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Foresee PHP®

1. PIN Rev d E 3 Saving and Viewing Test Results continues Test History Data Tho Test Results section is displayed in the following screens The following table identifies and describes the fields in each ofthe sections Tha table may provide a sample value for a given fold Test History History of Hyperacuity Deviation Maps Sections Q Search Results Test 3 History Figure 3 8 Test History History of Hyperacuity Deviation Maps Sections History ot Hyperacuity Deviation Maps H Title Patient name ID tested eye Maps lt Upto 4 Hyperacuy deviation maps are displayed The current map dertical to the one displayed in the main page and up to three maps of preceding tests The maps are lined eariy on the lef to currant on the right H there are less than 4 maps the remaining maps wi be denoted as N A Oniy maps of completed tests are splayed PIN s00F 005 101 Rev 3 Saving and Viewing Test Results continues Test History History of Result Parameters Sections Figure 3 9 Test History History of Result Parameters Sections History of Results Parameters History Charts The charts show the progression along time of wee est parameters pValue Total Area and Total Integrated Intensity there is no relevant historical data e g the historical tests have no clusters
2. Foresee PHP Taskbar Tho Foresee Taskbar is a toolbar that appears at the top of every Foresee PHP screen except for the Test and Tutorial screens The Taskbar provides graphical indications for essential status information o the calibration check status dato and time 1 and provides a shortcut lor performing common operations by clicking the taskbar tms e g checking the Screen calibration when required adjusting date and time etc Tho tems that appear on the taskbar from right to left are E The Clock cisplays te date and time using ne current local stings E BH Calibration Status Indicator Tre Calbravon icon displaye an mage he status of the caibraton checkup Tre posse cons and their coresponding tool ips are Last calibration check val alert needed Teo The sereen checkup is okay Last caltration check valid alert is needed tp sereen calibration checkup must be performed within 2 days Last check tailed or checkup overdue tip The sereen calibration vald and must be checked or The screen calibration checkup is overdue and must be performed Backup Status Indicator Green Al tests are backed up Red One or more tests do not have a backup correct is situation check that your backup disk ia plugged in Make sure that ne backup disk is not fl It is ful replace the back
3. extreme care in selection checking echacking and packing 1o eliminate e posti ot error any hpi eom are covered anen unt waa unpacked 2 Care dealer you purchase product rm and repo he Shortage The atria are packed ie ctr and none houla be misang t e bor has never been opened Gina must be ed WS 30 days of purchase Gur shipping sparsity ceases wih sale delivery n good colon to me company Caine ft Tass or damage ana shou be made pri and arcc tothe company I Un Jever the ute af e pacing case shows eudenca of ough handing or damage company sagen Gould Be recanted make a Recened Bad Order notation on he delv receipt Hin 48 hours ol etary damage noted upon unpacking me shipment and no ext evidence a rough handing s apparet tbe PIN soFoos 101 Rev D a 10 End User Software License Agreement End User Software License Agreement CAREFULLY READ THE FOLLOWING TERMS AND CONDITIONS BEFORE USING THIS PRODUCT IT CONTAINS SOFTWARE THE USE OF WHICH IS LICENSED BY REICHERT INC TO YOU THE ORIGINAL END USER FOR YOUR USE ONLY AS SET FORTH BELOW IF YOU DO NOT AGREE TO THE TERMS AND CONDITIONS OF THIS AGREEMENT DO NOT USE THE SOFTWARE USING ANY PART OF THE SOFTWARE INDICATES THAT YOU ACCEPT THESE TERMS Software included with this product that aro not products of Reichert Inc are licensed to yo
4. Rev D 29 2 Running the Foresee PHP Test continued When the tutorial begins the folowing banner appears Figure 27 Tutorial Screen Initial Banner 78 Note The banner appears remind the examiner that the space bar should be used during the tutorial Note Ihe space bar is used ONLY during the tutorial and nol during the actual test To continue Press the space bar 2 Running the Foresee PHP Test continues Figure 28 Stationary Signal Screens Tutorial Stationary Test Explain to the patient what they wil soo during the tutorial the Fixation Target the Stationary Signal dotted signal Ine and Distortions Ask them to point where the distortions of the Stationary line are located on the screen using the stylus 1 Instruct the patient to use the stylus to ouch the screen and to mark the location where the distortions appear Instruct the patient return their hand to the home base after marking the screen Encourage the patient to do their best and that if they do not see distortions the test may Include stationary signals without distortions 4 Explain to the patient that they can use as much time as necessary mark the distortions I ho distortions are not marked accurately and tho signal did not disappear instruct the patient to mark the distortions again as accurately as possible To continue to the next signal Wait unti the patient s hand is returned Ihe h
5. Rev D 2 Running the Foresee PHP Test continued Alter testing ol the first eye is complete the screen indicates il tho other eye would Ike to be tested Rater to Figure 2 13 Selecting Other Eye to Test E Test Do you wish to test the left eye Figure 2 13 Select eye screen View test results for the first tested eye Click Skip to view the results of the tested eye without testing the other untested eye Tho Test Results screen appears E PIN so0F 005 101 Rev 2 Running the Foresee PHP Test continues Performing the PHP Test Other Eye To test the other eye perform the following 1 Qcclude the eye that has already been tested 2 Click ether Right Eye or Left Eye lo lest the eye that has not yet been tested you can only select the untested eye In this screen The test is run forthe selected eye 3 Enable the patient to take the lest When the test is complete he Test Completed Screen appears 4 liek Next to view the test results Performing the PHP Test Incomplete Test The Foresee PHP device analyzes the patents responses and performance throughout the test Il the system identities that the patients not performing the test correctly and the results are meaningless the lest is automatically aborted and the Incomplete Test screen appears Thank You You may move your head from the chin rest Please relax and wait for the examiner The test was
6. WITHOUT TAKING PROPER ESD PRECAUTIONS CAUTION MEDICAL ELECTRONIC EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING EMC AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION PROVIDED IN THE ACCOMPANYING DOCUMENTS CAUTION THIS INSTRUMENT IS NOT TO BE USED NEAR HIGH FREQUENCY EMITTING SURGICAL EQUIPMENT Introduction Congratulations on your purchase of the Reichert Foresee PHP Preferential Hyperaculty Perimeter The Foresee PHP is a visual old analyzer used for monitoring and early detection ot changes in macular function Foresee PHP Features Tho key features of the Foresee PHP system are Full macular field testing of 14 X 14 Automated analysis Visual field mapping Statistically significant correlation with stereo color fundus photography and fluorescein angiography lt Software upgrade capablit tor future applications Foresee PHP Benefits The key benefits of the Foresee PHP system Siructured tutorial reduced technician dependency Technician roe test operation Easy to use by the patient Test history presentation enables long term tracking of AMD Rapid testing Ergonomically improved solutions chin rest home base This User s Guido is designed as a training and roferonco manual We recommend you carefully read and follow the steps in this guide to ensure optimum performance from your new instrument Please retain this guide for future reference and lo share wit
7. and Viewing Test Results continues Test Results Test Details Section Stadl verses str E mens 172 Sota araz ws Recommendation rosea Note 5 22909 mea tnat tho vil Fill dec h stes staring ete Ios A poate Gs hata CI Fest Parameters Horizontal Stimuli The numberof horizontal simu Vertical Stimuli The number of vertical stima M PValus The chartis very similar to the one shown on the history part of he frst raport page Numbers of Clusters The number of Clusters in the data Total integrated intensity Displays the progression in time ot the integrated intensity over all clusters in the test Area Displays the progression in time of the total areas area of all clusters in the test in square degrees of six discrete levels heights along up to 4 time points The legend shows Schematic cluster and te corresponding Level Area 1 up to Level Area 6 The bottom ine for example corresponding to area A1 is the progression of ie area s contained within the frst cluster color level e the total cluster area The forth ine shows the area progression in he dth color level The number af levels in the legend dynamically corresponds to the number o levels in the splays maps Comments Comments regarding recommendations o subsequent steps and testing for patent management Comments based on test results and baseline protocol
8. and enter Foresee PHP modo Checking the Touch Screen Calibration Choose this option to check the screen calibration Click the Calibration Check link 1o start the calibration check For full details refer to Calibration Monitoring page 20 Calibrating the Touch Screen Click the Calbrate the Touch Screen Ink to start Ihe touch screen calibration For ful details refer to Calibration Monitoring page 20 Installing Software Updates Software updates for tne Foresee PHP software wil be provided in the for of a standard executable that automates instalation In order to install a given update switch 1o the Microsoft Windows environment and use Windows Explorer to find select and run the executable fle 4 Note When installing software updates always use the default path and names PIN soFoos 10t Rev D 7 Maintenance and Troubleshooting Maintenance This section describes maintenance activities you perform periodically and maintenance actviies you can perform and may be instructed to perform by Customer Support They include Cleaning and Covering the Foresee PHP Monitor Cleaning the Homo Base Chin Rest and Stylus Replacing the Hard Drive Replacing the Home Base Replacing Power Entry Unit Fuses Cleaning the Covering on the Foresee PHP Monitor Any standard glass cleaner can be used to clean the touchscreen monitor but avoid products Containing ammonia Always spray the glass cleaner on the cioth or towe
9. instrument when A Assembly disassembly repair or modification is made by unauthorized dealers or persons instrument is not used in accordance with this User s Guide WARNING AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY OR DEATH WARNING ANY REPAIR OR SERVICE TO THE FORESEE PHP MUST PERFORMED BY EXPERIENCED PERSONNEL OR DEALERS THAT ARE TRAINED BY REICHERT SO THAT CORRECT OPERATION OF THE FORESEE IS MAINTAINED WARNING THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC MIXTURES SUCH AS OXYGEN OR NITROUS OXIDE CAUTION AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE TO THE PRODUCT CAUTION DO NOT USE SOLVENTS OR STRONG CLEANING SOLUTIONS ON ANY PART OF THIS INSTRUMENT AS DAMAGE TO THE UNIT MAY OCCUR REFER TO MAINTENANCE SECTION FOR DETAILED CLEANING INSTRUCTION CAUTION USE OF AMMONIA BASED CLEANERS ON THE LIQUID CRYSTAL DISPLAY LCD MAY CAUSE DAMAGE TO THE DISPLAY REFER TO MAINTENANCE SECTION FOR DETAILED CLEANING INSTRUCTION CAUTION THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC MIXTURES SUCH AS OXYGEN OR NITROUS OXIDE CAUTION PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT CAUTION THE INTERNAL CIRCUITRY OF THE INSTRUMENT CONTANS ELECTROSTATIC DISCHARGE SENSITIVE DEVICES ESDS THAT MAY SENSITIVE TO STATIC CHARGES PRODUCED BY THE HUMAN BODY DO NOT REMOVE THE COVERS
10. main menu without saving you be reminded and asked il you want to save these results Printing Test Results Foresee PHP is supplied with an external color printer to enable you to print copies of the test results ly Nn Oniy epee Rice ro copa vit ha Forano PHP uan Tho PHP is supplied with the following printer drivers It is suggested that you use only these printers with the PHP or the data may not print or print properly HP Deskjet 2300 Series HP Deskjet 2400 Series HP Deskjet 2500 Series HP Deskjet 2600 Series Cannon 1700 Cannon 3300 Cannon 4300 The PHP device provides you with the following two options to print test results From the Test Results screen From the Search Results screen as PIN so0F 006 101 Rev 3 Saving and Viewing Test Results continues To print test results for a specific eye In the Test Results screen or the Search Results screen select the eye Left or Right for which you want to prin the results 1 Click the arrow next to the Print button A monu pops up 2 Select one of the following Print Current View This option wil prin Ihe current screen data ether Figure 3 10 Printing Options the Test Results or the Test History on one single page Print Current Test and History This option wil print the detailed Test Results and the Test History report on 2 pages printer 1 Inthe Test Results screen or after you have selected
11. or i they were created with previous Foresee PHP versions an empty chart wil be displayed PAValue The chartis very similar to the one shown on the history part ot fe frst report page Area Displays the progression in time of the total areas area of clusters in the test in square degrees of six discrete levels heights along up to 4 me points The legend shows schematic cluster and te corresponding Level Area 1 up to Level Area 6 The bottom ine for example corresponding to ara A1 is the progression of the area s contained Within the frst custer calor level Le the total cluster area The forth ine shows the area progression in the 4th color level The number of levels in the legend dynamicaty corresponds to the number of levels in the splays maps integrated intensity Displays the progression in ime of the integrated intensity over all clusters in the test Rev d a 3 Saving and Viewing Test Results continues Saving Test Results To save the tes results Click the Save bution A progress bar indicates that the save operation is running The progress bar disappears when the saving operation is completed A single save operation saves the test results for both eyes If both eyes were tested Its highly recommended to always save patient s results for future analysis and follow up In case you try to close the test report and return to the
12. shut down is complete use the on off switch to turn the device of 4 Click Switch to Windows to switch to the Microsoft Windows environment For detailed instructions refer to Switching to the Microsoft Windows Environment pago 78 Darkening the Foresee PHP Screen From the Foresee PHP Main Menu screen click Dim Sereen to darken the screen To reactivate the Foresee PHP Main Menu screen cick Back to Foresee PIN 900F006 101 Rev D 1 1 Getting Started continues Calibration Monitoring Foresee PHP has an integrated touch screen calibration monitoring system At regular intervals this system monitors the calibration status of the Foresee PHP touch screen and alerts you If a calibration checkup is required The dale and results of the last calibration checkup either failed or passed determino the calibration status in light of the following system parameters Checkup frequency 30 days Tho maximal timo alowed between calibration checkups Alert frequency 1 day Alerts appear once a day when the system needs to alert you Prior notice interval 2 days Alerts appear tuo days prior to reaching the maximal Ime allowed between checkups There are four diferent statuses The calibration is invalid This means the last known calibration checkup failed The calibration is overdue This means the last checkup was performed more than 30 days ago The calibration is due soon This means the next c
13. tended toa pre ited or perd na manner ren accordance e her nich product whic has ben cl served Haie or repaired oiher an Mfr tcr Technca Soie Center or auborzed Recta Dealer bulbs charts cards and oiher expandabe tems rot covered by his warranty Adams under is warranty must be in wing and directed to Reicher alr Technica Serce Center Auhorzed netten dedi m te ord sale and musi be accompaned by a ol a purchasers iie warranty isin leu of al oher warranties or expressed A implied warranties of merchantabilly or nee Yer are hereby diclamed N represente ate person s auorgad o maie any oer igitor or Recher Rehr shi nt be table ray ident orcoeequen damages ry breach O waranty siret or any omer damages vun ar reg 1o desi menace Sa ise or nanding o e produet notte prompt witing ol any selon brought against e purchaser based ciam hal me nstumentnt nges AUS Pater Recher wil delend suc acon as expen and wil pay cst and damages awarded any such provided a her shal sole control of dens any such acon wi and stares fat Reicnarrs expanse or such detense and of a negotiation for element and compromise erect Reichert reserves he foh to make change i design orto ake ations ta improvements i o products without to add such to products pvo manche
14. test file will be recovered and its test report wil bo displayed Click Save to save he fle The recovered test wil be removed from the tests for recovery list To delete a test from the list 1 Select the desired test trom the ist by clicking I 2 CickDelete Tho selected test wil o deleted and wil be removed from the tests for recovery list Adding and Editing Clinic Det Tho Foresee PHP application enables you to insert your clinic details which will appear on both the screen and printouts The clinic details can consist of up to s lines of free text To addledit Clinic Details 1 From the Options screen click Clinic Details 2 Fil in the eine details and clik OK to save them PIN spoFoos 101 Rev D 6 The Microsoft Windows Environment Overview Tho Foresee PHP deve operates in two modes Ihe Foresee PHP mode and the Microsoft Windows envionment In ho default Foresee PHP mode you can perform all Foresee PHP functions except certain maintenance operatans which are avaiable only in the Microsoft Windows environment These maintenance operations include standard Windows functions ike sening the ime and dale but also includa functions specie to Foresee PHP such as configuring printers and others options described in s chapter Note Most maintenance operations require you to be logged in with a user account having administrator privileges To use its ful capabilities he Foresee PHP application al
15. 24 Edit Patient Screen 2 Type addtional patient information or madly the existing Information 3 Glick OK The patient information is updated and previous tests are updated accordingly Q TPP lex Caneel o aseara cages PIN o00F008 101 Rav d 2 Running the Foresee PHP Test continues Adding a New Patient 1 Inthe Select Patient screen cick Add Now Patient or Click Next without selecting a patient from the List o patients Reter to Figure 2 2 2 Tho Now Patient screen opens Refer to Figure 2 5 mem M om ome Figure 25 New Patient Screen 3 Enter the following patient information ID Must be 4 15 characters long Last Name First Name Middle Name Optional Birth Optional Noto The patient s ID is a unique patient identifier unlike the other patient information fields Therefore although thoro may be multiple patients withthe same namo in the system each patient is assigned a unique ID 4 Click Next to proceed to tho Test screen Rev D a 2 Running the Foresee PHP Test Selecting Eye to Test LY Note Maka sure that he patient s non tested eye occluded n Figure 26 select Eye to Test Sereen Click either Right Eye or Left Eye referto Figure 2 6 Note You can si the toriai by clearing the Tutorial and test Sy ae pakne e e Performing the Tutorial Purpose ol he Inroduco the patient to e various tasks to ba
16. Database Tools Tho Database Tools screen opens 73 Database Tools Figure 5 11 Database Tools Screen PIN s00F 005 101 Rev d 5 Using the Advanced Options continues Manual Backup and Restore Use this option to manually backup or restore selected tests or all tests The last backup date is presented Note a warning is displayed if you have not manually backed up your data for more than 14 days and tho ext wil change color from green to red Iis recommended to make a periodical backup copy for protection against loss of data due to a malfunction or accident Backing Up the Database To backup your data 1 In the Database Tools screen cick Backup Database The Manual Backup dialog box opens In this dialog box you can choose which tests to backup and the destination for the backup file Figure 12 Manual Backup Dialog Box 2 Inthe Tests to Backup section click the All Tests radio button to backup all tests the default stale click the Test Date radio button then enter a rango of datos In the From and the To fields to backup tests from a specific range of datos 3 Inthe Backup Destination section enter the destination of the backup fle in the Backup File 4 Inthe Backup Description field you can enter description of this set of tests 5 Glick Backup The folowing screen opens displaying the progress of the backup Rev D 5 Using the Advanced Optio
17. Foresee PHP Preferential Hyperacuity Perimeter Users Guide 20101072010 Reichert Ine Al rights reserved Rechortis registered trademark of Reichert Ine Reicher and Foresee PHP are registered ademas ot Reicher Ine retenti Hyperacuty respeciv met The information contained in is document was accurate at tme of publican Speiicatons subject change witout cher Inc reserves e p to make change in ihe produci descrbedin Ii anual hou lee and witout incorporan ose changes in any produci already sod Federal aw rests Ws device to sal by or on he order o a ya 180 9001 13485 Certi Reicher products are designed manulacured under quaity processes meeting 180 S001348Srequeemens No part ol his pain may be reproduced stared in a real system orate in any om or by any ectene mechanical recorsng or nerma hole pr af Reha inc Other Patents pending 2 PIN 900F006 101 Rev D Contents Symbols and Safety Information 5 Warnings amp Cautions s Introduction 7 1 Getting Started Site Preparation Requirements 2 Foresee PHP Device Components 13 Terms Acronyms and Abbreviations 16 Unpacking and Assembling the Foresee PHP Device 17 Starling Up ihe Foresee PHP Device 17 Screen Features 17 Foresee PHP Taskbar 18 Configuration ofthe Foreses PHP Device 19 Shutting Down the Foresee Device 19 Darkening the Foresee PHP Screen 19 Cali
18. HP Test Alter the device has been turned the Main Menu screen appears ee Welcome To begin the PHP test i Start Figure 2 1 Main Menu Screen Click Start Reter to Figure 2 1 The Patient Information Selection screen opens ala pa ra en tm p PIN o00F008 101 Rev 2 Running the Foresee PHP Test continues Select Patient In the Select Patient screen you can select an existing patient or add new patient to the system Pater to Figure 2 2 Selecting an Existing Patient Tho List of patients area in tho Select Patient screen displays a list patients who exist in the system reer to Figure 22 1 Locate patient from this it Tip To faciltate your search you can narrow the lit by typing the patents last name fist name or ID For example typing in the fied above the list wil display only Patients whose last name frst name or ID starts with tho letters co 2 Select the patient s name and click Next or double click the patient s name The Patient Information screen opens Refer o Figure 2 3 ccm TTT Figure 2 3 Patient formation Screen PIN Rev d 25 2 Running the Foresee PHP Test continues Editing Patient Information To edi patient s dei 1 In the Patient Information screen or in the New Patient Screen cick Edit Patient The Edit Patient screen opens Refer to Figure 24 All fields are edtabl Figure
19. NOT completed sucessfully mw Figure 2 14 Incomplete Test Screen A description ol the problem detected by the system appears at the bottom af the screen To return to the Main Menu screen click Next PIN Rev D a 3 Saving and Viewing Test Results Overview Tho Foresee PHP device enables you to view test results in the following ways After completing the test for one or both eyes By searching tho Foresee PHP device s local disk refar to Searching Test Results page 50 Alter exporting PHP test results to a private user s standard PC Viewing Test Results Tho Foresee PHP application provides you with tno ways to view est results Atter completing the test fr one eye After completing the test for both eyes You can view the test results of one eye by clicking Skip when asked whether to test the other je following the test completion screen Otherwise Ino Test Results screen opens automatically alter you completo the second eye Changing from Detailed Test Results report screen to the Tests History report screen To change the apa rom Test Results pag oho Tess Histor page lek he elo To toggle back to the Test Results press the Current Test button Printed Test Results Details Tho following sections describe and explain what you soe on a Foresee PHP test results report Tho report is consisted 2 pagos Tes Results page 1 Test Hi
20. This License Agreement is effective unti terminated You may terminate it at any ime by destroying the Sofware and documentation together with all copies and merged portions in any form fi wil le terminate immediately you Tai to comply with term or condition of fhis License Agreement such termination you agree to destroy Software and documentation together wih all copies GOVERNING LAW This License Agreement shal governed by the laus of Now York State excluding hai conflcis of law principles The United Nations Convention on Contracts for the International Sale of Goads 1980 hereby excluded in its entirety rom application to this License Agreement LIMITED WARRANTY LIMITATION OF LIABILITY warranties and limitations of lability appcabl to the Software are as stated on the Limited Warranty Card or in the product manual accompanying the Software Such warrarties and imitations of tabiy are incorporated herein in their eraty by Ps reference SEVERABILITY inthe event any provision of his License Agreement is found to be invalid ilegal or unenforceable the validity legality and enforceability of any of the remaining provisions shal notin any Way be affected or impaired and a valid lagal and enforceable provision o smiar intent and economic impact shall be substituted there for ENTIRE AGREEMENT This License Agreement sets forth the entro understanding and agreement between you and Reichert Inc supersedes
21. a report to view in the Search Results screen cick Print Setup The Print Setup dialog box opens Refer to Figure 2 11 The selected default printer appears in the Printer fied 2 To select a diferent printer to print Ihe PHP reports select a printer from the Printer drop down ia 3 Glick OK to save your preferences or Cancel to discard your changes If you cick OK these printing preferences wil apply to subsequent printing test results fu E Nol Unless connect 16 the PHP it wil not be displayed in the drop down list en prts pn d Figure 3 11 Print Setup Dialog Box Rev D E 4 Searching Test Results Searching Test Results Using the Foresee PHP Search Parameters Tho Foresee PHP application enables you to search and retrieve PHP test results saved to the local disk You can search using tho folowing search parameters All Tests Retrieves an unfitered list of tests stored on the local disk Test Date Enter the time period e g 07 13 2002 to 01 23 2005 of the test Patient Enter the patient s details for which to search Test number The Foresee PHP automatically assigns a unique 12 digit number to each test To search for test results 1 Inthe Foresee PHP Main Menu screen cick Search The Search screen opens EE xg mer s Ir Figure 4 1 Search Screen 2 Glick the radio button on off indicated w
22. al mts on Ihe same examination day his indicates poor reliability There is a low ikelihood that wet AMD has developed in both eyes simultaneously The more experienced the technician and the patient the better the results I the technician or the patient is relatively now to the Foresee PHP take this into consideration when reviewing the test results 10 PIN 900F006 101 Rev Introduction continues Determine if there is Another Pathology Causing the Defect Ia test result is unreliable determine if here is another pathology that may have caused the visual field defect To do so 1 Check if the p value is lt 10 or lt 5 Although wet AMD may be present some patients in this group are expected to be negative for wet AMD 2 Perform a comprehensive biomicroscopy exam to search for other pathologies that may cause abnormal Foresee PHP results Remember the Foresee PHP test is a subjective test for the diagnosis of wet AMD A test result thal is outside normal limits may be an early indicator of progression to the more serious form of AND You should apply your expertise to determine if further diagnostic measures andlor referral are appropriate PIN 900F006 101 Rev D 1 Getting Started Great care has been taken to deliver your now Foresee PHP to you safely The container and packaging was specially designed to transport this uni Please retain the packaging I future transportation is required Site Preparation Requ
23. alibration test ete Calibration Checkup Touch Screen calibration test To use the System Information option 1 From the Foresee PHP Main Menu screen click Options 2 The Options screen opens gt System Information Database Toots Clinic Details Switch to Windows Figure 5 1 Options Sereen PIN Rev D so 5 Using the Advanced Options continues 3 From the Options screen click System Information Tho System Information screen opens Figure 5 2 System Information Screen The About Section Tho About section of the System Information screen displays the product namo the Foresee application version the Microsoft Windows version and the OS runtime revision This number identifies the revision number af the specific embedded OS Only technical support personnel may need this information Refer to Figure 5 2 and 5 3 About me simmo osname nenen En Figure 5 3 Foresee PHP Device Version Information PIN so0F 005 101 Rev 5 Using the Advanced Options continues The Foresee PHP System Diagnosis Option The Foresee PHP application enables you run system diagnosis checks on the Foresee PHP device After you run the diagnosis checks you can save the diagnosis results report to log file which in case of technical problems should bo sent to Customer Support In addition to many internal unit tests the Foresee PHP perfo
24. all prior agreements whether witen or oral wh respect io the Software and may be amended in writing signed by bot paries PIN 900F006 101 Rev d Notes This page left intentionally blank 9 PIN 900F008 101 Rev D Notes This page left intentionally blank a Reichert Reichert Inc 3362 Walden Ave Depew NY 14043 Usa Tol Free 888 849 8955 Phone 716 686 4500 Fax 716 686 4545 Email info reichert com ww reichert com Reichert GmbH Huberstrasse 2 D 82229 Seefeld Germany Tel 49 8152 993530 Fax 49 8152 993535 150 9001 13485 Registered 200F006 101 Rev D October 2010 PIN s00F 005 101 Rev
25. anent 2 Glick Yes PIN aoroog ttt Rev D 75 5 Using the Advanced Options continues A second confirmation dialog box opens reminding you that his operation is reversible 3 Click Yes When the cleaning operation is complete a dialog box opens indicating that all tests were deleted and prompting you to restart the application 4 Glick OK to restart the Foresee PHP application Using the Recovery Feature Tho recovery feature provides a mechanism for preventing oss o test data due to unexpected errors e g aller power failure In such cases during next system startup you will be prompted witha corresponding message allowing you to load the recovered tes Figure 5 20 Test Recovery Message It you choose to load the tests each recovered test wil be displayed on screen and you wil have to save the test samo as you do for any other test when 1 ends It you choose not to load the tes s and wil click the Close button you wil aways be able to do this later through the Recovery button in the Options Database screen This button will be enabled only when the system wil contain fles for recovery Pressing this button wil pop up the Test Recovery Screen 7 PIN o00F008 101 Rev 5 Using the Advanced Options continues Test Recovery Figure 521 Test Recovery Message To recover a test trom he Ist 1 Select he desired lest from the ist by 2 Click Load Tho selected
26. bration Montoring 20 2 Running the Foresee PHP Test Postoning the Patient 2 Staring ihe Foresee PHP Tost 24 Select Patent 25 Selecting an Paton 25 Ealing Patient Information 26 Adding a Now Patient 27 Selactng Eye to Test 28 Performing the Tutorial 28 Stationary Test E Flashing Signal Seco 32 Patient 33 Incomplete Test Porterming the PHP Teci Eje 35 Completng the First Eye as Selecting Other Eye to Test Ed Porforming the PHP Test Other Eye ar Incomplete Test a 3 Saving and Viewing Test Results Overview Viewing Test Changing rom Detaled Tast es to Test History Sereen Printed Test Results Deals Test Resuts Data Tite Section Results Seton Examinaton Mision Section Hyperacuty Deviation Hyperacuty Delect Clusters Sector Cine Detalls Sacton Test Details Secon Test History Data History of Hperaculy Deviation Maps Secon History of Result Parameters Section Saving Test Results Printing Test Results To Punt Results tra Specie Eye Print Setup Contents continues 4 Searching Test Results Searching Test Results Using he Foresee PHP Search Parameters Search Resuls Screen Buttons Exporting Test Results Selocing Test Resistor Export Exporing Detailed Raw Data 5 Using the Advanced Options Using the System Information Option The About Section The Foresee PHP System Diagnosis Opin Performing tha Foresee PHP System Diagnosis The Calibration Check
27. copy also recommended rule out retinal pathologies A test result that remains outside normal Imits on re testing excludes that eye from further monitoring with the Foresee PHP A baseline examination a result that is within normal limits and reliable is the cornerstone for interpreting test results Subsequent examinations should always be compared a previous baseline examination Test results that indicato a change from the baseline indicating a visual field defect that is outside normal limits probably indicates Ihe presence of wet AMD Itis also important to take Into consideration the p value on the report which indicates the percentage of dry AMD patients who may have a visual field defect that is outside normal imits Other pathologies or improper testing can also cause a visual field defect that is outside normal imis Other pathologies that may cause visual defects include AMD relatod Geographic Atrophy Pigment Epithelial Detachment Drusenoid PED Scar Vascular Vein Occlusion Diabetic Retinopathy Artery Occlusion Central Nervous Determine if the Test Results are Reliable It test report is outside normal limits the next stop in making the diagnosis is to determine if the estis reliable To do so Review tho reliability indices and tho overall test reliabilty Retest an eye that demonstrated a visual field defect that is outside normal limits it both eyes showed results that were outside norm
28. d on the home base the examiner can continue the tutorial by pressing the space bar If however the stationary signal did not disappear pressing the space bar will not trigger the next signal In such a case the examiner should instruct the patient to mark the distortion again this time being more careful to mark it accurately and retum their hand to the home base Note if ho patient cannot identity or mark Ih distortions presented in the stationary signals the pallet should be disqualified from performing the test Note Tho frst lew times that a patient attempts to mark the screen the patient might nat be able to estimate thee distance from the screen or they might be afraid touch the screen with enough pressure to actually mark on the screen I ho patient touches the screen and the white dot falls to appear or the beep is not heard instruct the patient to press harder when touching the screen Explain to the patient that this is a ouch Screen and there is problem touching I with the stylus Note The patient s hand must retum to the home base following the marking of each signal This Indicates that the patient completed marking the distortions and assures hat the patient s hand is nol obstructing the screen Note if here is more than one distortion the patient must mark al distortions accurately in order to make tho signal disappear and enable the examiner to continue the tutorial Go GG PIN
29. e Tools pane choose the automatic Backup option and click Initialize Backup Disk Tho Foresee PHP application Initializes the now Backup disk for use and displays the following message Figure 5 19 Backup Disk initialized Successfully Message application wil recognize the last disk initialized only You cannot initialize more than one and use them interchangeably In case you remove an initialized disk trom the device and then plug it back in and attempt lo initialize 1 you receive a message indicating that this backup disk is already initialized Cleaning Test Results from the Local Disk This option will permanently delete test results from the device s local disk This operation is irreversible and therefore should be used only in very rare cases e when Instructed to do so customer support Do not use this option unless you are perfectly sure it is necessary I you are forced to clean the database it is highly recommended to manually backup any test results You want to retain before performing this operation Note f you attempt to initialize more than one removable backup disk the Foresee PHP After you click Clean Local Disk Foresee PHP permanently deletes the test results from the local disk delete test results from the local disk be specific according to clean screens 1 From the Database Tools screen click Clean Database confirmation dialog box opens indicating that the deletion is perm
30. e based on Ihe patient s performance of the tutorial Il to the best of your judgment the patient understood how to perform the test then Qualfy the patient and begin tho test To quality the patient and begin the test Click Start Test To disqualify the patient Click Quit You are returned o the Main Menu screen shown in Figure 24 Tutorial Incomplete Test Tho Foresee device analyzes the patient s responses and performance throughout the tutorial I the system identifies that the patient was unable to perform the necessary tasks required for tho PHP test terminates the tutorial with the Tutorial Terminated screen Figura 2 11 Under normal testing conditions the Tutorial does not terminato the test and tis up to the examiner to decide whether or not the patient is able lo take the test Test Thank You You may move your head from the chin rest Please relax and wait for the examiner The test was NOT completed successfully 55 nyaaa Figure 2 11 Incomplete Tutorial Screen Q you teel mat tne patient needs luther practico consider rerunning he To return to the Main Menu screen Click Next PIN odor doe ei Rev 2 Running the Foresee PHP Test continues Performing the PHP Test First eye After the patient has successfully completed the tutorial the patient immediately begins the tost The Foresee PHP test consists of lashing signals w
31. e device speakers pay a stereo audio test 9 Did you hear the sound Select the Yes or No radio bution 10 Click Next The System Diagnosis Home Base dialog box opens PIN o00F008 101 Rev d 5 Using the Advanced Options continues S N lt lt oso MENHENEND Im Figure 5 8 Home Base Dialog Box Note Cick Abort lo leave the system diagnosis at this ime without geting tho resul Click Skip any time to skip this diagnosis 11 Make sure that your hand is not on the homo base then cick Start Test The Home Base stato should be Released 12 Follow the instructions and place your hand on the home base The Base stato should change to Pressed 13 According to the instructions your hand from the homo base and clik Check release The Home Base stato should return to Released PIN Rev D 5 Using the Advanced Options continues 14 Click Next Tho System Diagnosis Final Report dialog box opens zm Options System Information Figure 5 9 System Diagnosis Final Report Dialog Box Note Each line of the System Diagnosis Final Report contains a status icon Status icons can indicate Errors Warnings Information Notes Tho diagnosis ID number is a label that you can provide to Customer Support to identify types of problems The Description column provides details and tho Resolution co
32. eracuity Deviation Map A plot fa visual field hyperaculty disturbances ested wih test parameters detailed in Test parameters The cross in the center represents the point which is nat necessarily the fovea Each point in the map has a color corresponding to the level of disturbance at this point A metamorphopsia scale legend provided darker colors correspond larger disturbances This map may contain zero one or more areas of hyperacu ly defect clusters These areas rect soma degree of retinal abnormally that may be due to Drusen CNV atrophy or others The analysis defines areas that are suspected as being related to AMD Such ares are called Hyperacuity Defect Clusters a PIN s00F 005 101 Rv d 3 Saving and Viewing Test Results continues Test Results Hyperacuity Defect Clusters Section TNE Cister 2 Figure 3 5 Test Results Hyperaculty Defect Clusters Section Hyperacuity Detect Clusters Table Tre arger tour areas that were defined as Hyperacuity defect cluster are described in tables one tabla per cluster The tables ists the folowing properties for each cluster Clusters Custer number Clusters are displayed rom larges to smallest in size Cluster Consistency The higher the value the higher he that this visual feld defect real and d
33. esee PHP test results to your removable disk verily that itis nat the backup disk and that it has enough free space I you attempt to export backup disk you will receive an error message ee ues E AN mero ar 5 PIN Rev D 4 Searching Test Results onines Selecting Test Results for Export Each row in the Search Results list represents a single test result To select test results for export To unselect a test result press Ese Exporting Detailed Raw Data It you need to export Ihe raw data on which the reports are based 1 Click Export History Summary Sheet csv flo wil bo exported to the selected destiny I wil contain raw data available by any spreadsheet application e g MS Excel s PIN s00F 005 101 Rev 5 Using the Advanced Options This chapter includes Using the System Information Option Accessing tho Database Tools Option Using the System Information Option Tho Foresee PHP device provides you with the functionality to view tho System Information via the Options screen Refer to figure 5 1 Tho System Information screen enables you to refer to the following Forest information PHP system About Provides information about the Foresee PHP application version Windows version and OS operating system runtime revision System Diagnosis Performs system diagnostic tests e g Printer Checkup Flash Drive checkup Touch Screen c
34. eshooting continues Fuse Holder Figure 7 1 Power Entry Unt Fuse Holder 4 Pull he fuse drawer out completely and remove it from the device 5 Replace the blown fuse with a spare fuse from the accessories bag and push the drawer my back in place Troubleshooting In the folowing section the error recovery procedure for the Foresee PHP device is described Error Recovery Message When you receive the folowing unexpected error message follow the instructions writen in the Error Recovery dialog box Q oo oo Figure 7 1 Error Recovery Dialog Box Service Information SERVICE OR REPAIR ARE TO BE PERFORMED BY QUALIFIED AUTHORIZED PERSONNEL ONLY The Base hard drive and fuses are the only user serviceable parts in the device Disassembly of the device beyond the extent required to replace the Home Base hard drive fuses as described in this manual presents a possible electrical shock hazard and wil void the warranty AI repairs on products under warranty must be performed or approved at an authorized Service location Unauthorized repairs wil void the warranty Products af warranty Should be repaired al an authorized service location or by other qualified electronics personnel PIN spoFoos 101 Rev D a 7 Maintenance and Troubleshooting continues Technical Assistance Information 1f you have a device problem you cannot resolve call your authorized distributor for assi
35. eter to Figure 1 7 Clicking Calibrate screen invokes the touch screen calbration application Use this application to ro calbrato your screen Figure 1 7 Touch Screen Calibration Checkup Dialog Box with the Calibrate screen Option 22 PIN s00F 005 101 Rev D 2 Running the Foresee PHP Test Positioning the Patient 1 Help the patient sit as close as possible to the table 2 Place the stylus and homo base in the correct position based on the patients dominant hand Right handed patients Stylus in the right hand homo base on the left side Left handed patients Stylus in the elt hand home base on the right side 3 Occludo tho patient s non tested eye 4 Instruct the patient to pace their dominant hand holding the stylus on the home base The ther hand can rest comferlably on the table 5 Ask the patient to rest their chin gently in the chin rest Adjust ho patient so they can easily see both top and bottom ol tne screen Adjust chin rest table height and chair height accordingly Note The screen ol the Foresee PHP device is lower than the patient s face and therefore ihe chin rest should be tited slighlly downward Note Most patients can perform Ihe Foresee PHP test with eir own glasses However you use the PHP trial frame to provide near distance correction for patients with bilocals PIN soFoos 10t Rev D 2 Running the Foresee PHP Test minus Starting the Foresee P
36. f Patients Dialog Box Note in the List o Patients popup dialog box you can either select a patient from the ist or type the first name last name or ID of tho desired patient to narrow down the number patients that appear in the list 3 Click Search Tho Foresee PHP device search engine opens the Search Results screen to the page and lino entry of the requested test results refer to Figures 4 2 and 4 3 4 Use the page serol direction arrows or the Up and Down arrows on the keyboard to navigate to tho test results you need 5 Click the Details button or press Enter to display the details of the selected patient 6 Select the desired test by one ol the following Selecting the Details button at Ina bottom ofthe screen Double clicking on one of the fields of the desired record Rev D 4 Searching Test Results coninues Figure 4 3 Search Results Screen The Search Results screen contains the following information First name Patient frst name Middle name Patient s middle name Last name Patient s last name Eye Indicates the tested eye Patient ID Patient s identification number Tes ato Date patient took the test Result Detection of possible CNV Within normal imits Outside normal mits Year of Birth Patient s year of birth Test Number Tho tests unique Idntiler assigned by the Foresee PHP system In the status line at the bottom of the screen the folowing info
37. fthe backup disk is available in terms of how many more tests can be stored and many kilobytes of free space are available A message thal Indicates whether the backup disk is Plugged or Unplugged Copying to Backup Local Disks Tho Foresee PHP device uses a removable storage disk for backup storage Each regular test requires approximately 50KB Therefore a removable storage disk of 128MB wil oid approximately 2500 Foresee PHP tests Alter a removable storage disk is plugged in and Initlalized as a backup disk backup occurs automatically by default Note Tho backup removable storage disk supplied with the device is already initialized to be a backup disk When the backup disk is full you can replace it with an empty removable storage disk that was initialized as a backup disk refer to Initializing New Backup Disk page 74 tis highly recommended that you store a full st of backup disks in a secure locaton In casa ol a full backup disk or a disconnected backup disk the appropriate message will appear in the Save dialog box itis possible that tests saved to the local disk are not backed up to the removable storage disk The fied Tests stored on the Local disk but not on the Backup disk indicates the number ol teste backed up to the removable storage backup disk Itis strongly recommended that you back up such tests using the following procedure To copy tests to a Backup disk 1 Read the Backup Status notice message
38. g notes include important safety intormat PPB Guidance for Application Reter othe operating instructions The symbol is intended to alert the operator to the presence of important operation or maintenance instructions in the documents accompanying the device CAUTION Risk of elect eal shock due to the prasence of uninsulated high voltage inside the device Do not remove the covers BF Indicates this is a Type B product with a Type BF app ed part the patient stylus used to touch the screen Tip Important information that will make it easier to perform a task Note Comment that indicates important information Fus Symbol Indicates presence of a fuse There are no user serviceable parts inside the Foresee PHP device Disassembly iol the device beyond the extent required to replace the printer paper replace the thermal printer or replace fuses as described in his user manual presenta possible electrical shock hazard and wa VOID tne warranty External Printer you are using an external printer position it at least 5 1 5m fram the patent Replacement Parts and Accessories Use approved replacement parts and accessories as specified in the maintenance section of this user manual Power Cord Use the power cord provided or an approved grounded power cord only PiN Rev D 5 Warnings amp Cautions Reichert Inc Reichert is not responsible for the safety and reliabilty of this
39. h other users Additional copies be obtained from your authorized Reichert Inc dealer or contact our Customer Service department directly at Tel 716 686 4500 Fax 716 686 4555 E mail inlo relchert com Indications for Use The Foresee PHP is intended lor use in the detection and characterization of central and paracentral melamorphopsia visual distortion in patients with age related macular degeneration as an aid in monitoring progression of disease factors causing metamorphopsla including but not imited to choroidal neovascularization CNV I is intended be used in the office of a licensed eye caro pracliioner in patients with stable fixation PIN soFoos 101 Rev D 7 Introduction continued Foresee PHP Technology Foresee PHP technology is based on the wall studied visual phenomenon of hyperacully Hyperaculi alo termed Vernier acuity is defined as the ability to perceive a minute diference in the relative spatial localization of two or more visual simul refer to Figure 0 1 The hyperacully threshold may be as low as 3 to 6 seconds of arc which is approximately 10 times better than the resolution around 30 60 seconds of arc in the fovea The hyperacuity stimuli are highly resistant to retinal image degradation and thus sutable for assessing retinal function in patients with opaque media as wel Hyperacuity Figure 0 1 Hyperacuity Diagram When a dot deviation signal is projected to a hea
40. heckup is due in two days or in other words the last checkup was performed 30 2 28 days ago Calibration is okay An alert appears refer to Figure 1 5 when any of the first three statuses exist When an alert appears you have two options Click Remind Later This closes the alert dialog box and the system will send tho alert again in ono day Click Check Now This opens the Calibration Checkup dialog box which enables you to perform a calibration checkup and if required calibrate the screen To perform a screen calibration checkup refer to Figure 1 6 perform the following From the Options System Information screen click Calibration Checkup Select Start a calibration checkup from the Touch Screen Calibration screen A oceans Noto if the Start calibration checkup fails two times the screen wil prompt you to Calibrate screen Until his is performed the system prevents you from performing test 20 PIN s00F 005 101 Rev 1 Getting Started coninued Th Seren Carsten is invalid uml tren caran de ern crai is al Figure 1 6 Touch Screen Calibration Checkup Dialog Box Rev D a 1 Getting Started continues However if the checkup falls more than vice the system suspects that the touch screen is indeed not calbrated Therefore in case of repeated fallur of the calibration test an additonal option Calibrate screen is avaiable r
41. iated in the Backup or the Export locaton that drive letter remains wih ts flash drive For ho future Ii may bo helpful to label either Backup or Export D or E on the llash drive Additional when the Foresee PHP is shipped from the manufactura the Backup flash disk is nid with a red dot sticker installed onto the top of tho flash disk Rev D s 1 Getting Started Terms Acronyms and Abbreviations Term or Acronym Description AD The acronym for Ani Distorion Aricia dtorion generated by system appears on te lashed ine during tne Foresee PHP lest AWO The acronym tor Age lated Macular Degeneration CNV The acronym or Choroidal Neovascularizaton Flash Dive USE based memory slorage davies Examiner The technician rained to perform the Foresea PHP Test Personal computer PHP The acronym tor the computerized Preferential Fyperacuy Perimeter Tes A test can be c one or two eyes each aye Table 1 4 Terms Acronyms and Abbreviations 1 Getting Started continued Unpacking amp Assembling the Foresee PHP Device 1 Remove the Box Contents List rom the packing box refer to List of Foresee PHP Device Box Contents and Replaceable Parts page 86 2 Take the accessories out of the box 3 Itis recommended that you save packing material for future re packing CAUTION The device weighs approximately 33lb 15kg To p
42. irements Before unpacking and initializing the Foresee PHP device the following ste preparations must be completed Power outlet 100 240 VAC Table 30 depth and 40 with 76 X 101 5 em 7 Two chairs one height adjustable without armrests for the patient and one for the examiner of any Room conditions Tho room must be quiet There must be no direct source of light on the screen and no back reflection Its strongly recommended that you use a surge suppressor of the type used for a standard 12 PIN 900F008 101 Rev 1 Getting Started connus Foresee PHP Device Components This section introduces the Foresee PHP device components Foresee PHP Device pem Table 1 1 Foresee PHP Device Components Rev D 1 Getting Started continues Figure 1 2 Foresee PHP Back View Tia an Raa Cr Table 1 2 Foresee PHP Device Components 1 Getting Started continued Figure 1 3 Backup Disk and Export Disk 4 Figure 1 4 Backup Cover Table 1 3 Backup Disk and Cover Components Note When installing the lash drives in the Foresee PHP for the first time the drive letters hat are established are D for the Backup Disk ft and E for the Export Disk tight However after the disk has been init
43. ith distortions As in the tutorial he patient should mark the perceived distorions aer disappear rm the screen The test is operated by the patent and does NOT require you to press the space bar to tigger signals In the lest he system automalaly lashes a new signal after the patient s hand has been retuned othe home base ithe patient s hand remains on 1e home base Tor a certain length cl tme te System automaticaly triggers the nax signal For example his can occur he patient does nat erosive any distortons for a certain interval Note tis recommended tha you welch to palet for e frst tew signals to make sure LY matting danrin and hal hand o ina home bse Make sure to encourage the patient but do not correct he patient at any time during the test Due to the patient s clinical condition the patient may see distortions that do nat exist on the signal and might fal to see distortions that exist on the signal To abort the test at any time Press Esc You are prompted to confirm that you want to abor the lest Click Ves to abort the test after which you are returned to the Main Menu screen shown in Figure 2 1 Completing the First Eye When the system finishes testing the first eye the Test Completed screen opens Thank You You may move your head from the chin rest Please relax and wait for the examiner The test was completed Figure 2 12 Test completed screen PIN
44. ith without a dot in a circle next lo the desired Search category and whore appropriato enter the data you wish to search or as follows To view an unfilered list of all tests select All Tests To search for tests by date select Test Date and from the drop down lists select a From and To dale To search for a test by its test number select Test Number and entar the 12 digi test number To search for a test based on a patient s details select Patient and enter patient information in one or mare of folowing fields First name Enter all or of the patients first Last name Enter al or of te patients last name ID Enter all part of the patient ID Eye Check the relevant box right or let or Click List of Patients Tho dialog box opens Select a patient from the list s PIN s00F 005 101 Rv d 4 Searching Test Results coninues Note I you select to search according 1o the patient s first name fast name or ID you fil in only tha beginning of tha field and the search engine wil retrieve all patients that meet this criteria For example If you enter the letter J in the First namo field all patients whose first name begins with a J wil be displayed The search engine is case insensitive typing a lower case or typing an upper case J return the same search results Clicking OK displays tho patient s details in tho Patient elds Figure 4 2 List o
45. k Print Test Page The System Diagnosis option prints a sample test page Alter printing the test page you will be asked whether the page was printed successfully or not You Can cick the Print Setup button to setup your printing preferences or Click Abort to leave the System diagnosis at this time without getting tho result L Note The sample test page might take some time to print 3 Click Next The Touch Screen Calibration dialog box opens or Click Abort fo leave the system diagnosis at this time without getting the result EE M Figure 5 6 Touch Screen Calibration Dialog 4 Click Skip if you do not want to run the Touch Screen calibration diagnosis and skip to Ihe step Audio Diagnosis Click Abort to leave the system diagnosis at this imo without getting tho result Click Test Calibration The Touch Screen calibration process opens Following the on screen instructions use tho Foresee PHP stylus to touch the center of the four targets as they appear on the screen PIN Rev D 5 Using the Advanced Options continues 5 Click Next Tho System Diagnosis Audio dialog box opens m Em Figure 5 7 Audio Diagnosis Dialog Box 3 Note Cick Abort to leave the system diagnosis at this time without getting the result 6 ClekBeep Test The device emits an audible beep 7 Did you hear the beep Select the Yes or No radio button 8 ClekSound Test Th
46. l and then clean the touchscreen Cover the touchscreen monitor with the custom dust cover to protect the unit Warning DO NOT piace dust cover on instrument until the instrument is completely turned of Cleaning the Home Base Chin Rest and Stylus Itis recommended to disinfect the Home Base Pad Chin Rest and Stylus between users with 70 alcohol Replacing the Hard Drive The hard drive is a user replaceable It should only be replaced when customer support advises you to do so When customer support advises you to change the hard drive they wil Send you a replacement hard drive with replacement instructions Replacing the Home Base The Home Base isa user replaceable part I should be replaced only when customer support advises you to do so When customer support advises you to change the Home Base they vill Send you a replacement part with replacement instructions Replacing Power Entry Unit Fuses Always tum the device power olf and disconnect the power cable from the power entry before working with the power entry unt and fuses The power entry unit has fuses Either or both may burn out When a fuse burns out replace it as follows To replace a power entry unit fuse 1 Shut down the device and tum i ofl 2 Disconnect the power cable from the power entry 3 Press down the small handle in the center of the fuse holder The fuse drawer pops out slight PIN 900F008 101 Re D 7 Maintenance and Troubl
47. lthy retina it stimulates a colinear set of retinal receptive fields Specialized neuronal circuits In the visual cortex process this information leading to the perception of a straight dot deviation signal When retinal pigment epithelium elevation occurs both in the case of when drusen are present as in intermediate AMD and often to more significant degree when CNV develops a geometric shit in photoreceptor locaton might occur As a result an object mago that stimulates certain photoreceptor fields when presented to normal retina stimulates diferent ones when APE is elevated Therefore linear signals might be perceived as distorted or misaligned reor to Figure 0 2 AND With Photorecapton elevation Figure 0 2 Normal Retina vs AMD with Photoreceptor Elevation PIN odordoe ei Rev Introduction continues Sette Sac thea However when the same ine is projected on a retina with an AMD lesion as ilustratad in he diagram on tho right n Figure 0 2 the geometrical shit ofthe photoreceptors caused by renal pigment epithelium APE elevation causes activation of photoreceptors 2 and 7 instead of 2 and 6 Consequently one of the dots is perceived if i shifted to another location in the visual field and the line appears distorled How the Foresee PHP Test Works 1 The Foresee PHP test consists of a series of dot deviation signals white dots on a black background for maximum contrast lashed at p
48. lumn provides Instructions to address the problem e g Installation problem customer support 15 Click Save Tho Save As dialog box opens PIN so0F 006 101 Rev 5 Using the Advanced Options continues Figure 5 10 Save Diagnosis Dialog Box 18 Select the folder lo which you want to save the diagnosis report 17 Enter a filename in the field or Use the default flename ForeseeDiag time stamp zip 18 Glick OK Tho System Diagnosis report saves tothe selected folder Hie GRANUM M a en Pen ne en me co E a ea LT appe SR It C TUM EX pio a ee EIE NORD Tues stern EE espe tae Rev D 5 Using the Advanced Options continues The Calibration Checkup Option To check the calibration of the touch screen Click Calibration Checkup The Touch Screen Calibration dialog box will appear You wil be prompted to mark targets on the monitor that wil validate the touch screen calibration Accessing the Database Tools Option Database Manager option enables you 1 Backup and restore your database and monitor backup status details Copy tests to local or backup disks Select backup options For example you can select the option to overwrite od tests the Backup disk is ul initialize a now Backup disk Clean delete tests stored on your local disk drive To access the Database Tools From the Options screen click
49. must at the same time atr ancor all copies of the Software as wel as the supporting documentation 1 he same or destroy any such materials not ransfored Except as set forth above you may not transfer or assign the Sofware or your ighis under ths License Agreement Modicaton reverse engineering reverse comping or disassembly of he Softwares expressly prohibited However you are a European Union CEU resident Information necessary o achieve Interoperability of the Software wih oiher programs within the meaning ef the EU Directive on the Legal Protection of Computer Programs is available to you from Reichert Inc upon writen request EXPORT RESTRICTIONS You agree that you wil not export or re export the Software or accompanying documentation or any copies threo or any products zig tne Software such documentation in of any applicable laws or regulations of the United States or the country in which you obtained them TRADE SECRETS TITLE You acknowledge and agree that he structure sequence and organization of the Software are the valuable rade secrets of Rechen Inc and te suppliers You agree to hold such rade secrets in confidence You futher acknowledge and agree that ownership of and le to the Software and al subsequent copies hereof regardless ol the frm media are held Reichert nc and is suppliers PIN 900F006 101 Re D 10 End User Software License Agreement continued TERM AND TERMINATION
50. nd the patient to return their hand to the home base after marking the distortions inform the patient that Uthe patient sees more than one distortion on the flashing ine they should mark each distortion M the patient did not see any distortion on the flashing line they should not mark anything and the patients hand can remain on the home base PIN aboF 008 101 Re D 2 Running the Foresee PHP Test continues 5 Do not correct the patient Due to the patient s clinical condition the patient may see that do not exist on he signal and might fall to ee distortions that exist on the signal To continue to the next signal until the patient s hand is returned to the home base and press the space bar Pressing the space bar while the patient s hand is off the homo base wil not tigger the next signal Tutorial Qualifying the Patient After the tutorial is complete the Patient Qualification screen appears Refer to Figure 2 10 Noto f ho Incomplete Tutorial screen appears instead of ho Patient Qualification screen this indicates that the tutorial has been terminated by he system and that the Test should be performed again emat scans Sor ts Figure 2 10 Patient Qualification Screen PIN Rev D 2 Running the Foresee PHP Test continuad At his point itis your responsiblity to decide whether or not the patient is qualified to take the Foresee PHP test This decision should be mad
51. nmental Specifications operating Conditions Operating temperatura 59 F to 95 F 15 C to 35 0 Operating humidity 10 to 90 non condensing Storage and Shipping Conditions Storage temperature 4 F to 120 20 C to 60 C Storage humidity 0 to 95 non condensing 8 Appendix Test Specifications Visual Field 14 vertical x 14 horizontal Flash Duration 160 mlliseconds Test Format White on black maximum contrast Presentation Order Pseudo Random Signal 14 ines composed of 27 units Unit 50 03 02 Signal Resolution 0 75 Includes Artificial Distortions 5 Fixation White on black 035 radial Mean Background Iluminaton 1CCFT Standards Compliance Medical Device Directive respectively as amended by deviation CE EIE Arcos ray Roher sents proce D8222 Germany Reichert is committed to supporting the Waste Electrical and Electronics Equipment WEEE regulations At the end of Ihe device useful Ife contact your SS ocal distributor for disposal Embedded Microsoft Windows License Location Each Foresee PHP instrument is supplied with an Embedded Merosol Windows Icanse The license label is affixed to the inside the removable storage device ray To access I open the removable storage access door refer Figure 1 4 page 15 for an station Disposal This product does not generate any enviro
52. nmentally hazardous residues Athe end ofthe product follow the local laws and ordinances regarding proper disposal of this equipment PIN Rev D 8 Appendix continues List of Foresee PHP Device Box Contents and Replaceable Parts Description Part Number Foresee PHP Instrument 1 HD 35 with Win XPE and Foresee SW current version 0005012 D instalation Guide 6000040 1 Home Base Assembly 9005086 T Chin Rest Sub Assembly 9008089 Foresee Keyboard 100K002 1 Optical Mouse Toouoor T Mouse Adapter USB PS2 optional nocon 1 Foresee Sius 1001003 D North American Grounded Power Cord T Foresee Trial Frame 00Ko08 1 Flash Memory Dive Tul Note Locate inside the PHP device Fuse for Power Entry T 25A 250V 300F001 2 Allen Key MS 3008008 1 US Printer Gable p T PIN 900F008 101 Rev D 9 Terms Conditions and Warranty This products warranted by Rene lnc against defective materi ond workmanship under somal use a period one year tom he date ot invoize tthe cag purchase An autoradio ha rot be considered Stal pcre Under me wrayer sol to repal pe me dcn part or pot warranty apples to new produci and dos ot apply 1o a product hal has ben tampered aered in any misused by ace amp agicence or NEN has had san removed ated or Nor anali s waranty be
53. ns continues a Figure 5 13 Backup Database Screen 6 Click Stop to stop the backup process 7 Click Close to close the screen when the backup process Is complete Restoring the Database Use tho Restore Database option to restore previously backed up tests To restore the database 1 Inthe Database Tools screen cick Restore Database The Restore Database dialog box opens Figure 5 14 Restore Database Dialog Box 2 Glick the Browse buton to search for the backup Glick Restore The following window opens PIN o00F008 101 Rev 5 Using the Advanced Options continues Figure 5 15 Restore Database Finish Dialog Box 4 Glick Stop to stop the restore process 5 Click Close to close the screen when the estore completes Automatic Backup create an automatic backup Inthe Database Tools screen click Automatic Backup The Automatic Backup screen opens Automatic Backup mom prod Ium Figure 5 16 Automatic Backup Screen PIN Rev D n 5 Using the Advanced Options continues Viewing Backup Status Details You can view the following Backup Status deals The number of tests stored on the local disk but not on the backup disk The number of tests stored on the backup disk but not on the local disk How much of the backup disk is used n terms of the number ol tests backed up and the number of kilobytes of space used How much o
54. oes not reflect an This cluster consistency reflects how unlikely he possibilty hat this defect was caused by random scattering of abnormal responses Area Total area in square degrees a certain factor times the number ot colored pixels within he boundaries of he cluster integrated Intensity volume The intensity is analogous to the volume it we look a he Guster as a mountain on a topographical map The intensity ia a summation over al individual cluster pixel scores expressed by pixel color and is analogous to he visual feld defect intensity Estimated Location Presumes tne anatomical location of the zone on the rin PIN Rev D E 3 Saving and Viewing Test Results continues Test Results Clinic Details Section R icheit um Siti Code Figure 36 Test Results General Eie Details folowing information appears in the Ciric Deals section clinic name Name of the cine where the Foresee PHP test was given e g Jahn Dos Cini Street address reet adress of the ini e g 123 Broadway Bl city Zip Code Cy country and zip code of the cinic a g San Francisco CA 97125 Phone number Phone number of the cti 585 555 5858 Fax number Fax number of the cinic e 585 555 5858 Email Emad address of the cinic e eyecinie eyes com PIN 1 Re D 3 Saving
55. ome base and press the spacebar prompted to confirm that you want abort the tutorial Click Yes to abort the 45 Note To abort the tutorial at any time press tha Esc key on the keyboard You are The screen wil then go to the Main Menu screen 2 Running the Foresee PHP Test continued Tutorial Flashing Signal Section After the stationary signal section of the tutorial is complete the following banner appears Figure 29 Flashing Signal Banner Screen Tho banner indicates that the flashing signal section of the tutorial is beginning and reminds you instruct the patient to notice tha distorted areas on the lashing lines and mark them after they disappear tho screen Tre flashing signal section of the tutorial tests the patient s perception This means that he patient may se diferent distortons than you da Because of his fhe patient shouid not be corrected during this section of the tutorial This section of the tutorial is the samo as the actual test and enables the patient to practice marking distortions before actually taking the test Press tho space bar The banner draps and the first signal flashes For the flashing signal section of the tutorial Explain to the patient that the flashing signals appear on Ihe screen for a very short time 2 Instruct the patient to mark the area on the screen where the distortion flashed after it no longer appears on the sereen Remi
56. performed duin the actual test 1 Train tna padn to an einen ando mark hem on ine Tach soon using he Teach the patient to always retur the hand to the home base after marking distorlons Successfully teach the patient to perform the test without any assistance PIN so0F 005 101 Rev 2 Running the Foresee PHP Test continued Tho tutorial consists of a stationary signal section and flashing signal section Definitions Fixaton Target A white dot in the center of the screen that the patient should fixate on during testing Distortions Curved locations on a straight Stationary Signal that the patient identifies during the tos Stationary Signal A dolled signal ine wih distortions that appears on Ihe sereen during testing to enable tho patient to identify the distortions Home Base The triangular pad the patient places their hand on alter marking a distortion The tutorial was designed to teach the patient to mark distortions accurately Whenever the patient marks the location of a distortion on the screen a white dot appears on the screen The distance between this white dot and the actual distortion is calculated Only when the patient marks the distortion accurately and beep is heard and the distance calculated is small does the stationary signal disappear The signal disappearing indicates to the examiner that the patient performed the task correctly and after ensuring that the patients hand is locate
57. py to Local Disk Progress Bar 2 Click Close The Database Tools screen closes and retums to the Options screen Selecting Backup Options You can enable and disable the following backup disk settings Automatically backup test results when saving tests recommended Overwrite oid tests as needed not recommended amp Domotoverert tests clear disk manually or initialize new Backup Disk Automatic Backup Option When its checkbox is selected Automatically backup a test when saving it means that when you save a test result it is copied automatically to tho backup removable storage disk It is Selected by defaut When the target backup removable storage is full a warning message is displayed If this happens plug in a new removable disk and initialize fs backup disk refer a initializing a New Backup Disk page 74 Clear the check box to disable automatic backup In this case you must back up test results manually using the Copy to Backup Disk button refer to Copying to Backup Local Disks page 7 h Before using a new backup storage disk you must initialize it Tho Foresee PHP application provides you witha database tool that enables you to initialize a new backup disk alizing a New Backup Disk To initialize a new Backup disk 1 Insert the new backup storage disk into the backup storage compartment s USB connector m PIN ap0F 008 101 Re d 5 Using the Advanced Options continues 2 From the Databas
58. rd compressed imago format PIN 900F006 101 Rev D E 4 Searching Test Results onines 8 Intha Export Folder area enter Ihe export folder in the fe or click the Browse button next to the and irom the Browse For Folder dialog box select the destination folder tor the tests you are exporting Figure 4 5 Browse For Folder Dialog Box Noto Athough you can export test results to the local disk itis highly recommended thal you do not This drive is used by the system and storing test results on it may cause 1 System to malfunction If you select this drive and click OK a warning dialog box d notifies you that this selection is nat recommended You have the option to warning and continue or to go back and select a different drive tis best lo export test results o a different drive preferably network drive or the removable storage device DP wai RSH a a ae ia Select the desired export folder and click OK Tho specified test results or all test results copied from tho Local disk to the selected folder E PIN s00F 005 101 Rev 4 Searching Test Results coninues Toro Search Results Test 3 of 3 Figure 4 6 Exporting Tests in Progress Dialog Box 10 When export completos cick Close The Exporting Tests dialog box closes 11 From the Search Results screen cick Close The Search Results screen closes and to the Main Menu screen Betore you attempt to export For
59. redefined intervals across the central 14 of the patient s macular visual field 2 Projection of dot deviation signal on a retinal lesion can cause the patient to perceive distortion scotoma andlor blurring of part of the ine 3 The patient is asked to report any abnormalities in the dot deviation signal by touching the screen at the location of the abnormality with the stylus Existing visual fld defects can be identified should the dot deviation signal be positioned on a lesion 4 During the course of the test artliclal distortions that imitate distortions similar to those seen by patients with AMD related macular lesions are flashed These artical distortions act as bath a quanliying measure and a relabllty measure The patents responses to these distortions are evaluated to identify AMD lesions and to judge test reliably 5 The Foresee PHP system consists of a screen based application that runs on the Foresee device The patient s responses are recorded and analyzed by a pre designed algorithm 6 Following the analysis the resulting output indicates whether progression of AMD is suspected or not Rev D Introduction continues Foresee PHP Test Results A test result on intial examination that was outside normal mits cannot serve as the baseline examination It is recommended to retest the patient within 1 2 weeks This may overcome learning effects inherent to visual field testing Blomicros
60. revent injury ii carefully with sufficient assistance 4 Assemble the Foresee PHP using the Installation Instructions found in the packing box Starting Up the Foresee PHP Device 1 Place the assembled Foresee PHP device on a dedicated table 2 Connect the keyboard and mouse if applicable into thelr connectors 3 Verity tho Backup and Export Removable Storage Disks aro Installed in Ihe Removable Disk Compartment comes pre installed 4 Plug the electric cord into power supply socket Locate the power switch on ho right side ol he device and on the device Tho device boots up and opens to the Foresee PHP Main Menu screen Screen Features Beseripion Start buon Initiates the Foresee PHP tutorial and est sequence Search buton Opens he Search results screen and enables you to search tor Foresee PHP tests saved on the Local disk Examiner Guide bution Runa tre Examiner Guide fash video This instructs the examiner on how to operate the Foresee PHP device and how to prepare patents to take the Foresee PHP test Options buran Opens the Options screen which contains the folowing System Information button Database Tools button Cnie Details button Switch to Windows button Shut Down Shuts down the device or to such Windows Dim Screen buon Darkens the screen Rev D v 1 Getting Started
61. rmation is displayed Tests Found Displays the number of test records retrieved by the search Search Criteria Displays the selected Search parameters PIN so0F 006 101 Rev 4 Searching Test Results connus Search Results Screen Buttons The information in tho folowing table describes the function each button on the bottom of the Search Results screen Description The List Details buttons toggle the Search Results screen between a ist ot test resus and details of one selected test The List button s enabled unen the detailed test results dep The Details burton displays test results for he selected test The Details buton enabled oniy when displaying the ist Sick Edit Patient modit ls selected Sick Print i prin the selected test results Sick Print Setup to set up your printing preferences Sick Export ta Export he test results to ie in one of he folowing Formats jpg or bmp Gick New Search to reopen the Search screen and parorm a new search RE Not haf the previous search are vale u you replace nem Sick Close to close the Search results sereen and return to the main TELLE Inte Search Results screen you are in he Ls view ick Previous i ssec he previous test record tha search resus ist 1t you aro in the Test Details view clicking Previous displays the test resuts ort test you
62. rms automatically during the system diagnostics You can manually run the folowing system diagnosis checks Removable storage diagnosis Print diagnosis Touch Screen calibration diagnosis Audio diagnosis Home Base diagnosis Performing the Foresee PHP System Diagnosis To perform the system diagnosis In the System Information screen click System Diagnosis Reer to Figure 5 2 The software fst checks the status of removable disks Tho System Diagnosis Removable Disks dialog box opens tete Pa ove sap manda you shoul aan data On en aT etta Sean Pace eere st Cosy ao naka fore E ft Now Been Sag for bath removable disks If a removable disk is almost full It is recommended thal you replace it Remember that after replacing Ihe removable backup disk you must Initialize the new disk 9 Tip By examining the Removable Disks table you can check the remaining disk space PIN Rev D 5 Using the Advanced Options continues Figure 5 4 System Diagnosis Dialog Box 1 Click Next The System Diagnosis Printing dialog box opens or click Abort to leave the system diagnosis at this time without getting the result fonse t Options System Information Figure 5 5 System Diagnosis Printing Dialog Box PIN s00F 005 101 Rev 5 Using the Advanced Options continues 2 Click Skip if you do not want to run the Printout diagnosis and skip o the nost step inthe System Diagnosis check or Clic
63. selected prior ta your selection of the curent test In na Search Results screen f you are in the Lt view cick Nex To select he u ee al lowe mo ur no it you are in the Test Details view cick Next to display the results for the test at flows the current record Rev D 4 Searching Test Results onines Exporting Test Results Foresee PHP enables you to export PHP test results to local disk drive a network drive or to a removable storage device For example you can use the Export lash drive connected to your Foresee PHP device lo export a selection of test results to a PC Alter exporting you can unplug he device and plug it into Ihe USB port of a PC where the results can bo viewed Since exported flos ara stored in standard formats there is no need for a dedicated viewer in which view these results To export Foresee PHP test results 4 Glick the arrow next to the Export button A menu pops up Export Test Export History Summary Sheet Print Export 2 Glick Export Test The following Export dialog box opens Export Tests 7 Selected tests Include test history data Inco patiant details 2 Ovorwrt ong os ot pat fole zd Figure 4 4 Export Dialog Box PIN s00F 006 101 Rev 4 Searching Test Results coninues 3 Inthe Export Tests area of tho Export dialog box select tho radio button nex
64. so requires you ta be logged In with user account having administrator peivieges I you or a system administrator ads new user accounts ta the system itis recommended to grant them administrator privileges Switching to the Microsoft Windows Environment In the Foresee PHP Main Menu screen click Shut Down then cick the Switch to Windows button refer to Shutting Down tho Foresee PHP Device page 19 from the Foresee PHP Main Menu screen click the Options button to navigate to the Options screen then cick the Switch to Windows button Refer lo Foresee PHP Screen Features page 17 Switching to Foresee PHP Mode When you switch to the Microsoft Windows envionment the Fores launches automaticaly when the device restarts PHP Control Panel Figure 6 1 Foresee PHP Control Panel 7 PIN s00F 005 101 Rev 6 The Microsoft Windows Environment continued To switch back to Foresee PHP mode 1 In the Microsoft Windows environment go to the Foresee PHP Control Panel Tip t the Foresee PHP was accidentally closed you can reopen it as follows a Glick the Windows Start menu b Open the Al Programs panel Click the Foresee PHP Control Panel icon in the applications ist The Foresee control panel opens 2 Click the Switch to Foresee PHP Ink The Switch to Foresee PHP dialog opens 3 Glick Yes to switch and restart the device or No to cancel switching When you click Yes the device wil restart
65. stance Monitor Power Management The Foresee PHP device monitor shuts down alter dling for 20 minutes Reactivate the monitor by moving the mouse pressing any key or by touching the Touch Screen PIN 900F 008 101 Rev D 8 Appendix This appendix includes Technical Specifications Standards Compliance Embedded Microsoft Windows License Location List of Foresee PHP Device Box Contents and Replaceable Parts Technical Specifications 8 Appendix continues Instrument Spec Specification Description Simus Dot Deviation signal lashed over macular loci Area ol Field tested Canta visual fed 1 Mode of operation tutorial alowed by an automated patiant driven test Data storage backup and Results sored on a hard are Dedicated USB memory sick for automatic results backup Removable USB memory stick for results export and SW Upgrades Results export format HTML JPEG BMP Device ready tor office networking Primer Dimensions Device 20 51 cm width 127 30 5 em depth x 12 305 im height Chin rest and hand switch assembly 18 40 5 cm width x 16 405 cm depth x amp 20 cm height whan the chin rest is at the lowest postion Overall system weight Abs 18g 100 240 V 50 0 He TA max 1 0 320 standard power inlet connector for wordwide use Enviro
66. story page Mot Patti rt aotig ara doae aren econ appears on the PHP screen The data the same however it is positioned differently Note The printed version of the test results do not have the same visual layout as what 3 on the page of tho printed version E PIN s00F 005 101 Rev 3 Saving and Viewing Test Results continues Test Results Data Tho Test Results section is displayed in the following screens The following table identifies and describes the fields in each of the sections The table may provide a sample value for a given fied Test Results Title Section Name rst Lo T Right Eye teat Figure 3 1 Test Results Title Section Patient Detalles folowing information appears in the Patents Detais section Patient s name Name o patient including the patients first name mide name and last a g John F Sma 1D Unique patient number e Social Security number M Date of Birth Patient s birth date in the format mmiddyyy e g 8711938 Gender Patents gender male or female M Eye The patient examined eye Right Eye Let Eye Test No Unique test number Test Date Date that the frst Foresee PHP test for the specified patient was administered inthe format mmidd yyy e 41712006 Test Duration Total duration time of test execution in the format mms eg 04 11 min Re
67. t to one of ho following Export Range options All Select this radio button to export all ho tests stored on tho Foresee PHP device s local disk o the removable disk Select this radio button to export the selected tests to the removable 4 Ifyou need to export the History data check the Include test history data check box I the selected format for export is mit he additional history page wil be appended to the existing data at the bottom of tho ht page I this fle wil be printed two pages wil be created Ifthe selected format for export is bmp or jpg two separato bmp jpg pages wil be created having part 1 and part 2 in the file name correspondingly 5 you want to exclude the paient details in the exported file s clear the Include patient details check box by default tests are exported with patient details Using this option wil result in non significant fle names to the exported fies 6 I you do not want to overwrite files of tests that might already bo on the export disk uncheck the Overwrite existing fles check box By default if a test is already on the removable export disk it will be overwritten 7 From the Fle format drop down list select the format in which you want to export the results Options are mbt default bmp or HTML Ike format with embedded images Files in this format can be opened Using Internet Explorer version 5 or above bmp Bitmap format jpg Standa
68. to verily that the removable storage disk is plugged into the USB itis nol plug tin now 2 Inthe Backup Status area click Copy to Backup Disk PIN o00F008 101 Rev 5 Using the Advanced Options continues Tho Foresee PHP application automatically selects all saved lasts not yet backed up and copies them to the backup removable storage disk While copying the Copy to Backup Disk progress bar appears porem e unt Figure 5 17 Copy to Backup Disk Progress Bar Note Ihe Copy to Backup disk als an eror message appears in the Copy to Backup progress bar reor to Figure 5 17 3 Glick Close The Database Manager screen closes and retums to the Options scree Ills possible that tests stored on the Backup disk ara not saved to the Local disk Tho field Tests stored on the Backup disk but not on the Local disk refer to Figure 5 18 page 71 indicates the number of tests not saved locally To save these tests the Local disk use the following procedure To copy tests from Backup disk to Local disk 7 From the Backup Status area click Copy to Local Disk Tho Foresee PHP application automaticaly selects from the removable storage disk all teste not stored on the local disk The Copy to Local Disk progress bar is displayed as Ih tests are copied from the backup disk to the local disk Rev D n 5 Using the Advanced Options continues fied ne Say Figure 5 18 Co
69. u bythe Software provider Refer to ihe Beense contained in the providers product for the tems of use belore such products LICENSE Reichert inc grants you nonexclusive icense to use the accompanying software program s he Software subject to he terms and restctons set toh in ie Leense Agreement You are not pemited o lease or rent except under separate mutually agreeable terms set foh in writing or subicense tne Software or to use the Sofware m a time sharing arrangement or in any other manner Further icense is granted 1o you m ne human readable code of tne Sofware code Except as provided below his License Agreement does nat grant you any rights lo paleis copyrights vado secrets trademarks or any other nights in respect to tha Software Notwithstanding any other provision of this License Agreement his License Agreement shal not be deemed to apply the Windows sofware or any other applications sofware licensed to you by third partes that is included on the same media as Reichert Inc Software Other Software the Other Software providas that he use of t e Other Software s subject ota terms and conditions of e third oense agreement NO ASSIGNMENT NO REVERSE ENGINEERING You may transfer t e Sofware and this License Agreement to another party ifthe other party agrees in wrting to accept the terms and conditions of this License Agreement T you transfer the Sotware you
70. up Option Accessing the Database Tools Opin Manual Backup and Restore Backing Up tho Database Festong the Database Automate Backup Viewing Backup Sls Details Copying to Backup Disks To Tests to Backup Disk To Tests Backup Disk to Local Disk Selecting Backup Options Automate Backup Option a New Backup Disk Cleaning Test Rosuls rom the Local Disk Using he Recovery Feature Adding and Eating Cirical Deal 6 The Microsoft Windows Environment verve Switching 1 Micros Windows Switching to Foresee PHP Checking the Touch Screen Calbation Calirating the Touch Sera Instling Sofware Updates Maintenance and Troubleshooting Maintenance Replacing Power Enty Uni Fuses rovbleshootng Error Recovery Massage Service Information Monitor Power Management 8 Appendix Techical Specifications Instrument Speciicatons Enveonmental Speciicat ns Test Specifications Standards Complange Embedded Microsoft Windows License Location Disposal stot Foresee PHP Device Box Contents and Replaceable Pars Terms Conditions and Warranty To End User Software License Agreement so s E E E so F1 s s sa F1 sa E 70 n m 72 T m 75 78 7 7 m E s0 80 a E a as 85 85 8 36 a Di Symbols amp Safety Information The following symbols appear in this manual Cu A k 9 3 The followin
71. up disk wih a fash driva nfiaize the new backup ash arive I your backup disk iz plugged n and Ihas enough fee space cick ho Database burton and change the automate backup settings Network Status Indicator aree connected Network is disconnected Input Language Indicator The Input Language icon displays a two letter code Incieatng the current input language Dim Screen tutos Darkens the screen 1 Getting Started continued Initial Configuration of the Foresee PHP Device Initial configuration of tho device includes Setting the dato Setting ho time Setting the input language defauit English Selecting a printer defaut printer Ihe external printer supplied with the device To configure any of these settings you must switch to ho Microsoft Windows environment and use he appropriate Windows tool To switch refer Switching 10 the Microsoft Windows Environment page 78 Shutting Down the Foresee PHP Device As a matter of safety and to extend the of the device you are advised to shut down the Foresee PHP device at the end of each working day To shut down the Foresee PHP device 1 From the Foresee PHP Main Menu screen click Shut Down The Shut Down dialog box opens and prompts you to select whether you vant to shut down the device or want to switch to tha Microsoft Windows environment 3 When
72. v D 3 3 Saving and Viewing Test Results continues Test Results Results Section Outside Normal Limits p lt 5 6 Reliable No Baseine Test Available Relabity Indices False Negative Errors fabe postive trons Pp Figure 3 2 Test Results Results Section Resuns Within Normal Limits means that simisr visual ieia findings are found in the normal population c Intermediate AMD patents dry AMD in the normative database Note that small percentage ot cases CNV patients may produce test results a visual feid that is within normal Outside Normal Limits means that similar visual ek findings are found in the population of CNV patients wat AMD in the normative database he deviation is outside normal mts a p value is given For example p lt 10 means that the visual ld detect in this testis found among 10 of the intermediate AMD population This intormaton may heip you decide what measures you wil take in futher evaluating this case Categories tor p values are p 10 p lt 5 pe 1 Reliable indicates i the overal test performance is reliable It can be ether YES or NO The testis reliable both reliabiity indices refer o below are reliable When at least on of the indices is unreliabie he testis to be considered as unreiaie Baseline Test Indicates whether a baseline examination a test that is within normal Imis and reliable is available Without a baseline e
73. xamination monitoring ot an eye and indication of change can not be made Reliability indice indices False Negative Errors This index indicates the frequency w h which the patent failed to respond expected to be visible M False Positive Errors This index indicates the frequency with which the patent responded to stimuli hat could not have been seen Each of above can be ether Reliable or Unrelable as indicated using bar chart for each index This bar chart provides measure for he level ot relabilty I the black ange indicator points to he blue part of the bar the index is liable If it points to the Back it is unreliable hese indices determine the reta of the examination There are wo 40 PIN s00F 006 101 Rev 3 Saving and Viewing Test Results continues Test Results Examination History Section Figure 3 3 Test Results Examination History Section Examination History Chart char assists in racing and monitoring patient results over time Patient monitoring can begin ater a baseline examination is avaiable marked wih two concentric circles Each test can isa be marked as resable or unreliable PIN Rev D E 3 Saving and Viewing Test Results continues Test Results Hyperacuity Deviation Map Section Figure 3 4 Test Results Hyperacuity Deviation Map Section Hyp

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