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Manual for Viewer versions 1.02.041 and earlier

1. Copy Selected Score File button located in the Scores Window see Section 4 6 Refer to Figure 5 1 below Itis recommended to re name the file by adding to the original file name the name of the person performing the editing and the word edit behind it For instance original file name Kris edit ev Copy Selected Score File je Duratio i 7230 Lights Off 240 3 Wake 240 180 Desat 277 75 47 25 Desat 336 75 36 25 Desat 384 20 25 Figure 5 1 85 User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING 5 2 How to Edit a Study Once the score file has been copied it can be thoroughly edited Editing a file produces a log file that records all changes made to the file This file consists of entries that contain the following information Time of Day of edit Action Epoch changed from original value to new value The file name for this file is identical to the name of the scoring file being edited with the extension changed to txt This file is located within the patient s subfolder along with the EDF txt files and all else that will be generated The following is a summary of the different editing activities that can be done 1 Events can be deleted by selecting an event and pressing the Delete key 2 Events can be added in one of two ways a By left clicking on an empty s
2. C h e eC Document Number YST UDoc USM 22 SLEEP SCORING File 0004 0107 Uploading Upload Progress 35 Downloaded Out of Date Uploading File Name Status 0004 0107 Uploadin 0004 0030_nasal Available eee 0004 0102 Downloaded 0004 0115 Downloaded 0004 0177 Downloaded Connection Status Figure 4 6 The checkboxes located in the Status Filters pane list all potential file statuses and can be used to control which files are shown in the Remote Files pane Any file with a status that is not checked will not be shown All statuses are checked by default A user may un check any status according to their preference for the display of file statuses For instance if a user does not want to see the list of files that have already been downloaded the Downloaded status may be un checked The File Information pane shows relevant information related to the status of the file This information consists of a combination of the following the time of the upload the time of scoring the time of download the upload percentage or an error message What is displayed is dependent on the status of the file The Remote Files pane lists all of the files that were sent for scoring The status of each file will be displayed such as Uploading Scoring Available Downloaded New Scoring Available and Error The additional status Previously Downloaded would be displayed if a second computer logs into the Viewer and reviews the
3. Critical Update There is a critical update to be installed You will not be able to connect to YST servers until it is installed Figure 2 23 If the user decides to ignore this message by selecting the X closing the window they will notice that several functions within the main File Menu will be disabled as shown below in Figure 2 24 File View Configuration Preferences Help EF Open Patient File Close Patient File Channel Information l Save Score File Manager Montage Manager Import Export Mantages Remote File Manager Modify Login Information Report Editor Report Manager Import Export Reports g Print Figure 2 24 The greyed out menu items are no longer functional and will remain disabled until the critical update is installed The user may exit the Viewer and reopen it selecting OK to update their version of the Viewer when the message box shown in Figure 2 19 appears The normal software update proceeds as described throughout the Software Update Instructions information of this User Manual Section 2 3 34 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING The release notes pertaining to the critical update can be reviewed also as described earlier in this section Figures 2 22a and 2 22b 2 4 Creating Proper Score File Directories It is necessary to store all EDF REC f
4. SLEEP SCORING TABLE 1 User Manual MICHELE Sleep Scoring System Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 AGREEMENT BETWEEN AUTO SCORING AND CONSENSUS 2 3 OF THREE TECHNOLOGISTS SCORING FUNCTION SLEEP STAGING Awake N1 N2 N3 REM No Consensus AROUSALS Yes None No Consensus PLMs Yes None No Consensus RESPRIRATORY EVENTS Criteria A Hypopnea Obstructive Apnea Mixed Apnea Central Apnea None No Consensus Criteria B Hypopnea Obstructive Apnea Mixed Apnea Central Apnea None No Consensus Agreement MICHELE APPA ANPA Overall kappa Total by Techs 24967 6563 2411 9846 2862 3285 283 17648 2278 15370 104 18461 1741 16720 47 17746 1513 329 214 174 15516 132 17824 1822 359 214 177 15252 133 2 8 2 8 48 4 86 3 4 0 28 1 44 7 9 3 14 8 34 8 16 7 90 1 5 1 15 5 34 2 16 6 89 0 99 8 99 1 46 7 59 2 99 8 70 3 93 4 95 3 92 0 99 1 99 1 48 0 94 1 91 7 99 1 98 9 47 1 ALICE APPA ANPA Overall Agreement 30 5 57 9 88 3 78 0 19 9 kappa 6 1 38 2 24 7 23 1 Numbers in Sleep Staging rows are number of 30 second epochs Numbers in Event rows are numbers of events and not epochs except in the None category where the number refers to number of epochs with no events APPA Averaged Positive Percent Agreement ANPA Averaged Negative Percent Agreement N1 N2 and N3 Non RE
5. Start Time displays the event start time Duration displays the event duration Channel Name displays the name of the channel that the event is currently bound to located on Marker tags are not bound to any specific channel The Main Window can be sorted by any of the following categories e Start Time Epoch same category e Event Name e Event Duration The Scoring File List allows the selection of which existing scoring file to display Scoring files located in the same directory as the patient file are automatically detected by the application and placed in this list When a study is scored for the first time the YSTevents ev file will be shown After the study has been copied and edited the last score file used will be displayed when opened next The drop down menu allows the user to switch between study scores The Copy Selected Score File button can be used to copy the current scoring file into a new file Copying a file in this manner preserves all settings however it does not preserve the read only tag Copying may also be done by choosing to Save the current event file and then entering a new name The Import Body Position File button is used to import a file with position and lights data which the user has created in the manner described in Section 4 2 following item 4 b in that section This option does not need to be used prior to executing automated scoring because the autoscoring allows a body position file to be spe
6. and With Respiratory will be disabled This can be seen in Figure 5 4 a and d Figure 5 4 b and c both have potential associations with other events e Ifa PLM event is associated with an arousal or a respiratory event the appropriate checkbox should be checked 89 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 i i C h e Document Number YST UDoc USM 22 o SLEEP SCORING e If a respiratory event is associated with an arousal or a desaturation the appropriate checkbox should be checked These data are used for compiling statistics for the final report The displayed event name is updated for ease of identification for these associations The Start Time property determines when the event starts This can be changed by entering a new value in the text box or by using the mouse to move the event around The Duration property determines the length of the event This can be changed by entering a new value in the text box or by using the mouse to drag the edge of the event around If the selected event is a Graph Tray marker event the only modifiable property is the Start Time Score File Manager Figure 5 5 displays a dialog box that allows managing of the score files found for the currently opened EDF file allowing you to delete score files as well as choose which score file to display Score files deleted by this method cannot be recovered Y Score File Manager
7. modifying the start time but keeping the duration intact As well either the left or right boundary of the event can be dragged e Dragging the right boundary will extend the event preserving the start time but increasing the duration e Dragging the left boundary will also extend the event moving the start time back while increasing the duration and preserving the end point e Either boundary can be dragged over the other boundary This will flip the event turning the end point into the start point and vice versa Events can be removed by selecting them and pressing the Delete key on the keyboard 91 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 mMm C h e e Document Number YST UDoc USM 22 SLEEP SCORING 5 5 The Graph Tray The Graph Tray shown in Figure 5 7 below composed of two rows displays additional information about the state of the patient and shows global marker events g i op Row Patient 44 Start 12 06 AM End 6 22 AM Body Position Supine CPA p gj Bottom Row Figure 5 7 In the lower row to the left the Graph Tray displays the patient name the start time of the file and the end time of the file In the lower row to the far right the Graph Tray displays the current body position as well as the current status of CPAP either Off On or On with additional information which will subsequently be elaborated on In the top row the Graph Tray disp
8. 4 0 Scoring a File 4 1 Study Review It is recommended to review the patient file prior to engaging the scoring process if the signal quality is poor channels should be re referenced and the polarity of specific channels inverted if necessary prior to sending the file for scoring Upon opening the study ensure the correct montage with the correct channel mapping is used 4 2 Channel Mapping for Scoring To initiate the process of scoring an opened patient file select Score File from the File Menu This will initiate dialog shown in Figure 4 0 below that inquires about the status of pre filtering re the primary channels pre filtered Figure 4 0 Selecting Yes indicates that the primary channels EEGs EOGs and EMGs have been filtered either by hardware filtering or through software filters applied while exporting the EDF file If filters have not been applied to these signals during data collection and or exporting then select No Most systems do not apply the filters in the hardware and most systems do not allow for applying filters during the export process When the option is given to apply filters during the export process it is recommended not to do so and to export the study raw unfiltered and unreferenced If these recommendations are followed No should always be selected when the dialogue box above appears Note that if the filters which have been applied using the Viewer are the only filters that have be
9. 8 31 PM End 352 AM 49 50 com 52 Hypnogram _ a URE TON in a Maa sal S wau ul 63 sam w U Page 64 s Body Position 64 Desat 1910 25 22 25 spo e 65 H D 1920531 12313 Effo ma i 65 A 1938 5 992 EEG 65 Desat 19395 7 Spo 65 H A D 1939 531 26907 Effort Wt Ol 66 WR 1962004 20992 EEG js 2 o 1 amp Desat 1969 75 30 25 Spo i r 3 m manh 278 Figure 3 6 In Figure 3 6 the Properties Window is currently being dragged Since the mouse is currently being held over top of the Scores Window docking options are presented over top of the Scores Window Selecting one of these options will apply the docking options described above using the Scores Window as the current window Selecting the tabbing option causes both the Selected Window and the current window to become tabbed You will also notice a second set of docking options presented those located along the edges of the screen and lacking the tabbing option Using one of these options will dock using the main interface window as the current window If no docking option is selected the window switches to the floating state 40 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING The default layout can be viewed at any time by selecting View from the main menu and then selecting Default Layout 3 2 T
10. The epoch boundary aligns with the left most edge of the display Additional information is provided to help with rescoring this can be accessed via the View menu see Section 5 7 Note Events are automatically re associated when they are moved renamed created or deleted This can be overridden by setting the associations manually Section 5 3 below Once an association has been toggled it will never be changed automatically To re enable automatic association for that event the event will need to be deleted and a new event placed in its spot Note Events are automatically deleted when the sleep stage they occurred in is changed to Awake 86 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING 5 3 Creating an Event There are two modes of event creation Standard Mode and Quick Mode Quick Mode involves right clicking anywhere on a channel This will create an event of type Default Event and duration Default Duration with the start being located at the cursor The creation of default events was described in Section 3 3 as part of the description of the Graph Channel Properties window Quick mode is disabled if Right Click Adds Event is not selected in the Configuration Menu In Standard Mode events are created by holding the left mouse button down anywhere on a channel and then dragging the mouse while still holding down
11. v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING 1 5 Validation Results The software performance was measured by A Determining epoch by epoch agreement between MICHELE s scoring and the scoring of three technologists with respect to the four scoring functions Sleep staging Arousals Periodic Leg Movements PLMs and Respiratory Events Objective 1 B Determining the agreement between MICHELB s results of Clinically Relevant Data such as Total Sleep Time Time in Different Stages Apnea and Hypopnea Index AHI etc and the results of the three technologists Objective 2 MICHELE s performance so determined was compared with the results of analysis of the same validation files by one of the predicate devices Alice 5 510 k Number K040595 using the same scoring guidelines AASM 2007 It was also compared with the published performance of the two other predicate devices Somnolyzer K083620 and Morpheus K022506 1 5 1 Files Software performance was assessed using 30 full night studies recorded in the sleep laboratory of a tertiary care facility Foothills Hospital Calgary Canada The files were selected at random and included 19 patients with sleep apnea Fifteen of these patients had moderate to severe sleep apnea AHI 73 38 hr and underwent split studies with one part pre CPAP where sleep was severely fragmented and a second part on CPAP with fairly normal
12. 0 731 SD 40 29 28 Stage 2 min 167 168 159 0 925 0 926 SD 57 57 50 Stage 1 2 min 219 212 202 0 830 0 903 SD 62 61 62 Stage delta min 55 36 60 0 671 0 967 SD 43 36 46 Stage REM min 55 51 51 0 948 0 953 SD 28 25 26 Arousal Index events h 32 33 25 0 875 0 594 SD 18 24 11 PLM Index events h 11 12 13 0 849 0 959 SD 31 32 31 Resp Disturbance Index SD AHI A events h 30 28 32 0 947 0 985 SD 40 41 40 AHI B events h 34 31 29 0 932 0 967 SD 43 43 37 0 872 0 903 0 838 0 845 0 738 0 706 Average Significantly different from Auto Significantly different from Tech 2 Sianificantlv different from both Tech 2 and Auto 18 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 Mm C h e eC Document Number YST UDoc USM 22 SLEEP SCORING REFERENCES 1 Altman DG Machin D Bryant TN Gardner MJ Statistics With Confidence British Medical Journal 2000 2 Pittman SD et al 2004 Assessment of Automated Scoring of Polysomnographic Recordings in a Population with Suspected Sleep disordered Breathing SLEEP 27 1394 1403 3 Svetnik V et al 2007 Evaluation of Automated and Semi Automated Scoring of Polysomnographic Recordings from a Clinical Trial Using Zolpidem in the Treatment of Insomnia SLEEP 30 1562 1574 4 Anderer P et al 2005 An E Health Solution for Automatic Sleep Classification according to Rechtschaffen and Kal
13. 1 a L Patient Start 8 31 PM End 3 52 AM Body Position N A CPAP Off Scores 9 D 2a 0004 A0030364_YSTEvent m EE OO eee ae a 1 Lights Off 0 3 1 Wake 0 660 es 1 BadOnygen 1 10 90 sap 13 Desat 389 25 33 25 Spo Sape l Ban 16 Desat 45275 27 25 Spo on 17 Desat 506 25 37 25 Spo 21 Desat 617 435 Spo tr te 23 Stage 1 660 30 24 Desat 707 75 28 25 Spo 32 Desat 949 75 95 75 Spo Figure 3 4 To display a collapsed window the mouse must be placed over top of the tab in this case the tab says Hypnogram bottom left corner of Figure 3 3 This will cause the window to appear To keep the window from re collapsing dock the window by either clicking on the pin icon or clicking anywhere within the window If the window is not selected or pinned it will once again become collapsed when the cursor is removed from the area it occupies To change the state of a window the Selected Window click on the window name and drag the mouse This will detach it from the current Docking point and will present you with many sets of display options Figure 3 5 Figure 3 5 shows the five major docking options While still holding the mouse down drag the cursor over one of these options and then release the mouse The options are as follows bl Docks the Selected Window above the current window shares a horizontal boundary 39 User Manual MICHELE Sleep Scoring System it u Revi
14. 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING When the Viewer is launched for the first time you will be prompted to provide a Client ID and a Password all of which will be provided by YST Figure 2 14 below shows the dialog box where you enter the information 2 2 Login Information Figure 2 14 If your sleep management facility utilizes a proxy server click on the box beside I require connecting through a proxy server shown in Figure 2 14 and the menu box will expand for the user to enter the relevant information as shown below in Figure 2 15 28 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Figure 2 15 Once your information has been entered select the Verify option If Do this Later is selected the Viewer will still launch but an error message will appear from the Remote File Manager within the Viewer indicating it could not connect to YST Servers The Viewer is still functional but features such as Scoring and Automatic Updates will not function Scoring is discussed later in this manual Automatic Updates are discussed in the following section 29 User Manual MICHELE Sleep Scoring System Revision 22 mMm Effective Date 7 Aug 13 C gt a Document Number YST UDoc USM 22 6 SLEEP SCORING 2 3 Software Update Instructions YST will update it
15. Aug 13 Mm C h e eC Document Number YST UDoc USM 22 SLEEP SCORING properties are described below The Appearance Channel Data Numeric Display Position and Scale categories apply specifically to the display of channels in the Main Window and the settings do not have an impact on scoring The Events category will not impact scoring but may be used to set default events that will allow for Quick Mode editing described in Section 5 Settings made in the General category will affect autoscoring and are therefore described in this section as well as Sections 3 4 and 3 5 The Appearance category allows adjustment of how the channel is graphically represented The Color property sets the color of the channel and any events placed on it The Visible checkbox is another way to hide a channel This cannot be used to make a channel visible as the channel properties window is only visible when a channel has been selected The Channel Display displays the visible channels for the specified time window It also displays all events at the appropriate start time with the appropriate duration and name The Channel Data category enables the display of extra numerical information about the channel in the Channel Info Area Often used with the SaO2 CO2 and CPAP pressure channels the values appear at the right side of the channel in the Graph Window The Display Min checkbox displays the minimum value of the current window The Display Max checkbox d
16. By selecting a channel from this list the visibility is toggled if a currently hidden channel is selected it is added at the location of the mouse if a currently visible channel is selected it is hidden and no longer shown in the graph window To change the vertical position of a channel click to select a channel and then while holding down the mouse drag it up and down To remove a channel from the graph window select the channel and then press the delete key To have the channel shown again right click in the Channel Header Area and select the channel The bottom of the Channel Header Area displays the time of the cursor both in real time and in seconds past the start of the file 44 michele 3 3 Setting Up Individual Channels and All Properties Within SLEEP SCORING User Manual MICHELE Sleep Scoring System Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 Once all desired channels have been selected and displayed according to your preferred layout you will need to set the properties for individual channels 3 3 1 Properties Window The Properties Window is used to control the properties of all components in the main user interface window The following have properties l oe a Graph Window Graph Channels Individual Events Hypnogram Hypnogram Channels To access the properties of any of the above items they must first be selected The different properties windows are placed in
17. Export Montages Figure 3 33 Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 Select the Import Export Montages and a dialog box will appear as shown below in Figure 3 33 If Export Montage is selected the dialog box will be as shown below in Figure 3 34 65 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 j i C h z Document Number YST UDoc USM 22 o SLEEP SCORING r Y Import Export Montage Tool i x Exporting montages will export to a file of your choice It is recommended that you select an easily accessible file location for quick retrieval of the exported montages Z Montaaes Calaarv Test Montaae 1 Cancel Previous Next Figure 3 34 You will need to specify the file location where the montage is to be copied to by clicking on the lt button next to the montage name Choose the location and enter the montage file name that you wish to export in the file name area Click on save A box will appear noting that the montage does not exist and asking if you want to create it Click on Yes Once you have selected the location for the montage to be saved at you are returned to Figure 3 34 above but the text box will be filled in with the file path you had specified Select the Next button and the figure shown in Figure 3 35 below will appear Y Import Export Montage Tool XS Please select the montages you wish
18. MICHELE Sleep Scoring System may result in erroneous results or failure of the software to operate If data files are sent to YST for processing or troubleshooting failure to remove confidential patient information from the file may result in breach of patient privacy if files are lost in transit or accessed by unauthorized personnel Caution US Federal law restricts this device to sale by or on the order of a physician User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Introduction The MICHELE Sleep Scoring System MICHELE is a software system that automatically scans physiological data recorded during sleep studies referred to as polysomnography PSG records and applies a variety of analytical approaches to identify the occurrence of certain events that relate to the presence and type of sleep state breathing abnormalities and limb movements The system is capable of scoring Sleep Stages Arousals Respiratory Events and Leg Movements At the end of the analysis the system generates a PSG Report that includes tables and graphs typical of those generated following manual scoring of PSG records by certified technologists The results of the automated scoring may be displayed using the PSG Scoring Viewer referred to as Viewer in this User Manual application which allows manual editing of the results and generation of a revi
19. Tray Alternatively dragging the channel up and down as described earlier in the Channel Header section can modify the Y option The Scale category deals with how the channel data is represented inside the physical space specified by the Height and Y settings 49 1AF User Manual MICHELE Sleep Scoring System Revision 22 Effective Date 7 Aug 13 HC e Document Number YST UDoc USM 22 d SLEEP SCORING Note The descriptions of the Upper Limit and Lower Limit apply to a non inverted signal For an inverted signal switch the definitions of Upper Limit and Lower Limit The description of Auto Scale must also be adjusted by switching Upper Limit with Lower Limit The Upper Limit option sets the upper limit of the channel defined as the maximum value that will be visible in the graphical representation of the channel Any value that is above the upper limit will be clipped for display purposes to be equal to the upper limit The Lower Limit option sets the lower limit of the channel defined as the minimum value that will be visible in the graphical representation of the channel Any value that is below the lower limit will be clipped for display purposes to be equal to the lower limit Upper and lower limits will need to be entered for all AC channels and for the DC channels that show numerical values such as SaO2 CO2 and CPAP pressure Examples for various channels of settings in the graph channel properties window a
20. and or by body position Alternatively the oxygen times can be reported in minutes Note The custom oxygen threshold will include all the values below but not including the specified value e g If a user enters 83 in the report generator the field would include values from 0 82 Heart Rate data Maximum Average Minimum and 95 Percentile can be inserted into the report through the Heart Rates field Heart Rate data can be included for All entire study All Sleep All Awake individual sleep stages including REM and NREM and or by body position Snoring data Number of Snores Epochs with Snoring Sleep Time with Snoring Snore Index and Sleep Time with Snoring can be inserted through the Snoring field Snoring data can also be specified by the stage of sleep the events occurred in including REM and NREM and or which body position the 11 1AT Appendix A Report Editing Mm Revision 06 C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING patient was in when the event s occurred Supine Prone Upright Right Left Lateral Non Supine REM Supine REM Non Supine NREM Supine and NREM Non Supine 2 1 3 Graphs and Tables Fields The Graphs and Tables fields allow users to include graphs summarizing Sleep Staging Body Position Respiratory Events Leg Movements Oximetry PAP Pressure Audio Heart Rate Average Delta EEGI Average Delta EEG 2 Full Graph Hypnogram Vs O2 Heart Rat
21. be foundd in the Graphs menu 21 1AT Appendix A Report Editing Mm Revision 06 C Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING 3 6 Selecting a Report Template Once the Patient Information has been entered the user must select the report template they wish to use In the drop down menu users will see a list of all report templates they have created Figure A 27 Default reports described in section 2 3 can be selected through this menu also Select the appropriate template as well as the output file format for the report Figure A 28 Please note that rtf reports will be able to be modified after generation whereas pdf reports will not be modifiable In order to generate a report it must first be confirmed that the scoring data used to generate the report is correct The scoring data that is used is the currently selected file A report cannot be generated from a read only scoring file provided by YST The scoring data is confirmed by checking the Events have been Verified checkbox which in turn enables the Generate button Users will then select Generate and a window will appear displaying the generation progress Figure A 29 Michele CPAP Study m Michele Split Study eer Michele Level 3 Rep Figure A 27 Report Template YST Diagnostic Report bed Output Format Figure A 29 3 7 Opening the Customized Report 22 1AT Appendix A Report Editing Mm R
22. from the File menu or the Generate Report shortcut icon on the Toolbar of the Viewer A window will then pop up prompting them to enter Patient Information Figure A 22 This Patient Information will appear in the Report as it is typed in these fields Patient Information can be imported by clicking the Import Patient Info button near the bottom right of the Report Generator Window A file directory will open where users can browse their computer and select the patient information txt file that pertains to that particular study The Report Generator will then ask the user which data collection system was used Figure A 23 The user may also enter the patient information manually Users can enterthe patient s weight in pounds or kilograms from the drop down menu Figure A 24 Height can be entered as feet and inches inches centimeters or meters Figure A 25 Units are automatically added to the Height and Weight fields in the report Ex Entering 200 and selecting lbs will appear as 200 Ibs in the report If the user would like the Report Generator to calculate the patient s Body Mass Index BMI check the Automatically Calculate BMI box The BMI value will not appear in the Report Generation Options window but will be calculated and appear in the report Alternately the user can manually enter the patient s BMI by unselecting Automatically Calculate BMI and typing the data into the text box Please be sure to
23. install of the NET Framework Once Accept has been selected the Viewer Setup window shown in Figure 2 4 will appear YST Data Viewer Setup The following components will be installed on pour machine Visual C 2010 Runtime Libraries x86 Do you wish to install these components IF you choose Cancel setup will exit Install Cancel Figure 2 4 Select Install This installs the Microsoft Visual C 2010 component libraries If this does not happen automatically i e if the window as shown below in Figure 2 5 does not appear run the installation manually after completing the Viewer software installation by double clicking on the file vceredist_x86 exe that was included in the Viewer installation package and proceed as described below 22 User Manual MICHELE Sleep Scoring System fy a Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Microsoft Visual C 2010 x86 Redistributable Setup b xX Welcome to Microsoft Visual C 2010 x86 Redistributable Setup Please accept the license terms to continue MICROSOFT SOFTWARE LICENSE TERMS MICROSOFT VISUAL C 2010 RUNTIME LIBRARIES V IT have read and accept the license terms F Yes send information about my setup experiences to Microsoft Corporation For more information read the Data Collection Policy Figure 2 5 Click on the I have read and accept the license terms che
24. open within the Viewer and present itself as a blank document The Report Editor interface looks and functions similarly to most word processing software systems such as Microsoft Word OpenOffice or LibreOffice Please note that while the Report Editor is open all other features or applications in the Viewer will be inaccessible 1 2 Title Bar On the top of the Report Editor window is a long bar called the Title Bar On the left side of the title bar there is an icon that represents the application To use the system menu on the application icon click the small icon A menu will appear and from this menu you are able to Maximize Minimize or Restore the window to its original size Move the window or Close the window The Report Editor can also be maximized or minimized by double clicking the blank area inside the Title Bar Figure A 1 Y Michele Report Editor Title Bar Restore Form Move Size Minimize O Maximize x Close Alt F4 Figure A 1 1AT Appendix A Report Editing Mm Revision 06 C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING 1 3 Menu Bar Directly under the Title Bar is the Menu Bar which is composed of several menus File Edit View Insert Format and Table Figure A 2 Each menu on the Menu Bar allows the user to perform many Operations pertinent to word processing Most users may be familiar with these menus from prior experience using word proces
25. quite slow when ALL is selected and it is recommended that filtering and referencing are disabled when using this display mode View Previous Epoch moves the current display back by the Epoch Duration This button does not adhere to epoch boundaries if the view has been shifted off the epoch boundary This functionality can be accomplished by pressing the Left arrow key Pressing the minus key either on the numpad or the main keyboard will move the current display half an epoch backwards in time View Next Epoch moves the current display forward by the Epoch Duration This button does not adhere to epoch boundaries if the view has been shifted off the epoch boundary This functionality can be accomplished by pressing the Right arrow key Pressing the plus key either on the numpad or the main keyboard will move the current display half an epoch forwards in time 98 User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING The Time of Position in File controller is used both for informational purposes showing the current time of the displayed window as well as for control purposes The time displayed in the controller is in HH MM SS AM PM Any of the first three fields are selectable which is indicated by a highlighting effect Entering a new value can modify a selected field or it can be incremented decremented through the
26. same files with the Remote File Manager Since it was not the original computer but same Login ID and Password Previously Downloaded would appear as a status Multiple files can be uploaded and sent for scoring The first will upload and the next will be pending until the first has uploaded The files will upload and score in a consecutive manner See Figure 4 7 below 75 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 ry C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Y Remote File Manager Available a File 0004 0107 Uploading Upload Progress 64 Downloaded Out of Date Uploading File Name Status 0004 0107 Uploading A0040648 Pending Remove 0004 0030_nasal Available eee 0004 0102 Downloaded 0004 0115 Downloaded Connection Status Figure 4 7 Each row in the table represents a patient file uploaded to the YST servers Each patient file is assigned a specific status Uploading the file is currently uploading to the YST server Pending the file has been prepared for uploading but is waiting for another upload to finish Scoring the file is currently being scored Error scoring the file has been attempted by YST but resulted in an error Files with this status will be investigated and you may contact YST to obtain further information Unavailable the file has been uploaded but has not been scored Available the file h
27. the Scoring of Sleep and Associated Events 2007 Specifically 1 3 1 Identification of sleep stages This is done according to the Rechtschaffen amp Kales rules as modified by the new 2007 AASM guidelines from analysis of the frequency profile of the EEG presence of EEG spindles k complexes and delta waves level of chin EMG and eye movements Each 30 second epoch of data will be designated as being in stage W awake REM sleep NI Non REM sleep N2 Non REM sleep or N3 Non REM sleep 1 3 2 Detection of arousals Each 30 second epoch will be searched for the presence of one or more arousals following the guidelines of the American Sleep Disorders Association Sleep 15 174 184 1992 Whenever an arousal is found it will be classified as respiratory related leg movement related or spontaneous based on the temporal relation of the arousal to preceding events 1 3 3 Detection of respiratory events Each 30 second epoch is searched for the presence of one or more respiratory events characterized by reduction hypopnea or complete cessation apnea of airflow in and out of the patient or Respiratory Effort Related Arousal RERA Whenever an apnea is detected it will be characterized as central obstructive or mixed The software uses the guidelines established by the AASM The AASM Manual for the Scoring of Sleep and Associated Events published by the AASM in 2007 The user will have the choice of identifying hypopneas according to crite
28. the desired file or image and select it from the drop down menu beside the File name drop down menu Figure A 6 Y Michele Report Editor File Edit View Insert Format Table el B eb QS File Image i Hyperlink lt gt Break Figure A 5 File name Windows Bitmap BMP brnp b Windows Bitmap BMP bmp Tagged Image Format TIF tif Windows Metafile WMF wmf I Portable Network Graphics PNG pnq JPEG File Interchange Format JPG JPEG jpg Graphics Interchange Format GIF gif Windows Enhanced Metafile EMF ernf Figure A 6 1 8 Format Menu The Format menu Figure A 7 allows users to change the font type attributes position and color through the Character menu item Changes to paragraph formatting and indents and frame and page breaks can be made through the Paragraph menu item Tab stops bullets and numbering borders columns and headers and footers can be customized through their respective menu items A specific combination of a font type paragraph formatting indents frame and page breaks tab stops and bullets and numbering can be saved as a particular Style through the Styles menu item and used in future reports The text color and background color can be easily changed through their respective menus found at the bottom of the Format menu 1AT Appendix A Report Editing Revision 06 l
29. the height and repositions each channel so that all visible channels occupy the same amount of space without overlap Refresh Hypnogram updates the hypnogram channel display This redraws all channels reflecting updates to data such as the sleep staging body position and location of events Align to Epoch Boundary shifts the start of the currently displayed window to re align itself with a multiple of the epoch length Show Patient Name if chosen will show the patient s name at the bottom of event window The patient s name is stored within the EDF file which is not shared with YST Only the signals are sent to YST for scoring and no patient information is transferred 95 User Manual MICHELE Sleep Scoring System 1AF Ea u Revision 22 Effective Date 7 Aug 13 ry C h e e Document Number YST UDoc USM 22 SLEEP SCORING 5 8 Additional Information Show Additional Information opens a window that provides additional information to help with scoring as shown in Figure 5 13 Additional Information Breath High N A Flow Limitation N A Desaturation Percent lt 2 N A Delta Wave Duration EEG1 1 22 5 Delta Wave Duration EEG2 0 5 Figure 5 13 This data window shows four categories of information about the current display e Breath High shows the current breath as a percentage of the nearby reference breath as well as the respiratory channel that provided the measurement the dat
30. 0040651 Scoring Disconnect from Server Connection Status Figure 4 8 If there is an error in establishing a connection to the server a notification will appear over top of the Remote Files pane as shown in Figure 4 9 Out of Date Uploading File Name Status Unable to connect to YST Servers Connection Status Figure 4 9 There are three error messages that can appear here T1 User Manual MICHELE Sleep Scoring System i i ii i T Revision 22 Effective Date 7 Aug 13 Mm C h e eC Document Number YST UDoc USM 22 SLEEP SCORING e Unable to connect to YST Servers This message indicates a problem identifying the YST Servers The most common solution to this error is to verify that the computer has Internet access This message is also shown during YST Server downtime e Invalid Username and or password This message indicates a problem with your login credentials Follow the steps described in Section 2 2 e Unable to set up connection This message indicates that the YST Servers are refusing the connection attempt If this message is shown please contact YST Support for assistance see Section 8 for contact information Downloading from the YST Server If a new automated scoring results file 1s available a small YST icon will appear on your task bar You will also see a Download button next to the File Name in your Remote File Manager Click on the Download button to download the scoring resu
31. 0415 51000425 1000465 Total Non Rem 51000475 51000485 51000515 Figure A 12 2 1 5 Finalizing and Accessing the New Report Template The user may now save the report template by either clicking on the Save shortcut on the Toolbar or by selecting Save As under the File menu Users will be prompted to enter a report name e g CPAP Report 12 1AT Appendix A Report Editing Mm Revision 06 l C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING Once a custom report has been created it will be available to be opened and modified as needed in the future Users may access previously created reports through the Open shortcut in the Toolbar or by selecting Open under the File menu Please note that saved report templates are only stored within the Viewer and will not be accessible through the user s hard drive 2 2 Uploading a Preexisting Report Template Into the Report Editor To insert a preexisting report template select File from the Insert menu The user will be presented with a window in which they can locate the report template on their computer The report editor can upload rtf html doc docx xml pdf txt and tx file formats Please note that the user must be aware of the format of the document they are uploading and ensure that this is selected when locating the file Figure A 13 Rich bext Format tt Rich Text Format rtf Hypertext Markup
32. 3 Spontaneous Arousals These are arousals that are not associated with Respiratory events or with PLMs 1 4 1 3 4 Total arousals Sum of all arousals 1 4 1 3 5 Total arousals awakenings Sum of arousals and awakenings from the SLEEP VARIABLES box For each arousal category arousals are separately reported for REM sleep and non REM sleep periods for each arousal category All arousal data are reported both as numbers of arousals and as an Arousal Index The latter index represents the per hour frequency of occurrence of a certain category of arousals during a specified sleep state For example the Total Arousal Index for non REM sleep is given by the total number of arousals in non REM sleep divided by total time in hours spent in non REM sleep 1 4 1 4 LEG MOVEMENTS box The top section of this box reports all leg movements whether they meet the periodic criteria or not The lower section reports leg movements that meet the PLM criteria published in the 2007 AASM guidelines These criteria exclude leg movements that occur in the interval between 0 5 seconds before the start of a respiratory event and 0 5 seconds after the end of the respiratory event Within each category the leg movements with and without arousal are reported separately Both categories of leg movements PLMs or Total are reported separately for REM sleep and for each of the different stages of non REM sleep The Index represents the per hour frequency of occurren
33. 7 Aug 13 C h e a Document Number YST UDoc USM 22 o SLEEP SCORING Fle View Configuration Preferences Help Gaika e gE TETA m eww wo oa Hus OOO gt Montage Default sje x Properties hd Appearance Background L Pick Primary Line Pice Secondary Line E Picts Epoch Divider B e Sleep Stage E e aie GB 9 a 0004 A0030364_YSTEvent i Epoch Event Start Time wwe Ne bh eM Oe gt amp We Ss a BEYKER Body Positiore N A CPAP Off 3 i ni ih i l Figure 3 2 A floating window can be placed anywhere on the screen it is not confined to being located within the main interface window To Collapse a window clickon the pin icon in the top corner of a docked or tabbed window Figure 3 3 shows the Hypnogram window collapsed and Figure 3 4 shows the Hypnogram window docked a ie a 0004 A0030364_YSTEvent ia Event Duration Char a Patient Start 8 31 PM End 3 52 AM Figure 3 3 38 User Manual MICHELE Sleep Scoring System fi i Revision 22 Mm Effective Date 7 Aug 13 C Document Number YST UDoc USM 22 d SLEEP SCORING File View Configuration Preferences Help gdib ali eS simpre raw PS o 3 Bms 1s O11 gt Montage Default OFr AAINNINANNNNINNIN NAINN NNININN NAIN A
34. 7 Aug 13 Document Number YST UDoc USM 22 E Respitrace Inductive E Audio Processed E Process Nasal co2Units Hypopnea Type A Desaturation Interval 90 30 Airway Pressure Scaling Factor Multiply 1 The Channel Type column lists the fundamental channel types required by the automated scoring These are listed and are the names used by YST Channel Name corresponds to the specific channel in the current EDF file The Viewer cannot automatically correlate specific data channels within the EDF file to the required channels necessary for scoring this must be done manually through the process described in this section A channel name must be chosen for each individual channel If this is not done YST will not be able to distinguish the channel type and will not be able to score the file There is a minimum selection of channels required to perform the automated scoring for a Level 1 or 2 study The following channels are required Two central EEG channels occipital EEG s should not be mapped 1 2 EKG 3 Right EOG 4 Left EOG 5 Chin EMG 6 O2 Saturation 7 Thermistor 8 Nasal cannula OR CPAP flow signal 9 Chest and abdomen bands 10 Right and Left Leg EMG if PLM scoring is required 60 User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING However to improve scori
35. ARIABLES Box This table presents an all night summary of relevant sleep data i e it includes pre CPAP and on CPAP times in the case of split studies Each number in this table is calculated according to the 2007 guidelines of the AASM 1 4 1 1 1 Lights Off clock time 1 4 1 1 2 Lights ON clock time 1 4 1 1 3 Total Sleep Time TST TST is calculated from the sum of all periods scored as N1 N3 and REM between Lights Off and Lights ON It is reported in minutes 1 4 1 1 4 Total Recording Time Difference between Lights On and Lights Off in minutes 1 4 1 1 5 Sleep Efficiency This is calculated from TST 100 Total Recording Time 1 4 1 1 6 Sleep Latency Time from Lights Off to Sleep Onset Sleep Onset is the first time there is a change to stage N1 N2 N3 or REM 1 4 1 1 7 Wake After Sleep Onset WASO Total time in stage Awake minus Sleep Latency User Manual MICHELE Sleep Scoring System fils v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING 1 4 1 1 8 REM Latency Time when REM sleep first appeared minus Time at which any sleep N1 N2 N3 or REM first appeared 1 4 1 1 9 Sleep Period Time Time from Sleep Onset to Lights On 1 4 1 1 10 REM Latency Minus Wake Time REM Latency minus sum of all periods in stage awake between lights Off and REM Onset 1 4 1 1 11 Stage 1 Cycles Number of times patient entered stage N1 sleep 1 4 1 1 12 Total Awakenings Number of
36. Current Score Files 0004 0025 Y YSTEvents Kinnaird Score File Select Delete Close Figure 5 5 90 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 ry C h e e Document Number YST UDoc USM 22 SLEEP SCORING 5 4 The Hypnogram The hypnogram shown in Figure 5 6 below is equivalent to a leaner form of the Graph Window MMM H MET MT Time Marker Figure 5 6 The hypnogram contains a Time Marker that when dragged by the mouse changes the display of the Graph Window to the new location of the marker This functions both ways and changing the display in the Graph Window will automatically move the marker The hypnogram supports adding channels in the same manner as the Graph Window and the ability to evenly space channels The Channel Display displays the visible channels for the specified time window It also displays all events at the appropriate start time with the appropriate duration and name of the event The event name is displayed on the physical event item The Channel Display allows the creation of events Events can be selected in the same way as a channel by simply clicking on the event Multiple events can be selected by holding down the Ctrl key while clicking on events A selected event will have its background color inverted Events can be modified through the interface They can be dragged horizontally with the mouse
37. EPORT Patient Name Sample Recording Information Study Date June 3 2013 Study Type Split ID 23 Patient Patient Name Sample Gender M Date of Birth April 2 1988 Social Security 25651 Healthcare 3 Neck Circumference 20 Weight 220 Ibs Height 5 10 BMI 31 5 Epworth Scale 7 Medications Advil Medical Personnel Referring Doctor A Interpreting Doctor B Collection Technician D Scoring Technician E SLEEP ANALYSIS REPORT Patient Name Sample PRE CPAP SLEEP VARIABLES Lights Off 21 28 41 Time at CPAP On 23 57 36 Total Sleep Time TST 95 0 Total Recording Time 148 9 Sleep Efficiency Wake After Sleep Onset WASO 15 9 Sleep Latency Rem Latency 0 0 Sleep Period Time Rem Latency Minus Wake Time N A Stage1 Cycles Total Awakening 18 Total Stage Shifts TIME IN EACH STAGE Total Non Rem AROUSALS Total Rem Non Rem Number Index Number Index Number 0 0 0 0 0 0 Respiratory With PLMs Spontaneous Total Arousals LEG MOVEMENTS Total Rem Non Rem N1 N2 N3 Number Index Number Index Number Index Number Index Number Index Number Index 4 2 5 N A N A 4 2 5 3 5 1 1 1 0 N A N A PLMs With Arousal 0 0 N A N A 0 0 N A N A Without Arousal 2 5 N A N A 2 5 N A N A Patient Name Sample SLEEP ANALYSIS REPORT RESPIRATORY EVENTS BY SLEEP STAGES Central Apnea Obstructive Apnea Mixed Apnea Obstructive Hypopnea Undefined Hypopnea RERA All Apneas Apneas Hy
38. G Note Each EDF file should have a unique file name that does not include any identifiable patient information EDF files that have been scored should never be re named You should see a screen similar to the one shown below in Figure 3 9 Note that the hypnogram and scoring pane are blank as there is no scoring associated with this file yet Y YST Data Viewer Emx File View Configuration Preferences Help Swi adgi eB FIND DS www wim 20 s 25PMS 1 Se 1 1 Montage Default ar 0 061 _ En En 0c a a eee Sess non omens oan 1 Oi hdaob ehh eece On esene endana l cera pas seh NE ethenpnctel pp ceuihdesiait r derdana t Aae anga S Appearance l pN AA nayean i g pee a p 4 n P diadan tua aandiindiida GALS Background C Pick wo Maaah A ne i I ji Peedi ror Primary Line Ea Pick sage dA promoted p AN panpe a A ah sacana C ea erg aaan ca aasa lt aap daadaa s aaa Epoch Divider E Ea Pe a ee ce a lt aaua anni oe teen aa heated a a eep Stag oO Pick ae CS _ ee ee ee ee ee ee ee es OO ee a oe i RS et ee ee ee ee AS ee ee ee T T n a e a a Ter a m a S a Se ee a aneneen Log dpe phe hg dp dpe re bab pe ph ph ee peed a gt Trey L ninn FUUUUVUUF TUT TUUUUUUU TIT VUUU V UU Tn Uyut UPYAN MANAT Too anna 4 no SI 1 4 4 n AAR AAA AOU A NAAA UAA AATA R yanana non LJ Wy w in U LJ LIJ LJ LJ
39. Index hr PLM Index hr AHI A hr AHI B hr Average 0 918 0 064 0 966 0 946 0 965 16 User Manual MICHELE Sleep Scoring System fils v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING The fourth and fifth columns are the corresponding results for the predicate device Alice Shaded cells in columns 3 and 5 indicate significant difference p lt 0 05 between the Auto score MICHELE or Alice and the average of the three technologists The last five columns contain the intra class correlation coefficients for comparisons between each of the five scorers and the average score of the three technologists The results show good agreement in general between MICHELE scores and the average of three technologists With the exception of the arousal index where concordance ICC between the Auto score and the average was only modest ICC 0 566 concordance was excellent and mostly within the range observed in comparisons between individual technologists and the average of the three technologists Average ICC for MICHELE vs Average was 0 918 bottom row table 3 only marginally below S1 p 0 03 by ANOVA for repeated measures and not significantly different from S2 or S3 The results for analysis with the predicate device Alice are also shown in Table 3 It is clear that MICHELE s performance is superior in all respects Alice found no REM sleep in 27 of
40. LE_vX_XX_XXX exe icon shown below which is provided as part of the Viewer software distribution Ii I S k F MICHELE w1_ 01 020 exe Figure 2 0 Depending on your settings one or more Open File Security Warning windows such as the one shown below in Figure 2 1 may appear after initiating the installation process In each instance select Run A Microsoft Windows message may appear asking if you want to allow the following program from an unknown publisher to make changes to this computer The program is MICHELE vX XX XXX exe where the X represents specific version numbers of the software Select Yes if you wish to proceed with the installation A window will appear asking if you want to install the MICHELE Data Viewer as shown in Figure 2 1 below Select Yes to proceed with the installation 20 User Manual MICHELE Sleep Scoring System Ve a Revision 22 Effective Date 7 Aug 13 i i C h e O Document Number YST UDoc USM 22 o SLEEP SCORING MICHELE Data Viewer Do you wish to install the MICHELE Data Viewer Figure 2 1 A WinZip Self Extractor will appear as shown in Figure 2 2 and will begin unzipping the following programs that are required for Viewer operation e Microsoft NET Framework 4 e Microsoft Visual C 2010 x86 Redistributable e The MICHELE Sleep Scoring System Viewer titled YST Data Viewer Win ip Self Extractor MICHELE v1_01_020 exe P Welcome t
41. Language htm html Microsoft Word docx eee Microsoft Word 97 2003 doc Extensible Markup Language xml Adobe PDF pdf Plain Text tet Plain Unicode Text bet TX TextControl Format t d Figure A 13 Once the user has uploaded their template report they may click the fields that they wish to include in the report and drag the Unique Identifier Keys into the appropriate fields in the template as described in section 2 1 4 above The report may then be saved as described in section 2 1 5 above 2 3 Using a default template There are five template reports that are preloaded into the Report Editor The five preloaded reports are titled Michele Diagnostic Report Michele CPAP Study Michele Split Study Michele Level 3 Rx Report and Michele Level 3 Dx Report These preloaded reports include the data fields that are most commonly used in reports for those particular types of studies However users may add extra fields to the template reports or remove fields that they do not want included in their reports The template reports may be customized for each lab by adding additional tables inserting columns and or rows or deleting tables and removing columns and or rows as described in section 1 9 through the Table menu The user would then click and drag the Unique Identifier Keys into the new table cells they have created as described in 2 1 4 Customized lab information such as a lo
42. M stages 1 2 and 3 PLMs Periodic Limb Movements No Consensus all three technologists gave different scores 13 User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING 1 5 3 1 1 Comparison with Other Predicate Devices There is only one study dealing with the performance of Morpheus 2 These authors reported on the agreement between Morpheus and two individual i e not a consensus technologists M1 and M2 as well as the agreement between M1 and M2 The paper includes data on all four functions Data available for sleep staging include agreement for 5 stage scoring along with PPA for each stage and the overall Yagreement and kappa They also provided agreement and kappa but not PPA for 4 stage scoring Awake NI N2 N3 REM and 3 stage scoring awake non REM and REM For scoring of arousals PLM and respiratory events they provided overall agreement and kappa for scoring one event two events or no events 3 x 3 matrix There was no information on agreement for different categories of respiratory events Two studies are available for the Somnolyzer In one 4 the authors reported on agreement for sleep stages only in comparisons between the Somnolyzer and a 2 3 consensus of technologists Their subjects were mostly normal but the study included 25 patients with sleep apnea severity unspecified The agreement
43. Maximum N A N A ee a A inimum desaturations gt 2 Index N A N A N A N A desaturations gt 3 Index N A N A N A N A desaturations gt 4 Index N A N A N A N A Sleep Time gt 90 N A N A Sleep Time 80 90 f N A N A Sleep Time 70 80 i N A N A Sleep Time 60 70 N A N A Sleep Time 50 60 i N A N A Sleep Time lt 50 l l N A N A Sleep Time with Bad Signal N A N A Only time in sleep considered SLEEP ANALYSIS REPORT Patient Name Sample Graphs i T E Li E E n a a l 21 30 22 00 2230 23 00 ae 00 00 0 20 07 00 01 30 02 00 02 30 03 00 03 20 2 me Ot COT I ee EE nn LIME Tid A ER ana a a a i i or 0c LLI gt e 13 20 23 2300 23320 O00 ww O10 OF OO 3x GO BW Supine Prone 0 Left a Right Upright Out of Bed 2130 2200 223002 0 30 O00 01 30 OOO w Ew AM 12 w 10 8 nH r 4 gt 2 0 130 20 2730 2300 23320 O00 ON OW OF OO xw BO BW DURATION RESPIRATORY OXIMETRY Level Total REM NREM Cen Obs Mxd Undef Hypop A H AHI Max Min Avg min min min Apnea Apnea Apnea Apnea nea Total SpO2 SpO2 SpO2 7 14 8 0 0 0 5 0 0 0 1 0 1 119 8 98 0 89 0 96 8 9 38 3 31 8 6 0 0 0 0 3 3 6 95 98 0 88 0 95 4 10 182 7 17 7 160 5 1 0 0 0 1 2 0 7 100 0 90 00 97 3 SLEEP ANALYSIS REPORT Patient Name Sample AUDIO F130 77 00 22 30 2300 23 30 00 00 00 30 01 00 0130 OO 0230 00 OS PLM
44. NG Update EDF ezm F Do you want to rename the channel in the EDF File WARNING This lt action cannot be undone No Figure 3 25 Selecting Yes will permanently modify the EDF File while selecting No will only modify the current viewing of the file Once the file 1s closed any temporary name changes will be lost 3 7 Hypnogram Properties Properties Hypnogram A l Appearance Background Figure 3 26 Selecting the hypnogram is done in a manner similar to selecting the graph The only configurable property of the hypnogram is the background color which functions in the same manner as in the Graph Window This is shown in Figure 3 26 Selecting a hypnogram channel is performed in the same manner as selecting a graph channel There are two types of channels that can be displayed in the hypnogram these are hypnogram specific channels and generic channels The hypnogram specific channels are e Hypnogram shows Sleep Staging o Uses a color scheme for displaying sleep stages Awake and stage transitions Black Stage 1 Orange Stage 2 Red Stage 3 Green REM Purple e Body Position e Leg Movements shows a tick for each event 57 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 Mm C h e eC Document Number YST UDoc USM 22 SLEEP SCORING e Arousals shows a tick for each event e Respiratory shows a tick for each event Hy
45. Number YST UDoc A1 06 SLEEP SCORING Y Michele Report Editor iew Insert Format Table Paste Ctrl V Delete Select All Corl A Find Ctrl F Replace Ctrl H Figure A 3 1 6 View Menu The View menu Figure A 4 allows users to view the current report in either Page Layout view or in Draft view as well as create and edit any existing headers and footers The Toolbar Button Bar Status Bar and Horizontal and Vertical Rulers are all shown in the Report Editor by default The user can remove any of these from view by de selecting them in the View menu The user can also adjust the size of the report on their monitor by increasing the Zoom to see a close up view of the file or decrease the Zoom to see more of the page at a reduced size Y Michele Report Editor Insert Format Table Ea H w Fage Layout Ctrl 1 Draft Ctrl 2 Headers And Footers Toolbar Button Bar Status Bar Horizontal Ruler Vertical Ruler Zoom FigureA 4 1AT Appendix A Report Editing Mm Revision 06 l C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING 1 7 Insert Menu The Insert menu Figure A 5 allows users to insert files such as existing report templates images text frames hyperlinks or page breaks When inserting a file or an image a dialog box will appear and the user will have to search for the desired file or image in their computer directory The user will need to be aware of the format of
46. On 03 57 41 Total Sleep Time TST 217 5 Total Recording Time 240 1 Sleep Efficiency Wake After Sleep Onset WASO 21 5 Sleep Latency Rem Latency 24 0 Sleep Period Time Rem Latency Minus Wake Time 7 9 Stage1 Cycles Total Awakening 7 Total Stage Shifts TIME IN EACH STAGE Non Rem Number Respiratory With PLMs Spontaneous Total Arousals LEG MOVEMENTS Total Rem Non Rem N1 N2 N3 Number Index Number Index Number Index Number Index Number Index Number Index 10 2 8 0 0 0 10 3 6 2 3 6 8 3 6 N A N A PLMs With Arousal 0 0 N A N A Without Arousal 0 0 i N A N A SLEEP ANALYSIS REPORT Patient Name Sample RESPIRATORY EVENTS BY SLEEP STAGES Total Rem Non Rem Duration Number Index Number Index Number Index Average Maximum 0 3 0 0 0 0 4 Central Apnea Obstructive Apnea Mixed Apnea Obstructive Hypopnea Undefined Hypopnea RERA All Apneas Apneas Hypopneas Apneas Hypopneas RERAs OOMDDdONNOGO gt OOOO O0O0 O OODDdONNOGO gt Scored by criteria A RESPIRATORY EVENTS BY BODY POSITION Total Supine Right Left Prone Upright Number Index Number Index Number Index Number Index Number Index Number Index 1 1 0 3 Central Apnea Obstructive Apnea Mixed Apnea Obstructive Hypopnea Undefined Hypopnea RERA ALL Apneas Apneas Hypopneas OoOo o0o0aonNnNOO OO oOo n anNnnN O O Apneas Hypopneas RERAs O2 SATURATION STATISTICS Overall Supine Lateral Prone
47. RY EVENTS BY BODY POSITION box The first column in this table is identical to the first column in the preceding table and provides the number and index of events in each category in all body positions The total numbers are then subdivided by body position The Indexes are obtained by dividing the number of events in a given position by the time in hours spent asleep in this body position 1 4 1 7 O2 SATURATION STATISTICS box This table lists a number of statistics related to SpO2 data oxygen saturation of hemoglobin The following values are reported 1 4 1 7 1 Maximum The highest valid SpO2 between Lights Out and Lights On 1 4 1 7 2 Average The average of all valid SpO2 data between Lights Out and Lights On 1 4 1 7 3 Minimum The lowest valid SpO2 between Lights Out and Lights On 1 4 1 7 4 desaturations gt 2 Total number of events where SpO2 decreased by gt 2 1 4 1 7 5 Desaturation Index desaturations gt 2 Total Sleep Time in hours 1 4 1 7 6 desaturations gt 3 Total number of events where SpO2 decreased by gt 3 1 4 1 7 7 Desaturation Index desaturations gt 3 Total Sleep Time in hours 1 4 1 7 8 desaturations gt 4 Total number of events where SpO2 decreased by gt 4 1 4 1 7 9 Desaturation Index desaturations gt 4 Total Sleep Time in hours 1 4 1 7 10 Sleep Time spent in different SpO2 ranges The table provides this data for six SpO2 ranges 1 4 1 7 11 Sleep Time with bad si
48. User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING MICHELE SLEEP SCORING SYSTEM USER MANUAL APPROVALS Operations Research and Development Prepared by Marc Soiferman Technician YRT Ltd Director Human fh michele SLEEP SCORING User Manual MICHELE Sleep Scoring System Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 Table of Contents Label Information including Intended Use and Warnings and Cautions 4 Introduction a User Training 5 1 System Overview 5 1 1 System Requirements 5 1 2 Data Collection Requirements 6 1 3 Scoring Rules Used 7 1 4 Reported Variables 8 1 5 Validation Results 12 2 Viewer Installation 20 pe Instructions 20 2 2 Login Information 28 pe Software Update Instructions 30 2 4 Creating Proper Score File Directories 35 3 Set up and use of the Main Graphical User Interface Window 36 oy How to Customize the Main Window Layout 36 3 2 The Main Menu 41 3 3 Setting Up Individual Channels and All Properties Within 45 3 4 Filters 53 stn Referencing 54 3 6 Channel Renaming 56 Ae Hypnogram Properties 57 3 8 Body Position Channel 58 3 9 Channel Mapping 59 3 10 Montages 63 4 Scoring a File 68 4 1 Study Review 68 4 2 Channel Mapping for Scoring 68 4 3 Finalizing User Input Required for Scoring T2 4 4 Uploading to th
49. a source o Data Sources are as follows NC Nasal Cannula CPAP CPAP Flow Therm Thermistor Sum Represents Respitrace bands when Inductive bands are used e Flow Limitation indicates if the current inspiration is showing any indication of flow limitation Flow limitation applies only when the data source 1s CPAP or NC e Desaturation Percent indicates if there is an oxygen desaturation in the vicinity of the cursor and if yes what percentage the desaturation is Only desaturations of 2 or more are reported those less than 2 being insignificant e Duty Cycle The Duty Cycle is the time of inspiration Ti divided by the time of the entire breath Ttot The final value is the Delta Wave Duration value This is provided for both EEG and EEG2 Delta Wave durations are intended to assist scoring and are therefore only shown when the epoch duration is set to 30 seconds and the view is aligned to the epoch boundary the same conditions that allow sleep staging 96 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING The Breath High Flow Limitation Desaturation Percent and Delta Wave Duration can only be viewed if the autoscoring has already been completed for the opened file and the generated data file extension dat is kept in the same directory as the opened file The reported values for all fields bu
50. and kappa values for sleep staging by MICHELE 82 5 Table 1 exceeded the values reported in this study both for the apnea patients 75 6 and the normal subjects 80 4 The other study on Somnolyzer 3 reported on agreement and kappa in comparisons between the Somnolyzer and one scorer Comparisons were limited to sleep staging and the subjects were all normal In order to compare our results with those cited above 2 3 it was necessary to analyze and report our data in the same fashion i e one on one comparisons between the Auto score and two technologists and between the two technologists This is presented below for our first two scorers S1 and S2 along with the agreement indices that correspond to what they reported Table 2 Table 2 shows that the agreement between MICHELE and individual technologists equals or exceeds the corresponding values in the Morpheus study 2 It is to be noted that the criteria for scoring respiratory events used in the Morpheus study the Chicago criteria 5 were different from the criteria used by MICHELE 6 and that the latter criteria are more complex than the former It is also notable that the agreement between MICHELE and each of the two technologists S1 and S2 is substantially comparable to the agreement between the two technologists The other published study dealing with the Somnolyzer 3 reported a agreement of 72 3 with a kappa of 59 1 for agreement between the Somnolyzer and one scor
51. as been uploaded and has been scored by YST but the user has not downloaded the results files A Download button is available for the user to press to download the results files Downloaded the file has been uploaded scored by YST and the user has downloaded the results files New Scoring Available the file has been downloaded previously however the results files present on the server are newer than the version that the user has downloaded A Download button is available for the user to press to download the updated results files Previously Downloaded the file has been uploaded scored by YST and the current user was not the original user that has downloaded the results file When there is an error during the scoring process the file status will show as Error in the Remote Files pane and there will be information within the File Information pane An example is shown in Figure 4 8 below 76 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 j i C h a Document Number YST UDoc USM 22 o SLEEP SCORING Y Remote File Manager t nn lt w2 _ Available File A0040647 Scoring Error Error i Time of Upload 11 38 AM 24 02 2012 Downloaded Index was out of range Must be non negative and less Out of Date than the size of the collection Uploading File Name Status 0004 0151 Downloaded 0004 01668 Downloaded AO040548 Out Of Date Download A
52. at accompany a file The Score File Manager is described in Section 5 3 Montage Manager displays a dialog that lists all of the current montages For more information on montages including importing and exporting thereof see Section 3 9 4 User Manual MICHELE Sleep Scoring System A rir Revision 22 Effective Date 7 Aug 13 ry C h e eC Document Number YST UDoc USM 22 SLEEP SCORING See Section 4 2 for details on selecting Score File from the File Menu The Remote File Manager is described in Section 4 5 How to generate a report using the Generate Report option is covered in detail in Section 6 of this manual The Print option allows printing of any of the Graph Window Hypnogram Event List or Analysis Notes The Recent File List displays a list of recently opened files Selecting a file from this list is the equivalent of utilizing Open Patient File Exit attempts to close the application first prompting to save changes 3 2 1 Opening a Patient File To open a file go to the File Menu and choose Open Patient File File View Configuration Preferences Help _ E3 Open Patient File in Save Montage Manager Import Export Montages Remote File Manager Report Editor Report Manager Import Export Reports Figure 3 8 42 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 i i C h e Document Number YST UDoc USM 22 o SLEEP SCORIN
53. at should not be renamed or modified outside of the application The notes if present are appended at the end of the generated report Editing the analysis notes is done using the provided interface which functions as a text editor Selecting Save Analysis Notes will save the analysis notes Since there is only one set of analysis notes per file no secondary prompt is required 5 11 Print Example Print allows printing of any of four windows These are the Graph Window the Hypnogram the Analysis Notes and the Event List All of these windows are printed as they are shown on the screen Selecting Print brings up a dialog that allows the selection of which window to print shown below in Figure 5 16 100 User Manual MICHELE Sleep Scoring System Revision 22 mMm Effective Date 7 Aug 13 C e Document Number YST UDoc USM 22 d SLEEP SCORING Graph Window Hypnogram Ewent List Figure 5 16 Note Printing the Event List applies the specified event filters Event filters are discussed further in Section 4 6 101 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING 6 0 Generating the Report Generate Report allows for the user to generate a customized report for the opened patient file and scoring file using the Report Editor Please refer to Appendix A Report Editing for information on using t
54. ative Up and Positive Down inverted Clicking on the Invert Signal checkbox will automatically invert the limits entered see Scale Specifying an upper limit that is lower than the lower limit will automatically invert the signal While the EEG and EOG channels should be inverted for every patient file within individual studies certain signals such as EKG and thermistor may need to be inverted for correct polarity as well The Grid Lines option can be utilized to draw dashed horizontal grid lines on a selected channel An example of grid lines set at 37 5 and 37 5 appears in Figure 3 16 These grid lines enable the user to easily see the size of a 75uv Delta wave Figure 3 16 Selecting the Grid Lines option presents the dialog box shown in Figure 3 17 Specification of Grid Lines Add Figure 3 17 Here the levels at which grid lines are displayed are listed in the Level box To add a new grid line click on the Add button which will display the window shown in Figure 3 18 52 User Manual MICHELE Sleep Scoring System Ve a Revision 22 Effective Date 7 Aug 13 ry C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Add Grid Line Seles Enter Level 50 Figure 3 18 To delete a grid line select the level from the list shown in Figure 3 17 and press the Delete button Grid lines can be used for other channels besides EEG like SaOQ2 CO2 or CPAP pressure Figure 3 19 provides an example o
55. automatic scoring in the other variables were in the same range as what we observed with MICHELE Both systems underestimated the arousal index With Morpheus the difference was 11 hr 0 5 30 36 22 while MICHELE underestimated the index by 8 hr 0 5 32 33 25 The correlation coefficients for comparisons between manual and MICHELE s scoring S1 vs Auto and S2 vs Auto exceeded the corresponding coefficients in the Morpheus study M1 vs Auto and M2 vs Auto in all categories except the Arousal Index where it was only marginally lower The averages of all correlation coefficients for the comparisons between Tech 1 amp Tech 2 Tech 1 vs Auto and Tech 2 vs Auto are given at the bottom of the table There were no significant differences by ANOVA for repeated measures between the three averages in the case of MICHELE 17 ba User Manual MICHELE Sleep Scoring System Fii michele SLEEP SCORING Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 Table 4 Comparison between Michele and Morpheus for Scoring Clinically Relevant Variables Michele Auto Scoring System Morpheus Variable Total sleep time min 330 300 312 0 876 0 934 SD 73 76 72 Sleep efficiency 79 72 75 0 883 0 941 SD 16 18 17 Sleep onset latency min 22 25 24 0 98 0 94 SD 27 27 29 REM onset latency min 131 121 126 0 92 0 90 SD 72 71 73 Stage wake min 91 120 108 0 886 0 942 SD 72 80 74 Stage 1 min 52 44 42 0 692
56. box will appear as shown in Figure A 16 Users will need to specify the file location where the report template s is to be copied by clicking on the button next to the report name Choose the location through the file directory By default the exported reports are saved as export rep but users may rename the export if they wish Figure A 17 Users will then click Save and a dialog box will appear noting that the exported report file does not exist and ask if the user wants to create it Click on Yes Once the report export has been saved users are returned to Figure A 15 above but the text box will now be filled in with the file path that was specified Users are now able to click Next to proceed Y Import Export Report Tool _ 3s Exporting reports will export to a file of your choice It is recommended that you select an easily accessible file location for quick retrieval of the exported reports pT Cancel Previous Next Figure A 16 File name ales Save as type Report Files rep Figure A 17 15 1AT Appendix A Report Editing Mm Revision 06 l C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING Users will then select which reports they would like to export A dialog box will appear listing all customized reports that have been created on the user s computer Figure A 18 Select a single report template by clicking on its name or sel
57. can all be specified through the Properties menu Y Michele Report Editor File Edit View Insert Format Table Ea B A E E Insert b ie ete eG ie ok ba p E ve Grid Lines Figure A 8 1AT Appendix A Report Editing Mm Revision 06 l C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING 1 10 Toolbar and Button Bar The Toolbar beneath the Menu Bar Figure A 9 allows users shortcut access to several frequently used features found under menus in the Menu bar Reports can be created opened saved and printed through their respective shortcuts in this Toolbar Images or text can be cut copied pasted or deleted actions can be undone and or redone words can be searched for and headers can be formatted through the Toolbar The Page Setup menu can also be easily accessed through the Toolbar To see which shortcut a button corresponds to the user may hover their mouse over the button and a description of what the button does will appear Figure A 10 The Button Bar allows users to quickly change their paragraph style font font size and attributes change the alignment of the text create a bulleted or numbered list zoom in or out of the report view paragraph marks and other formatting symbols and create or modify existing tabs Y Michele Report Editor File Edit View Insert Format Table Ea E j E Normal 10 B F U Be 100 T L 1 L k i lt L 1 i L f
58. ce of a certain category of leg movements during a specified sleep state For example the PLM index for non REM User Manual MICHELE Sleep Scoring System fils v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING sleep is given by the total number of PLMs in non REM sleep divided by total time in hours spent in non REM sleep 1 4 1 5 RESPIRATORY EVENTS BY SLEEP STAGE box The first column in this table reports the total number of each type of Respiratory Event that occurred during sleep along with the relevant Index i e number total sleep time in hours At the bottom of the first column the total number of apneas along with relevant index Apnea Index are reported The sum of all apneas and hypopneas along with the Apnea hypopnea index AHI are also reported Finally the sum of all 6 categories Apneas hypopneas RERAs and its index are given These three Indices are calculated by dividing the relevant number by TST in minutes and then multiplying by 60 In the next two columns the total number within each category is broken into numbers occurring in REM sleep and in non REM sleep For each such number the relevant Index is obtained by dividing the number by total sleep time in minutes of the relevant sleep stage and then multiplying by 60 The last column shows the average and maximum durations of events in each respiratory event category 1 4 1 6 RESPIRATO
59. ced checkbox the fourth is the Apply button located beside the Score button and the fifth is the Airway Pressure Scaling Factor Once this window is open the procedure for specifying the information required to enable scoring of a file is as follows l 2 Verify that the channel mapping is correct for each individual channel a Edit it if it is not Confirm the polarity of the EKG flow channels chest and abdomen Once all are in phase and set correctly within the main viewing window make note of which channel does not have the invert box checked and which channel does have the invert box checked For the mentioned channels make sure the polarity within the channel mapping is set to negative for all the channels that have the invert box checked The polarity should be set to positive for all the channels that do not have the invert box checked in the properties area If apply is then selected it will save it in that study as long the study is open Verify that the correct options on the right side of the window are selected 69 User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING a Check the Respitrace Inductive box if Inductance Plethysmography of any type was used for monitoring chest and abdominal movement during the study b Check the Audio Processed box if audio was used and if it was processed prior to bein
60. cified The Synchronize with Body Position Channel button tells the software to read the body position out of an existing channel Pressing this button will remove any body position markers already placed For this feature to work a body position channel must be defined in the Channel Mappings window see Section 4 2 and voltage ranges must be defined and enabled see Section 3 8 It should be noted that the autoscoring package automatically extracts information from the body position channel if both it and voltage ranges are defined This option does not need to be used prior to executing automated scoring The Filter Event List button allows for specification of the type of event that should be displayed in the Main Window Clicking this button will display a menu that lists the different categories of events as shown in Figure 4 11 80 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 ry C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Arousals Respiratory PLMs Oxygen Events Markers sleep Snoring Cardiac Observations General Observations i i a a a a Custom Figure 4 11 Any item with a check is displayed in Main Window and any item without a check is not displayed Selecting an item will toggle its state The events included in each category are as follows e Arousals o Arousals e Respiratory o All Apneas Hypopneas and RERAs e PLMs o PLMs e Ox
61. ckbox and then click on the Install button The installation progress will be displayed as shown below in Figure 2 6 Microsoft Visual C 2010 x86 Redistributable Setup Installation Progress Please wait while the Microsoft Visual C 2010 x86 Redistributable is being installed File security verification All files were verified successfully Installation progress Installing Microsoft Visual C 2010 Redistributable Cancel Figure 2 6 You will be greeted with a Windows Installer message asking if you want to allow this program to make changes to the computer at which time you will need to select Yes to continue with the installation Another Windows message will appear asking the same question quoting file dotNetFx40 Full x86 x64 exe Select Yes After the Microsoft Visual C 2010 component 23 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 i i C h e O Document Number YST UDoc USM 22 o SLEEP SCORING libraries are installed the installer will automatically install the NET Framework The window shown in Figure 2 7 will be displayed while it is being installed i YST Data Viewer Setuy Installing Microsoft NET Framework 4 k86 and x64 Figure 2 7 The Viewer Setup Screen will open up next as shown in Figure 2 8 Select Next Welcome to the YST Data Viewer Setup Wizard oN Se wj S i The installer wall guide you through th
62. d Report Including a Custom Oxygen Threshold Outputting a Sample Channel Selecting a Report Template Opening the Customized Report The Report Manager W CONNDNW NH HA A W W YW 1AT Appendix A Report Editing Mm Revision 06 C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING Introduction To suit the individual needs of each user the Viewer has the ability to create and use report templates to display the results of autoscoring by MICHELE for both Level and Level 3 studies To facilitate the development and deployment of report templates the Viewer software package includes a Report Editor The Report Editor presents users with a free style word processing interface which allows for the construction of customized reports Default templates are included and can be used as is or as a starting point and modified to suit each user s requirements Users are also able to upload a report template currently being used in their lab and configure it to display the pertinent information using Unique Identifier Keys There is no limit to the number of customized reports users are able to create users may wish to create a report template for each type of study their lab performs Split night CPAP only no CPAP etc 1 0 Features of the Report Editor 1 1 Opening the Report Editor To open the Report Editor from the Viewer Main Menu select Report Editor from the File menu The Report Editor will
63. d be lt 5KQ 1 2 2 Sampling rate The sampling rate should be a minimum of 120 Hz for AC channels EEG EOG EKG EMG and Audio a minimum of 20 Hz for Respiratory signals Thermister Flow Respiratory bands Airway pressure Airway CO2 a minimum of 5 Hz for SpO and a minimum of 1 Hz for body position if position is recorded directly in the digital file 1 2 3 Signal filtering of AC channels EEG EOG EKG EMG and Audio Filtering must be performed either in hardware at the amplifiers or in the software after recording If you use hardware filters you should export the file into the EDF format without any additional filtering If you do not use the hardware filters it is recommended that you export the file without additional filters You will be asked as described in Section 4 2 whether the file has been pre filtered either by hardware or during export before automated scoring begins If the signals are to be filtered by hardware or during export each of the 5 primary AC channels must be filtered as per the American Academy of Sleep Medicine AASM guidelines shown below In addition a 60 Hz notch filter must be used where available Low Frequency Filter High Frequency Filter EEG 0 3 Hz 30 35 Hz preferably 30 EOG 0 3 Hz 30 35 Hz preferably 30 EMG 10 Hz 100 Hz ECG 0 3 Hz 70 Hz Audio 10 Hz 100 Hz User Manual MICHELE Sleep Scoring System fils v Revision 22 Effective Date 7 Aug 13 M C h e eC Document N
64. e Type2 different version a sample of any channel labelled as ECG Sample and or a CPAP BiPAP Summary table The Full Graph Hypnogram Vs O2 Heart Rate Type2 and ECG Sample graphs were specifically made for one user but are available for useby any user if so desired For a full description on how to use the ECG Sample function see Section 3 5 below 2 1 4 Unique Identifier Keys Once the user has determined which data graphs and or tables they would like to include in their report they can click the particular field and drag it over into the appropriate column in a table or field in the report E g if a user wanted to include Time of Lights Off they would expand the General field by clicking the symbol beside General then expand the Dates and Times field in the same manner click and hold Time of Lights Off and drag the item into the correct place in the report The data will appear as a Unique Identifier Key Figure A 12 This Unique Identifier Key will be replaced with the appropriate data once the report is generated Do not delete or modify any of the Unique Identifier Keys as this will affect how the report is generated and may result in incorrect data being displayed in the report TIME IN EACH STAGE Sleep Stage Time min TST Awake 100017 1000185 Ni 31000235 51000245 51000275 NZ 51000295 51000305 51000335 N3 51000355 51000365 51000395 Rem 100
65. e YST Server 74 4 5 Remote File Manager 74 4 6 The Scores Window 79 4 7 The Graph Window 83 5 Editing a File 85 5 1 Copying a File for Edit 85 D2 How to Edit a Study 86 33 Creating an Event 87 5 4 The Hypnogram 91 a The Graph Tray 92 fas michele SLEEP SCORING 5 6 EKG Artifact Removal 5 7 The View Menu 5 8 Additional Information 5 9 The Toolbar 5 10 Analysis Notes 5 11 Print Example 6 Generating the Report 7 The Help Menu 8 Troubleshooting 8 1 Error Message 8 2 Notifying YST of Perceived Software Failure 9 Optional Server Setup 9 1 Requirements 9 2 Installation 9 3 Configuration 9 4 Miscellaneous 10 Attachments 10 1 Sample Report Appendix A Report Editing User Manual MICHELE Sleep Scoring System Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 103 105 105 105 106 106 106 106 106 107 107 User Manual MICHELE Sleep Scoring System fils v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Name and address of the manufacturer Younes Sleep Technologies YST 1 Morley Avenue Princess Elizabeth Building Winnipeg Manitoba R3L 2P4 Canada Tel 1 888 942 6774 Name and address of the EU Authorized Representative Advena Ltd Pure Offices Plato Close Warwick CV34 6WE UK CE Mark C a 0086 Intended Use The MICHELE Sleep Scoring System is a computer program soft
66. e notes should be used only for short notes or to represent custom markers Any long or in depth notes should be added to the analysis notes Notes cannot be edited once placed however an unlimited amount may be added and deleted Notes added via the notes marker are printed with the event list rather than the analysis notes Figure 5 9 below shows an example of a Left Body Position marker next to a CPAP level 30 marker If any markers overlap each other the markers will turn red to indicate that there are hidden events shown in Figure 5 10 amp left CPAPLevel 30 SS CPAP S veBaijen Level 90 Figure 5 9 Figure 5 10 Several restrictions apply to different types of markers e The Lights On and Lights Off markers automatically align to the nearest 30 second epoch boundary o Only one of each of these markers can exist at a time For example placing a second Lights Off event will remove the first Lights Off event e Body Position markers automatically adjust their length based on surrounding body positions o The last Body Position marker in the file will stretch to the end o Placing two or more consecutive markers of the same Body Position will keep only the earliest marker e Only one CPAP On flag may be present in the file Placing a second one will delete the first Adding a CPAP On flag turns the study into a split study This causes the report to be split into two sections pre CPAP and post CPAP For information on Report Generati
67. e scoring results for the given file as well as provide an interface for handling multiple scoring files including deleting and renaming events This window is illustrated below in Figure 4 10 Copy Selected Score File I Filter Event Import Body a List Position File Event Start Time Stage 1 2690 Scoring File Synchronize with AR 3696 C3 A7 List Body Position PLM ASR 3698 042 R LEG1 R LEG2 Channel C A D 3701 805 Nasal CPAP Fle Main Window Desat AJR Stage 2 HOA Desat A R Stage 1 Desat PLM AYR O D Wake tage 1 RERA A a a A 3709 3 14 3720 3720 906 3726 3730 3730 3731 75 3733 883 3797 641 3780 3810 3811 906 he ch Figure 4 10 SaQ Nasal CPAP Fle sabe E3 A2 Sal R LEG1 R LEG Masal CPAP Fle Nasal CPAP Fle ci gt y The Main Window displays all scoring events and marker tags that are present in the file Double clicking on a line in the window will jump to the epoch containing the event and select the event Note If a marker tag event is double clicked the display will jump to the epoch but will not select the event The categories shown in the Main Window are as follows 79 User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Epoch displays the 30 second epoch that contains the start of the event Event displays the event name
68. e steps required to install YST Data Viewer on your computer Cancel Figure 2 8 If a window displaying a License Agreement opens as shown in Figure 2 9 read the agreement and select I Agree then Next to proceed with the installation Note that the License Agreement may not be written as shown in Figure 2 9 and furthermore may be provided as a separate document that the end user must sign and return to YST prior to being able to complete the installation of the Viewer 24 User Manual MICHELE Sleep Scoring System Ve a Revision 22 Effective Date 7 Aug 13 i i C h e Document Number YST UDoc USM 22 o SLEEP SCORING License Agreement Please take a moment to read the license agreement now IF you accept the terme below click I Agree then Mest Othenvise click Cancel End User License Agreement EULA for the Younes Sleep Technologies YST MICHELE Sleep Scoring System Viewer software Viewer By clicking Agree the client agrees to abide by the terms set out in the EULA for the YST Viewer provided by YST to the client in a separate document and declares that the EULA for the YST Viewer has been signed by the client and that a copy of the signed document has been provided to YST D Do Not Agree Agree Figure 2 9 For the installation folder dialog shown in Figure 2 10 it is recommended to choose Everyone and to keep the default location as is for all insta
69. e this General Sleep Clinic Location Sleep Disorder Centre 12 Address Road Winnipeg MB R4D 7B5 Tel 204 911 8226 Fax 204 311 9741 Study Date Subject Code Hospital Contact Referring Physician Contact 2 T Sleep Specialist Sex Billing Info re Date of Birth re Age Recording Tech MHSC Scoring Tech Height Weight ee RECORDING COLLECTION OBSERVATIONS SCORING ANALYSIS OBSERVATIONS 2 1 2 Data Fields The Data Fields section includes fields for Sleep data Body Position Respiratory Events Arousals Leg Movements Oxygen Heart Rates and Snoring for Pre and Post CPAP as well as the combined results when needed e g Split Studies Sleep data is categorized into General Items Staging Breakdowns and ORP General Items which may be included are Wake After Sleep Onset Sleep Period Time Awake as of Sleep Period Time Sleep Efficiency and REM Latency Minus Wake Time The Staging Breakdown field allows users to include information on Time in Stage Total Sleep Time Total Study Time Shifts into Stage Latency from Lights Out and Latency from Sleep Onset for all stages including awake all sleep stages and or the individual sleep stages Stage 1 Stage 2 Stage 3 including REM and NREM REM Supine REM Non Supine NREM Supine and NREM Non Supine ORP allows the user to determine quality of sleep for Wake All Sleep Stages including REM Wake After Sleep Onset All and or All After Sl
70. ect multiple report templates by clicking on multiple file names To deselect a report click on the file name a second time After selecting the reports to export click Next A dialog box will appear confirming that the export was successful Figure A 19 The dialog box will indicate that the exported file must be transferred to be imported to another computer Transferring the exported file can be done via attachment to e mail or a usb flash drive however users may wish to save the exported reports on a shared network drive that can be accessed by other users wishing to use the Viewer Y Import Export Report Tool Please select the reports you wish to export from the following list To select a report click on it in the list A second click will deselect a report SAMPLE Sample Report 1 Cancel Previous Figure A 18 16 I ii michele SLEEP SCORING 2 4 2 Importing Reports Appendix A Report Editing Revision 06 Effective Date 24 Jun 14 Document Number YST UDoc A1 06 Y Import Export Report Tool The export has been successful To import these reports on another computer transfer the rep file that was created via this process and run the import export tool Figure A 19 To import report templates that were previously exported select Import Reports shown in Figure A 15 and browse for the exported reports using the button to the right of the text box After the exp
71. ection of a channel holding the mouse button down and moving the mouse This uses the Default Event property of the channel to determine event type see Section 3 3 and the section on Creating and Event below b By right clicking on an empty section of a channel Uses two properties of the channel to determine events Default Event to determine the event type and Default Duration to determine the event duration see Section 3 3 and the section on Creating an Event below 3 Events can be resized by left clicking on either vertical edge of the event holding the mouse button down and moving the mouse 4 Events can be moved by left clicking on the event holding the mouse button down and moving the mouse 5 Events can be renamed in one of three ways a Selecting an event and choosing a new event name from the list provided by the Event Name property b Selecting an event and pressing one of the key bindings that are set as described below see Figure 5 land the text that corresponds to it c Right clicking an event and selecting a new event name from the list provided 6 Event associations can be toggled by using the check boxes provided in the properties window when an event is selected see Section 3 7 Sleep staging can be restaged by using one of the key bindings that are set as described below see Figure 5 1 and the text that corresponds to it if the following conditions are met a Epoch duration is set to 30 seconds b
72. ection system is used but the channel order or numbering is different from one room or system to another a new montage and new channel mapping within will be required for each room or system Once a montage has been built for each collection system and or each room if the channels were numbered or ordered differently from one room or system to another saving the montage will store it so it can be re opened in the future 3 10 2 Importing Exporting Montages Users have the ability to copy a Montage for other Users to import and utilize within their operation This allows a Sleep lab to create a Montage once and have it used in multiple Viewers within their lab To import or export a Montage select the File menu at the top left corner of the Viewer and a drop down menu will display as indicated in Figure 3 32 below 64 michele SLEEP SCORING User Manual MICHELE Sleep Scoring System File View Configuration Preferences Help Open Patient File Close Patient File Channel Information Save Score File Manager Montage Manager Import Export Montages Score File Remote File Manager Modify Login Information Generate Report Open Generated Report Report Editor Report Manager Import Export Reports a Print Figure 3 32 Y Import Export Montage Tool Importing and exporting montages allows you to transfer your settings between users Please select which action you wish to perform D Import Montages
73. editing the current montage and then selecting Save Montage from the File Menu This will open the window shown in Figure 3 31 By entering a montage name that does not currently exist the edits will be saved into the new montage and any old montage will remain as it was before the edits were done The second method involves immediately saving a new montage The new montage can then be edited to your liking and saved by selecting Save Montage and selecting the current montage name in the list Selecting Save Montage displays Figure 3 31 63 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 ry C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Y Save Montage Current Montages Michele new default Calgary montage 1 files Test Default Enter Montage Name Save Cancel Figure 3 31 This prompt allows you to either overwrite a current montage or create a new montage with the current settings Creating a montage is done by entering a name in the Montage Name box that does not exist in the list of current montages If all of the data acquisition systems are set up in the exact same way with the same collection system and the same channel order and numbering only one montage will be required which will include one channel mapping If data acquisition systems are set up differently different montages channel mappings will be required for each setup If the same coll
74. eep Onset The Body Position field allows users to include data on Total Time Including Awake Total Time Sleep Only Total Study Time and Total Sleep Time for each individual body position the patient was in Supine Prone Upright Right Left Lateral and Non Supine 10 1AT Appendix A Report Editing Mm Revision 06 C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING The Respiratory field allows users to include data collected regarding the Number Index Maximum Duration Average Duration Minimum Duration Total Duration Minutes and Total Sleep Time for Undefined Apneas Central Apneas Obstructive Apneas Mixed Apneas Obstructive Hypopneas Undefined Hypopneas All Hypopneas RERAs All Apneas Apneas Hypopneas and All Events that occurred in the sleep portion of the study Respiratory event data can also be specified by the stage of sleep the events occurred in including REM and NREM and or which body position the patient was in when the event s occurred Supine Prone Upright Right Left Lateral Non Supine REM Supine REM Non Supine NREM Supine and NREM Non Supine Arousal data which include Number and Index of Respiratory PLM Spontaneous Awakenings and Total Arousals are able to be broken down into the same categories as Respiratory Events as described above All Sleep individual sleep stages including REM and NREM and or body position The Leg Movements fie
75. ellaneous There is a known issue wherein if two instances of the Viewer download the same file and they both finish within 1 second of each other one will crash This is not expected to occur in daily use and is being addressed in later revisions 106 fh michele SLEEP SCORING 10 0 Attachments User Manual MICHELE Sleep Scoring System Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 10 1 A sample report generated by the MICHELE Sleep Scoring System is attached nine pages including the cover page label 107 fle Michele Sleep Scoring System Report Label h Document Number YST Label 001 11 IIC e e Revision 11 SLEET een ae Effective Date 25 Apr 13 This Report Was Generated by MICHELE Sleep Scoring System Name and address of the manufacturer Younes Sleep Technologies YST 1 Morley Avenue Princess Elizabeth Building Winnipeg Manitoba R3L 2P4 Canada Tel 1 888 942 6774 Name and address of the EU Authorized Representative Advena Ltd Pure Offices Plato Close Warwick CV34 6WE UK Intended Use The MICHELE Sleep Scoring System is a computer program software intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders The MICHELE Sleep Scoring System is intended to be used for analysis automatic scoring and manual rescoring display redisplay retrieve summarizing reports generation and networking of digital data collected by mo
76. em i i ii i T Revision 22 Effective Date 7 Aug 13 Mm C h e eC Document Number YST UDoc USM 22 SLEEP SCORING A Arousal Apnea unclassified Arrythmia Asystole Atrial Fibrillation Bad Oxygen Bad Oxygen Section Bradycardia Bruxism C Central Apnea Desat Desaturation H Hypopnea HO Obstructive Hypopnea M Mixed Apnea Narrow Complex Tachycardia O Obstructive Apnea PLM REM Behavior Disorder RERA Rhythmic Movement Disorder Sinus Tachycardia Snore UNKNOWN EVENT Wide Complex Tachycardia The Default Duration property allows setting the duration of default events The default events can be added to scored files using the Quick Mode of editing described in Section 5 3 and the duration can be modified also as described in that section The Position category in the graph channel properties window Figure 3 12 deals with how the channel is positioned on the screen The Height option allows for specifying how much of the Graph Window as a percentage of the total height the channel should occupy The value entered here must be greater than O and less than or equal to 100 Invalid entries are rejected The Y option allows for specifying where on the Graph Window as a percent of the total height to place the top of the channel The value entered here must be greater than 0 and less than 100 Note that if Y Height is greater than 100 part of the channel will be clipped by the Graph
77. en applied No must be selected The filters applied within the Viewer are for viewing purposes only Once this question has been answered the Channel Mapping window is shown Figure 4 1 below 68 michele User Manual MICHELE Sleep Scoring System Hh y Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 SLEEP SCORING Y Score File Channel Mapping Channel Type Abdomen Audio Body Position Chest CPAP Flow Expiratory Pressure Inspiratory Pressure Chin EMG EEG 1 EEG 2 EKG End Tidal CO2 Heart Rate Left Eye FOG Left Leg EMG Nasal Cannula Right Eye EOG Right Leg EMG O2 Saturation Thermistor Channel Name ABDM Snore Sensor None CHEST CFLOW CPRESS None Chinl Chin2 C3 M2 c4 M1 EKG None HEARTRATE El M2 L LEG PFLOW E2 M1 R LEG SA02 Thermistor Polarity E Respitrace Inductive E Audio Processed E Process Nasal co2units Hypopnea Type A hal Desaturation Interval 90 30 Airway Pressure Scaling Factor Multiply E Valid E Referenced specify Tags and Lights Figure 4 1 This window is identical to the one described in Section 3 9 with the addition of five more options The first of these new options is the Valid checkbox located on the right side of the window the second is the Referenced checkbox located under the Valid checkbox the third 1s the Specify Position and Lights button located under the Referen
78. ent Number YST UDoc USM 22 SLEEP SCORING Docked 1s the term used to indicate that a window has a fixed place on the screen entirely unto itself Dragging the edges of a docked window will resize all docked windows that are adjacent to the window being dragged In Figure 3 0 all four windows are displayed in the Docked mode Tabbed is the term used to indicate that two or more windows share the same fixed place on the screen Resizing of the shared space has the same results as resizing a Docked window The following Figure 3 1 displays a tabbed window hosting both the Scores Window and the Properties Window Event Start Time Lights Off 0 Wake 0 Right 0 02 Desaturation 1 9 Desaturation 100 75 Desaturation 132 79 Desaturation 222 Desaturation 247 29 Desaturation 313 79 Stage 1 330 Hypopnea 331438 Arousal 342 Leg Movement 352 742 Desaturation 362 Mixed Apnea 368 Arousal 378 Desaturation 393 CentralApnea 394 512 Cag Scores Sy Properties Tabs Figure 3 1 The tabs in the Viewer are located at the bottom of the window Clicking on a tab will switch the display in the tabbed window Floating is the term used when a window does not have a fixed place on the screen Resizing a floating window does not affect any other window Figure 3 2 below shows an example of a floating window In this example the Scores Window 1s floating 37 User Manual MICHELE Sleep Scoring System Revision 22 Effective Date
79. ent is inspiring and any of the listed signals are decreasing then the polarity for those channels is considered to be negative and should be selected as such The polarity of the signals is important for the proper detection of respiratory events This will have to reviewed with each of these signals in each study The polarity will have to be adjusted when the polarity of the signal is changed within each individual study prior to sending for scoring The polarity also applies to the EKG signal The polarity of the EKG signal has a slightly different interpretation than the polarity of a respiratory signal If the R Wave Peak contains the most negative point then the polarity should be set to negative Figure 3 30 below illustrates this concept 61 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 mMm C h e e Document Number YST UDoc USM 22 SLEEP SCORING R wave Peak is the most positive point of the EKG Channel R wave Peak is the most negative point of the EKG Channel 500 0 aott wedi ee od cds ee se td 500 0 a a Positive Polarity b Negative Polarity Figure 3 30 Polarity is not applicable to any other channel and cannot be set If the EDF file contains Chest Thorax and Abdomen effort bands that use the inductive respitrace to produce a signal check off the box in the upper right hand corner of the dialog box shown in Figure 3 29 labeled Respitrace Inducti
80. er Limit 70 E Figure 3 14 In the Scale category the Auto Scale checkbox enables and disables auto scaling When auto scaling is enabled the Upper Limit is automatically set to the maximum value in the current window and the Lower Limit is automatically set to the minimum value in the current window When Auto Scale is checked the Upper Limit and Lower Limit cannot be modified Auto scaling automatically updates the limits each time the displayed data is changed in any way It is recommended to check the Auto Scale box only for Chest Abdomen Thermistor Nasal Pressure and CPAP Flow Make sure not to check the Auto Scale box for the channels that you have entered upper and lower limits for such as the EEG and SaQ2 channels See Figure 3 15 below Properties q Channel Nasal CPAP Flo General Invert Signal Grid Lines Collection a Filters Collection ass Reference Channel Collection vs Position Height 5 Y 5248 Scale Auto Scale v Upper Limit 147 08 Lower Limit 142 75 Figure 3 15 51 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 ry C h e e Document Number YST UDoc USM 22 SLEEP SCORING The General category deals with signal processing functionality that can be applied to a specific channel The Invert Signal option allows for a signal to be represented as either Positive Up and Negative Down non inverted or Neg
81. er in staging sleep The agreement between MICHELE and either technologist S1 or S2 exceeds their reported value 14 User Manual MICHELE Sleep Scoring System Vb michele SLEEP SCORING Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 TABLE 2 COMPARISON OF MICHELE SLEEP SCORING SYSTEM AND MORPHEUS meton Tempore auers Sleep Scoring System Morpheus 2 Function Test reported Auto vs S1 Auto vs S2 S1 vs S2 Auto vs M1 Auto vs M2 M1 vs M2 agreement kappa 80 9 74 4 76 7 68 4 79 6 72 3 77 7 67 0 73 3 61 0 82 1 73 0 PPA 94 4 82 6 75 0 68 7 69 6 80 9 PPA 41 4 41 9 53 6 13 1 19 9 21 3 PPA 80 9 76 1 82 9 73 5 68 9 77 1 PPA 89 7 89 2 90 5 58 0 35 3 47 7 PPA 87 3 85 8 94 2 60 7 57 1 79 0 Yagreement kappa Yagreement kappa AROUSALS 3X3 agreement kappa PLMs 3X3 Yagreement kappa Yagreement kappa Yagreement kappa Yagreement kappa 88 0 81 8 91 4 83 5 84 1 38 8 95 0 66 2 94 8 78 3 94 3 76 5 83 3 74 6 91 1 81 8 87 9 49 3 94 6 67 0 94 6 75 2 93 9 71 7 84 9 76 6 90 8 82 8 85 7 46 4 93 8 60 2 94 9 76 4 93 8 74 3 82 6 71 0 88 0 75 0 76 2 28 0 93 1 68 0 89 7 66 0 79 9 65 0 88 0 74 0 76 1 30 0 92 2 66 0 89 7 66 0 88 7 80 93 5 87 0 83 7 57 0 95 6 77 0 94 9 82 0 1 5 3 2 Objective 2 testing In this section we discuss agreement between automatic and manual scoring f
82. es Validation Study of the Somnolyzer 24 x 7 Utilizing the Siesta Database Neuropsychobiology 51 115 133 5 Sleep related breathing disorders in adults recommendations for syndrome definition and measurement techniques in clinical research The report of an American Academy of Sleep Medicine Task Force Sleep 22 667 689 1999 6 The AASM Manual for the Scoring of Sleep and Associated Disorders American Academy of Sleep Medicine Westchester Illinois 2007 19 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 l j C h e Document Number YST UDoc USM 22 o SLEEP SCORING 2 0 Viewer Installation 2 1 Instructions Follow the instructions below to install the Viewer Instructions on the software update process are provided in Section 2 3 Note l During the install process if a Windows pop up asking if filename exe is allowed to make changes to this computer Yes must be selected to enable the installation Note 2 For the Windows XP 64 bit operating system the following items need to be installed before successful installation of the Viewer e Microsoft net Framework 3 5 e A Microsoft patch entitled wic x64 enu that should look like this The patch can be downloaded by pasting this url into your web browser http www microsoft com en us download details aspx id 1385 To initiate the software installation process double click on the MICHE
83. evision 06 l C eC e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING The report will automatically open in either Microsoft Word for rtf reports or Adobe Reader for pdf reports The report can then be printed or saved to the user s hard drive 3 8 Using the Report Manager Users can edit delete or rename any custom report template they have created by accessing the Report Manager found in the File menu of the main Viewer window 23
84. f grid lines on the SaO2 channel Figure 3 19 3 4 Filters The Filters option allows for different filters to be applied to the selected channel Low and high filter settings will need to be applied to all AC channels i e EEG EOG EMG and EKG It is not necessary to apply filters to the DC channels e g flow The maximum high frequency filter setting cannot exceed that of half of the collection sampling rate Selecting this option in the General category of the graph channel properties window see Figure 3 12 opens a filter management dialog box shown in Figure 3 20 Y Channel Filter List po Channel Filters High Frequency Filter 35 Hz yY Low Frequency Filter 0 3 Hz yY Notch Filter None 50 Hz Figure 3 20 53 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 ry C h e e Document Number YST UDoc USM 22 SLEEP SCORING Select the box next to the filter frequency you wish to enter and type in the numeric value to be applied A Notch Filter can also be selected with an allowance for either a 50 Hz or 60 Hz setting to accommodate the variability between geographical regions Figure 3 21 below displays the end result of entering filter settings Y Channel Filter List csa High Frequency Filter 100 Hz ZW Low Frequency Filter 10 Hz Sf Notch Filter None 50 Hz Figure 3 21 Note that the green c
85. g loaded into the Viewer c Check Process Nasal if nasal root was used with the Nasal Flow 4 Select Specify Tags and Lights which will result in the window shown in Figure 4 2 below a Lights Off and On as well as CPAP On can be entered manually in the boxes under the Set Time category b The information can also be imported from a text file Select Import Data From File click on the text file related to the study that is open and select Open Click on OK All the tags such as lights on off and body position tags will be included in the scoring 5 The Airway Pressure Scaling Factor feature allows multiplication of the Airway Pressure channels both Inspiratory and Expiratory to allow for alterations in the gain of these channels This feature was enabled in case files that are exported from data acquisition systems measure pressure in units other than cm of water Where the conversion factor is known this feature can implement the required adjustment As indicated above the Import Data From File button in the Body Position and Lights window Figure 4 2 can be used to import a text file with position and lights data which the user has created This text file should be created using Microsoft Notepad or other software that allows saving as a txt file The file must be encoded in the following format Epoch Event extra Each event receives its own line in the file As long as the first two parameters are present on the l
86. gnal All of the above values which pertain to the entire file are subdivided into values that occur in REM vs non REM sleep as well as being sorted by body position 1 4 2 Graphical Report The graphs see attached Report are generated by use of the Microsoft Chart Controls for Microsoft NET Framework 3 5 The sample report shows the default report format which includes all seven possible panels these can be adjusted to display only the desired values and graphics see Section 6 0 1 4 2 1 The Sleep Stage and Arousal Panel This panel displays the sleep histogram In addition a tick is placed each time an arousal occurs 10 User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING 1 4 2 2 The Respiratory Panel There are four groupings in this panel Within each grouping there are the six types of respiratory events central apnea Ap C obstructive apnea Ap O mixed apnea Ap M obstructive hypopnea Hyp O undefined hypopneas Hyp U and respiratory effort related arousals RERA In the first grouping from top to bottom a tick is placed in the appropriate row every time there is an entry in this category regardless of whether the event was associated with arousal or desaturation For example 1f there is an obstructive apnea at time X a tick will be placed in the Ap O row at time X In the second
87. go or address may be added through the header and footer as described in section 1 6 above 2 4 Importing and Exporting Report Templates 13 1AT Appendix A Report Editing Mm Revision 06 l C eC eC Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING Users have the ability to copy report templates for other users to import and utilize within their operation This allows a sleep lab to create a report template once or one per study type and have the report template s used in multiple Viewers within their lab To import or export a report template select the File menu at the top left corner of the Viewer and select Import Export Reports Figure A 14 Y YST Data Viewer File View Configuration Help eS Open Patient File ba Save i Montage Manager Import Export Montages Remote File Manager Report Editor Report Manager Import Export Reports Figure A 14 A dialog box will appear as shown in Figure A 15 below Y Import Export Report Tool Importing and exporting reports allows you to transfer your settings between users Please select which action you wish to perform Import Reports Export Reports 14 1AT Appendix A Report Editing Mm Revision 06 C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING Figure A 15 2 4 1 Exporting Reports If the user wishes to export reports select Export Reports A dialog
88. grams as follows e Folder DotNetFX40 for Microsoft NET Framework 4 e Folder vcredist_ x64 x86 for Microsoft Visual C 2010 x86 Redistributable In each case there is either a exe or a msi file that must be used to install the program Any file name referencing x64 is to be installed on a 64 bit operating system and a file name referencing x86 is to be installed on a 32 bit operating system The only way to confirm the correct installation of Microsoft NET Framework 4 and Visual C Runtime Libraries is to check Add or Remove Programs in the Control Panel and verify that e Microsoft NET Framework 4 e Microsoft Visual C 2010 x86 Redistributable are listed under Currently installed programs The Viewer installation can be confirmed by checking the status of currently installed programs as described above and by successfully executing it as described in the remainder of this User Manual The Viewer is ready to be launched To launch the Viewer either double click on the Viewer icon shown in Figure 2 13 above or access the Viewer through the Windows Start menu on the lower left hand corner of the desktop screen of any Windows PC where the Viewer should be contained within a folder labeled YST Limited which also contains shortcuts to the uninstaller the release notes and the User Manual 27 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug
89. grouping only those events associated with arousal are represented by ticks In the third grouping only those events associated with desaturation are represented by ticks Finally in the bottom grouping a tick is placed when an event is associated with both arousal and desaturation The four groupings to be displayed in the graph can be selected or deselected in the generate report settings The height of the Respiratory panel is adjusted automatically based on what groupings are selected 1 4 2 3 The Oximetry Panel This panel shows the instantaneous oxygen saturation values as a function of time 1 4 2 4 The Pressure Panel This panel shows the instantaneous airway pressure values as a function of time 1 4 2 5 The Audio Panel This panel shows the instantaneous Audio level as a function of time 1 4 2 6 The Legs Panel There are two rows in this panel In the top row a tick is placed for every PLM regardless of whether or not it was associated with arousal In the lower row a tick is placed only 1f the leg movement was associated with arousal As indicated earlier when an arousal is associated with both a PLM and a respiratory event the arousal is classified as related to a respiratory event and thus is displayed in the top but not the bottom row of the leg movement panel 1 4 2 7 The Body Position Panel This panel shows the instantaneous body position as a function of time 11 User Manual MICHELE Sleep Scoring System fils
90. he Main Menu The Main Menu is composed of five sub menus These are the File Menu the View Menu the Configuration Menu the Preferences Menu and the Help Menu The File Menu is discussed below The View Menu is discussed in Section 5 7 the Configuration Menu is accessed as discussed in Sections 3 7 5 3 and 5 6 and the Help Menu is discussed in Section 7 The File Menu is used to access and manipulate high level functionality of the application Selecting Open Patient File brings up a dialog box in which a patient file can be selected The patient file must be encoded as an EDF file the file extension is irrelevant provided the EDF syntax is followed Opening a patient file automatically opens all ev scoring files located in the same directory as the selected patient file Close Patient File closes the currently opened patient file and provides an opportunity to save changes to different components of the system Channel Information shows a small dialog box that presents three aspects of the opened file the channel numbers names and sample rates This is displayed in Figure 3 7 Y EDF Channel Information Channel Name sample Rati EMIGI EMG2 128 0 EMG3 EMG2 128 0 C3 A2 128 0 C4 At 128 0 Ol A2 128 0 O2 A1 128 0 L EQG A2 128 0 R EOG Al 128 0 1 2 3 4 9 6 7 g Figure 3 7 The Save function can be utilized to save a montage an edited file current working copy or analysis notes th
91. he Report Editor to create customized reports from scored patient files 102 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 j C h z Document Number YST UDoc USM 22 o SLEEP SCORING 7 0 The Help Menu File View Configuration Preferences alp SHE Gi BS Se a View UserManual Fs ews 1 IO View Release Notes Regulatory Information EEG C3 A2 0 659 Sr dt EEG C4 A1 18 68 aR EEG O1 A2 2 271 O Em E E M e See a oH aa aA a M EEG F4 A1 32 89 an ieee imeem an Figure 7 0 In the Help menu shown in Figure 7 0 About displays a dialog box giving information about the software version as well as copyright information View User Manual displays a PDF formatted current User Manual associated with the current Viewer Release as shown below in Figure 7 1 File Edit View Window Help A cete O BD 8 uale orpBDEB 1 7 us W co 7 Tools Comment Share fly User Manual MICHELE Sleep Scoring sin michele E oi m LA SLEEP SCORINI i MICHELE SLEEP SCORING SYSTEM USER MANUAL Figure 7 1 View Release Notes displays a Text box indicating release notes pertaining to the current Viewer in use as shown below in Figure 7 2 103 fle User Manual MICHELE Sleep Scoring System Revision 22 an Effective Date 7 Aug 13 C z Document Number YST UDoc USM 22 o SLEEP SCORING E Release_Notes Notepad File Edit Forma
92. heck marks appear if the numeric values you entered are allowed for the frequency filter selected If a non appropriate value is entered a red X will appear beside the box indicating that the values need to be revised Once entries have been accepted select OK to save your selections thereby applying the filters to the channel selected 3 5 Referencing The Reference Channel option in the General category of the graph channel properties window see Figure 3 12 allows for referencing to be applied to a given channel Referencing each of the AC channels is required unless the channels are already referenced when exported It is recommended to export the channels unreferenced when possible to allow for re referencing within a study during subsequent viewing and editing Some data acquisition systems such as Alice 5 export all channels referenced automatically The channels are displayed in the channel header area If the channel already has a reference an example of the display shown would be C3 A2 or C3 M2 If C3 A2 is displayed it is known that the channel was exported referenced If each signal is displayed separately 1 e C3 A2 M2 Right EOG Chin EMG 1 Chin EMG 2 etc that means the channels were exported un referenced and references will need to be applied for all AC channels within the montage When references are applied either during the export or when setting up the montage the channel will be displayed showing the reference in the chan
93. i l C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING Y Michele Report Editor File Edit View Insert Format Table Paragraph se ee fe o o Tabs 9 a Z Bullets And Numbering D Borders Columns dB amp E A Character i m Headers and Footers 3 Styles Target Markers i Text Color i Text Background Color Figure A 7 1 9 Table Menu The Table Menu Figure A 8 allows users to insert delete or select a table as well as merge or split cells found in the table s Grid lines in tables can be turned on or off through this menu and rows and columns can be added or deleted though the Insert and Delete menus found within the Table Menu Users may highlight several cells in a table and choose Merge Cells either through the Table Menu or right click and select Merge Cells to combine those cells together To split cells that have been previously merged left click in the cell that is to be split and select Split Cells either through the Table Menu or right click and select Split Cells from the drop down menu To customize table properties left click anywhere inside the table and select Properties from the Table menu Alternatively users can right click anywhere inside the table and select Table Properties The frame width table and background color cell margins and text alignment
94. iles in separate folders Keeping them together in one folder will corrupt the scoring data Create a folder on your hard drive called YST Data Files It can be anywhere as long as it s NOT under the newly installed YST Limited folder Within the YST Data Files folder you will need to create subfolders for each individual study using a patient s name or subject code to store all of your individual EDF REC files Figure 2 25 YST Data Files subfolders Figure 2 25 35 User Manual MICHELE Sleep Scoring System Revision 22 Effective Date 7 Aug 13 C h e a Document Number YST UDoc USM 22 o SLEEP SCORING 3 0 Setup and Use of the Main Graphical User Interface Window 3 1 How to Customize the Main Window Layout Once the Viewer is launched the Main Graphical User Interface GUI Window will be shown as per Figure 3 0 1 Main Menu 3 Graph 2 Toolbar n 4 Properties 6 Hypnogram Figure 3 0 Note that in Figure 3 0 there is no file open Subsequent figures Figure 3 1 and onward show images from open scored files The main GUI window has the potential to be customized extensively There are four main ways to display the four major windows numbered 3 through 6 in Figure 3 0 Docked Tabbed Floating Collapsed does not apply to Graph Window 36 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 mMm C h e eC Docum
95. ime of Study Start Time of Study End Time of Lights Off Time of Lights On Time of CPAP On Time of Sleep Onset Time of Sleep End Total Recording Time and Today s Date general information about the sleep study Study Date Study Type ID patient information Patient Name Gender Date of Birth Patient Age Social Security Healthcare Neck Circumference Weight Height BMI Epworth Scale Medications names of medical personnel Referring Doctor Interpreting Doctor Collection Technician and Scoring Technician and miscellaneous information Page Number and Hypopnea Criteria which indicates the Hypopnea Type that was selected in the Channel Mapping window before sending the file for scoring in the Viewer In the final report the information specified in the General Fields will precede the tables and graphs that contain results of autoscoring The Cover Sheet is a special field that allows importing of patient information into the final report To utilize it drag and drop the code coversheet onto the report it will then call information from the Report Generator Options Window see Figure A 22 below The information is stored in an rtf file that is created prior to generating the report The rtf file can be loaded by clicking on the es button 1AT Appendix A Report Editing Mm Revision 06 l C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING The rtf file should look something lik
96. ine extra can contain anything and will be ignored Epoch is the 30 second epoch in which to insert the marker and Event is the event name Accepted event names are e Lights Off Lights On Out of Bed Upright Right Left Prone Supine Treatment Bi Level Level1 Level2 CPAP Level These are not case sensitive however any other spelling or event name is ignored Spacing is important with one space between each word for the multi word names 70 User Manual MICHELE Sleep Scoring System Revision 22 mMm Effective Date 7 Aug 13 C e Document Number YST UDoc USM 22 o SLEEP SCORING Lights Off 11 Lights On 6 17 18 AM CPAP On 609 Supine 11 44 35 PM Figure 4 2a 4 2 1 Body Position Lights Marker Specifics a Body Position channel always overrules supplied tags if it is mapped as shown in Figure 4 2a b Pressure tags will overrule a pressure channel assuming the Use Pressure Tags box in the above window is checked This box is checked by default if pressure tags are identified in the file Figure 4 2b 71 User Manual MICHELE Sleep Scoring System Revision 22 mMm Effective Date 7 Aug 13 C Oe Document Number YST UDoc USM 22 o SLEEP SCORING Lights Off 11 Lights On 6 17 18 AM CPAP On 609 Use Pressure Tags 12 44 35 PM 6 17 18 AM Figure 4 2b Using a body position channel requires s
97. is a 5 R t Toolbar Figure A 9 Button Bar Fle Edit View Insert Format Table Ca E dia 35 Atal 0 wit L 1 F 1 a ti re n Figure A 10 2 0 Using the Report Editor Users have three options when customizing a report template Create a new report template upload a template that is currently being used in their lab or use one of the default report templates 2 1 Creating a new template To create a new template open the Report Editor by selecting Report Editor in the Viewer File menu The Report Editor will open and the document will be blank The user can now insert tables headers and footers images and page numbers as well as label specific fields that they wish to include in the report format font and use many other features as described in section 1 above Once the user has created the report template they will then have to insert the Unique Identifier Keys further explained in 2 1 4 in the report that pertain to each data field The Fields section on the right 1AT Appendix A Report Editing Mm Revision 06 C eC e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING side of the Report Editor contains three categories of fields General Fields Data Fields and Graphs and Tables Fields Figure A 11 ent eal 4 General Data Fields Graphs and Tables Figure A 11 2 1 1 General Fields The General Fields allow for entry of relevant dates and times T
98. isplays the maximum value of the current window The Display Avg checkbox displays the average value of the current window The Numeric Display category allows you to modify numeric values displayed within a channel across the Graph Window Numeric display modifications are available to all channels within the Viewer The Show numerics box activates the numeric entries chosen across the channel horizon within Graph Window The Numerics to show box is where you enter the amount of numerics to show across the channel horizon Example Entering 10 would show 10 numeric values within the current window horizon of the channel The Decimal box is where you would enter the number of decimal places to be shown for the numeric values At s a CO Remini aes eC ae ee ee a oe ee ee ee CRS aeae a a Co el ec ee ae a Max 95 steele be mb lt n a a bs lee lt 4 a pees n Be eeen a ap Avg 93 925 kai 4 kal 4 kal kal a kal YH 3 Figure 3 13 Figure 3 13 shows a Numeric display for the SaO2 channel with 10 values and zero decimals selected The Events category allows creation of events on this channel This may be done for scored files only Refer to Section 5 0 for description of the creation of events Default Event determines the default event created for the selected channel Once a default event is created it can still be altered manually The events that can be created using this function are 48 User Manual MICHELE Sleep Scoring Syst
99. lays key global events associated with the patient file These include body position changes lights on off CPAP on time CPAP level changes BiPAP level changes oxygen level changes and custom notes To add one of these global events a right click on the top row of the Graph Tray brings up a selection menu that allows a marker to be specified as shown in Figure 5 8 below Lights On Lights Off CPAP On CPAP Level gt BIPAP Level Oxygen Level sn Out of Bed wal Note Upright Right Left Prone Supine Figure 5 8 When one of these markers has been selected from the menu an icon with the name of the marker is placed on the Graph Tray at the location of the mouse This icon can be selected by clicking on it and moved by holding down and dragging the mouse or deleted by pressing the delete key Adding a CPAP Level BiPAP Level or Oxygen Level event brings up a dialog box that requests parameters e CPAP Level requires a value for the new level e BiPAP Level requires three values Inspiratory Level Expiratory Level and Backup Level e Oxygen Level requires a value for the new level 92 User Manual MICHELE Sleep Scoring System i i ii i T Revision 22 Effective Date 7 Aug 13 Mm C h e eC Document Number YST UDoc USM 22 SLEEP SCORING These parameters can be edited at any time by right clicking on the event marker icon Adding a note will provide an option to enter some text Thes
100. ld allows users to include data on the Number Average Duration Total Time and Total Sleep Time of PLM Chains Users can also include summaries of the Number and Index of all Leg Movements that occur With Arousal Without Arousal or Total Movements with and without arousal in All Sleep Stages individual sleep stages including REM and NREM and or by body position The Oxygen field allows data collected on Oxygen levels to be inserted into the report Users have the option of including Desaturations gt 2 Count Desaturations gt 2 Index Desaturations gt 3 Count Desaturations gt 3 Index Desaturations gt 4 Count or Desaturations gt 4 Index Lowest SpO2 with Longest Apnea Lowest SpO2 with Longest Hypopnea Average Desaturation Amplitude and or Lowest SpO2 with Respiratory for All entire study All Sleep Stages All Awake individual sleep stages including REM and NREM and or by body position Additionally users have the option of including Summaries of the Maximum Saturation Average Saturation Minimum Saturation Sleep Time gt 90 Sleep Time 80 90 Sleep Time 70 80 Sleep Time 60 70 Sleep Time 50 60 Sleep Time lt 50 Sleep Time lt CUSTOM a custom oxygen threshold the user can define when generating the report see Including a Custom Oxygen Threshold section 3 4 Sleep Time Bad Signal for All entire study All Sleep Stages All Awake individual sleep stages including REM and NREM
101. lect Yes and the installation of the new Viewer will commence Updates Ready Updates have successfully downloaded Please close the YST Data Viewer to update Figure 2 19 Figure 2 20 below shows the software gathering information about the current version and tools that are currently loaded on the computer YST Data Viewer a Please wat while Windows configures YST Data Viewer Gathering required infomation Figure 2 20 Figure 2 21 below shows the window that will appear when the software is about to remove the old version of the Viewer 31 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Figure 2 21 Notice the continuation of the two status windows shown in Figures 2 20 and 2 21 above and their progression This is normal during the upgrade process In Windows 7 Windows Vista and Windows XP a window will pop up asking you to approve the installation of the software Select Yes to proceed Once Yes has been selected the Viewer Setup Wizard Window will appear as indicated below in Figure 2 8 above Select Next to proceed The installation of the new Viewer will follow the steps shown in the original install procedure indicated between Figures 2 8 and 2 12 above As shown in Figure 2 22a below a final status window will appear This window provides the user the option of viewi
102. llations Choosing Everyone will allow any user account on the computer to access the YST Viewer Choosing Just me will only allow the YST Viewer to be utilized by the same account used in installation Settings for the YST Viewer are kept individually when Just Me is selected during the installation If the installation is for Everyone the following information will be accessible to all users montages login information documentation downloads report templates and software update information including version identification Select Installation Folder The installer will install YST Data Viewer to the following folder To install in this folder click Next To install to a different folder enter it below or click Browse Folder C Program Files ST Limited YST Data Viewer Install YST Data Viewer for yourself or for anyone who uses this computer Everyone 0 Just me 25 fle User Manual MICHELE Sleep Scoring System Revision 22 Mm Effective Date 7 Aug 13 C e Document Number YST UDoc USM 22 o SLEEP SCORING Figure 2 10 After selecting the installation folder a Confirm Installation dialog will be shown next as per Figure 2 11 Select Next to proceed Confirm Installation The installer i ready to install YST Data Viewer on your computer Click Next to start the installation Figure 2 11 You will then see a progress bar indicating the installation stat
103. lts file When the download is complete you can close the Remote File Manager The Remote File Manager can be used either with a file open or with no file open If the automated scoring results file that corresponds to a currently opened file has been downloaded the scoring results are automatically loaded The results file may require selection from the dropdown box when other scoring results files are present If a results file has been downloaded for a file that is not currently open the results are automatically retrieved when the file is opened There is no need to specify target directories for the download or try to seek out the results file on the computer file system The scoring results will be displayed in the Scores Window within the Viewer 78 User Manual MICHELE Sleep Scoring System fal Mii Revision 22 h Effective Date 7 Aug 13 micneie Document Number YST UDoc USM 22 SLEEP SCORING 4 6 The Scores Window The scoring results file is given the name patient file name _YSTEvents ev and is set as read only This means that it cannot be modified without first using the copy functionality located in the Scores Window The results file is automatically found but may require selecting it from the dropdown box Example If the patient file is named patient_0030 edf the output of the autoscoring will be placed in the same directory and named patient_O0030_YSTEvents ev The Scores Window is used to show th
104. mploys select criteria A or criteria B as per AASM 2007 guidelines for the automatic detection of hypopneas Criteria A is defined as a reduction in airflow accompanied by an O desaturation of at least 4 Criteria B is defined as a reduction in airflow accompanied by an O desaturation of 3 or an associated sleep arousal The Desaturation Interval combo box allows for selection between three search intervals that specify the search range for an Omax after a desaturation has been identified Changing the search interval may change the amount of desaturations called e 90 0 looks up to 90 seconds back from a desaturation and does not look ahead e 60 0 looks up to 60 seconds back from a desaturation and does not look ahead e 90 30 looks up to 90 seconds back and up to 30 seconds ahead from a desaturation Selecting Save after configuring all of these parameters will allow them to be saved in the current montage file when the montage is saved Section 3 9 describes montages 3 10 Montages The montage is a collection of settings including all channel settings as well as the channel mapping information described in Section 3 2 By storing the channel settings the montage effectively stores the way the Graph Window is organized and how the data are displayed Montages are handled via the toolbar through the Montage Selector 3 10 1 Creating a new Montage There are two ways to create a new montage The first method involves
105. mport export tool Finish Figure 3 36 Note If you opt to use the Windows Explorer tool outside of the Viewer operation to see if the montage files were imported exported it will appear that the operation did not complete In order to see mon files the Viewer is required Furthermore if multiple montage files were imported exported it will appear as if only one file was successfully copied You should confirm that the transfer was successful by selecting the drop down Montage Menu in the Viewer toolbar to review the Montage list available to select as indicated below in Figure 3 37 File View Configuration Preferences Help eee File 2 z EEOaNRREN File v X Properties q EMG1 EMG2 ile Graph File12 A z C3 Aa Wrenn ae porrttted le sel Mbyegemeett _f of of iy File15 Appearance C4 A1 att aa n E a e A Asi amaS File18 Background L Picku File19 fe 01 A2 Aa ppoe CARs pea Ok food i aai File29 Primary Line I Pick 02 Al Leeann pl A arnt po File30 Secondary Line _ Pick Filed L EOG A2 Moown nann a an aeaaaee ee Epoch Divider i e R EOG Al ee opel hen Ho Sleep Stage Pick Ne Chest ey Filed File13 Figure 3 37 67 User Manual MICHELE Sleep Scoring System 1AF pe 5 u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING
106. n reassigning events from multiple channels onto a single channel there is no way to restore events to their previous individual channels This operation does not distinguish between Left Leg events and Right Leg events 88 ja User Manual MICHELE Sleep Scoring System rei michele SLEEP SCORING Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 Individual Event Properties Properties Properties Event General General 3696 25 11 383 With Arousal F Event Name Event Name 38934 16 25 Start Time Start Time Duration Duration With Arousal With Desaturation With Desaturation v b Properties Properties Event General Event Name 691 592 3 108 With Arousal Start Time Duration With Respiratory Event Name Start Time Duration With Arousal With Desaturation c De d Figure 5 4 Selecting an individual event is done by clicking on the event box in the Graph Window or on the marker in the Graph Tray The individual event properties deal with all configurable parts of the event The figures above show four different states for the event properties window Figure 5 4a shows a Desaturation event Figure 5 4b shows a Respiratory event Figure 5 4c shows a Leg Movement and Figure 5 4d shows a Body Position graph tray marker event Note If an event cannot be associated with another event the check boxes for With Arousal
107. nel header area 1 e EMG1 EMG2 or C3 A2 DC channels such as flow do not need to be referenced By selecting the Reference Channel option the referencing dialog box is opened shown in Figure 3 22 Referencing a channel to another channel is the equivalent of subtracting the referenced channel from the original channel potentially removing common artifacts 54 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 mMm C h eC Document Number YST UDoc USM 22 SLEEP SCORING Channel Reference List for C3 ig mfx Channel List Reference Channels Name a J Id Name Therm Al NASAL PRESSURE PES Protec CHEST Protec ABDOMEN z Al 1 2 3 4 9 6 Fi a E Nasal Flow CPAP Pressure CPAP Leak Figure 3 22 The channel reference dialog is split into two sections One is the Channel List which shows a list of all channels in the opened patient file the other the Reference Channels list shows all the channels that are currently being used for referencing To add a channel to the Reference Channels List first select it in the Channel List and then press the right arrow button gt To remove a channel from the Reference Channels List select it in the Reference Channels List and press the left arrow button lt The up and down arrows can be used to move channels up and down in the Reference Channels List although this has no impact on the results If more than one cha
108. new name for sample 1 Rename Repart Figure A 21 A dialog box will appear indicating that the import has been successful and the new reports will be available for use via the report selector Select Finish to close the dialog box 18 1AT Appendix A Report Editing Mm Revision 06 C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING Users can edit rename or delete the imported report templates by selecting Report Manager from the File menu shown in Figure A 14 To open an imported report template open the Report Editor as described in section 1 1 select Open under the File menu or select the Open shortcut in the Toolbar A dialog box will appear and users may then select the Report they wish to open 3 0 Using the Customized Report s Once the user has created their customized reports they can now generate these customized reports from scored patient files as described in the following steps 3 1 Sending the file for scoring The user sends the file for scoring and downloads the scored file as described in section 4 0 of the User Manual 3 2 Downloading and Reviewing the scored file After downloading the scored file the user must review and edit the file as necessary as described in section 5 0 of the User Manual 3 3 Generating the Customized Report Once the user has completed their review and edit of the scored file they would select Generate Report
109. ng accuracy all of the channels in the Channel Type column should be included in the EDF file used for automated scoring Similarly there is a minimum selection of channels required to perform the automated scoring for a Level 3 study The following channels are required 1 Thermistor or Nasal pressure ideally both 02 Saturation 3 Chest and abdomen bands To improve scoring accuracy the following channels in the Channel Type column should be included in the EDF file used for automated scoring 1 Audio 2 EKG 3 Body Position 4 Pulse Rate To map a specific channel type to a channel within the EDF file select the Channel Name text box with the mouse When this is done a drop down box listing all of the channels in the EDF file will be displayed If a specific channel type exists with the EDF file select it with a mouse click Repeat this process for all of the channels specified in the Channel Type list If some channels do not exist within the EDF file leave the Channel Name as None The Polarity is used only for the following respiratory related signals 1 Abdomen 2 Chest 3 CPAP Flow Inspiratory and Expiratory 4 Nasal Cannula 5 Thermistor The polarity of each signal is defined by the nature of the signal values as the patient is inspiring Example If the patient is inspiring and the Abdomen signal is increasing in numerical value then the polarity of the abdomen signal is positive If the pati
110. ng the release notes pertaining to the update installed When View Release Notes is selected the release notes will appear as shown in Figure 2 22b below Referring again to Figure 2 22a once Close is selected the window will disappear If the Release Notes window shown Figure 2 22b was open Close must be selected in that window prior to selecting Close in the status window shown in Figure 2 22a Note With respect to release notes once the Viewer has been installed the release notes can be accessed by selecting the appropriate menu items within the Help Menu as described in Section 7 Users will need to restart their Viewer at this point in order to use it All scored studies and saved montages will remain intact and available to use again 32 User Manual MICHELE Sleep Scoring System ja ii Revision 22 ry Effective Date 7 Aug 13 C h e Document Number YST UDoc USM 22 o SLEEP SCORING Figure 2 22a Figure 2 22b On rare occasions critical software updates may be required End users are required to implement these updates immediately End users will receive a message that an update is available via the Splash Screen within the Viewer when a critical update is required A window will also appear as shown below in Figure 2 23 33 User Manual MICHELE Sleep Scoring System VE u Revision 22 Effective Date 7 Aug 13 j C h Document Number YST UDoc USM 22 o SLEEP SCORING
111. nitoring devices typically used to evaluate sleep and respiratory related sleep disorders The device is to be used under the supervision of a physician Use is restricted to files obtained from adult patients Warnings and Cautions The MICHELE Sleep Scoring System does not analyze data that are different from those analyzed by human scorers The attached report contains numerical and graphical data typical of those generated following manual scoring of polysomnograms It does not contain any interpretation diagnosis or recommendations for treatment These decisions are to be made by the treating physician The scoring provided by the MICHELE Sleep Scoring System must be reviewed edited as necessary and approved before the report is generated Special attention should be paid to confirm the first epoch of Rem sleep and of non Rem sleep since occasionally brief periods of either kind can be missed or mistakenly scored resulting in large errors in sleep latency or Rem latency Arousals may be underreported in cases where arousal frequency is very high Any modification to any component of the MICHELE Sleep Scoring System may result in erroneous results or failure of the software to operate Caution US Federal law restricts this device to sale by or on the order of a physician Identifier of the device CE mark Viewer Version 1 02 041 Release Date 19 Jun 14 4 Autoscoring Version 1 00 107 Release Date 09 Nov 12 0086 SLEEP ANALYSIS R
112. nnel is selected for referencing the average of the selected channels is calculated and used as a single reference channel Note For referencing to function properly the selected channels must have the same sampling rate as the current channel If any channel that is added to the Reference Channels List does not have the same sampling rate it is simply ignored 55 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 j C h z Document Number YST UDoc USM 22 o SLEEP SCORING 3 6 Channel Renaming The Viewer allows you to rename each channel within the Graph Window The renaming can be either a temporary or permanent change to the EDF file To change a channel name right click on the channel name and a message box will appear as shown in Figure 3 23 below Figure 3 23 By clicking on the dialog box called Rename Channel another dialog box will be displayed requesting a new name to be entered shown below in figure 3 24 Rename Channel Enter a new channel name 16 characters max Cancel OK Figure 3 24 Once the name is entered select OK for the change to take place You will be presented with a new dialog inquiring as to whether the change is to be temporary or permanent see Figure 3 25 56 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 ry C h e Document Number YST UDoc USM 22 SLEEP SCORI
113. ntaining critical information about the error encountered during its use at that particular point Users do not have to do anything at this point Pressing OK will cause the software to terminate which is a normal event 8 2 Notifying YST of Perceived Software Failure In the event that an error in autoscoring has been incurred or perceived it is recommended that the user first consider and verify the following a Correspondence between the list of channels specified prior to data processing and the order of channels in the data file see Section 3 9 above on channel mapping b Specification of times of lights on and lights off Section 4 2 c Use of data collection requirements per Section 1 2 above d File type e Report specifications see Section 6 above If the user is unable to resolve the error it is recommended that the file causing the failure be sent to YST with a full description of the events preceding identification of the error so that it can be appropriately investigated and potentially used to improve the reliability of the software If the results of autoscoring have been manually edited YST may also request that the user send the results of manual editing Contact Information Please contact YST for enquiries technical assistance or for reporting complaints Please phone toll free 1 888 942 6774 or e mail support michelesleepscoring com Mailing address 1 Morley Avenue Princess Elizabeth Building Winni
114. o the installer for the MICHELE Sleep Scoring ii System Viewer Unzipping dotNethe40_ Full 86 264 e e Figure 2 2 If the target PC has all of the above listed programs installed the Viewer Setup Wizard shown in Figure 2 8 will appear If the target PC does not have all of the above listed programs installed the Viewer setup process will attempt program installation automatically In each case the user will be required to read and accept license terms and confirm installation For example if the target PC does not have Microsoft NET Framework 4 0 and Microsoft Visual C 2010 installed the following Viewer Message as shown in Figure 2 3 may appear 21 1AF User Manual MICHELE Sleep Scoring System Revision 22 Effective Date 7 Aug 13 l IIC e Document Number YST UDoc USM 22 SLEEP SCORING _ gt YST Data Viewer Setup x For the following components Microsoft NET Framework 4 x86 and x64 Please read the following license agreement Press the page down key to see the rest of the agreement MICROSOFT SOFTWARE SUPPLEMENTAL LICENSE TERMS MICROSOFT NET FRAMEWORK 4 FOR MICROSOFT WINDOWS OPERATING SYSTEM View EULA for printing Do you accept the terms of the pending License Agreement vr If you choose Dont Accept install will close To install you must accept this agreement Figure 2 3 Select Accept A Microsoft window will appear asking the user to accept the
115. observed I Stop the animation 2 Select Align to Epoch Boundary from the menu or toolbar 3 Select a slower time interval The first two steps are vital to guaranteeing proper functionality of any further operations The third step is required only if animation is to be attempted again To use the Animation Controller first select a time from the drop down box then press either Play to scroll forward or Rewind to scroll backwards The Montage Selector is used to change the current Montage Montages are discussed in Section 3 9 Selecting the Save Scoring File option that is listed under the Save option of the File Menu displays the window shown in Figure 5 15 Note If the software crashes an option will appear to save your edited scored file Please note that this may corrupt the ev file if an event was what caused the crash 99 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 ry C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Y Save Score File Current Score Files 0004 0025 _YSTEvents Kinnaird Score File Enter Score File Name Figure 5 15 5 10 Analysis Notes The Analysis Notes tab should be used to enter additional information about a patient file that cannot be added through the scoring interface Only one set of notes is allowed for each patient file and they are stored in a specific file notes extension th
116. on refer to Section 6 5 6 EKG Artifact Removal EKG Artifact Removal is used to remove R wave artifacts from the EKG that are corrupting other electrodes Selecting this menu option from the configuration menu will display the dialog box shown in Figure 5 11 93 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 ry C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Y Remove EKG Artifact All Channels EKG Channel Enable EKG Artifact Removal Figure 5 11 This dialog has four key components all of which must be used to remove r wave artifacts The list of all channels present on the left The list of channels for which the R wave should be removed present on the right A drop down selection box for the EKG Channel A checkbox used to enable the R wave removal algorithm For the R wave artifact to be removed from a channel it must be moved from the left list into the right list This is done by selecting the channel name and either double clicking or pressing the right arrow gt button A similar approach will move a channel back to the left list either double click or select a channel and press the left arrow lt button The EKG channel is selected using the provided drop down box The same channel entered in the channel mapping for EKG must be the EKG channel entered here Finally the Enable R wave Artifact Removal check box must be checked Pre
117. or summary variables that appear in the clinical report used by physicians to assess sleep disorders Table 3 shows the results for 14 variables These were selected because they are the most commonly used variables in the clinical assessment The first data column of Table 3 is the average score of the three technologists for each of the 14 variables of interest The averaging was done on a file by file basis The values and corresponding standard deviations SD given in column 1 are the average and SD of the 30 averages The second column contains the average and SD of the values obtained from Automatic analysis with MICHELE Sleep Scoring System The third column lists the average and SD of the thirty differences between MICHELE and the corresponding average of the three technologists Bland and Altman analysis 15 User Manual MICHELE Sleep Scoring System fils v Revision 22 Effective Date 7 Aug 13 M C h e e Document Number YST UDoc USM 22 SLEEP SCORING Table 3 Agreement between Manual and Automatic Scoring for Relevant Scoring Variables Average Michele Intra class Correlation Coefficients Variable S1 S3 Michele ave Alice Michele Alice Sivs S2vs S3vs SD SD SD SD vs Ave vs Ave Ave Ave Ave Total sleep time min 0 983 0 226 Sleep efficiency Sleep onset latency min REM onset latency min Stage wake min Stage 1 min Stage 2 min Stage 1 2 min Stage delta min Stage REM min Arousal
118. orted file has been located click on it and select Open Users will then be returned to the dialog box shown in A 16 and can select Next A dialog box will appear listing the report templates contained in the exported report file Figure A 20 Select a single report template by clicking on its name or select multiple report templates by clicking on multiple file names To deselect a report click on the file name a second time Select Next to continue 17 1AT Appendix A Report Editing mMm Revision 06 C eC eC Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING Y Import Export Report Tool l Please select the reports you wish to import fram the following list To select a report click on it in the list A second click will deselect a report Cancel Previous Figure A 20 If a report is being imported that has the same file name as a report already present on the user s computer a dialog box as shown in Figure A 21 will appear Click the duplicate report name and type a new file name for the report in the text box below Select Rename Report to continue Once all duplicate files have been renamed users can select Next _Y Import Export Report Tool eo The names of the following reports conflict with reports already present on this computer Please specify new names for each report in the list below to eliminate the conflicts sample 1 Enter a
119. pecifying voltage ranges If voltage ranges are not specified the default value of Supine is used for the entire file See Section 3 8 1 Specifying neither a body position channel nor a body position file will use the markers placed on the current events file If no markers are placed the following default values will be used Lights Off will be set to time 0 epoch 1 2 Lights On will be set to the last epoch 3 Body position will be set to Supine for the entire file 4 3 Finalizing User Input Required of Scoring Once the process of specifying the body position and lights on off has been completed proceed to the following remaining steps in the Channel Mapping window shown in Figure 4 1 1 Verify that the appropriate channels have been referenced see Section 1 2 4 a If this had been done prior to exporting the EDF file check Referenced after verifying that no referencing is applied in the Viewer 12 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING b If this was not done prior to exporting the EDF file apply the proper referencing in the Viewer before checking Referenced 2 Check the Valid checkbox to indicate that everything has been checked and is correct within the Channel Mapping window Figure 4 3 shows an example of what the Channel Mapping window will look like once all information required for scoring ha
120. peg Manitoba Canada R3L 2P4 105 User Manual MICHELE Sleep Scoring System i i ii i T Revision 22 Effective Date 7 Aug 13 f i i C e 2 Document Number YST UDoc USM 22 SLEEP SCORING 9 0 Optional Server Setup 9 1 Requirements e Microsoft Windows Server 2003 or later 64 bit e 6GB of RAM per instance of the viewer 9 2 Installation Complete the installation as described in Section 2 0 making sure to install the Viewer for Everyone and not Just for me see Figure 2 10 9 3 Configuration Create the master download directory This is the location that all Viewers once configured using the steps below will download results files to In this example C downloads will be used For each user on the server do the following e Login to the server using the user s credentials Run the Viewer once Close the Viewer This is to create the Application Data directory and the default download directory which is empty at this point e Remove the downloads directory located at C Users USERNAME AppData Roaming Yst Limited Yst Viewer downloads Note that showing hidden folders will be required to be on to see AppData e Open a command prompt and link the master downloads directory in place of the user specific one This can be done with the following command substituting USERNAME as before mklink D C Users USERNAME AppData Roaming Yst Limited Yst Viewer downloads C downloads 9 4 Misc
121. pnogram specific channels use the properties window shown in Figure 3 27 a Generic channels use the properties window shown in Figure 3 27 b Additional generic channels can be displayed within the hypnogram such as SaO2 This is done in the Same manner as adding channels and setting the properties within as in the main window channel header area Properties Hypnogram Channel Sa02 Appearance Color Visible A General Properties Invert Signal Al Position A l Appearance 1 1 1 ee ee eee eee Height Y Visible A Scale Auto Scale Al Position Height Upper Limit Y Lower Limit a b Figure 3 27 3 8 Body Position Channel Body Position Channel Levels found under the Configuration Menu in the toolbar is used to extract body position information from a body position channel If the body position information is stored in a channel voltage levels must be assigned to the different positions that are extracted from the channel As well a body position channel must be designated in the Channel Mappings discussed later 58 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Y Body Position Channel Levels 1 Upright E Disable Voltage Lewels Figure 3 28 Selecting a row in the table shown in Figure 3 28 and pre
122. popneas Apneas Hypopneas RERAs Scored by criteria A RESPIRATORY EVENTS BY BODY POSITION Total Number 58 Central Apnea Obstructive Apnea Mixed Apnea Obstructive Hypopnea Undefined Hypopnea RERA ALL Apneas Apneas Hypopneas Apneas Hypopneas RERAs O2 SATURATION STATISTICS Maximum Average Minimum desaturations gt 2 Index desaturations gt 3 Index desaturations gt 4 Index Sleep Time gt 90 Sleep Time 80 90 Sleep Time 70 80 Sleep Time 60 70 Sleep Time 50 60 Sleep Time lt 50 Sleep Time with Bad Signal Only time in sleep considered Index Overall 98 0 78 0 196 79 0 193 77 8 193 77 8 Number Index Total Rem Number Index Number Index 58 N A N A N A N A N A N A N A N A N A N A N A N A N A N A N A N A Right Number 98 0 79 0 196 123 8 193 121 9 193 121 9 Non Rem Number Index Left Index Number Index Supine 98 0 79 0 196 123 8 193 121 9 193 121 9 Duration Average Maximum Prone Number Index Lateral N A N A N A N A N A N A N A N A N A N A N A N A N A N A N A N A Upright Number Index Prone N A N A N A N A N A N A N A N A N A N A N A N A N A N A N A N A SLEEP ANALYSIS REPORT Patient Name Sample POST CPAP SLEEP VARIABLES Time at CPAP On 23 57 36 Time at Lights
123. raph Window indicating the sleep stage that was scored for the currently viewed 30 second epoch Selecting Top will allow the sleep stage to appear on the top of the Graph Window selecting Bottom will display the sleep stage on the bottom of the Graph Window and selecting Both will display the sleep stage on both the top and bottom of the Graph Window To modify sizing of the graph window the borders may be clicked and dragged 46 VE michele SLEEP SCORING 3 3 3 Graph Channel Properties User Manual MICHELE Sleep Scoring System Properties Channel Ol A2 Appearance EE ricx Visible F Color Channel Data Display Min E Display Max E Display Avg E AJ Numerical Display Show Numerics E Numerics to Show 0 Decimals 0 Events Default Event UNKNOWN EVEN Default Duration 10 General Invert Signal iv Grid Lines Collection P Filters Collection Reference Channel Collection ma Position Height 10 16 99 Scale Auto Scale E Upper Limit 60 Lower Limit 60 Figure 3 12 Revision 22 Effective Date 7 Aug 13 Document Number YST UDoc USM 22 To view or change the individual channel properties click on the channel in the Channel Header Area The graph channel properties are separated into seven categories as shown in Figure 3 12 Those 47 User Manual MICHELE Sleep Scoring System i i ii i T Revision 22 Effective Date 7
124. re shown in Figure 3 14 below Properties 4 Properties 4 Properties Sai Channel Channel Channel C3 AZ CPAP Pressure EKG1 EKG2 General General General Invert Signal Invert Signal E Invert Signal Grid Lines Collection Grid Lines Collection Grid Lines Collection w Filters Collection Filters Collection Filters Collection w Reference Channel Collection Reference Channel Collection m Reference Channel Collection a Position l Position Al Position Height 10 Height 5 4 35 Height 3 5 96 Y 0 Y 75 98 Y 42 14 A Scale ZLA Scale Scale Auto Scale E Auto Scale E Auto Scale E Upper Limit 50 Upper Limit 20 Upper Limit 700 Lower Limit 50 z Lower Limit 0 Lower Limit 700 z 50 fle User Manual MICHELE Sleep Scoring System Revision 22 Effective Date 7 Aug 13 l IIC e Document Number YST UDoc USM 22 SLEEP SCORING Properties fl Properties y Channel Channel EMG1 EMG2 Sa02 l General Al General Invert Signal Ei Invert Signal E Grid Lines Collection e Grid Lines Collection e Filters Collection pm Filters Collection ma Reference Channel Collection Reference Channel Collection z Al Position Position Height 5 56 Height 12 Y 37 92 Y 47 1 Scale CA Scale Auto Scale E Auto Scale E Upper Limit 100 Upper Limit 100 Lower Limit 100 Low
125. ria A or criteria B of the 2007 AASM guidelines With criteria A a hypopnea is identified if the amplitude of the breathing channel used decreases by 230 from the reference value for 10 seconds and is associated with 24 decrease in oxyhemoglobin User Manual MICHELE Sleep Scoring System fils v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING saturation SpO2 With criteria B a hypopnea is identified if the amplitude of the breathing channel used decreases by gt 50 from the reference value for gt 10 seconds and is associated with an arousal or gt 3 decrease in SpO2 The software continuously evaluates the signal quality of the various respiratory channels nasal cannula flow or CPAP flow thermister and chest and abdomen bands and uses only signals that meet minimum quality criteria If more than one channel is of acceptable quality the amplitude criteria are assessed from nasal flow or CPAP flow if patient is on CPAP if valid If not the thermister is used and if this is not valid also the chest and abdomen bands signals are used to assess amplitude changes Hypopneas identified by either criterion are further classified into obstructive or undefined An obstructive hypopnea is one where there is associated snoring and or chest wall paradox and or flow limitation An undefined hypopnea is one that lacks these features It should be emphasized that lack of these feat
126. ring System 1AF Ea u Revision 22 Effective Date 7 Aug 13 ry C h e e Document Number YST UDoc USM 22 SLEEP SCORING 4 4 Uploading to the YST Server Upon pressing Score see Figure 4 3 the upload component attempts to automatically connect to the YST servers using the login information specified as described in Section 2 2 The progress of this process will be indicated by the window shown in Figure 4 4 Preparing for Scoring Preparing for Scoring Figure 4 4 The file will be compressed during the upload to speed up the uploading process The progress will be displayed as shown in Figure 4 5 below Compressing File Ai sa g al Compressing File Figure 4 5 4 5 Remote File Manager Remote File Manager is used to access the results of patient files scored by YST The Remote File Manager connects to the YST server using the supplied login information For the Remote File Manager to operate login information must be specified via the Enter Login Information menu item discussed next If the login information is invalid for any reason the Remote File Manager will display an error message When connected as seen below a green check mark will be displayed beside connection status Opening the Remote File Manager with correct login information will result in the window shown in Figure 4 6 74 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 ry
127. rk with Windows XP and Windows 7 1 1 2 The Viewer requires a minimum of 4GB of RAM 1 1 3 Processor requirement is 1 6 GHz or faster 1 1 4 Monitor requirement 19 inch or greater 1280 X 1024 resolution or greater 1 1 5 Keyboard and mouse for control and a printer if hard copies are required 1 1 6 50 MB of free hard drive space User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING 1 1 7 Patient files must be in the EDF format 1 1 8 A new directory must be created for each patient file 1 1 9 Access to the Internet is required 1 1 10 Outgoing UDP traffic on port 53 is allowed to hosts ns1 younessleeptechnologies com and ns2 younessleeptechnologies com This is required to implement automated failover in the event of a YST server outage For more information contact YST Support contact information provided in Section 8 2 1 2 Data Collection Requirements In order to properly execute the automated scoring module embedded in the Viewer the PSG data must meet the requirements described in this section Section 3 8 elaborates on the signals that the Viewer is capable of analyzing as well as the signals that are mandatory for data processing 1 2 1 Electrode positioning and Impedance Electrode placement should follow the Standard Placement procedures as per Rechtschaffen and Kales Electrode impedance shoul
128. s 73 into this field the report will display the total of sleep time and or minutes of sleep time that occurred when the patient s oxygen saturation was anywhere from 0 72 99 By default this value is set to 0 If users do not wish to use this feature they can leave the value as 0 n El a hg Generate Report Generation Options Epworth Scale Medications Study Type ID Referring Doctor Interpreting Doctor Ordering Doctor Collection Technician Scoring Technician Al Reporting Options Custom Oxygen Threshold Baseline ECG Start Epoch Report Template Michele Diagnostic Report Output Format pdt E Events have been Verified Figure A 26 3 5 Outputting a Sample Channel If desired the user may display a sample of any of the channels in the EDF file in the report The start time of the sample may be selected as seen in Figure A 26 where it shows Baseline ECG Start Epoch The sample may be 30 60 90 or 120 seconds in length and the length of the sample is selected in the drop down box shown to the right of the start time Which channels are displayed there can be as many as the user desires is determined by clicking on ECG Display Channels situated above the Generate box as shown in Figure A 26 For the sample s to show up in the report the corresponding code for ECG Sample must be present in the report template The code for ECG Sample is ECGSample which can
129. s LEGS PLMs 4 130 100 A 70 40 10 21 30 2200 2230 2300 2330 0000 003 000 01 30 0200 03 BW Heart Rate SLEEP ANALYSIS REPORT Patient Name Sample This is an electronically generated secure document Generated 6 24 2014 12 43 35 PM Date 1AT Appendix A Report Editing Mm Revision 06 C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING MICHELE SLEEP SCORING SYSTEM APPENDIX amp REPORT EDITING ih michele SLEEP SCORING Appendix A Report Editing Revision 06 Effective Date 24 Jun 14 Document Number YST UDoc A1 06 Table of Contents Introduction 1 0 Features of the Report Editor 1 1 1 9 1 10 2 0 Using the 2 1 22 2 4 3 0 Using the AP a 3 3 3 4 3 5 3 6 Ik 3 8 Opening the Report Editor Title Bar Menu Bar File Menu Edit Menu View Menu Insert Menu Format Menu Table Menu Toolbar and Button Bar Report Editor Creating a new template PA General Fields pA A Data Fields 2L Graphs and Tables Fields 2 1 4 Unique Identifier Keys 2 1 5 Finalizing and Accessing the New Report Template Uploading a Preexisting Report Template into the Report Editor Using a default template Importing and Exporting Report Templates 2 4 1 Exporting Reports 2 4 2 Importing Reports Customized Report s Sending the file for scoring Downloading and reviewing the scored file Generating the Customize
130. s Viewer software and associated components on a regular basis Users have the option of receiving updates automatically or manually checking for updates via the Preferences Menu Figure 2 16 of the Viewer Main Menu as described in Section 3 of this User Manual The default selection is to receive automatic updates as described below File View Configuration Preferences Help gU Eg IS Disable Automatic Updates y 03 17 39PM 0 Q gt Check for Updates M a a Figure 2 16 When new updates are available you will be notified on the Splash Screen when the Viewer has been opened as shown in Figure 2 17 below YST Data Viewer YST Version 1 01 017 Currently Released Version 1 01 020 Update is required YST Limited Copyright YST Limited 2010 Figure 2 17 The update will start downloading automatically and will be indicated by an alert in the user s bottom right corner of their monitor as shown in Figure 2 18 below Automatic Updates Downloading Updates Figure 2 18 30 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Once the update has finished downloading a window will appear on the user s monitor as shown in Figure 2 19 below Select OK and close the Viewer Users will notice a window appear asking if they wish to install the new Viewer Se
131. s been specified It is very important that all aspects of the channel mapping are checked for each individual channel and for every individual study when sending for scoring If the channel mapping is wrong the study will not score If the Polarity is wrong the quality of the scoring may be affected Y Score File Channel Mapping Channel Type Channel Name Polarity TE ABDM a E Respitrace Inductive Audio Snore Sensor E Audio Processed Body Position None E Process Nasal Chest CHEST CPAP Flow CFLOW Expiratory Pressure CPRESS i Hypopnea Type A Inspiratory Pressure None Desaturation Interval Chin EMG Chinl Chin Eas oe Airway Pressure Scaling EEG 2 C4 M1 Factor EKG EKG Multiply x End Tidal CO2 None Heart Rate HEARTRATE Left Eye EOG El M2 Left Leg EMG L LEG Nasal Cannula PFLOW Valid Right Eye EOG E2 M1 Right Leg EMG R LEG O Saturation SAOZ Specify Tags and Lights COZ Units 90 30 1 Thermistor Thermistor Score Close Figure 4 3 3 Press Score Upon pressing Score the file will be uploaded to YST servers for remote autoscoring performed at YST By using the Remote File Manager described in Section 4 5 you will be able to check the status of your file and retrieve the scoring results when they are available Reminder Each EDF file should have a unique file name EDF files that have been scored should never be re named 73 User Manual MICHELE Sleep Sco
132. scroll down as there are additional fields to be filled in below what is initally presented in the Patient Information menu 19 1AT Appendix A Report Editing Y Revision 06 C e 2 Effective Date 24 Jun 14 J Document Number YST UDoc A1 06 SLEEP SCORING ptions 4 Patient Information Cover Sheet rtf Study Date MM DD YYY Patient Name Gender Date of Birth MM DD YYYY Social Security Health Care Neck Circumference Weight Height BMI o l Automatically Calculate BMI Epworth Scale a Medications po Tee aa E Events have been Verified Generate Save Figure A 22 Select File Type Please Select The Collection System Used Automatically Ca fv Figure A 24 Figure A 25 20 1AT Appendix A Report Editing Mm Revision 06 C e e Effective Date 24 Jun 14 Document Number YST UDoc A1 06 SLEEP SCORING 3 4 Including a Custom Oxygen Threshold Users may enter a custom oxygen threshold to be included in the report as described in section 2 1 2 above Oxygen Data Fields To do this scroll to the bottom of the Patient Information menu or left click the button beside Patient Information to collapse the menu A Reporting Options menu will appear and users can enter in a numerical value that will capture the total of sleep time and or minutes of sleep time that occurred under that specified oxygen level Figure A 26 e g if a user enter
133. sed PSG Report The Autoscoring software package is currently not available to users outside of YST The Autoscoring is currently provided as a service by YST users may access the Autoscoring feature remotely via File Transfer Protocol FTP using the Viewer software as described in Section 4 User Training This User Manual provides a comprehensive description of the full capabilities of MICHELE and in particular of the Viewer The User Manual along with descriptions of functions within the Viewer user interface comprises the primary training material for use of MICHELE and the Viewer It is strongly recommended that users read this User Manual at least once prior to using the Viewer and that users refer to the User Manual as often as needed in conjunction with use of the Viewer Additional training may be provided on site and or via video by YST personnel covering both installation and use of the software Any user should have a prior understanding of the physiological signals associated with PSG studies and should be appropriately qualified in the scoring and interpretation of PSG records as per a physician in sleep medicine or a Registered Polysomnographic Technologist RPSGT Appropriate qualifications and training as described above will enhance the user s experience with MICHELE and ensure accuracy in scoring and report generation 1 0 System Overview 1 1 System Requirements 1 1 1 The Viewer has been verified to wo
134. sing software however they are detailed in sections 1 4 1 9 below Ifa particular menu item has a keyboard shortcut this is indicated beside that item in the menu e g to create a new report the user can press Ctrl N on their keyboard instead of accessing this function through the File menu Additionally certain functions have picture icons beside them in their respective menus This is to indicate which functions have shortcuts on the Toolbar menu further explained in section 1 10 below 1 4 File Menu The File menu Figure A 2 allows users to create a new report open an existing report save the current report print the current report view recently opened reports or exit the Report Editor Michele Report Editor Y po File Edit View Inset Format Table _ New Ctrl N H Open Ctrl 0 Menu Bar A I E Save Ctrl 5 Save As m Print Ctrl P ST Diagnostic Report Sample Report 1 mi Exit Figure A 2 1 5 Edit Menu The Edit menu Figure A 3 allows users to undo previous actions redo actions that have just been undone cut copy paste or delete text and images select all text or images find a particular word and find and replace a word with a different word The Hyperlink function allows users to edit a URL link that they ve previously inserted via the Insert menu described in section 1 7 below 1AT Appendix A Report Editing Revision 06 i i l C e e Effective Date 24 Jun 14 Document
135. sion 22 Mm Effective Date 7 Aug 13 C z Document Number YST UDoc USM 22 o SLEEP SCORING Docks the Selected Window to the left of the current window shares a vertical boundary Docks the Selected Window below the current window shares a horizontal boundary Docks the Selected Window to the right of the current window shares a vertical boundary Tabs the Selected Window with the current window shares all boundaries The current window refers to the window over which Figure 3 5 appears Figure 3 6 illustrates this phenomenon Y_YST Data Viewer TOM C ee nS es File View Configuration Preferences Help Sid si TELELE ELEELE 2 BSemS 1s Olo i Montage Defaut xX Scores 3 a H i 0004 A0030364_YSTEvent oe Epoch Event Start Time Duration Char 452 7 S SOENEN SON UTE S ES ee TOEN ree A S o S O E S R A A NESO RO AR TK O SON EDE Oe See 17 Desat 05 25 37 25 po tthe de wb ha Ae nd pe het 4 4 S5 pa oe A aon a arms aaa nea fe 21 Desat 617 435 J v y v SEF g i U ee LA wT 23 Stage 1 660 30 24 ilaia et aa TH dp na Properties g Fortran tte a aa IAAT ARAL eA AN NAAA AANA AAN ANAA 32 Se ote ieee ne ee N nn a ee Nt Oe Se en 3 Sh SM ie a cet ell eer ae aa Ye nen a n I Pe nes i 35 36 ISLA ISOS OSL NISI NI NINININI NT m Hd bai a 5 38 MALD 40 Body e 45 imp o 47 8 3219 PM 24 375 seconds Patient Start
136. sleep and breathing The group also included 9 patients with PLMs 8 to183 hr average 38 55 hr two patients with severe sleep fragmentation for no apparent cause non organic insomnia and seven patients with normal sleep Overall the quality of sleep varied considerably among the 30 patients with Total Sleep Time ranging from 2 6 to 7 8 hours 4 2 1 1 hours sleep efficiency ranging from 37 to 99 61 18 and arousal index ranging from 9 to 97 hr 17 4 hr A total of 24967 thirty second epochs were scored 1 5 2 Technologists Each of the three scorers is Board certified and has had at least 15 years of hands on experience in scoring polysomnograms 1 5 3 Analytical Methods and Results 1 5 3 1 Objective 1 testing epoch by epoch agreement Table 1 left panels shows results of epoch by epoch agreement between MICHELE and a consensus 22 of the scorers agree of the three scorers The right panels show the results for a predicate device Alice 5 referred to as Alice using the same files and scoring guidelines Positive Percent Agreement PPA Negative Percent Agreement NPA Overall agreement and Cohen s kappa kappa were calculated according to Altman DG et al 1 The weighted average of test and reference scorers was obtained for PPA i e APPA and NPA i e ANPA APPA ANPA Overall agreement and kappa obtained with MICHELE exceeded the corresponding values obtained with Alice for all comparisons 12 michele
137. ssing Delete will undo that mapping Checking Disable Voltage Levels is the equivalent of temporarily deleting all of the entries In order to close the Voltage Ranges dialog box there must be no conflicts A conflict is defined as two or more positions having the same voltage mapping or two or more voltages being mapped to the same body position Once all channels have been edited to the desired specifications Channel Mappings need to be assigned 3 9 Channel Mapping In order to properly execute the automated scoring module embedded in the Viewer the Viewer must know which channels within the currently open EDF file contain the primary signals required for automated scoring To configure the channel mappings select Configuration gt Channel Mapping in the Main Menu The following window will be displayed as shown in Figure 3 29 below 59 michele SLEEP SCORING Y Channel Mapping Channel Type Abdomen Audio Body Position Chest CPAP Flow Expiratory Pressure Inspiratory Pressure Chin EMG EEG 1 ERG 2 EKG End Tidal CO2 Heart Rate Left Eye EOG Left Leg EMG Nasal Cannula Right Eye EOG Right Leg EMG Channel Name ABDM Snore Sensor None CHEST CFLOW CPRESS None Chinl Chin2 C3 M2 C4 M1 EKG None HEARTRATE User Manual MICHELE Sleep Scoring System Polarity Figure 3 29 Revision 22 Effective Date
138. ssing Save will save your settings only and close the window The first time you press Save with the enable box checked the window shown in Figure 5 12 will be displayed for a period of time 94 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 ry C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Y Calculating R Wave Figure 5 12 This window closes automatically when the required calculations are finished Note The R wave removal module is automatically disabled whenever a file is opened and must be re enabled as required Another way to remove EKG artifact from selected channels would be to reference Al and A2 or M1 and M2 together refer to Section 3 5 for guidance on this procedure In other words reference C4 A1 A2 as opposed to only referencing C4 A1 thereby averaging the two reference electrodes this often removes the EKG artifact 5 7 The View Menu The View Menu is used to access different features related to how the information is displayed on the screen Default Layout re sizes the different windows Graph Window Properties Window Scores Window and Hypnogram to a default size and position on the screen This should be used to restore windows if one is accidentally moved off screen or closed Scale Channels scales the selected channels to fit their height entirely in the space assigned to the specific channels Evenly Space Channels resizes
139. t M D O A D Desat 3062 75 HOD 3064 867 Desat 3100 M O 3108 836 Desat 3141 75 Figure 4 12 82 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING 4 7 The Graph Window Mouse Cursor Indicator Sleep Display Channel Info View Toggle EMG1 EMG 5 113 C3 A2 18 206 Channel Header Area p C4 A1 63 976 R LEG1 R LEG2 74 077 EAG Nasal CPAP Fio 108 631 12 44 57 AM 4 G 0882 664 seconds Patient 7ee Start 10 50 PM End 6 06 AM Body Position Left CPAP Off Figure 4 13 Epoch Divider Epoch Number The Graph Window consists of the main display for the application It contains the graphical representation of all channels events key markers patient information and sleep staging as shown above in Figure 4 13 The View Toggle allows switching between viewing the graphical representation of the current file and viewing the analysis notes The currently opened file name is displayed in the left most orange tab of the Graph Window file name not shown in Figure 4 13 The analysis notes are discussed in Section 5 10 The Mouse Cursor Indicator shows a line representation of where the mouse cursor is located on the screen The Epoch Divider is a solid line that can be used to distinguish where the boundaries between 30 second epochs are located Epoch dividers are no
140. t Delta Wave Duration change based on the location of the mouse cursor on the Graph Window 97 User Manual MICHELE Sleep Scoring System 1AF Revision 22 Effective Date 7 Aug 13 ry C h e e Document Number YST UDoc USM 22 SLEEP SCORING 5 9 The Toolbar The majority of the functionality in the toolbar is also accessible through the menus described earlier Figure 5 14 below shows the Toolbar with definitions for the numbered items following it g AIE Ig B E AU a a Te So oo 12 49 38 AMS 103 Ho 1 Montage Default 1234 5 6789 10 11 13 1412 15 16 Figure 5 14 The following commands work exactly the same as the menu items described earlier 1 Open Patient File 2 Save prompts to save all three of the Montage Score List and Analysis Notes assuming there are unsaved changes Generate Report Print Import Notes From File Scale Channels Refresh Hypnogram Evenly Space Channels Align to Epoch Boundary So ee The following features are unique to the toolbar 10 Set Epoch Duration 11 View Previous Epoch 12 View Next Epoch 13 Time of Position in File 14 Current 30 second Epoch Number 15 Animation Controller 16 Montage Selector The Set Epoch Duration buttons consist of a number of durations which when clicked set the currently displayed window length to that amount of seconds The exception to this is the ALL button which displays the entire file Note Processing can be
141. t View Help Version 1 00 061 Bugs Files can upload despite being disconnected from the Server Opening Patient File causes viewer shutdown Features Add additional statuses to the Remote File Manager in the viewer New workflow is Pending gt Uploading gt Uploaded gt Downloading gt Scoring gt Available i Hide IP Address in Login window The IP Address can be edited via Left ctrl Left Alt I P being pressed simultaneously with the login information window open undocumented Features IP Address in viewer 1 00 061 defaults to ftp 01 youness leeptechnologies com Figure 7 2 End users can review the release notes or the User Manual at any time by selecting these menu items within the Help Menu These documents can be printed if desired Regulatory Information displays the Label for the Michele Sleep Scoring software as well as Instructions for Use and Younes Sleep Technologies contact information 104 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 ry C h e eC Document Number YST UDoc USM 22 SLEEP SCORING 8 0 Troubleshooting 8 1 Error Message In the event of a failure of any part of the Viewer application an error message will appear shown below in Figure 8 0 x An error occurred while performing the last operation Figure 8 0 Pressing OK will signal the Viewer to automatically send an email to YST Support co
142. t shown if the compression is set to either 1000 seconds or the entire file The Epoch Number is placed to the right of any epoch dividers including the bottom left corner if the display is aligned to epoch boundaries This number indicates which epoch starts at a given boundary 83 User Manual MICHELE Sleep Scoring System fy u Revision 22 Effective Date 7 Aug 13 M C h e e Document Number YST UDoc USM 22 SLEEP SCORING The Channel Header Area displays the name and a value for different channels that are visible This is the value at the point in time where the mouse cursor is located Selecting a channel is possible by clicking on the channel name in the channel header Multiple channels may be selected by holding down the Ctrl key and clicking on multiple names ki aaah lbs ll A Figure 4 14 Figure 4 14 shows a selected channel Dotted lines outline it and two arrows appear beside the name The dotted lines show the bounds of the channel and no part of the channel will appear outside of these bounds The arrows beside the channel name are used for quick scaling of the channel Pressing the up arrow will enlarge the channel by halving the limits about the midpoint while pressing the down arrow will shrink the channel by doubling the limits about the midpoint These limits are discussed in more detail in the Section 3 3 describing the Graph Channels property window Example If a channel is se
143. t to display values from 25 to 75 the midpoint is 25 with 50 on either side Pressing the up arrow changes the limits to 25 25 Pressing the down arrow changes the limits to 25 100 The value appearing beside the channel label is the signal value at the cursor location 84 User Manual MICHELE Sleep Scoring System ih u Revision 22 Effective Date 7 Aug 13 j i i C h a Document Number YST UDoc USM 22 o SLEEP SCORING 5 0 Editing a File The results of automated scoring must be edited before the final report can be created The graph window will display UNEDITED in the background of any file that has not been edited Figure 5 0 This section describes the features of the Viewer that allow editing a file Y YST Data Viewer File View Configuration Preferences Help SAaIEGIi SS eID ET a ww e nn o Aas 5 OO Montage File30 EMG2 36 86 23 13 f H 1 i D S io C4 A1 1 388 A2 13 16 R EOG A1 2 288 Chest 353 Abdomen 246 4 H Therm 102 2 SNORE 1 585 57 64 L LEG1 L LEG2 6 679 R LEGI R LEG2 4 29 i Sa02 93 CPAP Fon 145 338 seconds Patient Start 12 06 AM End 6 22 AM Body Position N A CPAP Off Figure 5 0 5 1 Copying a File for Edit Before a file can be edited the results file provided by YST must be copied This is done by using the
144. the 30 files even though REM was present in 28 of the files as identified by each of the three technologists and by MICHELE 1 5 3 2 1 Comparison with Other Predicate Devices Table 4 shows results for MICHELE left 6 columns and the only results available in the literature for another predicate deice Morpheus 2 The first three columns in each set are the average results for the two human scorers S1 and S2 in the case of MICHELE and M1 and M2 for Morpheus and the corresponding automatic score The next three columns are intra class correlation coefficients ICC for the relation between the auto score and the two technologists as well as the relation between the two technologists As may be expected from comparisons involving a large number of pairs and as shown in the table by highlighted cells there were many significant differences between the three scorers even though the average differences were small The results of Morpheus were significantly different from both M1 and M2 in 8 variables solid shade and diagonal stripes MICHELE Auto scoring was different from both S1 and S2 in five As in the case of the MICHELE the authors of the Morpheus study 2 commented on the occasional inaccuracy of the Morpheus system in estimating REM onset latency They indicated that Morpheus missed the first REM period in 10 patients 32 whereas MICHELE missed the first REM period in only one patient The differences they reported between manual and
145. the left button either forward or backwards Once the event is covering the desired area releasing the mouse button will finalize the event The created event will be the default type specified in the Channel properties Pressing one of the following keys while an event is selected will change the name of the event as follows e O Obstructive Apnea e M Mixed Apnea e C Central Apnea e H Hypopnea e R RERA Key Bindings can be customized through the Set Key Bindings option in the Configuration menu Sleep staging key bindings can be customized as shown in Figure 5 2 below Event Scoring and Event Associations key bindings can also be customized through their respective sections in this menu Y Set Key Bindings Stage NREM Stage NREM 1 3 Stage NREM Stage REM OK Cancel Figure 5 2 Pressing one of the function buttons displays Figure 5 3 below Once this window is open press a key and the binding for this function will be modified If a key is already bound to another function it cannot be bound to a new function without first un binding it 87 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 ry C h e e Document Number YST UDoc USM 22 SLEEP SCORING Y Press A Key Press any Key Invalid keys un map this key binding Invalid keys are Esc Delete Backspace Arrows Figure 5 3 Pressing one of the invalid keys sho
146. the same frame of the user interface the default layout has the properties window in the top right portion of the screen and the contents are changed depending on which item is selected 3 3 2 Graph Window Properties Appearance Background _ Pick Primary Line B Secondary Line _ Pick Epoch Divider A Picx Sleep Stage _ Pick Lights Tag ae ricx Body Tag E ic CPAP Tag ae ic BiPAP Tag E ric Oxygen Tag a Pick Notes Tag E ric Stage Display Type Both Figure 3 11 45 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 Mm C h e eC Document Number YST UDoc USM 22 SLEEP SCORING To select the Graph click anywhere in the Graph Window except on a channel name or an event The only customizable properties of the Graph Window involve how the graph is colored as shown above in Figure 3 11 The Background color sets the color of the background The Primary Line color sets the color of the dashed vertical lines The Secondary Line color sets the color of the solid vertical lines The Epoch Divider color sets the color of the epoch divider line The Sleep Stage color sets the color of the sleep stage lettering The Lights Tag Body Tag CPAP Tag BiPAP Tag Oxygen Tag and Notes Tag colors set the color of the tags that can be placed in the Graph Tray Stage Display Type changes the position of the Sleep Display which appears in the background of the G
147. times sleep state changed from any sleep stage to stage awake 1 4 1 1 13 Total Stage Shifts Total number of shifts from any stage to any other stage 1 4 1 2 TIME IN EACH STAGE box The time spent in each of the five stages awake N1 N2 N3 and REM is given in minutes and as of TST The latency to entering each stage provided in the last column is the time of first appearance of the stage minus Lights Off The sum of all times spent in non REM sleep sum of stages N1 to N3 in the same table is reported at the bottom of the table With split studies the values in this box and subsequent boxes reflect either the Pre CPAP or the On CPAP period as indicated in the heading above this box 1 4 1 3 AROUSALS box The arousal statistics are reported into three categories Respiratory related PLM related and Spontaneous 1 4 1 3 1 Respiratory Arousals Arousals are attributed to respiratory events if they start within 5 seconds of the end of a respiratory event 1 4 1 3 2 Arousals with PLMs As per AASM guidelines an arousal is attributed to a leg movement if there is A overlap between arousal time and PLM time OR B an arousal end in the interval PLM onset to PLM onset 0 5 second OR C an arousal onset in the interval PLM end to PLM end 0 5 second At times recurrent respiratory events are associated with recurrent arousals that involve leg movements In such cases the arousal is classified as Respiratory related 1 4 1 3
148. to export from the following list To select a montage click on it in the list A second click will deselect a montage Michele new default Calgary montage 1 files Test Default Messy Montage Kris YST Delta montage YST Delta montage room 1 Delta YST Delta montage room 4 CPAP YST Delta montage A Viewer 100059 test Cancel Previous Next Figure 3 35 66 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING Select the file by clicking on its name or you can select multiple montages to export by clicking on multiple names Select finish to complete the process To import an existing montage Figure 3 34 would still appear but you would be clicking on the lt button to search for a montage that already exists on another PC Network File location Once you have selected that montage file you are returned to Figure 3 34 again but with the file path information for the montage to be imported specified in the text box Click on next Highlight the montage or montages you that you would like to import Click on next and Figure 3 36 will be shown as displayed below Click on finish to complete the process Y Import Export Montage Tool xo The export has been successful To import these montages on another computer transfer the mon file that was created via this process and run the i
149. u u u U LJ aN AU eee Auta n amii 7 A TT ir hr ee ae S yr pa m 7 Epoch Event Start Time Duration Channe 20 724 seconds Patient Start 10 58 PM End 6 05 AM Body Position N A CPAP Off Hyprogram wat a ts e Figure 3 9 Once a study has been opened in the Viewer it will be necessary to build a new montage by setting up each individual channel all properties settings within and the Channel Mappings If channels numbers are ordered differently between collection systems or rooms beds a montage will have to be built and saved for each configuration of channels Once a montage has been saved it will not have to be built again and can just be chosen for each related study Right clicking in the Channel Header Area brings up a channel selection menu shown in Figure 3 10 below 43 User Manual MICHELE Sleep Scoring System 1AF Ea u Revision 22 Effective Date 7 Aug 13 ry C h e e Document Number YST UDoc USM 22 SLEEP SCORING EMG1 EMG2 EMG3 EMG2 C3 A2 C4 A1 01 A3 02 Al L EOG A2 R EOG A1 Chest Abdomen LAIAS 4 4 i 4 l s Therm SNORE EKG1 EKG2 L LEG1 L LEG2 R LEG1 R LEG2 SaQ TepCo CPAP Pressure Ww CPAP Flow ECO w PULSE NASAL PRESSURE Ww Nasal Flow lt 1 1 1 ST lt Figure 3 10 This menu allows for adding and removing channels from the graph window Any channel with a checkmark is currently visible
150. umber YST UDoc USM 22 SLEEP SCORING 1 2 4 Signal referencing As with filtering Section 1 2 3 referencing of AC signals must be performed either in the hardware at the amplifiers or in the software after recording If you use the hardware referencing you should export the file into the EDF format without any additional referencing If you do not use hardware referencing it is recommended that you export the file without referencing Referencing can be done through the interface provided with the Viewer You will be asked as described in Section 4 2 to confirm that the AC channels have been referenced by hardware during export or through the Viewer interface before automated scoring begins 1 2 5 Signal noise Noise should be kept to a minimum through appropriate cable insulation and connections Although the software continuously evaluates the signal quality of certain channels and in those cases uses only signals that meet minimum quality criteria as a best practice noise should be minimized as signals that are damaged or noisy can greatly affect scoring quality If desired YST staff can advise you on ways to reduce the noise Section 8 of this User Manual provides contact information 1 2 6 Calibration All AC signals must be calibrated using a 50uV calibration switch 1 3 Scoring Rules Used The MICHELE Sleep Scoring System adheres to the most recent guidelines of the American Academy of Sleep Medicine The AASM Manual for
151. up and down arrows This has the potential to remove the alignment with the epoch boundary preventing the scoring of sleep Using Align to Epoch Boundary will reinstate this alignment and allow scoring to resume Scrolling the mouse wheel up will advance the graph window by the number of seconds currently displayed in the graph while scrolling the mouse wheel down will move the display back by the number of seconds currently displayed in the graph Ex If Display 30 Seconds is selected as the currently displayed window length scrolling the mouse wheel forward will advance the display by 30 seconds while moving the mouse wheel down will move the display back by 30 seconds Pressing the Left and Right arrow keys on the user s keyboard has the same effect as scrolling the mouse up right arrow key and down left arrow key The Current 30 second Epoch Number displays the current 30 second epoch that is shown earliest in the displayed window This number can be modified and doing so will shift the start of the displayed window to the beginning of the 30 second epoch number entered The Animation Controller allows for continuous scrolling of epochs across the screen at a fixed time interval which is set using the drop down box The time intervals are in increments of 0 25 seconds ranging from 0 25 to 3 00 seconds Note When animating large compressions with a fast time interval this feature may behave irregularly If irregular behaviour is
152. ures does not rule out an obstructive basis for the hypopnea Hence such hypopneas are called undefined meaning they can be obstructive or central 1 3 4 Detection of leg movements Each 30 second epoch is searched for the presence of one or more leg movements Whenever a leg movement is found it will be characterized as associated or not with arousal and whether the leg movements follow a periodic pattern periodic leg movements PLMs following the guidelines established by the American Academy of Sleep Medicine The AASM Manual for the Scoring of Sleep and Associated Events published by the AASM in 2007 1 4 Reported Variables When a file is scored and edited approved by the technologist a report will be generated The report has two components numerical and graphical The default report contains all values and graphs that are available The user may choose to omit some values from the report using a procedure described below in the Generate Report Function Section 6 In the event the study was a split study there will be two numerical reports in the same document one for the pre CPAP period and one for the On CPAP period 1 4 1 Numerical Report This consists of several sections that relate to the output of the different functions of the software namely sleep variables arousals detected periodic leg movements PLMs and respiratory events The following paragraphs describe how each value is calculated 1 4 1 1 SLEEP V
153. us as shown in Figure 2 12 below 78 YST Data Viewer Installing YST Data Viewer YST Data Viewer is being installed Please wait Cancel Figure 2 12 The Viewer should then appear as an icon on the desktop as shown in Figure 2 13 26 User Manual MICHELE Sleep Scoring System 1AF u Revision 22 Effective Date 7 Aug 13 M C h e e Document Number YST UDoc USM 22 SLEEP SCORING a YST Data Viewer Figure 2 13 Do not attempt to start the Viewer yet Continue with the installation process described below As described earlier the Viewer setup process will attempt to automatically install each program that is required to use the Viewer To determine whether the programs have installed automatically go to Add or Remove Programs in the Control Panel and review the Currently installed programs list to determine whether all four are listed as per the list shown earlier and below Any program that is not listed will need to be installed from the Viewer installation disk If a program needs to be installed in this manner it will be necessary to determine whether the operating system on the target PC is 32 bit or 64 bit in order to access the appropriate folder on the installation disk either the folder labelled 32 Bit for a 32 bit system or the 64 Bit folder for a 64 bit system Within the appropriate folder there will be additional folders that correspond to the four pro
154. ve Do not check this box if the Chest and Abdomen bands use any other sensing technology such as piezoresitive or RIP belts If the Audio or Snore signal has been pre processed such that it is no longer an AC signal and contains a smoothed waveform representing the recorded audio select the Audio Processed box If you are uncertain about the nature of the audio signal leave this box unchecked If the Nasal Cannula channel requires processing by the square root function check the Process Nasal checkbox This is necessary when the Nasal Cannula is strictly measuring nasal pressure without any signal processing applied as the nasal pressure measured is proportional to the square of nasal flow It is therefore necessary to take the square root of the pressure signal to get an accurate representation of nasal flow in such cases In most cases nasal root is not used and this box should not be checked Checking this box will not affect how data is displayed on the screen only how the autoscoring algorithms treat the signal for the detection of respiratory events 62 User Manual MICHELE Sleep Scoring System i i ii v Revision 22 Effective Date 7 Aug 13 M C h e eC Document Number YST UDoc USM 22 SLEEP SCORING If the EDF file contains a signal representing the end tidal CO concentration of exhaled air verify the CO units in the drop down box as either or mmHg Depending on which option your sleep lab e
155. ware intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders The MICHELE Sleep Scoring System is intended to be used for analysis automatic scoring and manual rescoring display redisplay retrieve summarizing reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders The device is to be used under the supervision of a physician Use is restricted to files obtained from adult patients Warnings and Cautions The MICHELE Sleep Scoring System does not analyze data that are different from those analyzed by human scorers The report generated by the MICHELE Sleep Scoring System contains numerical and graphical data typical of those generated following manual scoring of polysomnograms It does not contain any interpretation diagnosis or recommendations for treatment These decisions are to be made by the treating physician The scoring provided by the MICHELE Sleep Scoring System must be reviewed edited as necessary and approved before the report is generated Special attention should be paid to confirm the first epoch of REM sleep and of non REM sleep since occasionally brief periods of either kind can be missed or mistakenly scored resulting in large errors in sleep latency or REM latency Arousals may be underreported in cases where arousal frequency is very high Any modification to any component of the
156. wn above in Figure 5 3 will remove the key binding Key bindings are stored in the Montage Right Click Adds Event is a toggle that when selected in the Configuration menu will enable or disable the ability for right clicking on the graph window to automatically create a default event Once created right clicking on an event allows for the event name to be changed The Sleep Display indicates the sleep stage that was scored for the currently viewed 30 second epoch If the epoch length is longer than 30 seconds or a time offset has been added to the window the sleep stages of multiple epochs are displayed To modify the sleep stage one of six keys can be pressed Pressing 0 sets the sleep stage to Awake displayed as W Pressing 1 sets the sleep stage to stage N1 displayed as 1 Pressing 2 sets the sleep stage to stage N2 displayed as 2 Pressing 3 sets the sleep stage to stage N3 displayed as 3 Pressing 5 sets the sleep stage to REM displayed as R Pressing 6 sets the sleep stage to Movement displayed as M These are the default key bindings Keys can be re assigned by using the interface illustrated above in Figure 5 2 Modifying the sleep stage can only be done when the epoch duration is set to 30 seconds and the window is aligned to the epoch boundary Reassign Events relocates all events of a specific type Respiratory Arousal Desaturation or Leg Movement to a specified channel Upo
157. ygen Events o Desaturations and Bad Oxygen Regions e Markers o Body Position Lights On Off CPAP On CPAP Levels BIPAP Levels Oxygen Levels e Sleep o All Sleep Stages e Snoring o All instances where snore signals have been detected e Cardiac Observations o All instances where Cardiac Observations have been detected e General Observations o Any other observations besides Cardiac e Custom o All Notes and Unspecified Events To delete an event from the scores window left click on the event to highlight it and press Delete on the keyboard Multiple events can be deleted at one time by left clicking an event and holding down the Ctrl key while left clicking on additional events to be deleted 81 User Manual MICHELE Sleep Scoring System Ve u Revision 22 Effective Date 7 Aug 13 j i C h z Document Number YST UDoc USM 22 o SLEEP SCORING Note Sleep or Body Position events cannot be deleted from the Scores Window To rename an event from the scores window right click the event A menu will appear with events that the selected event can be renamed to Figure 4 12 To rename multiple events at once the user can left click an event hold down the Ctrl key while left clicking other events to be renamed The user would then right click one of the selected events and choose the new event name Note This will only rename respiratory events Epoch Event uration 99 Desat B29 100 MAD Desat Desa

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