Altow Nc a SQL Server Windows NT Prevate Yes Allows No I m Page 67 of 86 800
31. Button below to build the DGH Scanmate database If a prior database version exists select Update DB to update it to the latest version Page 25 of 86 z ad Database Creation Update A database is already installed on HPPROBOOK4520 DGH6000 Database Name DGH Version 1 0 6 Click Update DB to upgrade database to latest version 8000 INS UMENG Rev 2 The following message may appear if the DGH Database Server was previously uninstalled and the database was not removed If the database contains files that should be retained refer to section 19 5 Attaching an Existing DGH Scanmate Database to a DGH Database Server If the previous database is not wanted delete it before proceeding a Database Creation Update ole x Old database files detected Please attach files at C Program Files DGH Technology Inc Data to SQL server or remove them before clicking Create DB again Click on Create DB to continue After successful database creation a notification screen will appear Click Next to continue E a Database Creation Update The DGH Scanmate database was successfully created on HPPROBOOK4520 DGHSERVER server Click the next button to continue configuring the DGH Scanmate application Page 26 of 86 8000 INS UMENG Rev 2 A database user must be created A single log in will be used for all users of the computer system a Cr
32. DGH 8000 SCANMATE B ULTRASONIC B SCAN ScANMATE DGH 8000 OPERATOR S MANUAL For Use with Scanmate Software v3 0 0 Equipment Manufactured By Authorized Representative DGH TECHNOLOGY INC EMERGO EUROPE 110 SUMMIT DRIVE Molenstraat 15 SUITE B EC REP 2513 BH The Hague EXTON PA 19341 The Netherlands Phone 31 70 345 8570 USA 610 594 9100 Page 1 of 86 8000 INS UMENG Rev 2 Page 2 of 86 8000 INS UMENG Rev 2 TABLE OF CONTENTS GENERATLADE VIG EADES CRU TION merane a eases ie leet tere e 7 2 IDEVICE CLASSIFICATION coccion e dut eU euo NR a inh ee bue MER Ui baditqt dns 7 3 ANDICA TIONS OR USE 5uectbseseteeesdevetee esee ce oed PER ssid usdin a tn eee petere 7 A WARNINGS AND CAUTIONS cremene inae niveau ape eno mec V IEEE Eme IU UDINE 8 Ah jMeaningoroienal W OOS ven seatomabers aie Mad auepin aaa ese 8 A SUESCHDDUOB OBSS VEIDOLS s nee casera tate nena Metu iat T nu atta Rit St o 8 4 4 General Cautions and Warnings ccccccccccsssssseeccccccccaesseeeccecesseesaseseeeeees 9 2 PRESCRIPTION DEVICE STATEMENT 5 eecseuccset ess peus bee cnet EH e eoo eet co dedvededdeasaets 10 6 OPERATOR OUALIPICA TION S 2o oi eeoetia peto abi orae o tete tide deb utet ee Uie Ebo ds 10 7 USE OF ULTRASOUND IN OPTHALMIC DEVICES esee 11 8 ULTRASONIC EXPOSURE AND INTENSITIES eere 11 8 1 Tissue Exposure to Ultrasound Energy ccccccccsssesseeccecceeeeeseneeeeeeeee
33. HSERVER SQL Serva Lg Databases LL System Databases J DGH Scanmate 3 Lj Security Lg Server Objects Lj Replication 3i Lg Management ACA ACA EM 4 ES Connect Disconnect Register New Query Activity Monitor Stop Pause Resume Restart Policies Facets Start PowerShell Reports Refresh Properties 8000 INS UMENG Rev 2 19 4 Deleting a Database The following steps describe how to permanently delete the DGH Scanmate database A N WARNING Be certain that the database has been successfully moved or backed up before performing removal Removing the database without backing up will result in data loss 1 Launch SQL Server Management Studio on the computer hosting the database Management Studio can be found from the Windows Start Menu by selecting Programs gt Microsoft SQL Server 2008 R2 gt SQL Server Management Studio 2 Connect to DGHServer by entering the system administrator password that was created when the DGH Database Server was installed see section 10 6 for details Microsoft SQL Server2008R2 Server type Database Engine Server name HPPROBOOK4520 DGHSERVER Authentication SQL Server Authentication Login sa Password Remember password Cancel Help Options gt gt Page 61 of 86 8000 INS UMENG Rev 2 3 Expand Databases right click on DGH Scanmate and select Delete Wz Microsoft SQL Serve
34. Install the Scanmate Software and Create a New DGH Database Server on the current computer This choice will be used for standalone operation In a networked arrangement this choice will also be used for the computer that houses the database if that computer will be used to perform B scans Choosing to Install Scanmate software and Connect to an Existing DGH Database Server will prepare a computer to operate the B Scan E iiy The information collected by the B Scan will be saved on a networked i database the database should already be installed on a network location before selecting this option Create New DGH Database Server will only install the DGH Database Server This choice will be used for a server or networked computer that will store patient records but will not be used to perform B scans Click on one of the three icons to select the desired setup option The setup will begin automatically Page 15 of 86 8000 INS UMENG Rev 2 10 5 NET Framework Installation The NET framework is necessary for the proper operation of the DGH Scanmate software If it is not present the installer will install the NET framework before proceeding Click Start to begin If prompted click Next to install the NET framework Install NET Framework NET Framework 2008 Click start to verify that the NET Framework is installed If the Net framework is already present or when it has completed installi
35. Installation Complete announcement Click Close to exit the installer i9 DGH Scanmate 5 DGH Scanmate Installation Complete Installing DGH Scanmate DGH Scanmate is being installed DGH Scanmate has been successfully installed Click Close to exit Please wait Please use Windows Update to check for any critical updates to the NET Framework Cancel A new shortcut will now appear on the desktop Please complete the configuration steps before launching the Scanmate application n EU do Page 23 of 86 8000 INS UMENG Rev 2 10 13 Database Configuration After successful installation a configuration dialog will automatically launch This establishes how the Scanmate software will connect with the SQL database Click Start to begin ud DGH Scanmate Configuration at Welcome The following screens will help you configure the DGH Scanmate application Select the DGH Database Server you wish to connect to in the combo box If no database servers are listed select Browse For More to get a list of all available DGH Database Servers Enter the adminstrator password created in section 10 6 and click the Connect button When the Connection Status shows Connected click the Next button Fill out the fields below to connect to the SQL Server 2008 instance Fill out the fields below to connect to the SQL Server 2008 instance SQL Server Connection SQL Server Connection ee
36. Page 19 of 86 8000 INS UMENG Rev 2 When the drivers have been installed a success window will appear Clicking Next will conclude all prerequisite installations Install DGH Scanmate Drivers DGH Scanmate Drivers The DGH Scanmate Drivers have finished installing Click next to continue Cancel To continue with installation of the DGH Scanmate software click the Install Scanmate button DGH Scanmate Prerequisites mm The selected prerequisites were installed successfully Install Scanmate Page 20 of 86 8000 INS UMENG Rev 2 10 9 DGH Scanmate Installation Note If the computer or server being set up will only be used to host the database and will not perform B scans this step will automatically be skipped by the installer The DGH Scanmate Setup Wizard will launch automatically once the prerequisites have been successfully installed i9 DGH Scanmate c mese Welcome to the DGH Scanmate Setup Wizard CERES w The installer will quide you through the steps required to install DGH Scanmate on your computer WARNING This computer program is protected by copyright law and international treaties Unauthorized duplication or distribution of this program or any portion of it may result in severe civil or criminal penalties and will be prosecuted to the maximum extent possible under the law Click Next to continue Note If the DGH Scanmate program has already been installed on the cu
37. Restore 2 Connect to the DGH Database Server by entering the system administrator password that was created when the DGH Database Server was installed see section 10 6 for details Configure Back Up Restore em g Server Connection Status Not Connected Server HPPROBOOK4520 DGHSERVER User Name sa Password IDGHTest1 Use Windows Authentication Back Up Restore Last Back Up None Database Page 56 of 86 8000 INS UMENG Rev 2 3 Select the desired database to Back Up from the combo box and select the Back Up button J Configure Back Up Restore Server Connection Status Connected Server HPPROBOOK4520 DGHSERVER v User Name sa Password IDGHTest1 Use Windows Authentication Back Up Restore Last Back Up 4 4 2013 3 30 42 PM Database DGH Scanmate AC Done 4 Once the back up process has completed a message box will display the location of the backup file It is recommended that the backups be performed regularly and stored in a safe location Preferably backup files should not be stored on the same physical drive that hosts the database Back Up Complete e Database Backed Up To C Program Files DGH Technology Inc Data Back Up DGH Scanmate DGH Scanmate bak H M 19 2 Restoring the DGH Scanmate Database If it is necessary to restore a prior database the back up version can be reinstalled Any
38. Tools Window Community Help T New Query D Ls G3 a Object Explorer Connect 3 SY as 21X 3 S HPPROBOOK4520 DGHSERVER SQL Se Lg Databases Lg System Databases uj DGH Scanmate 3j Lg Security Lj Server Objects amp Lg Replication 3 Lg Management Connect Disconnect Register New Query Activity Monitor Pause Resume Restart Policies Facets Start PowerShell Reports Refresh Properties 4 Navigate to the DGH Technology Inc directory using Windows Explorer This can typically be found at C Program Files DGH Technology Inc 5 6 Copy the Data folder and Paste it in the desired location For back up purposes this folder can be stored anywhere though preferably on a separate physical drive If you plan to use the database on a different computer the Data folder must be placed in the DGH Technology Inc folder that was created when the DGH Database Server was installed on that computer See section 19 5 for details on attaching the database to a new instance of the DGH Database Server To continue to use the database on the original computer the DGH Database Server must be restarted In Management Studio right click on DGHServer and Select Start i Microsoft SQL Server Management Studio File Edit View Debug Tools Window Community Help T New Query iy Ls E wey Page 60 of 86 Object Explorer Connect 3j 39 as 21xXx HPPROBOOK4520 DG
39. a bscan file select File gt Import B Scan File A browser window will open to select a bscan file to open Once opened the file will load the Patient Data and B Scan information into the Scanmate program The opened file can be saved in the database at this point Page 65 of 86 8000 INS UMENG Rev 2 19 7 Importing Legacy Files bs or cini It is possible to import bs and cini files from prior versions of the Scanmate B software To import a bs or cini file select File gt Import B Scan File A browser window will open to select a bs or cini file to open Because these files don t contain all the necessary information to be included in the DGH Scanmate database a dialog window will open requesting additional information when importing these file types Select Import Settings Select the Desired Patient Name Scan Date and Eye for the Imported File Doe John B OD Video 02 01 2013 11 55 AMx cine Patient Last Name First Name Patient ID D O B Adams Sue 111 234 5434 5 8 1962 Anderson Don 876 658 7960 1 13 1963 Conner Sam 435 234 6556 6 8 1959 Conrad Joseph 232 453 8785 12 15 1960 _ Jane 123 456 789 11271986 Em 111 224 564 4 5 1959 George 564 897 4594 7 19 1942 Jessica 453 986 5947 4 28 1969 Tim 987 452 5437 5 17 1949 Kim 936 45 6543 9 23 1939 Mary 143 567 3243 9 12 1958 Russ 678 465 3205 5 23 1961 Scan Date 02 01 2013 11 55 40 AM El amp OD A OS Mote If th
40. and orbit The position map indicates the area of the eye being imaged not the position of the probe The marker on the black membrane covering the tip of the probe as well as the blue start stop button corresponds to the top of the displayed image By convention the marker is generally aimed either superiorly or nasally Axial Probe Positions An axial scan provides an image of the posterior globe with the optic nerve centered on the right side of the image The probe is positioned so that it is centered on the cornea while the patient is looking forward When properly aligned the optic nerve will be centered on the right side of the image Example of 12 00 AX VAX Scan Use the selection tool to indicate the meridian being scanned where the yellow marker matches the orientation of the marker on the tip of the probe Once the Page 46 of 86 8000 INS UMENG Rev 2 desired position has been selected use the Set button to save the orientation to the current B Scan Image or Video Longitudinal Probe Positions Longitudinal scans provide a radial image from the posterior pole to the anterior periphery The probe is positioned on the sclera perpendicular to the limbus while the patient 1s looking toward the area of the eye being examined The probe marker is pointed towards the limbus causing the optic nerve to be towards the bottom of the image Example of 12 00 L Scan For a 12 00 Longitudinal scan the marker on the
41. be shared with EMR systems or practitioners that do not have the Scanmate Software To do this select the Open File button on the B Scan screen and drag the image thumbnail s to the desired location Note Jpeg files cannot be imported back into the Scanmate program See section 19 for other import export options Page 50 of 86 8000 INS UMENG Rev 2 16 15 Saving B Scan Videos as AVI Files The Scanmate software can convert saved B Scan videos to AVI files so that they can be used outside of the Scanmate program To create an AVI file first load a B Scan video from the Scanmate database and select File gt Export B Scan File Change the file type from BSCAN to AVI in the file type drop down box and select the Save button Note AVI files cannot be imported back into the Scanmate program See section 19 for other import export options 16 16 Creating Reports Click the Print icon to quickly create a B scan report The report will include the patient information doctor operator and date A window with all the saved images and videos for the current patient will open Use the checkboxes in the top right corner of each image to include them in the report The selected images will be shown inserted in a report preview window Clicking the Add Comments button in the report preview will open a comment box for text entry Reports can be sent to a printer saved in the database or saved as PDF files For more information on creati
42. can either be saved on the computer operating the DGH 8000 on a networked computer or on a server Deciding whether a system will be used to perform scans store data or both will determine which software components should be installed Standalone Operation A single computer is used to operate the DGH 8000 B scan review the data collected and store the database MATE Networked to a Server The database is stored on a server on the local network Any networked computer can be set up to perform scans and review the data collected Page 12 of 86 8000 INS UMENG Rev 2 Networked with other Computers Multiple computers perform B Scans and all the data is stored in a single database on one of the computers Once the desired configuration has been determined the installation wizard will ensure that only the necessary components are installed on each system Note Depending on the security settings of the computer system the computer may ask for permission at various points during the installation process Click Yes to allow the installer to make the necessary changes to the computer system during installation A N WARNING Using Non Essential Software in Conjunction with the Scanmate System Could Have Unknown Adverse Impact on the Operation of the Device and is Therefore Not Recommended 10 1 Automatic Launching of the Installation Program Insert the Scanmate DVD into the DVD drive of the computer or c
43. canmate B have an obligation and responsibility to provide the highest degree of infection control possible to patients co workers and themselves To avoid cross contamination follow all infection control policies established for the office department or hospital as they apply to personnel and equipment A N WARNING Always disconnect the DGH 8000 from the host computer before performing maintenance or cleaning Always follow the manufacturer s instructions when cleaning and disinfecting probes Do not use a surgeon s brush when cleaning probes Even the use of soft brushes can damage the probe Page 75 of 86 8000 INS UMENG Rev 2 21 1 Probe Cleaning 1 Wear protective gloves when performing the cleaning process 2 Disconnect the probe from the system 3 Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any particulate matter or body fluids that remain on the probe or cable 4 To remove remaining particulates rinse with water up to the blue strain relief where the USB cable enters the probe Do not immerse the strain relief or USB cable 5 Wipe with a dry cloth or wipe with a water dampened cloth to remove soap residue and then wipe with a dry cloth 21 2 Probe Disinfection The following disinfectants are recommended due to their biological effectiveness as well as their chemical compatibility with the DGH 8000 materials Solutions Country Type Active ingredient FD
44. cation computer name and password for connecting to the database server are correct e If connecting to a database over the network verify that the computer hosting the database 1s powered On and the firewall on the computer hosting the database has been configured to allow access to SQL Server see section 19 8 for details In addition verify that both computers are in the same WORKGROUP or DOMAIN e If the system administrator password for SQL Server has been lost or forgotten it will be necessary to reset it using Management Studio 1 Launch Management Studio as described in section 19 2 Select Windows Authentication instead of SQL Server Authentication 3 Right Click on the sa User Account found under Security gt Logins and select Properties 4 Enter and confirm the new password USB Probe Not Connected e Confirm that the drivers have been installed for the USB 2 0 port the probe is currently connected to See section 10 8 for details e Confirm that the USB cable is firmly connected to the probe e Try connecting the probe to a different USB port on the computer Probe Key Expired e The USB probe must be connected to the PC running the Scanmate application after every 20 hours of use e If connecting the probe does not reset the Probe Key try the steps described in USB Probe Not Connected section of the troubleshooting guide Page 81 of 86 8000 INS UMENG Rev 2 24 Warranty DGH Techno
45. caused It is the user s responsibility to ensure safety when the probe is to be used with other devices If safety cannot be ensured use of the probe with other devices is not allowed A N WARNING The use of a Non Medical grade AC Adapter could potentially cause harm to the system the probe the operator and or the patient 5 Prescription Device Statement A N CAUTION The DGH 8000 is a prescription device and is only to be used by or under the supervision of a licensed physician 6 Operator Qualifications This DGH 8000 is intended to be used by trained medical professionals The medical professional operating the DGH 8000 must have a general knowledge of the use of ultrasonic imaging devices and imaging protocols Page 10 of 86 8000 INS UMENG Rev 2 7 Use of Ultrasound in Opthalmic Devices Ultrasound offers a non invasive method to examine the interior of solid objects Ultrasonic pulses consist of sound waves of a frequency level too high to be heard by the human ear When a sound impulse strikes an interface some sound is reflected and some sound is transmitted Because some sound will pass through the surface and be reflected by the next surface complex structures can be examined with ultrasound When ultrasound penetrates an object with several interfaces the reflected ultrasound can be observed on a display as a Brightness Scan that shows the relative position and magnitude of the echo spikes received by
46. cmtes license 79 22 JOISDOSdL osiedexiieit Ue etoile uten idu otia te d EM Mie ane 79 29 TROUBLESHOOTING itecto tuviese tete unb te pe It oen uva dod tese Ub te o ut opti dui tesa tote eds 80 24 WARRANTY e a a ouce nate teenth 82 25 IEE TIME 7 SHELF LIFE crae a o Mas N MI uibem 82 26 CUSTOMER SERVIC Eessen aa T 83 APPENDIX A COMPUTER SYSTEM SPECIFICATIONS cer 84 APPENDIX B SUMMARY OF ACOUSTIC OUTPUT 12 0 MHZ PROBE 85 APPENDIX C SCANMATE B SPECIFICATIONS 2 tnentet pera bae aaa rua qu pee ouo 86 Page 5 of 86 8000 INS UMENG Rev 2 Page 6 of 86 8000 INS UMENG Rev 2 1 General Device Description The DGH 8000 is a diagnostic ultrasound device used by professionals in the ophthalmic field to produce cross sectional images of the eye and orbit The probe is comprised of a 12 MHz single element transducer that is mechanically oscillated to perform a 60 degree sector scan of the eye The probe hand piece contains the electronics used to pulse the transducer as well as to measure filter and amplify the resulting echoes from intraocular and orbital tissue The probe is powered and controlled via a USB 2 0 cable which must be connected to a PC or Laptop running the Scanmate software The Scanmate software interprets the digital signals transmitted by the probe and displays a Brightness Scan that shows the relative magnitude of the echo spikes received by the transducer The software allows the user t
47. e 28 11 2 Found New Hardware Wizard i i nates ERE el e ether h tune Reno 28 11 5 Automatically Install Di Vers o oio niae n Ret rte Sue poe Eta oE 20 ee MWandoWsDogo Ves tire seccion uide Hone eia Eutaiek itus Ne etse ao abes 20 11 5 Complete Installation of Drivers eeeeeeeeerneeeeeeen nere 30 11 6 Further Driver Installation eeeeeeesssseeseeeeeeenenneeenene nnne 30 12 STARTING THE SCANMA TE SOETWANRE ettet near tete oen a HERES 3l 2 1 baunching the ADDHO3HOD uu corre O ETR b eens 3l 2 05 DIAS CEEE D sssettestedsuitonitetidbcs haltet ossa et moneta cuan eere 3l 2 SOS SCICCN aspe a bord eae m USER ecu I ee eens 3l 12 4 No USB Devices Detected Wartilng iieon re peciit eene co todo eene aco oa ihe 32 13 CONFIGURING THE SCANMATE SOFTWARE RE Etats 33 5 L System Prereren Ces naom E tay ADM Medal ane 33 15 2 Operator Pree ro NCS Serasa a aa ena EA 35 15 5 WOCIOR Pre NC a aa E RT 37 Page 3 of 86 8000 INS UMENG Rev 2 t THEPATIENT DATA SCREEN e eio EE ue E e 38 I4 Patent Data Screen CODEEOIS secare eet rb Sen eate Seded usted reus Fee anos 38 2 Sterne a New Pauelit uecet vam nte rode tech Aderat bed qas cote o aioe 39 14D searching TOr 3 Pate DE sosidieudot bores c On uidi se dirt aided tulis d Urine Ede 40 Id Iditme a Patient RECON usce me rediere eese opta edid eqa etes 40 d el eee 2 esie qo Bids H 4 to THE BSC ANC SCREEN i iiaisciet
48. e Desired Patient Record is Not Shown Select Cancel and Add the Patient Cancel to the Database Select the Patient that you would like to associate the imported file with If the desired patient is not shown select Cancel and add the patient to the database Verify that the Eye OD or OS and the Scan Date are correct and select Import Once opened the file will load the Patient Data and B Scan information into the Scanmate program The opened file can be saved in the database at this point Page 66 of 86 8000 INS UMENG Rev 2 19 8 Configuring Firewall for DGH Database Server When sharing the database over a network the firewall of the computer hosting the database must be configured to allow access to SQL Server Client computers will be unable to connect to the database unless this is done Note opening ports in your firewall may make your computer less secure and increase the risk of it being exploited by malicious software The following procedure describes the necessary steps for configuring the firewall to allow access to a DGH Database Server that is being hosted on Microsoft Server 2003 2008 Windows Vista Windows 7 or Windows 8 1 On the Start menu of the computer server hosting the database click Run type WF msc and then click OK 2 Right Click on Inbound Rules and select New Rule File Action View Help 7217 s ur rei vh Neme Group z Profile Enabled Action Override inboundRues
49. eate DGH Scanmate SQL Login Please enter the user information you would like to use to log into the DGH Scanmate software Usemame DGHUser Password IDGHTest1 Password Hint IDGH Hint 1 To avoid being accidentally locked out of the system it is recommended that the user name and password be written down in a secure location USER NAME PASSWORD Note Please select a strong password A strong password contains a mixture of capital and lowercase letters numbers and symbols ud Save DGH Scanmate Configuration j a DGH Scanmate Configuration Complete Please confirm the configuration information displayed on the screen If the information is The configuration application has successfully configured the DGH Scanmate database correct press save to save the information to the configuration file If the information is incorrect press back and correct the information before continuing SQL Server HPPROBOOK4520 DGHSERVER Login DGHUser Password IDGHTest1 Password Hint IDGH Hint 1 Language en US Click Save to save the configuration settings A final window will appear to confirm that the configuration was completed successfully Page 27 of 86 8000 INS UMENG Rev 2 11 Installation of Scanmate Drivers In order to complete the driver installation connect the DGH 8000 Probe to an available USB 2 0 port The drivers will automatically be installed If this does not happen the steps below
50. ect the A Mode checkbox to enable the diagnostic A Scan V A Mode overlay Use the scroll bar on the right of the 1mage to select V Comments the desired A scan vector gm DGH Scanmate File Edit Preferences Reports Help Video Saved 04 08 2013 03 12 44 PM 7 e d jf Patient TN A scan B Scan IOL Calc Lf ti S o OpenFile Save Image Save Video Print Jane Doe 123 456 789 OS 1 30AX ES ree poen m Scan 4 06 2009 11 45 00 AM NUN NA R Pulse Freq 15 MHz Freq 15 MHz n TT Ed m Depth 5 cm Pulse Power 10 V A Mode 7 Calipers 7 Comments 9 A B Operator Smith Change C Eye Start Scan e Near Gain 5 0 Mid Gain J 0 Far Gain p 3 Intensity p 3 Contrast p 8 Save Frame 22 l4 b Settings X 524 LJ Y 344 0 0 fps T Page 44 of 86 8000 INS UMENG Rev 2 16 10 Adding Exam Comments Select the Comments checkbox to enter comments The comments box can be dragged to any location on the image 16 11 Caliper Tool To use the Caliper Tool right click and drag the mouse across the image A second caliper can be selected by clicking B in the caliper selection box The caliper measurement values are displayed in the bottom left corner of the scan image v Calipers masssnnam iA H B H H Saaeeneas 16 12 Zoom Double clicking on the image allows you to Zoom into an area of interest The
51. ect to the database To change the username select the Change Configuration button and follow the steps described in section 10 13 The Password textbox displays the password that the Scanmate application uses to connect to the database To change the password select the Change Configuration button and follow the steps described in section 10 13 The Hint textbox allows the user to enter a hint for the password If a user is logging in manually clicking the Show Hint button at log in will display the hint text To change the hint select the Change Configuration button and follow the steps described in section 10 13 Page 34 of 86 8000 INS UMENG Rev 2 13 2 Operator Preferences The Operator Preferences window provides controls to identify Operators and configure their preferences The Operator Preferences window can be accessed by selecting Preferences gt Operator from the Menu Bar 2 Operator Preferences miim Operator A Scan Settings Video Playback Speed Video Buffer Frames Default Preferences Probe LED Intensity B Scan Settings Video Playback Speed Video Buffer Frames LJ Video Buffer File Size 15 777 KB Save Video On Stop Scan Bidirectional Scan Save Image On Stop Scan 4 Average Display Control Values 7 Interpolate OK Cancel Apply Note Please refer to the DGH 6000 Scanmate A User Guide for information on configuring A Scan related Ope
52. eeaas 11 D WIEASOMIC Men E a a s male MUS 11 9 BIOMETRIC IMAGING CAPABILITIES uenia teen E Cea Ya eth cuu e eta o Eee bens 11 10 SOFTWARE INSTALLATION INSTRUCTIONS eeeeeeeeee nennen nennen nnns 12 10 1 Automatic Launching of the Installation Program esses 13 10 2 Manual Launching of the Installation Program eeeesssss 14 TOS Welcome S CEEI ear e rubus ime NT enisi atta uad eq NE med edictum 14 LOA Setup COMM SUA ON cieee ut saves to odio CoU V seid bre e od iod seq aub suas 15 105 NEF Framework Installation o eciam oe ns Puto pta ba oo Ee aeu uda 16 IOG SOES fc a pert etter Seon ne ne Pn vei uM MM ME M EMEN ELEM 16 I0 Crystal Reports Installation 2530 ioo true ioe nce iii idee tar euet OU Daun 18 10S DGH Scanmate DELVOLS vias Sages tus oso cides hanna a mune et bete EE ER een 19 10 9 DGH Scaninate InstallattOfs sid ueste emen t Pone epe Gebr ed eg ua erbe pe T 21 10 10 DGH Scanmate License Agreement Window ccccccceeecesseeeeeeeeeeeeeeaes 27 10 11 Selecting an Installation Folder eseeeeeeeeeeeeeeees 22 TO E mstalfdblOEod eieiidonde coute E stes td ta toS EU Laut 23 I0 15 Database C OBnITSUEALlODl cisco dao o nh ig de dea Ur E ve sida ees d eU reta 24 11 INSTALLATION OF SCANMATE DRIVERS eeeeeeeeeeeee eene 28 11 1 Connecting USB Interface NIGAM Cs usea see niet cedere eU non teb ue de bet
53. electric shock The R DGH 8000 Scanmate B is classified as type BF equipment This symbol instructs the operator to read the operating manual This mark indicates that Notified Body 0120 SGS United Kingdom Ltd 0120 has certified the management system of DGH Technology Inc meets the requirements applicable requirements of 21 CFR 1010 Performance Standards for Electronic Products General and 21 CFR 1050 Performance Standards for Sonic Infrasonic and Ultrasonic Radiation Emitting Products The device also conforms to the following International Standards EN 60601 1 Medical electrical equipment Part 1 General requirements for safety IEC 60601 1 EN 60601 1 2 Medical electrical equipment Part 1 General requirements for safety Collateral standard Electromagnetic compatibility requirements and tests IEC 60601 1 2 NEMA Standard Publication UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA Standard Publication UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Page 8 of 86 8000 INS UMENG Rev 2 This symbol indicates that Emergo Europe is the European Authorized Representative for this device This symbol indicates that DGH Technology Inc is the manufacturer of the DGH 8000 Scanmate B device The YYYY under the symbol indicates the did year the device was manufactured REF This symbol indicates
54. en m Use the checkboxes in the top right corner of each image to include them in the report The selected images will be shown ino inserted in a report preview window Patent Jane Doe B 5ean Report Apr 171 2613 Clicking the Add Comments button in the report preview will open a comment box for text entry Select the desired number of images per page using the Image Page Radio Button The colors of the images can be inverted by selecting the Invert Colors checkbox This helps conserve ink toner when printing images Page 54 of 86 8000 INS UMENG Rev 2 18 2 Using Reports All types of reports can be printed browsed and saved in the same ways Clicking the small printer icon in the top left corner will send the report to the printer The arrows and page icon next to the printer icon will z navigate through the report The Export to PDF button will save the report as a PDF to the ExporttoPDF Default Data Directory specified in System Preferences A browser window will open to allow the user to select the save location and name of the PDF created The Save to DB button will add the report to the DGH Scanmate save to DB database Once saved the report can be retrieved by searching the patient s name or ID number Clicking Cancel will exit the report and return to the Scanmate Cancel ee c o application 18 3 Opening Reports To view a previously saved r
55. eport select the patient through the Patient Data screen search Using the Menu Bar go to File gt Open gt Report A dialog box will display all the saved reports available for that patient Each report is automatically given a unique name consisting of the type of report the date it was created and the time it was created If more than one report is created within the same minute these reports will then be numbered 1 2 3 etc Saved reports can be printed or saved as PDF files Page 55 of 86 8000 INS UMENG Rev 2 19 Database Management Patient data scan images measurements video files and reports created by the Scanmate application are saved in an DGH Scanmate database The database allows patient records to be shared centralized or accessed remotely according to the needs of each biometry department For example several operators in a large practice could use several DGH 6000 or DGH 8000 units simultaneously but all patient records would be stored in a central database Or a doctor could perform scans in an examination room then later access patient records from an office computer The database can be backed up and restored migrated to another location or removed 19 1 Backing Up the DGH Scanmate Database Electronic records should be backed up regularly as a safeguard against loss due to computer malfunction damage or theft 1 Open the Back Up Restore window by selecting File gt Database gt Back Up
56. he password in a secure place SERVER NAME DGHServer LOG IN NAME sa PASSWORD Note Please select a strong password Depending on the security settings of the system the SQL application may reject a weak password such as password A strong password contains a mixture of capital and lowercase letters numbers and symbols and 1s at least 8 characters long Please review the SQL Server 2008 R2 End User License Agreement EULA before continuing After selecting the I Agree button click the OK button to continue Page 17 of 86 8000 INS UMENG Rev 2 EULA far SQL Server 2008 R2 MICROSOFT SOFTWARE LICENSE TERMS IMICROSOFT SOL SERVER 2008 R2 EXPRESS WITH TOOLS MICROSOFT SQL SERVER 2008 R2 EXPRESS WITH ADVANCED SERVICES These license terms are an agreement between Microsoft Corporation or based on where you live one of its affiliates and you Please read them They apply to the software named above which includes the media on which you received it if any The terms also apply to any Microsoft updates supplements Internet based services and support services for this software unless other terms accompany those items If so those terms apply BY USING THE SOFTWARE YOU ACCEPT THESE TERMS IF YOU DO INOT ACCEPT THEM DO NOT USE THE SOFTWARE C IDoNot Agree 10 7 Crystal Reports Installation Note If the computer or server being set up will only be used to host the database and
57. he wizard 11 6 Further Driver Installation The DGH Scanmate has two sets of drivers The second set of drivers will be installed the first time the Scanmate application 1s launched Note You must install the drivers for each USB port you wish to use the Scanmate product s with It is recommended that you install the drivers on each USB port of the computer at this time following the steps above Page 30 of 86 8000 INS UMENG Rev 2 12 Starting the Scanmate Software 12 1 Launching the Application Once installed the DGH Scanmate shortcut appears on the Windows desktop and in the start menu Click on the desktop icon to start the DGH Scanmate application MATE a 12 2 Splash Screen The Scanmate splash screen will appear while the application loads 12 3 Login Screen A single username and password is used to gain access to the software and database for all users By default the Scanmate software is set to automatically log in when the application is started using the username and password specified in System Preferences To change this setting uncheck the Automatic Login preference in the System Preferences menu If a login is requested enter the username and password created in section 10 13 TECHNOLOGY INC Username Password Page 31 of 86 8000 INS UMENG Rev 2 12 4 No USB Devices Detected Warning If the USB probe is not attached a warning box will appear
58. l button on the Confirm Installation Selections dialog box 7 When the Installation Results dialog box appears click the Close button Error During Installation of SQL Server 2008 R2 e Confirm that the user has administrative privileges on the system where SQL Server is being installed e If SQL was previously uninstalled the computer must be restarted before SQL can be installed again e Depending on the security settings of the system the SQL Server installation may fail if a Strong password isn t used Make sure the system administrator password uses a mixture of capital and lowercase letters numbers and symbols and is at least 8 characters long DGHTestl is an example of a strong password Unable to Connect to DGH Scanmate Database e Confirm that the location user name and password for connecting to the database are correct e If the database was moved or SQL server was re installed you will need to re attach the DGH Scanmate database to the DGH Database server See section 19 5 for details e If connecting to a database over the network verify that the computer hosting the database 1s powered ON and the firewall on the computer hosting the database has been configured to allow access to SQL Server see section 19 8 for details In addition verify that both computers are in the same WORKGROUP or DOMAIN Page 80 of 86 8000 INS UMENG Rev 2 Unable to Connect to DGH Database Server e Confirm that the lo
59. lect Attach Wz Microsoft SQL Server Management Studio File Edit View Debug Tools Window Community Help T New Query y E gt G7 ae Conect 9 39 YAS Bg id HPPROBOOK4520 DGHSERVER SQL Server 10 50 1600 sa mti E Gy New Database E La D a Restore Database Restore Files and Filegroups Start PowerShell Reports Refresh 4 The Attach Databases dialog window will open Click the Add button T Attach Databases E Script v 3 Help Databases to attach MDF File Location Database Attach As Owner Status Message Remove Database details E Original File Name File Type Current File Path Connection Server HPPROBOOK4520 DGHSERVEF Connection 32 View connection properties 5 The Locate Database Files dialog window will open Browse to the mdf file for the old DGH Scanmate database If it was installed in the default location the mdf file will be in C Program Files gt DGH Technology Inc gt Data gt DGH Scanmate gt DGH Scanmate mdf Select the mdf file and click the OK button Page 63 of 86 8000 INS UMENG Rev 2 i Apple Software Update _ mg Bonjour E 2g Broadcom E Business Objects EE g Cisco Systems Eg Common Files EH Corel B CrashPlan Eg DGH Technologies Inc Eg DGH Technology Inc EMO Data BHO Back Up Eg DGH 6000 Eg DGH Scanmate Ef DGHScanmateFS 6 Data 01 02 2013 f y Data 01 14 2013
60. logy Inc DGH warrants each new DGH 8000 and its accompanying accessories hereinafter called Equipment to be free from defects in material and workmanship for twelve 12 months from the date of delivery to the original purchaser This warranty is not applicable to any defect that is the result of an accident misuse mishandling neglect improper installation improper repair or improper modification by persons other than DGH This warranty does not apply if the Equipment has not been operated and maintained in accordance with the operating and maintenance manuals and instructions or bulletins issued in respect thereof by DGH The cost of servicing replaceable and expendable items including parts and labor made in connection with the routine maintenance services as described in such Operator s Manual is not covered under this warranty and is the responsibility of the purchaser This warranty is strictly limited to replacement or repair of the part that is found to be defective in material and workmanship At the option of DGH said part shall be replaced or repaired free of charge F O B our factory by DGH DGH reserves the right to make changes in the design and material of Equipment without incurring any obligations to incorporate such changes in Equipment already completed on the effective date of any such changes This is the only warranty of this product and is expressly in lieu of all other warranties expressed or implied by law
61. lp toolbar Manufactured by DGH TECHNOLOGY INC TECHNOLOGY INC 110 SUMMIT DRIVE SUITEB 2 EXTON PA 19341 USA 610 594 9100 Authorized European Representative EMERGO EUROPE Molenstraat 15 EC 2513 BH The Hague The Netherlands Phone 31 70 345 8570 Page 83 of 86 8000 INS UMENG Rev 2 APPENDIX A COMPUTER SYSTEM SPECIFICATIONS Minimum System Requirements Processor 32 bit or 64 bit 2 GHz Memory 2 GB RAM Optical Drive DVD ROM For Software Installation Hard Drive 1 GB minimum 100 GB recommended Ports USB 2 0 Display 1024 x 768 Resolution Peripherals Mouse or Touchpad Keyboard AC Power Supply Medical Grade Compatible Operating Systems Microsoft Windows XP SP3 or higher 32 Bit Microsoft Windows Vista SP1 or higher 32 or 64 Bit Microsoft Windows 7 32 or 64 Bit Microsoft Windows 8 32 of 64 Bit Microsoft SBS 2003 or 2008 SQL Server Installation Only A N WARNING The use of a Non Medical grade AC Adapter could potentially cause harm to the system the probe the operator and or the patient A N WARNING Using Non Essential Software in Conjunction with the Scanmate System Could have Unknown Adverse Impact on the Operation of the Device and is Therefore Not Recommended A N WARNING Due to the Threat of Computer Viruses it is Recommended that an Anti Virus Program be Installed on the Computer Running the Scanmate Application and that Patient Records Be Backed up
62. ng a success window will appear Click Next to continue Install NET Framework NET Framework 3 5 The NET Framework is installed Click next to continue Back Cancel 10 6 SQL Server Note If the computer being set up will only be used to perform scans and will not host the database this step will automatically be skipped by the installer Please proceed to section 10 7 Crystal Reports The DGH Scanmate database requires SQL Server 2008 R2 The installer will check for the presence of this application If it is not present the installer will install the necessary SQL Server 2008 R2 pre requisites before proceeding It may be necessary to restart the computer in order to complete the SQL Server installation if prompted restart the computer and restart the installation procedure Page 16 of 86 8000 INS UMENG Rev 2 Install SQL Server Please create a System Administrator Password for the DGH SQL Database server Server Name DGHServer Administrator Login sa A Note A strong password is required The password must be atleast 8 characters long and contain a combination of upper case characters lower case characters and either numbers or symbols Back Cancel If installing SQL Server for the Scanmate application for the first time an administrator name and password must be created The server will be named DGHServer The system administrator log in name is sa by default please record t
63. ng reports see section 18 Creating Reports Page 51 of 86 8000 INS UMENG Rev 2 16 17 Performing a B Scan Exam The ultrasound probe must be cleaned and disinfected before each biometry procedure See Section 21 for Cleaning and Disinfection Instructions 1 Launch the Scanmate Software Application as described in section 12 2 Select the Patient Data Page and either enter a new patient or select an existing patient 3 Navigate to the B Scan page and select the eye to be examined OD or OS by pressing the Change Eye button 4 Select the desired probe frequency and depth from the drop down box 5 Select the name of the Operator performing the measurement If the operator is not listed in the Operator drop down box add the new operator by selecting Preferences gt Operator gt New 6 Seat or recline the patient in a comfortable position Use a firm comfortable head rest to prevent unwanted head movement Position the DGH Scanmate display so that it is easily visible during the examination 7 If desired use the Position Map to indicate the area of the eye being examined 8 Press the Blue Button on the probe to begin scanning The Space Bar or the Start Scan button can also be used The software will begin recording B Scan frames The software will start recording over itself once the video buffer has reached the Video Buffer Frame Size specified in the Operator Preferences 9 Direct
64. ns The Save button saves New or Modified patient records to the DGH Scanmate database The Undo button allows the user to undo the last changes that were made to the Patient s Record All fields will revert to the most recent saved state 14 2 Entering a New Patient Select the New button and enter the following required fields e Last Name e First Name e ID Number The ID Number must be unique for each patient The Scanmate Software will prevent a new patient from being saved to the database if a patient with the same ID Number already exists A default unique ID number is created based on the date and time the new patient is entered this can be replaced with any other numbering system desired The Patient s Last Name First Name and ID Number are required fields and must be entered before the record can be saved The following optional fields can also be entered at this time Patient Date of Birth Patient Gender Doctor Comments K1 and K2 Only Needed for IOL Calculations Desired Refraction Only Needed for IOL Calculations Select the Save button once all of the desired fields have been entered Page 39 of 86 8000 INS UMENG Rev 2 14 3 Searching for a Patient Select the Search button to search for a patient record that has been saved in the database Patients can be searched for by Last Name First Name or by ID Number To search by Last Name type the first few letters of the patient
65. nterpolation can be turned off to improve display performance at the expense of image quality Page 36 of 86 8000 INS UMENG Rev 2 13 3 Doctor Preferences The Doctor Preferences window provides controls for the user to identify Doctors and configure their preferences Doctor Preferences define the default protocol for performing A Scans and IOL Calculations The Doctor Preferences window can be accessed by selecting Preferences gt Doctor from the Menu Bar Dox tee Preference Imm eile z Dottor A Scan Auto Stop Scan Criteria Default IOL Calculator Settings New tat AXL Sid Deviation Threshold 005 mm Min Cases 25 Bofore Automatically Updating Personalized Lens Constants When Automalicall N ACD Sid Dewiahon Threshold 0 05 mm Update Constants is Selected dame Detault Preferences z LT Std Deviaton Threshold 0 05 mm Moas Source DGH 6000 Average Default Scan Measurement Mode OL 1 2 i0LA Notes Contact immersion 1OL 2 IO Default Preferences A Scan Timing Mfg Measurement Delay D gt ms m Model Alignment Timeout 20000 gt ms Forrnul Scan Velocilies Table IOL Configuration Table Personalized Lens Constants Table Caution Accepting changes to Doctor Preferences may e E wem alter currently loaded cata Please review data on all forms OK Cancel Apply J Note Please refer to the DGH 6000 Scanmate A User Guide for information on configuring A Scan related Doctor Preferences
66. o adjust the scan rate of the probe 12 or 15 MHz as well as the gain contrast intensity and depth of the displayed image Once the exam is complete the application allows the user to save video s image s or create a report to document the results 2 Device Classification Device System Imaging Pulsed Echo Ultrasonic Panel Radiology Product Code IYO Device Class II Regulation Number 21 CFR 892 1560 3 Indications for Use The DGH 8000 Scanmate B is an ultrasonic device used by professionals in the ophthalmic field to perform a Brightness Scan of the eye The main function of the device is to produce cross sectional images of the eye and orbit and to serve as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria Page 7 of 86 8000 INS UMENG Rev 2 4 Warnings and Cautions 4 1 Meaning of Signal Words In this manual the signal words Warning and Caution are used to highlight important safety and usage instructions All users of the DGH 8000 must understand the meanings of these signal words Signal Word Indicates a potentially hazardous situation which if not avoided could cause injury or harm to the equipment or erroneous results Indicates a potentially hazardous situation which if not avoided may result in minor injury or harm to the equipment 4 2 Description of Symbols This symbol indicates the degree of protection against
67. on USB Ultrasound Probe If your hardware came with an installation CD QEA or floppy disk insert it now What do you want the wizard to do Install the software automatically Recommended cmm xs SAN Click Next to continue 11 4 Windows Logo Testing During the installation process the Windows Logo testing warning screen may appear Click the Continue Anyway button to continue with the installation Hardware Installation The software you are installing for this hardware Interzon Corporation USB Ultrasound Probe has nat passed Windows Logo testing ta verify its compatibility with Windows P ET ell me why this testing I Important Continuing your installation of this software may impair or destabilize the correct operation of your system either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the hardware vendor for software that has passed Windows Logo testing Continue Anyway D STOP Installation Page 29 of 86 8000 INS UMENG Rev 2 11 5 Complete Installation of Drivers After successful driver installation the Completing the Found New Hardware Wizard window appears Click the Finish button to complete the installation Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has Finished installing the software for Interson Corporation USB Ultrasound Probe Click Finish to close t
68. onnect a USB drive with the Scanmate installation files If the installation does not start automatically follow step 10 2 below Page 13 of 86 8000 INS UMENG Rev 2 10 2 Manual Launching of the Installation Program On most systems the installer launches automatically upon placing the DVD in the DVD drive In some cases the Windows system policy may require manual launching of the application Insert the Scanmate DVD or USB drive Go to My Computer Right click on the DVD USB drive icon Select Explore Double click Setup exe 10 3 Welcome Screen 99 A Welcome Screen will appear at the beginning of the installation Click the Next button to continue with the installation Click Cancel to exit the installation DGH Scanmate Prerequisites Installation Procedure NMATE The following screens will install the DGH Scanmate software eal al Page 14 of 86 8000 INS UMENG Rev 2 10 4 Setup Configuration There are three possible installation configurations If the DGH 8000 will be used in a networked environment the DGH Database Server should be installed on a computer or server before the Scanmate Software is installed on other computers Setup Configuration eem Setup Configuration Install Scanmate Software Install Scanmate Software Create New DGH Database and Create New DGH and Connect to an Existing Server Database Server DGH Database Server Cancel The first choice is to
69. or otherwise including any implied warranties of merchantability and of fitness for a particular purpose Without regard to the alleged defect DGH does not under any circumstances assume any responsibility for the loss of time inconvenience or other consequential damages including but not limited to loss or damage of personal property or loss of revenue DGH has neither assumed nor authorized any other person including any distributor authorized to sell its Equipment to assume for it any other liability in the connection with the sale of Equipment 25 Lifetime Shelf life The shelf life lifetime indicated for this device is 5 years Page 82 of 86 8000 INS UMENG Rev 2 26 Customer Service If you are having problems with this unit please refer to the appropriate sections of this manual Most service calls result from a misinterpretation of the operation of the instrument The instructions in this manual have been carefully reviewed to ensure error free performance of the DGH 8000 However if you feel there is a problem with the unit or a transducer please contact the Customer Service Department at the address below DGH Technology Inc can also be contacted via our website at www dghkoi com When contacting us please provide the model and serial number for the unit The model number and serial number are located on the side of the USB probe and can also be viewed on the display by selecting the About button found on the He
70. ormal Post Refractive Vitreous Normal ow 7 Post Refractive Pre Operative Data Pre Operative Data Meas Type Immersion K Correction Method K Correction Method Source DGH 6000 Average v Source User Input v History Derived Y Total 8 Meas Meas 3 17 mm ACD 3 15 mm a Kcorr 35 10 D 4 99 mm LT 5 02 mm 23 50 mm Desired Rx AXL 23 49 mm Desired Rx 0 05 D IOL1 i02 1013 IOL1 i012 0 3 Mfg DGH IOLPWR Refraction DGH IOLPWR Refraction Model 10L1 2500 115 IOL 1 3000 1001 25 50 0 81 r 30 50 0 64 c D Posterior x zr 26 00 0 46 i 0 26 Hoffer Q v Personalized 5 261 Type Posterior Target Power Target Power Emmetropic a Emmetropic Page 53 of 86 8000 INS UMENG Rev 2 18 Creating Reports Reports can be created for viewing from the Menu Bar The DGH Scanmate software can produce IOL Calculator Reports A Scan Short Reports A Scan Custom Reports and B Scan Reports Reports can be printed out saved as PDF files and added to the patient record database All reports are created with a header that includes the Patient s Name ID Number Doctor and Operator and identifies the revision of the DGH Scanmate software used to generate the report 18 1 B Scan Report Click the Print icon on the B Scan Screen to quickly create a B scan report A window with all the saved images and videos for the current patient will op
71. r Management Studio File Edit View Debug Tools Window Community Help TI New Query D B amp uj Object t Explorer ay x Connect 3 39 7 2 id HPPROBOOK4520 DGHSERVER SQL Server 10 50 1600 sa Lg Databases Ll System Databases MT Lg Security Lg Server Obje New Query Li Replication Script Database as Lj Manageme New Database Tasks Policies Facets Start PowerShell Reports gt Rename Refresh Properties 19 5 Attaching an Existing DGH Scanmate Database to a DGH Database Server Moving the DGH Scanmate database or re installing the DGH Database Server will require the DGH Scanmate database to be re attached to the DGH Database Server 1 Launch SQL Server Management Studio on the computer hosting the database Management Studio can be found from the Windows Start Menu by selecting Programs gt Microsoft SQL Server 2008 R2 gt SQL Server Management Studio 2 Connect to DGHServer by entering the system administrator password that was created when the DGH Database Server was installed see section 10 6 for details Microsoft 4 SQL Server 2008 R2 Server type Database Engine Server name HPPROBOOK4520 DGHSERVER Authentication SQL Server Authentication Login sa Password Remember password Gees Cmn Rb Page 62 of 86 8000 INS UMENG Rev 2 3 Under the DGHServer right click on Databases Folder and se
72. rator Preferences The New button allows the user to create new operators and assign preferences to the newly created operator New E dit The Edit button allows the user to make changes to an existing operator s preferences To change an operator s preferences click the Edit button while the desired operator s name is selected in the Name combo box Changes to operator preferences are saved by clicking the Apply button or can be discarded by clicking Cancel The OK button will save the current settings and close the Operator Preferences window The Delete button will delete an operator from the system When clicked the user is prompted for confirmation prior to deleting the operator s preferences Delete Page 35 of 86 8000 INS UMENG Rev 2 The Name combo box selects an existing operator from the database to view edit or delete their preferences Selecting an operator s name will display that operator s preferences on the screen Name Default Preferences The Notes textbox allows the user to associate notes to an operator s preferences Notes B Scan Settings The B Scan Video Playback Speed 20fs Slide bar adjusts the frames per second fps that the B Scan video is played for Video Playback Speed Video Buffer Frames 1j 32 the currently selected operator The speed of video playback can be adjusted from 1 Video Buffer File Size 16 777
73. rrent computer it will be detected The Setup Wizard will be able to repair many installation problems it can also uninstall the DGH Scanmate to allow a new clean installation A choice will be offered to repair or remove the Scanmate program Select either Repair or Remove and click Finish Page 21 of 86 8000 INS UMENG Rev 2 10 10 DGH Scanmate License Agreement Window Note If the computer or server being set up will only be used to host the database and will not perform B scans this step will automatically be skipped by the installer Please proceed to section 10 13 Database Configuration Please review the End User License Agreement EULA before continuing After selecting the I Agree button click the Next button to continue 10 11 ji DGH Scanmate Lol e License Agreement os Please take a moment to read the license agreement now If you accept the terms below click I Agree then Next Otherwise click Cancel END USER LICENSE AGREEMENT FOR DGH SOFTWARE SCANMATE EULA RO IMPORTANT READ CAREFULLY Be sure to carefully read and understand all of the rights and restrictions described in this DGH End User License Agreement EULA You will be asked to review and either accept or not accept the terms of the EULA This software will not install on your computer unless or until you accept the terms nf this FIILA 2 Do Not Agree U Cancel lt Back
74. s includes only connections that have been authenticated by using IPsec Connections will be secured using the settings in IPsec properties and rules in the Connection Security Rule node t mize ASOT ERS Block the connection Leam more about actions 6 Select the network profiles where you want this rule to apply and then select Next Profile Specify the profiles for which this rule applies Steps Rule Type When does this rule apply Protocol and Ports Action 4 Domain e Profile Applies when a computer is connected to its corporate domain Name Private Applies when a computer is connected to a private network location Public Applies when a computer is connected to a public network location Page 69 of 86 8000 INS UMENG Rev 2 7 Enter a name for this Rule and then select Finish Name Specify the name and description of this rule Steps Rule Type w Protocol and Ports w Action e Profile Name DGH Database Server TCP Port Name Description optional 8 Open UDP port 1434 by repeating the steps above and selecting UDP instead of TCP and entering 1434 instead of 1433 in step number 4 Page 70 of 86 8000 INS UMENG Rev 2 Configuring DGH Database Server to Use the Static Port defined above 1 Launch SQL Server Configuration Manager and Expand SQL Server Network Configuration Select Protocols for DGHServer r aa Sal Server Configuration Manager
75. that it is used in such an environment Phenomena Accordance to Standard Emissions Class a Limit Electrostatic EN60601 1 2 2Kv 4Kv 8Kv_ 36 202 1 G EN61000 4 2 Apply to all accessible Discharge contact discharge components 2Kv 4Kv 8Kv air discharge Immunity 3V m 80 kHz field I O Only 5 50 5kHz Conducted EN60601 1 2 0 15 80MHz 36 202 1 f EN61000 4 6 None Immunity 3Vrms I O Only 80 kHz Page 74 of 86 8000 INS UMENG Rev 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The DGH 8000 Scanmate B is intended for use in the electro magnetic environment specified below The customer or the user of the DGH 8000 should ensure that it 1s used in such an environment Field strength from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios armature 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 DGH 8000 is used exceeds the applicable RF compliance level the DGH 8000 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the DGH 8000 21 Cleaning and Disinfection A N WARNING Users of the DGH 8000 S
76. the patient to look in the desired direction and gently apply the probe directly to the eye or over the eyelid For best results an acoustic coupling gel such as GenTeal should be used 10 Once the desired image has been obtained press the Blue Button on the probe to stop scanning 11 The image frames captured during the exam can be reviewed on the display by pressing the gt or cursor keys The video playback controls can also be used to play back the video of the exam 12 Use the Gain Intensity Contrast and Zoom controls to enhance the quality of the image If desired annotate the exam with comments or use the A Mode amp Caliper Tools 13 Save the desired image s or the entire video by selecting the Save Image or Save Video buttons 14 Repeat the steps above until all the desired regions of the eye have been examined 15 When the exam is complete select the Print button to create a B scan report Page 52 of 86 8000 INS UMENG Rev 2 17 The IOL Calculator Screen The IOL Calculator Screen allows the user to perform and review intraocular lens power calculations for the currently selected patient Please refer to the DGH 6000 Scanmate A User Guide for instructions on using the IOL Calculator ya DGH Scanmate File Edit Preferences Reports Help 229 Patient NN sen B B scan ES zi d cii K Corr Calculate Jane Doe 123 456 789 Doctor O D Lens Normal Calculate OD OS Lens 7 Calculate OS Vitreous N
77. the transducer Note Ultrasound cannot travel through air because air is not dense enough for the high frequency waves to propagate Ultrasonic measurements must therefore be performed by direct contact or through a denser medium such as coupling gel or water 8 Ultrasonic Exposure and Intensities 8 1 Tissue Exposure to Ultrasound Energy The ultrasound energy emitted by the DGH 8000 is low intensity and will have no adverse effects on the patient and or operator However the operator is still cautioned to perform examinations using the principle of ALARA As Low As Reasonably Achievable All examinations should be done so that the patient receives as little ultrasound radiation as possible Do not hold the probe against the eye or other tissue with the system activated except when performing an exam Do not perform unnecessary exams 8 2 Ultrasonic Intensities See Appendix B of this manual for acoustic measurements 9 Biometric Imaging Capabilities The following table shows the resolution for the DGH 8000 Scanmate B Page 11 of 86 8000 INS UMENG Rev 2 10 Software Installation Instructions The following section describes the installation process for the Scanmate software Before proceeding review Appendix A Computer System Requirements to make sure the computer meets the minimum system requirements for the Scanmate software Please consider the desired usage of the DGH 8000 Scanmate B before installation The data recorded
78. tip of the probe is pointed toward the area being examined at 12 00 The probe is positioned at 6 00 which 1s opposite of the area being examined Use the selection tool to indicate the meridian being scanned Once the desired position has been selected use the Set button to save the orientation to the current B Scan Image or Video Page 47 of 86 8000 INS UMENG Rev 2 Transverse Probe Positions Transverse scans provide a lateral image of the globe that traverses several clock hours The position of the transverse scan is indicated by the center of the clock hours in the scan as well as the portion of the globe being examined P for Posterior Pole E for Equator EA for Anterior to the Equator etc Example of 12 00 EP Scan The probe is positioned on the sclera parallel to the limbus while the patient is looking toward the area of the eye being examined The probe marker is held parallel to the limbus and pointed superiorly during vertical and oplique scans For horizontal scans 6 00 and 12 00 positions the marker is pointed nasally to keep it parallel to the limbus For a 12 00 EP scan the probe is positioned at 6 00 with the marker parallel to the limbus and pointed nasally The probe is pointed toward the Equator Posterior at 12 00 Use the selection tool to indicate the area of the globe being scanned Once the desired position has been selected use the Set button to save the orientation to the current B Scan Image
79. tocols for SQLEXPRESS Protocols for DGH6000 Be Protocols for DGHSERVER b 3 SQL Native Client 10 0 Configuration Name i SQL Server DGH6000 SQL Server DGHSERVER E SQL Server SQLEXPRESS Ea SQL Server Agent DGH6000 a SQL Server Agent DGHSERVER E SQL Server Browser State Running Resume Restart LocalSystem Restart stop and then start selected service Page 73 of 86 8000 INS UMENG Rev 2 20 Electromagnetic Compatibility Like other medical equipment the DGH 8000 Scanmate B requires special precautions to ensure electromagnetic compatibility with other electrical medical devices To ensure electromagnetic compatibility EMC the DGH 8000 must be installed and operated according to the EMC information provided in this manual The DGH 8000 has been designed and tested to comply with EN 60601 1 2 requirements for EMC with other devices A N CAUTION Portable and mobile RF communications equipment may affect the normal function of the DGH 8000 Scanmate B AN CAUTION Do not use cables or accessories other than those provided with the DGH 8000 Scanmate B as they may result in increased electromagnetic emissions or decrease immunity to such emissions Guidance and Manufacturer s Declaration Electromagnetic Emissions amp Immunity The DGH 8000 Probe is intended for use in the electromagnetic environment specified below The customer or the user of the USB Ultrasound Probe should ensure
80. uctions on using the A Scan features of this program DGH Scanmate Lo mtm File Edit Preferences Reports Help Transducer Default Measurements Saved 04 04 2013 12 26 51 PM LI ES aL 2 Patient ll A Scan B Scan IOL Calc im ci zi New Meas Save Print Jane Doe 123 456 789 Immersion mm Average mm OD viros noma MER ETE x 23 50 T te Std Deviation mm 001 Ti Operator Lens Normal Vitreous Normal Silicone Oil Change Eye 1 OD Measurements Frame 81 Page 41 of 86 8000 INS UMENG Rev 2 16 The B Scan Screen The B Scan Screen allows the user to perform and review B Scan exams for the currently selected patient Refer to section 14 for details on how to load or create patient records gym DGH Scanmate File Edit Preferences Reports Help Video Saved 04 08 2013 01 30 43 PM LJ 29 Patient M A Scan 53 B Scan 75 IOL Calc Ly s e 4 b I Open File Save Image Save Video Print e a ma Doe R OS 1 3OAX Probe Type DGH 8000 v aaam Dama om Scan 4 06 2009 11 45 00 AM At Pulse Freq 15 MHz v Freq 15 MHz GLR ANET Vo A pem Depth 5cm E Pulse Power 10 A Mode 4 Calipers 4 Comments 9A OB Operator Smith Change Eye Near Gain 5 0 Mid Gain y 0 Far Gain p 3 Intensity p 3 Contrast p 8 Frame 26 i4 gt Settings

USB ULTRASOUND PROBE SYSTEM USER MANUAL

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