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USB ULTRASOUND PROBE SYSTEM USER MANUAL

1. SF 1 79 Holladay 1 a2 0 100 Haigis Edit oL 7 aN Automatically Update Personalized Lens Constants om After Min of Cases Achieved New Personalized Constants A Constant 119 00 A Const 419 20 SRKT a0 2216 Haigis pACD 6 938 HofferQ a1 0 400 Haigis Selected Cases 1 ACD SF 2 47 Holladay 1 a2 0 100 Haigis Use Post Refractive Record Method None 09 14 2010 12 15 51 11 5 2010 Userlnput 43 05 43 05 0 52 12 01 None 11 23 2010 12 55 43 11 1 2010 Userlnput 4405 4405 16 16 Surgery Measurement Desired Implanted Patient ID Date Source KI K2 Rx Lens Power OK Cancel Page 48 of 121 6000 INS OMENG Rev 2 13 6 1 Overview The DGH 6000 assists the user in performing personalized lens constant calculations for the following formulas SRK T A Constant Hoffer Q PACD Holladay 1 SF Haigis Single Optimization of a0 Note The DGH 6000 performs a Single Optimization a0 for the Haigis Formula Triple Optimization a0 al and a2 is unavailable at this time The Personalized Lens Constants Table contains the following features Doctor The Doctor combo box selects an existing doctor from the database Personalized Lens Constant calculations are performed for the currently selected doctor Manufacturer The Mfg combo box selects the manufacturer of an IOL The list of IOL manufacturers is limited based on the manufacturers that are associated with the selected doctor Model
2. Page 10 of 121 6000 INS OMENG Rev 2 5 Prescription Device Statement AN CAUTION The DGH 6000 is a prescription device and is only to be used by or under the supervision of a licensed physician 6 Operator Qualifications This DGH 6000 is intended to be used by trained medical professionals The medical professional operating the DGH 6000 must have a general knowledge of the use of ultrasonic medical devices Use of the DGH 6000 requires adequate dexterity to position the probe safely The DGH 6000 uses audio feedback to inform the operator of the scan status 7 Use of Ultrasound in Opthalmic Measurements 7 1 Introduction to Ultrasound 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 graphic display as a two dimensional waveform with peaks that are related to the positions of the interfaces The DGH 6000 transducer emits ultrasound pulses and detects ultrasound signals that have been reflected back The time delay between the echoes is used to calculate dist
3. Crystal Reports 2008 Click start to begin the installation of Crystal Reports 2008 sok _ coud C eT Page 23 of 121 6000 INS OMENG 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 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 cont Tse J I Click Start to install the DGH Scanmate drivers The installer will now install the drivers to operate the DGH 6000 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 peewee All DGH devices must be disconnected from the USB port s before proceeding Please disconnect all DGH devices and select OF Page 24 of 121 6000 INS OMENG 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
4. File Action View Help 7217 gt 86 panieeerud Neme Group z Profile Enabled Action Override inboundRuls Aa Sa Connection Security Rules O rgen me Prete Yes Aliou No E New Rute E Monitoring O ngee Private Yes Albow No ell T Firer by Profile v avgupd_exe Prevate Yes ASow Ne Bonjour Private Yes Atow No T Paty Ree r EBoryour Prate Yes Allow Ne V iter by Group d Dropbox Private Yes Allow No View gt e Dropbux Prate Yes Auw No eh feket O dropboxexe Public Yes Allow No EEN o diopborere Public Yes Auw No gt Export Lis FileMaker Pro Private Yes Allow No H Hep e FileMaker Pro Public Yes Auw No C FileMaker Pro Public Yes Allow Ne FileMaker Pro Prate Yes Allow Ne E Google Farh Private Yes Allow Ne e Google Earth Prate Yes Allow No v McAfee Shared Service Host Prevate Yes Allow No McAMlee Shared Service Host Prate Yes ABow No E Microsoft Office Groove Private Yes Allow No O Micresett Office Groove Prate Yes Auw No E Microsoft Office OneNote Public Yes Allow No Microsoft Office OneNote Private e Allow No E Microsoft Office OneNote Prevate Yes Allow No Microsoft Office OneNote Public es Ablow No E Microsoft CHfice Outlook Prevate Yes Allnw No amp NAVBrowser Private es Alow 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 Au Yes Aow No SQL Server Windows NT Prevate Yes Aflnw Ne G SOL Server Windows NT Domain No Alt
5. f y Data 01 14 2013 6 Data 01 30 2013 6 Data 01 31 2013 Data 02 08 2013 m a Data 09 26 2017 C Program Files DGH Technology Inc Data D Database Files mdf Y DGH Scanmate mdf 6 The Attach Databases dialog window will now show the DGH 6000 mdf Click OK S somt i Heb 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 96 of 121 6000 INS OMENG Rev 2 19 6 Importing and Exporting Data Individual measurement and video files can be imported or exported from the DGH Scanmate database to be consulted in other locations or by other practitioners The Scanmate software must be installed on a computer to view measurement or video files To export a measurement file use the menu bar at the top to go to File gt Export gt Export Measurements The measurements currently in the measurement bank will be saved as a meas file To export a video file use the menu bar at the top to go to File gt Export gt Export Video Buffer The images currently in the video buffer will be saved as a vdo file To import a measurement file that is not currently in the database use the menu bar at the top to go to File gt Impor
6. 17 11 Selecting IOL Power Calculation Formulas The formula selection drop down box allows the user to choose a formula to use to perform an IOL Power Calculation for the selected lens Each pre set IOL has a preferred formula associated with it that will appear automatically in this box but all other formulas can be selected from the drop down list If the Post Refractive Calculator has been used to calculate Kcorr only the appropriate formulas will be available for selection Page 74 of 121 6000 INS OMENG Rev 2 17 12 Selecting Personalized Lens Constants The Personalized checkbox allows the user to use a personalized lens constant for the selected formula This checkbox is only selectable if the lens constant for the selected formula can be personalized and the minimum number of cases has been reached using the currently selected IOL See section 13 6 for more information on how to calculate personalized lens constants 17 13 K Correction Method Selection This drop down box selects between different methods of predicting the true corneal power of eyes that have undergone corneal refractive surgery This field is only available if the Post Refractive Calculator has been used If the K Correction Method is changed to a method that requires information that has not been completed the Post Refractive Calculator will reopen to request the additional inputs If the new method chosen does not require more information the Kcorr va
7. 2008 Received Feb 2 2009 Hoffer Q Hoffer K J The Hoffer Q formula A comparison of theoretic and regression formulas Journal of Cataract and Refractive Surgery 19 6 Nov 1993 700 712 Errata in Journal of Cataract and Refractive Surgery 33 1 Jan 2007 2 Author response in Journal of Cataract and Refractive Surgery 33 1 Jan 2007 2 3 Holladay 1 Holladay J T et al A three part system for refining intraocular lens power calculations Journal of Cataract Refractive Surgery 14 1 Jan 1988 17 24 SRK I Sanders D R et al Comparison of the SRK IJ Formula and Other Second Generation Formulas Journal of Cataract and Refractive Surgery 14 2 Mar 1988 136 141 SRK T Retzlaff JA et al Development of the SRK T Intraocular Lens Implant Power Calculation Formula Journal of Cataract and Refractive Surgery 16 3 May 1990 333 340 Errata in Journal of Cataract and Refractive Surgery 16 4 Jul 1990 528 Page 119 of 121 6000 INS OMENG Rev 2 Post Refractive Surgery Formulas By in large these methods have been implemented as described in H John Shammas s book Intraocular Lens Power Calculations published by Slack Incorporated 2004 History Derived Keor pre Kayg SE post S E pre 1 S E post 1 S E pre Refraction Derived Keor post Kayg 0 23 x SE post S E pre 1 S E post 1 S E pre Clinically Derived Keor 1 14 x post Kayg 6 8m Contact Lens Ov
8. Once the patient record has been loaded select New Procedure from the Procedure List Box The pre operative and post operative data fields will be blank and ready for the new procedure information to be entered Note To enter data you must first select Edit To return to an existing procedure click on the Procedure List Box and select the desired procedure Once selected all of the pre operative and post operative data associated with that procedure will be visible 14 6 Entering Pre Operative Data Pre Operative Data is the biometric measurement and procedure data that was used as the basis to perform IOL power calculations for a patient This information is automatically imported from the IOL Calculator Screen when the save button on the IOL Calculator Screen is selected The following Pre Operative data fields can be entered on the Patient Data Screen e Kl e K2 e Desired Rx Pre Operative Data entered in the Patient Data Screen is automatically imported into the IOL Calculator Screen The corneal refractive index nc associated with the K1 and K2 values can be viewed and changed on the IOL Calculator screen if it is not changed the default nc from the System Preferences menu will be used 14 7 Entering Post Operative Data The Post Operative Section of the Patient Data Screen allows the user to input the stabilized surgical results for the current patient and procedure This section of the Patient Data Screen is
9. See section 13 6 for more details on calculating personalized lens constants Meas Source DGH 6000 Average The Meas Source combo box allows the user to choose the measurement source that the IOL Calculator uses by default for the currently selected doctor The user can choose to use DGH 6000 Average DGH 6000 Single or User Input as the selected doctor s preferred default measurement source The IOL Calculator Screen will automatically load using the Default Measurement Source for the selected doctor See section 16 6 for more information on selecting a Measurement Source Page 44 of 121 6000 INS OMENG Rev 2 The IOL 1 IOL 2 IOL 3 tabbed display allows the user to specify up to three Mfg DGH preferred IOLs for the currently selected doctor The default IOL manufacturer Mfg Model OL model and formula are selected from searchable combo boxes for each preferred IOL The IOL Calculator Screen will automatically load the Preferred IOL tabs for the currently selected doctor IOLs are created in the IOL Information Table see section 13 5 If more than three IOLs exist for a doctor the additional IOLs can be selected on the IOL Calculator Screen Formula 13 4 Configuring Custom Velocities The A Scan Velocities Table button on the Doctor Preferences Screen provides the user access to the Velocities Table dialog From this screen the user can view the speeds of sound for each lens and vitreous type Thes
10. e Confirm that the drivers have been installed for the USB 2 0 port the module is currently connected to See section 10 8 for details e Confirm that the USB cable is firmly connected to the USB Interface Module e Try connecting the USB Interface Module to a different USB port on the computer Probe Key Expired e The USB Interface Module must be connected to the PC running the Scanmate application after every 20 hours of use e If connecting the USB Interface Module does not reset the Probe Key try the steps described in USB Interface Module Not Connected section of the troubleshooting guide Unable to Get a Measurement e Verify that the correct measurement mode Immersion Contact and Eye Type has been selected e If performing a Contact measurement it may be necessary to adjust the Compression Sensitivity Comp Sens See section 15 8 for details e If performing an Immersion measurement verify that the transducer is properly inserted in the Prager Shell See section 15 10 for details Page 114 of 121 6000 INS OMENG Rev 2 e There will be some eyes which cannot be measured in Automatic Measurement Auto Meas mode In these cases measurements can be made by using the Manual Measurement Manual Meas mode 23 Warranty DGH Technology Inc DGH warrants each new DGH 6000 and its accompanying accessories hereinafter called Equipment to be free from defects in material and workmanship for twelv
11. measurements that will be used for IOL calculations Figure 7 C illustrates an ultrasonic pattern typical when alignment along the visual axis is met Please note the two high clear peaks representing the anterior lens and posterior lens interfaces along with a strong peak representing the retinal interface Figure 7 D illustrates a pattern representing misalignment Incorrect alignment will result in improper measurements Page 12 of 121 6000 INS OMENG Rev 2 Figure 7 C Correct alignment along the Figure 7 D Incorrect alignment along the visual axis visual axis O e The DGH 6000 Scanmate A incorporates a pattern recognition program that automatically checks for proper alignment It first looks for the proper pattern of reflectance peaks from each expected interface Then the software examines the retinal spike for particular signal characteristics which are produced only by retinal interfaces Incorrect signal patterns will not be measured until the alignment is corrected Audible feedback will guide the operator to proper alignment Page 13 of 121 6000 INS OMENG Rev 2 7 3 Ultrasonic Measurement The speed of sound increases in denser materials Liquids or substances containing large amounts of water conduct ultrasound very well air does not conduct ultrasound Figure 7 E shows a list of the established speeds of sound for ophthalmic Structures Do i Aqueous AA TR Silicone Cornea 1641 m s Aqueous Vitreous Aqueous 1532 m
12. 7 The New Personalized Constants group box shows the results of the Personalized Lens Constants calculation based on the Procedures that are currently selected in the table The Current Personalized Constants group box displays the lens constants that are currently being used for the selected Doctor and IOL 8 Use the Up Arrow to replace the Current Personalized Constants with the New Personalized Constants These new Personalized Lens Constants will now be available for use in future IOL power calculations Automatically calculating lens constants is similar to the procedure described above except that the lens constants are recalculated as soon as Add to Personalized Constants Table checkbox is selected on the Patient Data Screen See step 5 for more details Page 51 of 121 6000 INS OMENG Rev 2 AN WARNING Results for Patients That Have Undergone Corneal Refractive Surgery Should Not Be Used To Calculate Personalized Lens Constants AN WARNING Only A Scan Measurements Performed Using the DGH 6000 Should Be Used to Calculate Personalized Lens Constants AN WARNING Only Stabilized Post Operative Results Should Be Used to Calculate Personalized Lens Constants AN WARNING Corneal Power Measurements Used For Calculating Personalized Lens Constants Should Be Performed Using the Same Keratometer Page 52 of 121 6000 INS OMENG Rev 2 14 The Patient Data Screen The Scanmate application w
13. Arrow button Up Arrow When this button is clicked the values that are displayed within the New Personalized Constants textboxes are stored in the Current Personalized Constants textboxes Page 49 of 121 6000 INS OMENG Rev 2 Automatic Constants Update The Automatic Constants Update checkbox will enable or disable the Automatic Constants Update feature This feature automatically calculates and updates the personalized lens constant for the selected doctor and lens based on the records in the table that have Use Record selected The Personalized Lens Constants are also automatically recalculated when new records for the specified doctor and IOL manufacturer and model are created and the Add to Personalized Lens Table checkbox on the Patient Data Screen is checked The number of records used to calculate the constants are also counted and stored automatically upon each recalculation Automatically Calculated Personalized Constants are only available for use once the number of selected records exceeds the Min Cases Before Using Personalized Constants set in Doctor Preferences Min Cases Before Using Personalized Constants This value is displayed on the Personalized Constants table The minimum number of cases used in calculating personalized constants is set in Doctor Preferences It cannot be edited on this screen Selected Cases This value is a counter that notifies the user how man
14. Calculation Methods cccccsseceeccecccecceeeeeeeeeeeeeeeeeeeees 76 17 17 Using the Post Refractive Calculator eiei 79 17 18 Petf rming IOL Calculations aers 81 17 19 Overview of IOL Power Calculation Formulas ccccccccssseeeeeeeeeeeeeeees 82 17 20 Factors Impacting the Accuracy of IOL Power Calculations 4 83 LS CREATING REPOR TSi e a a a R 85 Is TOL Calculator Report air ernie ae 85 18 2 AsSean Shor REPO erince tanec eimaueccians 85 18 3 A Scan Custom REport vicicinccsesavedubcnseneduesadedssandtneeuesaaeddsandenadud adedatanciacssesavees 85 ISA Ume IRC POLS enaa a outed eeu aes 86 tSo SAV CIR DO ceca at erate ct et ius neater Aa ape ra cet aa aback eens 87 19 DATABASE MANAGEMEN V osicesicxetectennite cia a E A 88 19 1 Backing Up the DGH Scanmate Database ec cceeeeeeeeeeeeeeeeeeeeeees 88 19 2 Restoring the DGH Scanmate Database ecccccccccccesseeseeeeeeeeeeeaeeeeees 89 19 3 Copying or Movin the Database nesnese a S 91 LOA Deleting a Database st tsseccectestiactensaleahsdieadcacdahancte a a a a ebeanes 93 19 5 Attaching an Existing DGH Scanmate Database to a DGH Database eE Bo E EE E E E ey E E EE E eee ENEE E E AEN 94 19 6 Importing and Ex portine Data ercsi an e a A N 97 19 7 Configuring Firewall for DGH Database Server eccecceceeeeeeeeeeeees 98 20 ELECTROMAGNETIC COMPATIBIUIGIY Yate i wctecsuashesceiieusabensasnts volismcniscanducsvaiedgacsenadscs 105 2k CARE AND MAINTENA
15. 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 s The selected prerequisites were installed successfully Install Scanmate Page 25 of 121 6000 INS OMENG 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 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 ie DGH Scanmate o Se Welcome to the DGH Scanmate Setup Wizard ex Ve The installer will guide 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 current 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 repa
16. FDA Z 0 069 x fx z I I xe where J is the estimated in situ intensity J 1s the measured intensity in water at the focus of the transducer f is the ultrasonic frequency and z is the distance from the face of the probe to the transducer focus which is the point of measurement 23 millimeters Page 16 of 121 6000 INS OMENG Rev 2 The nominal piezoceramic crystal frequency of these transducers is 10 MHz The actual frequency of a particular transducer may vary from this value The tissue calculations above were done with the measured frequency of the transducer used for the tests 9 Biometric Measurement Capabilities The following table shows the measurement range and capabilities for the DGH 6000 Scanmate A Axial length 15 mm to 40 mm Anterior chamber depth 2 0 mm to 6 0 mm Lens thickness 2 0 mm to 7 5 mm 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 6000 Scanmate A before installation The data recorded can either be saved on the computer operating the DGH 6000 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 ins
17. Microsoft SQL Server Management Studio File Edit View Debug Tools Window Community Help T New Query D Ls 27 Ee Object Explorer Connect 3 SY as ax 3 O HPPROBOOK4520 DGHSERVER SQL Se 9 Databases B System Databases Uy DGH Scanmate Q Security Lj Server Objects A Replication 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 lz Microsoft SQL Server Management Studio File Edit View Debug Tools Window Community Help T New Query iy Cs BF wey Page 92 of 121 Obj
18. Module Connect the DGH 6000 USB Interface Module 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 curent and updated software by looking on Your computer on the hardware installation CD or on the Windows Update Web site with your permission Read our privacy policy Can Windows connect to Windows Update to search for software Yes this time only yand every time connect a device Click Next to continue Page 33 of 121 6000 INS OMENG 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 Interson Corporation USB Ultrasound Probe If pour hardware came with an installation CD QEA or floppy disk insert it now What do you want the wizard to do Install the sof
19. O a BlOvOoO 8 SQL Server Configuration Manager Local E SQL Server Services 4 4 SQL Server Network Configuration B Protocols for SQLEXPRESS Be Protocols for DGH6000 B Protocols for DGHSERVER D 3 SQL Native Client 10 0 Configuration Name Ei SQL Server DGH6000 SQL Server DGHSERVER fi SQL Server SQLEXPRESS Ea SQL Server Agent DGH6000 Fa SQL Server Agent DGHSERVER JD SQL Server Browser State Running Start Resume Restart LocalSystem NT AUTHORITY Ne NT AUTHORITY NE NT AUTHORITY NE 0 NT AUTHORITY LO Restart stop and then start selected service Page 104 of 121 6000 INS OMENG Rev 2 20 Electromagnetic Compatibility Like other medical equipment the DGH 6000 Scanmate A requires special precautions to ensure electromagnetic compatibility with other electrical medical devices To ensure electromagnetic compatibility EMC the DGH 6000 must be installed and operated according to the EMC information provided in this manual The DGH 6000 has been designed and tested to comply with EN 60601 1 2 requirements for EMC with other devices AN CAUTION Portable and mobile RF communications equipment may affect the normal function of the DGH 6000 Scanmate A AN CAUTION Do not use cables or accessories other than those provided with the DGH 6000 Scanmate A as they may result in increased electromagnetic emissions or decrease immunity to such emissions Guidance and
20. Print button will create and print an IOL Calculator Report When clicked the report is automatically saved and sent to the default printer To preview the report before printing use the menu bar to go to Reports gt IOL Calculator Report 17 2 Patient Information The Name and ID Number of the patient currently selected on the Patient Data Screen are displayed in the top left corner of the IOL Calculator Screen This information can be verified to confirm that the calculation is being performed on the correct patient 17 3 Selecting the Doctor The doctor performing the IOL Calculations can be selected using the Doctor drop down box This field will default to the Doctor that was selected on the Patient Data Screen If the doctor is not listed in the drop down box add the new doctor by selecting Preferences gt Doctor gt New When a doctor is selected the doctor s preferred IOLs and Formulas will automatically be loaded into the IOL Calculator See section 13 3 for more information on configuring preferred IOLs and formulas 17 4 Eye Selection By default the Scanmate software will perform IOL Power Calculations for both OS and OD Use the Calculate OD or Calculate OS checkboxes to change this default setting when performing calculations on only one eye Page 72 of 121 6000 INS OMENG Rev 2 17 5 Post Refractive Selection Select the Post Refractive checkbox if the patient has previously undergone
21. Scanmate application is 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 35 of 121 6000 INS OMENG 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 36 of 121 6000 INS OMENG Rev 2 12 4 No USB Devices Detected Warning If the USB Interface Module is not attached a warning box will appear Warning essen A No USB Devices Detected Clicking OK will complete the log in and allow the Scanmate software to be used without the USB Inter
22. Single is selected When User Input is selected the lens type and vitreous type fields become drop down boxes for the user to select and the measurement type field is removed 17 7 Corneal Refractive Index The Corneal Refractive Index nc of the keratometer used to calculate the corneal power K1 and K2 for the current patient should be entered in this field This field will automatically be completed with the default corneal refractive index nc set in System Preferences but it can be changed by the user on this screen Note Failure to adjust the default nc to match the actual nc of the keratometer used to measure corneal power can result in errors in the IOL Calculation See section 16 20 of this guide for more details Page 73 of 121 6000 INS OMENG Rev 2 17 8 Corneal Power K1 and K2 The corneal power values K1 and K2 for the current patient are entered in these fields If available these values will automatically be imported from the Patient Data Screen When the Save button is selected on the IOL Calculator Screen these values will automatically be saved in the Pre Operative Data section of the Patient Data Screen for the current patient and procedure These fields must be completed before performing IOL calculations Corneal power can be entered in either millimeters mm or diopters D the software will automatically determine which units to use so the user only needs to enter the number K1 and K2 mus
23. The Model combo box selects the model of an IOL The list of IOL models is limited based on the models that are associated with the selected doctor and the selected manufacturer A Constant The A Constant textbox allows the user to view the A Constant for the currently selected IOL This is the Manufacturer s A Constant that was entered in the IOL Information Table ACD The ACD textbox allows the user to view the ACD Constant for the currently selected IOL This is the ACD Constant that was entered in the IOL Information Table Current Personalized Constants The Current Personalized Constants group box displays the lens constants that are currently being used for the selected Doctor and IOL All textboxes within this group box are read only unless the user clicks the Edit button Once the Edit button is selected all textboxes become editable to allow the user to manually change any of the current constant values for the selected Doctor IOL Manufacturer and IOL Model If a value outside of the accepted range for each variable is entered it will be highlighted in red and must be corrected before continuing New Personalized Constants The New Personalized Constants group box displays the lens constants as they are calculated by selecting and deselecting records in the Personalized Lens Constants table This allows the doctor to view the updated calculation before accepting it with the Up
24. and Expand SQL Server Network Configuration Select Protocols for DGHServer E w Sal Server Configuration Manager File Action View Help e 4 0 Gis a SQL Server Configuration Manager Local Protocol Name Status E SQL Server Services wis ezi Y Shared Memory Enabled t cm i eee Named Pipes Disabled Protocols for ate TCP IP Enabled l Protocols for DGH6000 5 REPT y 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 102 of 121 6000 INS OMENG Rev 2 TCPYIP Properties El ips Active Yes Enabled No 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 Fort IP All TCP Dynamic Ports TCP Fort Active Indicates whether the selected IF 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 103 of 121 6000 INS OMENG 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 es F
25. criteria or the standard deviation requirements Note The default video buffer duration is 1024 frames This can be adjusted in the Preferences gt System menu 22 All of the waveforms captured during the exam can be reviewed on the display by pressing the gt or cursor keys If the currently selected waveform is associated with a measurement in the measurement bank the corresponding record in the measurement bank will be highlighted 23 The video buffer can be played or rewound to the beginning by clicking on the arrow buttons in the bottom right corner The slider bar beneath the arrow buttons can also be used to select an image for viewing from the video buffer series 24 Ifa measurement is observed which is suspect because it does not agree with the other measurements it may be removed or replaced with a different measurement a Using the mouse RIGHT CLICK the measurement in the measurement bank you wish to remove b Press the DELETE key to erase the measurement from the measurement bank c Use the gt and cursor keys to scroll through the captured waveforms and add the desired measurement to the measurement bank by RIGHT CLICKING on the measurement bank and selecting the INSERT key 25 After obtaining the desired measurements for the first eye OD or OS the operator may obtain measurements on the same patient s other eye if desired by clicking on the Change Eye button and repeating the
26. 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 is powered ON and the firewall on the computer hosting the database has been configured to allow access to SQL Server see section 19 7 for details In addition verify that both computers are in the same WORKGROUP or DOMAIN Page 113 of 121 6000 INS OMENG Rev 2 Unable to Connect to DGH Database Server e Confirm that the location 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 7 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 Interface Module Not Connected
27. eu secs eae aie cialtes ecw accesses 14 8 ULTRASONIC EXPOSURE AND INTENSITIES ee ccccccceeeeeeeeeeeeeceeeeeeeeeeees 16 8 1 Tissue Exposure to Ultrasound Energy ccccccccsssessseccceeeeeeeeseeeceeseeeeaas 16 S2 Ultrasone Intens lUe Sosia tian iees eae taece niece a E 16 9 BIOMETRIC MEASUREMENT CAPABILITIES 0 ccccccccccccccccceeceeeeeeeeeeesseeseeeeees 17 10 SOFTWARE INSTALLATION INSTRUCTIONS c cc cccceceeeeeeeeeceeeeeeeeeeeeees 17 10 1 Automatic Launching of the Installation Program eeeeeeeeeeeeeeeees 19 10 2 Manual Launching of the Installation Program eee cccccceeeeeeeeeeeeees 19 OS WCO STEE ce See aS essai saitaatnne icin ce tian octet so ee ue eeeecmneaee 19 HOA Setup GC OnteuranOn siete sess toh duce taltes essen sau toh daen te meansg es 20 LOS NETFramework Instalator A E Eis 21 OG SOL Sry ei aona r E 21 10 7 Crystal Reports Installation cssssissctses oreina ieia aa o a E a aa 23 108 DOH Scanmate Di Vers seco cist esvesaaedeetetondteesteupselsabonvesobaule etiam dometiegeetssieaiet 24 10 9 DOH SC animate Ins Callan On si isse tosses ntutac E 26 10 10 DGH Scanmate License Agreement Window ccccccccceeeeseeseeeeeeeeeeeaes 21 10 11 Selecting an Installation Folder oicssiesinatrtiectasedlienaietuilnctGusdsinatvnnt dela vacseedeese 27 1012 IS talaA On sesh wiasiosstactetcndaeuicct N uaa 28 101 Database Con Noura ON eia EEE 29 11 INSTALLATION OF SCANMATE DRIVERS eeeesssssssssss
28. fields for all of the necessary patient data inputs for performing an IOL calculation Any inputs for performing an IOL Power Calculation that are either missing or out of range are automatically highlighted in red The results of the IOL calculation Target IOL Power Emmetropic Power and Range of IOL Power and Refractions are displayed for up to three 3 IOLs for each eye Page 71 of 121 6000 INS OMENG Rev 2 17 1 IOL Calculator Screen Controls Depending on the selections made by the user up to four 4 action buttons are available at the top right corner of the IOL Calculator Screen The K Corr button launches the Post Refractive Surgery Calculator The Post Refractive checkbox must be selected for at least one eye OS or OD for this button to be available The Calculate button allows the user to perform calculations using the selected formula for each of the six 6 selected OLs on the screen The Target IOL Power Emmetropic and Range of IOL Power and Refractions are all calculated for each selected IOL The Save button saves the pre operative data for the current patient and current procedure When clicked the pre operative data on the IOL Calculator screen is sent to the patient data screen and will become part of that patient file In addition measurement data on the A Scan Page and patient data is automatically saved and the IOL information is automatically saved with the pre op data The
29. for easy visibility during patient examination 8 Seat or recline the patient in a comfortable position so that the head can be positioned in a nearly horizontal plane Use a firm comfortable head rest to prevent unwanted head movement 9 Insert the biometry probe into the clean and disinfected shell Gently insert the transducer into the shell until it reaches the auto stop point Verify that the transducer tip 1s even with the line scored on the barrel of the shell Once the correct position has been found tighten the white nylon set screw to hold the transducer in place Do not overtighten the set screw The software will work only if the probe is in the proper position 10 Connect the catheter tubing to the immersion shell filler port and to the saline reservoir either a syringe or bottle 11 Administer routine topical anesthesia to the patient s eye 12 Place a towel on the patient s shoulder and rest the saline reservoir on the towel Hold onto the transducer and shell in preparation for the insertion with the filler port and transducer cord oriented in a position that is comfortable for the operator and the patient 13 Press Start Scan to start the measurement sequence 14 Direct the patient to look upward Pull the patient s lower eye lid down and insert the flared rim inside the lid the lower portion of the shell will make contact with the sclera while the upper part of the
30. on the audible feedback while viewing the transducer with shell as it is aligned with the visual axis It is not recommended that the operator view the waveforms on the graphic display during the actual measurement cycle The significance of the audible tones that are emitted during the measurement cycle is explained below 17 If the transducer is in proper alignment when the saline is injected measure ments will be obtained almost instantaneously as indicated by a beep with a higher tone The axial length measurement can be observed on the graphic display along with its echo waveform Measurements for the anterior chamber depth and lens thickness are also given If the unit is configured for the Aphakic lens type only the axial length will be given 18 As soon as proper alignment is achieved a measurement will be obtained as indicated by a beep with a higher tone Each high pitched beep indicates a measurement being recorded in the measurement bank 19 In Auto Stop mode the scan will stop automatically as soon as 8 measurements are obtained that meet the ranking 3 star and standard deviation requirements In Manual Stop mode the user must select the Stop Scan button to stop the scan 20 If a measurement is not obtained instantaneously and the beep rate remains approximately once per second then the transducer is out of alignment Move the shell around the sphere of the eye to bring the line of the transducer closer to
31. only editable if valid Pre Operative Data has been entered for the selected eye The following data fields are available e Surgery Date The date that the lens replacement surgery was performed Doctor The surgeon that performed the lens replacement surgery Personalized constants are performed for this doctor IOL Mfg The manufacturer of the implanted IOL Model The model of the implanted IOL Power The power of the implanted IOL Sph The Stabilized Post Operative Spherical Refractive Error Cyl The Stabilized Post Operative Cylindrical Refractive Error Page 56 of 121 6000 INS OMENG Rev 2 e Add to Personalized Constants Table Selecting this checkbox indicates that the Doctor would like to include these Results in the Calculation of Personalized Lens Constants See section 13 6 for more information about Personalized Lens Constants AN WARNING Results for Patients That Have Undergone Corneal Refractive Surgery Should Not Be Used To Calculate Personalized Lens Constants AN WARNING Only A Scan Measurements Performed Using the DGH 6000 Should Be Used to Calculate Personalized Lens Constants AN WARNING Only Stabilized Post Operative Results Should Be Used to Calculate Personalized Lens Constants AN WARNING Corneal Power Measurements Used For Calculating Personalized Lens Constants Should Be Performed Using the Same Keratometer Page 57 of 121 6000 INS OMENG Rev 2 15 The A Scan Screen The A Scan Screen allows the u
32. 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 making a measurement Do not make unnecessary measurements 8 2 Ultrasonic Intensities The DGH 6000 has only one mode and ultrasonic intensity settings are not under the control of the operator Thus the values below are the values to be expected for a typical transducer Since the DGH 6000 is not capable of exceeding either a TI of 1 0 or an MI of 1 0 in any operating mode the output of the system is reported as shown in the Table below The appropriate Thermal Index is the Thermal Index for Soft Tissue TIS for the non scanning case with a beam aperture of less than 1 0 cm Output Summary Table Transducer Model used with DGH 6000 ls cen ue Tpa3 MInax DGH6006 0 469 mW cm a rae 0 0004 0 131 3 49 W cm aprt The acoustic output values given above are based on a presumed attenuation of ultrasound on tissue as developed by the U S Food and Drug Administration in 1985 and later incorporated into other international standards The attenuated intensity in the eye at the transducer focus corresponding to maximum intensity may be calculated according to the formula recommended by the
33. test block 7 Readings outside these limits do not necessarily indicate the DGH 6000 is out of calibration Erroneous measurements may be due to the following a During the test mode the algorithm does not preclude measurement of tear film as it does during normal operation Therefore if excessive water was placed on the reference block the water depth may be measured causing longer axial length measurements b The polystyrene reference block is sensitive to temperature The block must be stabilized at 72 F 10 F before measurements are taken If an erroneous reading is obtained verify that these fault conditions are not present and repeat the measurements on the reference block 8 If the reference block readings are outside the limits stated above it is possible that the unit 1s defective and needs repair Contact the Customer Service Department of DGH Technology Inc at 610 594 9100 to arrange for repair 9 If desired the results of the calibration check can be saved in the Test Block patient folder 21 8 Storage When the DGH 6000 is not being used it should be stored in a clean dry area To prevent damage to the DGH 6000 do not store in areas where it might be exposed to Excessive vibration Excessive dust and dirt Liquids or condensation Impact Store the DGH 6000 under the following ambient conditions e Temperature 10 C to 50C 14 F to 122 F e Relative Humidity 20 to 80 e Atmosph
34. the visual axis The beep rate will increase as the transducer approaches the visual axis 21 If 8 valid measurements are not obtained prior to the video buffer expiring the scan will time out as indicated by two long beeps A message will appear indicating that the measurements did not meet the measurement selection criteria or the standard deviation requirements Note The default video buffer duration is 1024 frames This can be adjusted in the Preferences gt System menu Page 67 of 121 6000 INS OMENG Rev 2 22 If the unit has trouble obtaining measurements then the transducer alignment procedure described in steps 17 20 should be repeated until successful If transducer alignment is not successful the shell should be removed from the patient s eye see step 23 and the procedure should be repeated from step 13 23 After measurements are obtained remove the shell from the patient s eye Direct the patient to look straight ahead during removal Raise the patient s upper eyelid which releases the top part of the shell from under the eyelid Then pivot the shell downward directing the patient to continue to look straight ahead Then pull the shell away from the eye without contacting the cornea Upon the initial release the remaining contents of the shell 1 3cc of liquid will spill down the patient s cheek Be prepared with a towel or tissue 24 All of the waveforms captured during the exam can be reviewed on the displ
35. 00 INS OMENG Rev 2 18 5 Saved Reports To view a previously saved report 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 87 of 121 6000 INS OMENG 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
36. Back Up Restore window by selecting File gt Database gt Back Up 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 rome Semen 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 88 of 121 6000 INS OMENG 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 cs 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 gG Database Backed Up To C Program Files DGH Technology Inc Data Back Up DGH Scanmate DGH Scanmate bak MI 19 2 Restoring the DGH Scanmate Database If it is necessary to rest
37. Connect to the desired SQL Server 2008 instance to continue Connection Status Connected Connection to SQL Server HPPROBOOK4520 DGHSERVER was successful _ Bk n Page 29 of 121 6000 INS OMENG 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 7 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 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 30 of 121 z ad Database Creation Update A da
38. DGH 6000 SCANMATE A ULTRASONIC A SCAN SCANMATE DGH 6000 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 121 6000 INS OMENG Rev 2 Page 2 of 121 6000 INS OMENG Rev 2 TABLE OF CONTENTS L GENERATADE VIG EADIE S CRU TION meranie eared tee RNR 7 2 IDEVICE CLASSIFICATION vrceatectdateuieteadicact suntacacenaiaanahanecaleecddacttensaeacexaiaantaaceweteadteect ace 8 3 ANDICA TIONS BOR US Besser tssncsetevendincacnsusindse nadenelennusintels ceueaeaceswsnsupendenedeneesded endtacacesuseesies 8 A WARNINGS AND CAUTIONS cremeren a a 8 Ah IWeanine Or Seni Word Sen awe hcunds aueeni leaner 8 n OAE O E ra E ee ernment or ren ne reece re en ee ree 9 A WWESCIIPION OFSYIMDOIS chs on osisnueiiin kiss seu sie aes auel ie eae ieee maaan ain 9 4 4 General Cautions and Warnings ccccccccsssssssscccccceeeeeesseeccceseeeaeeeesseeeeess 10 gt PRESCRIPTION DEVICES EATEMEN T renon A R 11 6 OPERATOR QUALIFICATIONS nerenin a a E iae 11 7 USE OF ULTRASOUND IN OPTHALMIC MEASUREMENTS cc ceeeeeeeeeeeeees 11 Gs IntrOCuction to Uhra oundsacsere e S 11 7 2 Using Ultrasonic Signals to Ascertain Correct Probe Alignment 12 Teo Urmon Mesur men oso wane
39. Manufacturer s Declaration Electromagnetic Emissions and Immunity The DGH 6000 Scanmate A is intended for use in the electromagnetic environment specified below The customer or the user of the DGH 6000 should ensure 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 Radiated 80MHz 2 5GHz Expose all parts of EUT to Immunity 3V m 80 1kHz field I O Only 5 50 5kHz Conducted EN60601 1 2 0 15 80MHz 36 202 1 G EN61000 4 6 None Immunity 3Vrms I O Only 80 1kHz Page 105 of 121 6000 INS OMENG Rev 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The DGH 6000 Scanmate A is intended for use in the electro magnetic environment specified below The customer or the user of the DGH 6000 should ensure that it is 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 6000 is used exceeds the applicable RF com
40. NCE isinen a a T 106 ZN C eOr Ead O Erni Aa A yaaes 106 21 2 Cleaning and Disinfecting the Transducer Tip cccceeeseseceeeeeeeeeeeees 107 21 3 Cleaning and Disinfecting the Immersion Shell eeeeeeeeeeeeeees 110 214 Care or USB Interlace MOGUiC cicicas ietaten moan doveu seeead eta aaewess 110 21 5 Cleanine the USB Interface Module seciss rice ccsteerssenuaanerndtiatinvaocedendeniues 110 2KO Operalin eC ONnGiniONs sie geese a ee a eect ean ee baron ate 110 21 3 Venfyins AsScan Calibration aasuteiitewntutuieswseeitemademea eee 110 DNB OOI Co cera os cadaignucte E N 111 Diep anspor aO De eer a eta naueeels 112 ZN MO DIS pOS a liep a T Vaal axechoaerlas 112 2 TROUBEESHOOTIN rania ahcacecsieadlewdeaen dees aa tn outcaceusdsadleeteaca dime nveetncoutones 113 2 WINN as crs iet ate teeta tc toe ee cmnce teeta E A E eecuieemenas 115 2A Us Te es PY Teo ele De ots oe ocactbacn incre tene A ce Moemseatdbacedoenadenenen 115 23 CUSTOMERSERVICE teeta ecient el acetate a a a ctncleel ebacaieeute 116 APPENDIX A COMPUTER SYSTEM SPECIFICATIONS eeeeeeeeeeeeeeeeeeeeens 117 APPENDIX B SCANMATE A SPECIFICATIONS ee ceeseseeeeseeeeeeeeeeeeenseeeeens 118 APPENDIX C REFERENCES reoi E 119 APPENDIX D TERMS AND ABBREVIATIONS eeesessseseeseseereeeeeeerrererereererrerrrrrrrreees 121 Page 5 of 121 6000 INS OMENG Rev 2 Page 6 of 121 6000 INS OMENG Rev 2 1 General Device Description The DGH 6000 is a diagnostic ultrasound device used by p
41. SCREEN ccasscsujieadiiestaeiaceudiaenaleiiaieadietaaimaeudemieieialeadlws 53 41 Patent Data Screen Control S iressiiserenrr r 53 t42 Entrimo a New Palentina ender outed tees eerste 54 FAS gt Car mins TOK Av AU Cb soa de era pices eeatsecta A TR 55 WA Edun a Patient Record sseresion a chee xc cs a A E 55 t43 Creating a New Procedure sic occius cats 5e ete ated a a a 56 140 Eniterine PresO pera ve D ta esirin enn ra E RA TESERO 56 14 7 Entenne Post Operative Data nsiiseneninineiie err 56 O THEA SCAN SCREEN sgccccett cestaateachacant en a a a a a E ite 58 15 1 Selectii the Operati cenre a A A 58 15 2 selectins the Lens and Vitreous Type scscisisio niia onan 58 I peL ODOT OS aeea a a aes 59 15 4 Selecting Automatic Stop versus Manual Stop Mode sssssseeeseessssseeresssss 59 153 Automatic Measurement MOG i ccssisianiesvaindalsoiadionvehaunianiadiaitluadaidiiany 59 156 Marval Meas rement Mode s3ciciessuscescdeans teresa sasntaccsthwaisaandadtinbereenntanisecyones 59 15 7 Selecting Immersion or Contact Measurement Modes ccceeseeeeeeeeeeees 61 15 8 Setting the Corneal Compression Sensitivity ccccccccccccecceeesseeeeeeeeeeeeeaes 6l 15 9 Performing a Contact Measurement cccccccccessseeseeeeceeceeeaeeeeeseeeeeeeenaas 62 15 10 Performing an Immersion Measurement osoosssooeeeesssssssseeresssssssserresssss 65 ISL Sannea Measurement Pile onesie E E 69 HA Savne a Video BU oT o a T E aidan ee
42. Single e User Input If User Input is selected complete the required fields 8 If desired modify the IOLs and formulas using the appropriate drop down boxes The default lens constant for the selected IOL and formula will be shown underneath the formula selection box 9 If desired select the Personalized Constant checkbox This option will only be available if a personalized lens constant has been calculated for the currently selected Doctor and IOL When selected the personalized lens constant will replace the default lens constant See section 13 6 for more information on calculating personalized lens constants 10 When all the inputs are correct select the Calculate button to see the outputs of the IOL Calculator 11 Save the pre operative data for the current patient and procedure by selecting the Save button Page 81 of 121 6000 INS OMENG Rev 2 IMPORTANT The calculated IOL powers are NOT to be interpreted as suggested or recommended implant powers on the part of DGH Technology Inc The calculated IOL should be used as a guideline only It is based upon the accuracy of the IOL formula used and the data entered The final IOL implant power selection must be made by the surgeon based on personal experiences and previous post operative results 17 19 Overview of IOL Power Calculation Formulas The following IOL Power Calculation formulas are included in the DGH Scanmate IOL Calculat
43. Video Buffer File Size 16 77 KB E Save Video On Stop Scan Bidirectional Scan Save Image On Stop Scan Average Display Control Values W Interpolate OK Cancel Apply Note Please refer to the DGH 8000 Scanmate B User Guide for information on configuring B Scan related Operator Preferences accu The New button allows the user to create new operators and assign preferences to the newly created operator Edit 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 dropdown 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 Delete 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 Page 41 of 121 6000 INS OMENG 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 _ operat
44. al liquid soap followed by a thorough hot water flush some practitioners insure asepsis by including a soak in hydrogen peroxide alcohol or Cidex It is recommended that busy biometry departments should acquire two or three shells allowing one or more shells to be in the cleaning cycle while another one is in use DGH recommends using fresh saline for each patient The catheter tubing provided with the immersion shell has a backflow check valve so it can be attached to either a syringe or a sterile BSS squeeze bottle If using tubing that does not have a check valve only a syringe may be used 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 Fill out all of the fields in the Patient Info section of the page as described in section 14 3 Navigate to the A Scan page and select the eye to be measured OD or OS by pressing the Change Eye button 4 Configure the unit for immersion mode by selecting Immersion in the drop down box at the bottom edge of the screen 5 Select the correct Lens Type and Vitreous type for the eye to be measured Page 65 of 121 6000 INS OMENG Rev 2 6 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 7 Position the unit
45. ances between surfaces in the eye 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 water Page 11 of 121 6000 INS OMENG Rev 2 7 2 Using Ultrasonic Signals to Ascertain Correct Probe Alignment Sound travels in straight lines so the direction of reflected sound is based solely on its angle of incidence Sound hitting an interface perpendicularly will reflect back along the same path that it approached Figure 7 A Sound hitting an interface at an angle will reflect at an angle away from the source Figure 7 B The transmitted sound will continue on at a lesser amplitude because of reflected energy lost at the interface When reflected ultrasound is shown as a two dimensional waveform the peaks are related to the positions of the interfaces By comparing the relative height intensity of the peaks one can determine the angle at which the sound is striking it Figures I A and I B Steadily diminishing peaks are an indicator that the ultrasound is not perpendicular to the interfaces a a _ gt C Figure 7 A Sound hitting an interface Figure 7 B Sound hitting an interface perpendicularly at an angle Using these properties of ultrasound the alignment of an ultrasound beam through the eye can be determined Proper alignment is crucial to the accuracy of
46. 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 drop down 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 Note Once a patient record has been modified all associated Measurement Files Video Files and IOL Calculations will be updated to reflect the changes Page 55 of 121 6000 INS OMENG Rev 2 14 5 Creating a New Procedure Procedures are used by the Scanmate software to associate a set of patient A Scan measurements and calculations Pre Operative Data to a set of surgical outcomes Post Operative Data Patient records can contain multiple procedures To create a new Procedure select the desired patient record following the steps described in section 14 3
47. as well as those are not Profile n O Allow the connection if it is secure aii This includes only connections that have been authenticated by using Psec Connections will be secured using the settings in IPsec properties and rules in the Connection Securty Rule node tamiz p USORE 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 v Domain 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 100 of 121 6000 INS OMENG Rev 2 7 Enter a name for this Rule and then select Finish A l New Inbound Rule Wizard Name Specify the name and description of this rule Steps Rule Type Protocol and Ports Action Profile Name DGH Database Server TCP Port Name Description optional lt sk 8 Open UDP port 1434 by repeating the steps above using UDP instead of TCP and entering 1434 instead of 1433 in step number 4 Page 101 of 121 6000 INS OMENG Rev 2 Configuring DGH Database Server to Use the Static Port defined above 1 Launch SQL Server Configuration Manager
48. asurements the correct nc for that keratometer must be entered in the Post Refractive Calculator Page 79 of 121 6000 INS OMENG Rev 2 6 Select the Calculate button to calculate the corrected corneal power Kcorr If a required input is missing the calculation will be cancelled and the necessary field will be highlighted in red A successful calculation will display the Kcorr in the Outputs section of the calculator Kcorr is given in diopters D using a keratometer index nc of 1 3375 7 Once calculated the results will automatically be imported into the IOL Calculator Screen and used for IOL Power Calculations Selecting the OK button without calculating will close the calculator and save the values entered but will not import a Kcorr to the IOL Calculator Calculate 8 Use the K Correction Method drop down box on the IOL Calculator Screen to see the corrected corneal power Kcorr predicted by the other Post Refractive Formulas If the new method selected requires information that has not been entered the Post Refractive Calculator will open automatically 9 Once the desired Post Refractive Formula has been selected proceed with the IOL Power Calculation Note Only IOL Power Calculation Formulas that are compatible with the currently selected Post Refractive Calculation Method will be available for selection in the IOL Calculator Page 80 of 121 6000 INS OMENG Rev 2 17 18 Performing IOL Calcul
49. ated 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 IOL Calculator Report The IOL Calculator Report presents the results of calculations by the three selected IOL models for each eye To create an IOL Calculator Report click on Reports in the Menu Bar Select IOL Calculator Report A report will be created of the data currently available any fields which are missing will appear as blank in the report The standard IOL Calculations Report includes data for both OS and OD and for three IOL models If there is no need to view the IOL Report on the computer screen clicking the Print button on the IOL Calculator will instantly send the report to the default printer and save it to the patient file 18 2 A Scan Short Report The A Scan Short Report presents images of the waveforms captured and a table of measurements for each eye To create an A Scan Short Report click on Reports in the Menu Bar Select A Scan Short Report If there is no A Scan data available the software will prompt the user to create a scan If there is no need to view the A Scan Short Report on the computer screen clicking the Print button on the A Scan page will instantly send the report to the default printer and save it to the patient file 18 3 A Scan Custom Report The A Scan Custom Report allows the us
50. ations The general procedure for performing IOL Calculations is as follows 1 Select the Patient Data Page and either enter a new patient or select an existing patient Complete the fields in the Patient Info section of the page as described in section 14 2 Select the A Scan Screen and perform either an Immersion or Contact A Scan Measurement as described in sections 15 9 and 15 10 A saved file from a previous measurement can also be used 3 Select the IOL Calculator Screen The measurement and patient data information will automatically be imported from the A Scan and Patient Data Screens Verify that the information is correct and enter any missing Pre Operative Data 4 Select the Doctor that is performing the Lens Replacement Surgery using the drop down box The preferred IOLs and formulas will automatically be loaded for the selected Doctor 5 By default the Scanmate software will perform IOL Power Calculations for both OS and OD If only one eye will be calculated select the desired checkbox Calculate OD or Calculate OS and deselect the other checkbox 6 If the Patient has previously undergone corneal refractive surgery select the Post Refractive checkbox This will automatically open the Post Refractive Calculator See section 17 17 for more information about performing Post Refractive Calculations 7 Select the Measurement Source Choices include e DGH 6000 Average e DGH 6000
51. aveform display screen Page 58 of 121 6000 INS OMENG Rev 2 15 3 Selecting OD or OS The eye currently being measured OD or OS can be selected by pressing the Change Eye button The currently selected eye is shown in the top left hand corner of the waveform display screen 15 4 Selecting Automatic Stop versus Manual Stop Mode The Stop Mode selection is located in the status strip below the waveform display In automatic stop mode Auto Stop scans are stopped when the measurement criteria are met the video buffer fills up or the user clicks Stop Scan In order to meet the measurement criteria eight measurements must be obtained that meet the ranking 3 star and standard deviation requirements The standard deviation requirements can be viewed and adjusted by selecting Preferences gt Doctor If eight valid measurements are not obtained prior to the video buffer expiring the scan will time out Two long beeps will signal that the scan has timed out A message will appear indicating that the measurements did not meet the measurement selection criteria or the standard deviation requirements In Manual Stop mode scans are only stopped when the user clicks Stop Scan or if the video buffer expires 15 5 Automatic Measurement Mode The DGH Scanmate software can be configured for automatic or manual measurement mode The Automatic and Manual Measurement modes are selected using the drop down box below the wavefo
52. ay by pressing the gt or cursor keys If the currently selected waveform is associated with a measurement in the measurement bank the corresponding record in the measurement bank will be highlighted 25 The video buffer can be played or rewound to the beginning by clicking on the arrow buttons in the bottom right corner The slider bar beneath the arrow buttons can also be used to select an image for viewing from the video buffer series 26 Ifa measurement is observed which is suspect because it does not agree with the other measurements the measurement may be removed and replaced as follows a Using the mouse RIGHT CLICK the measurement in the measurement bank you wish to remove b Press the DELETE key to erase the measurement from the measurement bank c Use the gt and cursor keys to scroll through the captured waveforms and add the desired measurement to the measurement bank by RIGHT CLICKING on the measurement bank and selecting the INSERT key 27 After obtaining the desired measurements for the first eye OD or OS the operator may scan the same patient s other eye by clicking the Change Eye button and repeating the steps above Note The measurement data for the first eye will remain stored in memory while measurements are being obtained on the second eye 28 After measurements have been taken the operator may save a video that stores all of the waveforms captured durin
53. 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 21 of 121 6000 INS OMENG Rev 2 Install SQL Server Please create a System Administrator Password for the DGH SQL Database server Server Name DGHServer Administrator Login sa ee ee Note A strong password is required The password must be at least 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 the 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 a
54. by almost a full diopter depending on the make of the keratometer used Page 83 of 121 6000 INS OMENG Rev 2 With both potential sources of error in mind consider that an error of 1 diopter in the measurement of the corneal power produces an error of about 1 diopter in the post operative refraction Postoperative Anterior Chamber Depth The anterior chamber depth is another factor that affects IOL power calculations An error of 1 0 mm affects the postoperative refraction by approximately 1 0 diopter in a myopic eye 1 5 diopters in an emmetropic eye and up to 2 5 diopters in a hyperopic eye Surgical Technique Changes in corneal curvature are often noted postoperatively This fact as well as differences between actual placement and predicted placement of the IOL can produce an error An intraocular lens placed in the posterior segment requires a stronger power and inserting the implant with the convex side backwards necessitates an even stronger lens Implant Power The implant power is measured differently by different manufacturers This may require adjustments to IOL power predictions Page 84 of 121 6000 INS OMENG 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 cre
55. combo box selects an Doctor existing doctor from the database to view New Doctor edit add or delete IOL information that 1s associated with the specified doctor Manufacturer DGH The Manufacturer combo box allows the user to view enter and edit the manufacturer of an IOL Model IOL1 The Model combo box allows the user to view enter and edit the model of the IOL since deena The Manufacturer s A Constant is 118 05 entered by the user based on the IOL manufacturer s specifications SEE o COE The Step Range combo box has two 1 2 Diopter Posterior possible selections Diopter and 1 4 Diopter The Type combo box has two possible selections Posterior and Anterior The Calculate from Mfg A Const button will become active when the Manufacturer s A Constant has been entered on the left Clicking this button Calculate from Mfg A Const A Const 118 05 SRK I will automatically calculate and display all A Const 113 05 SRKT constants needed for the SRK I SRK T Hoffer Q Holladay 1 and pACD 4 996 Hoffer Q Haigis formulas These values can also be SF 196 Holladay 1 entered individually 1303 PER The ACD Constant used for the Binkhorst II formula is not calculated from the ai 0 400 Haigis Manufacturer s A Constant and should be oi entered here if the Binkhorst II formula Aidan reaps will be used with this IOL ACD Const Bink
56. d when using the DGH 6000 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 6000 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 Page 8 of 121 6000 INS OMENG Rev 2 4 2 Device Labels The label shown below is located on the underside of the USB Interface Module REF DGH 6000 SN yyyy xXxxx DGH TECHNOLOGY INC BA El ec REP EMERGO EUROPE Molenstraat 15 110 SUMMIT DRIVE ol SUITE B rs 2513 BH The Hague EXTON PA 19341 X Phone 13170345 8570 yyyy USA 610 594 9100 Site Scanmate A A CAUTION Federal U S A law restricts this device to sale by or on the order of a physician WARNING Explosion hazard Do not use in presence of flammable anesthetics gases or oxygen rich atmosphere WARNING When performing A Scan measurements the computer connected to the DGH 6000 must be powered with a medical grade power supply CAUTION Electrical shock hazard Do not open Refer servicing to qualified service personnel DOC 6000 LAB BKPNL REV 1 4 3 Description of Symbols This symbol indicate
57. database if that computer will be used to perform A scans Choosing to Install Scanmate software and Connect to an Existing DGH Database Server will prepare a computer to operate the A Scan A ni The information collected by the A 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 T 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 A scans Click on one of the three icons to select the desired setup option The setup will begin automatically Page 20 of 121 6000 INS OMENG 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 installing 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
58. e The IOL Information Table can only be opened when a doctor s preferences are being created or edited IOLs are specific to the doctor that creates them If more than one doctor will be using the DGH 6000 they will each need to enter their preferred IOLs Doctor New Doctor1 v Manufacturer A Const SRK II hd A Const SRK T Model pACD Hoffer Q SF Holladay 1 a0 Haigis Manufacturer s A Constant al Haigis a2 Haigis Step Range Type ACD Const Binkhorst Il Optional OK Cancel Apply aa The New button creates new IOL records When this button is clicked previously read only textboxes become enabled and editable Edit The Edit button allows the user to make changes to an existing IOL configuration for the selected Doctor Note When the lens constants specified by the IOL manufacturer are changed the personalized lens constants will be recalculated for the IOL record if Automatic Personalized Lens Constants Update is enabled A N WARNING Editing the manufacturer s A constant will impact the Personalized Lens Constant Calculations for the selected IOL Page 46 of 121 6000 INS OMENG Rev 2 Delete aiii The Delete button deletes an IOL configuration for the selected doctor The IOL information record will not be removed from the database but it is marked as inactive The Doctor
59. e 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 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 circum
60. e 69 t5 3 Reviewine Measurements sserserer iann ao a 69 AF IREVIOW Video OF Exa rea A aai Ei 69 lo EE Bes CAIN SC REIN crcepannan a R 70 17 THE IOL CALCULATOR SCREEN prieina a ia exeibenddenasenes 71 17 1 TOL Calculator Screen Controls eeseesseeeennesessssseeerrsssssssseeressssssssereesssss T2 2 Patent Oraa Oies E alecacdatundeatteaceinemctiils 12 Eo 2ClCC UMC Me DOCIO aera a A T T2 AAS Eye Selen coana a a a a a 12 17 5 Post Refractive SeleCtiOn siisiciesccsccsarcadecsevesseceascdesedevasseeiariadsoassetaveusacdazeiaseses 73 720 NICASUPEMICIE SOUCO ss sssandasncactincotaaeseceisosusdbdatesssndac EEE A 73 Lid Corieal Remactvc Mdee nere as anderen eae dee 73 ies Comeal Power Chl anda iscticatacssueticetaiete a ieadicatt here cteucidasssaaetta deeds 74 179 Desied ReMACUON iiss tsienen S 74 IALO Sele a tatesel Bc eieeemmennr rer emer reese wrens sapere menrerer Perey rere pene er en Tear A 74 17 11 Selecting IOL Power Calculation Formulas cccccsseseeeeeeeeeeeeeeeeeees 74 17 12 Selecting Personalized Lens Constants cc ccececceecccececeeeeeseeeceeeeeeeaaeeeeees 75 I K Cormection Method Selections iii ceiticen tute cadeian evant mentee 75 Page 4 of 121 6000 INS OMENG Rev 2 lA NOT Calculator Quiputs sdsenecesetictutet npapesarihoteniahaiast ekdadinaumesse seh deninaineet ies 75 LAIS Saving Pre Operative Data exis we cactaes badass ves cthaaadhenhvetiuselaantatra e a a 75 17 16 Post Refractive
61. e values are used by the software in calculations interpreting measurements taken by the DGH 6000 This screen also allows the user to enter desired speeds of sound for custom phakic aphakic and pseudophakic lenses See section 7 3 for more information about using the speed of sound in ultrasonic measurement A scan Velocities Table Note The Scanmate software can only store one set of custom velocities changing these values under one doctor s preferences will change them for all users CUZ Structure Type Speed m s Thickness mm Speed m s Cataract 1629 00 Measured Cornea 1641 00 Dense Cataract 1590 00 Measured Aqueous 1532 00 Normal 1641 00 Measured Aphakic 1532 00 PMMAIOL 2780 00 0 70 Silicone IOL 980 00 1 35 Acrylic IOL 2180 00 0 80 Vitreous Type Speed m s Thickness mm Normal 1532 00 Measured Silicone Oil 980 00 Measured Aphakic Phakic Pseudophakic Aphakic Custom Cornea Aphakic Speed m s 1641 00 N A 1532 00 Thickness mm 0 550 Measured NOTE Changes to custom velocities do not take effect until the lens type is re selected This can be caused through explicit selection starting a new measurement OK Cancel or loading a video Page 45 of 121 6000 INS OMENG Rev 2 13 5 Adding IOLs to the Database The IOL Configuration Table button opens the IOL Information Table dialog From this screen the user can create edit view or delete IOLs from the databas
62. ect Explorer Connect i 8 as v ix F HPPROBOOK4520 DGHSERVER SQL Serv agg 9 Databases Q System Databases J DGH Scanmate ij Security B Server Objects Q Replication I Management ACA ACA y 4 Connect Disconnect Register New Query Activity Monitor Stop Pause Resume Restart Policies Facets Start PowerShell Reports Refresh Properties 6000 INS OMENG Rev 2 19 4 Deleting a Database The following steps describe how to permanently delete the DGH Scanmate database AN WARNING Ensure that the database has been successfully moved or backed up before deleting Deleting 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 Server2008 R2 Server type Database Engine Server name HPPROBOOK4520 DGHSERVER Authentication SQL Server Authentication Login sa Password Remember password Connect Cancel Help Options gt gt Page 93 of 121 6000 INS OMENG Rev 2 3 Expand Databases right click
63. ed 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 connect 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 40 of 121 6000 INS OMENG 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 Operator Preferences peer Operator 4 Scan Settings Video Playback Speed Video Buffer Frames Default Preferences Probe LED Intensity B Scan Settings Video Playback Speed Video Buffer Frames LJ
64. efractive index nc used by the keratometer to calculate the corneal power matches the default corneal refractive index nc set in System Preferences The default nc should be set before K1 and K2 are entered for a patient The nc associated with each set of corneal power measurements can be reviewed or adjusted on the IOL Calculator Screen Failure to adjust the default nc to match the nc of the keratometer used to measure corneal power can result in errors in the IOL Calculation See section 17 20 of this guide for more details Select the Save button once all of the desired fields have been entered A new Procedure will be created once the patient record has been saved Procedures are used by the Scanmate software to associate a set of patient measurements and calculations Pre Operative Data to a set of surgical outcomes Post Operative Data 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 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
65. er Correction Koor CLioase curve CLover S E post CLpower 1 0 012m CLover 1 S E post Double K The Double K method modifies the SRK T formula to use both pre and post refractive surgery K values The pre refractive surgery K value is used to calculate the effective lens position and the post refractive surgery K value is used for IOL power calculations Aramberri J Intraocular Len Power Calculation After Corneal Refractive Surgery Double K Method Journal of Cataract and Refractive Surgery 29 11 Nov 2003 2063 2068 Page 120 of 121 6000 INS OMENG Rev 2 APPENDIX D TERMS AND ABBREVIATIONS The following terms and abbreviations are used within this Operator s Manual and in the Scanmate A program A constant The A constant is a constant provided by an IOL manufacturer to be used in IOL power calculations AC Anterior Chamber Depth is defined as the measured distance from anterior vertex of the cornea and the anterior vertex of the lens ACD constant The ACD constant is a constant provided by the IOL manufacturer to be used in Binkhorst formula IOL power calculations The a0 constant is calculated from the manufacturer s A constant to be used in Haigis formula IOL power calculations AXL Axial Length is the distance between the front face of AXT incomes nd the on faee of the etima tee the plano hard contact lens L OL CLpower The contact lens power is the known power of the plano hard co
66. er to select which information to include in the report To create a Customized Report click on Reports in the Menu Bar Select A Scan Custom Report A dialog box will open allowing the user to customize the report being created Page 85 of 121 6000 INS OMENG Rev 2 Print Customized Report Eye OD os Measurement Data W Measurement Bank Velocities Patient Fields W Additional Patient Information W Pre Op Data W Post Op Data Waveform Data All O Selected 5 None IOL Calculations a All E i A IOL IOL3 None Once the desired options have been selected click on the Generate Report button to create the report 18 4 Using Reports All types of reports can be printed browsed and saved in the same ways s5 Clicking the small printer icon in the top left corner will send the report to the printer rp The arrows and page icon next to the printer icon will navigate through the report The Export to PDF button will save the report as a PDF to the 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 ta 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 3 application Page 86 of 121 60
67. eric pressure 70 kPa to 106 kPa Page 111 of 121 6000 INS OMENG Rev 2 21 9 Transportation Never carry the DGH 6000 by the USB or transducer cables Never bend the USB or transducer cables in a tight radius This could result in damage to the cables Transport the DGH 6000 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 6000 to a different field location or when returning it for repair or maintenance use the original DGH 6000 packing enclosure If the original package is not available pack in such a way that the DGH 6000 is protected 21 10 Disposal Contact DGH Technology Inc before disposing of the DGH 6000 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 112 of 121 6000 INS OMENG Rev 2 22 Troubleshooting If a problem is experienced with the DGH 6000 try the suggestions listed below Error During Instal
68. face Module Although no scans can be completed the software can still be used to perform IOL calculations or view completed reports saved measurements and saved videos If the Scanmate software is being used without the USB Interface Module 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 USB Interface Module into a USB port authentication will complete in a few seconds Page 37 of 121 6000 INS OMENG 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 om System Preferences System Options Login Configuration Database Location IP or Computer Namet E Automatically Start With New Patient WIN PROX64 TESTDGHSERVER W Automatic Login Database Name DGH Scanmate Default Keratometer Index nc Username 1 3375 DGHUser Report POF Export Location Password pn IDGHTest1 selected A Scan Transducer Hint Default Configure Transducer Change Configuration Caution Accepting changes to System Preferences may Cancel alter currently loaded data Please review data on all forms Cancel The Automatically Start With New Patient checkbo
69. fault directory can be any local or mapped network drive The Selected A Scan Transducer drop down menu is used to select which A Scan transducer is being used A Default transducer will be preloaded with a Compression Sensitivity of 0 1 e no measurements will be locked out due to corneal compression See Section 15 8 for more details Additional A Scan transducers can be added and selected To enter a new transducer click on the Configure button next to the drop down menu This will open the Configure Transducer window Configure Transducers All parameters must be entered for each transducer that is added Transducer Comp Sensitivity a Transducer 1 21 00 Transducer 2 35 00 Cancel Apply Each transducer entered should be identified by its serial number The Comp Sensitivity number will reflect the adjustment of the slider on the A Scan screen see section 15 8 for the selected transducer Click Apply to save the transducers entered or OK to save and exit the window Once transducers have been successfully created they will be available to be selected in the drop down box Page 39 of 121 6000 INS OMENG 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 describ
70. g the exam or a measurement file that stores the eight 8 measurements and their associated waveforms Page 68 of 121 6000 INS OMENG Rev 2 29 The video buffer and associated measurements will remain in memory for each eye OS or OD until either a new scan is performed for that eye or a new patient is selected The Clear Meas button clears the measurement bank of the currently selected eye but does not clear the video buffer Clear Meas 15 11 Saving a Measurement File A Measurement File is a group of up to eight 8 A Scan measurements and their associated waveforms for both OS and OD Measurement Files can be saved by selecting the Save Button on the upper right hand corner of the A Scan Screen The Save Button will also save all changes that have been made to the Patient Data or IOL Calculator since the last save Alternatively Measurement Files can be saved using the toolbar at the top of the screen by selecting File gt Save gt A Scan Measurements 15 12 Saving a Video Buffer From the toolbar at the top of the screen select File gt Save gt A Scan Video to save a video recording of the current exam 15 13 Reviewing Measurements From the toolbar at the top of the screen select File gt Open gt A Scan Measurements to review previous exam information captured for the current patient 15 14 Review Video of Exam From the toolbar at the top of the screen select File gt Open g
71. he following ways e K1 and K2 will be replaced with Kcorr or Pre Ref K and Post Ref K Pre Refractive Surgery and Post Refractive Surgery depending on the Post Refractive Method selected e The values Kcorr Pre Ref K and Post Ref K are read only e KI and K2 are entered automatically into the Post Refractive Surgery section of the Post Refractive Calculator Note Deselecting the Post Refractive checkbox will return all fields to their original configuration 3 In the Post Refractive Calculator select the desired eye s on which to perform Post Refractive calculations using the Calculate OD and Calculate OS checkboxes 4 Select the desired Post Refractive formula using the method drop down box The required inputs for the pefraction Derived selected method will then be highlighted in white Clinically Derived CL Over Corr Double K History Derived 5 Enter all known inputs If a field is gray that input is not required for the selected method but it can still be edited K1 and K2 values can be entered as either mm or D but both K values in a section must be in the same units Pre Surgical and Post Surgical K values can be entered in different units Note The refractive index nc displayed in the IOL Calculator will be automatically transferred to both the Pre Surgical and Post Surgical sections of the Post Refractive Calculator If a different keratometer was used for Pre Surgical me
72. he captured echo spikes are then measured and converted into distance information A digital signal processing algorithm is used to analyze the waveform ensuring that the probe is properly aligned at the time of measurement The software assists the user in performing replacement IOL power calculations using established formulas The user can save videos or measurement files or create reports to document the results of the exam The captured A Scan waveforms associated measurements and IOL calculations should be evaluated only by trained medical personnel The DGH 6000 does not conduct nor provide any diagnoses drive therapeutic outputs or determine or maintain any life sustaining or life threatening equipment Page 7 of 121 6000 INS OMENG Rev 2 2 Device Classification Device System Imaging Pulsed Echo Ultrasonic Panel Radiology Product Code IYO Device Class II Regulation Number 21 CFR 892 1560 Device Diagnostic Ultrasonic Transducer Panel Radiology Product Code ITX Device Class II Regulation Number 21 CFR 892 1570 3 Indications for Use The intended use of the DGH 6000 is the measurement of axial length anterior chamber depth and lens thickness of the human eye The DGH 6000 is also intended to calculate the optical power of an IOL that is to be implanted during cataract surgery The DGH 6000 is intended to be used solely by qualified medical professionals Clinical consideration and judgment should be applie
73. horst II Optional The Notes textbox allows the user to Notes record any notes associated with an IOL configuration Page 47 of 121 6000 INS OMENG Rev 2 13 6 Personalizing Lens Constants Personalization of lens constants helps to improve the accuracy of a given IOL power calculation formula by correcting for consistent prediction errors caused by Surgical Technique A Scan Biometry Measurements Keratometer Biometry Measurements IOL Style Geometry The Personalized Lens Constants Table allows the user to manage how Personalized Lens Constants are calculated The table displays all Pre Operative Post Operative patient and procedure information associated with the currently selected Doctor and IOL The information in the table is placed in a default column order however the user is provided with the ability to rearrange the columns into any order The ability to sort the entire table allows the user to rearrange the rows based on the selected column The Personalized Lens Constants Table 1s opened by selecting in the Menu Bar Preferences gt Doctor then choosing to edit the selected doctor and then clicking the Personalized Lens Constants Table button r y Personalized Lens Constants Table Xal Current Personalized Constants Doctor Doctor Smithwick A Const 119 00 SRKT a0 1 902 Haigis Min Cases 25 pACD 5 552 HofferQ a1 0 400 Haigis Selected Cases 1 Mfg DGH
74. id 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 a 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 Hint1 Language en US Click Save to save the configuration settings A final window will appear to confirm that the configuration was completed successfully Page 32 of 121 6000 INS OMENG Rev 2 11 Installation of Scanmate Drivers In order to complete the driver installation connect the DGH 6000 USB Interface Module to an available USB 2 0 port The drivers will automatically be installed If this does not happen the steps below 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
75. ill 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 ascan HM e scan 101 calc LastName 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 53 of 121 6000 INS OMENG 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 bo
76. in at the three measurement points L1 L2 and R They can be adjusted independently while the video is paused or playing The amount of gain is displayed as a percentage of the incoming waveform amplitude Page 60 of 121 6000 INS OMENG Rev 2 15 7 Selecting Immersion or Contact Measurement Modes The DGH 6000 is capable of performing both direct contact and water immersion measurements Direct contact means that the ultrasonic probe must be applanated to the cornea This method is the quickest and most convenient way of taking measurements Because there is the possibility of indenting the cornea using the Contact method the measured axial length may be shorter than its actual value To improve accuracy the DGH 6000 has a pattern recognition program that rejects any measurement which contains a significant amount of corneal indentation however some degree of indentation may still exist The skill and technique of the operator will reduce possible corneal indentation The Compression Lockout Sensitivity setting determines how much indentation will be tolerated see section 15 8 When using the Immersion mode measurements are obtained in a column of water while the probe is suspended above the eye Since the probe does not actually touch the eye corneal compression is not an issue Immersion mode increases both measurement accuracy and precision To completely eliminate corneal indentation Immersion mode shou
77. ing A Scan Calibration The DGH 6000 uses a pattern recognition algorithm that looks for unique character istics of the human retina to obtain true probe alignment Under normal usage the DGH 6000 will not recognize standard plastic interface phantoms as eyes to be measured For this reason the DGH 6000 must be placed into a test mode to check calibration on a standardized polystyrene block provided with the unit The procedure for entering the test mode and verifying proper calibration of the unit is described below 1 Navigate to the Patient Data Page by selecting the Patient Data tab In the Last Name drop down box select Test Block 2 Navigate to the A Scan Page by selecting the A Scan tab The current eye should be displayed as Test Block in the waveform display screen and the lens type drop down box should be frozen displaying Test Block 3 Set the provided polystyrene reference block on a stable level surface Apply a small drop of water to the end of the reference block 4 Applanate the probe tip to the center of the reference block The probe tip and reference block have equal diameters to facilitate positioning Page 110 of 121 6000 INS OMENG Rev 2 5 The DGH 6000 should measure the reference block almost instantaneously If not move the probe tip slightly until a measurement is obtained 6 Observe axial length measurements to be within the stated tolerance marked on the reference
78. ing Frequency 12 5 MHz 1 25 MHz Damped Frequency 10 0 MHz nominal Fixation LED Focused Acoustic Beam 23 0 mm nominal Detachable via Lemo REDEL Connector Probe Dimensions L 55 7 mm x D 6 6 mm Cord Length 195 cm USB Interface Module Dimensions L 146 mm x W 88 mm x H 38 mm Weight 285 gm Interfaces USB 2 0 Lemo 4 pin Connector Power Requirements 5 VDC 500 mA 2 5 W max Integrated Probe Holder Measurement Range Axial Length AXL 15 mm to 40 mm Anterior Chamber Depth ACD 2 0 mm to 6 0 mm Lens Thickness LT 2 0 mm to 7 5 mm Measurement Repeatability 0 03 mm STDEV Immersion Resolution 0 01mm Catt n Contact IOL Formulas SRK T SRK II Binkhorst II Holladay 1 Hoffer Q Haigis Double K History Derived Clinically Derived Refraction Derived Contact Lens Files IOL Calculation Reports Environmental Operating Temp 18 C to 40 C Storage Temp 10 C to 50 C Relative Humidity 20 to 80 no condensation Atmospheric pressure 70 kPa to 106 kPa Page 118 of 121 6000 INS OMENG Rev 2 APPENDIX C REFERENCES IOL formulas The IOL Power Calculations are based on formulas published in peer reviewed journals Binkhorst II JEDMED Internal documents based on Binkhorst R D Pitfalls in Determination of Intraocular Lens Power Without Ultrasound Opthalmic Surgery 7 68 1976 69 82 STORZ CompuScan LT User Manual Haigis Haigis W Personal communication based on documents prepared July 2
79. ir or remove the Scanmate program Select either Repair or Remove and click Finish Page 26 of 121 6000 INS OMENG 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 scans this step will automatically be skipped by the installer Please proceed to section 10 13 Configuration Please review the End User License Agreement EULA before continuing After selecting the I Agree button click the Next button to continue Lol e 5 DGH Scanmate 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 of this FUOT A Do Not Agree a Cancel lt Back Next gt J 10 11 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 installe
80. isinfecting procedure 2 Detach the transducer from the unit Check the expiration date on the solution that is being used Use only solutions that are within the expiration date 4 Mix the disinfectant listed in the table above according to the standard operating procedure SOP or equivalent document established by your facility or institution 5 Immerse the tip of the transducer approximately inch 6 35 mm in the disinfectant solution 6 Follow the instructions in the SOP for the duration of probe tip immersion DGH probe tips may be damaged if immersed for longer than 1 hour Page 108 of 121 6000 INS OMENG Rev 2 7 If applicable follow the instructions outlined in the SOP for rinsing the probe tip 8 Examine the transducer for damage such as cracks splitting or sharp edges or projections If damage is evident discontinue use of the probe and contact a customer service representative AN 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 AN WARNING Using a non recommended disinfectant incorrect solution strength or immersing the probe tip deeper than described in step 5 above or for a period longer than 1 hour can damage or discolor the probe tip and will void the probe warranty Do not immerse the probe tip for longer than
81. ized European Representative EMERGO EUROPE Molenstraat 15 EC 2513 BH The Hague The Netherlands Phone 31 70 345 8570 Page 116 of 121 6000 INS OMENG 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 and Speakers For Alignment Audible Feedback 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 or 64 Bit Microsoft SBS 2003 or 2008 SQL Server Installation Only N WARNING The use of a Non Medical grade AC Adapter could potentially cause harm to the system the operator and or the patient AN 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 AN 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 Regularly Page 117 of 121 6000 INS OMENG Rev 2 APPENDIX B SCANMATE A SPECIFICATIONS Transducer Start
82. kes 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 transducer tip Instructions for Disinfecting Transducer Surfaces when Using a Cavicide Wipe 1 Wear protective gloves when performing the disinfecting procedure 2 Detach the transducer from the unit Check the expiration date on the wipes that are being used Use only wipes that are within the expiration date 4 Thoroughly wet down the transducer tip housing and cable if applicable according to the standard operating procedure SOP or equivalent document established by your facility or institution Caution Care must be taken to prevent any liquids from coming into contact with the probe connector 5 Follow the instructions in the SOP for the duration of exposure to the disinfectant 6 If applicable follow the instructions outlined in the SOP for rinsing the probe tip 7 Examine the probe for damage such as cracks splitting or sharp edges or projections If damage is evident discontinue use of the probe and contact a customer service representative Instructions for Disinfecting Patient Contact Surfaces when Using a Liquid Disinfectant 1 Wear protective gloves when performing the d
83. lation 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 Install 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
84. ld be used The Contact and Immersion Measurement modes are selected using the drop down box at the bottom left of the waveform display screen 15 8 Setting the Corneal Compression Sensitivity When in Contact Measurement Mode the Operator can control the Compression Lockout Sensitivity Comp Sens The Comp Sens slider at the bottom right of the waveform display iii screen adjusts the amount of corneal compression that the software will allow when taking measurements in contact mode Setting this slider higher will allow less compression making measurements more accurate but also more difficult to obtain The optimal setting for Comp Sens will be different for each probe and will depend on the operator s technique The Compression Lockout Sensitivity can be adjusted before replaying videos or on any paused frame to see the impact on the measurements A red green indicator next to the Comp Sens slider will show whether a measurement can be taken from a frame if the indicator is red there is too much compression for a measurement at that sensitivity level If the indicator is green a measurement can be taken When properly set the Comp Sens control should limit corneal compression in Contact Mode to 0 15 mm or less Page 61 of 121 6000 INS OMENG Rev 2 15 9 Performing a Contact Measurement Before each biometry procedure the ultrasound probe must be cleaned See Section 21 for Cleaning and Disinfection Instructions 1 Launch
85. ll be displayed on the screen but the unit will not begin recording 12 The hand holding the transducer can be stabilized on the cheek or forehead of the patient This will help minimize indentation of the cornea or excessive movement 13 The transducer can now be applanated to the cornea Applanation should be observed from a vantage point that allows the operator to look across the topography of the eye The transducer should be perpendicular to the surface of the eye as it approaches the cornea This method aids in seeing the exact moment when the transducer contacts the cornea so indentation of the cornea will be minimized Applanation should be made as close to the visual axis as possible An aid in this can be to point the back side of the tranducer at the fixation target while touching the front portion of the transducer to the center of the cornea Page 62 of 121 6000 INS OMENG Rev 2 Note When applanating the transducer be particularly careful that contact is made with the center of the transducer tip 14 At the moment of applanation the unit will start beeping at a rate of approximately one beep per second This means that proper coupling has been achieved and sound pulses are being transmitted through the eye If the beeping stops then the transducer is no longer applanated to the eye and a slight pressure should be applied to restore applanation The DGH 6000 will only record the live waveforms and perform measurement
86. lowing table summarizes the assumed thicknesses and velocities Page 14 of 121 6000 INS OMENG Rev 2 Velocity m s Thickness um PMMA IOL 2780 o 700 Silicone IOL 0 1350 Acrylic TOL 2180 Note The velocities table within the Scanmate application displays the preset velocities and allows the user to specify a custom velocity and thickness to be used for calculation Custom velocities are selected as Custom Aphakic Custom Phakic or Custom Pseudophakic lens types J Velocities Table Page 15 of 121 Type Cataract Dense Cataract Normal PMMAIOL silicone IOL Acrylic IOL Vitreous Type Normal Silicone Oil Aphakic Custom Speed m s Thickness mm Speed m s 1629 0 1590 00 1647 00 2780 00 ga0 00 2180 00 Speed m s 1532 00 950 00 Cornea 1641 00 0 550 Thickness mm Measured Measured Measured 0 70 1 35 0 80 Thickness mm Measured Weasured Ag ueus NOTE Changes to custom velocities do not take effect until the lens type is reselected This can be caused through explicit selection starting a new measurement or loading a video Structure Speed m s Comea 1641 00 Aqueous 1532 00 Aphakic 1532 00 Aphakic 1532 00 Weasured 6000 INS OMENG Rev 2 8 Ultrasonic Exposure and Intensities 8 1 Tissue Exposure to Ultrasound Energy The ultrasound energy emitted by the DGH 6000 is low intensity and will have no adverse effects on the patient and
87. lue will automatically be updated to the result of the method 17 14 IOL Calculator Outputs When the Calculate button is selected the DGH Scanmate will perform IOL calculations using the selected formula for each of the six 6 selected IOLs on the screen Any necessary inputs for performing an IOL Power Calculation that are either missing or out of range are automatically highlighted in red The Target Power is the ideal result However since IOLs are only manufactured in discrete power increments an IOL must be selected having a power that comes closest to the Target Power To aid the operator in selecting an IOL with the most appropriate power the DGH Scanmate performs the following calculations e An IOL power that predicts Emmetropia e A target IOL power that is based on the desired postoperative refraction e A selected IOL having a power that comes closest to the target IOL power e A postoperative refraction predicted by using the selected IOL power e Postoperative refractions predicted by using IOL powers for five power increments above and below the selected IOL power The power increments are set for each IOL in the IOL configuration table in Doctor Preferences by selecting 1 2 or 4 diopter 17 15 Saving Pre Operative Data The Save button allows the user to save the pre operative data for the current patient and current procedure When clicked the pre operative data on the IOL Calculator screen is sent t
88. m Files DGH Technology Inc Data Back Up DGH Scanmate DGH Scanmate 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 SQL Server2008 R2 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 91 of 121 6000 INS OMENG Rev 2 Ss
89. ma 3I i New Meas Save Print Jane Doe 123 456 789 Immersion mm Average mm OD Lens Normal 23 48 ACD 3 15 23 50 ACD 3 17 Vitreous Normal AXL a LT 5 01 AXL a LT 4 99 Std Deviation mm 0 01 ACD 0 01 AXL a LT 0 01 Operator Lens Normal Vitreous Normal Silicone Oil Change Eye ea OD Measurements 501 Man Meas Clear Frame 75 14 L1Gain L2Gain RGain n v AutoStop v Manual Meas v 191 361 a 284 e On a desired frame the measurement points can be set by the user In contact mode three red arrows represent measurement points that can be selected they represent the anterior and posterior lens surfaces L1 and L2 and the retina R In immersion mode the corneal peak is also visible in the waveform and is indicated by an additional arrow at the leftmost echo The red arrows can be moved horizontally by clicking on an arrow with the mouse holding the mouse button and moving the mouse until the arrow is in the desired position When a measurement arrow is released the arrow snaps to the closest intersection of the measurement level and the displayed waveform The measurement points can only be adjusted when the video is paused The horizontal green line represents the measurement level In manual mode it can be adjusted up and down while the video is paused or playing The three sliders control the ga
90. method can be used with the SRK T formula Required Inputs e Pre Refractive Surgery K measurements e Pre Refractive Surgery Spectacle Refraction S E e Post Refractive Surgery Spectacle Refraction S E ee IMPORTANT The corrected corneal power Kcorr calculated using the formulas described above should NOT be interpreted as a suggested or recommended corneal power on the part of DGH Technology Inc The calculated corrected corneal power Kcorr should be used as a guideline only It is based upon the accuracy of the post refractive formula used and the data entered The determination of the corrected corneal power Kcorr to use for performing IOL Power Calculations must be made by the surgeon based on personal experiences and previous postoperative results Page 78 of 121 6000 INS OMENG Rev 2 17 17 Using the Post Refractive Calculator 1 Select the Post Refractive checkbox on the IOL Calculator Screen next to the eye that has previously undergone corneal refractive surgery This will automatically open the Post Refractive Calculator Note The Post Refractive Calculator can be opened again at any time by selecting the Kcorr button on the IOL Calculator Screen The Kcorr button is inactive until the Post Refractive checkbox has been selected 2 When the Post Refractive checkbox is selected the Pre Operative Data group box on the IOL Calculator and Patient Data screen will change in t
91. nces 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 The Notes text box is provided to allow the user to associate notes to a doctor s preferences Notes The AXL Std Deviation Threshold textbox allows the user to enter the AXL standard deviation threshold for the currently selected doctor This threshold defines the standard deviation that the eight 8 axial length Auto Stop Scan Criteria AXL Std Deviation Threshold 0 05 ACD Std Deviation Threshold 0 05 LT Std Deviation Threshold 0 05 Page 43 of 121 6000 INS OMENG Rev 2 measurements in the measurement bank must fall within for the system to automatically stop scanning See Section 15 4 for more details on automatic and manual stop mode The ACD Std Deviation Threshold textbox allows the user to enter the ACD standard deviation threshold for the currently selected doctor This threshold defines the standard deviation that the eight 8 anterior chamber depth measurements in the measurement bank must fall within for the system to automatically stop scanning See Section 15 4 for more details on automatic and manual stop mode The Lens Std Deviation Threshold textbox allows the user to enter the lens standard deviation threshold for
92. nt of correction achieved through refractive surgery is unknown it is not factored into the calculation This method can be used with 3 generation formulas SRK T Hoffer Q or Holladay 1 Required Inputs e Post Refractive Surgery K measurements Refraction Derived This method is useful when the pre operative K values are unknown but the pre operative spectacle refraction is known Required Inputs e Pre Refractive Surgery Spectacle Refraction S E e Post Refractive Surgery K measurements e Post Refractive Surgery Spectacle Refraction S E Page 77 of 121 6000 INS OMENG Rev 2 Contact Lens Over Correction CL Over Corr This method requires the doctor to place a plano hard contact lens of a known curvature on the patient s eye If the refraction remains the same the corneal curvature 1s equal to that of the contact lens If the over refraction results in a higher myopic error the difference in refraction 1s added to the base curve value This method can be used with 3 generation formulas SRK T Hoffer Q or Holladay 1 Required Inputs Contact Lens Base Curve Contact Lens Power Contact Lens Over Refraction S E Post Refractive Surgery Spectacle Refraction S E Double K SRK T This method uses the pre refractive corneal power to estimate the post refractive anterior chamber depth also known as effective lens position The post refractive corneal power is estimated using the History Derived Method This
93. ntact lens Kor The corrected K value that should be used in IOL calculations for patients who have previously undergone refractive surgery KI Corneal Power in Vertical Meridian D K2 Corneal Power in Horizontal Meridian D Class The contact lens over correction 1s the measured refraction with the plano lens in place K K pACD The pACD constant is calculated from the manufacturer s A constant to be used in Hoffer Q formula IOL Power calculations refractive surgery refractive surgery C Refractive error measured after refractive surgery Refractive error measured before refractive surgery SF The Surgeon Factor constant is calculated from the manufacturer s A constant to be used in Holladay 1 formula IOL Power Calculations Page 121 of 121 6000 INS OMENG Rev 2 l 2 T E
94. o the patient data screen measurement data on the A Scan Page is saved if unsaved and the IOL information is saved with the pre operative data Page 75 of 121 6000 INS OMENG Rev 2 17 16 Post Refractive Calculation Methods It has been well established that the corneal power for patients that have undergone corneal refractive eye surgery cannot be accurately measured using current keratometry or topography methods The Post Refractive Calculator included with the DGH Scanmate helps predict the true corneal power for patients that have undergone corneal refractive surgery The DGH Scanmate is equipped with the following methods for calculating the corrected corneal power Kcorr History Derived Clinically Derived Refraction Derived Contact Lens Over Refraction Double K These methods have been implemented as described in H John Shammas s book Intraocular Lens Power Calculations published by Slack Incorporated 2004 The mathematical formulas used for each of these methods can be found in Appendix C of this User Manual Ma Post Refractive Calculators WM wi me Post Refractive K Calculator V Calculate OD Calculate OS OD Method Method Inputs Inputs Pre Refractive Surgery Pre Refractive Surgery mc 1 3375 nce 1 3375 K1 K2 K1 K2 Spectacle Refraction S E Spectacle Refraction S E Post Refractive Surgery Post Refractive Surgery nc nc K1 7 00 mm K2 K1 K2 Spectacle Refracti
95. occur for long and short eyes They did this by relating the predicted post operative ACD to the axial length The shortcoming of this approach is that it assumes that shorter eyes always have short anterior chamber depths and vice versa Page 82 of 121 6000 INS OMENG Rev 2 Third and fourth generation formulas have further refined the method for predicting the post operative ACD The SRK T Hoffer Q and Holladay 1 formulas predict the post operative ACD using the measured corneal power or radius as well as the axial length The Haigis formula uses the pre operatively measured ACD and axial length to predict the post operative ACD All third and fourth generation formulas allow doctors to personalize their lens constants based on their surgical results with a particular IOL 17 20 Factors Impacting the Accuracy of IOL Power Calculations Many factors play a role in predicting the correct IOL power for a patient Several of the most common factors are described in the following sections Axial Length Axial length measurement is the most important factor affecting IOL power calculations An error of 1 0 mm affects the postoperative refraction by approxi mately 2 5 diopters Corneal Power Corneal power is the second most important factor affecting IOL power calculations A keratometer is an instrument that measures the central 3 3 mm of the anterior curvature of the cornea in its two meridians The readings are called K readings The
96. on If the Procedure is a good candidate select the Add to Personalized Constants checkbox Note Selection of consistent results 1s the most critical step in Calculating Personalized Lens Constants Personalized Lens Constants only compensate for consistent errors in predicting the power of the implanted IOL For this reason all steps used to measure the patient calculate the IOL power and perform the lens replacement surgery should be performed as identically as possible Ultimately it is up to the doctor to decide which results to use but in general the following guidelines should be observed e Do not include results where complications occurred during the procedure e Only include results where the same surgical technique was used e Do not include results from patients that have undergone refractive eye surgery e Only include results where the A Scan measurement was performed using the same technique measurement mode immersion or contact and instrument e Only include results where the Corneal Power measurements were made with the same instrument 6 After a large population of results has been acquired for a given doctor and IOL model navigate to the Personalized Lens Constants Table to view the Procedures that were performed by the selected doctor using the selected lens Review the Procedures that have Use Record selected and modify as necessary See step 5 for considerations on filtering which results to use
97. on S E Spectacle Refraction S E Contact Lens Contact Lens CL Base Curve D CL Base Curve CL Power D CL Power CL Over Refraction S E D CL Over Refraction S E Note Vertex Distance 12 0 mm Note Vertex Distance 12 0 mm Outputs D Outputs D cauas Page 76 of 121 6000 INS OMENG Rev 2 The best method in any instance will depend largely on the available patient information The following section gives a brief description of the post refractive formulas and their required inputs History Derived The History Derived method is considered to be one of the most accurate methods for determining the true post surgical corneal power Unfortunately it also requires the most information about the patient some of which may not be available This History Derived method calculates the amount of correction that was achieved through refractive surgery and adds it to the pre surgical corneal power This method can be used with 3 generation formulas SRK T Hoffer Q or Holladay 1 Required Inputs e Pre Refractive Surgery K measurements e Pre Refractive Surgery Spectacle Refraction S E e Post Refractive Surgery Spectacle Refraction S E Clinically Derived The advantage of this formula is that no information prior to the refractive surgery is needed The only input required for this method is the average post surgical manual keratometry measurement of corneal power The disadvantage is that since the amou
98. on DGH Scanmate and select Delete Wz Microsoft SQL Server Management Studio File Edit View Debug Tools Window Community Help TI New Query D B amp a Object t Explorer z i x Connect 49 a Y BS id HPPROBOOK4520 DGHSERVER SQL Server 10 50 1600 sa L Databases B System Databases 18 O Security Lj Server Obje New Query a 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 SQL Server 2008 R2 Server type Database Engine Server name HPPROBOOK4520 DGHSERVER Authentication SQL Server Authentication Login sa Password Remember password Coa tenes tp Page 94 of 121 6000 INS OMENG Rev 2 3 Under the DGHServe
99. one hour The probe tip may be damaged by longer immersion times Disinfect the probe tip using only the liquid solutions above Using autoclave gas EtO or other non DGH Technology approved methods will damage the probe and void the warranty AN WARNING The transducer should NEVER be autoclaved or subjected to intense heat As a general rule the above cleaning instructions are sufficient to disinfect the transducer in ordinary use Do not scratch or chip the conical transducer tip which makes contact with the cornea Page 109 of 121 6000 INS OMENG Rev 2 21 3 Cleaning and Disinfecting the Immersion Shell The immersion shell is not sold sterile and must be cleaned and disinfected before each use The immersion shell cannot be autoclaved Clean as described in the immersion shell Instructions for Use included in package The catheter tubing cannot be reused 21 4 Care of USB Interface Module Keep the USB transducer plug dry at all times Regularly check the transducer and USB cables for cuts cracks and kinks The presence of these defects can impair the performance of the device 21 5 Cleaning the USB Interface Module The DGH 6000 USB Interface module housing and USB cable can be cleaned using a cloth dampened with a mild soap and water solution The connectors should not be exposed to water 21 6 Operating Conditions The DGH6000 Scanmate A should be operated between temperatures of 18 C and 40 C 21 7 Verify
100. or SRK II SRK T Haigis Hoffer Q Holladay 1 Binkhorst II The formulas selected for inclusion are commonly used and have been refined from earlier models IOL power calculation formulas have evolved from the first models to become more accurate in a wider range of cases selecting the appropriate IOL formula will be based on the individual practitioner s judgment and experience There are two types of first generation formulas theoretical and regression The theoretical formulas such as those developed by Thijssen Colenbrander Fyodorov Binkhorst and vand der Heijde are based on a two lens system where the cornea and pseudophakic lens focus images on the retina The first generation regression formulas were empirically derived from a large sample of patients that had undergone lens replacement surgery The SRK formula developed by Sanders Retztlaff and Kraff is an example of a first generation regression formula First generation IOL Power Calculation formulas calculated IOL power as a function of the measured Axial Length and Corneal Power These formulas typically assumed a constant value for the post operative anterior chamber depth Due to this assumption they often predict incorrect replacement lens powers for eyes that are longer or shorter than average The second generation formulas such as Binkhorst I Hoffer Shammas and SRK II attempt to correct the errors in predicting replacement IOL powers that typically
101. or s preferences Notes A Scan Operator Preferences A Scan Settings The A Scan Video Playback Speed Video Playback Speed 20 fps slide bar adjusts the frames per second f fps that the A Scan video is played for E es Y 1024 the currently selected operator The speed 2 of video playback can be adjusted from 1 Probe LED Intensity 400 to 20 fps The A Scan Video Buffer Frames slide bar adjusts the size of the buffer used when capturing A 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 is captured before recording is stopped The video buffer can be configured to store from 0 zero to 1024 frames The A Scan Probe LED Intensity slide bar adjusts the default intensity of the LED on the probe for the currently selected operator The intensity brightness can be adjusted from 0 zero to 100 Page 42 of 121 6000 INS OMENG 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 P Dox toe Preference jomme zamn l EEEE ie i z a 1 Do
102. ore a prior database the back up version can be reinstalled Any 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 89 of 121 6000 INS OMENG 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 7 Configure Back Up Restore r Som Server Connection Status Not Connected Server HPPROBOOK4520 DGHSERVER User Name sa Password IDGHTest Use Windows Authentication Lemna D 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 J Page 90 of 121 6000 INS OMENG 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 s The restore process will delete the current database amp replace it with A the data from back up file C Progra
103. ow No SOL Server Windows NT Prevate Yes Allows No I m t Page 98 of 121 6000 INS OMENG 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 O 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 to which this rule applies Steps Rule Type Protocol and Ports 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 o i i Example 80 443 5000 5010 Leam more about protocol and ports Page 99 of 121 6000 INS OMENG 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 Frotocol and Forts 7 Allow the connection So This includes connections that are protected with Psec
104. pliance level the DGH 6000 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the DGH 6000 21 Care and Maintenance AN WARNING Users of the DGH 6000 Scanmate A 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 21 1 Care of Transducer Be careful when handling the transducer If the transducer is dropped on a hard surface it can be damaged Regularly check the transducer front face for damage as this may impair the performance of the device The transducer may be submersed in water up to the cable not wetting the connector during normal use The transducer should be cleaned after every use using the following protocol 1 Wear protective gloves when performing the cleaning process 2 Disconnect the transducer from the unit 3 Use a soft cloth or equivalent dampened with a mild soap or 70 isopropyl alcohol solution to remove any particulate matter or body fluids that remain on the probe tip probe housing and probe cable if applicable Do not immerse the entire probe in the cleaning solution Caution Care must be taken to prevent any liquids from coming into contact with the p
105. r 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 fe 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 iai Page 27 of 121 6000 INS OMENG 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 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 Installation Complete announcement Click Close to exit the installer 5 DGH Scanmate 5 DGH Scanmate Installation Complete Installing DGH Scanmate DGH Scanmate is being installed DGH Scanmate has been s
106. r right click on Databases Folder and select Attach Wz Microsoft SQL Server Management Studio File Edit View Debug Tools Window Community Help T New Query L Ls Be SJ Connect 3 2 as i HPPROBOOK4520 DGHSERVER SQL Server 10 50 1600 sa o Gy New Database a La D Ga Restore Database Restore Files and Filegroups Start PowerShell Reports Refresh 4 The Attach Databases dialog window will open Click the Add button J Attach Databases E Script v f Help Databases to attach MDF File Location Database Attach As Owner Status Message Remove Database details 3 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 95 of 121 6000 INS OMENG Rev 2 _ i Apple Software Update _ 4 Bonjour 3 Broadcom E Business Objects _ G y Cisco Systems E Common Files H Corel B CrashPlan _ E DGH Technologies Inc DGH Technology Inc i Data Gf Back Up 6 DGH 6000 _ DGH Scanmate Ef DGHScanmateFS 6 Data 01 02 2013
107. re are two potential sources of error in keratometry First failure to calibrate the instrument can cause all readings to be in error by as much as 0 2 mm or 1 0 D A second source of error is hidden in the diopter calculation of any keratometer Keratometers cannot directly measure the refracting power of the cornea in diopters Rather they measure the radius of curvature of the anterior corneal surface and then convert this millimeter measurement into diopters Because only the anterior surface of the cornea is measured the effect of the posterior surface on the overall refracting power must be taken into account to convert the measurement into diopters The dioptric scale used for this conversion is based on an adjusted refractive index The true refractive index of the cornea is 1 376 but to estimate the true refracting power of the cornea from only the radius of the anterior surface a fictitious refractive index nc is used This index varies with the make of keratometer A radius of 7 8 mm will thus read 43 27 43 08 or 42 56 D respectively depending on which keratometer is used These differences may not be of much importance in contact lens fitting or the determination of corneal astigmatism However these differences are significant when calculating IOL power Any IOL power calculation formula which requires the dioptric power of the cornea is subject to this source of error With the same data one may calculate IOL powers varying
108. refractive eye surgery Selecting this checkbox enables the post refractive calculator which assists the doctor in predicting the true corneal power of eyes that have undergone corneal refractive surgery See section 16 16 and 16 17 for more details on using the Post Refractive Calculator 17 6 Measurement Source The Measurement Source drop down box allows the user to select the source of the Pre Operative Measurement values The following options are available e DGH 6000 Average e DGH 6000 Single e User Input When DGH 6000 Average is selected the average and standard deviation of the Anterior Chamber Depth Lens Thickness and Axial Length measurements are displayed in the pre operative data section of the IOL Calculator The total number of measurements used to create the average is displayed in the Total field When DGH 6000 Single is selected the Anterior Chamber Depth Lens Thickness and Axial Length measurements for the currently selected waveform on the A Scan page is displayed in the pre operative data section of the IOL Calculator When User Input is selected the user is able to manually enter the desired Anterior Chamber Depth Lens Thickness and Axial Length measurements The Measurement Source field will default to the current doctor s default measurement source The measurement type lens type and vitreous type will be imported from the A Scan screen when either DGH 6000 Average or DGH 6000
109. rm display Scans must be performed in automatic measurement mode but captured scans can be examined in either automatic or manual mode In Automatic Measurement Mode the DGH 6000 uses a pattern recognition algorithm to determine when the probe is properly aligned The alignment algorithm first looks for the proper pattern of reflectance peaks from each expected interface Then the algorithm examines the retinal spike for particular signal characteristics which are produced only by retinal interfaces Waveforms that meet the DGH 6000 alignment criteria are ranked and put into the measurement bank 15 6 Manual Measurement Mode Manual mode is not available during a scan When viewing a completed scan or a saved video manual mode can be selected from the drop down below the waveform display screen In this mode measurements can be manually entered into the measurement bank This is achieved by using the and gt cursor keys to scroll through the captured waveforms On the desired frame the measurement can be added to the bank by RIGHT CLICKING in the measurement bank and selecting the INSERT key Measurements can be removed from the measurement bank by RIGHT CLICKING the measurement with the mouse and pressing the DELETE key Page 59 of 121 6000 INS OMENG Rev 2 p DGH Scanmate A ise File Edit Preferences Reports Help Transducer Default Video Saved 04 04 2013 12 26 56 PM 3 9 Patient TW 4 scan MA B scan IOL Cale
110. robe connector 4 To remove remaining particulates rinse probe with water Do not immerse the probe in the rinse solution Page 106 of 121 6000 INS OMENG Rev 2 5 Wipe with a dry cloth or wipe with a water dampened cloth to remove soap residue and then wipe with a dry cloth AN WARNING Do Not Attempt To Open the Transducer or USB Interface Module 21 2 Cleaning and Disinfecting the Transducer Tip Keep the transducer tip clean and disinfected To prevent patient to patient infection a disinfection procedure should be followed after each patient After disinfection the tip should be rinsed in sterile distilled water before using The following disinfectants are recommended due to their compatibility with the probe tip material Disinfectant Concentration Tested O l 10 20 Isopropyl Alcohol and 1 5 Ethylene ee aon Glycol Monobutyl Ether E 10 20 Isopropyl Alcohol and 1 5 Ethylene E CEDE Glycol Monobutyl Ether ey 6 2 by w w Ortho Phthalaldehyde ane 1 2 benzenedicarboxaldehyde Isopropyl Alcohol 70 v v Isopropyl Alcohol Hydrogen Peroxide 3 w w H202 Note The concentrations listed in this table are the specific concentrations that were tested by DGH to ensure compatibility with the probe tip material DGH does not endorse or recommend the concentrations listed in the table above Household Bleach 0 6 w w Sodium Hypochlorite Page 107 of 121 6000 INS OMENG Rev 2 AN WARNING DGH ma
111. rofessionals in the ophthalmic field to perform axial length AXL anterior chamber depth ACD and lens thickness LT measurements of the human eye Measurements are obtained using ultrasonic pulse echo technology whereby short bursts of ultrasonic energy are transmitted and the resulting echoes are captured amplified filtered and processed The DGH 6000 is comprised of three main components a detachable 10 MHz transducer a USB interface module and the Scanmate software application The transducer uses a single element piezoceramic with a starting frequency of 12 5 MHz 1 25 MHz This ceramic after it has been damped runs at a center frequency of 10 0 MHz nominal The tip of the transducer has a spherical radius of curvature which focuses the acoustic beam at 23 0 mm nominal It is also equipped with a fixation LED to facilitate probe alignment The USB Interface Module contains the electronics used to pulse the transducer as well as to measure filter and amplify the resulting echoes from internal eye structures The USB Interface Module is powered and controlled via a USB 2 0 cable which must be connected to a PC or laptop computer running the Scanmate software application The Scanmate software interprets the digital signals transmitted by the USB Interface Module and displays a live Amplitude Scan which shows the relative magnitude and distance of the echo spikes received by the transducer Specific time distances between t
112. s password A strong password contains a mixture of capital and lowercase letters numbers and symbols and is 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 22 of 121 6000 INS OMENG Rev 2 EULA for SQL Server 2008 R2 MICROSOFT SOFTWARE LICENSE TERMS MICROSOFT 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 jwhich 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 IDo Not Agree 10 7 Crystal Reports Installation Note If the computer or server being set up will only be used to house the database and will not perform A scans this step will automatically be skipped by the installer Crystal Reports 2008 is a pre requisite used by the Scanmate software to create and view reports Install Crystal Reports 2008
113. s Lens Normal 1641 m s Lens Cataractous 1629 m s Vitreous 1532 m s Silicone Oil 980 m s IOL PMMA 2780 m s Comea IOL Silicone 980 m s l Phakic Aphakic Pseudophakic Figure 7 E Speeds of sound for ophthalmic structures Using the relationship between the density of a material and the speed of sound ophthalmic A Scans obtain distances in the eye by performing a two step process First a pulse of sound is timed as it travels through the eye reflects off the retina and returns to the transducer Second the lengths are calculated based on the travel time and the speed of sound through the eye distance velocity X time 2 Early ophthalmic ultrasonic units used an average speed of sound of 1550 m s for phakic eyes and 1532 m s for aphakic eyes The DGH 6000 Scanmate A lets the user select the type of eye being examined and will then automatically use the proper speed for each part of the eye Using specific velocities for each part of the eye increases the accuracy of measurements Ex lens thickness normal 1641 m s X time s 2 Cornea thickness in all eye types is assumed to be 550 um with a velocity of 1641 m s This assumption is part of the ACD calculation Anterior Chamber Depth is defined as the measured distance from anterior vertex of the cornea and the anterior vertex of the lens In pseudophakic eyes the lens thickness is not measured A standard thickness is assumed depending on the type of implant present The fol
114. s the degree of protection against electric shock The R DGH 6000 Scanmate A is classified as type BF equipment This symbol indicates that the DGH 6000 Scanmate A is an IEC Protection Class II double insulated device 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 9 of 121 6000 INS OMENG 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 manufact
115. s when it detects that proper coupling has been achieved IMPORTANT In order to obtain measurements the transducer must be in proper alignment Audible feedback from the unit is a key element for achieving proper alignment Measurements are best obtained by concentrating on the audible feedback while visually aligning the transducer It is not recommended that the operator view the waveforms on the graphic display during the actual measurement cycle The interpretation of the audible tones that are emitted during the measurement cycle is explained below 15 The alignment of the transducer may need slight adjustments keep the tip in contact as the angle is changed slightly As the transducer is brought closer to alignment the beep rate will increase 16 When the transducer is properly aligned a beep with a higher tone will sound Each high pitched beep indicates a successful 3 star measurement being recorded in the measurement bank The axial length measurement can be observed on the graphic display along with its echo waveform Measurements for the anterior chamber depth and lens thickness are also given If the unit is configured for the Aphakic lens type only the axial length will be given 17 In Auto Stop mode the scan will stop automatically as soon as 8 measurements are obtained that meet the ranking 3 star and standard deviation requirements In Manual Stop mode the user must select the Stop Scan b
116. ser to perform and review A Scan Measurements for the currently selected patient Refer to section 14 for details on how to load or create patient records 7a DGH Scanmate Lo jk File Edit Preferences Reports Help Transducer Default Measurements Saved 04 04 2013 12 26 51 PM L y j 7 Patient JILA A Scan B Scan IOL Calc WA i i EEEL New Meas Save Print Jane Doe 123 456 789 Immersion mm Average mm O D Lens Normal 23 50 ACD 3 18 23 50 ACD 3 17 Vitreous Normal AXL a LT 5 01 AXL a LT 4 99 Std Deviation mm 0 01 ACD 0 01 AXL a LT 0 01 Operator Lens Normal Vitreous Normal Silicone Oil Change Eye 1 OD Measurements Frame 81 The default settings for this page are dependent on the currently selected Doctor and Operator The default settings can be changed by selecting Preferences gt Operator or Preferences gt Doctor 15 1 Selecting the Operator The name of the Operator performing the measurement can be selected using the Operator drop down box If the operator is not listed in the drop down box add the new Operator by selecting Preferences gt Operator gt New 15 2 Selecting the Lens and Vitreous Type The lens and vitreous type of the patient can be selected using the drop down box and radio buttons directly under the operator selection box The currently selected lens and vitreous type is displayed in the top left hand corner of the w
117. shell will be held away from the eye Then direct the patient to look straight ahead with the other uncovered eye toward a fixation point Lift the patient s upper eyelid and gently pivot the upper portion of the shell into the upper fornix making sure by close inspection that it is in the fornix and not atop a fold in the conjunctiva This pivotal motion avoids contact with the cornea and insures centration of the device around the limbus 15 Rest the left palm holding the immersion shell on the patient s forehead to reduce shell pressure on the eye In this position the palm acts as the fulcrum or pivot point for the shell If necessary the operator can stabilize the shell with the other hand and make micro adjustments A tissue may be placed on the temporal canthus to catch any excess saline Page 66 of 121 6000 INS OMENG Rev 2 16 Pick up the saline reservoir from its place on the patient s shoulder and slowly inject the saline into the shell As soon as the liquid fills the shell sufficiently to reach the tip of the transducer about 2cc a beep rate of approximately once per second will be heard This means that proper coup ling has been achieved and sound pulses are being transmitted through the eye ee IMPORTANT In order to obtain measurements the transducer must be in proper alignment Audible feedback from the unit is a key element for achieving proper alignment Measurements are best obtained by concentrating
118. sssssssssssssssssssssssssssssssssssssseeeee 33 11 1 Connecting USB Interface Module sinacusicinssiieaeedidetueinausinniuiaetaas 33 11 2 Found New Hardware Wizard cccccccsssssssscccccccceeeesseeececeeeesaeeseseeeeeeeeaaas 33 113 Automatically InstallDriver Sen a a 34 liA WindlOws Logo Tesini aroen A ein ah een 34 11 5 Complete histallation Of Diy Crs ecnin a in nauasineent 35 11 6 Further Driver Installation susanna a a 35 12 STARTING THE SCANMATE SOP DW ARIE ssiiccatcesdeacustecvetud danced donnececssdeetegdeasededdeasanes 36 12 LCaonchine the Appli Cation sista reteritasdehisccreteviascathesteneievinhslelasarevienaeleientories 36 122 SPASS ClO aa toisdiaycahcnens noe E tay lataniete anes 36 23 gt MEO SUNS CLC OM A E A O A A E O E A A E E S 36 124 NOUSB Devices Detected Warmi snenenanies en hese ae caine aes 37 Page 3 of 121 6000 INS OMENG Rev 2 13 CONFIGURING THE SCANMATE SOFTWARE oi cesicccdedicieiecatiadscediedecudsiiadedabiciesecetens 38 EL System Preferentes asenu tanna ves ctbaanihenvbtiuvelaantanen E 38 13 2 Operator Pre leven Ces sca cesk ets asqeaus E aden ashanti adeewtsatetees aioe 4 o DOCTOR Prole reh es aan E E tana 43 13 4 Contisurme C stom VelociieS serene eee aE E ERS 45 13 5 Adding IOLs to the Database eesssessseeeeessssssssecrressssssseceresssssssecreessssss 46 136 Personalizing Lens Constants sosrusassnernesaeoi 48 NOt ONG ION e E E 49 OZ TPO dU a E E E TE 50 14 THE PATIENT DATA
119. stances 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 24 Lifetime Shelf life The shelf life lifetime indicated for this device is 10 years Page 115 of 121 6000 INS OMENG Rev 2 25 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 6000 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 underside of the USB Interface module and can also be viewed on the display by selecting the About button found on the Help toolbar Manufactured by DGH TECHNOLOGY INC TECHNOLOGY INC 110 SUMMIT DRIVE SUITEB y EXTON PA 19341 USA 610 594 9100 Author
120. steps above Change Eye Note The measurement data for the first eye will remain stored in memory while measurements are being obtained on the second eye Page 64 of 121 6000 INS OMENG Rev 2 26 After measurements have been taken the operator may save a video that stores all of the waveforms captured during the exam or a measurement file that stores the eight 8 measurements and their associated waveforms 27 The video buffer and associated measurements will remain in memory for each eye OS or OD until either a new scan is performed for that eye or a new patient is selected The Clear Meas button clears the measurement bank of the currently selected eye but does not clear the video buffer 15 10 Performing an Immersion Measurement Note The Prager Shell included with the DGH 6000 comes with instructions for use and images illustrating the catheter tubing connection Please refer to these sheets for more detailed instructions regarding the immersion shell Before each biometry procedure both the ultrasound transducer and the immersion shell must be cleaned This is in addition to disinfection procedures that should be performed between patients See Section 21 for Cleaning and Disinfection Instructions The asepsis procedure most commonly employed with a biometry transducer is a wipe down with an alcohol prep The immersion shell can be cleaned by removing the catheter tubing and washing using a bactericid
121. t A Scan Video to review stored videos for the current patient The video can be played back in the measurement window and the AXL ACD and LT measurements can be recalculated Page 69 of 121 6000 INS OMENG 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 Please refer to the DGH 8000 Scanmate B User Guide for more information on using the B Scan Screen gm DGH Scanmate File Edit Preferences Reports Help Ja Patient N A Scan SY B scan E IOL Calc Video Saved 04 08 2013 01 30 43 PM H e g OpenFile Save Image Save Video Print ayers ou poron n_a man e we ee E e iae a Jane Doe 123 456 789 OS 1 30AX Scan 4 06 2009 11 45 00 AM Freq 15 MHz Depth 5 cm X 211 Y 605 Page 70 of 121 B Scan Controls Position Map Probe Type DGH 8000 Pulse Freq 15 MHz Depth 5cm Pulse Power 10 _ A Mode 4 Calipers 4 Comments aOs Operator Smith Change Eye Near Gain 5 0 Mid Gain 5 0 Far Gain p 3 Intensity p 3 Contrast p 8 Frame 26 id e a 0 0 fps B 6000 INS OMENG 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 If available measurements and the selected lens and vitreo
122. t gt Import Measurements A browser window will open to select a meas file to open The opened file will replace any information currently in the patient data fields and the measurement bank The opened file can be saved into the database at this point To import a video buffer that is not currently in the database use the menu bar at the top to go to File gt Import gt Import Video Buffer A browser window will open to select a vdo file to open The opened file will replace any information currently in the patient data fields and the video buffer The opened file can be saved into the database at this point Page 97 of 121 6000 INS OMENG Rev 2 19 7 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
123. t be entered in the same units For Post Refractive calculations these fields will display the Corrected Corneal Power Kcorr calculated by the Post Refractive Surgery Calculator Kcorr is a read only value which can only be modified by changing the inputs to the Post Refractive Surgery Calculator Please refer to sections 17 16 and 17 17 for more information on the Post Refractive Surgery Calculator 17 9 Desired Refraction The desired surgical refractive result Desired Rx is entered in this field If available this value will automatically be imported from the Patient Data Screen When the Save button is selected on the IOL Calculator Screen the entered value will automatically be saved in the Pre Operative Data section of the Patient Data Screen for the current patient and procedure 17 10 Selecting IOLs These tabs IOL 1 IOL 2 and IOL 3 allow the user to select one of three preferred IOLs on which to base the IOL implant power calculation This selection will default to the preferred IOLs for the currently selected Doctor If the desired IOL is not one of the three preferred IOLs it can be selected using the drop down lists First select the manufacturer from a list of all the available manufacturers for IOLs entered for the current doctor The model drop down list will then offer a choice of all the IOL models entered for that manufacturer See section 13 3 for more information on configuring preferred IOLs and formulas
124. tabase is already installed on HPPROBOOK4520 DGH6000 Database Name DGH 6000 Version 1 0 6 Click Update DB to upgrade database to latest version 6000 INS OMENG 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 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 31 of 121 6000 INS OMENG Rev 2 A database user must be created A single log in will be used for all users of the computer system a Create 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 avo
125. talled Standalone Operation A single computer is used to operate the DGH 6000 A scan review the data collected and store the database Page 17 of 121 6000 INS OMENG Rev 2 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 Networked with other Computers Multiple computers perform A Scans and all the data is stored in a single database on one of the computers ee 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 AN 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 Page 18 of 121 6000 INS OMENG Rev 2 10 1 Automatic Launching of the Installation Program Insert the Scanmate DVD into the DVD drive of the computer or connect a USB drive with the Scanmate installation files If the installation does not start automatically follow step 10 2 below 10 2 Manual Launching of the Installation Program On most sys
126. tems 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 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 ANMATE The following screens will install the DGH Scanmate software Seen a Page 19 of 121 6000 INS OMENG Rev 2 10 4 Setup Configuration There are three possible installation configurations If the DGH 6000 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 mrte 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 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
127. 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 Fill out all of the fields in the Patient Info section of the page as described in section 14 3 Navigate to the A Scan page and select the eye to be measured OD or OS by clicking the Change Eye button 4 Configure the unit for contact mode by selecting Contact in the drop down box on the bottom edge of the screen 5 Select the name of the Operator performing the measurement If the operator is not listed in the drop down box add the new operator by selecting Preferences gt Operator gt New 6 Select the correct Lens Type and Vitreous type for the eye to be measured 7 Adjust the compression lockout sensitivity track bar Comp Sens to the desired setting Increasing the Compression Sensitivity will decrease the amount of error due to corneal compression but will make it more difficult to obtain measurements See section 15 8 for more details 8 Position the display for easy visibility during patient examination 9 Seat or recline the patient in a comfortable position for both the Patient and Operator Use a firm comfortable head rest to prevent head movement during the exam 10 Anesthetize the cornea and ask the patient to fixate with their fellow eye ona spot on the ceiling or wall 11 Press the Start Scan button A waveform wi
128. the currently selected doctor This threshold defines the standard deviation that the eight 8 lens thickness measurements in the measurement bank must meet for the system to automatically stop scanning See Section 15 4 for more details on automatic and manual stop mode The Default Measurement Mode radio Rare mene buttons allow the user to select either contact or immersion as the default A Scan measurement mode for the currently selected doctor Default Measurement Mode Timing Variables in timing used while aligning the probe Measurement Delay 0 ns can be adjusted in the Timing box Setting Alignment Timeout 10000 n Measurement Delay to O ms will make the DGH 6000 take measurements as soon as alignment is achieved Setting some Measurement Delay is useful in ensuring that a variety of different measurements are used to create an average The Alignment Timeout setting allows the user to specify how long the A Scan probe can be applanated before a message appears indicating why the waveforms aren t meeting the measurement criteria Default IOL Calculator Settings The Min Cases Before Using Personalized Min Cases 25 Before Automatically Updating Constants textbox allows the user to set the Personalized Lens Constants When Automatically ss Update Constants is Selected minimum number of Procedures that must be performed before a Personalized Lens Constant is calculated for a given IOL model
129. ttor A Scan Auto Stop Scan Criloria Default IOL Calcutalor Settings New tat AXL Sid Deviation Threshold 0 04 mm Min Cases 25 Bofore Automatically Updating Ae Personalized Lens Constants When Aulomulically N ACU Sid Deviation Threshold 0 05 mm Update Constants is Selected Jame Default Preferences bl LT Ste Dewiaton Threshold 0 05 mm Moas Source DGH 6000 Average Default A Scan Messurement Mode OL 1 oLa liota alter currently loaded cata Please review cata on all forms Notes Contact immersion Default Preferences A Scan Timing Mfg Measurement Delay D gt ms r Model Alignment Timeout 20000 ms E A Scan Velocilies Table IOL Configuration Table Personalized Lens Constants Table Caution Accepting changes to Doctor Preferences may mee rm OK Cancel Apply Mew The New button allows the user to create new doctor profiles and assign preferences to the newly created doctor Edit 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 Delete The Delete button deletes a doctor from the system When clicked the user is prompted for confirmation prior to deleting the doctor s preferences The Name combo box selects an existing doctor from the database to view edit or delete their prefere
130. tware automatically Recommended ele ae See 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 not passed Windows Logo testing ta very 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 STOP Installation Page 34 of 121 6000 INS OMENG Rev 2 11 5 Complete Installation of Drivers After successful driver installation the Completed 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 the 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
131. uccessfully 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 p b P Page 28 of 121 6000 INS OMENG 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 aJ DGH Scanmate Configuration pE 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 SQL ServerName HPPROBOOK4520 DGHSERVER HPPROBOOK4520 DGHSERVER SQL System Administrator Login sa SAL System Administrator Password IDGHTest1 Connect to the desired SQL Server 2008 instance to continue
132. urer of the DGH 6000 Scanmate A device The YYYY under the symbol indicates the a year the device was manufactured REF This symbol indicates that the model number of this device is DGH 6000 SN This symbol indicates the serial number of the device YYYY indicates the year of manufacture and XXXX indicates the unit number F This symbol located on the DGH 6000 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 Transducers 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 transducer or cables AN WARNING Equipment not suitable for use in the presence of flammable mixtures
133. us type are automatically loaded from the A Scan page Information from the Patient Data screen including Patient Name Patient ID Doctor Corneal Power K1 and K2 and Desired Rx are also automatically loaded r gm DGH Scanmate File Edit Preferences Reports Help gt gt LJ aii 9 Patient MEA A scan B Scan E H 4 ge K Corr Calculate Save Print Jane Doe 123 456 789 Doctor Smith x O D Lens Normal 7 Calculate OD O S Lens Cataract V Calculate os Vitreous Normal Post Refractive Vitreous Normal V 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 z History Derived Total 8 Meas ACD 3 15 mm a mm Kcorr 35 10 D Meas 3 17 mm 4 99 mm K2 LT 5 02 mm mm 23 50 mm Desired Rx AXL 23 49 mm mm Desired Rx 0 05 D 10L1 woL2 1013 10L1 aotz 10L3 Mfg DGH v IOLPWR Refraction Mfg DGH v IOLPWR Refraction Model 10L1 x 25 00 1 15 Model 10L1 30 00 1 01 30 50 0 64 31 00 0 26 25 50 0 81 Type Posterior Type Posterior 26 00 0 46 Formula Haigis X Formula Hoffer Q Personalized F Personalized a0 1 589 pACD 5 261 at 0 400 26 61 Target Power 31 28 Target Power a2 0 100 26 64 Emmetropic 31 34 Emmetropic The Pre Operative section of the IOL calculator contains
134. utton to stop the scan 18 If a measurement is not obtained successfully when applanation occurs and the beep rate is still approximately once per second remove the transducer from the cornea and position the transducer at a slightly different location or angle Repeat this removal and repositioning procedure until either a successful measurement or a very rapid beep rate is obtained Page 63 of 121 6000 INS OMENG Rev 2 19 At the higher beep rate measurements can be obtained by slightly tilting the back end of the transducer while the tip remains stationary and applanated at the same location As soon as proper alignment is achieved a measurement will be obtained provided that there is no corneal indentation present 20 If a lower tone beep is heard during the alignment procedure cornea indentation may be occurring The DGH 6000 uses a special algorithm that prohibits any measurements from being obtained if the cornea is significantly indented The Compression Sensitivity Comp Sens track bar adjusts the sensitivity of the unit in detecting corneal compression If low pitched beeps are heard maintain the transducer alignment and slowly withdraw the transducer from the cornea until measurements are obtained 21 If 8 valid measurements have not been obtained before the video buffer is full the scan will time out as indicated by two long beeps A message will appear indicating that the measurements did not meet the measurement selection
135. x allows the user to select if the program starts with a new patient or 1f the user is required to search for a patient upon program startup When the checkbox is enabled the program will begin a new patient file upon system startup The Automatic Login checkbox allows the user to select 1f login is required upon system startup or 1f the user is automatically logged in By default this checkbox is enabled indicating that the username and password will be entered automatically The Default Keratometer Index nc box is provided to give the user the ability to configure the default index of refraction used on the IOL Calculator screen Page 38 of 121 6000 INS OMENG Rev 2 A N WARNING To avoid IOL power calculation errors it is important that the corneal refractive index nc of the keratometer used to calculate corneal power matches the default refractive index nc set in System Preferences for the DGH Scanmate The default nc should be set before K1 and K2 are entered for a patient The nc associated with each set of corneal power measurements can be reviewed or adjusted on the IOL Calculator Screen Failure to adjust the default nc to match the nc of the keratometer used to measure corneal power can result in errors in the IOL Calculation See section 17 19 of this guide for more details The Report PDF Export Location setting allows the user to specify the default directory where pdf reports will be exported The de
136. xes 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 Post Operative controls become enabled for editing only if valid Pre Operative data exists for the selected procedure 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 OS OD Desired Refraction OS OD Page 54 of 121 6000 INS OMENG Rev 2 Note It is important that the corneal r
137. y records have been selected in the Use Record column It cannot be edited on this screen but will update automatically as records are selected or deselected for use in personalized constant calculations 13 6 2 Procedure Personalized Lens Constants can be manually calculated by the following procedure 1 Select the Patient Data Page and either enter a new patient or select an existing patient Fill out all of the fields in the Patient Info section of the page as described in section 14 Note Ensure that the nc set in System Preferences matches the corneal refractive index of the Keratometer used to measure the K values 2 Select the A Scan Screen and perform either an Immersion or Contact A Scan Measurement as described in sections 15 9 and 15 10 Note DGH does not recommend mixing Contact and Immersion measurement results when calculating personalized lens constants 3 Select the IOL Calculator Screen and perform IOL Calculations as described in section 17 Save the Pre Operative Data used to perform the calculations by selecting the Save button 4 Perform the lens replacement surgery Record the actual lens model and power that was used Page 50 of 121 6000 INS OMENG Rev 2 5 Enter the Stabilized Post Operative results in the Patient Data Screen Review the Pre Operative data and Post Operative Results and decide if the Procedure should be included in the Personalized Lens Constant Calculati

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