OPERATOR'S MANUAL Biomedical Systems Century Holter Analysis System C3000/C2000/C1000 Version 2.13 Revision Date: November 2008 PN: MCH-MNL-1610-2.13 Biomedical Systems 77 Progress Parkway, St.
INDICATIONS FOR USE ............................................................................................................................8 COMPATIBILITY .......................................................................................................................................8 WARNINGS AND CAUTIONS ......................................................................................................................8 PRECAUTIONS .............................................................
4.1.4 CONTROLLING THE ANALYSIS......................................................................................................... 28 4.2 THE ANALYSIS OPTIONS SCREEN .....................................................................................................31 4.2.1 DISPLAY REFRESH .......................................................................................................................... 31 4.2.2 SCAN SPEED ........................................................................
5.1.1 SUPERIMPOSE TEMPLATES .............................................................................................................. 45 5.1.2 REVIEWING ALL OCCURRENCES ....................................................................................................... 45 5.1.3 MERGING SELECTED TEMPLATES ..................................................................................................... 45 5.1.4 AUTOMERGE .............................................................................
9.2 DEFINING THE REPORT PAGES ...........................................................................................................74 9.3 CHANGING PRINT OPTIONS ..............................................................................................................74 9.4 PRINTING.........................................................................................................................................75 9.4.1 P RINT TO SCREEN (PREVIEW) ...............................................
12.8 THE QT TRENDS ..........................................................................................................................104 12.8.1 THE QT HISTOGRAMS/ECG TABS................................................................................................ 105 12.8.2 VALIDATING AND EDITING QT ................................................................................................... 106 12.8.3 QT OPTIONS...............................................................................
APPENDIX C - TRANSLATIONS – Non ANSI support …………………………………………….
PREFACE This manual provides operating instructions for the Century Holter Analysis System. It is designed for clinicians trained in Holter analysis. This manual addresses the C3000, C2000, and C1000 configurations.
CAUTION: Due to rapid changes in computer technology, the contents of this manual are subject to change without notice. Precautions The Century C3000/C2000/C1000 Holter Analysis System is intended for use in a hospital or clinical setting by trained and authorized personnel who are acting on the orders of a physician. Its purpose is the monitoring of ambulatory patients over an extended period of time. The final decision regarding the treatment of patients lies with the prescribing physician.
1.0 Main Menu A few seconds after the Biomedical splash screen comes up, this typical Main Menu appears. At the top of the screen you will find a menu system, a tool bar and several drop-down list boxes. The toolbar buttons are shortcuts to existing menu items that are frequently needed. They respond to a single mouse click. A double click will move the toolbar to another position on the screen.
You now have the option to: - Check-out a previously analyzed patient using the current patient list box. - Check-out a previously analyzed patient using the patient directory (icon) - Start a new analysis - Change the way you work using profiles 1.1 Main Menu toolbar 1.1.1 Checking-out a patient This toolbar button gives access to the patient and archive directories (the patient database).
1.1.4 Patient demographics This button allows you to access the patient demographics. It is only accessible if a patient is checked out. 1.1.5 Trends – retrospective analysis This module allows reviewing analyzed data on the beat level and has sophisticated editing tools like template editing, r-r interval editing, Event editing (validation), QT editing, ST editing and Table editing.. It is only accessible when a patient is checked out and most modules are unavailable when there is no raw data. 1.1.
2.0 Start Scan - Analyzing a new patient After clicking on the flashcard icon toolbar or selecting scan from the scan menu, you are entering the ‘Start Scan’ screen where you need to select the device. 2.1 Selecting the Holter recorder The image on the left shows the start scan screen with several icons, each representing a Holter recorder at a specific location.
2.2 Patient Demographics The Patient Demographics screen allows entry of pertinent patient information. Entries in these fields will appear on the printed report. Date of Birth Date of birth values should be entered in the format determined by your current Windows setting (e.g., if Windows is set for United States data format “mm/dd/yyyy”; then May 4, 1996 would be entered as 05/04/1996).
Initially, the analysis date will be set to the current date. The user may edit this field. Recording Date Initially, the recording date will be set to the preceding date. The user may edit this field. Analyst, Hookup Technician, Physician #1, Physician #2, Medications The descriptions for these fields are grouped together because functionally they all behave the same. Each will allow the user to enter information into the box provided.
2.3 Downloading Holter Data How the download screen looks depends on the device you have selected, but in most cases you will get the screen below. 2.3.1 Digital data The top of the screen tells you from which device (VX3) you are downloading data and where that device is located (D:\). The bottom line gives additional information on the type of dataset you are downloading. (The number of channels, sampling rate and data width).
3.0 Analysis Setup Scanning begins with the program searching for a calibration pulse, searching for the most prevalent normal beat, and calibration of the ECG signal with the found calibration signal. When enough normal beats have been, found the scanner will display the findings and allow the user to confirm the settings and set additional parameters. All this occurs in the screen below. The top of the screen displays a 25 beat averaged QRS complex for each of the 3 channels.
If the system is unable to present a good averaged beat, the user can allowed to select a beat on the ECG strip as the choice for the normal beat. The same procedure also allows you to take an additional template of a VE, PACED, or spike morphology. Start the procedure by clicking on the Template button. Adding a template Click on the arrow left/right buttons to move the rectangle until it is over the QRS complex on the strip that you want to use as a normal template.
3.1.2 ST Setup The cursors on the averaged ECG complexes are used to set up ST: Click on the I button to change the Iso electric point on all three channels (Purple cursor moves). Click on the J button to change the J point (end of QRS) on all 3 channels (Blue cursor moves) Click on the O button to change the Offset point on all 3 channels (Red cursor moves). While moving the cursors, the actual position of each cursor is indicated on the right side of the button.
3.1.4 Channel selection, inversion, gain Check boxes at the right side of each channel in the strip allow selection for: Arhythmia analysis ST analysis Channel inversion (only available on non derived signals) The gain of each channel can be set at the calibrated settings of: 0, 5, 10 or 20 mm/mV Clicking on the gain button selects the gain. 3.1.5 Auto-Scan select Checking this box will enable the Auto-scan feature.
The screen below is from a 12-lead recorder. If you are not using a 12-lead recorder, the screen will contain a warning message at the bottom and rather than showing 5, 10, 20 mm/mV the gain button will show 1X, 2X, 3X. Once the analysis is started, instead of selecting the channels for analysis, the panel at the bottom of the screen, will allow you to change the rhythm lead.
3.1.9 Start the scan Click the Start Scan button to start scanning the tape. A pop-up will display the important settings selected. Before beginning the scan, you are provided the opportunity to verify and confirm the channel settings for Arrhythmia, A-Fib, ST, and QT analysis. If desired any of these settings may be changed by the user. Click Cancel to return to analysis setup if you think these parameters need to be changed. Click Scan to proceed with scanning.
4.0 Analyzing 4.1 Main Analysis Screen (C3000 & C2000) The primary method of analysis on the Main Analysis screen is prospective superimposition scanning. The main screen consists of three windows: the Counts/Arrhythmia window (left), the Templates edit window (right) and the Superimpose View window (center). To pause the scan, press the Pause button.
4.1.1 Counts/Arrhythmia Graph The Counts window displays the relevant counts of Normal beats and ectopic activity on the left side of the screen. It also shows the heart rate and analysis time. The Arrhythmia Graph window shows a histogram where each line represents an R-R interval. The length of this line is proportional to the length of the R-R interval preceding the beat. The color of the line represents the beat’s classification. An orange line is an SVE, a red line is a VE, etc.
4.1.2 Templates Window The Templates window is the main editing tool while scanning. It allows review and editing of all templates and all of the occurrences within each template. During scanning, this window displays which template was last evaluated. In the example on the left, occurrence 4 of template bin 6 is shown. At this point, this template has 17 occurrences. Colored boxes below the template display represent the different arrhythmia classes that can be assigned to the currently displayed beat.
When you are reviewing templates, the program shows you the occurrence that was responsible for creating a new template (morphology). Generally this will be the first occurrence, but if a template has been added from the Unknown bin, this value could be higher. The occurrence shown does not guarantee that all matching templates will have the same category. That is why the program reevaluates each template bin after 12 matches.
4.1.3 Superimpose View This view superimposes (i.e., displays) one beat over another for validation by the operator. Normal beats are shown in Green with the Rpeak positioned on the red vertical bar. Relevant ST and QT points are presented on the superimposed beat. The complete R-R interval is drawn on the screen to allow the operator to view and validate long R-R intervals and Pauses. The maximum value visible is 2.4 seconds on 1024x768 screens.
4.1.4.1 Changing the analysis channel The Holter system allows you to independently select the channel(s) used to detect a QRS complex and the channel(s) used to classify a detected QRS by selecting the desired check boxes in the Trigger/Analysis panel. Up to two channels each may be selected for triggering and analysis. Under normal conditions, the analyzer may change either trigger or analysis channels to compensate for signal quality.
Works as in single channel mode, no new templates are created, but beats are compared using the most stringent comparison criteria. Note: Try ArtFilter before going into Turbo Scan Mode on recordings with Artifact. 4.1.4.3 Activating the Artifact Filter: The Artifact Filter (ArtFilter) will decide if the beat identified is Artifact or a real beat by evaluating small peaks around the selected beat. The Artifact Filter recognizes many Artifacts, but also reduces the ability to detect new morphologies.
4.2 The Analysis Options Screen Several parameters can be changed while scanning to optimize evaluation on difficult recordings. Select the Analysis Options tab to access the Analysis Options screen.. 4.2.1 Display Refresh Options: Normal or smart display tries to display the most important beats but not all to speed up scanning. Normal Refresh Displays: - 15% of all beats - First 20 occurrences of all templates - Any change in template - Any sudden R-R changes, like Pauses or possible missed beats.
4.2.5 Show ST Calipers Toggles the ST calipers on the Superimpose window. 4.2.6 Show QT Calipers Toggles the QT calipers on the Superimpose window. 4.2.7 Minimum Peak Height Minimum QRS peak height to accept a detected beat. The default value is 40% of the average height of the last two Normal beats. Select Page Dn for 20% or Page Up for 60%. Further Page Up selections will change from percentage values to real mm values (the reference height is 10 mm).
4.2.18 R-on-T Sensitivity Influences the calculated value of the Twave top position. After a Normal beat, detection of a new beat is only allowed X milliseconds after the expected position of the T-wave top. The default value for X is 60 milliseconds. From that point to the end of the T-wave is the R-on-T zone. A VE falling in this zone is interpreted as R-on-T.
4.2.24 The Arrhythmia Counts Menu and Stop Criteria The count menu provides detailed information on the current counts and allows you to program the analyzer to automatically stop when certain ectopics are detected. In typical operation, the system does not stop on arrhythmias, it just counts them. In this situation, all counts are considered On. If all counts are Off, this means that the system will stop and show the Diagnostic View each time it encounters one of the abnormalities in the list.
4.3 ST Screen (C3000 & C2000) The ST screen enables the user to correct the position of the ST points at any time during the scan process. You can access this screen by pressing the [S] key. To reposition any point, press or click I (Iso), J (Point) or O (Offset) to select the caliper you wish to move. Use the Right/Left arrow buttons to move the line and press [Enter] to save or click on Accept Settings. To change the ST channel analyzed, select the ST channel check boxes.
4.4 QT Screen (C3000 & C2000) The QT Screen can be accessed at any time during analysis by selecting the QT button. It allows the user to validate current QT, initialize QT settings, change QT parameters and save strips with all the details on the current beat (width, PR, QT, etc.) or over the last 25-beat average. The values displayed are the results of measurements during the analysis. From this screen, they can be modified for changing the QT values or saved for documentation.
4.4.1 Measuring QT A Set of colored markers are drawn on the enlarged beat at all important points of the complex. To reposition any marker, select or click the P-wave, Q-wave onset point, [T]-wave peak, or [E]nd of T-wave. Use the Right/Left arrow buttons to move the marker line. When moving the lines, the measured values on the right side of the screen will change. To save a strip with the currently measured QRS values (PR, QRS, QT), select the “Save QT Strip” button. 4.4.
4.5 Diagnostic View (C3000 only) To go to Diagnostic View, click on the Diagnostic View tab from the Main Analysis screen. If you do this while beats are superimposing, the analysis will stop and bring you to the Diagnostic View at the current scan position (i.e., the last beat analyzed). If you click on Diagnostic View while scrolling through temp lates or occurrences, you will be positioned at that occurrence within the data.
4.5.1 Moving around in the Scan Home: The Home key returns to the scan position at the last beat scanned. Arrow buttons: Click on the arrow buttons to move one beat at a time to the left or right. As long as you keep clicking or holding the arrow keys, the system will continue to move a beat to the left or right. This movement is visualized in the event or Arrhythmiagraph window. The screen redraws completely when you release the arrow keys or stop clicking the arrow button.
4.5.4 Inserting a Beat Low-amplitude VE’s that appear on the channel used for peak detection may not be classified. This is easily noticed during superimposition, as a Normal beat appears significantly to the right of its normal position. The problem can be fixed by changing the minimum R peak level or changing the trigger channel. To correct beats that have been missed, click on View Strip and search back for “false” R-R intervals or Pauses. Beat(s) can now be inserted by clicking on the Insert button.
4.5.5 Prospective Scanning For retrospective scanning all validation is completed after the Holter is scanned, such as in template editing or validation. Prospective scanning means that the operator validates and corrects anomalies at the time of occurrence. The Advanced System provides prospective scanning without losing the advantage of a retrospective analysis. To do this, open the Count Menu and select All Counts Off. The system will now stop on all abnormalities.
4.6 Page View (C3000 only) If you click the Page View tab, the view will change to page view. Page View displays three minutes of ECG on a single channel to provide a better view of the ECG surrounding the diagnostic strip. The strip in Diagnostic View is marked here with a green background. You can return to the Diagnostic View of the green section by clicking on Diagnostic or pressing [g] again. The [g] key toggles between Diagnostic and Page View.
4.6.1 Marking , relabeling a Block Single beats can be relabeled with the relabel window on the left side of your screen. To mark an episode of artifact , atrial fibrillation, atrial flutter , vtach …. go to the start of the episode and click with the left mouse button to update current time. Then right click for a floating relabel dialog to pop up. This dialog can be used to re-label single or multiple beats. Click on the Mark Block button to set the start of a block.
5.0 Template Editing After the scan, the default profile will bring you in the template edit section of Trends. 5.1 Editing Templates Bins The Template Edit screen contains a series of templates (pictures of each morphology shape found in the recording). All of the templates are colored to represent a specific classification of arrhythmia. The template picture is NOT an actual beat, but an averaged beat from the first 12 occurrences of that bin.
SVE Bin This bin was used in versions prior to v2.10 where it contained all single SVE occurrences. This bin is removed from template editing but a similar bin can be viewed and edited in the RR histogram section. If a bin is misclassified, select the appropriate Arrhythmia Key to reclassify. If you use the mouse, click on the beat to correct, and then click on one of the colored boxes at the bottom of the screen. This will relabel all the beats in that particular bin.
5.1.5 Aligning a Bin This function is only available using the keyboard. These functions adjust the r peak position of each occurrence in a bin, by moving the R-peak position to the most dominant peak in a small window surrounding the current detection. F6: Aligns the bin (left or right) using ECG data from channel 1. F7: Aligns the bin (left or right) using ECG data from channel 2. F8: Aligns the bin (left or right) using ECG data from channel 3.
In the center of the screen, every beat in the selected template bin will be superimposed at high speed. You may stop at any time and use the left and right arrows to scroll through the bin. The beat will be displayed in context based on the display width selected. You may reclassify by selecting the appropriate Arrhythmia Key. You can superimpose through the bin by: Click and holding down a single arrow button. This is controlled superimposition, where superimposition speed gradually increases.
5.3 Review Occurrences Once you have entered this screen, press PgUp/PgDn to view 20 more beats. Use the Right/Left Arrow keys to select an event or click on the event. Selecting Arrhythmia Keys or clicking on the colored boxes will reclassify individual events in this mode. Zoom will switch to a Diagnostic View and Save will save a sample strip. Pressing the Down Arrow key will superimpose the bin. Press [ESC] to exit.
5.4 Template Merging Template Merging can be done before or after editing templates. Merging templates reduces the number of template bins by merging templates together that have only minor differences. In some cases where VE’s and Normals look very much alike, some VE bins may contain Normals or some Normal bins may contain VE’s. In such cases, it is easier to edit several small, easily reviewed bins than to edit one very large bin.
6.0 Validation After template editing the scanner may guide you to validation. The purpose of validation is to show all events in the Holter recording in order of importance and ordered by category. Validation offers various editing possibilities to cleanup your analysis. If the analysis profile specifies that validation is required, the exit button in trends (always in the bottom left corner of your screen) may show a validation symbol instead of the exit symbol.
6.2 All example View The all example view shows all examples of the selected category with 12 examples per page. Deleted Examples show a small red barred circle. On the left side the information on the current category remains visible and on the top you can see information on the currently selected example and category.
6.3 Single example View Single example view looks very much like a diagnostic strip and offers most of the editing possibilities also found in diagnostic view. Here you can also make edits on a beat level. On top of the information as available in the all example view, the top of the page now also shows the time of the current beat. This is the beat at the center of your example, marked with a green caliper.
6.3.1 Measuring Measuring is activated by selection one of the interval ratio’s. This will bring up a set of calipers that allows the user to make interval, heart rate, PR or QT measurements. The current beat info above the radio controls will show updated information based on the distance between the 2 RED calipers. The heartrate value calculation is given in BPM and is based on a 2 beat RR interval before the current beat.
If you choose to update the interval or heart rate, the corresponding property of the example will be updated. Note though that an example usually only has 1 or 2 properties. One of them is always heart rate and the other one depends on the selected category. For pauses the second property is the RR interval and for the pr category it is the PR interval.
6.3.3 Deleting versus re -labeling an example The single validation view has not only the possibility to delete an example, but also to relabel it, like in diagnostic view. Both changes will update the tables, report and validation examples as soon as you advance to the next example or leave the current screen, but there are significant differences.
7.0 Managing Strips 7.1 Saving Strips There is a universal save dialog that can be used from nearly every screen. This dialog allows saving strips from different types and different lengths. It also allows you to preview the strips and print the strips from the preview screen. The default class label is the label from the beat that was selected when you clicked on the save strip button. It will appear in the center of the saved strip.
7.1.1 Saving strips from a marked block After selecting a block in page view the re-label box now shows a save strip button. A click on this button will show a slightly modified save dialog showing the length of the selected block. In the top right corner you can see the exact length of the strip. In our example this was 12 seconds.
7.2 Viewing saved strips The view saved strip tab, which is both present during the scan and in trends collects all strips that are saved in different locations in the program and also allows the user to add additional strips manually. This last feature replaces the strips from time method used in earlier versions of the software. The top of the screen shows the list of strips that are currently saved, while the bottom part shows the selected strip in detail.
7.2.2 Thumbnail view Strips can also be viewed as thumbnails by clicking on the thumbnail view button. As you move trough the strip list, the selected thumbnail will move too and selecting another thumbnail will also select another strip in the list.
7.3 Strip Types Diagnostic strip: 8, 16 or 24 second diagnostic strip. The saved strip has 16 extra seconds saved. (8 seconds before and 8 seconds after the actual strip) These additional seconds allow viewing the ECG that surrounds the strip as a 24 second bottom strip. Because this is stored with the strip it will remain available even after the raw data is no longer present. Additionally it allows the user to re-center the diagnostic part to a different location.
12 lead strips : These are 10 second strips saved from the 12 lead panel or the save dialog. The saved strips contain 10 sec data from all 12 channels which makes it possible to change the displayed rhythm lead , even when raw data is no longer available. The rhythm lead saved with the strip is the lead that was set in the analysis profile, but you can change the rhythm lead by changing the strip type. Just click on the type field to have a dropdown appear.
7.4 Adding a strip in view strips The last line of each strip list is always an empty line. It can be used to add a new strip manually. To do this, arrow down to the empty line and start typing the time. The time needs to be a valid one, which means it has the format HH:MM:SSDx or HH:MM:SS.TDx like 10:12:13D1 or 10:23:12.3D1 Times also need to be between start and end time of the tape. After entering the time hit the enter key twice.
The previewed strip is n’t taking his data from a saved strip, but from the raw data file. Notice ore bottom strip is coloured now. Currently shifting the previewed strip isn’t possible, so the only way to shift the location of the strip is by going back to the strip time cell and change the time a bit. The next enter will bring you in the type column. Click D or E and a dropdown will show you all available options. If you don’t select a strip type, the default diagnostic type will be used.
Once the strip is added it shows the requested 20 second format and a new line is added to the strip, ready for the next entry. Note that only when the strip is added, the strip is displayed in his correct format (Diagnostic or event).
7.5 Working with saved strips Modifying: Nearly all cells in the strip list can be updated just by changing the values in the list. The strip is updated when the selection on the cell changes, so there is no update button. Some cells can’t be changed or changes are limited. You can change an event strip to another type of event strip or FD strip, but you can not change it into a diagnostic strip. Add strip: Adds a new diagnostic strip immediately after the time is entered.
8.0 Tables Once all edits are done, you may review the results of the analysis in the tables and verify the contents of the cover page. To do this click on the tables tab. This will bring you in the general summary table, the first of 6 tables containing the results of your analysis. These tables show the results hour by hour. This means that the line with time ending set at 17:00D1 summarizes all data between 16:00D1 and 17:00D1 8.
If you leave the table after a cell is edited, you will get a warning. If you answer Yes, the table changes will be kept even if tables are recalculated. In this example re-calculating the tables will recalculate all tables except the ventricular table. 8.2 Verifying the cells If you have any doubts about numbers in the cells you can verify them by selecting the cell first and then right clicking on the selected cell.
8.3 The tabular summary The cover page of your final report can be in tabular or paragraph format. From version v2.10 tabular format is partially editable. Click on the ‘Tabular Summary’ report to review and edit it. Note that there are a few fields in this summary that will not be filled in and you might want to fill those in when you visit this page for the first time. Those fields are Rhythm, Morphology and Tape Quality.
8.4 The Paragraph Summary This is a freeform summary that is generated from the contents of the tabular page. The paragraph page has two big windows. The upper window shows the generated text, which is re-generated each time you enter the screen. It is the correct interpretation of the current results, but you may not like the format or you might want to add additional information. This window is not editable.
8.5 The physician comments Here the physician can add comments on the report. They will be added to the bottom of the cover page. Comments are to be added to the top window. The bottom window contains predefined sentences that you can use the enter text rapidly. Just double click on one of the lines to transfer this line to the current position in the top window. If your text is ready, click on ’Save and Exit’.
8.6 Recalculate Tables Although tables are recalculated in the background frequently, you may need to explicitly request recalculating the tables. Most of the times it is needed to modify an analysis parameter. Analysis parameters can be adjusted and tables recalculated with the new values. Note that these values are stored with the current patient but do not affect any profile.
9.0 Printing the report Although printing the report can be done from trends, it is recommended that you exit trends first to return to the main century screen. Printing from trends uses a lot of system resources so that it can fail on some systems. When you click on the print icon you will be in the current report profile from where you can setup and print the report.
The above header doesn’t have a logo by using the ‘No Logo’ selection for report logo. Above is the same header, but now using a small logo file With a wider logo, you can not enter text for the hospital name or company. This header was generated with the settings shown in profile report picture above. To be able to use a custom logo, you need to place a windows bitmap file in the Profiles\Report\Logos directory on your computer. Only then will they appear in the drop down list.
9.2 Defining the report pages Here you can define which pages you want to print and how many copies you want to print of the cover page. 9.3 Changing print options These options affect the way a page is printed. Strip Gain: In v2.10 it is recommended to use ‘Nearest factor of 5’ and individually alter the strip gain in ‘View saved strips’ if you want to increase or decrease the gain on a certain channel for a certain strip. Unlike v2.00 gain can be set individually for each channel on each strip.
Full Disclosure Resolution: Full Disclosure at half resolution or printing at Max speed, is not supported by all printers, so if you use this option and you see incorrect graphics set it back to the defaults as shown here. Usually you need to set print mode as raster mode. (Vector graphics not checked). Full Disclosure Format: Full Disclosure at 30 minute format will print full disclosure in landscape view at a higher gain. When this option is selected, only 30 minutes fit on a page.
10.0 Patient Directory The cabinet icon on the toolbar or Patient Directory from the Main Menu will bring you in this screen. This screen shows a list of all patients available in the central storage location. Whenever a patient is checked in, it is moved from the local directory (Usually containing a single patient.) to this central location. Whenever you want to review a patient, it is checked out from this location to the local patient directory.
The delete button allows the deletion of all selected patient(s), a popup will come up so that you can precise which data needs to be deleted. This can be the entire patient or the selected data type(s) only. (R, D, P,A). Deleting patients supports multiple selections. To select more than one patient you need to hold the CTRL or shift key and click on the very first column next to the patient you want to delete.
10.1 Archive options Archive with Delete This removes the archived data from the central storage location if the archive copy was successful. Select Files to archive Report data will always be archived, but if you want to keep raw, PDF or ASCII data, they need to be marked. If you want to keep more than one archive of a patient, like before or after an important edit, you can set the versioned files flag, so that the older archive isn’t overwritten. Archive Path Set the location of the archive here.
11.0 Patient Archive Directory From the patient directory screen you can access the archive directory by clicking on the Patient Archive Tab. The Patient Archive shows all archived patients and his main purpose is to let you restore a previously archived patient. Patients in the list can be sorted by the column criteria or deleted using the same method as in the patient directory screen.
12.0 Trends Select the Trends icon from the Main Menu to access the retrospective analysis part of the Century Holter scanner. This screen shows up to 12 tabs, each one specially designed to look at your analyzed data from a different angle. We have already discussed ‘Edit Templates’, ‘Validation’, ‘View Saved Strips’ and ‘Tables’ earlier in this manual. 12.1 Main Trend Screen This view is designed to allow correlation of heart rate, ST changes, pacer, and ectopic activity at a glance.
12.2 Multi-Graph Display 12.2.1 Ectopic Trend Graph’s To see the Ectopic trend click on the Ectopic Trend radio button if this graph is not already selected. This graph displays information about the PR interval averaged over the minute and the total number of ectopic events for that minute (SVE, VE, Paced beats, and Pauses). To assist the clinician in reading these graphs, they may be scaled by using the Low, Med, and High buttons at the top of the arrhythmia section.
12.2.4 ECG and Arrhythmia strip At the bottom of the screen, part of the current minute’s ECG data is displayed. The beat at the center is the first beat of the current minute and is surrounded with a red rectangle. The time of this beat is shown at the top of the trend screen. In the arrhythmia bar graph below, the R-R interval between a beat and its predecessor will be reflected in the length of the bar (the longer the R-R interval, the taller the bar).
The show saved strip option will show a vertical line on the main trend graph where the operator saved a strip. This gives you a good idea how many strips you saved and how evenly they are spread over time. Pacer spikes can also be enabled here; They are visible as thin lines on all strip types and in most screens. They can only be given if a recorder is used that has pacemaker info.
A block of ECG data may also be relabeled. To do this, select the first beat in a block to be relabeled by clicking on it with the mouse, then right-click. This will open a box that will allow the user to relabel the beat. It also has a button labeled Mark Area. Select Mark Area. Select the last beat in the block to be relabeled and click on it. Next, right-click on this beat. The Mark Area button has now changed to End Area. Click on it.
The Show saved strips option can also be set in this screen. Here, a different background color is given on the page location where a strip was saved.
12.3.3 Changing the end of tape in Trends When the Holter recorder isn’t shut down BEFORE the Holter leads are removed, you may have a lot of artifacts at the end of the recording. It is best to remove those artifacts to reduce editing. For C3000 users, this is made easy because the scanner will jump to diagnostic view at the end of the scan to show you the end of the recording. Here you can step back to the last clean beat and exit from there.
12.4 Diagnostic View The Diagnostic View in trends is similar to that in Analyze. The eight-second strip is displayed with a 30-second event strip beneath it. Beats are labeled and R-R intervals measured as in Validation and View Saved Strips. If the user feels that the system has missed a beat, the beat may be inserted by the following method. First, click on the detected beat to one side of the missed beat. Next, press the Insert Left or Right button, as appropriate.
Go To Time will allow the user to position the ECG data at a specific time. Shift Beat will move the marked beat cursor forward or backward one beat at a time. Next Arrhythmia will shift the ECG display to the next ectopic beat in the direction indicated by the selected arrow. Measure HR/RR/PR/QT allows the user to measure the selected interval as done in Analysis. Exit will return the user to the Main Menu. Relabeling block in diagnostic view This function was previously limited to page view, but in v2.
Note the gray line on the arrhythmia graph marking the start of the block. The block is now marked and can be relabeled after another right mouse click. Notes: - You can also mark a block in page view as is explained in 4.6.1 - The duration , rate and other properties of marked afib and aflutter blocks are reported in the final report when the Afib/Aflutter report option is checked.
Zooming in/out In all diagnostic type screens ( screens with a grid as background), it is possible to change the screen resolution by hitting the ENTER key.This is especially use full when measuring. The enter key toggles between zoom in, -out and normal.
2.5 Search View Search view allows searching for multiple occurences of an ectopy. They will be displayed page by page with each page containing up to 12 examples of the ectopy. You can also use this tool to review the data for erroneous events, then use the Page and Diagnostic views to make appropriate edits. The first time you enter the search view, you will be requested to select an ectopy to search. Do this by clicking in the search event window. The selected ectopy will be highlighted.
12.5.1 Notes on search 12.5.1.1 Start position of search By default, searching starts from the start of the tape but can also start from the current trend position. The current trend position is the position of the cursor in the Main Trend screen (time) before leaving it. This time does not change when you search through different pages or page to other trend pages in Page View. 17.5.1.2 Changing beat classes In the search window or after double clicking in diagnostic view, a beat can be relabeled.
To see details on the small bins, you can increase the gain (or decrease the scale) in discrete steps, using a spin button control. Notice also that the selected bin is not only marked by a different fill color, but also has a RED tip pointing to the bin. This is important as on very small bins the fill color of the bin can’t be seen. The histogram displays either all RR intervals or all RR ratios. Selection, of which is determined by the beat display radio button.
12.6.1 Sequence filtering A very important new feature in v2.10 is to apply filters to the RR interval and the preceding interval. The intervals or beats that will be inside a bin also depend on the applied filter. There are many cases when you only want to see certain beats and also cases when you want to impose a category on the preceding beat. To achieve this you must change the beat sequence in the dropdowns. The above shows the bins after a Normal-SVE filter was applied.
12.6.3 Relabeling a beat or bin(s) When you click on the re-label box or use one of the re-label shortcut keys, the following message will come up. Matching beats: Go trough all selected bins from start to end and look for beat similar to the current one. Relabel all matching beats to the new class. This function is similar to the match possibility in template editing. All beats: Re-label all beats in the current bin(s). Current beat: Re-label the current beat only.
12.6.4 Editing RR bins Edit occurs selected bins brings editing capabilities to the RR bins, similar to those in template editing. The bins now are composed of beats with similar RR intervals and classes (when filtering is applied) rather than the template number. When you click on ‘Edit Occurs Selected bin’ you will see a screen with 20 occurrences, similar to the template occurrence screen.
12.6.5 Inserting and shifting beats Using the Edit/Add R-peak button it is possible to move the position of a beat or to insert a new beat. Just move the caliper to the new beat position or to the position where you want to insert a beat. Then click ‘Shift RPeak’ or ‘Insert RPeak’ Quick insert 12.6.6 Quick Insert methods When you hold the shift key and click on the strip, the scanner will go to insert mode and put the caliper on the strip at the position you clicked.
After inserting the beats all intervals are correctly inserted. 12.6.7 Poincarre Graphs Just click on the ‘Graphs” button to view the patient’s ‘Poincarre’ graphs and details about the time domain HRV variables.
12.7 Enhanced ST Analysis When you enter from the Main Trend screen through the tabs, you will be positioned at the current time in main trend. If this time happens to be inside an ST event you will get the message Event xx on channel xx Duration x.x min. If you are outside an ST event, you will get the New Event message. This means that at the current position in the ST trend, a new event could be created, but currently no event is present.
12.7.1 ST Trend An enhanced ST event is a place in the recording with an abnormal ST event for the analyzed patient. ‘Abnormal’ in this context does not necessarily mean an ST deviation; it means ST levels that are different than the patient’s normal ST measurement. What this patient usually has is defined as the ST median over the whole analysis. This value is determined when tables are calculated and is visualized on the trend as a red line. In this example, the patient has a small ST deviation.
12.7.3 Adjusting the ST Points in an Event The three enlarged beats above the ST events are 20 beat-averaged ECG beats of the start, maximum and end of each ST event. The ST deviation is re-measured on the enlarged strips at beginning, maximum peak and end time, and the deviation from the baseline and median is given. One would expect the median deviations of the beginning and end values to be 1.0 mm for 1.0 mm thresholds and 2.0 mm for 2.0 mm thresholds.
12.7.4 Enhanced ST Options When you have many ST events on different channels, validating ST events can be difficult, since event one might be on channel 1, event two on channel 2 and event three could be a high-level threshold. The enhanced ST Options screen allows you to set the search criteria for next and previous events. By default, a search is done on the Selected Channel only and the threshold is set to Both Thresholds.
12.8 The QT Trends The QT Trend screen can be entered directly from the Main Menu or through the Select menu in trends. If you enter from the select menu, you will be at the same position in time as you where in the Main Trend screen. The screen has different trend graphs. HEART RATE: The top graph is the min/max Heart Rate Graph.
12.8.1 The QT Histograms/ECG Tabs Below the trends is a Form with two tabs. The tabs allow a selection between ECG View and QT Histogram View. Click on the tab to select. 12.8.1.1 The QT Histograms The QT histograms show the QT distribution in the current hour or over the whole tape (24 hr). There are always 10 bins in each histogram. The start of the first bin and the width of each bin can be set in QT defaults.
12.8.2 Validating and Editing QT Validating QT is done by searching the tape for possible invalid QT values while superimposing the QRS complex. 12.8.2.1 Searching for Bad QT Values You can superimpose forward and backward through all beats that are used for QT analysis by clicking on the left/right arrows under the superimposed beat window. While superimposing, the actual QT values are marked on the superimposed beat.
12.8.2.3 Editing QT Values Once the bad QT value is found, you can delete the beat from QT analysis or edit the QT measurements. Deleting means that the beat is marked to have an invalid QT, but is still used for arrhythmia analysis. The Reject QT button below the superimposed beat deletes the current QT beat. You can also permanently change QT values by re-measuring QT. Each QT point has a bar associated with it that can be moved with the arrow keys. While moving you will see the QT values change.
12.8.3 QT Options Included Beats in Bins The QT bin defaults allow you to set the beats that are included in the QT bins. This allows inclusion of SVE, VE, or Paced beats in the QT analysis. Minimum T Height If you notice invalid, frequent QT intervals due to small T-waves, increase minimum T height to eliminate these beats from the analysis. If you notice long gaps (white space) in the QT graph, try decreasing Minimum T Height.
12.9 12-Lead View True 12 lead view is available when working with a true 12 lead recorder. When analysing from a true 12 lead recorder you can select 3 channels for analysis during analysis setup by placing checkmarks next to the channels you want to use. Once the analysis is started you can no longer change your decision and the rest of the analysis is done like any other 3 channel recording. From trends, the true 12 lead display looks like the above screen.
If you are using a 3 channel recorder the 12-lead screen is still acessible but here the scanner assumes that you placed the electrodes using an orthogonal (XYZ) position as described by Frank. A warning message at the bottom of the screen warns you that you are loooking at derived rather than true 12 leads. Note that export is not possible from derived 12 leads and that the gain may not be precise either.
13.0 PROFILES Profiles are used to customize different aspects of the scanner. All profiles are presented in one dialog with several tabulated forms. Each profile has a form corresponding to a type of profile. The report profile which is one of those profiles will not be discussed here as all information is available in the Report Printing section. (9.0) 13.1 Managing profiles On the left side of each profile screen, you will find the same set of buttons.
13.2 Analysis Profile The analysis profile sets up the scanner for analysis . The Scan Parameters Screen is accessible as part of the scan profile screen. The settings made here are included as a part of the scan profile and may be customized to fit scanning needs. In general, the default values should be sufficient. 13.2.1 Analysis Parameters Hours To Scan This informs the system of how many hours of data are expected to be downloaded from the tape or flashcard. The maximum number of hours is 48.
Fast VT Rate (bpm) This value affects the run length table only. Here VT runs are split in slow and fast VT runs. By default fast VT runs have a run rate above 100BPM (v2.0x value). In v2.10, this rate is made user definable. Minimum Peak Height (ms or pct) Minimum QRS peak height to accept a detected beat. The default value is 40% of the average height of the last two Normal beats. Select Page Down for 20% or Page Up for 60%.
Sets the VE Dead Time, which is the period after the beat where detection of a VE beat is off. Default: 0.3 seconds R on T sensitivity (ms) This value (in milliseconds) sets the time after the t wave top where the r on t zone starts. A VE that falls between this point and the end of the T wave is classified as R on T. Increase this value to count more R on T’s. Decrease if false r on t‘s are counted. Note that this value affects future analysis only.
13.2.4 Auto-Save Strip Options Here you can define how many strips that the scanner needs to save automatically. 13.3 User Profile The user profile let’s the user set the way things are represented on screen and whether or not the analyzer needs to show detected arrhythmia’s (C3000 users only). Analysis preferences and Analysis Stop Criteria are also explained in section 4.2 The Analysis Option screen. 13.3.
13.3.2 Display Preferences Most of the options here are also available in the menu sections in Trends. The options displayed will always override the settings from the Trend menus. You should see those settings as temporary changes only, as they remain only active as long you are working in the trends module. At Trend start the user profile will reset them. Trend/Scan Resolution: Sets the initial size of the trend and scan screen.
13.4 The recorder profile The recorder profile is used to assign physical recorders and locations to a single button. Unlike all the other profiles recorder or device profiles are stored locally as they refer to devices connected to the local computer. In the above recorder profile you can see that there are already 4 buttons defined. On the left side of the screen you can see information on the button at position 2.
To assign a new button, set button placement on a free position and then select a profile from the selected profile dropdown. Let us assign a VX3 recorder to button position 5. Set button placement on Position 5 and with the selected profile dropdown select VX3. Next to button text, you can fill in any text you want. This text will appear on the button. The recorder type will already be filled in by selecting the profile, but the location still needs to be set.
When clicking on the ‘Set Fields’ button, you can specify which of the available information needs to be passed to the demographic info. Which fields are available and which fields need to be used depend on the recorder and on your operation procedure. Note that rather than updating the current profile, you can also save a new profile. This profile will then be added to the profile list drop down.
13.5 The account profile The account profile is useful when Holter analysis needs to be performed for different accounts with different needs. It is also understandable that the geriatric division of a hospital will have different requirements for the analysis than the pediatric division. Those differences do not limit themselves to the analysis parameters but also for the requirement of the report and maybe for the demographic information that they want to preserve with the Holter analysis.
the patient file. In this case an extra file will be generated with 24 extra fields with 8 of them to be used for long fields with lengths up to 100 characters. The other fields (first 18 – top of the page) should not be more than 25 characters long. Those limitations are there because the extra fields will be printed as part of the cover page and need to fit in the space available there.
14.0 Exporting ASCII Data 14.1 ASCII Data Export The cover page and all tabular information can be output to an ASCII file so that other programs are able to use this information. ASCII data is output as a text file with fields separated with commas or a CRLF code. Which files need to be included is setup in the ASCII export setup screen that can be accessed through the Patient File/Export Data menu.
Once generated, the current PDF file can be viewed from the main menu.
15.0 Admin Functions Admin functions can be setup through the configuration menu when you have administrator rights. This menu function will not be visible in the configuration settings. On a freshly installed program you will have administrator rights, but if you have different users on the same machine, it might be wise to protect more critical settings from less experienced users and not give all users administrator rights. 15.1 Program Defaults 15.1.
Enables Time Outs: When the current user no longer uses the current program for a specified time, the system will be locked. A new log on is required before analysis can be continued. Note that only users defined in the manage user screen have the possibility to unlock the system. Force the password to change every x days: This option is required for extra security.
15.2 Catalog Maintenance The catalog is a database that contains information about the patients that are available in the central patient directory. It is updated each time a patient is checked-in and out of the system or when a new patient is created. The catalog maintenance screen allows you to check the status of the catalog and allow you to create a new catalog in the event you suspect a catalog problem. Here you can also release files that where checked-out by a user but not checked-in.
15.3 Manage Users Here you can create different users for the system. A freshly installed system will not have any users defined, so if you want to setup the system for different users or passwords you need to add an admin user here first. Only then will the system allow you to checkmark the enable users/passwords box from program defaults. System rights There are two kinds of users: Admin users that have the right to do anything on your system and all other users.
16.0 Changing the password Assuming you have the system setup for users /passwords with an admin user defined, a login screen will come up when you start the scanner. Here a correct user name and password need to be filled in. The first time this login comes up, you need to supply your Username as the initial password. The system will then recognize that it is the first time you are using the system and allow you to change the password.
APPENDIX A – Heart Rate Variability Heart Rate Variability measures the variability of the heart rate. It has been suggested that victims who survive a first heart attack and have very little heart rate variability, are more prone to have a heart attack in the future. The details of HRV theory may be found in a variety of research journals and medical texts. It is left to the physician to decide what constitutes significant HRV.
take a bell curve shape. The narrower the bell curve, the less variability, while a broader curve signals more variability. Multiple bell curves, or multiple peaks on a curve indicate tendencies to focus around different rates. When the graph is displaying the N-N ratios, the HRVi Time domain graph will look slightly different. When there is no change or very subtle changes in rate, the ratio of one R-R interval to the preceding R-R interval will be close to 1.0.
APPENDIX B – Paragraph Templates The new paragraph screen with support for templates has several additional buttons on the bottom of the screen. The new buttons in the center allow the selection of the default text or the use of a paragraph template to create the text. Currently the default generated text is shown. In the upper right corner of the bottom edit window it shows the template number and id, used to generate the text or default text when there was no template used.
Generating a paragraph template. Click on ‘create template’ to switch to edit mode. This will erase both edit boxes. The bottom box is the place where you need to enter text and variables. While you are doing so, they will be translated and displayed in the top window. Type F2 to get to the variable list. This list contains two columns. The first is a 7-letter mnemonic used to describe a variable. As an example PTLNAME is the mnemonic for the patient’s last name.
After typing in the template you can save it by clicking on ‘Save template’ This will popup a dialog where the top line is already filled in with a sequence number, this number is the first available paragraph template id. On the second line supply some info for what or who it is used. Click OK to save the template. The above example will be saved as ‘PRTPL003.
Note that the upper window still contains the default text and that items missing or incorrect in the bottom text are highlighted. Things that are the same like min and max heart rate are not highlighted although they are completely differently phrased. You can still add comments, copy and past stuff from above to below and of course save the paragraph.
Here is an a more fully written template ‘Pace with no ST’ 135
APPENDIX C – TRANSLATIONS - NON ANSI SUPPORT The C3000.ini and Maintext.ini the English text that is used in the program. By replacing this text with another language, it is possible to translate all on screen text. However countries that use characters not supported by the ANSI character set cannot display all text correctly (even though text may appear correctly in the .ini files). To add support for those countries (like east European) you need to add a few lines to the C3000.
