Full Disclosure ECG Holter System Changes in software version 4.01

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1 Table of contents Full Disclosure ECG Holter System Changes in software version Improvement in the analysing algorithm Atrial Fibrillation...2 Atrial Fibrillation in SW Atrial Fibrillation in SW ST Levels...3 Example - ST in SW Example - ST in SW QT Levels...4 Example - QT and QTc in SW Example - QT and QTc in SW Heart Rate - HR...5 Heart Rate (HR) in SW Heart Rate (HR) in SW Templates...6 Templates in SW Templates in SW New Features Database New Filtering options in the Database window Exporting Records Importing Records Archivation on CD or DVD Recorder Status Exit menu New ECG editing options Editing of Atrial Fibrillation Deleting whole groups of events Templates menu USB Interface Status Control Box Question marks Setting of the Events View Parameters New parameters Systolic and diastolic pressure limits Automatic analysis after scanning Service Errors corrected Database problem with two-channel recorders Pacemaker Records Display problems with patient names Miscellaneous changes Interpretation of record status types Multilanguage Translator New languages available User Manual Memory Requirements - Recommendation Installation USB problems...15 Page 1 of 15

2 1. Improvement in the analysing algorithm 1.1 Atrial Fibrillation Atrial Fibrillation in SW 4.00 Occasionally in SW 4.00 atrial fibrillation was not detected correctly and was not displayed. Atrial Fibrillation in SW 4.01 Atrial fibrillation is now correctly detected and displayed in SW Page 2 of 15

3 1.2 ST Levels Example - ST in SW 4.00 Sometimes the ST levels showed some deviation in SW Especially if one of the two channels that the software used for ST-calculation was too noisy (here Channel 3). Example - ST in SW 4.01 ST level is corrected by SW Page 3 of 15

4 1.3 QT Levels Example - QT and QTc in SW 4.00 Sometimes the QT and QTc levels showed some deviation in SW 4.00 because of noise, or some non-detected beats. Example - QT and QTc in SW 4.01 The QTc level is corrected by the new software. Page 4 of 15

5 1.4 Heart Rate - HR Heart Rate (HR) in SW 4.00 Sometimes if one channel of the recording was too noisy the heart rate was not calculated properly at all in SW (see Channel 1) Heart Rate (HR) in SW 4.01 Now the heart rate is calculated correctly in SW 4.01 because the decision of the software is adaptive, which means that the heart rate is calculated automatically from the best two channels i.e. where the ECG signal is adequate (here Channel 2 and 3). Page 5 of 15

6 1.5 Templates The software s algorithm now classifies heartbeats more precisely which means that there are less beats classified incorrectly and the number of templates is considerably reduced. Templates in SW 4.00 Here you can see that the software created 21 templates. Templates in SW 4.01 The new software creates only 6 templates, which means that they can be overviewed and checked in less time and with less effort. Page 6 of 15

7 2. New Features 2.1 Database New Filtering options in the Database window New: Filter by date New filtering options The Latest record s date Record Location Actual Database Location You can set a filter on one, two, or three channel records and records with PM or ABPM. You can filter records based on creation date, too: you can set whether you want to see only records created today, this week, or this month. The Patients list contains only the names of those patients who have a record satisfying one of the filter conditions. The Patient s Recordslist shows only the appropriate records of the patients currently visible. By clicking the Default button you can restore the default settings of the filter conditions (to see all patients and all kinds of records). There are two new columns as wel: The latest record s date and Record location. The latest record s date shows the date of the latest record of the patient. The record location column displays the location of a record which can be found on a hard drive, or a CD/DVD for example. Page 7 of 15

8 2.1.2 Exporting Records The new export and import functions are useful if you have problems with a record and would like to send and show it to someone else. Using the export function you can easily make a copy of a record and send it for revision to another specialist for example. These functions are designed to help you manage smaller amounts of data at one time. Export Record isa new feature of the software which is similar to a Save as function i.e. the exported record will not be removed from the database only a copy will be created in the desired location. By choosing Database/Export Record you can save the currently loaded record to a directory of your choice. This directory can be on a network drive or on a removable storage medium as well (for example on a pendrive). And of course you can write your exported records on a CD or DVD and later import them for example on another computer. The exported record s filename wil contain the first name, surname of the patient, and the patient s ID separated by underscores, for example: Firstname_Surname_ID _DATE hdf Importing Records You can load a previously saved(exported) record from a directory of your choice (for example from a network directory, a CD/DVD, a pendrive, etc.). The newly imported record is automatically saved in the currently selected database Archivation on CD or DVD This function was designed to help you manage large amounts of data at one time. Use this function if, for example, you have run out of space on your hard drive. By using this function you can free up the space occupied by old records. The program will collect records starting with the oldest one into an archive database which you can write on a CD or DVD. You can specify different sizes for the archive: 650MB, 700MB (CD), 4.7GB (DVD), and custom size which can be adjusted up to 9GB (Double Layer DVD). If a record has already been archived the program will ask for the appropriate CD/DVD if you want to load the record. Of course an archive CD/DVD may be used as a standalone database, as well. Archivation is irreversible i.e. data will be physically moved to the archive Recorder Status In this menu you can have a look at which recorder has been handed out to which patient and when. So you can easily keep track of which patient has got which recorder Exit menu Here you can exit the Holter program. If you have made changes on the loaded record, the program asks you before exiting whether you want to save the changes. 2.2 New ECG editing options Editing of Atrial Fibrillation Editing of AF has been made easier in the new software. The percentage of atrial fibrillation (AF) is now displayed on the left hand side of the toolbar. It is advisable to turn on only one channel (one of good quality) before editing atrial fibrillation periods in order to be able to see a longer strip of ECG on the screen. (See Chapter in the User Manual on how to turn on/off a channel) Page 8 of 15

9 You need to select Full View from the View menu and either Full Disclosure or Rhythm/Atrial Fibrillation from the Events menu. The program indicates the AF periods with a different colour. Now it is possible to edit atrial fibrillation periods (AF) in two ways: Editing a whole page of AF using the keyboard: Use the PageDown and PageUp keys on the keyboard to move forward or backward in the ECG record. You can use the Delete key to delete the whole AF block that is currently visible on the screen. You can mark the currently visible ECG strip as AF by pressing the Insert key. Editing smaller periods of AF with the mouse: It is possible to mark new AF periods or you can delete existing ones by moving the mouse and continuously pushing the left mouse button (according to the method used in Windows to select a text). The changes you make on AF periods are immediately visible since the percentage of the whole evaluated strip changes on the left side of the toolbar (ex. AF: 99.57%). Help Percentage of AF Page 9 of 15

10 2.2.2 Deleting whole groups of events In the new software you can find a new button on the toolbar: the purple Delete Event Group button. By pressing it you can delete a whole group of events at once. This button deletes the currently selected event group in the Events menu. Before deletion of SVE group: Delete Event Group After deletion of SVE group: Delete Event Group Page 10 of 15

11 2.2.3 Templates menu Selecting single forms by clicking with the left button of the mouse, the program lists the possible classification of heartbeat-types in a popup menu. This menu will always appear on the right of the mouse and the highlighted template will always be centered. Clicking with the right mouse button now starts Fast Playback of a Template. Number / Percentage A red arrow indicates the place of QRS if you click on a template. There is a new button on the toolbar: the Number/Percent button. You have the choice to display either the number of beats in a template or the percentage of beats contained by a template compared to the number of all classified beats, if you click this button. Page 11 of 15

12 2.3 USB Interface Status Control Box USB Status Control Box There is a new item on the menu bar: the USB Interface Status Control Box. The program indicates with the colour of a small box in the upper right corner of the screen whether the USB INFRA interface is functioning properly. If the box has green colour, everything is in order, the connection and the device are working properly. If the box is shown in red colour, please check if the USB INFRA unit has been properly connected to the USB port of the computer and whether the software driver of the device has been installed in an appropriate way. By hovering the mouse over the box you can get detailed information about the status of the system: Page 12 of 15

13 2.4 Question marks At various places of the program you can find yellow question marks that invoke the corresponding chapters of the user manual. These question marks refer to the following important subjects: Merging Similar Templates Using of the ECG Rulers Editing of Atrial Fibrillation Setting of the Events View parameters 2.5 Setting of the Events View Parameters You can now change the order of events displayed in two ways. Help Zoom By clicking on the Zoom button on the left side of the toolbar you can display the checkboxes beside the individual event types. If you remove a checkmark from a checkbox the appropriate event s row wil not be visible after you close the settings with. If you want to change the order of event types, you can move a certain event row up or down by clicking the up and down arrows next to the checkboxes. Checkboxes The other way is using the menu. There is now a new menu item in the Settings menu. The Events View menu item offers the possibility to change the list of events displayed when selecting the View / Events View menu. You can add and remove events and you can change the order of their appearance on the screen by using the up/down arrows. If you click the Default button, the default settings will be restored. 2.6 New parameters Systolic and diastolic pressure limits You can now adjust the systolic and diastolic pressure limits during the day and night in Settings/Parameters/Miscellaneous Settings. Automatic analysis after scanning Systole and Diastole limits day and night Page 13 of 15

14 2.6.2 Automatic analysis after scanning If this option is turned on, the program will run an automatic analysis on every record you scan from the recorder. If this option is turned off, the program will not automatically analyse the record after scanning, the record will be saved with Temporary (T) status. When you first load this record from the database the analysis will automatically run and the record will be automatically saved as Pre-Evaluated (P). It is useful to turn this option off if you want to quickly scan more records at the same time and don t want to wait for the analysis to run, for example if there are lots of patients waiting. 2.7 Service If you choose Service from the View menu you can see which version of the program analysed the loaded record last time and which firmware version was used by the recorder. Recorder version The record has been analysed with this SW version 3. Errors corrected Several errors have been corrected in the new software version, which include: 3.1 Database problem with two-channel recorders There was a problem with two-channel recorders. If the patient had a longer ID and the record was scanned, sometimes the program stored the record under a diferent patient s name. This has now been solved. 3.2 Pacemaker Records The old software was sometimes unable to remember if the patient had a pacemaker and the recording did not show any pacemaker spikes. The new software corrects this problem. 3.3 Display problems with patient names Sometimes the surname of the patient disappeared when scanning his/her record from the recorder and only the first name remained in the recorder. This problem occurred only in the case of two-channel recorders. The new software can now handle this situation correctly. Some characters were not displayed correctly especially in Czech language (ř,ě,č). This has been fixed, too. 4. Miscellaneous changes 4.1 Interpretation of record status types The way the program interprets record types has changed. This is now automatically handled by the program. Temporary (T): It is a kind of record that has not been analysed automatically after scanning. If later you load such a record, the program will automatically analyse and save it, i.e. it becomes Pre-Evaluated.(See Chapter of the User s Manual on how to turn on/off automatic analysis after scanning) Page 14 of 15

15 Pre-Evaluated (P): It is a type of record that has been automatically analysed by the program and on which no changes have been made afterwards. (See Chapter of the User s Manual on how to turn on/off automatic analysis after scanning) Evaluated (E): It is a type of record that has been automatically analysed by the program, interpreted (i.e. changes have been made by an expert) and saved. 4.2 Multilanguage Translator In the new software the Multilanguage Translator is still available but its usage is limited. That means if you translate the software into a new language and/or you make changes in a language you will have to send the appropriate language file back to the manufacturer for authorization. A modified language file can only be temporarily used until it is approved by the manufacturer. 4.3 New languages available You can translate the various messages of the program into 4 additional new languages: Chinese, Arabic, Slovak, and Greek. 4.4 User Manual The User Manual is now in Portable Document Format (PDF). Adobe Reader needs to be installed on your computer to be able to display the user manual. This program can be found on the installation CD and will be installed together with the Holter software. 4.5 Memory Requirements - Recommendation The minimum memory requirement is still 256 MB for running the program but the recommended size of RAM for safe running is 512 MB. Increasing the amount of RAM in the computer will considerably speed up the analysis. 4.6 Installation Installation of the Holter system has become easier. If you connect the USB INFRA device on another USB port on which it has not been installed before, the operating system will no longer ask you for the installation CD (the location of drivers) but will install the drivers automatically. The whole installation process will require fewer steps as the installation of the hardware is done simultaneously with the software installation. 4.7 USB problems In rare cases Windows might not recognize the USB INFRA interface, it looses contact with it. Consequently, the interface does not work properly. The reason for this problem may be the sensitivity of the power supply of the PC and/or connecting/disconnecting an other USB device. If you should experience such a problem (the color of the USB Interface Status Control Box changes from green to red) please unplug and then plug in the device to make Windows recognize it again. This is a Windows-specific issue, Microsoft has been investigating it. You can find articles about various USB problems on the Microsoft website: Page 15 of 15

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