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ManoView ESO User Manual

1. 64 CONTACTING GIVEN IMAGING riui iuo sis siekes dese dex Re eN LR ee Goed ede Gl S REFUS Ee EENS Ge ed ees ee oe Ge ee 66 TABLE si NET YSIS WINDOW CONTROL DU FFONS sees Ese ME GM Ek SR eek Rd ea EN Re Ge eb RU N erk GR EES n AR Ee GRA ER ie Ee Mee Ee 22 TABLE 3 2 PRESSURE PROFILE PANEL CONTROL BUTTONSS eese ese ee ee ee see ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 25 TABLE EL MIENGOPINDKE a ie GE GE EE uM GE EO ED GE LEM EE 26 TABLE 3 4 VIEW MENU OPTIONS sees ees sees ee 26 TABLE BEUR IENEHOP DIG Ese GE Se Gee Ee Ee ee E Dur De De DE DM EDD UE 21 TABLE 320 TOOLS MENU OP IG neig De Ge oe 31 TABLE 3 7 SMART MOUSE SUBMENU osse esse sedes dese ee se 31 dy spe a ONE OL E 36 TABLE 4 2 KEYBOARD MOUSE SHORTCUTS iccssccccssscsssscssscccssccsssscessccesscesssscessccsssccsssscessccssscesssscessccssscosssscessccssscesssscesecessscesssscssscassscossssesens 36 FIGURE 1 1 MANO VIEW ESO ACTIVITY CYCLE sesse voa uti es ee ee ee ee Dies tatto es be ee ese e vba ee eed ee ee ee eg duos 6 FIGURE 2 1 ELEMENTS OF THE DISPLAY MAIN DISPLAY SHOWN IN CONTOUR MODE aisssessssniiesrsouvsnsesentsnsssodsossnantbndisonatuncueateennoes 10 FIGURE 2 2 ANALYSIS WINDOW WITH PATIENT INFORMATION LOADBED eerte ee ee ee see ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee en
2. A bein HEL SR TO 11 0 is 1 50 11 asked N e N 11 0 A K 4 fn 435 f 16 a od HS eee a ML E 11 0 m 1 LI ut 10 0 21 0 03 m L R DEE et 7f 1 EE ma EE so E 110 E 10 0 E a 0 03 tsi MEET PEER S N c 11 0 i d 10 0 0 03 I t d m M M a B a eee ES E ed mamas 11 0 EA 2 96 Hu 36 0 038 uS Nc 2 0 0 150 0 N i ry ae ql OO 8 E WE z Som e E 1 33 Stomach Figure 6 2 Impedance data in Line Trace mode 6 1 1 Impedance 6 1 1 1 Contour Mode The contour mode displays both the pressure and impedance information as color plots The impedance data are represented as monochrome color map i e a magenta color corresponds to impedance data The impedance data are superimposed over pressure contours The software automatically sets the range for impedance color map when any impedance study file is opened The user may adjust the range by moving the range labels up and down refer Figure 6 1 thereby setting the contrast to the desired values e g to enhance visualization of liquid or gas bolus 6 1 1 2 Line Trace Mode The mode displays impedance and pressure data as colored trace for up to 12 channels Figure 6 2 shows the impedance traces for a normal study 6 1 1 3 Trace on Contour mode Th
3. Landmark ld Peak Inspiration and Mid Expiration markers eecejecccjoccce oc oe ees eeZZeeeeze ee Dee ee hee aA A b Transverse Inferior View snfeudos3 a N x 3sec Figure 7 7 Peak Inspiration and Mid Expiration time instances are indicated using short vertical red lines This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GITEN ManoView ESO Analysis Program IMAGING l or M 7 3 2 Analysis Options The asymmetry slice locations can be changed from Analysis Options dialog available from Setup Menu see Figure 7 8 This dialog also allows to set how the Swallow Residual time is chosen When the User Defined Time for Residual Pressure is checked a red vertical line in the region of swallow relaxation is provided when swallow frame is opened All the 3D swallow analysis parameters are displayed for this time instance When the User Defined Time for Residual Pressure is unchecked the average from the swallow relaxation defined by 3sec Nadir or IRP is taken to calculate the 3D swallow analysis parameters eSleeve f LES trace LESr 3D Asymmetry Crass Sectians Location LES PIP cm above cm above eo s o cm below cm below eof eri User Defined Time For Residual Pressure Figure 7 8 Analysis Options for 3D
4. 11 11 11 7 p 16 n m 16 s d 9 gt rm 73 m un Un o e o x e I 21 4 2 gt zu 4 gt J 2l um z _ gt ue ui ui 4 26 gt s 4 3l vd 31 i 31 6 a r LE SA be 36 T astric 36 iM 36 aastric 36 uM 36 Stomach Stomach a Line trace pressure display with esophageal b Same setup in a except pressure shown as c Line trace pressure display with anatomy and anatomy and gastric marker shown color contour pressure color scale given in gastric marker not shown Main Display Figure 3 8 Pressure Profile Panel 3 2 2 Pressure Profile Control Buttons Table 3 2 identifies the controls for the Pressure Profile Control Buttons Table 3 2 Pressure Profile Panel Control Buttons Control Buttons Functionality Fr Nares Fr LES Changes the units shown on the display to From Nares based on the catheter position contained in the Sense Ch original data file From LES LES is shown at the 0 position and Sensor Channel 1 36 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIgEN ManoView ESO Analysis Program IMAGING Rare Provides a slider control for setting the pressure limits when the Pressure display is in Line Trace mode shown in subfigures a and c immediately to the lower right of the pres
5. Table 3 1 Analysis Window Control Buttons Activates the All Data Table window showing detailed study data Activates the Set Range control contour mode only Plays the contour trace line data as a video Display Mode Changes the Analysis window from Line Trace to Contour Mode and back 2D 3D If a 3D ESO catheter is used this will bring up a 3D Window which displays data corresponding to 3D Sensors Atmospheric Gastric Changes the pressure baseline used for display purposes from gastric to atmospheric and back This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIyEN ManoView ESO Analysis Program Functionality Enables or disables all event frame visible on the Main Display without removing them permanently from Control Buttons On Off the study This can be used as alternative to Tools gt Remove Frame feature which removes the frame permanently Control available only when enabled from Tools Display Mode Options 3 1 5 1 Capture Image Pressing the Capture Image button records an image of the current Main Display for later inclusion in the Report 3 1 5 2 All Data Table Window The All Data Table activate via the Data Table button shown in Figure 3 4 shows all current measurements in the analysis A control is provided that links to the Setup Table in which selectable parameters desired to appear in the All Data
6. O 2 columns Figure 5 3 Create Report This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIVEN IMAGING ManoView ESO Analysis Program 6 Combined Pressure Impedance Analysis ManoView ESO provides the tools to visualize and analyze pressure physiology bolus transit impedance and video together The data are obtained via the ManoScan Z system This chapter covers the additional features specific to the combined pressure impedance analysis The readers should refer Chapters 1 to 5 for pressure only features of Mano View ESO 6 1 Analysis Window Organization The analysis window operates in Contour Line Trace and Trace on Contour modes similar to the manner it displays the pressure only data EANO000 e Phgr nx mmHg kOhm Swallow 4 Swallow 5 Swe i i 1 zm dl A a De ee ees eoeieeeer sn6eudos3 Co _ Set Set Range t on soseer ME Figure 6 1 Pressure Impedance data in Contour mode This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIyEN ManoView ESO Analysis Program IMAGING mr EANOOOO 11 0 IU Swallow 4 V RE Swallow 5 Swe 1 9 1 84 i Pharynx Tansal EE ed N d pa d i a Los me Pic 11 0 1 69 6 Ed ER 8 03
7. This chapter provides a short walkthrough of ManoView ESO using the file Quick_Start_Example mvs provided as one of the case studies This file is located in the Case Studies folder installed with the software However any typical esophageal motility study can be used to follow the steps mentioned in this chapter The following system functions are discussed Opening a Patient s Study File Editing Measurement Frames Printing a Report Saving a Patient s Analysis Figure 2 1 shows the Main Display that appears following the opening of a ManoScan data file Both the Main and Pressure Profile displays may be viewed as a continuous color map or discrete line traces using the Display Mode controls ManoView ESO broadly provides two schemes for analyzing esophageal motility pressure data discussed below The software provides separate analysis parameters corresponding User Interface controls and report outputs for each scheme These schemes are Classic ManoView this term is used to refer to conventional esophageal manometry methodology of analyzing pressure data at discrete channel locations specified w r t LES position Wave duration wave amplitude etc are some of the analysis parameters that are used Chicago Classification this is the implementation of the recently published Chicago Classification scheme for classifying esophageal motility disorders based on high resolution esophageal pressure topography Integrated Relaxat
8. DP IP Double Triple Peaks FS Failed Swallow The criterion for establishing each of these conditions is described in Appendix A Analytical Parameter Notes To override any of these markers click on them to change their state or move their location T Figure 2 7 Simultaneous Contraction SC Multiple Peak MP and Failed Swallow FS markers 2 8 Special Swallow Characterization Tags Chicago Classification Certain special swallow characterization markers shown in Figure 2 8 are shown at lower right of the event frame to characterize abnormal swallows they are indicated by Hyper Hypercontractile contraction Rapid Rapid contraction Premature Premature contraction This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved OIgEN IMAGING ManoView ESO Analysis Program Figure 2 8 Swallow abnormality Hypercontractile contraction indicated at right bottom of event frame 2 9 Non Esophageal Study and Manual Analysis By default the analysis channels are located at LES UES and at adjustable distances from these sphincters However the analysis channels need not be constrained in such a manner ManoView ESO provides the functionality to select the position of the analysis channels independent of any anatomical landmark To perform the analysis manually From the Setup menu select Channels In the dialog box select F
9. All report information is also automatically saved within a saved ManoView ESO analysis mva file 5 1 Report Window and Controls The Report window becomes part of the main analysis file and is stored when the analysis file is saved 5 1 1 Report Window Organization The Report window consists of six information areas Each may be included or excluded from the report except Interpretation Findings and Signatory Physician which are always included Figure 5 1 identifies the areas in the report form Site Info provides site or medical facility information This information is carried over from the original data file mvs or may be specified in the ManoScan system program via the Setup menu Patient Info provides patient examination and physician information These can be edited from the Report window LES Esoph Motility Summary contains the indicated diagnostic information UES Pharynx Results contains the indicated diagnostic information Chicago Classification Findings provides an overview of the patient s swallow features as described by the Chicago Classification criteria Procedure Description Indications Interpretation Findings lets the user input the indicated information or select from previously saved pull down list Signatory Physician Allow for the name title and or affiliation of the signing physician to be input or select from previously saved pull down list This do
10. Finding Spastic Achalasia Subtype IIT Findings are based on published Chicago Classification scheme and are only intended to serve as a guide For patient diagnosis Figure 9 3 Chicago Classification Parameters and Findings presentation in Report Form This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GITEN IMAGING ManoView ESO Analysis Program Appendix A Analytical Parameter Notes Definitions Frame Gastric Mean The mean value of gastric channel during Measurement Frame Global Gastric Reference The gastric value used for display purposes only when Gastric pressure reference is selected Established as 30 second average of Gastric channel at time of time Bar 15 s when Gastric is selected in Pressure Reference Control Esophageal Channel Baseline The 6 second mean at the beginning of a given Swallow Measurement Frame for a given esophageal analytical channel one for which wave parameters are calculated L1 L2 and L3 The distal middle and proximal channels respectively used for esophageal body analysis these are set by default at 3 7 and 11 cm or 5 9 and 13 cm above the center of the LES U1 and U2 The distal and proximal channels respectively used for UES pharyngeal analysis eSleeve A function that outputs for every sample in time the maximum pressure at any site along an axial length defined by user adjustable proxi
11. The Landmarks amp References Panel displays current pressures and positions of the anatomical landmarks as set in the Landmark Id and Sphincter Pressure measurement frame 3 4 3 Swallows Data Panel The Swallows Panel displays the average of selected swallow measurements from all of the swallow measurement frames 3 4 4 3D Table The 3D button above the data table will appear when the 2D 3D display option is enabled By pressing the 3D Table the data table will display the landmark locations maximum pressure minimum pressure difference between max and min pressures and the asymmetry data for selected guidelines at the timebar location This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIg EN ManoView ESO Analysis Program Ss IMAGING 4 Frame Editing amp Navigation This chapter deals with the Frame Editing tools using which change the size of measurement frames and add new frames or delete existing ones It also discusses the various controls to navigate from one frame to another 4 1 Using Measurement Frames The Measurement Frames delineate special areas in the data record for which the program will assist in calculating diagnostic parameters For esophageal manometry there are two types of Measurement Frames Landmark Id and Swallows See Sections 2 3 and 2 4 for a description of editing anatomical landmarks and marker positions using the on sc
12. p Esophageal length LES UES centers cm z35 Evaluated 3 0 amp 7 0 above LES PIP from nares cm 44 5 Mean wave amplitude mmHg 106 7 from which to S ave and retrieve previou sly Intraabdominal LES length cm 25 Mean wave duration s 3 9 d f d d Hiatal hernia No Double peaked waves 0 LES Pressures Triple peaked waves a S ave In ormati on an text re ucing rep ort Pressure meas method eSleeve IRP Velocity 11 0 3 0 above LES cm s 4 0 e e Basal respiratory min mmHg 1235 9 Velocity 11 0 7 0 above LES cm s al Basal respiratory mean mmHg 1757 2 Velocity 7 0 3 0 above LES cm s 5 5 p rep ar atl on me B Residual mean mmHg 2 8 Wave ampl 11 0 above LES mmHa 54 5 Residual highest mmHg 6 0 Wave ampl 7 0 above LES mmHg 56 6 Percent relaxation 96 Wave ampl 3 0 above LES mmHg 156 7 Wave duration amp 11 0 above LES s 3 5 Wave duration 7 0 above LES s 3 4 The individual diagnostic parameters EE eres High Resolution Parameters Distal contractile integral mean mmHg cm s 1565 6 available may be customized through the p UE i Contractile Front velocity cm s 3 9 Report amp Analysis function in the Setup ER ee menu This is described in detail in Section 3 3 3 1 Report amp Analysis Figure 2 6 A snapshot of the report window Select the Create button at the bottom of the report window after the appropriate content is set Complete the Create Report dialog to cr
13. 11 FIGURE 2 9 SPATIAL MARKERS eters oe Ses eg Gie es ie ed eie se dees ne Ee pb re RR ie eke ee Gie Re E Ge ek DEP ED be ee SG EG G EUR ERR URP Ge be EG KG es EE 13 EIGURE 2 4 PRBSSUREJADIUSTMENII TOO Goa se cece es es Si ee oe saith wb cated set ap ee ob de Se eed cae Ge UM Sem ee ee ee ee de 14 FIGURE 2 5 SWALLOW MEASUREMENT ADJUSTMENTS A CONTOUR MODE B LINE TRACE MODR sesse ese see se ese ee see se ee ese 15 FIGURE 2 6 A SNAPSHOT OF THE REPORT WINDOW ccccsssssossssssccscssscsccvesssecevscssececsesscecesecssecessossesecsosseecesscsseeesecsscscesessescesecsseeescosseseesee 16 FIGURE 2 7 SIMULTANEOUS CONTRACTION SC MULTIPLE PEAK MP AND FAILED SWALLOW FS MARKERS 17 FIGURE 2 8 SWALLOW ABNORMALITY HYPERCONTRACTILE CONTRACTION INDICATED AT RIGHT BOTTOM OF EVENT jo iS EE OE EE OE ssa se ORE EE EN 18 FIGURE 3 1 MANOVIEW ANALYSIS WINDOW ORGANIZATION esse ee sesse ee ese ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee eea 21 FIGURE 3 2 ANALYSIS WINDOW A CONTOUR MODE B LINE TRACE MODE esse ese ese see se ese ee see se ese ee see see be ee see ge ee Gee se ese ee see se ee Ee 21 FIGURE 3 3 ANALYSIS WINDOW DISPLAYING PRESSURE DATA IN TRACE ON CONTOUR MODE esse ee sesse ees ee ee ee ee ee ee ee ee ee ee ee 22 PIGURE 2 4 ALL DATA TAPE EO OE OE Uicavecs ouvaxevs ote M home pd tes n 25 HIGERBOSSGLIUPTAXBDE ID E NU eed oi ated Re oe ee eset Dt docent DA cas I lu DL fa Rot CLP Sd f sep RE
14. 6 not selecoed OF 36 Chicago Clesafication aphan vet sa Chicago Classification Finding kobor contour Tor GC b net set bo 20 n dngr ane based on puablicfed Chicsga dardri ster edens and wa ri inbemded ro cerve oc 4 guide For patient Geom le Include Procedure Cwecription Aud frors ht Lette Procedure Description L Ichude Indictione Add frore bey v sger Delete incl JD code Mi see Comte Orcedord moderwie chat par Owork cma 2 Indications le Include Intempeet ation Findings Add frors ies Jra Dette beh KD di code Delite Interpretation Findings le Inchude horersons Acki frare ke w Save Dekio nel JCD dy code ai se ce 2 Inchate Sguro Signature w Sent Diaeta Buttons Gene Export Ore Corod Doto Takke Figure 5 1 ManoView ESO Report Window Organization w Control This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIg EN ManoView ESO Analysis Program Ss IMAGING 5 1 2 Customizing Pulldown Lists The Report window provides customizable pulldown lists to eliminate the need for re typing commonly used information The lists include Procedural Description Indications ICD Code Interpretations Findings ICD DX Code and Signatory Physician Adding accessing and removing data is similar for each list A snapshot of the pulldown l
15. Analysis This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIyEN ManoView ESO Analysis Program IMAGING 8 Video Visualization ManoView ESO when used in conjunction with a ManoScan V module provides the tools to acquire and visualize the video data This chapter covers the additional features specific to the video visualization Readers should refer to Chapters to 6 for standard HRM features of ManoView ESO 8 1 Overview If a video file is associated with a pressure impedance study file mvs or mva format files then on the Main Display directly above the Main Display one or more sections of blue markers is displayed The blue markers indicate that video is recorded for that duration see Figure 8 1 Swallow 3 Video Markers Figure 8 1 Blue markers over Main Display indicate the time range for which recorded video data is available To view the video window press the Video button on the Main Form Moving the time bar over the blue mark region will show the video frame corresponding to the time bar location Pressing the Play button will advance the time bar forward at an adjustable rate and cause the video frames to continuously update synchronously with the pressures displayed in the Profile Panel This document contains proprietary information Source Given Imaging Copyright 2013 Give
16. RE 23 FIGURE 3 0 SET LIMITS CONTROL CONTOURNIODB sae sarees iese HUE IU BTE MR DH SIR RYE ARI ed ee cons ee TOUR NNI FER M ERN N 24 TGR OS a E TRANCE CONTROL LINE TE E ate ees cag rv rU eee eee a DIM eed 24 FIGURE 3 8 PRESSURE PROFILE PANELi ccccsssssccsscsssssssccescsssssssscesscsssssssccssessssssscsssecsssesscessessssseseceseecsssuscessessssessecesesesssesscessessssssseessesesees 25 FIGURE 3 9 REPORT amp ANALYSIS WINDOW THE SELECTIONS RELATED TO CLASSIC MANOVIEW PARAMETERS HAVE BEEN UNSELECTED SO THE CORRESPONDING CONTROLS ARE NOT VISIBLE ON THE MAIN DISPLAY OR IN THE REPORT 28 FIGURE 3 10 ESLEEVE WINDOW A ESLEEVE LES TRACE TAB B LESR TAB escas tusskacsesteqg stseneoe eee es kes ee ed or uncover tae eke ie Sg 29 FIGURE 3 11 TRACE CHANNEL CONTROLIDISPIA Ses es ie ne De ed ke ie see ee Dee ee bes ee es Re ee ed tbe ee de 30 FIGURE 3 12 TRACE DISPLAY CHANNEL CONTROLS SETUP LANDMARK REFERENCE ees esse ee ese ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 30 FIGIRE A I ANALY SS WINDOW DATA cl Ut Zi Dee OD ED ee ee ee ROO ROT ME E LIS 32 ie dies OP Sie US oe avis 35 Ses BES Edele Rl a N i AO ME N A E E M M M EE M ON E M M 36 FIGURE 5 1 MANOVIEW ESO REPORT WINDOW ORGANIZATION esse ee ee esse se ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee aset e anas 38 FIGURE 5 2 PROCEDURE DESCRIPTION PULLDOWN LAST seed de ese ed bede ie Go Redes re o ES es ede ee ON Se ke ede a Vm d ee de 39 This document cont
17. and start editing Adjust the spatial markers UES LES LES upper and lower boundaries eSleeve upper and lower boundaries if used indicated by icon in the LES region of Pressure Profile and PIP Figure 2 3 identifies the adjustable spatial markers in Landmark Id frame These adjustments if necessary are done by moving the controls vertically in the Pressure Profile panel and viewing the horizontal guidelines in the Contour mode This establishes the positions of these landmarks for calculations within the program and for the analysis report See Appendix B Anatomical Marker Positioning Guidelines for more details A shortcut way to zooming in on a measurement frame is to double click its corresponding rectangle in the Navigation Bar The program will automatically open and center the frame and zoom in Use the zoom button or right click and drag on the Main Display for additional magnification This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIyEN ManoView ESO Analysis Program EAYODO4 WINX 4 amp ell Fharynx A 4 9 orizontal 14 Spatial Markers mt gt sner Stomach A tfeeeejDeecei oeccecso0c2 7 2222 HH oo 10sec i di RENE EE 10 sec le Figure 2 3 Spatial Markers Click the Display mode button located below the color
18. bar on the left side of ManoView ESO window This displays the pressure data in Traces mode Click it again to toggle back to Contour mode For Classic ManoView analysis adjust the horizontal pressure adjustment tools at the LES or eSleeve and UES in line trace mode to establish the basal resting pressures see Figure 2 4 Note The editing tools are provided for all reported diagnostic parameters While the program generally places these at satisfactory values always verify that these are appropriately placed This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIyEN ManoView ESO Analysis Program IMAGING Landmark Id a EE EET Rese Mean Pressure Adjustment EEN EEN mr Figure 2 4 Pressure Adjustment Tools 2 4 Editing Swallow Frames The Swallow frames are identified by solid rectangular boxes refer Figure 2 5 The label name is mentioned in the upper left hand corner of each frame Depending on the parameter settings in Report amp Analysis form available from Setup Menu Chicago Classification or Classic ManoView analysis controls are displayed on the Main Display See Section 9 for detailed discussion on setup and analysis controls for Chicago Classification To analyze and edit the diagnostic information in a Swallow frame Click on the icon lE located at right end of the navigation bar to move to the first swallow frame S
19. be zeroed at this location in time and the entire data record will be compensated accordingly the indicated pressure profile at that point in time will be subtracted from the entire record This technique combined with the initial recording of the procedure without touching or otherwise applying pressure immediately after extubation is recommended as a robust method of establishing proper thermal compensation Detailed Thermal Compensation is similar to the Set Thermal Compensation control except that it allows for setting the point in time at which the zeroing of pressure will occur for each channel individually An on screen message explains this process This is useful in a situation where the pressure was inadvertently applied to the catheter e g pinched by the operator at certain locations immediately after extubation The times in the record for setting thermal compensation may be chosen to give optimal compensation while avoiding the times of applied pressure in the affected locations Undo Last Thermal Compensation removes the last set thermal compensation When saving a ManoView ESO analysis file remember that the saved file will reflect the thermal compensation existing at the time the file was saved 3 4 Data Display Panels The Data Panel area displays numerical data as registered within the program The Data Display Area is divided by three sub areas Current Landmarks amp Pressures and Swallows as shown in Figure 3 13 A cont
20. ee De EE ees DEE Ge ee EE SG Ee DE 47 GE MINTY oe ID AE OE EE N N OE N N EE OE OE OE N OE EN ON 48 VIDEO VISUALIZATION EE RE EE EE N aa Er 51 MEE 29 208210 EE EE EE OO Se OE ae ee nS ee eee eee vee re 51 C MEE OO ei Ec AE EE EE EE EE OE ER TE OE OO OE eer EO ee 32 S3 VIDEO FILE ASSOCIATION DBEPATI Ses Se ee ie Ee SE Ee OE GE Ge Ee ie ee ID ee ED EE Ge Ee ie De ek ee GE Ge 53 CHICAGO CLASSIFICATION SETUP amp ANALYSIS ccccccccccccccccccccccccccccccccccccccccccccccsccccccccsccoees 54 9l EARAMETBES se so sec sec ces ee sc Me M de ep GE M e ES AE EE 54 MA iN EN EEN EE SEEN EENS EEN SEE EE EE EEN 54 iS AE N EEN EO SE EE EE SE EE SE EE HE EEN 55 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIyEN ManoView ESO Analysis Program IMAGING D EA N AA AE ONE RR RE ES 56 APPENDIX A ANALYTICAL PARAMETER NOTES sies ss ssd esse seed es ese see bee sewe ese es d ie dees eed Died ie 58 APPENDIX B ANATOMICAL MARKER POSITIONING GUIDELINES sccccsssssssssssccssssssssssccssssssssssces 61 APPENDIX C SWALLOW FRAME ANALYSIS GUIDELINES 2 cssssssssssssssssssscccssssscsssssssssssssssscssssssssssoees 62 APPENDIX D HOSPITAL INFORMATION SYSTEM HIS INTERFACE ecce eene e e eee eee eee enn sesse ee sege ee ee 63 INDE X qe
21. m vie Catheter Position 52 5 cm ILES Length 4 0 cm CFV 2 7 cmjs Atmosph LES Intraab Seg 2 5 cm Onset Veloc 3 0 11 0 2 3 cmijs Selects ID lods i 18 2 UES Pressure 86 3 mmHg Multiple Peaks No Patient Name First Name Middle N 22 23 UES Resid Press 1 1 mmHg 26 23 8 Figure 2 1 Elements of the display Main Display shown in Contour mode 2 1 Running the Program To run the program Start the ManoView ESO Analysis Program by double clicking on its icon or shortcut When the program starts the Open dialog box is displayed for convenience Browse and select any patient or sample data file for review and a window similar to Figure 2 2 appears This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIVEN ManoView ESO Analysis Program IMAGING Manoview Ls m c 2 4 coco H a aH A hes M EANOOOO ie Sd wd SA Sw Ia SA sa xo 1 Pharynx 200 0 180 f 160 140 1 120 E gt H 100 16 2 3 60 e we T 50 i 40 30 26 20 a 10 3 D E 10 0 31 6 l Set Range e 36 0 0 150 0 ON on pr EN EE o ON XE 1 l m eo RR EN NENNEN Li seas isplay Mode d Trace Channel Snapshot Log Data Landmark amp Pressures Swallows avg Hide Data Data Gastric g 00 03 39 ILES Press resp min 11 6 mmHg LES R
22. rectangle is red if that frame has not been opened yellow if it is currently open and green if it has been opened and closed Arrow controls to the right and left allows for the navigation forward and backwards through the frames as described in the figure and automatically open and close measurement frames as described in the previous section The time control allows for the adjustment of the width duration of data currently displayed in a manner parallel to the use of the Zoom tools described in Section 4 4 Clicking anywhere on the Navigation Bar or dragging the Slider will move the display to that region in the study Panning to the left and right can be done by left clicking any point on the main display and dragging Time Control Go to Beginning Cotes EES Zoom Previous Frame Slider Frame On Off Status or Dot Marker Next Frame Figure 4 1 Navigation Bar This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIg EN ManoView ESO Analysis Program J IMAGING n men 4 4 Zoom Controls The Navigation Bar supports the expansion and compression of the Landmark Id and Swallow frames in seconds Figure 4 1 identifies the Navigation Bar controls The Zoom Bar increases and decreases the amount of information displayed in the Main Display panel Figure 4 2 identifies the Zoom Tool Bar controls Figure 4 2 Zoom Tool Bar Zoom Out Fully Table 4 1 id
23. the free channel move only from one sensor position to another they cannot be positioned in between the sensors Note that the measurement frames will not open in analysis mode if Free Channel selection is invoked Landmark Reference Seplandmak Retenes Auto analysis Channels It is possible to select channels via Landmark Reference cm above LES UM See tere UES Cane this is required for auto assisted measurement frame 7 cm above LES UM em above UES center analysis analysis mode A snapshot of the setup i1 em above LES UM Second channel optional window is shown in Figure 3 12 By default the LES and EE ER UES channels will always be used for analysis mode and EMI M unused E may not be deselected In addition select at least three Unused BE Unused F analysis channels associated with the LES and either 1 or Unused fumsed z 2 analysis channels associated with the UES Additional EE ETER EET auxiliary channels may be selected for viewing that will not be utilized in the generation of diagnostic parameters Ed Figure 3 12 Trace Display Channel Controls Setup Landmark Reference 3 3 4 Tools Menu Options The Tools menu provides access to ManoView ESO s analytical tools and allows for configuration of on screen guidelines and markers Table 3 6 identifies each Tool Menu Option and describes its functionality 3 34 1 SmartMouse Submenu The SmartMouse tool prov
24. EET NERO TOR 6 Acronyms and Abbreviations 6 Adding To Pulldown Last 38 All Data Table Window 22 Analysis Window eeeeeeesss 19 21 C Capture Image 15 21 22 39 CHANING TENERE 17 26 29 Clear Analysis esse DA EE GR Ge 30 Contour Mode GE Ee ee 19 21 Contractile Front Velocity CEV AE N EO Ne 6 54 59 Control Buttons 21 25 Create Report see EE EE EE 38 Customizing Pulldown Lists 38 D Data Display Panels 32 D E E 6 54 59 Pip r MOO ee a a eN 24 Distal Contractile Integral D NE EET 6 54 59 E ed ele SA OE 11 26 28 31 F File Menu eere 25 26 30 File IN AAA see Da Re BEDE 26 areste a aa i asse EE EE 29 FS Failed Swallow 6 16 G Generating a Report esse see 15 OS aera eae EE AE RR E AK N N 6 H HRM e 6 IMAGING GITEN I edo 38 impedance 5 7 30 41 42 43 44 Inserting and removing a Frame 33 Inserting Removing and Editing Frames 33 Integrated Relaxation Pressure ld A 6 28 54 59 Intended Auden Ce sees ee De EG 5 Intrabolus Pressure IDP A 6 58 Isobaric C ODDOHE Sessie ie Gee 18 30 L Landmark amp
25. IMAGING GITEN ManoView ESO Analysis Program ManoView ESO User Manual Version 3 0 1 DOC 1966 03 March 2013 ENGLISH This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING ManoView ESO Analysis Program GIyEN COPYRIGHT Copyright 2013 Given Imaging Ltd TRADEMARKS GIVEN GIVEN amp Design PILLCAM PILLCAM amp Logo PILLCAM IMAGING CAPSULE amp Design AGILE RAPID RAPID ACCESS ORDERWIN ORDER WHEN I NEED FINGERS HOLDING A CAPSULE amp Logo FINGERS HOLDING PILLCAM CAPSULE amp Logo ICCE ICCE Logos International Conference on Capsule Endoscopy VUESPAN BRAVO PH SYSTEM BRAVO ENDONETICS VERSAFLEX GEROFLEX REPHLUX TRACER ION GASTROTRAC BILITEC DIGITRAPPER SLIMLINE PHERSAFLEX MANOSCAN MANOSCAN 360 MANOSCAN Z MANOSCAN 3D MANOSCAN HD MANOSCAN V MANOSHIELD MANOSHIELD AR MANOVIEW MANOVIEW Z ACCUTRAC ACCUTRAC Z ACCUVIEW ACCUVIEW Z SURETEC ACCUFET ACCUFET Z INSERTASSIST BOLUSVIEW POLYGRAF ID RESPSPONSE ION Z and GPS are Trademarks and or Registered Trademarks of Given Imaging Ltd its subsidiaries and or affiliates in the United States and or other countries All other company or product names are the trademarks or registered trademarks of their respective holders All rights not expressly granted are reserved U S Patent 7 476 204 The ManoView ESO Analysis Program is part of the ManoScan Syste
26. L3 amp L2 above LES cm s Iv Iv Iv Iv vi Figure 3 4 All Data Table Summary data reported as mean among measured swallows where applicable LI is closest esophageal analysis channel to LES U1 is closest pharyngeal analysis channel to UES Figure 3 5 Setup Table Window 3 1 5 4 Range Button The Set Limits button activates a control that provides the ability to adjust the maximum and minimum pressures of the color contour plots in the Main Display refer Figure 3 6 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GI TEN IMAGING ManoView ESO Analysis Program Ss Maximum 150 0 mmHg Minimum 10 0 mmHg Figure 3 6 Set Limits Control Contour Mode 3 1 5 5 Range Dialog Box The Range Dialog Box is activated by clicking on left hand channel controls in the Line Trace mode This provides the ability to adjust the range and baseline values for the individual traces or all traces at once when All is selected This control is also used to set the range for the Pressure Profile when in the line trace mode refer Figure 3 7 Range 200 0 mmHg Baseline Lall 6 0 mmHg Figure 3 7 Set Range Control Line Trace Mode 3 1 5 6 Pressure Reference Atmospheric Gastric Control The Pressure Reference control changes the pressure baseline used for display purposes from gastric to atmospheric and back By default all files open in A
27. Mode Red analysis flags e Not Fld Not Failed vs Failed e NoSC No Simultaneous Contraction vs SC Simultaneous Contraction e Esophageal Contraction Status Single Double Triple peaked contractions Chicago Classification Analysis LES relaxation brackets Left side of bracket should line up with the UES Relaxation The right side of the bracket should be positioned at the end of the esophageal body wave form Distal Contractile Integral DCI Place the proximal boundary of the DCI rectangular control at the proximal pressure trough Contractile Deceleration Point CDP Place at the inflection point along the 30 mmHg isobaric contour where propagation velocity slows Contractile Front Velocity CFV After placing CDP at appropriate location move the proximal end of the CFV line such that is tangent to the 30 mmHg isobaric contour Distal Latency DL Change the UES relaxation marker or the CDP point to modify the DL value Red analysis flags Following options can be set for the peristaltic integrity a Intact b Small Breaks c Large Breaks d Failed Panesoph and e Failed Absent This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIyEN ManoView ESO Analysis Program Appendix D Hospital Information System HIS Interface The software allows export of patient information and analysis Report to a user defined location T
28. ONNING TEE ad 016 9o UNE 10 2 2 PRIOR TO ANALYZING EVENT FRAMES cccoscscoscscescscaccecaccscescsceccscsccscscoscscscecascecaseecesescssescesescssescesescesaseesaseces 11 2 3 EDITING THE LANDMARK ID FRAME csceccscesceceecsceccececcscusescecescecescscescscescscescscesescesescesescesescssescecesessasencaseces 12 24 JEDITING SWALLOWERAMES EE taco ee Ge Oe oe EE Ee Ge Ge ee dux ee xe GEE RE GE Ge ee GE RE ee EG ee US 14 23 GENERATINGA REPORT EE AR ess sans va ee se GE ee selva tice oc ial Ge Go Ge GE ee Ge Ge ee oe ie 16 Ao DAEA Ane IS ek De ER EE ED Se EE OE EE GE ED SE eee EE 16 2 7 SPECIAL ESOPHAGEAL WAVE MARKERS CLASSIC ANALYSIS ee ee see ee ee ee ee see es ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 16 2 8 SPECIAL SWALLOW CHARACTERIZATION TAGS CHICAGO CLASSIFICATION ees ee see ese ee se ee se ee see ee ee ee ee ee ee ee 17 2 9 NON ESOPHAGEAL STUDY AND MANUAL ANALYSIS ese es ee ee ee ee ee ee ee ee ee ee ee es ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 18 ANALYSIS WINDOW sesse eise eo es ne de ee od ed Ge se ee Se ie n oe Ve ae ne Ge Ee SA Ge Ge ed de RE 20 3 1 ANALYSE WINDOW AND CONTROLS 2 2 02r ie nee SE dee oe ie oe DR ES Ee ie ee cet Ee ee us in Ee EG oe ee Ee AE ee ee Sins Pea ee Eg 20 32 PRESSURE PROPRIE PANEL Ee Oe SC e LUI MD MP UL LEUR e EE er ee EE 24 3 92 JMMENUCONTROLS AND OPTIONS icit ie Ee de Va Gee voee de Ge ee ege ode to dese PROP de NE cese De EG de GE rear Pe de o
29. Pressures Data Panel 32 Landmark Reference ees see ee ee ee 29 LES lr AE EE N N N 6 28 Lower Esophageal Sphincter 6 relaxation markers ee ee ee 14 Line Trace Mode ee ee scene 19 31 Load eu el RE Ee Ee EN 26 M Mask C Manm o is ie ea EE oe ee 26 Measurement Frame Editing 8 11 13 Menu Controls and Options 25 Millimeters of Mercury lg a 6 Motility Visualization System NIN 1 6 Moving and Resizing a Measurement Frame 34 MP Multiple Peaks 6 16 N Navigation Bar amp Time Controls 34 Non Esophageal Study and Manual Analysis 17 luc 2 Pressure Inversion Point This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved ManoView ESO Analysis Program PI n 6 11 30 Pressure Profile 8 11 19 24 25 26 28 29 Pressure Reference Atmospheric Gastric Gun EUR AE EE 23 Purpose of This Manual 6 R Range Dialog BOX ees ee 23 Removing Pulldown List Elements 38 Report amp Analysis 15 26 27 36 43 Report Window esessesss 21 36 37 Report Window and Controls 36 Report Window Organizati
30. S esophagus lower esophageal sphincter LES stomach sphincter of oddi small bowel colon duodenum and anorectal organs It is used in a medical clinical setting to acquire pressures impedance levels and video and store the corresponding data The system also provides visualization and analysis tools and information The real time data as well as the analysis information can be viewed for diagnostic and analysis purposes with an intention of assisting im the diagnosis and evaluation of gastrointestinal and swallowing disorders The device is intended for use by gastroenterologists surgeons and medically trained personnel This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIyEN ManoView ESO Analysis Program 1 5 Contraindications of Use The use of the ManoScan system for pharyngeal esophageal motility and impedance study and proximal gut gastric duodenal manometry is contraindicated for the following a patients with an inability to tolerate nasal intubation b patients with significant bleeding disorders for whom nasal intubation has been deemed contraindicated and c patients with a known esophageal obstruction preventing passage of the instrument The use of the ManoScan system for anorectal manometry is contraindicated for patients with known anal stricture obstruction preventing insertion of the instrument 1 6 Intended Use The ManoView ESO s
31. S givenimaging com Latin America supportLA givenimaging com Canada Given Imaging Inc Canadian Office 2425 Matheson Blvd E 8th Floor Mississauga ON L4W 5K4 Canada Phone 905 361 2830 Toll Free 1866 98 GIVEN Fax 1 800 786 1967 supportCA givenimaging com Australia amp New Zealand Given Imaging Pty Limited Unit 6A The Park 5 Talavera Road North Ryde NSW 2113 Australia Phone 61 2 9889 3944 Fax 61 2 9889 3955 supportAU givenimaging com Japan Given Imaging K K 2F KDX Kojimachi Bldg 3 3 Kojimachi Chiyoda ku Tokyo 102 0083 Japan Phone 81 3 5214 0588 supportUP givenimaging com Germany amp European Headquarters Authorized Representative in the EU Given Imaging GmbH Borsteler Chaussee 47 Hamburg 22453 Germany Phone 49 40 513 3000 Fax 49 40 4606 9611 supportEU givenimaging com France Given Imaging France S A S 22 Rue Guynemer 78600 Maison Laffitte Paris France Phone 33 0 1 34 93 80 00 Fax 33 0 1 34 93 80 11 supportF R givenimaging com Asia Given Imaging Asia Company Limited 27 F Unit A Cheuk Nang Plaza 250 Hennessy Road Wanchai Hong Kong Phone 852 2989 0888 Fax 852 2989 0899 supportAP givenimaging com This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved
32. Table and Report see below can be chosen 3 1 5 3 Setup Table Window The Setup Table Figure 3 5 enables the user to select which parameters will be displayed on the Report Detail sheet and the All Data table Certain parameters will be selected by default and may not be deselected When a user selects Save As Default the selected parameters will be saved with the settings The study summary data column will display the resting landmark and sphincter pressure data and the mean measured swallow data where applicable Select parameters to be included in report On screen analysis tools are provided according to selections Data Tae Normal Group Maan Swasti Swal 2 Swal 3 Smal a4 Sal 5 Swal 6 Swal a7 Tabular Graphical Individual ANATOMY BASAL PRESSURES N Parameter Summary Summary Swallows I LES mid postion from nares cm 0 ANATOMY BASAL PRESSURES LES proximal margin from nares cm 17 LES mid position from nares cm Iv Iv Iv LES distal margin from nares cm 7 0 LES proximal margin from nares cm Iv Iv MM LES length cm 3 LES distal margin from nares cm Iv Iv Iv LES intrasbdomina segment cm 5 LES length cm iv Iv Vv ee I LES intraabdominal segment cm Iv Iv Iv PIP position from nares cm Iv Iv MM eds er ed 205 UES mid position from nares cm Iv Iv v Esophageal length cm between sphincter midpoints 5 Esophageal length cm between sphincter midpoints Iv Iv Iv LES basal pressure maan cf respira
33. ains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIyEN ManoView ESO Analysis Program IMAGING le REEL Ee ANENE 8 GE OE EO EO EE OO N OE EE ancien 40 FIGURE 6 1 PRESSURE IMPEDANCE DATA IN CONTOUR MODE sesse ees esse ee ee ee ee ee ee ee ee ee see ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 41 FIGURE 6 2 IMPEDANCE DATA IN LINE TRACE MODE sesse sesse ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee en 42 FIGURE 6 3 A NORMAL SWALLOW PHYSIOLOGY SHOWN IN PROFILE PANEL cccssssccccccsssssscccccscsssscccescssssssecccssccsssseccessssssseeseesseessees 43 FIGURE 6 4 BOLUS STATUS CONTROL SHOWN DURING A PRESSURE IMPEDANCE ANALYSIS sesse sesse ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee gee 44 FIGURE 7 1 PRESSURE DATA IN CONTOUR MODE WITH 3D HRM WINDOW sesse ees sees see ee ee see ee ee ee ee ee ede ee ee ee ee ee ee ee ee ee 45 ie RENS O HRM AMI AE RE EK EE EE ON EE EO EE RE EE EO N N 46 FIGURE APE SP HRM TT 47 FIGURE 7 4 BUTTONS FROM LEFT TO RIGHT A ANATOMY TOGGLE B DEFLECTION RANGE C VIEW MODE D CAPTURE HE aw as ES AE OM Se de P 47 FIGURE 53D CYLINDER ROTATION BUTTONS oa EE ee ie n ee catia snus CERRO UR VERRE MR EE UR Ee E NERVOUS E VERA ER CUR 48 FIGURE 7 6 ASYMMETRY TYPE SELECTIONS IN SETUP REPORT amp ANALYSIS esse ees sesse ee ee see ee ee
34. an 20 mmHg from proximal to distal pressure troughs Distal Latency Interval between UES relaxation and the CDP expressed in seconds Peristaltic Breaks Gaps in the 20 mmHg isobaric contour of the peristaltic contraction between the UES and EGJ measured in axial length Contractile Front Velocity CFV Slope of the tangent approximating the 30 mmHg isobaric contour between proximal trough and the CDP Contractile Deceleration Point The inflection point along the 30 mmHg isobaric contour where propagation velocity slows demarcating the tubular esophagus from the phrenic ampulla Note The definitions of the CFV and CDP parameters are adopted by the software to enable robust implementation Like all the analysis markers the user should manually review and edit the position of these markers if the auto placement is not satisfactory 9 2 Setup The user may enable the Chicago Classification scheme from the Report amp Analysis dialog available from the Setup Menu see Figure 9 1 This is done by checking the Chicago Classification checkbox therein The user may keep Classic ManoView checkbox selected to enable corresponding line trace parameters or may unselect it gt The International High Resolution Manometry Working Group Chicago classification criteria of esophageal motility disorders defined in high resolution esophageal pressure topography Neurogastroenterology amp Motility March 2012 vol 24 57 65 This
35. chosen a Enable Traces on Contour b Enable Profile Trace Persistence c Show Catheter in Profile d Show Diaphragm in Anatomy e Show Measurement Frames On Off enables On Off button available on left of Navigation Bar Additional options are available for displaying impedance data when that version of the program is in use See Section 6 1 Set Thermal Compensation Sets thermal compensation at the time of the Time Bar see Section 3 3 4 3 Detailed Thermal Compensation Sets thermal compensation at the time of a marker for each individual sensor channel see Section 3 3 4 3 Undo Last Thermal Comp Removes the last set thermal compensation Insert Frame Inserts a Landmark Id Pressure or Swallow event at the time of the TimeBar Remove Frame Removes any measurement event at the time of the Time Bar Clear Analysis Clears all the analysis done in the mvs file including positioning of sphincters and PIP Table 3 7 Smart Mouse Submenu Submenu Option Functionality Basic e Contour mode continuous data display at point of cursor Time Bar shift left click rectangular region with pressure characteristics min max mean pressure velocity changes in time distance and pressure in enclosed area right click drag e Line Trace Mode Time Bar shift left click time between begin and end points Right click drag Incl Portable eSleeve e Provides in Contour mode Same functionality as basic except right click drag pro
36. color mapped to match the 2D HRM map This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIyEN ManoView ESO Analysis Program 7 1 2 2D HRM The 2D HRM view displays a cross section on the left and a 2D map of the 3D HRM plot The 2D map view can be panned by dragging the bar located at the top of the view see Figure 7 2 The cross sections locations can be set w r t LES and PIP anatomical markers These locations are also shown in the 2D map by means of horizontal lines See Section 7 3 2 Analysis Options for details on how to set the cross section locations Transverse Inferior View Cross Section Locations Minimum pressure path Figure 7 2 2D HRM View The path of minimum resistance to the bolus flow 1s determined by the software and denoted using dotted line in the 2D map The highest pressure point on this path is indicated using the red dot see Figure 7 2 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIVEN ManoView ESO Analysis Program IMAGING 7 1 3 2D 3D HRM The 2D 3D HRM view displays all the views discussed above at once Figure 7 3 Transverse Inferior View Figure 7 3 2D 3D HRM View 7 2 3D Window Controls Several controls are available to alter the display of the 3D window These are shown in Figure 7 4 and Figure 7 5 and the functio
37. cument contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved ly N ManoView ESO Analysis Program v M N NG iude Ste info From File Ez Include Patent Info Gren Dreging T bi Prt Mees Fig Mee Finighti lt in eft 5in EIE EF Mickie mid varkie raar es EET PIN Lact we Site Information Gender Foelie Referring Piryekian peter Phescn hire DOB Age 1 30 1956 Crartndaan Date 11 30 2008 7 behae LESCEsooh Vi My wes 2 Scroll Rar MR EE Sohna Renaa Normes Esaphegea red dd y te Lavtuets Hribar of eronliceen aak ad sr 9 Proc LES frons nares koro 41 5 Eveluaed o x D 11 0 serve LES LOS inrigthi cru se eke ively x 6 25 aor 199 Esooh sed lenorh 0L ES UES centers ow sure Ir raabcicarared LES berde ca a qe Hal hernia Motility EE LES Preenses 72 1 43 152 Pyessurt reset vestf eed sae bP Mean are churabiori 29 2 754 feed reapiracance min menit 1 6 4 6300 Double pasted waver a sU Basy resoeaony eorom 161 1248 Tritt peated movesi 0 qu Reckhed reese brew tg a0 c15 D Veipatey L11 D 3 D abre LES KERKE 2 3 2543 He Fersoluti n Par sees ected contracta Pieced rear nattg x l 611 2 30 5000 Contr ste frat veld yicay s 2 7 30 F7 Fctude VES PRE ve Hess Upper Esophageal vd va roteer asm aan have wel Mean bac perverse ik 9 Mean rende preis rry UES Pharynx Summary 73 Ez e Chago Oats cation Freire Ez behade E plan aon Ore ae Che i soon
38. document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved Gl VE IMAGING ManoView ESO Analysis Program elect parameters to be included in report In screen analysis tools are provided according to selections Tabular Graphical Individual Summary Summary Swallows Data Table Classic Manoview dAAAAIAIAAIATAIAYIATATIAA AATAAAITIAAITITITYTITITIAA AAAAAITIAAYITITITYTITIIAA High Resolution Parameters Distal contractile integral mmHg cm 5 Distal contractile integral highest in group rmmHug cm s Contractile Front velocity cms Intrabolus pressure LESR mmHg e avo max mmHg Um latency sec Failed Chicago Classification panesophageal pressurization So premature contraction rapid contraction OOO gaala TIAAAAAIAAIAAIAAYIATATIAA OWS OTS a TI1AAA gaa JAAA Figure 9 1 Sample Setup Report amp Analysis Form Setting for Chicago Classification The following Analysis Options settings are set by Default If these are changed the Chicago Classification Findings will not be presented in the Report Form e LES Relaxation 4 0 sec IRP e eSleeve used e DCI 20mmHg isobaric contour 9 3 Analysis The analysis workflow for Landmark and Swallow frame is similar to that of conventional analysis The Landmark frame is analyzed and then the Swallow frames Refer Section 2 Quick Start for a overview of analysis amp reporting
39. e placed in different directory as long as the mvd file is not moved from original location This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GITEN ManoView ESO Analysis Program 9 Chicago Classification Setup amp Analysis Chicago Classification is a recently developed scheme for classifying esophageal motility disorders based on high resolution esophageal pressure topography This scheme is published by the International High Resolution Manometry Working Group ManoView ESO supports the Chicago Classification metrics parameters and outputs corresponding diagnosis result suggestions in a semi automated fashion 9 1 Parameters The Chicago Classification scheme defines several analysis parameters based on high resolution esophageal pressure topography to characterize the swallows A brief description of these parameters as described in the publication is provided below Please refer Appendix A Analytical Parameter Notes for elaboration on specifics of implementation and adoption of these parameters within the ManoView ESO software Integrated Relaxation Pressure IRP Mean EGJ pressure measured with eSleeve for 4 contiguous or non contiguous seconds of relaxation in the 10second window following deglutitive UES relaxation Distal Contractile Integral DCD Amplitude x duration x length mmHg s cm of the distal esophageal contraction greater th
40. ean 1202 0 mmHg DCI 545 4 mmHg Catheter Position 52 5 cm 4 83 3 LES Length 4 0 cm CFY 3 2 cmjs ae 10 1 4 ILES Intraab Seg 2 5 cm Onset Veloc 3 0 11 0 2 7 cmjs lebanese eas 14 1 2 LIES Pressure 395 1 mmHg Multiple Peaks No Patient Name First Name Middle N 18 1 5 UES Resid Press 1 1 mmHg i30 13 1 Il EL IB o Data Panel Patient Information Figure 3 1 ManoView Analysis Window Organization Swallow 4 Swallow 2 o Swaloe 3 o Swallow 1 i Pharynx 1 T pa I K i 2 2 jj Ad ME es N EE MT pa Lascia s N A i A ef L M 7 5 2i eu SUN Colorbar 0 j e M i j n e 25 v N T a b Figure 3 2 Analysis Window a Contour Mode b Line Trace Mode This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved ManoView ESO Analysis Program IMAGING GIyEN EANDOOO ik i Pharynx 200 0 o a a 6 s 2 s 11 m Ei e amp 16 T L rd s 21 5 D 26 s 31 L gt iw e 0 0 Stomach Figure 3 3 Analysis Window displaying pressure data in Trace on Contour mode 3 1 5 Control Buttons The Analysis Window provides control buttons for frequently used functions Table 3 1 Analysis Window Control Buttons identifies these controls and describes their functionality
41. eate and print the report The program can generate a summary report and a table of detailed parameters It is possible to include images of each of the measurements in contour and or line trace formats and any screenshot captured images acquired captured via the Capture Image button in the Main Window The report is generated as a Microsoft Word document or PDF which may be printed and saved 2 6 Saving an Analysis It is possible to save patient analysis data to your computer or network drive after printing the report or at any time during the analysis process by selecting the Save Analysis option under File menu Important Notes for Saving and Opening Files It is advised to create and maintain a dedicated directory for analysis mva files separate from data acquisition mvs files to avoid confusion between the file types Assure that when re opening a previously saved analysis file select analysis file type mva rather than the original data acquisition file mvs with the same basic file name 2 Special Esophageal Wave Markers Classic analysis Certain special esophageal markers shown Figure 2 7 exist in the region of the Esophageal Wave adjustments to characterize abnormal swallows they are indicated by This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIyEN ManoView ESO Analysis Program C Simultaneous Contractions
42. ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 49 FIGURE 7 7 PEAK INSPIRATION AND MID EXPIRATION TIME INSTANCES ARE INDICATED USING SHORT VERTICAL RED LINES EER EE ER EK EA N N ON N DI OE ON totems A E E IT E T A A 49 FIGURE 7 0 ANALYSIS OPTIONS FOR OD ANALYSIS sesse sesse te OR be en ee see ee ee ee ea Ne Ee ee ee ee ee DIS UR AO Re don tuned ed GOEIE 50 FIGURE 8 1 BLUE MARKERS OVER MAIN DISPLAY INDICATE THE TIME RANGE FOR WHICH RECORDED VIDEO DATA IS PM di ES RS SON HEERS EE OE AR EE N OE OE OS OE Yxe Y 51 gie giis VIDEO VR EO ME ES T 57 FIGURE 9 1 SAMPLE SETUP REPORT amp ANALYSIS FORM SETTING FOR CHICAGO CLASSIFICATION ese ees ese see ee ee ee ee ee ee 55 FIGURE 9 2 SWALLOW ABNORMALITY TAGS IN EVENT FRAME A PERISTALTIC INTEGRITY INDICATED AT THE RIGHT TOP B HYPERCONTRACTILE CONTRACTION INDICATED USING ACRONYM AT THE RIGHT BOTTOM essere enne 56 FIGURE 9 3 CHICAGO CLASSIFICATION PARAMETERS AND FINDINGS PRESENTATION IN REPORT FORM cmm 5f This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIyEN ManoView ESO Analysis Program IMAGING ene 1 Introduction Welcome to ManoView ESO analysis program The ManoView ESO analysis program also referred as ManoView provides tools to efficiently analyze information obtained via the ManoScan system consis
43. entifies each tool bar control and describes its functionality The displayed time range can be zoomed in by right clicking on the Main Display and dragging it Table 4 1 Zoom Tool Bar Controls Tool Bar Controls Functionality Zoom In Zooms in the display width to 1 2 size in seconds Zoom Out Zooms out the display width doubling the size in seconds Zoom Out Fully Zooms out the display to show all the data in a single view Table 4 2 summarizes the shortcuts that can be used for easier navigation and frame editing Table 4 2 Keyboard Mouse Shortcuts Zoom in to any selected time range Open close measurement frame for analysis This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GITEN IMAGING ManoView ESO Analysis Program 5 Report Window The ManoView ESO Analysis Report window provides features and capabilities for rapid report generation and customization to a user s specific needs The use of check boxes allows for selection of information categories and pull down lists let and the user save and re insert commonly used textual information and ICD codes The particular analysis parameters that are available in the report form may be custom specified via Report amp Analysis described in Section 3 3 3 1 After reviewing and completing the on screen report form a Report document is generated that may be printed and or saved in a separate file
44. ents The pressure threshold is adjustable and has default of 20 mmHg Peristaltic Break Gaps in the 20 mmHg isobaric contour of the peristaltic contraction between the UES and EGJ Peristaltic breaks are used to classify the peristaltic integrity in one of the following types a Intact 20 mmHg isobaric contour without large or small break 2cm b Small Breaks Small break in the 20 mmHg isobaric contour 2 5 cm in length and DCI 5 000 mmHg s cm c Large Breaks Large break in the 20 mmHg isobaric contour gt 5 cm in length d Failed Absent Absent peristalsis Less than 3 cm integrity of the 20 mmHg isobaric contour distal to the proximal pressure trough in any swallow or DCI 100 mmHg e Failed Panesoph Panesophageal pressurization Contractile Front Velocity CEV Slope between two representative points on the contraction wave The proximal point on the contraction wave is located at 50 of the distance between LES proximal and UES The distal point on the contraction wave is located at 2cm from the LES proximal This implementation in software differs from the published definition for Chicago Classification The publication defines CFV as slope of the tangent approximating the 30 mmHg isobaric contour between proximal pressure trough and the CDP This definition is adapted in the software to enable robust implementation while at the same time keeping the essence of the parameter Like all the analysis markers the user shou
45. esid Press 8 0mmHg EER Pay 0 8 LES Press mean 18 1 mmHg DCI 633 2 mmHg c Catheter Position 52 5 cm 4 54 1 LES Length 4 0 cm CFY 2 7 cms s Atmosph 14 0 5 LES Intraab Seg 2 5 cm Onset Veloc 3 0 11 0 2 3 cms FRUI ID Leto y 18 2 2 UES Pressure 86 3 mmHg Multiple Peaks No Patient Name First Name Middle N 226203 LES Resid Press 1 1 mmHg 26 23 8 Figure 2 2 Analysis Window with patient information loaded 2 2 Prior to Analyzing Event Frames Prior to starting analysis a few basic steps are required to prepare the study for analysis Setting Thermal Compensation this adjustment adjusts the baseline pressures to account for signal drift caused by the warming of the pressure sensors while in the patient s body o On the Navigation Bar at the bottom of window click the icon gt i at the end of the Bar This will display the end of the study where the patient was extubated o Click Drag and place Red Vertical Time Bar beyond anatomical pressure waterfall image the beginning of the atmospheric dangle with no external pressure being applied o From the Tools Menu select Set Thermal Compensation This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIyEN ManoView ESO Analysis Program IMAGING o Click on Set Range Button located below the Pressure Color Bar on left side of Analysis Widow to adjust color of Contour Mode Ad
46. ew ESO All masked channels may be unmasked using this same Mask Channels control Mask channels functionality is generally used when one or more of the catheter sensors are not functioning properly Position Units Allows for selection of Position Units with the following options From Nares based on the catheter position contained in the original data file From LES LES is shown at the 0 position and Sensor Channel 1 36 Allows to choose the format of date time and height of patient to be printed in report Languages Displays a list of selectable languages for the User Interface After making a selection the user interface will be translated the next time the software is launched Allows user to select the default locations of Report and HIS Export folders This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved Gl VEN IMAGING ManoView ESO Analysis Program K 3 3 3 1 Report amp Analysis The Setup Report amp Analysis window allows for selecting parameters to be included in data table window and in the report If a parameter is deselected on this across all fields on the setup window the corresponding on screen analysis tool s will not be displayed Figure 3 9 shows a snapshot of the window Unchecking the header Classic ManoView or Chicago Classification disables all the parameters within the group In the sample case shown in the fig
47. for each selected parameter in the Report Form and Report Figure 9 3 shows a snapshot from the Report Form with relevant portions highlighted The mean value of each parameter selected in Setup is displayed The software also displays the final diagnostic findings based on Chicago Classification scheme The parameter values for individual swallows can be viewed in All Data Table or in the Report document The findings are based on published Chicago Classification scheme and are only intended to serve as a guide for patient diagnosis This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved TEN IMAGING fi ManoView ESO Analysis Program ii High Resolution Parameters Distal contractile integralimeanimmHg cm s 13309 8 500 5000 Distal contractile integralihighest irmrmHa cm s 39478 3 Contractile Front velocityiicmy s 11 7 za Intrabolus pressure LESR mmHg 13 zB 4 Intrabolus pressure avg max mmHg 90 4 zl itaga tlassirication Distal latency 5 Failed Chicago Classification panesophageal pressurization So premature contraction rapid contraction large breaks small breaks Include UES Pharynx Results Include Chicago Classification Findings Include Explanations EG Outflow obstruction Mean IRF 26 3 mmHg is greater than 15 mmHg Esophageal body No normal peristalsis Spastic esophagus premature contraction 83 is greater than 20
48. he system must have Microsoft Word 2007 2010 with Microsoft Save as PDF Add in installed for ManoView ESO to be able to send Report to HIS in PDF format The location can be set from Folders option under the Setup Menu The file format for export is shown in the figure below The Hospital Information System Electronic Medical Record can interface with the ManoScan ESO software to send patient information and to ManoView ESO software to receive the analysis Report lt stuay gt lt patient gt lt dob gt 1975 03 20 lt dob gt yyyy mm dd lt name gt lt first gt First lt first gt lt last gt Last lt last gt lt middle gt Middle lt middle gt lt name gt lt gender gt 1 lt gender gt Male 1 Female 0 lt height gt 1829 lt height gt units mm lt id gt 123 45 6789 lt id gt lt patient gt lt procedure gt lt impressions gt Impressions1 lt impressions gt lt indications gt Indications1 lt indications gt lt interpretations gt Interpretation1 lt interpretations gt lt procedure gt Esophageal Manometey lt procedure gt lt description gt ProcedureDescription1 lt description gt lt procedure gt lt studv gt Figure File Format for import export of patient information This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved ManoView ESO Analysis Program Index A abbreviations ees esse eee 6 2T FOYER
49. ides analytical information by using right and left clicks of the mouse The data is displayed next to the cursor and in the Current data table at the lower left of the screen This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING ManoView ESO Analysis Program GIyEN This submenu allows the SmartMouse to be turned on or off and selected between two modes of operation Table 3 7 identifies each Smart Mouse Submenu Option and describes its functionality Table 3 6 Tools Menu Option Tools Menu Option Functionality Smart Mouse Opens the SmartMouse submenu with diagnostic tools available through operation of the cursor see Section 3 3 4 1 Guidelines Opens a submenu that allows the user to turn on and off guidelines in the Contour display Isobaric Contour Toggles on and off Isobaric Contour control that shows a line in the contour main display mode at the constant contour pressure level adjustable via a control next to the color pressure map of the Main Display The displayed pressure is relative to the current pressure reference Additional isobaric contour may be enabled by pressing Shift key left mouse click mouse drag on the control located next to pressure map The additional contour may be disabled by bringing the additional control close to the original control Display Mode Options Allows one or more of the following display modes to be
50. imum minimum scale selected for the trace refer to Figure 3 2 b The minimum and full scale pressure ranges are adjusted by clicking on the legend range control Contour Mode and Line Trace Mode show the same information in the two primary display modes 3 1 4 Trace on Contour Mode This mode displays the pressure or impedance line trace data superimposed over the contour plot The data can be displayed in this mode by using the Display Mode Options button under the Tools menu Figure 3 3 shows an example in Trace on Contour mode This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING OIgEN ManoView ESO Analysis Program E4N0000 a GWEN zm Menu Bar a j T i e LE g 7 nim swi swal Swi Swe sw swi l aX Pharynx mal Zoom Tool Bar l S T 3 l m TE Profile Panel wu i li 4 5 83 De ee e Dee ee Dooce oeoo IE TN uL LaL dbi N Eg j Window Controls Navigation Bar G hr p IE m EM ON ON ON Ups EE SE mit 0 0 Stomach j EE om y MC wy Wy NER ALS EE ecu m 5 ny wn GE a BE as anaes je TrgteZhannel Snapshot Landmark amp Pressures Swallows avg fio fh3 39 ER ILES Press resp min 759 5 mmHg ILES Resid Press 8 0mmHg er y 0 5 ILES Press m
51. in ManoView ESO The peristaltic integrity for a swallow is classified into four types Intact Small Breaks Large Breaks and Failed The Failed swallows are further classified into Failed Panesoph indicating panesophageal pressurization and Failed Absent indicating absent peristalsis The peristaltic integrity tag is available at the right top of the event frame see Figure 9 2 a This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING OIgEN ManoView ESO Analysis Program The peristaltic integrity for Classic ManoView is defined differently than for Chicago Classification scheme The Classic ManoView uses esophageal wave markers to categorize swallow as Failed or Not Failed If both Chicago Classification and Classic ManoView are selected in the Setup Report amp Analysis form then the calculation of peristaltic integrity will be based on Chicago Classification scheme Certain special swallow characterization markers only applicable to Chicago Classification are shown at lower right of the event frame to characterize abnormal contraction pattern They are indicated by Hyper Hypercontractile Rapid and Premature labels Figure 9 2 Swallow abnormality tags in event frame a Peristaltic integrity indicated at the right top b Hypercontractile contraction indicated using acronym at the right bottom 9 4 Result The software presents the results
52. ion Pressure IRP Distal Contractile Integral DCI Contractile Front Velocity CFV Distal Latency DL Peristaltic Break and Contractile Deceleration Point CDP are the analysis metrics defined with this scheme Note the following section parallels the steps outlined by the Guide function located on the top right side of the screen By activating Guide the user will be walked through the analysis process The International High Resolution Manometry Working Group Chicago classification criteria of esophageal motility disorders defined in high resolution esophageal pressure topography Neurogastroenterology amp Motility March 2012 vol 24 57 65 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved OIgEN ManoView ESO Analysis Program IMAGING Manoview SIE II IE GWEN EM E4N0000 mmHg Landm O ie o T pesce Swe SwalO Swid Swe sw Swe aM p a EMI NI a e Pharynx 99078999 9 Pressure Profile Display 10 0 Set Range De ese ee ee eccesso Navigation Bar 0 0 150 0 ON on os OR on ON MT jon HE qnit l Display Mode a a on Joe Id EE T E LI B E I 1 a Hm ri Sense ch Ch Trace Channel Snapshot Log Data Landmark amp Pressures La Peter gt Mode Gastric Gastric ress resp min 6m 0 8 ILES Bea eal 18 1
53. is mode displays the impedance or pressure traces superimposed over the contour plot This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GITEN ManoView ESO Analysis Program 6 1 1 4 Pressure Impedance Profile Panel The profile panel shows both the pressure and impedance profile An intuitive depiction of bolus transit is also done by using the impedance information Figure 6 3 shows a normal swallow physiology in the profile panel Pharynx 35 Pharynx 35 Pharynx A A Pressure Impedance Pharynx N m un o a c uw snbeudos3 snbeudos3 Stomach Stomach Stomach Stomach Figure 6 3 A normal swallow physiology shown in profile panel The impedance profile range control can be activated deactivated using the corresponding option under Tools gt Display Mode Options 6 1 1 5 Show Z Hide Z This control allows showing or hiding the impedance data in the Contour mode It is located below the color bars on the bottom left side of the analysis window 6 1 1 6 Display Mode This button allows switching the analysis window display to any of the available display modes The available display modes can be selected by using Tools gt Display Mode Options 6 1 1 7 Display Mode Options The pressure and or impedance data can be visualized in several combinations of contour and trace modes The display modes can be selected using the Disp
54. ist is shown in Figure 5 2 Include Procedure Description List Name Field Figure 5 2 Procedure Description Pulldown List Adding To Pulldown List To create a custom Procedure Description enter the desired name e g Small Bowel Manometry in the List Name field Then type the description in the Text Field and select Save Note Selecting Save will cause all text in the Text field to be saved under the current list name If there is a blank text field and Save is selected no text will be saved under the name in the List Name field Using An Existing Pulldown To use a previously saved description select it from the pulldown list and select Add from list This will add the corresponding information to the end of any text already in the Text field If an additional selection is made from the list it will be added at the current insertion point where text would be added if typing Removing Pulldown List Elements To delete a saved description choose it from the list and select Delete ICD Codes ICD codes can be added or removed in the same fashion as described above To add a code type in the code and descriptive title e g ICD 787 2 Dysphagia that should to appear on the report in the corresponding text field No other text should exist in the text field at this time Type the title desired to list this code by e g Dysphagia in the List name field for the ICD code and select Save Deleting an ICD code 1
55. just Minimum to eliminate any grey color streaks and adjust Maximum to minimize any off scale pink colors Review Study Measurement Frames on the Navigation Bar at the bottom of window click the icon ll on the left side of the Bar this will allow you to review each individual Swallow Frame one at a time During this process adjust delete or add Measurement Frames as appropriate o Adjust the swallow measurement frames left edge such that it includes approximately 3 seconds of time prior to the UES relaxation to include a baseline for bolus transit pressures o Adjust the swallow measurement frames right edge such that it includes the LES clamp down approximately 10 seconds after LES relaxation o To delete an Event Frame place the Red Time Bar within the Frame click on Tools Menu and select Remove Frame o To add an Event Frame place the Red Time Bar over the desired area of the study click on Tools Menu and select Insert Frame and choose the Event to be added Landmark Id or Swallow 2 3 Editing the Landmark Id Frame The Landmark frame is identified by the green gray rectangle with dashed outlines To analyze and edit the diagnostic information in Landmark frame do the following Move the time bar to the Landmark frame and zoom in to expand this frame using the zoom button indicated by A icon Click on Landmark Id or on the O shaped icon in the upper right corner of the frame to open the frame
56. ke JO Kwiatek M Kahrilas PJ Impaired deglutitive EGJ relaxation in clinical esophageal manometry a quantitative analysis of 400 patients and 75 controls Am J Physiol 2007 293 G878 G885 2 The International High Resolution Manometry Working Group Chicago classification criteria of esophageal motility disorders defined in high resolution esophageal pressure topography Neurogastroenterology amp Motility March 2012 vol 24 57 65 3 Tutuian R et al Esophageal Function Testing With Combined Multichannel Intraluminal Impedance and Manometry Multicenter Study in Healthy Volunteers Clinical Gastroenterology and Hepatology 2003 1 174 182 4 Kwaitek MA Pandolfino JE Kahrilas PJ 3D high resolution manometry of the esophagogastric junction Neurogastroenterol Motil 2011 Nov 23 11 e461 9 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIyEN ManoView ESO Analysis Program Appendix B Anatomical Marker Positioning Guidelines The following guidelines may be followed to set the anatomical markers in the event frames The UES marker is placed in the middle of the horizontal UES pressure band The LES marker bisects the end expiratory pressure profile of the LES The LES upper margin UM marker is placed just at the upper extent of LES proximal end expiratory pressure signature The LES lower margin LM marker is placed j
57. lay Mode Options under the Tools menu The display combinations that are available for main display are Enable Traces on Contour This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIVEN IMAGING ManoView ESO Analysis Program Enable Impedance Traces Enable Impedance Traces on Contour The display combinations that are available for profile display are Enable Profile Trace Persistence Show Catheter in Profile Show Diaphragm in Anatomy 6 1 1 8 Bolus Clearance The status of the bolus swallowed during test maneuver can be indicated for swallow frames at the time of analysis by toggling the Bolus cleared Incomplete Clearance tag The bolus clearance status can be changed by clicking the magenta colored label indicating bolus status shown in Figure 6 4 If this label is not visible on the main display check the boxes which correspond to Incomplete bolus clearance under Setup gt Report amp Analysis Based on the bolus status indicated in each frame the incomplete bolus clearance is expressed as percentage of the total swallows in the Report Swalow S a Venns J l tag p Bolus status label control Figure 6 4 Bolus status control shown during a pressure impedance analysis This document contains proprietary information Source Given Imaging Copyright 2013 Give
58. ld reposition the CFV marker if the auto placement is not placed approximately at the tangent of the wave propagation Contractile Deceleration Point The point on the CFV line located at 10 of the distance between LES proximal and UES This implementation in software differs from the published definition for Chicago Classification The publication defines CDP as the inflection point along the 30 mmHg isobaric contour where propagation velocity slows demarcating the tubular esophagus from the phrenic ampulla This definition is adapted to enable initial placement of CDP marker in the software Like all the analysis markers the user use should reposition the CDP marker if the auto placement is not performed appropriately This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIyEN IMAGING ManoView ESO Analysis Program Distal Latency Interval between UES relaxation and the CDP expressed in seconds Impedance Parameters Bolus Transit Time The time interval between bolus entry and bolus exit point during a swallow Maximum impedance drop at 5 0 cm and 20 0 above LES proximal boundary is used to determine the bolus entry and bolus exit instances 3 Incomplete Bolus Clearance The of swallows for which the user has manually set the Bolus Status tag in the Main Display to Incomplete Clearance REFERENCES 1 Ghosh SK Pandolfino JE Rice J Clar
59. m The ManoScan system manual should be referred to before using the system for data acquisition or diagnosis Rx Only Given Imaging 3950 Shackleford Road Suite 500 Duluth GA 0123 30096 USA supportUS givenimaging com Ec REP Given Imaging GmbH Borsteler Chaussee 47 D 22453 Hamburg Germany supportEU givenimaging com This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GITEN ManoView ESO Analysis Program IMAGING 1 Table of Contents INTRODUC TONE ee oe ne SPR IE re eRe ee DE eR nO ose GE EE LET 6 LP INTENDED ADEN GC Bi esse ie sees Me oe ese see De ee ee EE ede Se ee ee ee Gee ee Se De es EE ee EE EA 6 1 2 PURPOSE OF THIS MANUAL ese ese ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 7 1 3 ACRONYMS AND ABBREVIATIONS cccsceccsceccsceccececcsceccececcsceceececeececscscesceceeescsscecsscscecescsceecscscececscsscscesescesescesecs 7 14 INDICATIONS OF USE cO 7 1 5 CONTRAINDICATIONS OF USE ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 8 16 INTENDED USE else iss ese dese ss ee sos se es oes de ee de ei ee ooo oe oe eg de ee es enn ee Ge ee ee oe ER 8 1 7 WARNINGS CAUTIONS bies sseskaen Sud ns soes sene eie es ee ee ge Ee se oi eo es ee ee ge oe ee ee GO Ge oe dep 8 OUICK STAR EE EE EE EE RE EE N EE N OE EE ONE 9 21 B
60. mal and distal boundaries patent pending Classic ManoView Parameters LES Pressure Taken relative to frame gastric mean using eSleeve or LES channel if eSleeve not used Esophageal Wave Amplitude L7 L2 and L3 Taken relative to esophageal channel baseline UES Pressure and U7 amp U2 Amplitudes Taken relative to atmospheric pressure Esophageal Multiple Peak Criterion Any peak that has at least a 10 mmHg valley between it and an adjacent higher peak and is separated by at least 1 second from the neighboring curve Simultaneous Contraction Criterion Velocity between wave onsets at LJ and L3 of at least 6 25 cm s Failed Swallow Criterion Swallow measurement frame containing at least two esophageal body analytical channels i e at LI L2 or L3 with peak amplitudes less than 20 mmHg Failed Swallows are not counted in the group summary parameters for the esophageal body and LES other than in percent failed swallows Intrabolus Pressure 1 IBP1 Average pressure in the intrabolus pressure region taken during the time of the LESR solution and constrained by the condition of an absence of significant pressure gradient gt 2 mmHg along the length of the IBP measurement The pressure is taken relative to gastric pressure This parameter is also known as IBP Esp Intrabolus Pressure 2 IBP2 The mean of the maximum pressure measured within the IBP within a non continuous duration of 3 second width Here as in IBPI the solutio
61. n Imaging All rights Reserved GIyEN ManoView ESO Analysis Program IMAGING 8 2 Controls The following buttons are available on the video window see Figure 8 2 l Magnification buttons the video display can be zoomed in zoomed out or set to 100 zoom using the buttons a and respectively Crop button tt to crop the video for view purpose only does not reduce the video file size Capture button ra to capture the image the captured image is available for printing in the Report Frame by frame navigation the video display can be navigated one frame by frame the lt amp gt keys on keyboard aoaaa Figure 8 2 Video Window This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GITEN ManoView ESO Analysis Program 8 3 Video File Association Details When a pressure video study is acquired and saved using ManoScan the software creates two files with identical names one for pressure impedance data extension mvs and one for video data mvd The ManoView ESO associates a video file with the mvs study file only if two files have the same name and they are in the same directory When ManoView ESO saves a pressure video analysis file extension mva it saves the name and location of the mvd file Hence ManoView ESO can associate the analysis file with the mvd file even if they are of different names and ar
62. n Imaging All rights Reserved IMAGING GIyEN ManoView ESO Analysis Program 7 3D Visualization and Analysis ManoView ESO when used in conjunction with a 3D ESO catheter provides the tools to visualize and analyze 3D data for the region encompassed by the 3D sensors The data is obtained via the ManoScan 3D module This chapter covers the additional features specific to the 3D HRM analysis Readers should refer to Chapters to 6 for standard HRM features of ManoView ESO 7 1 3D Window Organization The pressure data acquired from the 3D sensors of the catheter 1s displayed in a separate 3D Window see Figure 7 1 This window is initiated by the 2D 3D button available at the bottom left of the software The 3D sensor zone is marked in blue in the profile panel to distinguish from regular sensors Landmark Id Pee coGecceVeceely eeoeoReeeeSeeeeneseevles etes 4 Pharynx A 3D sensors zone marked in blue 3D Window A snf eudos3 SE Figure 7 1 Pressure data in Contour mode with 3D HRM window There are three different views in the 2D 3D window that utilize the unique functionality of the 3D ESO catheter 7 1 1 3D HRM The 3D HRM view displays a 3D cylinder view of the sensors Figure 7 1 Observe that clicking and dragging the mouse will cause the cylinder to rotate Also note that the top and bottom as well as the 2D map origin of the cylinder are
63. n is restricted to not include regions of significant pressure gradient gt 2 mmHg along the length of the IBP measurement The pressure is taken relative to atmospheric pressure This parameter is also known as IBP max This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIyEN ManoView ESO Analysis Program LES Relaxation LESR a 3 second nadir The lowest continuous 3 second mean value in a Swallow Measurement Frame using the difference between the eSleeve or basic LES and gastric channels b Integrated Relaxation Pressure IRP The lowest mean value measured by a non continuous window of user specified width set by default to 4s using the difference between the eSleeve or basic LES and gastric channels 1 Chicago Classification Specific Parameters Integrated Relaxation Pressure IRP Mean EGJ pressure measured with eSleeve for 4 contiguous or non contiguous seconds of relaxation in the 10second window following deglutitive UES relaxation The pressure is referenced w r t gastric channel The relaxation duration is user adjustable Distal Contractile Integral DCI The integrated value of pressure above some threshold over position and time The time boundaries are limited to be within the measurement frame the distal boundary is the upper margin of the LES and the proximal boundary is the pressure nadir between Ist and 2nd esophageal segm
64. nalities are described below NNI e Figure 7 4 Buttons from left to right a Anatomy Toggle b Deflection Range c View Mode d Capture e Home f Zoom 7 2 1 Anatomy Toggle The anatomy toggle button works in the 3D HRM and 2D 3D HRM views It turns on and off the anatomy drawing See a representation of the anatomical supplement in Figure 7 7 7 2 2 Deflection Range The deflection range buttons will change the deflection ranges of the cross section view in the 2D HRM and 2D 3D HRM views This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIVEN ManoView ESO Analysis Program 7 2 3 View Mode The button toggles between the following view mode a Wide cylinder b Narrow cylinder c Vector Volume 7 2 4 Capture Takes a screen shot of the current view of 3D HRM window for later printing or saving in the Report 7 2 5 Home amp Zoom The Home button will place the 3D window back in its original place in the lower left hand corner of the contour screen in the event that it is moved somewhere else or resized The Zoom button will increase and decrease the size of the 3D window 7 2 6 Rotation The rotation buttons translate the 3D cylinder view around its desired axis Figure 7 5 Clicking these buttons will rotate clockwise To rotate counter clockwise hold Shift then click the rotation buttons Figure 7 5 3D Cylinder Rotati
65. oftware program is a component of the ManoScan system and is intended to be used as an analysis tool that may be used for detailed analysis of pressure impedance and or video data acquired during ManoScan procedures The tool is intended for use by trained medical personnel when performing analysis and may be used to generate reports quantitative results and or reference images 1 Warnings Cautions The ManoView ESO software program is a component of the ManoScan system and is intended to be used by trained medical personnel only in performing diagnostic analysis of data collected using these systems This software tool assists in the diagnostic process by providing visual images and quantitative estimates of physiological parameters but clinical conclusions should not be made without proper medical training on the applicable physiological elements and proper consideration and understanding of the patient history Sections 2 through 5 illustrate the analysis and visualization features available with pressure data input Section 6 7 and 8 discuss the additional features that are enabled in the software while using combined pressure impedance pressure video and 3D pressure input files Section 9 discusses the details of Chicago Classification scheme This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIyEN ManoView ESO Analysis Program 2 Quick Start
66. ome of the characteristics of the swallow frame are marked by labels in the Main Display itself These are o Not Fld Not failed shown as ntact when Chicago Classification 1s enabled o No SC Not simultaneous o Single Indicates single peaked contraction This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GI TEN IMAGING Adjust the following markers if necessary LES relaxation markers eSleeve Start Peak and End Wave markers for the three esophageal body analysis locations for Classic ManoView analysis or the CFV CDP and DL markers for Chicago Classification analysis Some of these markers are shown in Figure 2 5 a and b ManoView ESO Analysis Program If analysis of the UES and pharyngeal motility is desired adjust the locations of the Start Nadir and End Relaxation for the UES and the Start Peak and End Waves for the pharyngeal channel located above the UES See Appendix C Swallow Frame Analysis Guidelines for detail guidelines on placing analysis markers for Classic and Chicago Classification schemes Repeat this process for the remaining swallow measurement frames Clicking on the icon cH located at the right of the Navigation Bar moves to the next event frame The Navigational Bar s colored dots change from red unopened to yellow currently open and then to green when closed to indicate which frames have been reviewed dN Pha
67. on 36 Running The Program esee 9 S Save aid SS ee RE de oe AE 25 Save Data ie T ei 23 Save Selected Data esse see see ee ee ee 25 Saye ELLOS es Es ee Ee 22 26 Saving an Analysis esses 15 SC Simultaneous Contractions 6 16 Set Detailed Restore Thermal Compensation Ee 3 GIyEN IMAGING Set Limits Button sesse se Ge Ee 23 setup VIG DU ese DE ee OE EE Mua 26 Setup Table WindOW esse ee 22 Detap Asie arie m 27 Smart Mouse Submenu 30 31 Swallows Data Panel ov T IDEE ese Te 6 Thermal Compensation 360 31 Three Second Nadir i 6 Trace Display Channel Control 6 U dio N 6 Using An Existing Pulldown 38 Using Measurement Frames 33 V View Menu sesse ee ee 26 Z TOON CONDOS si se cease 23 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved ManoView ESO Analysis Program GIg EN Z P IMAGING Contacting Given Imaging On the Web www givenimaging com USA amp Headquarters of the Americas Given Imaging Inc 3950 Shackleford Road Suite 500 Duluth GA 30096 USA Phone 770 662 00870 Toll Free 1 800 GIVENGI Fax 770 662 0510 USA supportU
68. on Buttons 7 3 3D Analysis Setup 7 3 1 Setup Report amp Analysis The Setup Report amp Analysis window available from Setup menu allows selection of the desired 3D parameters see Figure 7 6 These parameters can be calculated at the following time instances Peak Inspiration Mid Expiration and Swallow Residual see Section 7 3 2 for details on Swallow Residual This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING ManoView ESO Analysis Program OIgEN 3p ANALYSIS Time Peak Inspiration Mid Expiration Swallow Residual Parameters LES length cm Maximum pressureimrmHg Minimum pressuretmmHg Maximum to minimum difFerence mmHug Asymmetry type Of mmHg Asymmetry type 1 mmHg Asymmetry type 2t mmHg Asymmetry type 3trrmHa Asymmetry type dirmHa 1000044441 JAR 01000704441 OF Ed Figure 7 6 Asymmetry type selections in Setup Report amp Analysis The Peak Inspiration amp Mid Expiration time instance markers are available for the Landmark Event frame only see Figure 7 7 They are indicated by vertical red lines in the Main Display spanning the length of the 3D sensors Either of the location can be chosen by clicking on the corresponding red line The 3D window displays the data corresponding to the chosen instance The Regular 3D Table button located below the Main Display can be toggled to display hide the 3D parameter values
69. raximal margin cm above LES Distal margin cm below LES a b Figure 3 10 eSleeve window a eSleeve LES trace tab b LESr tab Integrated Relaxation Pressure IRP Use 40 E s interval 3 3 3 3 Channels Trace Display Channel Control The selection of channels that appear in the Main Display Line Trace mode may be made by Free Selection or reference to the anatomical landmark pointers Landmark Reference see Figure 3 11 In addition the channels may be repositioned using the channel markers in the Pressure Profile display Channel selection is only available before any measurement frames have been opened i e before analysis has begun Further computer assisted analysis to generate diagnostic parameters for the esophagus is only available when the channels are in Landmark Reference mode The free selection of Impedance channels during impedance study analysis is also available from this menu This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved Gl TEN IMAGING ManoView ESO Analysis Program Ss Pressure CO Free Selection Detent Landmark Reference Figure 3 11 Trace Channel Control Display Free Selection Choose any number of channels between 1 and 12 for display using the control shown in Figure 3 11 These channels may be repositioned by sliding the corresponding markers in the Pressure Profile When the Detent checkbox is selected
70. re automatically reassigned new numbers in the report A frame can be removed by moving the Time Bar over an existing frame and selecting Tools Remove Frame This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIg EN ManoView ESO Analysis Program Ss IMAGING 4 2 2 Moving and Resizing a Measurement Frame Move the right and left sides of a measurement frame by left clicking the upper or lower areas on the frame boundary then dragging to the desired location This allows for the resizing or moving of frames Moving and resizing of frames may be done at any time during the analysis 4 2 3 Annotations Annotations can be added by right clicking anywhere on the Main Display and clicking on Add Annotation label An existing annotation can be deleted by right clicking on the annotation line and clicking on Delete Annotation label The annotation can be moved by left clicking and dragging the marker Left clicking on the text allows the user to edit the current text associated with the annotation 4 3 Navigation Bar amp Time Controls The Navigation Bar allows the user to quickly move anywhere within the data record as shown in Figure 4 1 the bar includes a slider that shows the width of the current main display and its location in the record Green gray landmark Id and blue gray swallow rectangular areas show the location of measurement frames A dot in the center of each
71. ree Selection Specify the number of free channels using the drop down list Click Ok Adjust the free channels positions in the Pressure Profile panel as desired Once channel positioning 1s done the data collection can be done in the following manner Use built in tools such as the SmartMouse eSleeve and Isobaric Contour function to view data at a particular point refer Chapter 3 for description of these functions Data corresponding to the current tool or function being used are displayed in the lower left corner of the Main Display in the table labeled Current when Show Data button located at right bottom of Main Display is active Discrete values for all the channels are obtained by moving the time bar to the desired time instance and reading pressure values in the Current table This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIyEN ManoView ESO Analysis Program IMAGING Click Log Data button to store the data value displayed in the Current table To save all log entries in a text file use Save Log Data in the File menu This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GITEN IMAGING ManoView ESO Analysis Program 3 Analysis Window This section contains details on the ManoView ESO Analysis Window controls and menus These capabilitie
72. reen tools provided in the measurement frames Note Ensure that the marker adjustments are properly set relative to the data in order for the program to report proper diagnostic parameter values Guidelines for using Measurement Frames 1 The Landmark Id frame must first be opened before the Swallow frames may be opened 2 Frames are opened and closed by clicking on the open symbol in the upper right corner of the frame or by double clicking on their rectangle icon in the Navigation Bar An Open frame allows for the adjustment of the landmark markers and is signified by the frame border being red The associated rectangle in the Navigation Bar will now become a yellow dot 3 Only one frame may be open at a time 4 Moving from one frame to the next is done by clicking on the first right arrow to the right of the Navigation Bar Clicking the arrow closes the current frame and opens the next event for adjustment analysis It is also possible to close the current frame by clicking the X in the top right corner then open the next frame following the same instructions as outlined in step 2 above 4 2 Inserting Removing and Editing Frames 4 2 1 Inserting and Removing a Frame Frames are inserted by moving the Time Bar to the desired location in the data record and selecting Tools gt Insert Frame Landmark Frame to create a Landmark Id frame or Swallow Frame to create a Swallow Frame If the event is a Swallow type the swallow frames a
73. rol in the upper right of this area will either show or hide these data panels Current Landmark Lag Data Landmark amp Pressures Swallows avg Hide Data LES Resid Press 2 8 mmHg DEI 1565 6 mm FY 3 9 cms Distal Latency Bs LES Position 44 0 cm LES Position 44 0 cm LES Pressiresp min 1235 9 mmHg 4 ILES Presstresp min 1235 9 mr g 1757 2 mmHg 1757 2 MIT 4 3 cm 4 3 cm 2 0 CM 2 0 CM 44 5 cm ition 44 5 cm 20 5 cm ition 20 5 cm 53 5 mmHa 63 6 mmHr Intrabolus P iLESR 5 7 mmHg Intrabolus P avg max 5 3 mmHg AmplieLES 3 0 156 7 mmt AmnlinLES 7 0 56 6 mmH Figure 3 13 Analysis Window Data Panel This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GITEN ManoView ESO Analysis Program 3 4 1 Current Data Panel The Current Data Panel shows data from the current activities on screen These include the time position and pressure of the channels selected i e those displayed in the Line Trace main display at the time of the time bar the current measurement data if a measurement frame is open or the SmartMouse data if the SmartMouse is in use Log the data from this panel using the Log Data control see 3 3 1 The saved data log will include the entries for each time Log Data is selected since the last time the log file was saved or the program was opened 3 4 2 Landmark amp Pressures Data Panel
74. ryngeal UES wave markers adjustment markers Classic ManoView analysis eSleeve ae TREE mr mono 9 Pharyngeal UES o Esophageal wave a b Figure 2 5 Swallow Measurement Adjustments a Contour mode b Line trace mode This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved ManoView ESO Analysis Program IMAGING GIyEN 2 5 Generating a Report To generate the report Click the Report button in the main window A W in d OW S imil ar to th e on e sh own in Include Site Info From File Include Patient Info Sierra Scientific Instruments 366 641 8493 First Name First Name Height FE in sit 9 in Figur e 2 6 pop S up e Los Angeles CA Middle Initial Middle Name Procedure 3D Esophageal Manometry Last Name Last Name Physician Physician Name Id Researc h Operator Operator Name Gender Male Referring Physician Referring Physician Customize the content for the report to be DM RE printed This can be done by selecting the p c UE Lower Esophageal Sphincter Region Normal Esophageal Motility Normal checkboxes and editing the fields as desired gee le eee hia 2 e LES midpoint from nares cm 44 0 Evaluated 3 0 11 0 above LES E Proximal LES from nares cm 42 7 Peristaltic velocity lt 6 25 cm s 100 istal fi imul TT Yo The Report window includes pull down lists EE ie Serene a
75. s necessary tools for detailed analysis of pressure impedance and or video data acquired during ManoScan procedures The program is intended to provide stand alone and enhanced functionality relative to the analysis capability incorporated in the basic ManoScan ESO system software The purpose of this manual is to provide instruction on using this software Patient analysis and window controls are defined 1 3 Acronyms and Abbreviations Acronyms and abbreviations used in this document are identified below cm Centimeters IRP Integrated Relaxation Pressure CFV Contractile Front Velocity LES Lower Esophageal Sphincter CDP Contractile Deceleration Point LESr LES Relaxation DP Double Peak mmHg Millimeters of Mercury pressure DCI Distal Contractile Integral MP Multiple Peaks DL Distal Latency MVS Motility Visualization System FS Failed Swallow PIP Pressure Inversion Point GST Gastric S Second HIS Hospital Information System SC Simultaneous Contractions HRM High Resolution Manometry TDCC Trace Display Channel Control HRM Z High Resolution Impedance TSN Three Second Nadir Manometry UES Upper Esophageal Sphincter IBP Intrabolus Pressure 1 4 Indications of Use The ManoScan system obtains a high resolution mapping of pressures levels and optionally impedance levels in case of ManoScan Z or video data in the case of ManoScan V within organs of the human gastrointestinal tract These include the pharynx upper esophageal sphincter UE
76. s Ee EE ES Ee 26 QUNM E WIS UN dim USE RT OE N NOR EE N NOR EE RE N NE RE EN N 34 FRAME EDITING amp NAVIGATION asses dee os ke ken se se se usua i Ceo ee ee se esu aue Eee ev Y EFE Rue ea Ern E TEE De EE EE 34 4 USING MEASUREMENT FRAMEG cccscoscscoscecescscaccsceccscsccecscoscscoscecescscaseecasescssoscscescssascesscscaseecaseecasescesescesoecesess 34 4 2 INSERTING REMOVING AND EDITING FRAMES ccecceceececceccecccceececceccscescscscescescccsscecesctscesescescescescssescescusens 34 4 3 NAVIGATION BAR amp TIME CONTROLS cccscceccsccsceccecceccsccscccsccscescscescscescecsecestecscescecescescescesescescsctscesescescusens 35 4A ZOOM CONTROLS NNPTTRRRR U A 36 REPORT WINDOW MEE EE EE EE OE a OE OE Ee EE 37 5 1 IREPORT WINDOW AND CONTBOLS 5 eise se se Si oe ie ee SA Ee ee Go ie oe c Yao pae iPad oe be Ge Es Ee 37 COMBINED PRESSURE IMPEDANCE ANALYSIS 2 ccccccsccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccees 41 O L ANALYSIS WINDOW ORGANIZATION eie GE Ee OG EG ub AD n ed Re EG ES oe GE Ee added IMMO SP EE ee 41 3D VISUALIZATION AND ANAL YSINW ccccccccscccccccccccccccccccccccccccccccccccccccccccccescccccccccsccccccccccccccccccccsocces 45 TAa 3D NN INI Wy ORGANIZATION eat n GE EG GE espace GE EE Ee GE GO EG GE GE GE 45 Ta A WINDOW CONTROLS is eo NE EE Ge Oe EE RE De EE teres GE ER
77. s allow for a comprehensive analysis from the high resolution esophageal pressure data 3 1 Analysis Window and Controls The Analysis window provides multiple ways to access setup options and tools Functions are accessible either through the menu system or on screen control buttons and for most commonly used functions they are available both ways 3 1 1 Analysis Window Organization The Analysis window operates in Contour and Line Trace modes Contour mode provides a continuous time space image of pressures while line traces provide the pressure history of a given location The location for each trace channel is shown in the Pressure Profile The full Analysis Window is shown in Figure 3 1 3 1 2 Contour Mode Clouse Plot The contour plot displays pressure encoded in color with sensor channel location along the vertical axis and time along the horizontal axis A color coded key is shown indicating the corresponding pressure values in mmHg at each end of the color scale The key is adjustable to set minimum and maximum display pressure values refer to Figure 3 2 a 3 1 3 Line Trace Mode The line trace mode displays pressure as a colored trace and accommodates up to 12 horizontal traces The vertical space allocated for each trace is adjusted automatically as the number of displayed tracings is changed Each trace has a legend range control area at the left showing the current trace value at time of Time Bar trace position and the max
78. s identical to the process described above 5 1 83 Create Report After entering the appropriate information in the Report select Create to create the report document This will activate the window shown in Figure 5 3 From here select the information to be included in the Report document The Basic Report is the information set up in the Report window The Detailed Parameter List is a list of parameters derived for every Measurement Frame e g swallow The parameters that are included in the detailed report may be adjusted using the Report amp Analysis function described in Section 3 3 3 1 Select plot images to include in the report both of the This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GITEN ManoView ESO Analysis Program measurement frames and those screenshots taken using the Capture Image function of the main display Select the format of the report choose from Word Word 2003 or PDF By pressing OK the program will generate a report document Once generated the report document may be printed and or saved Include Basic Report Format Word Document v Graphical Report Summary Show Swallow Composite v Detailed Parameter Table Plots select below Plots Layout Print Measurement Frames Contour Print Measurement Frames Traces m EE Print selected screen images 1 column rm qe es
79. s window which allows for the selection specific parameters to view during analysis and to include in the report Save Settings Allows for the saving of currently selected settings preferences within the program such as pressure ranges view configuration pressure channel selection and report settings The program settings may be configured and named by the user By saving in the name Default the program will start in the current settings configuration Load Settings Provides a list of previously saved settings preferences to select from The program will adopt the settings of the selected file after completing the dialog box Allows the user to input Site Information for inclusion in the Report upper left hand corner File Naming Allows the default naming convention for ManoView ESO Analysis mva files to be set and saved This default may be overwritten when the file is saved Analysis Options Allows the user to select the classification system and parameters for study analysis Opens the Setup Channels dialog see Section 3 3 3 3 Mask Channels Allows for the masking of channels those selected will be ignored by the program Select the channel s to mask and the program will interpolate across adjacent channels in all displayed and calculated data Masked channels are indicated by amp symbol in the Pressure Profile panel If a channel was masked in the original ManoScan mvs file it will be masked when opened in ManoVi
80. sure profile data panel and indicating the limits 0 150 mmHg Toggles pressure display between trace and contour modes Shows and hides the Gastric Marker Toggles on off the Esophageal anatomy and provides a mode for generic landmark selection 3 3 Menu Controls and Options The Analysis window includes four main menu selections at the top left of the screen These support file handling File viewing patient information View analysis setup Setup and analysis tools Tool 3 3 1 File Menu The File menu supports file opening and saving in various formats and program exit Options identifies the file menu options and describe the functionality Table 3 3 identifies each File Menu Option and describes its functionality Table 3 3 File Menu Options File Menu Option Functionality Open Activates the Open dialog box to open either a ManoScan Acquisition mvs or previously saved ManoView ESO Analysis mva file Save Analysis Saves the current state of the analysis including original pressure and current parameter values and report information when applicable Save w o Pat Info Saves the current state of analysis but removes all patient identifying information from the study Save Selected Data Saves selected data in either text or ManoScan Acquisition mvs data format Data is selected as the data range that is visible in the current Main Display Save Data Log Saves logged data in text format selected via
81. ta set is preserved so that the axial pressure distribution may be visualized In addition the boundaries of This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GI TEN IMAGING ManoView ESO Analysis Program the eSleeve may be adjusted during the analysis to position it at the appropriate location relative to the anatomy Figure 3 10 a shows the eSleeve LES trace default setup control The eSleeve margins are specified relative to the moveable LES marker These margins also may be adjusted independent of the LES marker by moving them in the Pressure Profile display In addition the markers may be locked to the upper and lower boundaries of the LES to reduce the number of markers to be adjusted see Section 2 2 When eSleeve is not used pressure data from LES channel alone are used for LES relaxation residual pressure measurement Additionally 3 sec Nadir and Integrated Relaxation Pressure IRP methods can be selected and adjusted to determine the method of analyzing LES relaxation analysis and residual pressure measurements These options can be assessed though LESr tab shown in Figure 3 10 b eSleeve LES trace LESr eSleeve LES trace LESr Main display amp analysis eSleeve not For portable esleeve via Smart Mouse LES residual pressure measurement D Hide LES trace Use eSleeve 3s Nadir Tie eSleeve Boundaries to LES Boundaries P
82. the Log Data control above the Current display field near the bottom of the screen Log file includes all entries from each time Log Data is selected since the last log was saved or program was started Exit The File gt Exit option exits the ManoView ESO software application This will close all files and exit the application 3 3 2 View Menu The View Menu allows the user to open the Report form and view the All Data table Table 3 4 identifies each View Menu Option and describes its functionality Table 3 4 View Menu Options View Menu Option Functionality This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING ManoView ESO Analysis Program OIgEN All Data Table Activates the All Data table window see Section 3 1 4 2 for details Guide Window Displays the Guide function which walks the user through the proper analysis steps Video Window Activates a window that displays recorded video input during study Requires the corresponding video file mvd to be found 3 3 3 Setup Menu The Setup menu supports customization of the ManoView ESO application Analysis preferences and settings may be selected and used during analysis and reports Table 3 5 identifies each Setup Menu Option and describes its functionality Table 3 5 Setup Menu Option Setup Menu Option Functionality Report amp Analysis Activates the Setup Report amp Analysi
83. ting of one or more of following modules ManoScan 360 High Resolution Manometry module ManoScan Z High Resolution Impedance module ManoScan V High Resolution Video Imaging module or the ManoScan 3D High Definition Pressure Imaging module This user manual provides a description of ManoView ESO and its use Open Patient Data File Adjust Frame Markers Landmarks Sphincter Pressures Swallows Print Report Save Analysis File Figure 1 1 ManoView ESO Activity Cycle The ManoView ESO application is an easy to use graphical tool for analyzing the pressure impedance and video images obtained via the ManoScan system Figure 1 1 illustrates a normal activity flow when using this program for esophageal motility analysis This version of ManoView ESO supports review and analysis of study files created with all previously released versions of ManoScan ESO v1 2 2 0 2 1 and ManoView ESO v1 4 2 0 2 0 1 software 1 1 Intended Audience This document is intended for use by medical personnel in conjunction with ManoView ESO software application Computer literacy and familiarity with Microsoft Windows and graphical user interfaces is beneficial This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GIg EN ManoView ESO Analysis Program Ss IMAGING 1 2 Purpose of This Manual The ManoView ESO software program is a component of the ManoScan system and provide
84. tmospheric mode so that setting Gastric is an overt action The user should first identify an appropriate location for setting Gastric location using the Gastric marker in the pressure Profile Selecting Gastric in the Pressure Reference control will cause all data in the program to be presented relative to this gastric value taken as the 30 s average 15 s at the time of the Time Bar and at the location of the Gastric marker Note that the pressure reference button does not affect any calculated parameters as any that are dependent on gastric pressure are always taken relative to gastric taken at the location of the Gastric marker at the time in the record of the parameter of interest 3 2 Pressure Profile Panel 3 2 1 Pressure Profile Display Modes The Pressure Profile Display right pane shows the spatial distribution of pressure at the time of the Time Bar It also includes the spatial markers used in localizing anatomical landmarks and setting spatial channel parameters such as eSleeve boundaries and gastric pressure location Figure 3 8 gives This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GITEN ManoView ESO Analysis Program example graphical variations of the configurations that may displayed using the Mode Gastric and Anatomy controls s die Bharynx 4 d oos d B d e x E 6 4 os a de zi a
85. tory minima mmHg 1235 9 LES basal pressure mean of respiratory minima mmHg Vv Iv v LU LES basal pressure respiratory mean mmHg 175 LES basal pressure respiratory mean mmHg Iv Iv iv UES mean basal Pressure mmHg 63 6 UES mean basal Pressure mmHg Iv v V Histal hernia no yes cm Mo Hiatal hernia no ves cm Iv Iv Iv M Us ESOPHAGEAL MOTILITY EER Number of swallows evaluated Iz F 7 LES residual pressure mmHg IV Iv Iv Iv EE i E 23 LES residual pressure highest in group mmHg Vv Vv Vv LES residual pressure highest in group mmHg 0 LES percent relaxation Iv Vv Vv Vv LES percent relaxation 1 96 96 IV Classic ManoView Cassi Manoview Wave amplitude mean L1 amp L2 above LES mmHg Vv Iv iv Iv Wave amplitude mean 3 0 amp 7 0 above LES mmHg 106 7 91 5 143 5 106 7 103 0 114 3 104 94 5 Wave amplitude L3 above LES mmHg Iv Iv Iv Iv Wave amplitude 8011 0 above LES mmHg 4 62 0 48 4 58 55 0 Wave amplitude L2 above LES mmHg Vv Iv Iv Iv Wave amplitude 07 0 above LES mmHg 515 58 0 ss Wave amplitude L1 above LES mmHg Iv Iv Iv Iv Wave amplitude 83 0 above LES mmHg 1 131 4 219 0 1 l 152 1 ees ae oe EE LES sec E i i i Weve duration mean at 3 0 amp 7 0 above LES sec 3 9 4 1 4 0 3 6 4 0 4 1 3 8 y Wave duration L2 above LES ise Vv Vv v v Wave duration L1 above LES sec Vv Vv Iv Iv TT Onset velocity between L3 amp L1 above LES cm s Vv Iv Iv Vv a Onset velocity between
86. ure all Classic ManoView parameters are disabled Select parameters to be included in report On screen analysis tools are provided according to selections Report Reprt Data Table Tabular Graphical Individual Parameter mae Swallows LES residual Be aa in group rmm Hg sig iy E T ETE us Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv M Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv Iv High Resolution Parameters Distal contractile integral mmHg cm s ri v Iv Iv Distal contractile integral highest in group rmmHg cm s ri M m v Contractile Front velocity temis Iv v Iv Iv Intrabolus pressure iLESR mmHg v v Iv Iv Intrabolus pressure avg max mmHg Iv ve he he v Chicago Classification Distal latency sec E C Figure 3 9 Report amp Analysis window The selections related to Classic ManoView parameters have been unselected so the corresponding controls are not visible on the Main display or in the report 3 3 3 2 Analysis Options The Analysis Options menu allows the user to select the scheme used to analyze the study the eSleeve LES trace settings and the method of determining the LES relaxation analysis The eSleeve emulates the functionality of a conventional sleeve sensor 1 e it outputs a signal equal to the maximal pressure throughout its sensitive length The eSleeve has the advantage that the full da
87. ust at the lower extent of the LES distal end inspiratory pressure signature The PIP marker is placed where the diamond pattern of the green trace is at its maximum pressure reading and the blue trace is at its minimum pressure reading i e where the green and blue traces from the PIP locater tool are most out of phase The Gastric Marker is placed at 2 0 0 1 cm below LES lower margin Note The Pressure Inversion Point PIP may not be available in the study if the intubated catheter does not pass through the diaphragmatic junction For such studies the esophago gastric junction EGJ relaxation analysis should be performed with caution The LES relaxation normal values provided in the software as well as the Chicago Classification results are not applicable This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GIVEN Appendix C Swallow Frame Analysis Guidelines ManoView ESO Analysis Program The following guidelines may be followed to set the analysis markers in the event frames Classic ManoView Analysis LES relaxation brackets Left side of bracket should line up with the UES Relaxation The right side of the bracket should be positioned at the end of the esophageal body wave form Esophageal wave markers Place at the start peak and end of the three esophageal body analysis locations These locations may be best viewed in the Line Trace
88. vides localized eSleeve functionality for enclosed area Includes a plot of the eSleeve tracing and 3 second nadir value with the distal location of the enclosed area subtracted from the reading e g for LES relaxation unless Alt key is pressed When Alt is pressed the display is the simple eSleeve tracing for the selected area i e the maximum pressure at every time within the enclosed area e Provides in Line Trace mode Same functionality as basic e Turns off all smart mouse functions This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved IMAGING GITEN ManoView ESO Analysis Program 3 3 4 2 Display Mode Options Allows one or more of the following display modes to be chosen a Enable Traces on Contour b Enable Profile Trace Persistence c Show Catheter in Profile d Show Diaphragm in Anatomy Note The user must press Display Mode button located on the bottom left side of the analysis window twice after clicking Enable Trace on Contour for the settings to take into effect 3 3 4 3 Set Detailed Undo Thermal Compensation The Set Thermal Compensation control sets the thermal compensation at the time of the Time Bar To do this move the Time Bar to the desired location in the record e g at a time immediately after catheter extubation when no pressure was applied to the catheter By pressing Set Thermal Compensation the data record will

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