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Galix WinTer Holter Analyzer User`s Manual

1. 1 1 1 3 4 4 1 5 1 4 4 1 4 4 4 14 14 4 44 1 1 4 4 4 sari n Iro state pe inrcr d rir uer mins ja cd mie d m dea son nd i 14 4 4 4 4 4 4 4 4 4 4 44 4 4 1 4 418 44 4 4 4 4 4 44 4 4 4 44 4 4 1 1 4 4 1 4 1 4 4 448 4 Jt 1 4 a 5 4 4444 4 4 1 4 4 4 44 4 1 I H 1 144 4 44 4 1 4 4 1 44 4 5 41 4 1 1 1 4 1 4 4 4 4 1 4 4 1 4 1 4 4 14 44 4 1 1 4 4 4 4 4 1 4 4 4 1 4 4 4 4 4 4 1 4 4 4 5 4 4 4 4 4 4 4 4 1 1 1 i 1 11 1 EE 1 81 17 1589 1 1 0 01 B 3 31 4 5 1 apap ial sd CCOR estat 1 1 sh parsi 44 4 ON O S SSO 1 44 4 1 4 4 4 M L siena LEA So m Rs ad aen eae eee ez zz en Lom s en d 03 00 00 1 Current time Bar Graph When we click on any of the parameters in the table the lower part of the screen will display a bar graph corresponding to the selected classification e g Beats VE SVE ST X Axis Time Y Axis Values of the selected parameter Pacemaker Mode Hourly Table In case the study was performed to a patient with the GBI 3SM Holter Monito
2. BIOMEDICAL INSTRUMENTATION INC Galix WinTer Holter Analyzer User s Manual 2555 Collins Avenue Suite C 5 Miami Beach FL 33140 U S A Tel 305 534 5905 Fax 305 534 8222 INDEX LESS DE RO UO LO D eec 4 1 CORRECT EEECTRODE PEACEMEN lu 4 2 SITARDWARE E Deme RID A S DUE 5 2 SCREEN HIERARCHY 4 5 aate et eoa Tre auc e vaa Ft EN EE Ix OE VUE EYXVRE VE oue vedi ae ee eeu ten Fave See Gee as vas suae oves 6 3 OPENING THE HOLTER ANALYZER 5 7 3 Le SCREEN CONFIGURATION dep MIA MEE 7 FANAN MENU 9 TI INEA EATE DEEN 9 S CONFIGURATION Cre oe ea eU a ue 12 5 Ts PHYSICIANS INSTITUTION INB PIEB FOLDER 13 ERO ORO RAS SIS NETAS VATO S E
3. Pe Aeee PA e ere e ee PA er e e dpa en 922028 2 125525 8 pre eedah a Screen Description This screen contains a total of 20 lines each one of them displaying one minute of ECG signal therefore each scan page displays 20 minutes of the recorded signal The real time hh mm for each line is shown on the left of the screen Changing the current channel Galix Holter Analyzer WinTer Operation Manual 45 To change the current channel simply click the the corresponding channel button If the user clicks on the Ch 1 2 3 button all three channels are displayed in a 10 minutes per screen format 11 1 Full Disclosure Scroll Commands The Full disclosure toolbar allows the user to scroll the ECG display either automatically or manually it E Pl By clicking on the Up Down arrows the full screen will scroll backwards forward automatically By repeatedly clicking on these arrows the scrolling speed will change By clicking on the Pause command the one between the vertical arrows the scrolling will stop The Left Right arrows will make the display to skip to the previous next page 11 2 Full Disclosure Edition Commands Some of the most important features available at the Full Disclosure section are the abilities to e Access the normal 8 seconds 25 mm seg display of any beat by simply double clicking on it on the full disclosure screen Re classify any beat directly from
4. VER 58 10 ITY 60 16 1 TIME DONDAINOANOAL YS IS 96 dne So vA aure Inde dodici tu RD tide 60 16 2 FREQUENCY DOMAIN ANALYSIS c0ccccccsscccsccesccscccsccesccscccssscscssacescsecccsacesssecccsacesssecccsacessseccesscessseccesscescssccesscessseceees 61 PF STOUR EY TABLE 5 re edt eei Saee eo Ede 67 18 RETAINED STRIPS 70 PRIN FING REPORTS eene ee eoe ed even eae eaa d oue ee kv tu ve veu cov aa eve ea eve eva y eva ae yov 71 20 RETRIEVE STORED PATIENT 1 76 5 RT Uu A PE esL ED D C M IM ICI m 76 255 78 ZFS ERASE PATI NT S 79 22 STORE PATIENT INFORMATION 80 23 MORE THAN 24 HOURS RECORDI
5. z 1 ne phy 2j NES s MM UU 6 J A 4 38 T65 742 727 T27 T18 766 758 726 750 758 750 727 735 734 465 898 711 735 765 750 782 843 907 882 899 898 828 T66 742 T8 60 82 182 83 78 79 182 80 79 180 82 182 81 81 30 66 84 581 78 80 76 T1 66 68 66 66 78 180 mue Strip length 24 seconds 3 strips of eight seconds each one If for example at the moment of saving a 24 seconds strip the user gives it a label the same will be applied only to the first 8 seconds strip while the remaining two strips will be unlabeled 9 4 Printing Strips The user will be able to instantly print the ECG strips from the screen The quantity of strips to be printed depends on the selected length see Changing Strip Length Clicking on Print Strip will begin printing the amount of ECG strips indicated by the user Prnt ECG 9 5 Interval Measurement When selecting the Cursors button two vertical bars will appear on the 8 seconds strip screen that will allow us to measure time intervals Galix Holter Analyzer WinTer Operation Manual 37 The user can select any of cursors by clicking on it Once selected the cursor can be moved along the strip by dragging it with the mouse left button kept pressed or by means of the horizontal arrow keys The following screen will show us both bars being selected the left one Notice that a new box appears
6. 305 534 5905 Fax 305 534 8222 E mail info galix gbi com Galix Holter Analyzer WinTer Operation Manual 83
7. Address Physician s address Telephone Physician s phone number Fax Physician s fax number 5 1 1 New Institution In the Institution Information panel located in the Inf Physician Institution folder you can find the following icon When clicking on this icon the lower part of this window is deactivated to allow the user to complete only the data of the new institution In addition the inscriptions on the icons are changed allowing the user to update the changes introduced by clicking on the save icon Galix Holter Analyzer WinTer Operation Manual 13 cons to save or cancel changes insuubonintarmall l 9 Institution Address ft Phone Physician Institution Info Physician Configuration Cancel Physician Information by Institution m LastName ies s FirstName psen Address Phone Z Fax Ho Deactivated section Delete Every time an institution is added the system will automatically add a physician by default called Test Physician This field cannot be eliminated since each institution should have at least one physician but can be renamed Once the information has been entered click on the Save button to store the data into the database or cancel this operation by clicking on Cancel The system will not save any cha
8. Manual Search With this option the user manually indicates the path where the information is located This can be done by typing the path directly into the space provided or by using the Browse button When this button is pressed a typical exploration window will appear from which the user can select a data source Once the folder containing the files is selected the user should select the Ok button Galix Holter Analyzer WinTer Operation Manual 19 fur Folder Select a folder Desktop 89 e BACNET 29 E uns Biomedical C DVD CD RW Drive D 3 Shared Documents 822 GALIX s Documents 4 JORDAN s Documents Bg 2 My Network Places Cae Note Pressing the symbol found in front of each disk unit allows the user to view all the folders contained in each disk unit To select one of these folders the user should left click on the one desired and then press the OK button Confirm or cancel changes Finally the user will confirm the changes to update the database by selecting Apply Clicking on the Exit icon will display the following message Holter Configuration Save changes w omen If the user selects Yes the program will save the changes and exit the system If the user selects No the program will exit the system without saving the changes Selecting Cancel will go back to the previous screen Galix Holter Analyzer WinTer Operation
9. Reducing the filesize of a study stored in complete format changing to summary format To reduce the size of a study click on the Reduce Study button the study will then be stored in summary format 20 2 Study selection To select a particular study the user should click on the study View studies retained If there are retained studies these can be viewed by selecting the View Retained icon in the toolbar Fetained The program will then search through the retained patients and display them on the screen View stored studies and Reprocess icons will no longer be available The Process icon will be available as it is the only function that can be performed Selected icon Fa Open Patient Holter Retained VLP 2 Address 2555 Collins Ave Phone 305 534 5905 D O B 1 10 1971 Age Sex C Female amp Male Date Stattime Hows Referredby Physician Indications Medications OOo o O 10 22 2008 00 00 24 Doe John Processes the study of the retained patient Galix Holter Analyzer WinTer Operation Manual 78 21 ERASE PATI ENTS The user can erase a patient s record and all the reports belonging to that patient by selecting the Open option Open Patient in the Main Menu and clicking on the Erase button bottom left part of the screen The program prompts the user to confirm the deletion of the patient s records The following screen w
10. From now on we will refer to this screen as the Main Menu Galix Holter Analyzer WinTer Operation Manual 8 4 MAIN MENU From the main menu the following options are available Connect Retain Electrodes Backup c WinTer Holter Analyzer Biomedical Instrumentation 4 1 Toolbar Options Connect Open Retain Electrodes Backup ir A 1 et IT cas Connect Allows the identification of each memory card containing the patient data before recording the 24 hour ECG signal If desired this option enables the Patient Diary printing New Decompresses and analyzes the ECG recordings stored in a memory card Open Allows visualization of the analyzed studies in either summary form about 400 Kb or complete form 34 Mb or studies that have only being retained Retain Decompresses the ECG signal recorded but does not analyze it Exit Kal This option is used to quit the program Galix Holter Analyzer WinTer Operation Manual 9 Quit Holter system Demo Run this option to process a demo signal in order to start getting familiarized with the program To process the demo signal click the demo icon located in the Main Menu toolbar The program will enter the New Patient screen explained in section 7 with the demo patient information New Patient Patient Information Date 11 7 2008 SH 00 Ad
11. Galix Holter Analyzer WinTer Operation Manual 2 112 FULL DISCLOSURE EDITION COMMANDS 46 I2 ARRHYTHMIA 5 252552555555545 54546 644056000646 0 MEE Eua SE CH 48 I2 855 eed lE 48 122 5 lu 49 123523 00 8 tex Rte eR eR di deb ttd at ud cd eb i El DR ELE 50 13 CATEGORIES 51 3 CH w c 51 1359 CHANGING THE CURRENT PEA T 255 DD a MOL 2 13 3 DETAILED VIEW OF THE BEAT uas dec EDUC MR somes 54 15 4 CHANGING THE BEAXTIABE I 5 06 sr e dus Rer M OM MR du UM DU tones 54 I4 S 56 I5 SIGNIFICANT EVENTS EDITOR 25 225206 Uo oe bou Ve va
12. If No is selected the system will remain in the current screen without modifying the stored information 7 7 More than six studies per patient This system allows a maximum number of 6 Holter studies per patient to be stored in the database If the program detects that there are already six studies it will check if there is another study with the same date and will ask the user if he she wishes to overwrite the study with the message shown previously But if a study with the same date does not exist then the following message will appear Nev Holter study Patent already has 6 studies stored Do you wish to delete any If the No option is selected the system will remain on the same screen If the Yes option is selected the Delete Patient Study window containing all the patient studies will be displayed ID 236566778 First Name Smith Last Name Jhon Physician Peter Ar 1 2005 alrauss Peter 2 16 2005 atrauss Peter Ar a5 mirauss Peter 12 21 2005 alrauss Peter 1341 2005 alrauss Peter Galix Holter Analyzer WinTer Operation Manual 28 The patient s information appears in the upper part of the window In the lower part all the studies with their respective dates processed hours and the physician who performed the study will be displayed The boxes on the left of each study are used to select the studies to be deleted in order to leave space for the new study Onc
13. WinTer v3 1 2 7 Microsoft Office 1 Ergo PS 7 Microsoft Works 7 Multimedia ECS ECG PS 7 National Instruments 23 7 Norton AntiVirus dm WinTer PS v3 1 2 l an Physio 28 Star a Physio Scan starte 77 User Guides and Manuals Physio 28 Internet Explorer MSN Encarta Plus Ww MSN Explorer 2 Outlook Express Remote Assistance Uninstall USB Reader SA2 e Windows Media Player F NES OW F XS OU All Programs Recyde Bin Alternatively you can double click on the Holter icon located on the Windows Desktop 3 1 Screen Configuration Initially the program will automatically control the screen configuration In case the user does not find the following recommended configuration 1024 x 768 large pixels Appearance Standard Windows Galix Holter Analyzer WinTer Operation Manual 7 The following message will appear Screen configuration x 600 Small Fonts or 1024 7668 i In order the screen to be displayed correctly please set the display configuration bo Press to exit Ehe system order to change the screen configuration manualy Press Cancel to continue When the option is selected user should manually modify the screen configuration before the program continues If the user chooses to cancel the action the system will continue with the program Next the main menu will appear
14. the Edit and Label icons on the toolbar will be deactivated as shown in the following figure Demo Patient 123456700 Morphologies Trend Full Morphol Significant Howl Retained Print aphics Disclosure Events Table Strips Mem Reclassify 12 3 Save changes If the user has made some changes and has not selected the Apply icon and wishes to do one of the following View the beats that have been associated to a particular template Exit the screen to see the Significant Events Next or the 24 hour Statistical Graphs Previous The system will then ask if he she wishes to save the changes Morphologies Important the user must take into account that changes made on this screen will affect the 24 hour statistical graphs the significant events already calculated and the heart rate variability Therefore the user must be very careful with any modifications We suggest that changes be made in the order of appearance of these screens first Morphologies then Morphology Categories and finally Significant Events Galix Holter Analyzer WinTer Operation Manual 50 13 MORPHOLOGY CATEGORIES Features t shows a detail of each one of the beats that formed a particular morphology Displays the eight seconds in which the selected beat can be found Accessing the screen From the Arrhythmia Morphologies screen Morphology Categories Demo Patient 123456700 Trend Full Morphol Significant
15. 00 23 CJ 2 Hourly Table 01 00 02 02 00 Retained ECG strips 2 D 04 00 08 00 06 00 Histogram and Long Term 29 3 PDF 07 00 16 00 00 Cascade Spectral Array Patient Data Cancel Note For good quality Full Disclosure printing make sure that the printer graphic properties have the option Use Raster graphics instead of Use vector graphics selected Galix Holter Analyzer WinTer Operation Manual 75 20 RETRIEVE STORED PATI ENT INFORMATION Features t enables modification of the patient s information t allows to review the patients analyzed and stored in Summary or Complete format e It displays Retained patients Accessing the screen From the Main Menu pressing on the Open icon located in the toolbar Open Patient Information _ 123456700 zi Last Name IT TRITT Optional Data Address 24 Smith Av Phone 4865 1097 D O B 1 10 1971 Ag Sex C Female Male Start time Hours Referred by Physician Indications Medications Bakup 9 07 11 2002 00 00 Test Physician Not Backuped 07 11 2008 00 00 9 Test Physician Not Backuped 11 07 2008 08 50 9 Test Physician Not Backuped iew stored study 20 1 Store patient files There are three ways of storing patient files In Summary form The user chooses to save only the files necessary to generate printed reports These files
16. 300 0 1000 0 0100 200 B 100 br ii 0 0 0000 0 00 0 10 0 20 0 30 0 40 0 50 0 60 0 0001 0 0010 0 0100 0 1000 1 0000 TP ms2 ULF CS BETA 1 67 15 79 22 56 11 00 2 051 0 351 Galix Holter Analyzer WinTer Operation Manual 63 Lorenz Graphic To watch Lorenz graphic press the following button Lorenz Plot Duration of Interval 2 1 ms 1500 1000 Hi 1 ms interval duration Spectrum on logarithmic scale graph on the right of the screen The slope of the spectral curve on logarithmic scale is another of the available parameters This one is derived from the 1 f infinity symbol that represents the 24 hour PSD and is associated with non linear phenomena present in biological systems but there is not enough information available on this subject The system calculates each graph averaging the 288 spectrums previously obtained Summary and Recommendations for the interpretation of the HRV frequency domain analysis Vagal activity is responsible for HF There are controversies with respect to the LF components some studies suggest that the LF expressed in normalized units is a quantitative marker of the vagal and sympathetic modulations and thus some scientists consider the coefficient LF HF as a Galix Holter Analyzer WinTer Operation Manual 64 mirror of the balance between the sympathetic and parasympathetic systems The interpretations of the low frequency componen
17. Full Morphol Hourhy Retained Punt Modules 7 t hus Lusclosure Events Table Strips Mer 16 1 Time domain analysis The figure below illustrates the type of graph the user will see when entering the Heart Rate Variability screen It consists of a histogram representing the time domain analysis of heart rate variations of the patient Demo Patient 123456700 Heart Nate Variability Anais Tine don Short i Trend Full Morphol Significant Retained Print Tim Te i LT aphics Disclosure Events Table Strips Mem west eso E Cursor Values Parameter SDNN ms HRV SDANN ms 85008 2 61 6 18 5 38 2 17 8 The time domain analysis of the HRV is based on statistical methods A series of RR intervals distance from two R wave peaks is obtained from the ECG recording From these only those intervals related to normal auricular beats will be taken into account Galix Holter Analyzer WinTer Operation Manual 60 A series of parameters calculated based on these RR intervals These parameters used to compare the different patient conditions such as resting sleeping walking and others with the purpose of evaluating the activity of the autonomous nervous system The parameters that the system provides are the following SDNN msec Standard deviation of the normal RR interval series It is an estimate of the Overall HRV Given that the Variance is mathemat
18. SVE count Print Disabled Channel This option enables the printing of the disabled channel even though the signal is too noisy Heart Rate Limits The user must select the desired heart rate which the system will use as heart rate upper and lower limits Galix Holter Analyzer WinTer Operation Manual 17 Printing The user can select the type of printing from color to black amp white Doc amp Print Enables Disables the automatic printing of a configurable report Report Pressing on this icon located in the lower left section of the Configuration Menu will allow the selection of the pages to be printed in the report Print Reports Holter Report Summary Detail 24 Hour Statistic Graphics Full Disclosure Channel m EF 5 IMorphologies Hourly Table Retained ECG strips Histogram and Long Term HR Y PDF Cascade Spectral Array Select the appropriate boxes in order to include the different pages in the report and press Apply when the selection is completed or Cancel if these changes are not desired 5 3 Data Source File folder In this folder the path which the program uses to find the ECG signal files for analysis can be found There are two ways of searching for the data path The first is automatic and the second is manual selected by the user Our Digital Holter Analyzer uses memory cards as a recording medium and a memory card reader as the interface
19. allow the user to view but not modify the information The advantage of this storage system is that the patient files take up to 600 Kbytes assuming the operator has stored 32 eight second strips The disadvantage of this storage system is that once stored in this way the data cannot be modified Galix Holter Analyzer WinTer Operation Manual 76 In Complete form The user chooses to save all the files generated by the Holter analyzer system together with the 24 hour ECG signal The advantage of this system is that the user can modify data conclusions and study reports The disadvantage of this format is that each patient study takes at least 34 Mbytes on the hard disk Patient Retained The 24 hour ECG signal for this patient has been decompressed and stored for future analysis Patient I nformation Patient files are organized by identification number in ascending order If a particular patient s last name is repeated the list of last names will show it only once but in the list of first names those that share a last name will be shown one by one Searching for a particular patient To find a particular patient the user can enter the identification number and the system will search the database to see if it can find a match For example In the following figure the user has only entered the number 12 and the system shows the first patient starting with that number and the other in ascending order 123456700 The user can
20. also click on the pop down arrow shown below and select the patient that he she is looking for 123456700 20535145 30333617 123456 700 123456 789 Another method consists of searching by the patient s first and last name Arrow that unfold all the ID s found in the Database The lower part of the screen shows all the studies performed on a particular patient a maximum of6 stored in the database Current study Date Start time Hours Referred b Physician Indications Medications 09 25 2008 00 00 9 Doe John 04 14 2008 00 00 Doe John Doe John Doe John 00 00 9 Doe John 10 14 2008 16 05 9 Doe John Erase Reduce Study View stored stu Reprocess cons that indicate if the current study can be modified or not Patient stored in complete format If when selecting one of the current patient s studies the View stored studies and Reprocess icons are activated then this particular patient study was stored in complete form and thus can be modified and reprocessed Galix Holter Analyzer WinTer Operation Manual 77 Important If the user decides to reprocess a stored study the analysis corrections and diagnosis will be eliminated It is like processing the ECG study for the first time Patient file stored in summary format If when selecting a particular study only the View stored study icon is activated then the patient study has been saved in summary form and thus this study can be viewed but not modified
21. beats detected within the 8 seconds graph will be labeled as follows Normal beat marked with a dot e Ventricular beat marked with a V Galix Holter Analyzer WinTer Operation Manual 33 Supraventricular beat marked with S Artifacts marked with an X Aberrant marked with an A Paced Beat marked with a P Heart Rate and R R Interval The Heart Rate measured in beats per minute and the R R Interval in milliseconds are displayed on the screen between two consecutive beats HR RR nterval Smith Albert 30333617 See ECG Save Strip ied Prnt ECG Gian Trend Morphol Significant Hourly Retained Prnt cds Ms M gt Disc ail Strips am lt se 229 i 711 719 710 719 735 711 1 679 680 86 84 83 84 cl be 88 88 4 x1 Eig ht i ye pn ES SA an ee 00 15 00 15 00 Imam One minute ECG signal Eight seconds strip In the one minute graph the user will see a red frame This indicates the position within the minute where the eight seconds are represented To change the current eight seconds ECG strip The user will be able to use the arrows of the keyboard to move from one side to another of the minute according to the following scheme Arrow Goes backwards 100 milliseconds in the signal gt Arrow Goes forward 100 milliseconds in the signal Arrow Goes backwards 2 seconds in the
22. by a red arrow Red Arrow that indicates the current beat in the morphologies category _ Patient 123456700 See ECG Strips _ X Save Strip Print ECG Pacer Trend Full Morphol Significant Howly Retained Prnt Modules Length stnp ikes aphics Disclosure Events Table Strips Mem 4 COMO 9 9 446 wv 1007 812 134 59 12 54 56 Strip Label label E E 1 i mau mmm To go back to the Morphology Categories screen press the Previous button 13 4 Changing the beat label The user can change the label for a beat or for a complete row depending on which mode is selected To make the change the user should select one of the following four icons that appear on the toolbar Trend single Reclassity Normal Ventricular Supraventricular Artifact Depending on which icon is selected the colors are Black if Normal is selected Red if VE is selected Blue if SVE is selected Yellow if artifact is selected Galix Holter Analyzer WinTer Operation Manual 54 Next a screen showing beats pertaining Normal template on which the following modifications were made is displayed below In the selection mode Row the complete row was changed from Normal to SVE In the selection mode Beat two beats were modified the first from Normal to artifact and the second from Normal to VE V Demo Patient 123456
23. in which the reclassification has to be done from the ECG strip itself beat by beat Pause Apnea ST HR and Pacer Events edition e Pause Apnea ST HR and Pacer Events are edited only from the Significant Events Edition screen On this screen the user can o Select one or several events and click on the Reject Event button This procedure will discard the selected events from this classification Galix Holter Analyzer WinTer Operation Manual 58 Tip for multiple events selection To select a single event the user simply has to click on it To select the second third the user has to hold the Control key pressed and click on them one by one o Click on the Reject Page button In this way all events on screen will be discarded from this classification o Click on the Reject button In this way all events of this kind are discarded Galix Holter Analyzer WinTer Operation Manual 59 16 HEART RATE VARIABILITY This system provides all the parameters required for analysis of the Heart Rate Variability as suggested by the European Society of Cardiology and the North American Society of Pacing and Electrophysiolosy and published in the American Heart Association AHA magazine Circulation 1996 93 1043 1065 Heart Rate Variability Standards of Measurement Physiology Interpretation and Clinical Use Accessing the Screen To access the screen press the Modules button and then select HRV
24. which can be internal or external to the PC Since this method of analysis is conventional among the digital Holters the system Is prepared so that the analysis takes place in direct form i e with the Automatic Search enabled Nevertheless because of the extraordinary advances in data transmission methods Galix considered it necessary to program access via alternative methods such as CDs fiber optic transmission fast internet access and others In this case the user will select the Manual option where the alternative data path can be specified Galix Holter Analyzer WinTer Operation Manual 18 IMPORTANT If studies are only processed from the memory card the option Automatic Search must be enabled and the memory card must be placed in the corresponding card reader Automatic Search When this option is selected the system will search in all the units connected to the computer for the card containing the information for analysis If the system does not find the unit with the information it will ask the user to insert the memory card into the card reader Physician Institution Info Physician Confiquration Data Source File Path for the compressed Signal 4 path C GBlWinTerDemosSignal Automatic Search Manual search of the disk unit where compressed signal is stored Automatic search of the unit containing the compressed signal
25. will appear Paciente Demo 123456700 See ECG Strips Strip ECG Eng Trend Morphol Significant Howy Retained Print Modules Length strip 2 Spikes Graphics Disclosure Events Table Strips Mem us M ln g 6 77400 7i 844 445 y 1023 821 828 820 844 TI 71 134 xx 73 71 x1 e v 1 i i H Strip Label Label Insert Cancel 00 16 37 Then the user will be invited to add a label to this strip Once this is done program will instantly store the strip on disk 9 3 Changing the strip length The length of the strip refers to whether the strips will be saved or printed in strips of 8 16 or 24 seconds By default the length is 8 seconds To change the length the user should click on the following icon Galix Holter Analyzer WinTer Operation Manual 36 In the first graph of the 8 second screen only the first eight seconds of the minute displayed on the graph will be shown Paciente Dene 123456700 See ECG Strips TUUS Save Stip Stup Print ECG UE Pacer Trend Full Morphol Significant Eetamed um IE 6 Length strip 5 Spikes Graphics DBuselosire Events Table Strips
26. 6 F 8 3 ST values for each channel QT values VEs per hour SVEs per hour 10 1 Minutes not analyzed The first minutes which by default are not analyzed will not be included in the graphs 10 2 Heart Rate and Tachogram In the first graph displayed on the screen the user is able to switch between Heart Rate and Tachogram graphs By default when this screen is first displayed the graph will represent Heart Rate minute by minute but by clicking on the Tachogram icon the representation can be changed When accessing the Tachogram curve the R R interval variations measured in milliseconds are plotted minute by minute Galix Holter Analyzer WinTer Operation Manual 41 Pachogrart To return to the Heart Rate graph the user should select the HR icon Note The Tachogram and HR icon disable each other depending on which graph type is selected 10 3 Detailed View The user will be able to navigate throughout the entire Heart rate or Tachogram graphs searching for a specific minute using the keyboard or the mouse With the keyboard e Up arrow key moves the cursor 10 minutes to the right e Down arrow key moves the cursor 10 minutes to the left arrow key moves the cursor 1 minute to the left e Right arrow key moves the cursor 1 minute to the right Current minute indicator Current minute pointed with the red Once the cursor is positioned the corresponding ECG signal can be ac
27. 700 Morphology Categories _ Singl Row All 2 v TOLLLLLLLLLLLL LL EL EL LLLA VE Red Beat Adebdb gba Ll LLL ean eRe ee SVE Blue 1 1 141 54 11 114 4422 Reclassify Trend Full Morphol Significant Retained Print Modules aphics Disclosure Events Table Strips Mem lt E Save changes If the user has made any changes on this screen when exiting using the Previous or Exit icons the program will prompt the user to save the changes made Holter If the user selects Yes the system will update the corresponding files and the totals next to each template in the Arrhythmia Morphologies screen If the user selects No then no modifications will be made Galix Holter Analyzer WinTer Operation Manual 55 14 SIGNIFICANT EVENTS Features It enables a quick identification of the significant events and the amount of each type of event Accessing the screen From Morphologies screen clicking on Next button e By clicking on the Significant Events button Significant Events organization The Significant Events are organized in 5 sections with four subsections each Most of the names of the sections and subsections are self explanatory e Ventricular Events o Ventricular Ectopic o V Tach Couplets Bigeminy V Trigeminy V Supraventricula
28. 8 00 Erase Cancel By pressing the Erase button both edition boxes will be cleared The patient personal data can be modified by clicking on the Patient Data button in the Print Menu The following screen will appear Patient Data Editor ID 123456700 Demo First Name Last Name Fatient Address 24 Smith Av 4805 1097 Phone 01 10 1871 Weight NOTE The Institution data CANNOT BE MODIFIED FROM THIS MENU Galix Holter Analyzer WinTer Operation Manual 74 Full Disclosure Printing If the Full Disclosure box is selected the user can select to print 1 or 2 hours per page of ECG signal Thus for a 24 hour study 24 or 12 pages can be printed respectively The user can also select the number of hours to be printed as shown in the following figure In order to do this the user should select the Hours button and then click on each of the hours he she wishes to print As the selection continues the hours selected will remain highlighted indicating that they have been selected To de select an hour press its corresponding icon once more Each hour will be printed on a different page Selected hours Select Hours Holter Report Summary Conclusions L 7 Detail E msn 24 Hour Statistic Graphics 13 00 Disclosure 16 00 18 00 18 00 Channel 1 125 Hours per C E e page 1500 2000 2100 6 6 2 Morphologies 22
29. BASUREMENT EE Mast asit M ad 37 90 CIANGEBEATSACEASSIBICATION aede tini LM 39 9 1 PACEMAKBR 0016 2222 au ipM Mr LB LL LM 39 10 TWENTY FOUR HOURS STATISTICAL 41 NMIENUTESTNOTCAN AI ZED E ee enol aren cM 4 10 2 PHBAXRTICATEANDLACHOGBANI clay tabes erro olet 41 UB Cn 42 ST SEGMENT DEVIATION vetant Deep MeL i cc 42 PO OTINTERVAE VALUES 43 VENTRICULAR ECTOPIGS VIE PER HOUR ea ounces teed ete E 43 10 SUPRAVENTRICULAR 5 5 VE PER HOUR 44 E B a e 1 43150 1 03 51 Oe icon eed eec Leo dte 45 DI PDBEDISCEOSURESCROEECOMMANDS etait dis Der te 46
30. CG signal This value is calculated minute by minute and is constant during the chosen minute B means of this parameter the system is able to choose for each study the best quality channels for the analysis thus improving the analysis results The CQI has a temporary sensitivity of approximately 15 seconds or in other words the noise has to be present at least 15 seconds during the minute of analysis to affect the value of the CQI This index allows the Analyzer to detect those signal segments in a particular channel that could interfere with the process of beat detection and classification The is coded with values from 0 to 100 where the higher the value of this index the higher the signal quality Normally values range from 65 to 80 values that are 40 or less indicate that the signal is inadequate for analysis The graphic representation of the allows the user to quickly verify if the Holter recordings obtained is acceptable in terms of signal quality throughout the study By inspecting this index it is also possible to determine which segments present anomalies due to different circumstances such as If the index decreases in a specific channel this could indicate a loose electrode or a similar defect If the index decreases simultaneously in all three channels then the following should be considered Muscular movements e Significant heart rate increase e Problems with the recorder Once you fini
31. Computer B s Galix Biomedical C 81 425 Bundle 81 42 Documents and Settings EB 2 Drivers Ec GBI Hic winTer ot Folder C GBI WinTer DemoSignal cancel _ Click on the OK icon and exit the Holter Configuration screen IMPORTANT Remember that after testing the system with the DemoSignal the user must return to the Holter Configuration screen to select the Automatic Search option in order for the system to resume searching the memory card Access to New Patient screen Features Used to update the database with the patient s information and the Holter study data Used to decompress the ECG signal To process the ECG signal Galix Holter Analyzer WinTer Operation Manual 25 Accessing the screen Prior to starting the user must insert the memory card in the card reader in order for the patient data to be automatically transferred assuming that the Connecting process has been carried out Next the user must do one of the following Left click on the New icon located in the Main Menu Toolbar The Holter system will show the following message P moment pleaze Then the New Patient screen will be displayed L New Patient Date 9 16 2008 Start time 1 22 gt Referred by Physician E AN Age Indications Medications 7 2 Automatic data update When this window is opened the program will search for the patient information f
32. IIE IAES EHI 13 X IC PE DES PARAT 000 AON 14 EON set DAI 15 16 9 2 PHYSICIAN C ONFIGURA TION FILE FOEDER 17 DATA SOURCE FIRE POR DER wr paces E A est 19 HOOR 21 OE 10122221 22 PZS OPTIO AE mn Te te CTE Oc 23 CANCELING MEMORY CARD IDENTIFICATION iunge petes us et i De ch naa 23 6 4 COMPLETING MEMORY CARD IDENTIFICATION c ccscoscescecceccscesceccecescescescecescescescescscescescescssescescescssessescscesessescesceseucs 23 6 5 FILE CONTAINING THE CURRENT PATIENT INFORMATION ccscsccecceccsccscecceccecescscescscescescescesescescescesescescscesessescesceseucs 24 DING PATEN NERO NOCT TTA 25 KURIER EL OM DFM SCR 25 20229002 i tr GS SE 26 TP ATEN TE INFORMATION E eI eto 24 JAF EIER IMS SS IE Rm
33. Manual 20 6 PATIENT HOOK UP Features 15 used to control the proper patient electrode placement before recording the ECG signal Enables the identification of each memory card that will be placed in the Galix Holter Recorder GBI 3SM with a text file containing patient data prior to carrying out the 24 hour recording To provide the patient with the Patient Diary before he or she leaves the physician s office Accessing the screen To access the Connecting Memory Card screen the user must click on the first icon on the Main Menu Toolbar Connect The Holter analyzer will immediately display the following screen Va Connect Memory Card Config Patient Information Date 9 16 2008 Address Indications Medications Start time Sex C Female C Note the same screen will appear when the user performs one of the following operations Identification of the memory card saving patient data before recording see Patient Connection screen New patient analysis see Patient Connection screen Retain Patient see retain Galix Holter Analyzer WinTer Operation Manual 21 Screen Information On this screen the user will enter the patient data The user will be able to move from one field to the next one using the TAB key or with the mouse There are two sections Patient Information and Optional Data 6 1 Patient Information Filling in all these fields is mandatory in order to p
34. NG ssossssesscsssssssesscsecssssessosecsessessoseossssessosscssoseosessessossosessessoseoseseosessessossssesse 82 24 WARRANT Y 6 83 Galix Holter Analyzer WinTer Operation Manual 3 1 INTRODUCTI ON The continuous monitoring of ECG signal over a 24 hour period is a powerful tool for a thorough evaluation of a cardiac patient both in hospital and ambulatory environments The Holter study should only be performed on a patient when prescribed by a physician In this section we describe the main characteristics of the Galix WinTer Holter analyzer program The program has been designed to offer the user all the tools necessary to perform advanced Holter analysis while maintaining communication with the user in simple and easy terms The Holter analyzer program allows Storage of as many complete Holter studies as the particular hard disk allows As a reference each 24 hour Holter study takes 34 Mb of disk space The storage of Holter reports in the hard disk A maximum of 6 Holter reports or complete Holter studies per patient can be stored in the hard disk Analysis of 3 channel Holter studies by measuring the ST segment deviations the QT interval ventricular ectopics supraventricular ectopics etc 4 The deactivation of one of the three channels for analysis This feature is valuable in order to obtain a good Holter an
35. Polarity Change State A Switch Polarity i Y Processing Button Progress Bar dE Smith Albert 30333617 ECG Strips 1 4 StartAnalysis 9 FL VL i 3 Dhange State 8 Eight CO sich Polar die strips Change State 712711 a Change State Hour 00 15 00 Channel Quality Index 00 Quality Channel Index Processing Button Click this button to start processing the ECG signal Gain The system will change the gain of the channel selected as shown the figure below To change press the buttons or as desired Galix Holter Analyzer WinTer Operation Manual 30 s 4 p 2 En mud PUE Bi E Gain rre ER bens dee erii 752351 54 54 22265255 Hun G a n decreased N j 1 1 220 1 vM hange State Y increased Switch Polarity The system will change the polarity of the channel as shown in the following figure To change 98 Jl M mh NJ uy M b po 5 4 X Inverted Polarity oa Change State If one of the three channels has excessive noi
36. Retamed T Graphics Duselosure Events Table Strips 4 Single Loar All Reclassify ELLE LLL DEMEURE pu M au 41 1 4 1 444444 4 444 4 4 4 444 de LL Eel el ed 141441 M 2 13 1 Beats For each screen a maximum of 102 beats 17 columns and 6 rows will be displayed The system will indicate the following Channel corresponding to the beats Label for this category Current channel Cyrrent Total A Label page pages A NN ZN GBI Morphology Categories MIT 14172 Channel 3 1 of 137 NLLN N A Fille Galix Holter Analyzer WinTer Operation Manual 51 Eight seconds strips Six 8 seconds strips one for each row are displayed on the left side of the screen This is where the selected beat will be graphed When accessing the screen the first eight seconds of the first beats for each row will be graphed by default Red circle Current beat Eight seconds ECG al Current beat strips that contain the current beat nh EST 13 2 Changing the current beat To change the current beat click on the desired beat or use the arrows on the keyboard lt Goes back a beat within the row gt Goes forward one beat within the row V Goes down one beat within the column Goes up one beat within the column Galix Holter Analyzer WinTer Oper
37. TK TET 21 S CN ELO SR TD 21 1 A 28 SECSTUDIES 28 29 5 ad oe Ue onic eaeveasdeudcucdenctensesevsdeacawsteusevecs 30 S ECGSIRIPS POST ANALEYSIS ve ce dove oe au cea cuv eoe Co vaa Con cope vv Ep eed cuv doe Seb eus epe oue do esc eee 33 9 1 EIGHT SECONDS AND ONE MINUTE GRAPHS ccccceccsceccececcccsccscecscscscecesesceceecsceecscecscscscsscscesescesescscescscescscesescusesces 33 Us STE EDS 222 0201 08 50 bc ase Meat orbes Moe ca ete 35 CHANGING EHE STRIP DENG EH eden cedars 36 S ra UB ir FR UPPER RERO 37 INTERVALM
38. alysis even when one of the channels is noisy The evaluation of arrhythmias and the possibility to edit morphology classifications The Galix Holter Analyzer program provides a series of tools that enable a better reading of electrocardiographic studies These are Automatic Detection and Classification Supervised Detection and Classification Page Scans 1 1 Correct Electrode Placement This is the most important phase in acquiring the 3 channel ECG signal during a 24 hour period The most important issue to obtain a good quality ECG tracing is a proper electrode placement technique This is essential in order to reduce the recording of artifacts and poor quality baselines ELECTRODE PLACEMENT 5 LEAD 5 LEAD 5 LEAD 2 CHANNEL 3 CHANNEL 7 CHANNEL 5 4 Blue 4 3 Brown ow Ene een Semen et rer ee pm I er Black ic brej Orso Galix Holter Analyzer WinTer Operation Manual 4 To obtain clean ECG tracings it is recommended that the patient is shaved in the area where the electrodes will be placed Electrode sites should be clean dry and free of any residue If oils liniments or lotions have been used in the patient s care alcohol will be required to remove the residue When alcohol is used allow the sites to dry completely 1 2 Hardware Requirements The only hardware requirement is a recent PC with a Windows operating system Nevertheless the more up to date the PC is the be
39. art s that is finds to be defective during the period of this limited warranty Should a defect become apparent the original purchaser shall first notify GALIX Biomedical Instrumentation of the suspected failure The instrument should be carefully packaged and shipped prepaid to GALI X BIOMEDICAL INSTRUMENTATION Service Department 2555 Collins Avenue Suite C 5 Miami Beach FL 33140 U S A Tel 305 534 5905 Fax 305 534 8222 Your instrument will be repaired in the shortest possible time and returned by the same shipping method as received by the factory This limited warranty is void if the instrument has been damaged by accident misuse negligence act of God or if the instrument has been serviced or modified by any person not authorized by GALI X Biomedical Instrumentation Equipment distributed by GALIX Biomedical Instrumentation such as but not limited to personal computers and printers will carry the original equipment manufacturer s warranty and will not be warranted by GALI X Biomedical Instrumentation This limited warranty contains the entire obligation of GALIX Biomedical Instrumentation and no other warranties expressed implied or statutory are given No representative or employee of GALIX Biomedical Instrumentation is authorized to assume any further liability or grant any further warranties except as set herein GALI X BIOMEDICAL INSTRUMENTATION 2555 Collins Avenue Suite C 5 Miami Beach FL 33140 U S A Tel
40. ates a normal beat and an X indicates of an artifact 9 7 Pacemaker Analysis When recording a study with the GBI 3SM Holter recorder you can detect implantable pacemaker pulses To visualize the pacemaker spikes recorded click on the following button Parer Spikes 7 The screen will look like this Galix Holter Analyzer WinTer Operation Manual 39 Smith Albert 30333617 See ECG Strips Save Strap Stup EGG CEDE Mager Trend Full Morphol Ew enzth z strip ec Spikes Graphics Disclose vents Table Les 938 Galix Holter Analyzer WinTer Operation Manual 40 10 TWENTY FOUR HOURS STATI STI CAL GRAPHS Features It provides a quick gauge of the recording quality of each one of the channels It displays in a single screen the heart rate variations the ST segment deviation the QT interval and the hourly ventricular and supraventricular ectopics during the 24 hour recording period for each channel Accessing the Screen Pressing the next button if you are in ECG strips screen Pressing the Trend Graphics button re Demo Patient 123456700 Hoi Statistic Graphics l achograr Heart Channeli Trend Full Morphol imificant Howly Retained Print s pita Graphics Disclosure Events Table Strips Mem 2 Y Heart Rate Beats min 120 30 11 12 13 14 15 16 1 18 19 20 21 22 23 0 1 2 3 4 5
41. ation Manual 52 The 8 seconds ECG strip graph in the left will also change as user moves from beat to beat Change the current beats page If one of the categories contains more than 102 beats the Next icon will be activated This icon allows the user to move forward through all the pages of the category Once the Next icon is selected the Previous icon will be activated to allow the user to return to the previous pages if necessary Selection Modes There are three ways of making a selection Single Row and All The first selects a single beat and is the default mode The second mode selects a complete row The third one Selects all beats in the page The figure below shows the screen that appears when choosing to view a row of beats V Demo Patient 123456700 Morphology Categories ingle All Reclassify Trend Full Morphol Significant Howly Retained Print Modales pi aphics Disclosure Events Table Strips Mem y niaes ma a ne e dd dl LLL LA LL LLL 41 14 41 4 1 1 4 444 4 4 4 4 1 44 44 1 14 14 4444 Jod ded oed od ode In this case the 8 second ECG strips to the left of the screen will be modified Galix Holter Analyzer WinTer Operation Manual 53 13 3 Detailed view of the beat By double clicking on a beat the user will be able to see the selected beat in detail The beat will be pointed
42. ation between the percent of patients with abnormal counts and the extent of the autonomic neuropathy determined by conventional methods In spite of the growing sensibility these methods of 24 hours are strongly correlated with other established measurements of HRV and have demonstrated reproducible results Similar to the survival of AMI the patients with AND are also predisposed to sudden death but the verdict is still out on whether or not the HRV has a prognostic value for diabetics Frequency Domain Measurements The following abnormalities in the frequency analysis of HRV are associated with AND 1 Decrease in the spectral power density in all frequency bandwidths 2 Lack of LF increase when patient stands up which is a reflection of the imbalance in the Sympathetic response or decreased sensitivity to baroreflex 3 Abnormal reduction of the total power density without changes in the LF HF coefficient A slide of the central LF frequency to the left In patients with severe neuropathies resting in supine position the power spectrum presents very low amplitudes in all spectral components making it difficult to identify the signal from the noise In these cases it is advisable to carry out the tests with the patients in standing position Future Investigations connecting changes to the HRV to different cardiopathy and other systemic illness appear every day This work is based on information prior to 1996 thus it is advi
43. c SY Tach 98 bpm 10 04 28 12 06 06 8 Sec 12402551 SV Coupleis Supraventricular Ectopic Ventricular Ectopic 4 9 pd o 13 44 18 1 8 Sec 11 33 29 8 Sec 14 49 57 8 Sec Maximum HR 104 bpm Minimum H R HR 70 bpm 4 14 53 47 Galix Holter Analyzer WinTer Operation Manual 70 19 PRINTI NG REPORTS Features Identification of the reports to be printed Screen access e From the Hourly Table screen by clicking on the Next button if strips have not been ci Retained Strips screen by clicking on the Next button if strips have been saved By clicking on the Print Menu button Through the Holter Configuration selections the user chooses which reports are going to be printed by default see Holter Configuration screen Holter Report Summary Conchisions Detail 24 Hour Statistic Graphics Full Disclosure Channel m zz 124 Hours per page IMorphologies Hourly Tahle Retained ECG strips Histogram and Long Term H R V Cascade Spectral PEF atient Data The chosen reports are marked in the box next to each option These options can be temporarily modified but the selections will always revert back to the default options when re entering this screen To make permanent changes on this screen the user should access the second folder of the H
44. cessed by double clicking on the cursor or by pressing the Enter key 10 4 ST Segment Deviation The ST segment deviation mV of each channel is automatically measured with respect to the isoelectric line aS seen in the Heart Beat figure below PQ segment ST segment Galix Holter Analyzer WinTer Operation Manual 42 The user can easily identify each channel either by its color code or means of channel indication on top of the ST trend graph as shown below Current channel 1 Pink Channel 1 Light Blue Channel 2 Violet Channel 3 ST segment value Hours from O to 24 To see the 24 hour ST trend of a different channel the user must click on the channel icon If one of the three channels has been deactivated the ST deviations for that channel will be plotted in gray Calculation To calculate the ST segment deviation first of all the QRS peak isoelectric baseline and J point are located The ST segment is then calculated as the amplitude of ECG signal 60 milliseconds after J point 10 5 OT Interval Values The QT interval in milliseconds is measured from the beginning of the Q wave to the end of the T wave The end of the T wave is determined as a function of the maximum value of the filtered signal after the peak of the T wave The QT interval stored and presented on the screen is the maximum of the three derivatives for each beat QT Interval indexes Hours from O to 10 6 Ventr
45. displaying the time interval measured in milliseconds between the two bars Cursors Save Strip Strip PrntECG soy Pacer Tr Moyphol Significant Howly Retained strip Spikes Disclosure Events Strips A e 1 2 J A A 461 898 711 735 130 66 84 81 00 20 58 Time interval between bars measured If you double click the box the reading will change to heart rate If you don t have the cursors available you can click on any sector of the screen and it will display the exact time at that point as shown in the following figure 679 680 7 688 9 6 Change beats classification This function is used for the edition of beats you can add delete and re classify any beat you want Galix Holter Analyzer WinTer Operation Manual 38 To change beat classification the user must right click on it and select one of the options displayed in the menu The options are Normal Ventricular Supraventricular Aberrant Artifact Paced Delete beat Add beat ps Paciente Demo 123456700 See ECG Strips Save Strip Print ECG 554 Trend Full Morphol Significant Howly Retained strip em x Disclosure Table Strips Ms 7 672 i 648 656 222 680 89 92 91 88 Normal 4 Ventricular S Supraventricular A Aberrant R Artifact P Paced D Delete Beat B Add Beat i i i i A dot indic
46. dress 12555 Collins Avenue Suite C 5 Phone 305 534 5905 Sex Female Male Indications IIedications Galix Holter Analyzer WinTer Operation Manual 10 To start analyzing the demo signal press the following icon VLP Enables the Ventricular Late Potential analysis module For more information please refer to VLP operation manual Electrodes This option offers a visual help for the correct placement of the electrodes To access click the following icon located in the Main Menu toolbar Electrodes T The program will open the following file Galix Biomedical Electrode Placement for 3 Channel ECG Holter Ventricular Late Potentials Resting 12 Lead ECG D2 V2 Vs Exercise Stress Test Providing visual aid for obtaining a quality recording the Holter recorder Galix Holter Analyzer WinTer Operation Manual 11 5 CONFI GURATI ON MENU Features All the necessary parameters for the system to analyze the ECG signal according to the user s needs are set up here Entering the Configuration Screen With the left button of the mouse click on the icon shown below located on the Toolbar of the Main Menu The program will display the following screen Icons to add and Stored Menus delete institutions institutions Data Source Institution Informit eee Fhysician institution Info Physician Configuration Institution Test In
47. dules Disclosure Table Strips Mem E v LI 91 Empty template Lg Amount of beats Template s label associated to the template 12 1 Templates Templates refer to each one of the possible groups that are formed from similar beats If one of the beats has been grouped with a template from channel one it will not be associated with any of the templates of the other two channels Thus if a template in channel 1 is changed from VE1 to normal there may still be a VE1 template in channels two and three Every template for every channel is independent from those in other channels The label corresponding to each template and a number representing the number of beats associated with each template are shown below every template If the label for a template is changed then all those beats are re classified Templates will have one of the following labels Galix Holter Analyzer WinTer Operation Manual 48 Normal The system may detect more than one normal template It may happen that one of the channels does not have a normal template This will only occur if at least one of the other channels has a Normal template detected by the system Label white dot VE These are templates which differ from the Normal template and which are less frequent than the Normal The user will be able to find a maximum of 7 categories of VE beats Labels VE SVE These are beats that do not differ substantial
48. e a message saying that this action cannot be performed Holter Configuration x 1 Cant delete Physician Galix Holter Analyzer WinTer Operation Manual 16 5 2 Physician Configuration File Folder This file folder contains Parameter information that the system will consider for detection and classification of the ECG signal Selection of the reports to be printed Physician Institution Info Physician Configuration Confiquration SVE Prematurity Hours to process Pause time 2 Print Disabled Channel HR Limits Lower HR limit Higher HR limit 1120 Printing Color Report Doc amp Print Hours to process Allows user to choose the processing time This option is useful when the Holter study has lasted less than 24 hours thus saving processing time Pause Time Allows choosing the time in seconds that is considered as a pause absence of a beat for a specific patient If the period between two beats exceeds in seconds the one indicated in this field the system will consider it a pause SVE Prematurity Allows setting the percentage at which a beat is considered premature in order for the program to classify it as an SVE Supra Ventricular Ectopic This option is useful when the user knows that the patient is experiencing atrial fibrillation Increasing this percentage to about 4096 will eliminate most of the premature beats atrial fibrillation of the
49. e postural hypotension persistent tachycardia gastroenteritis and others Once the clinical manifestations of the autonomic diabetic neuropathy AND take over the estimated mortality rate after 5 years is 5090 Therefore the early detection of the autonomic dysfunction is important for risk stratification and subsequent treatment For patients that present NAD real or suspect there are three HRV measurements from which to choose Galix Holter Analyzer WinTer Operation Manual 65 Simple measurement methods of RR intervals in bed Time domain measurements over long term recordings which are more sensitive and reproducible than the short term recordings Frequency domain analysis performed under short term stationary conditions which is useful for the separation of the sympathetic and parasympathetic components Long term measurements in the time domain The HRV calculated from a 24 hour Holter recording is more sensitive than the HRV calculations performed on a resting patient test such as the Valsalva maneuver the orthostatic test deep breathing test for the detection of AND The most frequently used method is the 50 count and the 5050 When the 50 is used with a confidence interval of less than 95 for total counts in the range of 500 to 2000 depending on the patient s age approximately half of the patients with diabetes demonstrated abnormally low count values during a 24 hour period Furthermore there is a strong correl
50. e the studies to be deleted are selected the user must click on the Delete icon and the system will ask to confirm the studies to be deleted Clicking on Yes will delete these studies and clicking on No will cancel this action and will remain in the Delete Patient Study screen ID 236866778 First Name Smith Last Mame Jhon Due A 22005 2 11 2005 2 16 2005 22 Do vau confirm to delete 2 studies 2 26 2005 QO 272112005 Yes 3 11 2005 If the user wishes not to eliminate any of the studies the Exit icon should be selected to return to the New Patient menu 7 8 Closing the current patient file When the user wishes to exit the New Patient screen he she should click on the Exit icon located on the bottom left corner of the screen Galix Holter Analyzer WinTer Operation Manual 29 8 ECG STRIPS PRE ANALYSIS Features Lets the user know the parameters the system takes into account when detecting and classifying the ECG signal Allows modification of the parameters polarity gain template labels etc in order to achieve the best detection and classification of the ECG signal Accessing the screen The user will be able to access the screen after making click on the Next button mentioned before on the New Patient screen Once the signal has been decompressed the system will show the following screen TUS Gain S witch
51. ectral Densities The spectral densities graphed on the right of this screen and the central frequencies corresponding to the peaks present on each of the listed parameters are not fixed and can vary in relation to the changes in the autonomous modulation of the cardiac cycle Galix Holter Analyzer WinTer Operation Manual 62 Long Term Heart Rate Variability LTHRV Clicking on the icon shown below the system will display the screen with the long term frequency domain analysis Long Tenn On the screen shown below there are two graphs Spectrum of the 24 hour record of normal RR intervals Average of all the 5 minute spectrums graph to the right of the screen This result includes one ultra low frequency or ULF component also mentioned in the short term analysis Parameters calculated over this spectrum are the following Total Power msec Power between the ranges 0 4 Hz ULF msec Power between the ranges lt 0 003 Hz VLF msec Power between the ranges 0 003 0 04 Hz LF msec Power between the ranges 0 04 0 15 Hz HF msec Power between the ranges 0 15 0 4 Hz ALFA slope of the linear interpolation of the specter in logarithmic scale in the 0 4 Hz range Demo Patient 123456700 Heart Rate Variability Analysis Long Term 2 Short i Lovers Trend Full Morphol itificant Hourly Retained 48 aphics Disclosure Events Table Strips mS 2 Hz 500 10 00 1 0000
52. epresent 5 minute HR signals are obtained Each one of these segments is multiplied by a Hanning window to correct the frequency run ins due to signal truncation On the tool bar of the Heart Rate Variability screen the user can observe two buttons that correspond to the short term and long term frequency analysis Galix Holter Analyzer WinTer Operation Manual 61 Short term Heart Rate Variability STHRV Clicking on the icon below the program will display the short term frequency domain analysis The screen that is shown below corresponds to a spectral density analysis Power Spectral Density PSD of the 5 minute segments described earlier The following parameters are calculated for each of these segments Total Power msec2 Power between the ranges 0 4 Hz It is correlated with the RR variance in the segment VLF msec2 Power between the ranges 0 04 Hz LF msec2 Power between the ranges 0 04 0 15 Hz HF msec2 Power between the ranges 0 15 0 4 Hz ra Demo Patient 123456700 Heart Rate Variability Analysis Cascade Spectral Array Short Trend Ful Morphol Significant Homly Retained Print Modules T m aphies Disclosure Events Table Strips Mem 1 Cs 4 w gt 5 mS2 He Heart Rate se Spectral Density in the current interval 5 minute current interval T T MM bif T A epee pucr Sp
53. f the memory card contains information from a previous patient the system will ask the user if the card should be overwritten File with patient information is not empty T Do you want to overwrite this file Selecting Yes will delete the file and allow a new ECG recording If the user selects No the program will go to the Main Menu Incomplete Patient nformation If the user does not provide the required patient data in Patient Information and still presses the Next icon the following message will be displayed Holter Configuration o 1 jJ Ak least Institution Name should be entered Galix Holter Analyzer WinTer Operation Manual 24 7 NEW PATI ENT 7 1 Patient Demo If desired the complete operating sequence of the Holter analyzer can be run with a special program called Demo This demo program is a valuable tool for learning the operating procedures and features of the Holter program The demo signal can be found in the following directory C GBIHolter DemoSignal In this way the user can test the system without using a memory card following these steps Enter the Holter Configuration Menu Access the Data Source file folder Deselect the Automatic Search option by clicking on the box Press the Browse button Click just once on the sign located to the left of each subdirectory until reaching the path C GBIHolter DemoSignal 8 0 My Documents El 9 My
54. formation by Institution LastName 2 Fistan 000111 Address Phone Fax 15 to save cancel changes Galix Holter Analyzer WinTer Operation Manual 15 Once the information has been entered click on Save icon to store data in the database or cancel this operation by clicking on Cancel The system will not save any changes unless the physician s name is entered When trying to save a file that misses the physician s name the following message will appear Holter Configuration I sure to enter new physician s name and last name 5 1 4 Delete Physician In the lower panel of the Physicians Institution Inf folder the following icon can be found Once one of the existing physicians is selected the user will be able to click on this icon and the system will request confirmation for deleting the selected physician as shown in the following screen Physician Institution Info Physician Configuration Institution Information Institution Gaie Cardsalogieal Institute Address 12555 Collins Awe Suite 5 Phone ji 305 594 5905 Delete nshitution Confirm bo delete phusidisnDos John 7 After deleting the selected physician involved shuckes vell be kopt assigning Test physician ho the corresponding phrisician held report Yes No Note The Clinic Physician cannot be eliminated If the user tries to delete it there will b
55. he user entered a valid date the system will automatically calculate the age of the patient If this is not the case then this value can be entered with the keyboard e Sex The system accepts F for female M for male f Weight The value entered should be in pounds or kilograms g Height The value entered should be in feet inches or in meters h Referred by Name and last name of the referring physician i Physician Name and last name of the physician who will analyze the study j Indications Symptoms presented by the patient at the time of the study k Medications Medications that the patient is currently taking 6 3 Canceling memory card identification The user will be able to exit this screen by clicking on the Exit icon located on the left of the current screen toolbar 6 4 Completing memory card identification Once the patient data has been entered the user should click on the Next icon located on the right of the Toolbar Galix Holter Analyzer WinTer Operation Manual 23 The program will then Record the patient information on the memory card Ask if you want to print the Patient Diary that will be given to the patient Do you wish to print the pacient diary e Inform the user that the card must be removed and inserted into the GBI 3SM Holter recorder You can remove memory card now Accept 6 5 File containing the current patient information I
56. ically equal to the total spectral potential the SDNN reflects all the cyclical components responsible for the variability in the recorded period This variable is dependent on the length of the recording Triangular Index Total number of normal RR intervals divided by the height of the HRV histogram of all the normal RR intervals measured in a discrete scale of 7 8125 miliseconds A Dimensional This index which is a geometric method is not appropriate for short recordings The principal advantage of this method is the relative insensitivity to the analytical quality of the RR series due to the robustness to errors in the beat classification It is an estimate of the overall HRV SDANN msec Standard deviation of the averages of the RR intervals in 5 minute segments It is an estimate of the long term components of the HRV This index is an estimate of the changes of the HRV due to cycles longer than 5 minutes RMSSD msec Square root of the mean of the sum of the squares of differences between the adjacent normal RR intervals It is an estimate of the short term components of the HRV This index is an estimator of the variations of high frequency or short periods in the HRV 16 2 Frequency domain analysis The frequency analysis is based on applying the Fast Fourier Transform or FFT The RR signal is converted to Heart Rate HR linearly interpolated and graphed in regular intervals of 0 5 seconds 2Hz This way 288 segments that r
57. icular Ectopics VE per hour This bar graph represents the ventricular ectopic beats detected per hour Plot X 24 hours Plot Y VE Ventricular Ectopic Beats per hour with automatic scaling Galix Holter Analyzer WinTer Operation Manual 43 10 7 Supraventricular Ectopics SVE per hour This bar graph represents the Supraventricular Extopics detected per hour Plot X 24 hours Plot Y SVE SupraVentricular Ectopics per hour with automatic scaling To Exit and Record Patient Data If the user wishes to exit the Main Menu from this screen the Exit icon must be selected The system will prompt the user to confirm the action Do you wish to return to Main Menu m Yes Galix Holter Analyzer WinTer Operation Manual 44 11 FULL DISCLOSURE Features It displays the 24 hours of ECG signal recorded of a specific channel in a 20 minutes per page format in order to show the user the quality of the signal stored as well as its content Accessing the screen From the Trends Graphics screen by clicking on Next By clicking on the full disclosure button Full Dusclosure Demo Patient 123456700 Full Disclosure Ch 1 2 3 Chi Trend Full Morphol Sirificant Haily Eetamed 2 ame Graphics Dasclosure Table Stripe Memi Di Tm P Ch3 A gt 8 4 k Pee edle els s pe Dee e e De pill ddr deor
58. ile GBI PAT If the system finds the file in the Data Path indicated in the Holter configuration all the data will automatically be shown in the corresponding fields on the screen and can be modified by the user before decompression In any case the user must complete at least the fields provided in the Patient Information panel Galix Holter Analyzer WinTer Operation Manual 26 The Optional Data panel is not required for the Holter analyzer operation but is important for the proper maintenance of the database of the patient to be analyzed 7 3 Patient Information See Patient Information in the Connecting section 7 4 ECG signal decompression Once the necessary data has been entered in order to decompress the ECG signal the user must press on the Next icon located on the right of the Toolbar The program then begins to decompress the ECG signal t will verify that the data found is correct If the ECG data is not found the system will show the message below X ECG DA2 missing In the same way the system will display other error messages that will not allow the signal to be decompressed These are The file CRECG INF could not be created Missing File ECG DAT The file CRECG DAT could not be created ncorrect Data Source specified Note There are three other situations Missing file GBI INF Missing file GBI SES The file GBI SES cannot be created Although they do not cause an interrup
59. ill appear you sure you want to delete study performed on 10 07 727008 corresponding to patient Patient Warning To delete study all ECG data will be lost Yes Galix Holter Analyzer WinTer Operation Manual 79 22 STORE PATI ENT INFORMATI ON Features Enables to download the patient information without analyzing it Accessing the screen From the toolbar on the Main Menu select the Retain icon This function is useful when the user wishes to download and decompress the files from a memory card to the hard disk ge Retan Patent Date 10 26 2008 00 00 Address Phone 1 10 1971 Sex Indications Medications In this case the signal will be decompressed and stored together with the patient information until the user decides to perform the analysis This is the same screen accessed when connecting a memory card or when analyzing a new patient Once all the data is entered the user should select the Next icon 4 Galix Holter Analyzer WinTer Operation Manual 80 The system will store the study and then show the following message Successful data decompression Accep 1 j To exit the screen To exit this screen select the Close icon and the program will return to the Main Menu Galix Holter Analyzer WinTer Operation Manual 81 23 MORE THAN 24 HOURS RECORDI In case more than 24 hours have been recorded with the Gal
60. ix GBI 3SM Holter Recorder the WinTer analysis program will detect automatically this recording length and will introduce the following changes A Trend Graphics A new Day button will be placed it will enable to view the days 1 2 or 3 corresponding to the first second and third recorded day maximum 72 Hours B Full Disclosure No difference will be noticed at first sight but the user will be able to scroll the signal to the end The day appears on the top left part of the screen C Morphologies and Significant Events In both screens the events shown will correspond to the total numbers recorded D Hourly Table In this case the table also extends for all the recorded time E Print Menu When more than 24 hours are recorded it enables to print the trend graphics and the hourly table corresponding to the different recorded days Galix Holter Analyzer WinTer Operation Manual 82 24 WARRANTY BIOMEDICAL INSTRUMENTATION Limited Warranty GALIX Biomedical Instrumentation provides to the original purchaser the following limited warranty from date of invoice All serialized parts 18 months Accessories 90 days GALIX Biomedical Instrumentation warrants each instrument to be free from defects in material and workmanship Liability under this warranty covers servicing of the instrument when returned from the customer s facility prepaid to the factory GALIX Biomedical Instrumentation will repair any component s or p
61. ly from a Normal template and their incidence is very low The system does not classify premature SVE templates The system classifies beats as premature SVE but not in its template analysis Label S Artifact These are beats that the system is unable to classify Label A 12 2 Edit morphologies The user is able to view in more detail all the beats that form a template To do this the user should select any template and then Press the Edit icon or Press the ENTER key or Double click on the template Once this is done the system will display the Arrhythmia Morphology Categories screen see Morphology Categories screen Change the label of a specific template All the templates are labeled by the program Nevertheless the user might disagree with one of the labels and he can change it by selecting the template and then pressing the Reclassify button Eeclassty E Once this is done the system displays the following screen 7 Change Label Previous Label N New Label Accept Cancel lE Once the new template label has been selected the user will accept this change by pressing the Accept button and the small window will disappear If the Cancel button is pressed the small window will disappear without any changes Deactivated channel Galix Holter Analyzer WinTer Operation Manual 49 If a channel has been deactivated the file folder will also show all the deactivated templates and if selected
62. nges unless the institution s name is entered When trying to save a file without the institution s name the following message will appear Holter Configuration 1 least Institution Name should be entered 5 1 2 Delete Institution In the Institution Information panel the icon Delete can be found Galix Holter Analyzer WinTer Operation Manual 14 Once one of the existing institutions is selected the user should click this icon in order to delete the selected institution Valores 2 Confirm to delete Miami Heart If the user selects the Yes option the Institution will be removed as well as all the physicians related to that Institution If the No option is selected no change will take place 5 1 3 New Physician In the Physician Information by Institution panel the following icon can be found When clicking on this icon the upper part of the window will be deactivated to allow the user to complete only the new physician data In addition the inscriptions on the icons are changed allowing the user to update the changes introduced by clicking on the save icon Physician Institutian Info Physician Confiquration e Institution Information Institution Cardiological Institute Address 2555 Collins Ave Suite c 5 Phone 305 534 5205 305 534 8222 infocbgalix gbi com Deactivated section Delete E Physician In
63. olter Configuration screen from the Main Menu and select the Reports option where the desired selections may be chosen Galix Holter Analyzer WinTer Operation Manual 71 Once the user has included all the desired pages in the final report the Print icon should then selected To exit this screen without printing simply select Cancel and the system will go back to the previous screen When selecting the Conclusions icon in the upper portion of this screen the user will be able to enter conclusions for the study performed The following screen will appear 22 Conclusions Save Cancel If the Automatic Conclusion option in the Physician Configuration screen is selected the program will automatically write some lines in the conclusion s field Otherwise the screen will be blank Report Print Preview The View button allows the Holter Report Summary print preview and its edition After clicking on it the report preview will appear Galix Holter Analyzer WinTer Operation Manual 72 Date 11 7 2008 Test Institution ECG Holter TE E Mail Report Patient Patent Demo ID 123456700 D O B 140 1971 Address 24 Smith Av Start time 00 00 3f Height 1 71 Phone 4865 1097 M Weight 5 Medications Indications Referred by Physician Jest Physician Heart Rate WE Average HR Total Min 4 Beats 06 10 29 Pairs Total 4 Beats 04 58 00 V Run Total Pai
64. r Events o Supraventriculr Ectopic SV Tachycardia and Couplets o Bigeminy SV Trigeminy SV e Pause Apnea SV Events o Pause o Apnea o ST Segment ECG with the maximum positive ST deviation o ST Segment ECG with the maximum negative ST deviation e HR Events o Maximum HR o Minimum HR o HR Higher than limit the limit is set up in the configuration menu o HR Lower than limit the limit is set up in the configuration menu e Pacer Events o Pacer Capture Pacemaker spike detected and beat detected o Capture Failure Pacemaker spike detected and beat not detected o Oversensing Undersensing The Significan Events screen looks like the following Galix Holter Analyzer WinTer Operation Manual 56 Paciente Demo 123456700 Significant Events Trend Full Morphol Significant Hourly Retained Print tie Disclosure Events Table Strips n Ventricular Events Pause Apnea ST Events HARRY 00 02 39 Supraventricular Ectopic 8 SV Tach and Couplets 00 45 04 1 47 The user can enter any of the sections by clicking on the corresponding tab like the supraventricular events one The user can enter any of the subsections by clicking on it The screen will be as follows ra Paciente Demo 123456700 Significant Event Edition Save Strip Trend Full Morphol Significant Hourly Retained Print iphies Disclosure Events Table Strips Menv b
65. r in Pacemaker Mode we will have the possibility to access a special Pacemaker table by clicking on the PM Table button Galix Holter Analyzer WinTer Operation Manual 68 To go back to the conventional Hourly Table click on the Standard Table button Galix Holter Analyzer WinTer Operation Manual 69 18 RETAI NED STRIPS Features It displays all retained ECG strips and allows their edition Screen access From the Significant Events screen By clicking on the Hourly Table button If we click on the Hourly Table button and there are no strips retained the following message appears There is no retained strips Accept the 8 seconds ECG strips that have been retained in the course of the 24 hour analysis can visualized and reviewed A maximum of 32 eight second ECG strips in chronological order can be stored These strips can be accepted or rejected individually or all together The 25mm sec ECG strips retained may be visualized in screen by clicking twice on the left button of the mouse All the remaining ECG strips may be printed later by selecting the corresponding option in the printing menu V Demo Patient 123456700 Wetanied SUITS ESES i Trend Full Morphol Significant Howl Retained Pnnt Page 4 Graphies Disclosure Events Table Strips Mem ERES Es Strip ET 4 1 A A i i v ST Segment ST 168 ST Ventricular Ectopi
66. rocess the Holter study Date This shows the date in which the study was performed The system will automatically take the current date from the PC Date 9 16 2008 Change the current date The following figure shows a small calendar where the user will be able to alter the date that appears on the screen This calendar will appear if the user clicks on the arrow on the right of the control 9 16 2008 Go to next month Go to the previous b Start time this time will be stored in the database as the time the Holter recording began This data will be taken from the PC The user will be able to modify these values through the keyboard as long as these are numerical values Otherwise the following message will appear A Please enter a valid time C IDZ Social Security Number or any identification number which is unique to each patient Only numbers are allowed in this field If the user enters letters periods or any other character the system will inform the user that there is an error Galix Holter Analyzer WinTer Operation Manual 22 Hew Patient m 4 2 Please enber patient 1 0 number d Last Name Patient s last name Name Patient s name 6 2 Optional Data a Address Patient s address b Telephone Patient s phone number c Birth date Patient s date of birth in month day year format If the date is not valid the system will inform the user d Age If t
67. rs Toss Hourly HR Min 06 00 00 VE s per 1000 Hourly HR Max 04 00 00 V Run Min HR Total Beats V Run Max HR Minutes Analyzed mom Longest V Run SVE ST Segment SVE Total 23 CH 1 Total ST Minutes 0 SVM Run Total 2 Total ST Minutes 1 SVEs per 1000 CH 3 Total ST Minutes 1 SV Run Min HR 00 38 01 Longest ST amp segment ev 1 00 02 43 SV Run HR 02 55 13 Max ST Depression 275 at 00 02 43 Longest SV Run at 00 36 01 KR DEED R R Hissegram H R V Conduction QT SDNN 61 6 E Pauses 2 5 Sec 1 means of the scroll bar on the right the whole preliminary report can be viewed The lower part of the report contains the details and the conclusions Those details are a series of data that are already included in different parts of the report and here they are summarized This details section can be ommited by de checking this option from the Print Menu In this case all the lower part of the report is left for conclusions printing which are entered manually by the operator Any of the data in the report preview can be edited by double clicking on it by means of the following windows If it is a numeric value the user will be able to enter the new one Holter Accept 01 vEsTo Cancel Galix Holter Analyzer WinTer Operation Manual 73 If the parameter has an associated time of occurrence the window to enter it will be the following 115 HH 4 Beats m 04 5
68. sable to consult more recent documentation as well To exit this screen the user can click on any button on the toolbar Galix Holter Analyzer WinTer Operation Manual 66 17 Hourly Table Features It displays a statistical table hour by hour of the complete study Screen access From the Significant Events screen or clicking on the Hourly Table button Each cell shows the value quantity for the corresponding parameter within a specific hour of the study As it can be seen a cell highlighted in a light color indicates a minimum value while a dark color will highlight a maximum value cell P Paciente Demo 123456700 Hon Tale nem Standard PM Trend Full Morphol iznificant Hourly Retained Print Table Disclosure Events Table Strips Menu A F A T r T h T T M 1 nos n 1 c 1 4 2 LI 4 FA 14 F 1 Lh 4 V 2 3 3 AR eu E ER Open ECG in a certain one hour period The user can instantly visualize the ECG corresponding to any one hour period in the table to do it simply click on the one hour period you want to open Galix Holter Analyzer WinTer Operation Manual 67 The following screen will appear Paciente Demo 123456700 See ECG Strips SaveStrp Strip Print ECG Trend Full Morphol Significant Hourly Retained Print Length 5 Spies 2i Pis Disclosure Events Table Strips Menu
69. se the user has the option to deactivate the channel and thus this channel will not be taken into account when detecting and classifying each beat Only one channel can be deactivated To deactivate press ias P p witch Polar 1 Deactivated A 5 channel it I HON POM color changes to grey Channel quality The first graph below shows the Quality Index for each channel Galix Holter Analyzer WinTer Operation Manual 31 Each channel will be identified by the colors already designated channel one is pink channel two is light blue and channel three is violet Hour 00 14 00 Channel Quality Index 00 Pr b aT ap rer orc ET Tier e ueris n R 4 1 1 I 71 mi m o 1 2 4 5 B 7 8 9 1 13 14 15 16 171 18 18 2 2 Quality indexes from 0 to 100 Hours from O to 24 On both sides of this graph the user will see the scales that indicate the quality of the recording in each channel which ranges from 0 to 100 The closer the tracings are to 0 the higher the noise and thus the lower the signal quality and vice versa If one of the three channels is deactivated that channel s graph is displayed in gray and has a quality index of O Channel Quality Index The Channel Quality Index 15 a parameter that estimates the noise content of an E
70. shed setting up all the previous parameters click the following button to start analysis Start Analysis Galix Holter Analyzer WinTer Operation Manual 32 9 ECG STRI PS POST ANALYSI S Features Displays 3 channels eight seconds ECG strips at 25 mm sec Locates the eight seconds strip within the one minute signal displayed Stores the strips that will later become retained strips Labels the retained strips Instantly prints 8 16 or 24 seconds of the ECG signal Smith Albert 30333617 See ECG Strips Save Strip Strip Print ECG Trend Full Morphol Jigmificant Hourly Retained Print P strip aphics Disclosure Events Table Strips Mem YS ee a ae re PEE 735 679 81 84 88 Print Reports Holter Report Summary v Detail 24 Hour Statistic Graphics Ful Disclosure Channel hn 1 24 Hours page Select Hours Morphologies Hourly Table Retained ECG strips 16 20 00 Histogram and Long Term HR Y Hour Print Reports screen will be described on chapter 18 Press Cancel to continue with the analysis without printing at this stage 9 1 Eight seconds and one minute graphs On this screen two important graphs are displayed The first one contains eight seconds of the electrocardiographic signal and the second the minute that corresponds to these eight seconds Beat classification The beat label will be placed on it Each one of the
71. signal Arrow Goes forward 2 seconds in the signal Page up Goes forward 1 minute in the signal Page Down Goes backwards 1 minute in the signal Also the same action can be accomplished by using the scroll bar located under the 8 second signal graph Galix Holter Analyzer WinTer Operation Manual 34 688 711 711 695 695 688 672 222 648 l Backs down 8 Advances 8 seconds Backs seconds down by 1 Button goes backwards increments and forward Another way to change the current 8 seconds is by clicking in any place of the one minute signal The user clicked this point Current time On the left of the screen between the two graphs the time is displayed in Hr Min Sec format Hour 00 15 00 9 2 Storing strips The user will be able to store up to 32 eight second strips Each one of these strips will be saved with the following information Strip label Classification of each beat Heart Rate between two beats R R Interval between two beats Galix Holter Analyzer WinTer Operation Manual 35 The number of strips to save or to print will be determined by the size of the red panel in the current minute graph According to user needs 8 16 or 24 meaning 1 2 or 3 8 seconds strips can be saved or printed see Changing Strip Length All the stored strips can be viewed from the Retained Strips screen To save strips the user must click on eave cnp The following screen
72. stitution Address Phone Emal NN Physician Information by Institution LastName poe FistName om O Address 2555 Collins Ave Suite c 5 Phone 305 534 5905 Fax 305 5341 78222 Icons to add and delete physicians Galix Holter Analyzer WinTer Operation Manual 12 This window contains three file folders Physicians Institutions Information Physician configuration Data Source 5 1 Physicians Institution Inf File folder This file folder contains A Institution Information Information corresponding to those institutions which have already been stored in the database Institution Name of the clinic hospital etc This name will appear as a header in the Holter Summary Report and the Patient Diary Clicking on the arrow found on the right of the control will display the institution names in alphabetical order Address Address of the selected institution Telephone Phone number of the selected institution Fax Fax number of the selected institution Physician Information by Institution Information of the physicians belonging to each institution Last Name Last name of the physician who will analyze the study for the selected institution in the upper quadrant If the user clicks on the arrow to the right of this control he she will note that all the last names of the selected institution s registered physicians are found in alphabetical order Name Physician s name
73. t Vu A 1 v Supraventricular Ectopic AGREE TID miden m SN T 11111114 4 00 02 39 Day 1 02 39 1 IIR lng 30 Day 1 nm oe i 1 Y LRL EAT i i a Kis 46 26 00 46 26 Day 1 ey 00 48 Day 1 40 minii E M tit i 5 UTE wn LLLI Lll 48 43 Day 1 pn Ug 00 50 08 Day 1 oe ebb nin 01 29 Dax 1 01 13 40 Day 1 40 Dav 1 The user will be able to access any of the ECG strips on screen by double clicking on Galix Holter Analyzer WinTer Operation Manual 57 15 SIGNIFI CANT EVENTS EDITOR Features e t shows in detail each one of the events detected by the system t enables the rejection of those events where the user does not agree with the events detected by the system Accessing the screen From the Significant Events screen The Significant Events edition can be performed in two different ways and the procedure depends on the type of event to deal with Ventricular and Supraventricular Events edition Ventricular and Supraventricular Events are edited by reclassifying the beats that generate them For example being a Ventricular Couplet a sequence of two consecutive ventricular ectopic beats to delete a V Couplet from the classification we should change at least the classifica
74. the full disclosure screen by right clicking on it The usual re classification pop down menu will appear where the user can perform the proper selection RO RR AM N Mormal V Ventricular 8 Supraventricular hk A Aberrant R Artifact 07 Paced D Delete Beat th Arh Galix Holter Analyzer WinTer Operation Manual 46 e chain of beats and re classify all of them in a single step By holding the mouse left button pressed and moving the mouse the user will draw a red frame on the Full Disclosure screen Then by right clicking on any point inside the frame the re classification pop down menu will appear Then when the user selects one menu option all beats inside the frame are re classified under that category wipes vele Sal Nye parer Hol dde d len 11 MAMAS exem Md v 22 1117 11111111 it pras Pda dd Galix Holter Analyzer WinTer Operation Manual 47 12 ARRHYTHMI A MORPHOLOGI ES Features e It identifies all the templates detected by the system for each channel he user can change the template labels at will Accessing the screen From the Full Disclosure screen clicking on the Morphologies button in the toolbar Current template blue background Demo Patient 123456700 00 BITTE m Reclassify Trend Full Morphol Significant Retained Print Mo
75. tion of one of these two beats This can be done in two different ways e From the Significant Events Edition screen which shows many different events of the same nature see the figure above On this screen the user can o Select one or several events and click on the Reclassify Event button This procedure will open a pop down menu from which the user can select the new classification for the selected events Tip for multiple events selection To select a single event the user simply has to click on it To select the second third the user has to hold the Control key pressed and click on them one by one o Click on the Reclassify Page button In this way all events on screen will be selected and the same menu of above will appear for beats reclassification o Click on the Reclassify button In this way all events of this kind are reclassified with the same procedure as stated above e From the ECG strip itself which is accessed by double clicking on any of the events on the Significant Events Edition screen The corresponding event is opened and the user can reclassify anyone or all of the beats that form the event NOTE Performing the reclassification from the Significant Events Edition screen is very fast and easy the other hand in multiple beats events like couplets triplets bigeminy and tachycardia all beats that form that event receive the same classification This might not apply to certain cases
76. tion of the Holter analysis it is important to know that these messages have appeared For this reason a control file CRECG LOG is created to report these messages If everything is OK the system will recognize if one of the following options was selected in the configuration process Supervised detection and classification Page Scan The screen corresponding to the option selected will appear after the signal is decompressed If neither option was chosen then the Statistical Graphs for 24 hour period screen is displayed The following describe certain possibilities that may occur during analysis 7 5 Existing patient If a previous Holter study has been done on a patient entering the identification number or the patient s name will automatically display the rest of the patient s information Galix Holter Analyzer WinTer Operation Manual 27 7 6 Existing patient study Since each ECG recording normally is conducted over a 24 hour period the system expects to find only one study per day Thus the system uses the IDz and the date of the study to identify the patient If it finds out that there is already a study on that date for that patient most probably we are about to make a mistake for that reason we are requested to double check this download Patient already has a study for that date you wish to rewrite the study If Yes is selected the system will rewrite the patient data and the Holter study data
77. tion of the predictive value of decreased HRV after Acute Myocardial I nfarction The following should be observed when assessing the prognostic value of HRV in clinical studies that include survivors of an Acute Myocardial Infarction Decreased HRV is a predictor of mortality and arrhythmogenic complications independent from other risk factors There is a general consensus that the HRV should be measured a week after the infarct episode Although the short term HRV provides prognosis information the HRV measured in 24 hour record is a stronger predictor The short term HRV can be utilized for an initial assessment of AMI survivors For prognosis purposes there is no better measure than the time domain HRV statistic that calculates the total HRV SDNN or the Triangular index Some other measures for example the ULF spectral density over the 24 hour record is also useful A high risk group should be chosen in conjunction with the following variables SDNN 50 or a Triangular index 15 Even if the predictive value of HRV by itself is modest it is the most important and the combination with other risk factors will provide a better diagnosis Assessment of Diabetic Neuropathy Autonomic neuropathy as a complication of diabetes Mellitus is characterized by an extensive and early neuronal degeneration of the small nerve fibers of both the sympathetic and parasympathetic tract The clinical manifestations are functional disparity and includ
78. ts VLF and ULF have not been completely figured out Clinical Utility of HRV Even though HRV has been the subject of numerous clinical studies only a general consensus was reached on the clinical utility of HRV in two scenarios A decrease in HRV can be used as a risk predictor after an Acute Myocardial Infarct and as an early warning signal for diabetic neuropathy Risk Assessment after Acute Myocardial nfarct AMI The observation that in patients with AMI the absence of respiratory arrhythmias is associated with an increase in intra hospital mortality rate represents the first of a long series of reports that have demonstrated the prognostic value of the HRV for the identification of high risk patients Decrease in HRV is a powerful predictor of mortality and arrrhythmogenic complications such as Sustained Sympathetic Ventricular Tachycardia in patients after a myocardial infarction The predictive value of the HRV is independent of other factors established for the stratification of post infarct risk such as decrease in left ventricle ejection fraction increase in ventricular ectopic activity and presence of late potentials For the prediction of any cause of mortality the value of the HRV is similar to the left ventricle ejection fraction Nevertheless the HRV is superior in predicting the arrhythmogenic events such as sudden death and ventricular tachycardia Recommendations Summary and recommendations for the interpreta
79. tter the Holter or ECG analysis will be Up to date refers to the capacity of the hard disk RAM size video card resolution and microprocessor speed All these upgrades will enable the user to obtain greater speed in the calculations and an optimization in the presentation of graphic displays Similar arguments apply to the printer which we recommend be a laser one Before loading any supporting or informative programs the user should contact Galix Biomedical Instrumentation or an authorized representative Galix Holter Analyzer WinTer Operation Manual 5 2 SCREEN HI ERARCHY Automatic Holter Analysis Automatic VLP Analysis Heart Rate Variability 24 Hour Statistic Graphics Print Menu Galix Holter Analyzer WinTer Operation Manual 6 3 OPENING THE HOLTER ANALYZER SOFTWARE To open the Holter Analyzer Software click on the Start button of the Windows Bar and then select Programs gt Holter gt Holter Play DvD 23 Windows Messenger SetProgram Access and Defaults Windows Movie Maker WS Windows Catalog Windows Update Physio 28 Operation M Accessories 7 Adobe vr BigFix My Computer ECG PS 7 Ergo Ps m Games 7 WinTer v3 1 2 7 GBI USB ECG Monitor 7 Get Internet Access 7 Internet Internet Explorer Instant Messaging H 99 Internet Browsers Microsoft Office Outl LPA 7 Microsoft Money

Galix WinTer Holter Analyzer User`s Manual

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