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User's Manual - Premed Pharma

1. Difference Std Dev OF RNFL 2 39 2 22 0 17 Overall RNFL 71 67 4 5 Hemisphere 70 64 6 I Hemisphere 73 70 3 TEMPO 62 i IT 49 EJST 76 SUPERIOR 72 i Ehe 97 FNS 46 NASAL i FSN IN INFERIOR i NI Ehr 2006 02 23 15 43 43 3 45mm Scan Diameter Re NF BF rs bM Oh A TS Trei Hei NS 2006 02 23 15 43 38 2006 02 23 15 43 43 IN NI 200 100 TI TH H NI 6 30 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 11 NHM4 Analysis Presentation The NHM4 map includes several pieces of important disc morphology information disc margin contour cup contour and RNFL thickness map from disc margin up to 2 mm radius from the center of disc OD Cup Depth 150 um NHM4 SSI 59 4 RNFL On Diameter 2 80mm 250 Radial Line Diameter 3 40mm Video Guided a 150 100 50 Show Boundary Curves Save As OCT Basline Section Thickness um Disk Area 2 21mm 0 um Cup Area 0 35mm Rim Area 1 86mm2 Rim Yolume 0 207mm Nerve Head Volume 0 376mm Cup Yolume 0 034mm Cup Disk Area Ratio 0 16 100 Cup Disk Horizontal Ratio 0 40 Cup Disk Vertical Ratio 0 49 0 RNFL Average Thickness on Diameter 3 45mm 111 07 um A A Diagnosis Superior Hemisphere Inferior Hemisphere 6 31 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Click on the list Analyze Menu 6 3 11 1 TSNIT Histogram RNF
2. 6 39 RTVue User Manual Version 2 0 PN 5000 42929 Rev B 07 2007 Analyze Menu 6 3 12 3D Optic Disc Presentation Iw 4 Aig j Y AM ah i L A ti m dp WT Hild BOU ri Baseline i u o d Ir J A y Hi A A dr U WA Ai j 7 6 40 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 13 Comparison Image comparison is a very handy tool used to see the difference of the retina between two visits This option is available on all scan patterns To use image comparison first select the patient scan in the analyze window Ifthere are examinations available for comparison the Comparison button will be available This is the same method used to select progressive and asymmetry option Comparison Progressive Asymmetry Progressive Asymmetry Image Comparison options 1 2006 11 07 11 02 34 2 2006 11 07 11 03 29 pa 1 2006 11 07 11 04 15 2 2006 11 07 11 04 54 1 2006 11 07 11 07 36 2006 11 07 11 08 31 Y d a Mk p f z ji h eer a 1 2006 11 07 11 05 47 6 41 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu Comparison continued Two rows of images will appear You can select which frame image to compare by using the slider on the fundus image SLO image in 3D scan to choose the images on each visit The horizontal and vertical image locations
3. 7 784 Smm Thickness Elevation Full Retinal A O ILM Inner Retinal Outer Retinal O RPE Diagnosis Show Boundary Curves Report Date Wednesday April 18 15 08 31 2007 Missing lines indicated in gray Date in this area is interpolated based on the nearest adjacent complete scan data 6 26 RTVue User Manual Version 2 0 PN 5000 42929 Rev B 07 2007 Analyze Menu MM6 Slicer Option Display Patient Name Suspect Glaucoma Disease Category Photographer DOB 03 02 1972 Algorithm Version A1 3 3 0 Examine Date 05 04 2007 ID Gender F Primary Physician OD MM6 SSI 60 8 Y Display Slicer Click once on any scan to display it in the larger window at the top right Double click on any scan to go immediately to the measurement mode presentation Note The Radial Slicer and the Slicer report displays have been changed to fit all scans onto one screen These scan patterns will also print to one page 6 27 RTVue User Manual Version 2 0 PN 5000 42929 Rev B 07 2007 Analyze Menu 6 3 8 MM6 Progressive Analysis Presentation The MM6 progressive Change analysis shows the difference between two MM6 analyses To speed up the comparison results it is better to analyze each individual MM6 scan first before making comparisons OD 04 09 2007 18 49 58 Progression MM6 SSI 47 2 Thickness Map Sonne Smiri ven OD 04 09 2007 19 06 20 SmmxSsmm _ zen 700 Difference Map 5mm x 5
4. Diagnosis Y Show Boundary Curves Show Lines This option toggles the map display between showing with or without scan reference lines Map graphic without lines works well for case study presentations 6 25 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 7 Missing scans Due to blink With version 2 0 scans that were saved which included missing B scans due to blinking or weak signal for any reason eyelash obstruction iris clipping etc are rendered with the missing scan s indicated in gray in stead of white scan indicator lines Note This rule is valid for MM5 MM6 and MM7 scans Up to 50 of the scans from these patterns can be missing and the algorithm will still render amap All missing scans blank or scans not used will be indicated in gray More scans missing equates to more interpolation in the map values Patient Name MM6 Patient Disease Category Photographer DOB 02 09 1968 Algorithm Version 41 3 2 0 Examine Date 04 09 2007 ID Gender M Primary Physician OD MM6 SSI 47 2 C Display Slicer Show Lines Thick um Yol mm3 221 0 174 Thickness 182 um ParaFovea 308 1 932 5 Hemisphere 0 976 I Hemisphere 304 0 956 Tempo 312 0 490 Superior 0 488 Nasal 303 0 476 Inferior 304 0 477 Perifovea 268 5 677 5 Hemisphere 269 2 850 I Hemisphere 267 2 827 Tempo 261 1 488 Superior 267 1 416 Nasal 261 1 382 Inferior 262 1 391 vol within 0 174 1mm 2 106 3mm
5. RPE or ILM relative to a reference plane The reference plane is the best elliptical fit to the RPE boundary The reference level can be user adjusted using the value field marked Ref above the log scale e The RPE elevation map is a sensitive tool to show choroid based pathology Show Lines Height 21 um 0 00 0 00 mm 5mm x 5mm 200 Pa re I Hemisphere Tempo Perifove u I Hemisphere Ges uperio RIA D N Rmn ino wa wa yy ye Vol within e 0 013 3mm 0 024 5mm O Full Retinal O Inner Retinal O Outer Retinal Diagnosis Show Boundary Curves 6 23 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 5 MM5 Progressive Analysis Presentation The MM5 progressive analysis shows the difference between two MM5 analyses To speed up the comparison results it is better to analyze each individual MM5 scan first before making comparisons Note In all analysis functions the analysis data boundaries maps etc will be stored in a file for future use after first analysis so the result of future analyses comes much more quickly Progressive MM5 SSI 67 8 Average Thickness Chart Thickness Map 5mm x 5mm 750 Be S N T 222 p 219 Ge Difference Map Difference Chart Volume Base Compare Vol Diff Fovea 0 172 0 171 0 001 ParaFovea 1 642 1 647 0 006 5 Hemisphere 0 812 0 316 0 004 I Hemisphere 0 829 0 831 0 002
6. Rev B 07 2007 Analyze Menu 6 2 3 Progressive Asymmetry Comparison If there are eligible scans available in the patient visit history the related progressive and or Asymmetry option will be available as shown in the following graphic Click the button to activate the additional analysis 1 2006 11 07 11 04 34 Click to list scans that may be used in comparison with 2 006 11 07 11 03 29 current scan Le 1 2006 11 07 11 04 15 2 2006 11 07 11 04 54 1 4006 11 07 11 07 36 2 2006 11 07 11 00 31 l 2006 11 07 11 05 47 Patient Visits Patient 13 Ate OD Cross Line Z006 06 01 16 58 11 Progressive 2006 05 29 16 06 50 Asymmetry 2006 06 01 17 04 13 2006 06 01 17 06 51 In the comparison window click 2006 06 01 17 16 29 the first line to exit comparison window 6 18 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 Analyze Result Layout 6 3 1 Line If you used the Averaging option prior to saving the Line or Cross Line scan Both the Average and last single B scan image are saved and available for review in the Analyze view for review Note The HD Line and HD Cross Line do not have the average option Cp Line SST Eh 4 6 Olen Sa Length Click on the Average amp No Average button to select which image will be displayed 250 ym RTVue User Manual Version 2 0 PN 5
7. around the center a Radial Slicer is the same as MM6 4 RNFL 3 45 scan 4 circular scans at 3 45mm diameter from Temple to Superior to Nasal to Inferior back to Temple TSNI 5 3D Raster scan A scans from left to right B Scan from inferior to superior a Slicer is the same using a vertical raster pattern 6 NHMA scan First line from 6 O clock to 12 O clock then rotate the lines clockwise 7 MM7 scan 15 7mm vertical scans and 1 7mm horizontal scan through the midpoint of the vertical scans 9 2 1 Line Objective To acquire a high resolution cross sectional image anywhere in the retina Description Single line 1024 A scan captured 16 times 0 038 seconds ea After Stop Scan The last 16 frames are displayed as thumbnails in the left side bar for review 9 2 2 MM5 Objective To measure the macular retinal thickness map for DME CNV CME Description 5x5 mm square grid centered on fixation The grid spacing is 0 25 mm in the inner 3x3 mm area and 0 5 mm in the outer area PERE EE LI ke WU r u KL EZ ZU ZZ u ZZ ZZ ZU ZU ZU ZU ZU ZU ZU ZU ZZ I ZU ZU ZU ZU ZZ ZZ ZZ ZU ZZ 2 ZZ 2 E Fig 2 Illustration of Macular Grid 5x5 scan pattern 9 3 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Technical Data MM5 Continued Detailed parameter scan length of long horizontal line 5mm Scan length of short horizontal line 3mm Interval of two neighbor long horizontal line 0 5 mm Interval of two n
8. data points averaged to single scan image 2 x 1024 8 scans in each direction are then averaged 1 x 4096 4 scans are captured one is selected for saving 2 x 4096 8192 data points 4x 1024 4 scans are taken and presented Avg is also presented in TSNIT 101x512 51 712 data points RTVue User Manual Version 2 0 Transverse 2 12mm 0 5 mm increment Angle 0 to 180 1 increment Transverse 2 12mm 0 5 mm increment Angle 0 to 180 1 increment Transverse 2 12mm 0 5 mm increment Angle 0 to 180 1 increment Transverse 2 12mm 0 5 mm increment Angle 0 to 180 1 increment Transverse 3 8 mm 0 5 mm increment Angle 0 to 180 1 increment PN 500 42929 Rev B 07 2007 6mm O degree from left to right of the monitor screen 6mm O degree from left to right of the monitor screen 6mm O degree from left to right of the monitor screen 6mm O degree from left to right of the monitor screen 3 45mm diameter From Temple to Superior to Nasal to Inferior TSNI convention 4mm x 4mm 101 frames equally 2 2 seconds spaced B scans to cover a square volume fixation at 20 nasal Radial Slicer 0 34 seconds MM6 Radial 12 radial line scans Slicer through a central 0 27 seconds point 11 horizontal lines with 5mm scan length and 0 5mm interval 6 horizontal lines with
9. name or visit date to view options e Add New Visit automatically create a new visit using the current date for the selected patient which takes the system directly to the Examination screen e Delete Current Visit Deletes the selected visit any visit in the patient visit history e Delete Current Patient Deletes the selected patient a warning message appears first to verify that this is the intended action Warning Deleted Patient cannot be recovered Do ou want to continue Click OK to confirm delete or cancel to withdraw the operation RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Patient Menu 4 5 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 5 Examine Menu 5 1 Acquiring OCT Images The following is a general procedure to acquire OCT images Select an Existing Patient or Create a New Patient Select a visit or create a new visit Click the Examine tab Select desired scan patterns or scan protocol Select the eye s to be scanned Click ADD Double click or highlight the scan name then click on the SCAN button at bottom center this will activate the scanning process Align patient pupil with center of scan and move through pupil Adjust to get best fundus IR image view of fundus from edge to edge there may be dark areas on either side when imaging the optic disc 10 Hold scanner head still and adjust Z motor if necessary a Double clicking in the
10. pattern to show the results in the report window NOTE Depending on the type of scan it will sometimes take 5 to 10 seconds for the to the measurement result to appear the first time the scan data is selected This is due to calculation time After the first time the calculated data is stored and subsequent viewing will open in less time 6 1 3 Diagnosis Field At the bottom of the Report screen is a textbox labeled Diagnosis Any text entered here will be saved automatically when you exit the Analyze menu whether you move to another window or exit the application entirely RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 2 Measurement The measurement tools are accessed by clicking the measurement icon AN 6 2 1 Tools 2 1 Distance tool Measures the distance between two points 2 Area tool Measures the area of a polygonal area 3 Point Line Draws a line between two points 4 Text Annotation Add text to images 5 Grey Color Toggles scan display from gray scale and pseudo color 6 Snapshot Saves the Report Page in jpg format File name has default but is user editable User defined destination 7 Select Click to deselect the tool in use 8 Pan Moves the OCT image around in window Undo Redo Return to previous or prior state before after an action 10 Zoom Zooms in or out of the OCT image No interpolation 11 Zoom to fit Fits all scans in the scan pattern into the windo
11. scanner cables 3 Connect the wires as shown in the picture 4 Replace base cable cover RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Connect cables for scanner Caution Use screw to secure the base cover for safety RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Caution The power cord is the only way to disconnect the scanner from the power source To emergency power off the system unplug the power cord from the wall or from the system immediately 3 2 3 Unlock the RTVue Scanner 1 Use a fingernail or small flat screwdriver and remove the cap on the right side of the joystick 2 Unscrew the lock until the screw lifts up do not try to remove 3 Replace the caps RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 3 2 4 Powering up the system 1 2 3 4 5 3 3 RUS Plug the power cord into the wall to power up the table Turn the main power switch on the table to ON down to power up the scanner monitor and computer Turn on the power button on the monitor Press the computer power button to boot up the system Double click the RTVue icon to start RTVue If no icon is available click the lt Start gt button located on the bottom left of the screen When the menu pops up select Program then click on RTVue to start running the program The main page of the application software will start Test System Controls Unscrew the X Y scanner anchoring
12. 000 A scan per second or 65 times faster than the conventional OCT system Due to the increase in scan rate artifacts in OCT images caused by eye motion are eliminated in most scan designs 3D scans with nearly 52 000 A scans take 2 seconds to acquire Motion artifacts may be present The RTVue system also employs a high bandwidth light source the tissue resolution is about 4 5 micrometer double that of a conventional OCT system With such an improvement in speed and resolution RTVue provides a much more reliable and detailed retinal and nerve head map with metrics in a much shorter period of time 2 1 RTVue System Configuration The RTVue system is shipped in one paletted box which contains the following hardware 1 RTVue Scanner This is the main component of the RTVue system It is used to view and scan the patient s retina collect the OCT signal and send it to the computer for processing It also provides a fixation light target on which the patient can fixate during the scan as well as a position sensor for automatic detection of whether the left or right eye is aligned for scanning Communication between the scanner and computer is achieved via a USB cable connection The RTVue uses a medical grade power supply 2 Computer The computer is used to control the scanner during the patient examination The application software provides data analysis presentation and data storage and archiving A relational databas
13. 000 42929 Rev B 07 2007 Analyze Menu 6 3 2 Cross Scan ep Cross Line SSI 62 5 8 00mm Scan Length 250 um Show vertical and horizontal of the scan images and the fundus image 6 20 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 3 3D Macula Presentation OS 3D Macular SSI 49 3 4 00 x 4 00 Scan Size mm eal sumlum fe o Sr SUM PR ad ege ae AE AE e Blue line C scan position can be tilted by adjusting left side of slider e Red line Position of vertical B scan e Green line Position of horizontal B Scan e 3D quadrant show 3D perspective view e C Scan quadrant show the SLO C scan or Sum of C scan e Brown line Right click to show the draw disc option e Sum um You can determine the depth of the scan Sum presentation microns in the C Scan window Check or uncheck Sum box to change the presentation e Clicking anywhere in the SLO image in the upper left will automatically section the 3D presentation and B Scan slice to the corresponding cross section 6 21 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 4 MM5 Analysis Presentation OD MM5 SSI 52 0 S IR Color Map Diameters Fovea 1 00 mm Parafovea 3 00 mm Perifovea i Show Lines Section Vol mm3 Fovea 0 260 Height 301 um ParaFovea 1 557 0 00 0 00 mm S Hemisphere 0 764 I Hemisphere 0 792 Tempo 0 420 Superior 0 364 Nasal 0
14. 12 1 RTVue User Manual PN 500 24034 Rev B 11 2006 Lee Th Safety notes 1 Safety notes General This is instrument has been developed and tested in accordance with Optovue safety standards as well as national and international regulatory guidelines to ensure a high degree of instrument safety Please observe all safety notes and information in this manual and on the device labels This device does not produce any waste that needs disposal Product contains no material which has a chemical hazard concern Proper instrument use 1 Always enter patient information first 2 Clean patient contact surface forehead and chin rest according to the cleaning method in this manual 3 Instantly turn off the power switch of the instrument and disconnect the power cable if uncertain problems arise 4 Clean ocular lens frequently to ensure good image quality 5 Adjust power table height properly to ensure patient comfort during the examination D Align the patient s head and eye position to the canthus indicator mark on the chin and forehead rest assembly 7 Dim the room lights to allow natural dilation of the patients pupil and to provide a comfortable visualization of the fixation target without glare Intended Use The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina retinal nerve fiber layer and optic disc as an aid in the diagnosis and management of retinal d
15. 2 0 Clinical Advanced Eye Color Dark Eye O Light Eye Illumination 150 0 lt gt 1023 O Gray Scale Color Scale Auto ZMotor 7290 345 lt gt 1345 Focus 0 25 15 lt gt 10D P Motor 0 0 gt 100 Vitreoretinal Fixation Control Chorioretinal 00800 H 5 9 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu Default ROl Anchor region for averaging delp Y A as Se REN KA te en EH an SEET Result of averaging 5 10 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 5 11 Set Image control default The Scan Parameter Setting menu can be found by clicking the OCT Image menu scan Parameter Setting Dark Eye Light Eye Illumination Illumination 240 video Brightness 110 video Brightness 190 video Contrast 126 video Contrast 140 OCT Image O Gray Scale Color Scale Image Quality Signal Strength Index NOTE Setting for Image Quality Signal Strength Index should not be changed by other than Research site users with prior approval from Optovue personnel RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 5 12 Reviewing Scan Images After stopping the scan the window will automatically bring up a list of thumbnail images Click on any thumbnail image to display that scan in the working window The window can be closed with the MSWindows Close X box
16. 379 Inferior 0 393 Perifovea 2 072 5 Hemisphere 1 003 I Hemisphere 1 068 Tempo 0 502 Superior 0 487 Nasal 0 522 Inferior 0 561 Vol within 0 260 1mm 1 817 3mm 3 888 5mm N LD o 8 o pa un o Thickness Elevation O Full Retinal 50 O ILM O Inner Retinal Diagnosis Show Boundary Curves 0 um Macular thickness values and retinal cross sectional images can be seen by moving the mouse cursor around the macular color coded map The grid shows the MM5 scan pattern scans indicated in white The horizontal and vertical cross section image will be displayed corresponding to the red color highlighted scan lines The thickness will also be displayed e Full Retinal Thickness measured from VRI to IS OS layer e Outer Retinal Thickness measured from the IS OS layer to the IPL e Inner Retinal Thickness measured from VRI to IPL e The tracing lines boundary curves are viewed or hidden by deselecting the Show Boundary Curves check box The thickness map is further organized and presented at the top right in four macular regions Stereoscopic Altas of Macular Diseases diagnosis and treatment J Donald M Gass Mosby 3 a edition volume 1 P3 The Perifovea region is split further into inner and outer regions Each annual ring region is further split into 12 sections 6 22 RTVue User Manual Version 2 0 PN 5000 42929 Rev B 07 2007 Analyze Menu Using the RPE or ILM elevation maps show the height of the
17. 3mm scan length and 0 5mm interval 11 vertical lines with 5mm scan length and 0 5mm interval 6 vertical lines with 3mm scan length and 0 5mm interval all centered at fovea MM5 0 78 seconds Retina MM7 0 58 seconds Glaucoma 1 horizontal line with 7mm scan length followed by 15 vertical lines with 7mm scan length and 0 5mm interval centered 1mm temporal to fovea NHM4 0 39 seconds 12 radial line scans 3 4mm length amp 6 concentric rings 2 5 4 0mm diameter All centered on disc Glaucoma RTVue User Manual Version 2 0 17 parallel line scans Technical Data 101x512 Transverse 3 8 4mm x 4mm mm 0 5 mm increment Angle 0 to 180 1 increment 51 712 data points 17 x 512 C 10 mm in en L 6mm 8704 data 1 6 mm in width W 4mm points 12 x 1024 6mm scans at Zen diameter circular Zen 22x 668 12x400 19 496 data points Fixed 5 x 5mm outer region 3 x 3 mm inner region E 1x467 Horizontal line 15 x 400 Vertical line 12x 452 line 3x587 ring 2 5 2 8 3 1mm 3x 775 ring 3 4 3 7 4 0mm PN 500 42929 Rev B 07 2007 Technical Data 9 2 Scan Orientation Convention 1 Line scan Zero degree line scan from 9 o clock to 3 o clock Plus angle rotates line clockwise Minus angle rotates line counter clockwise 2 MM5 scan 17 5mm horizontal then 17 5mm vertical line scans 3 MM6 scan 12 radial line scans 6mm pivoting
18. Chorioretinal Ooe co 5 8 Clinical Tab Controls 1 Eye Color Select dark or light according to patient iris color to optimize the illumination brightness and contrast settings for IR image The individual Brightness and Contract adjustment are in the Advanced Tab a If neither eye color is selected then the default settings are the average of the respective values of illumination brightness and contrast for the dark and light eye Illumination Adjusts the IR illumination for the IR video image Level is set by selecting Eye Color but may be adjusted separately to attain best image Grey Scale Color Scale Toggles live OCT image in gray scale or color Z Motor Auto position adjustment Click on the OCT image window then use thumb wheel on the mouse to adjust Z position Double clicking on the OCT image window will auto search Z position This is the same as clicking on the Auto button next to the Z Motor Focus adjustment Use to focus OCT and video image resulting in a sharper image P Motor Polarization adjustment to optimize the OCT image signal strength resulting in a clearer image Vitreoretinal Chorioretinal Setting are programmed based on scan design to enhance either the information above the RPE Vitreoretinal or the choroid and overall information choroiretinal Fixation Control Use to turn on preferred fixation light location for patient to focus on There are five fixation blue lights Proc
19. L thickness profile in the NHM4 is the thickness of RNFL at a calculated 3 45mm diameter around the center ofthe disc NOT THE CENTER OF THE SCAN The thickness measurement is re sampled relative to the disc center not scan beam center so the de centering of the disc relative to the scan beam will not affect the measurement NOTE This is the weak point of the conventional Time domain 3 45mm RNFL circular scan The RNFL thickness measurement is sensitive to disc and scan centering alignment ST Ts NS SH IH NI TI z00 100 6 3 11 2 Stereometric analysis results are listed in the spread sheet as follows Section Thickness um Disk Area 2 0 mm Cup rea 0 52mm Rim Area 1 54mm Rim Volume 0 232mm Nerve Head Volume 0 364mm1 Cup Volume 0 141mm Cup Disk Area Ratio 0 25 Cup Disk Horizontal Ratio 0 51 Cup Disk Vertical Ratio 0 47 RNFL Average Thickness on Diameter 3 45mm 100 9um to expand Superior Hemisphere 104 06 TEMPO 140 65 SUPERIOR 67 4 Inferior Hemisphere 97 52 6 32 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu Definitions Rim Volume cross sectional Cup Line 150um above view Area above cup line disk line Nerve head volume cross sectional view White line shade area above disk line TS Ts ust NS Cup area enclosed by green line Average sectional RNEL thickness at 3 45mm diameter
20. LAYOUT ae Rn 6 19 A EE 6 19 09 2 AA O O ete coerce 6 20 Dao EN EE 6 21 0294 MMSAnalys s Presentan dci 6 22 6 3 5 MMS Progressive Analysis Dresenioation 6 24 0 2 0 SMMOANGIVSIS Presenation nen ain ans iensleitnsste 6 25 SE e EE 6 26 6 3 8 MM6 Progressive Analysis Dresenioation 6 28 6 3 9 RNFL3 45 Analysis E 6 29 6 3 10 RNFL 3 45 Progressive Analysis Dresentoaiton 6 30 6 3 11 NHM4 Analysis Presentalion au susanne 6 31 6 3 12 SD Opie Dise Presentation ansehen 6 40 6 3 13 COMPASS AAA AAA an 6 41 6 3 14 MM Analysis PLES ETA TON AA AA aa 6 43 7 FILE MANAGEMENT MENU 2 2 ee 7 1 7 1 ARCHIVE DATA ee needs ai 7 1 1 2 AN EE 7 2 1 3 BACK O ee ee ee ee 7 3 7 4 RESTORE atar ao 1 3 7 5 IMPORT IMAGES ne A een ee 7 4 1 6 BATCH PROCESS oerrinne 7 5 7 1 CLEAN DIAGNOSIS DATA oc id ias 7 5 7 8 DATABASE MANAGEMENT MENU aran 7 6 8 MAINTENANCE amp TROUBLESHOOTING 00000000000000000000000000ssssssssessnunnsnnee 8 1 8 1 ROUTINE C AR EE 8 1 8 2 DATABASE MAINTENANCE nee ehe 8 2 9 SCAN PATTERN SPECIEICA TIONS d sea OnT Roosi E nae 9 1 9 1 SCAN PATTERN Sicilia ETA 9 1 9 2 SCAN ORIENTATION CONVENTION used a ge eedgueg e 9 3 O2 E 9 3 922 EE 9 3 NS A A A 9 4 924 sP Macular D pperuabavng A AEC nadie eee nea OO 9 4 22 NI nennen 9 5 0 230 EE 9 6 10 TUSER PREFERENCE eessen 10 7 11 TECHNICAL DATA EE 11 9 11 1 SYSTEM SPECIFICATION gan sense eher 11 9 12 APRENDE oscila id 12 1 12 1 PRINTER INSTATLATION oc
21. RTVue Model RT100 User s Manual Version 2 0 AO optevue Publishing details RTVue Version 2 0 Optovue Inc Fremont CA 94538 Phone 510 623 8868 Fax 510 623 8668 www optovue com e mail info optovue com For Customer Service or Technical Support 510 623 8868 Revision Control Part Number Rev Software ver Description 900 42929 B v 2 0 3 2 Release Date 7 24 2007 License and use of the RTVue 100 systems is intended only for trained medical personnel in accordance with the license agreement all other usage is prohibited warranty restrictions and possible claim limitations apply 1 2 Contents SAFETY NOTES ee 1 1 INSTRUMENT DESCRIPTION 00000000000000000000000000000000000 0000000000000 00 0 RR 0000000000 2 1 2 1 REVUES YSTENCEC OTT E AR E 2 1 GETTING STARTED cias 3 3 3 1 UNPACKING THE RTVUE SYSTEM ocnocnnccnocnnccnnccnaconoconccnaronoconccnaronoconocnaronoconocnaronoss 3 3 Seht SED LS TAS PECES UPME LANA A AA AA 3 3 3 1 2 Step2 Remove the cover and enclosure ooooooonnnccnnnnnnnnnonocnnnnnnnonannnnnnnnnnnnnnnnos 3 3 3 1 3 Step3 Remove Scanner Computer and Monitor 3 4 3 14 Step 4 Unpack Scanner Computer and Monitor 3 4 3 2 SETTING UP THE SYSTEM tala cia 3 5 3 2 1 Setting up the LCD monitor Arm and PC 3 5 3 2 2 Setting up the OCT SCAN A A ER 3 6 32 3 Unlock the RIVne Scanner een 3 8 3 2 4 Powering up the system ooooonnncnnnnnnnnnnnn
22. Tempo 0 397 0 397 0 000 Superior 0 406 0 405 0 003 Nasal 0 424 0 428 0 004 Inferior 0 415 0 415 0 001 Perifovea 2 982 2 951 0 031 5 Hemisphere 1 463 1 452 0 011 I Hemisphere 1 519 1 500 0 020 Tempo 0 698 0 684 0 014 Superior 0 733 0 734 0 001 Thickness Elevation Nasal 0 794 0 780 0 014 Full Retinal Om Inferior 0 757 0 752 0 005 Inner Retinal O RPE Vol Diff 0 001 1mm 0 005 3mm 0 026 Smm 6 24 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 6 MM6 Analysis Presentation The MM6 12 Radial scans accomplishes the same function as the MM5 34 grid scans however with fewer data points 12 000 VS 19 500 A scans The MM5 Grid pattern is more accurate with tie points and less interpolation that the radial pattern Note Only the MM5 is included in the Normative Database collection that is in process Display Slicer option Toggles the display of the MM6 between the standard presentation and as Radial Slicer presentation including all 12 scans Disease Category Photographer Algorithm Version A1 3 3 0 Examine Date 05 04 2007 Gender F Primary Physician Fovea 77 ParaFovea 114 0 719 ES Hemisphere 117 0 369 30 a Hemisphere 112 0 350 Tempo 113 0 178 H Superior 118 0 185 H Nasal 115 0 181 Inferior 112 0 176 Perfovea 96 2 043 Thickness Elevation O Full Retinal ILM Inner Retinal pl O Outer Retinal PE
23. Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 Analyze Menu 6 1 Analyze Layout E Diabetic Maculopathy DOB SIS Print E Aug 21 2006 03 19 PM RTVue File Tools OCTImage Database Management Home Help _ Patient i Analyze Patient Name Maculopathy Diabetic DOB 04 26 1941 j ID 08883823 shown on Report Report Form Remove from Report Ana Tora Measuring Tools yaueas Measurement tools and image enhancement tool Editing Tools Image viewing tool Analyze list Patient Visits Diabetic Maculopathy y El Aug 21 2006 03 19 PM ES OD Cross Line 08 21 2006 15 20 36 l Report form window OS Cross Line 08 21 2006 15 23 09 E OD 3D Macular 08 21 2006 15 21 21 analyze report 3 os 3D macular 08 21 2006 15 23 52 tat ON MMS 12421 anna IE IR 1 Report Form The window shows the analyze result Measurement Activates the tools for manual measurement on the OCT images 3 Print Prints the current report form window RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 1 1 OCT Image Selection Above the Measuring Tools there is a drop down menu labeled Scans If the scan pattern performed had more than one image the different scan images are available for viewing by selecting from the drop down menu 6 1 2 Analyze List After selecting the patient a list of scan records will appear under the tool window Click a particular scan
24. appropriate box To begin the backup process click the Backup button near the bottom of the window NOTE If your database is of a substantial size it may take up to a few hours to complete You might consider letting the backup sequence run overnight as it is completely safe to leave the computer system on overnight RESTORE Under the File menu heading select Restore to bring up a window asking for the destination drive to which the database will be restored By default the destination drive is D but a different destination can be specified by typing in the appropriate box When you are ready to begin database restoration click the Restore button near the bottom of the window RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Technical Data 9 Scan Pattern Specifications 9 1 Scan Patterns Summary Adjustability Default Scan Pattern Line 0 039 seconds Cross Scan 0 078 seconds HD Line 0 156 seconds HD Cross Scan 0 312 seconds RNFL3 45 0 15 seconds Glaucoma 3D Macular 2 2 seconds Single line scan with speckle elimination process option Cross line scan with speckle elimination process option High definition single line scan High definition cross line scan Four 3 45mm diameter circular scans center on disc 101 frames equally spaced B scans to cover a square volume fixation at center 1x 1024 16 scans for 16 384 total
25. are indicated by horizontal and vertical highlight lines on the SLO image The C scan image plane is indicated by the horizontal line tilt adjustable on the horizontal image The images to be displayed are independently adjustable for each visit If the images from each visit are registered on the SLO image and the horizontal B scan image the adjustment bar will lock both visit images together and allow side by side comparison A similar image comparison layout is available for all other scans except for RNFL3 45 and NHM4 scans Lines to register c scan plane bh 2006 08 17 11 35 40 Lines to register the horizontal and vertical image frames Image fly through bars 6 42 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 14 MM7 Analysis Presentation Thickness 53 um Difference S 1 0 jm 7mmx3mm Show Lines 50L 7mm x 7mm 250 Map Output O Full Retinal Inner Retinal O Outer Retinal Show Boundary Curves The thickness map shows the Inner Retinal thickness by default Display may be changed based on user selection in the Map Output The vertical cross sectional scan is displayed on the left side when moving the cursor in the thickness map Above the thickness map there is a thickness difference map between superior and inferior retina defined by the red horizontal line A target cursor in the difference map is synchronized with the cursor position in t
26. c Drive gt 300GB minimum or higher Back up Hard Disc Drive gt 300GB minimum or higher Archive DVD RW and Removable HD Disk RAM 2 GB DAQ Camera link frame grabber E Display Unit 17 Flat Panel LCD Monitor F Power Table Power Input 110V a c RTVue RT100 1 230V a c RTVue RT 100 2 Current 1 8AMPS Frequency 50 60 Hz Power Rating 160W Maximum Force 2500N Motorized adjustment range 200 mm RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Technical Data G Circuit Breaker and Fuse Thermal circuit breaker main power entry Rating GAMPs 125 250VAC Dielectric Strength 2500 VAC 1 minutes Operating Temp 10 C to 60 C Fuse Power supply in Scanner Rating 4AMPs 250V Package 5mm x20mm Type Fast Acting Short Time Lag H Compliance General Medical EN60601 1 Medical System EN60601 1 1 EMC of Medical System EN60601 1 2 ITE Computer EN60950 I Environment Operating Condition no condensation Ambient Temperature 10 to 40 C Relative humidity 30 to 75 Atmospheric pressure 700 to 1060 mbar Storage and Transport Condition Ambient Temperature 40 to 70 C Relative humidity 10 to 100 include condensation Atmospheric pressure 500 to 1060 mbar 11 10 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Appendix 12 Appendix 12 1 Printer Installation WARNING When powering a USB interfaced printer to the RTVue system it is recommended to connect th
27. center around the disk T N IT NA Rim area enclosed between red and green line NI Disk area enclosed by red line 6 33 RTVue User Manual Version 2 0 PN 5000 42929 Rev B 07 2007 Analyze Menu 6 3 11 3 Optic Nerve Head Morphology The ONH analysis can be performed with either one of four disc border baseline modes 3D Baseline Disc drawing from 3D Optic Disc scan Default Video Baseline Disc drawing from IR image NHM4 OCT Baseline No Baseline No disc drawing or RPE tip setting is required a ade Ee The No Baseline option removes any serial registration capability and therefore removes the possibility of progression analysis 6 3 11 3 1 The default setting for which baseline guides the analysis is set in Tool Bar Glaucoma Suspect DOB 03 02 1972 May 04 2007 12 39 Tools File OCT Image Database Management Home Help Patient Nai DOB 03 0 ID Average Property v 30 Baseline Video Baseline NHM4 Mode can Parameter Setting OCT Baseline No Baseline 6 34 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 11 3 2 3D Baseline is the disc boundary that is drawn using the SLO image in the 3D Disc scan presentation Right click the mouse cursor on the SLO image and selecting Draw Disc Then position the cursor and click the left mouse button on points coinciding with the disc bounda
28. coma Standard OD Follow Up Glaucoma Standard OD Retina Standard 05 Baseline Glaucoma Standard OS Follow Up Glaucoma Standard 05 Retina Test Test traing TestiF TestB RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 File Management Menu The Scan Pattern Management Screen allows the user to show or hide any of the scan patterns in the exam list This allows the user to reduce the number of scan designs visible to only those that are used in the clinical site Scan Pattern Management v 3D Disk 200x200 v 3D Disk 4x4 3D Macular 4x4 Cornea v Cross Line JHD Cross Line HD Line Line MBAS MIME MM e NHK44 Radial Slicer ANFL3 45 Slicer Cancel Done RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Maintenance amp Troubleshooting 8 Maintenance amp Troubleshooting 81 Routine Care 1 Dust Prevention When not using the RTVue make sure the cloth dust cover is placed over the unit You can Shut down the PC at the end of each day However it is recommended that you leave the main power switch in the ON position This helps keep the system at or near optimum operating temperature 2 Ocular Front Objective Lens Cleaning We recommended that the ocular front objective lens of the RTVue be cleaned daily A weak OCT image or blurry video fundus image may be caused by an unclean front lens eyelash finger or nose prints or exce
29. d patient visit will be indicated by the letter a appearing next to the scan information El Patient No 1 Hy Apr 07 006 01 30 PM 11 Scans E Dec 22 005 11 00 AM 16 Scans Mow 29 2005 12 00 AM 9 Scans Noy 25 2005 12 00 AM a Scans Noy 26 2005 04 00 PM 3 Scans a Noy 26 005 01 00 PM 13 Scans a Noy 26 005 01 00 PM 1 Scans a Patient No 2 Patient ODBC date test El Patient CU Oct 19 006 12 45 PM 9 Scans Jul 16 2006 10 57 AM 15 Scans Patient Susan Patient Susan To retrieve a patient visit select Retrieve from file menu The retrieve data window will list all archived patients and the media label in which the data is stored Follow the software prompts to retrieve the desired patient visit data test 10 7 Oct 13 2006 11 56 AM 7 Oct 13 2006 11 15 AM O Oct 11 2006 12 01 PM Patient No 1 7 Apr 07 2006 01 30 PM 7 Dec 22 2005 11 00 AM C Nov 29 2005 12 00 AM Nov 26 2005 12 00 AM Nov 26 2005 04 00 PM Nov 26 2005 01 00 PM 17 Nov 26 2005 01 00 PM 9 Scans 5 Scans 12 Scans 11 Scans 16 Scans 9 Scans 5 Scans 3 Scans 13 Scans 1 Scans RTVue User Manual Version 2 0 Media label Search Ar2 Sort By E Arz Arz Time Criteria A to Ar2 Arz Ar2 SelectAll Patient Collapse Expand Arz Arz Arz 7 2 PN 500 42929 Rev B 07 2007 File Management Menu 7 3 Backup The RTVue software performs backup automatically but this process can also b
30. e disc The thickness measurement is re sampled relative to the disc center not scan beam center so the decentering of the disc relative to the scan beam will not affect the measurement OCT Image Database Management Home Help Average Property Patient Mare COB 06 01 f1 ID Reload Baseline Nd Mode Scan Parameter Setting 3D Baseline Video Baseline OCT Baseline No Baseline You can change the NHM4 mode according to your preference of where you want to draw the disc shape baseline The No Baseline selection does not require the user to set RPE endpoints or draw the disc shape NOTE This selection does not allow serial registration of data for progression analysis IR Color OD Cup Depth 150 um NHM4 SSI 58 4 RNFL On Diameter 3 40mm 250 Radial Line Diameter 3 40mm NO Guide 200 150 100 50 Show Boundary Curves Save As OCT Baseline Show Lines Thickness um D um Cup Area 0 00mm Rim Area 0 00mm Rim Volume 0 000mm en ES ue Si IN NI i Yi Ir Nerve Head Yolume 0 000mm Cup Yolume 0 000mm Cup Disc Area Ratio 0 00 Cup Disc Horizontal Ratio 0 00 Cup Disc Vertical Ratio 0 00 RNFL Average Thickness on Diameter 3 45mm 133 99um e o Diagnosis Superior Hemisphere 149 04 Inferior Hemisphere 118 94 The No Baseline selection will provide no information on the Disc and Cup It will only have RNFL information
31. e done manually The system automatically writes data into both the C and D drives when the data is saved in the system The patient information database is automatically saved when the RTVue application software is closed Manual backup and restore can be performed by clicking the BackupRestore exe program on the desktop 7 4 Restore Restoring data is usually only required if the data in the C drive has been corrupted or accidentally deleted The Restore function is used to copy the backup data from the D drive to the C drive The Restore function can be initiated by clicking BackupRestore exe on the desktop RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 File Management Menu 7 5 Import Images The Import Image function allows the importing transfer of fundus images from any location or device into the patient visit scan file First select patient visit then click on File gt Import gt Import Image Select image in the network or from removable media file types compatible are listed and click Open Tools OCT Image Database Management Home Print Ctrl P Print Setup Print Header Info Data Transfer Export k Import Image Archiwe Retriewe k Im Report Analysis Batch Process b Clean Diagnosis Data Exit Dialog Eye Select Oop os Image Type Color Image Red free Image FA Image IA Image Patient Name Patient Normal Visit Date Mo
32. e is included to organize all patient information and data as well as to allow for search capability 3 System Table The system table provides power to the RTVue scanner computer and computer display through a medical grade isolation transformer to prevent 2 1 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Instrument Description leakage current from main AC power The table elevation can be adjusted to fit patient height The telescopic lift that supplies the power of the RTVue system is medical grade 4 Monitor Computer Display A 17 LCD flat panel display for graphic user interface and data presentation 5 Keyboard and Mouse System Configuration Model RT100 1 110V AC Model RT100 2 230V AC Monitor Power switch RTVue Scanner Pri 8 Label rinter optional Up Down Keyboard amp Mouse switch Computer RTVue Label amp serial number Power reset button A C Power Plu System Table 2 2 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 2 2 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 2 3 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 3 Getting Started 3 1 Unpacking the RTVue System Crate contains the following items RTVue Scanner Power Table Computer monitor Computer system Monitor Holder Keyboard Mouse Accessory Box TI NT 3 4 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 3 1 1 Step1 I
33. e power through the designated power supply outlet in the PC compartment This outlet is isolated from the wall plug building power through RTVue s isolation transformer If the printer is powered from somewhere other than the designated power outlet the printer should be placed at least 1 5 meters away from the patient to avoid electric shock 12 1 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007
34. ee that all required fields are filled RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Patient Menu 4 4 New Visit To create a new visit click the New Visit button fill out the information fields and click the save button If you would like to cancel this operation then simply click the cancel button to exit the New Visit screen 4 5 Change Date of Birth Format The preferred format of date of birth can be selected in the user preference Tools atabase Management Copy Examine List Paste Examine List Sync Calibration Scan Pattern Management Protocol Management Clear Log File Change Password Reset System ser Preference Date Format gill Middies MOO www MM dd yyyy dd sheet fy dd 4 6 Editing Patient or Visit Information To edit a patient s information select the patient name and click the Edit button To edit a patient s visit information select a visit time and click the Edit button Visit Infomation Physiciary Operator Comments 4 3 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Patient Menu 4 7 Patient List Short cuts E Patient Normal Apr 23 2007 11 42 AM Add New visit Apr 20 2007 10 15 AM ae Delete Current Visit Dec 10 2006 11 39 AM 17 Delete Current Patient Dec 09 006 11 55 AM amp Scans Moy 06 2006 06 21 PM a Scans Click on the patient s name to view patient visits Right click on the patient
35. eighbor short horizontal line 0 5 mm Interval of short to long horizontal line 0 25 mm Number of a scans in long horizontal line 668 Number of a scans in short horizontal line 400 scan length of long vertical line 5mm Scan length of short vertical line 3mm Interval of two neighbor long vertical line 0 5 mm Interval of two neighbor short vertical line 0 5 mm Interval of short to long vertical line 0 25 mm Number of a scans in long vertical line 668 Number of a scans in short vertical line 400 Total a scans 19 496 Total scan time 19 496 26000 0 75 seconds Total overhead 0 03 seconds Pilot display central cross hairs and the top and bottom horizontal lines 9 2 3 RNFL3 45 Objective To obtain a RNFL thickness measurement with a conventional 3 45mm diameter circular scan around the disc Description Four circular scans with a 3 45mm diameter centered on the disc The RNFL thickness of each circular scan is measured and displayed Each circular scan contains 1024 A scans Average RNFL thickness of user selected circular scans will also be calculated and displayed in the circular and linear chart 9 2 4 3D Macular Disc Objective To image 3D retinal structures at macular region disc region with 101 equally spaced high resolution 512A scans line lines scans Description The rectangular boundary defines the out area the 101 equally spaced line scan will cover Scan Control The size and location of the scan area can be adju
36. ess Average For the Line scan and Cross Line scan only you have the option of averaging the multiple scans to achieve and final averaged image This process is used to reduce the noise of the OCT image and provide a smoother result Eye or operator motion may limit the number of frames that can be used in this process Quick eye motion may also smear the OCT image and reduce the resolution 5 7 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu Clinical Advanced OCT Image Noise 1 1 20 3 gt a0 Lenath RB 2g gt 12mm Diameter T FE Scan width 0 p gt Onn Angle 0 90 0 Wideo Brightness 105 log gt 255 Contrast 1134 OR 255 Tr Offset 0 0 0 0 set Frame Display pe A Current Frame No 1 i KR L Current Group A Ye 5 9 Advanced Tab Controls 1 OCT Image Noise Adjusts the noise level of OCT for best visualization of retina tissue 2 Scan Length To adjust the scan length with the center of scan fixed Scan Width To adjust the width of a raster scan The number of raster scan lines will be equally spaced in the width of scan pattern selected 4 Scan Angle To rotate the scan around the center of the scan Use slider to rotate the scan or click on the scan graphic in the IR window and use the mouse wheel to rotate the scan direction 5 Video Brightness Controls the brightness of the Video image only not the OCT scan 6 Video Con
37. he lower thickness map Both thickness value and thickness difference superior thickness minus inferior thickness appear on top of the difference map Note Data in the white area is not used for any calculation 6 43 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 File Management Menu 7 File Management Menu 7 1 Archive Data To archive patient data into IOMEGA removable hard disk first insert a HD disk and select the archive in the file menu Archived patients will still appear on the patient list however to analyze the patient s data the same HD disk must be inserted to retrieve the patient s data EJ Glaucoma Suspect DOB 03 02 1972 May 04 Tools Print OCT Image Database Management Home Print Setup Print Header Info Data Transfer b Import Batch Process H Retieve Clean Diagnosis Data The basic archive unit is the visit Check the visit date on the patient to be archived Use the sorting functions to help organize the patient list After selecting the visits follow the software instructions to archive the data The disk should be labeled exactly the same as the label name entered in the software Itis advisable to make an extra copy of the archived disk in the event that the original disk is accidentally damaged or lost RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 File Management Menu 7 2 Retrieve Data The archive
38. head screws Table up and down control Chin rest up and down control Chin rest up and down limit indicators yellow light on 3 19 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 5 Stop scan button on top of the joystick 3 20 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Patient Menu 4 Patient Menu The patient menu contains three components 1 Patient List 2 Patient Information 3 Visit Information In the patient menu the user can search add and edit patient information It is designed to help you schedule a patient s visit in advance preview today s or this week s scheduled patients and search for a patient s history 4 1 Patient List The patient list displays the results of the user defined search criteria Choroidal Neovascularization E All Patients Current Patient This week Today UNA The patient list display can be filtered by following criteria 1 Physicians name 2 Disease 3 Scan protocol You may sort the results by 1 Patient Name 2 Last Visit Time You may search for a specific text string EMR ID Name first or last Last Name only First Name only u 1 Type the patient s EMR ID Name or Last First Name in the Search By space and click on the designated button this will move the searched patient to the top of the list 2 Clicking on the patient s name will list all the patient s visits and will open the patient s informa
39. icon on the upper right hand corner Eve blinked Please try again MI 5 13 Saving Scan Images After reviewing the image pressing the Save disc icon button m will save the images Pressing the scan button again without saving will discard the current scan images and will restart the same scan RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 5 14 Correct Alignment of live OCT image In all scan patterns you will see one or more pairs of parallel red dashed lines Some scans may have as many as four live scan windows with the target zone parallel lines In any scan the optimum placement of the live scan is between the red dashed lines If the lines are horizontal the scan should be in the upper part of the target area 3D disc scan will have some of the scan image fall below the lower line this is OK In the case of vertical red dashed lines such as in the NHM4 the physiology targeted should be between the two parallel lines see below If you select a different scan mode Vitreoretinal or Chorioretinal than the default setting the location of the red dashed lines will shift to the top or the bottom of the screen depending on where the default position is Example of NHM4 scan images location 1 Place RPE tips between two vertical guide lines 2 Place circular scan between two horizontal guide lines Note This guidance applies to all scan patterns RTVue User Manual
40. iseases Note The RTVue OCT is not intended to be used as the sole diagnostic aid in disease identification of classification Warning User Changes to Software or Hardware The RTVue is a medical device The software and hardware has been designed in accordance with U S European and other international medical device design and manufacturing standards Unauthorized modification of the RTVue software or hardware or any addition or deletion of any application in any way can jeopardize the safety of operators and patients the performance of the instrument and the integrity of patient data ANY CHANGES ADDITIONS OR DELETIONS TO APPLICATIONS OPERATING SYSTEM OR MODIFICATION TO HARDWARE IN ANY MANNER OR FORM VOIDS THE WARRANTY COMPLETELY 1 1 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 A A CE A Safety notes Warning Phototoxicity Because prolonged intense light exposure can damage the retina the use of the device for ocular examination should not be unnecessarily prolonged and the brightness setting should not exceed what is needed to provide clear visualization of the target structures The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time If the value of radiance were reduced in half twice the time would be needed to reach the maximum exposure limit While no acute optical radiation hazards have been identified for direct or indirect ophthalmosco
41. mage Patient Name DOB 03 02 12 ID Print Setup Print Header Info Data Transfer Import Archive Retrieve Batch Process Clean Diagnosis Data Current Visit Current Patient NHM 4 MMS MMS MM Fditina Tonle RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 File Management Menu 7 8 Database Management Menu File Tools OCT Image Database Management Home Help Patient gt Analyze Patientlist All Patients Filter By Physician Disease Protocol Physician Pahent r Operator Disease SI Last N Protocol r Sort By Fagl H PATIENT NAME M search By Middle In the Database Management drop down menu you may edit and determine the various fields and scans that are displayed in each category e Protocol These can be created or modified per user preferences e Physician Add a new physician edit the name or other information of a current physician or delete a physician if not used by users e Operator Add a new operator edit the name or other information of a current operator or delete an operator if no longer exists e Disease Add delete or edit disease category RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 File Management Menu Protocol editor enables the user to modify the set protocols Protocol Editor Mame Ad AIGS PGIGSPPG Cle PatientT Standard OD Baseline Glau
42. mm 400 Volume Base Compare Yol Diff Fovea 0 174 0 175 0 001 l ParaFovea 1 932 1 912 0 021 5 Hemisphere 0 976 0 960 0 017 I Hemisphere 0 956 0 952 0 004 Tempo 0 490 0 456 0 004 Superior 0 488 0 480 0 008 Nasal 0 476 0 467 0 010 Inferior 0 477 0 478 0 001 Perifovea 5 677 5 606 0 072 5 Hemisphere 2 850 2 760 0 091 I Hemisphere 2 827 2 846 0 019 Thickness Elevation Tempo 1 488 1 432 0 056 Full Retinal Om Superior 1 416 1 354 0 062 O Inner Retinal Nasal 1 382 1 395 0 016 O Outer Retinal Inferior 1 391 1 421 0 031 Diagnosis O RPE Vol Diff 0 001 1mm 0 020 3mm 0 091 S5mm Report Date Wednesday April 18 15 37 03 2007 Note The MM5 MM6 and MM7 all have a new layer presentation for the Outer Retinal This selection will show the IPL to IS OS layer of the map 6 28 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 9 RNFL3 45 Analysis Presentation RNFL3 45 SSI 56 3 3 45mm Scan Diameter 250 um Section 1 Std Dev Of RNFL 2 73 Overall RNFL 73 ee 5 Hemisphere 71 3 I Hemisphere 75 TEMPO VE Avg i ST ST SUPERIOR i TS NS NASAL i SEI IN INFERIOR i NI Eh Diagnosis 6 29 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 10 RNFL 3 45 Progressive Analysis Presentation Progressive RNFL3 45 SSI 62 2 2006 02 23 15 43 38 3 45mm Scan Diameter Section 2006 02 2006 02
43. n has not been completed A solid green circle indicates that the scan has been completed Examine To Do List Test Patient 5 Scan Type Repeat Lo Line RNFL3 45 Slicer MHM14 MPS MMT Line RAFLS 45 Slicer MHI 4 MMS MMT MHMA4 3 3 H 3 H A 3 H 3 3 A 3 H RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 5 5 Scan Protocol A scan Protocol is a pre defined group of scan patterns that can be linked under a defined protocol name i e Glaucoma Protocol or Retina Protocol under the lt Exam Protocol gt tab You can create a scan protocol which will be added to the scan protocol list The specific scan list will be saved as a scan protocol with the name you have chosen for later use Save the list as a protocol by clicking the Save List as Protocol button and entering a name The scan protocols can be found by clicking the Exam Protocol button and can be selected for use by clicking on the desired protocol in the list All scans contained in the protocol will be displayed in the scan list along with any other scan choices before performing the scans The Protocol Management menu allows the user to control the protocols visible in the lt Exam Protocol gt tab Protocol Management Screen Protocol Management Y AIG Normal AIGS NORMAL Y AIGS PG GSPPG Y Macula Study Macular Study YINeuro Study Neuropathy Study Optic Nerve Study Y Optovue Tes
44. nday November 06 2006 Imported Image abe yoshiaki jpg Image will be opened in a window for identification Select eye OD OS then image type and then Save file You may import each type of image for the same scan RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 File Management Menu 7 6 Batch Process This option can be run if you have not opened patient s scans in the Analyze view and wish to pre process all date This will reduce the time required when scans are selected in the Analyze view If there are new algorithms supplied from Optovue for particular scan patterns you would first Clean Diagnosis Data see next topic and then run the patch process on All Patients Tools Print File OCT Image Database Management Home Help Print Setup Print Header Info Data Transfer Import Archive Retrieve Current Visit Current Patient Today s Patients All Patients It is best to use the Batch Process function whenever the system is not in use Processing time is based on the number of patient and scans 7 7 Clean Diagnosis Data This process removes any previous calculations on the raw data When opening a patient visit and scan in the Analyze view the raw data will be processed again This can also be used prior to reprocessing with updates alternative or custom research sites algorithms Tools Database Management Home Help OCT I
45. nnnnnnnnnnnnnnnonnnnnnnnnannnnnnnnnonnnannnnnnnnnnnnnnoos 3 9 3 3 WEST SYSTEM CONTROLS csi EE 3 9 PATIENT MENVD ss 2 2532er A 4 1 4 1 PATENTES RE 4 1 4 2 NEW BATIEN KEE 4 2 4 3 PATIENT INFORMATION Zu een Sas 4 2 4 4 NEW See ee N da o ieee nee 4 3 4 5 CHANGE DATE OF BIRTH FORMAT 2a ae ae 4 3 4 6 EDITING PATIENT OR VISIT INPORMATION 4 3 4 7 PATIENT IST SHOR TCU RS zu an 4 4 EXAMINE MENU geegent 5 1 5 1 ACOUIRING OCT IMAGES sopa ts a dad 5 1 3 2 SCAN PATTERNS ORGANIZATION une ee 5 2 5 3 SELECTING A PATIENT TO BE EXAMINED eege ENNER REENEN EENS 5 3 5 4 SCAN DIS Tarda ia een 5 3 5 5 SCAN DA ee EE 5 5 5 6 ER E 5 6 57 SCANNER CONTROL TABS a it 5 6 5 8 CLINICAL TAB CONTROLS ee 5 7 5 9 ADVANCED EECH 5 8 5 10 PROCESS AVERAGE 2 3 an a en ee 5 9 5 11 SET IMAGE CONTROL DEFAULT cccccosccossccccecceccscscccsecceccsccecsccasctscseessconsesecs 5 11 I2 REVIEWING SCAN IMAGES essen 5 12 5 13 SAVING SCAN IMAGES ass een Nas 5 12 5 14 CORRECT ALIGNMENT OF LIVE OCT IMAGE 5 13 Example of NHM4 scan images location eiennenn EE RRA KEE N 5 13 ANALYZE MENU dai dois 6 14 6 1 ANALYZE EA a A A ee ee 6 14 OES OCT Image Selection A ae 6 15 US AAA ee ee one 6 15 SE E Panos TC Cacia ansehen 6 15 6 2 IMERSUREMEN Erna Sek tess cua eta cae ine 6 16 6 2 1 OO se A E A 6 16 6 2 2 Manna Measurement dias tia ed eee 6 17 RTVue User Manual PN 5000 24034 Rev B 11 2006 Contents 6 2 3 Progressive Asymmetry Comparison ricsina EA ES 6 18 6 3 ANALYZE RESULT
46. nspect the shipment The instrument is shipped in a single crate Check for any damage to the package RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 3 1 2 Step2 Remove the cover and enclosure Monitor 3 6 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Computer Scanner Power Table 3 1 3 Step3 Remove Scanner Computer and Monitor First remove the scanner computer and monitor followed by the power table from the crate RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Remove power table from the crate RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 gt gt 3 1 4 Step 4 Unpack Scanner Computer and Monitor Remove all packing material and then carefully lift the scanner from the scanner box Note Lift the scanner from the bottom of the scanner DO NOT grab the patient head rest The scanner weighs 61 Ib 27 kg so it is recommended to have two people hold on to each side Refer to the manufacturer manuals to unpack computer and monitor Before removal After removal RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 3 2 Setting up the system N Caution Equipment assembling must be done by trained personnel only 3 2 1 Setting up the LCD monitor Arm and PC 1 2 3 RTVue User Manu Mount the monitor holder arm onto the table top and secure with the washer and nut provided Connect the LCD monitor to the top section of the mo
47. pes it is recommended that the intensity of light directed into the patient s eye be limited to the minimum level which is necessary for diagnosis Infants aphakes and persons with diseased eyes will be at greater risk The risk may also be increased if the person being examined has had any exposure to the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours This will apply particularly if the eye has been exposed to retinal photography Caution Federal law restricts this device to sale by or on the order of a Physician or Practitioner CFR 801 109 b 1 Product Compliance 93 42 EEC Medical Device Directive Indicates this equipment contains Type B applied parts Electromagnetic Compatibility EMC EN 60601 1 2 2001 The RTVuel100 device has been tested to comply with the emission and Immunity requirements of EN60601 1 2 2001 The RTVuel00 is intended for use in an electromagnetic environment where radiated RF disturbances are not beyond the standard defined in EN60601 1 2 2001 CB Certification under IEC 60601 1 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Safety notes Symbols and Labels Caution consult accompanying documents Note There are important Operating and maintenance instructions found in the manual Presence of electrical shock hazard Note Indicates risk of electrical shock due to the presence of uninsulated high voltage inside
48. phy This normally occurs in patients with high myopia Using the 3D SLO image to draw and verify the disc boundary is recommended 6 37 RTVue User Manual Version 2 0 PN 5000 42929 Rev B 07 2007 Analyze Menu 6 3 11 3 5 OCT Baseline The radial scans from the NHM4 pattern are presented in the left portion of the NHM4 report pages The placement of the tips can be verified in this wndow Adjustment is achieved by placing the mouse cursor on the small yellow circle holding down on the left mouse button and dragging to where you feel is correct Then release the mouse button Use mouse to drag the RPE tips to a correct location Show Boundary Curves Save As OCT Basline Save the RPE tips to form OCT baseline after dragging all RPE tips to proper locations The modified RPE tips can be saved as an OCT baseline In this case 24 RPE tips define the shape of the disc margin The operator can reprocess the analysis with the OCT baseline by right clicking on the NHM4 map Reprocess with video baseline Reprocess with OCT baseline Reprocess without baseline Modify RPE Anchor Points NOTE The cup is defined by the intersection points of the nerve head inner boundary and a parallel line which is 150um above the connecting line of the RPE tips 6 38 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu RNFL thickness profile is the thickness of RNFL at 3 45mm diameter around the center of th
49. ry a Zei Draw Disk A dl Wi ku i ye my IN We iG Ay ly h MA 6 35 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 3 11 3 3 You may also use the 3D presentation screens to precisely determine the optic disc boundary by using the RPE endpoints visualized in the B Scan lower left and A Scan upper right Ne Wr Add Adds an anchor point on the image for disc boundary Click the SLO image to find the correct point RPE tip position then click Add Fit Uses anchor points to draw the disc boundary to close contour Clear Clears any currently marked anchor points Save Saves the resulting disc drawing as the baseline for the NHM4 Note As you click on any position in the SLO image screen the three perspective windows also change to reflect the location and cross section within the 3D presentation 6 36 RTVue User Manual Version 2 0 PN 5000 42929 Rev B 07 2007 Analyze Menu 6 3 11 3 4 Video Baseline is the disc boundary drawn on the video IR disc image Video Disk Baseline Editor Right mouse click to show this box Auto Reset The Video Baseline can be modified if the baseline has been changed or if a clinician determines that it should be drawn differently The brightness and contrast adjustment on the video image help the operator better visualize the disc boundary NOTE It is a challenge to draw a disc margin with a disc which has atro
50. s scan Select YES to draw RPE Tips before saving the scan or select NO to draw them during the Analysis viewing 5 User Interface Setting Controls the level of GUI complexity that is viewed 6 Default Scan Rates Defaults can be changed as per the user s preference N Click OK to save user preference changes lf Cancel is clicked no changes will be saved 10 7 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Technical Data 10 8 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Technical Data 11 Technical Data 11 1 System Specification A RTVue Scanner OCT Image Acquisition Rate 26 000 A scan second Frame Rate 256 to 1024 A scan Frame Optical Resolution in tissue Depth 5um Beam Spot Size 15um Image Sampling Rate Depth 2 9um Transverse 8um nominal Scan Range Depth 2 or 2 3mm Transverse 2mm to 12mm Scan Beam Wavelength A 840 10nm AA FWHW 50nm Exposure Power at pupil 750uW B Fundus Imager FOV 32 H x 22 V Monochrome CCD Camera 768 x 498 pixel 1 3 CCD Format NIR Illumination 735nm LED C Patient Interface Working Distance 22mm Motorized Focus Range 15D to 12D Internal Fixation Center 3 5 Horizontal and 18 Horizontal Motorized Chin Rest adjustable range 65mm Joystick controlled X Y Z adjustment X 100m Y 85mm Z 25mm Lock mechanism Electro magnetic activated D Computer Unit CPU gt 3GHz Dual Core Processor Primary Hard Dis
51. scan window same as Z Auto button will bring scan to the window OR b Ifscan is visible in the window click once in the scan window and use mouse scroll wheel to bring scan to target area 11 Adjust scan position in live IR image if it is not where you wish it to be by a Double clicking the mouse cursor in the center of where you want the scan to be done IR image OR b Click and hold down on left mouse button with cursor on scan pattern drag to desired location and release the left mouse button 12 Adjust scan image quality using position X Y Focus or P Motor 13 Stop scan by pressing the joystick button this is the capture function 14 Review OCT slices 15 Save the scan AI oO RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 5 2 Scan patterns organization Scan patterns available are organized into two groups based on primary purpose Retina and Glaucoma Glaucoma Tab Patient 4 Examine H Analyze Retina Glaucoma Protocol A RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 5 2 1 The Protocol tab includes standard protocols for Glaucoma Baseline Glaucoma Follow up and Retina Any protocols created by the user since the initial installation of the RTVue will also appear in the list Protocol Tab T Patient Examine Retina Gla
52. ssive dust or dirt from the environment Material required to clean front lens 1 Diluted Acetone or Lens cleaning solution 2 Lens cleaning paper Method Wet the lens paper with cleaning solution and wipe the ocular lens with one pass in one direction Discard the used lens paper Use a new sheet for each repeat cleaning until the lens is clean 3 Head and Chin Rest Cleaning The headrest pad and chin rest cup should be cleaned before every patient visit Material required 1 Disinfecting agent such as an anti germicide or isopropyl alcohol AND 2 Cloth or cleaning towels OR 3 Wet isopropyl alcohol cleaning paper pad Method Soak the cleaning cloth or towel in disinfecting solution or use a wet isopropyl alcohol cleaning paper pad Wipe the chin rest cup and head rest pad RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Maintenance amp Troubleshooting 82 Database Maintenance Database maintenance is designed to help with the preservation and restoration of the system database It is a separate application from the RTVue system and cannot be accessed from within the RTVue Application The two available actions are Backup and Restore BACKUP Under the File menu heading select Backup and a window will appear asking for the destination drive to which the database will be copied The default drive is D however the destination drive can be changed simply by typing in the desired drive in the
53. sted and rotated by using length width and angle control After Stop Scan All 101 scans will be displayed in the review window To see details of individual images click on the image and the details will appear in the working window a 3D Scan design y RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Technical Data 9 2 5 NHM4 Objective To measure the RNFL thickness and optic disc Description 24 radial lines with 3 4mm scan length followed by 6 concentric rings all centered at the optic disc Illustration of NHM4 scan pattern Detailed parameters Circular scan diameters 2 5 2 8 3 1 3 4 3 7 4 0mm Meridian scan length 3 4 mm Meridians 0 15 30 45 60 75 90 105 120 135 150 165 degree Number of a scan in rings 587 587 587 775 775 775 Number of a scan in meridian scans 452 Total a scans 9510 Total scan time 9510 26000 0 37seconds Total overhead 0 02 seconds Pilot display centered cross hairs vertical and horizontal meridian scans and the outermost circular scan 4 0 mm diameter and inner most circular scan 2 8mm diameter 9 5 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Technical Data 9 2 6 MM7 Objective To measure the inner retinal thickness map and total retinal thickness map for the glaucoma Description One horizontal line with a mm scan length followed by 15 vertical lines with a 6mm scan length and a 0 5mm interval and centered one millime
54. t Pattern Retina Study Cancel Done RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 5 6 Copy visit To repeat a scan list from a previous visit the copy visit function can be used to copy a specific list of scans and scan pattern settings to the clip board and then pasted to a new visit Previous visit scan list Copy to a new list Scan Type Eve Repeat Scan Type Line OD 1 HD Line OD Cross Line OD RNFL3 45 OD 3D Macular OD Slicer OD MHM4 OD MMS OD MM OD HD Line OD HD Cross Line OD 1 1 1 1 1 1 1 1 1 1 Save ListAs A New Protocol Save List s A New Protocol 5 7 Scanner Control Tabs The scanner controls are organized into two primary groups Clinical and Advanced The Clinical tab contains all of the controls that are needed in a normal clinical environment to obtain the optimum scan images The Advanced tab holds controls for modifying the scan the noise level default is 3 and the appearance of the live IR image NOTE During scanning any time that a new scan is initiated the presentation will default to the Clinical tab RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu Clinical Advanced Eye Color O Dark Eye O Light Eye Illumination 190 0 gt 1023 2 Gray Scale O Color Scale Auto Z Motor 3445 114 lt 2145 Focus 0 0 15 10D P Motor 0 O gt 100 Vitreoretinal Fixation Control gt
55. ter temporal to fovea Fig 3 Illustration of Macular Raster7X7 scan pattern Detailed parameters Scan length of horizontal line mm Scan length of vertical line 7mm Interval of two neighbor vertical line 0 5 mm Number of a scans in horizontal line 934 Number of a scans in vertical line 800 Total a scans 14 810 Total scan time 14 810 26000 0 57 seconds Total overhead 0 01 seconds Pilot display Cross hair scan centered at fovea right and left most vertical scans RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Technical Data 10 User Preference User Preference can be found under Tools Menu User Preference Date Format Allow save eye blink data Fixation LED Current 0 1000 Select RPE tips before saving scan User Interface Setting Clinical wi Set Data Transfer Options Raw Data Directory CHRTOCTVIEW_Demo Default Scanning Range Line 2 12mm 6 00 HD Line 2 12mm Cross Line 2 12mm 8 00 HD Cross Line 2 12mm 5 00 3D Macular 2 10 X 1 6 mm 30 Disk 2 10 X 1 6 mm 4 00 Slicer 2 10 X 0 6 mm Radial Slicer 2 10 mm Date Format allows you to choose different format for Date Allow save eye blink data select YES to save even if there are blinks or NO to force a rescan when an eye blink is detected 3 Fixation LED Current 0 1000 adjust the blue LED output by increasing or decreasing the value 4 Select RPE tips before saving
56. the instrument Do not remove the instrument cover or parts Fuse Type B Applied parts Note This instrument complies with the specified requirements to provide protection against electrical shock particularly regarding allowable patient leakage current Manufacturer Authorized European Community Representative Serial number Catalog number part number A m European Conformity Ar mn European Notified Body T V Rheinland Product Safety GmbH Am Grauen Stein K ln 51105 Germany CE 00197 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 dd i a Du Ma a I Ye j CONDENSED i Ep Se E 500 hPa 1060 hPa Safety notes Protective Packing Symbols The protective packing symbols specify the handling requirements and the transport and storage conditions Fragile Handle with care Keep Dry This end up Relative Humidity 10 to 100 including condensation Temperature 40 to 70 deg C 1 4 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Safety notes Product Labels RTVue system labels Model RT100 1 for 110Va c input Model RTVuel00 1 E E 5 Voltage 120 V A C opt Svue Frequency 50 60 Hz Current 6 A 41752 Christy Street Fremont CA 94538 USA AAR ES ECC standard qa 2007 P N 500 43070 Model RT100 2 for 230V a c input Model RTVue100 2 8 Voltage 230 V A C opt vue Frequenc
57. tion 3 Clicking on the visit will open the visit information RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Patient Menu 4 2 New Patient To create a new patient click the New Patient button fill out the information fields fields marked with a are required if the Refraction is 0 diopters spherical equivalent then leave blank and click the Save button at the very bottom of the window If you would like to cancel this operation then simply click on Cancel button to exit the New Patient screen 4 3 Patient Information The patient information is shown when a patient is selected Patient Information pass Io EMA ID Facial Disease Category Gender Male Female Refraction HHH OD a dpt OS TZ dpt ats FP Cone dystrophy k Heoure Field 1 Required information fields are marked by an 2 Refraction value at the time patient is being examined is used to set the initial focus for scanner The focus scan beam and video fundus image can be further adjusted in the Clinical Tab before or during a scan 3 Disease Category is a user defined list of diseases The disease category multiple choices can be used as a patient list filter 4 Diseases can be entered one at a time by clicking the add new button 5 The selected Patient Name DOB and EMR ID are always shown on the title bar of the Report window 6 Ifthe Save button is grayed out check to s
58. trast Controls the amount of contrast or shading between areas in the Video Image only not the OCT scan 7 XY Offset Arrow keys can be used to move the scan pattern around in the IR image a Scan Pattern may also be moved around the IR image by clicking and holding down the left mouse button on the scan graphic in the live video image and drag the scan pattern to desired location b Scan pattern can also be moved to the desired location in the IR image by double clicking the mouse cursor in the center of where you want the scan to be centered recommended method RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 5 10 Process Average To obtain the final averaged image in either the Line or Cross Line scans 1 Move the rectangle s on or over the region of interest 2 Then click OK in the message box The rectangles may be adjusted to any size in order to encompass the area of primary interest You may repeat the Process Average function as many times as you wish using any of the scans as the averaging basis 1 Click on any image from the individual scans at the left side of the screen to see it in the large window Place the rectangle and click on the Process Average button NOTE Larger ROI coverage may sometimes produce better results however increasing the box size also increases the processing time Process Average Please place rectanale in the region of interest OD SSl 6
59. ucoma Protocol Standard OD Baseline Glaucoma Standard OD Follow Up Glaucoma Standard OD Retina pi Standard 05 Baseline Glaucoma Standard 05 Follow Up Glaucoma Standard 05 Retina 5 3 Selecting a Patient to be examined There are two ways to select a patient for examination 1 Select Patient from Patient Menu and then click the lt Examine gt tab 2 Use the lt Search gt tab in the Examine Menu To exit the search window click anywhere outside the window 5 4 Scan List The scan list shows the scans to be performed in the current visit Select the scan pattern from the upper window or a scan protocol click on the lt Exam Protocol gt tab to bring up the scan protocol window Select OD OS or both Select how many times each set of scans will be performed Click the Add button to add the scans into the scan list Repeat steps 1 through 4 for another scan pattern 01 028 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu Line HD Line 1 Select scan 1 ITS a HD Cross Line 3D Macular Slicer Radial Slicer 2 Select OD OS or 3 Select number of times each scan will be Do A O K 4 Click to add to Examine To Scan Number more Examine To Do List Scan Type _ optovue Test Pattern MHM4 Nid MPS MMS MPT MM7 Line Line RAIFLS 45 RAFLS 45 3 a 3 3 a 3 3 3 3 3 An empty green circle indicates that the sca
60. unting arm assembly with the four screws provided Place fiber washer over the support post and place the top section connected to the LCD on to the support post Secure hex screws Secure the monitor cables to the arm with clips and drop the power and VGA cables through the tabletop opening PN 500 42929 Rev B 07 2007 L A 5 Install the computer and connect the computer as shown in the image RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 6 Secure the computer to computer holder by link a steel wire from computer case to computer holder Use screw to tighten the wire to both ends as shown in the picture 7 Replace the back panel of the system N Caution Use screw to secure the back panel cover for safety RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Connect cables for computer 3 2 2 Setting up the OCT scanner 1 Hold the scanner by the bottom only and lift onto the table N Caution The OCT scanner weighs 61 pounds and the x y scanner head may move around causing the scanner to tip over 2 Set scanner head carefully into the four foot holes Remove the hex screw and open the cable connection cover on the underside of the table top RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Correct way to hold the scanner unit RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Open the cover for
61. w 12 OCT noise Increase white and reduce gray OCT noise level 13 Video Brighten white and reset Grey video image contrast 14 Show boundary Display remove boundary on the OCT image Patient i Analyze alien Scans Image 2006 09 11 09 11 28 Ke Shown on Report 2 Area tool 4 Text Annotation 1 nun ma 5 Grey Color taa 3 A iS A 12 OCT Noise TN SE Editing Tools a all Gage 7 Select gt EA 9 Undo Redo RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Analyze Menu 6 2 2 Manual Measurement To make a manual measurement first select the tool then make the desired measurement on the selected OCT image First select an initial or anchor point then proceed to the second endpoint linear measurement or arrow or the next in a series area measurement Right clicking on the measurement will show the properties of the tool at Di ie a qe die er ee A a a a a Default Properties Background Color Transparent Background Hatch a No Hatch 2 Downward Diagonal Crosshatch Brightness Diagonal Crosshatch L Upward Diagonal si S El Con trast e You can select the Snapshot Tool to export a jpg of the Measurement report screen e You may select the Print option to print a copy of the Measurement report screen 6 17 RTVue User Manual Version 2 0 PN 500 42929
62. y 50 Hz 41752 Christy Street Fremont a CA 94538 USA EE A 0197 Tested to comply with FC FCC standard mel 2 00 7 P N 500 43067 1 5 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Safety notes RT Scanner Label common for both RT100 1 and RT100 2 models Model RTVue Scanner Voltage 120V A C Frequency 50 60 Hz Current 3 1 A Fuse Rating 4A 250V Type Fast Acting optevue 41752 Christy Street Fremont CA 94538 USA mlao CE 0197 P N 500 43072 System PC Label Model RTVue PC geal optevue 41752 Christy Street Fremont AA k amp Tested t ly with re 02007 P N 500 43074 Frequency 50 60 Hz Current 6 3 A Voltage 115 230 V A C 1 6 RTVue User Manual Version 2 0 PN 500 42929 Rev B 07 2007 Instrument Description 2 Instrument Description What is the RTVue system The RTVue is a Fourier Domain OCT system that can non invasively make images of retinal tissue in vivo with high acquisition speed and high resolution scans The first generation OCT system developed in early 1990s was a Time Domain system which relied on the mechanical scan method to obtain the tissue depth signal The scan speed is limited to 400 A scan per second in conventional time domain OCT due to the mechanic motion barrier The RTVue uses a camera to acquire the A scan signals simultaneously without mechanical motion The RTVue system s scan speed is 26

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