3DMP User Manual
Contents
1. fo l 01212005 9K Cancel The patient s data will be saved when the OK button is pressed or when the user switches to another tab in the patient dialog edit an existing patient To make changes to an existing patient first find the patient you wish to make changes for For information on how to find a patient click here Find a patient Once the patient is selected the Patient dialog box will appear 16 3DMP User Manual LPH 7 Male donos Sio io 2401 21 20 2K Cancel You may change any of the data on this screen When you have completed your changes press the OK button and all changes you have made will be saved in the database find a patient To find a patient select Patient gt Find Patient from the menu bar This brings up the Find dialog box Make sure the Patient Name button is selected then type in the name or partial name of the patient you are trying to find and press the Search button This will bring up the Search results dialog box 17 3DMP User Manual 1l 1010 Patient Test This dialog box contains all possible matches from the search You can now click on the patient you are looking for and press the Select button to bring up the Patient dialog box If you type nothing in the Find dialog box and press the Search button it will bring up a list of all patients delete a patient To delete a patient select Patient gt List Patients from the menu bar This will bring up2. the Patient List dialog box E a Patient Test Male Mon May1 30088 Fri Jan 21 2 Click on the patient you wish to delete then click the Delete button A message box will open asking you to confirm that the patient should be deleted Click OK to finish deleting the patient 18 3DMP User Manual Patient test EKG data test a patient Be sure to read the Patient Testing Checklist before proceeding To create a new test first select the patient you would like to run a test for using either the Patient gt List Patients or the Patient gt Find Patient menu item Once you have selected a patient the Patient dialog box will appear Tesis aa O a JE es Mate o fo l 01212005 2K Cancel In this screen select the Tests tab 19 3DMP User Manual 1039 TES11164 Created o Tu 20 3DMP User Manual Select the EKG Sample tab Connect the EKG leads to the patient and press Record EKG No EKG Sample This will begin the EKG sampling process When the sampling is complete approximately 82 seconds you may review the EKG data using the EKG Image Display dialog box If the quality of the EKG data is poor check the leads connected to the patient and press Record EKG to obtain a new sample When an adequate EKG sample has been obtained review the EKG data and rate the EKG Tracing Quality You can then press Send to send the data to the server or press OK to save the test information
3. Contents Notice Overview Patient Testing Guide Tutorial 3DMP User Manual 3DMP User Manual Safety Notice Specifications Technical Support Testing and Lead Placement Reviewing ECG Data Quality User Management Patient Management Patient Test EKG Data Reports valas RAN QL S va E o 3DMP User Manual Safety Notice e Follow the normal safety precautions for any office equipment when using the 3DMP machine e Use only the AC adapter power supply included with the 3DMP device e To protect against electric shock and to ensure good quality ECG signals plug the AC adapter into a properly grounded electrical outlet e Avoid using wall outlets controlled by wall switches or shared with other equipment e Do not remove any component from the 3DMP machine this will void product warranty e Use the equipment only for its intended use to collect and transmit human ECG data and to display the test results Warnin During cable connection and installation take care not to turn on either the computer or the monitor To prevent electrical shock do not remove cover No user serviceable parts are located inside Refer servicing to qualified personnel In the unlikely event the computer or the circuit on which it functions is hit by lightning it may shut down Before rebooting take note of the data that may have been lost from the time the computer shut down before recommencing testing During setup try to work in a st
4. G data and to display reports and a Database Server which automatically analyzes the patient EKG data and generates reports on demand This manual contains the documentation for the 3DMP application The application GUI consists of a menu a toolbar for common tasks and dialogs for interacting with the user 3DMP User Manual ORR y sores Tate B14 TORE ine a TU HAREE Theo Terei 1 d Livcoast Your tlasrt 3DMP User Manual Patient Testing Guide Testing Procedure and Lead Placement pa Select a quiet room with minimal foot traffic away from other heavy diagnostic equipment such as CT or MRI scanners with a sign on the door 3DMP testing in progress please do not enter 2 Select an electrical power outlet which is well grounded without other devices sharing with 3DMP device power cords 3 The examination table should not have any metal surface to avoid interference Be sure the patient turns off all personal electronic devices Let the patient rest comfortably supine on his her back completely relaxed for a recommended 20 minutes 6 During the resting period use 70 isopropyl alcohol swabs to prepare the skin surfaces for the lead placements 7 A razor can be used to shave off the excess hair in and around the sites for better adhesion of the hydro gel electrodes or contacts for the limb clamps 8 Attach the conductive adhesive hydro gel ECG electrodes to all five sites or one adhes
5. Quality The 3DMP device is an electrocardiography apparatus that represents patient cardiac electric signals in both time and frequency domains Because of the sensitive diagnostic capabilities of the device fidelity to a true electrocardiograph waveform must be maintained This constitutes a relatively artifact free waveform over the 82 second time span necessary for complete waveform capture This section describes criteria used to exclude or resample a particular test because of some element confounding the tracing artifact such as patient movement or noise for example Use the following criteria to determine whether to accept or discard i e resample ECG data immediately after sampling The test should be resampled if the waveforms represented in five or more 5 second segments of ECG data contain idiopathic extrema that deviate from the baseline by gt 2mm and appear gt 10 times ii 1 Va ee he F E no al aa J 1 Gik i aiia re Ley ar A The test should be resampled if two or more 5 second segments of ECG data demonstrate idiopathic extrema that deviate from the baseline by gt 5mm The test should be resampled if within a 25mm section of waveform in any 5 second segment of the ECG data the waveform strays from the baseline by gt 3mm 3DMP User Manual pa es ey ae i ges creme i gt 25mm 34mm The test should be resampled if the waveform demonstrates e a radical
6. atic free environment While testing the patient the 3DMP system must be insulated at all times from metal objects cellular phones and any device that creates an electro magnetic field If the EKG leads or other cable components are touching a metal surface the extremely sensitive equipment may pick this up as interference inducing an artifact in the waveform displayed 3DMP User Manual Specifications Software 3DMP Client v 1 0 0 Leads V5 and II Environmental Requirements 50 F 10 C 95 F 35 C Relative Humidity lt 85 Input Impedance Transdermal electrode signal amplifier A D Converter A D Set 2 channel 12 bit Power Requirements 100 115 VAC 50 60Hz Leakage Patient gt 2 uA Ground Chassis gt 10 mA Frequency Domain Resolution 0 2Hz Input Offset Tolerance Protected 2 5kV min 25V Equipment Type Safety Classification Class 1 CF 3DMP User Manual Technical Support If a user encounters difficulty during installation or test administration of the 3DMP device technical support can be accessed via Online Service and Support or via the telephone Online Service and Support Connect with Premier Heart online by visiting our website at http www premierheart com The website will also provide you with the latest updates downloads and contact information Premier Heart Telephone Fax Support Premier Heart telephone support services are available to all of our customers For information o
7. atients A list of patients will be displayed Select the patient whose report you wish to view The list of reports available for the patient will be displayed Note In the initial release of the 3DMP Web Application the report must be downloaded via the 3DMP GUI or made available by Premier Heart staff before it will be listed in the Web Application Press the PDF button for the report you wish to view This will open the report in Adobe Acrobat Reader 36 3DMP User Manual Troubleshooting test the network connection To test the connection to the database server select File gt Test Connection from the menu bar The Test Connection Dialog will appear and display the current status of the network connection a Connected Connection If the connection fails use the Force DB Reconnection menu item to renew the connection If this fails check the network cables and ensure that network settings are correct test the EKG sampling hardware To test the connection to the database server select File gt Test Hardware from the menu bar The Test Hardware Dialog will appear and display the current status of the EKG sampling hardware EKG Hardware Detected test report displaying To test the downloading and displaying of reports select File gt Test Reporting from the menu bar A sample report will be downloaded from the database server and displayed in Adobe Acrobat Reader 37 3DMP Us
8. deviation away from the baseline 80 amp plumn 10 at gt 2mm two or more times e a single episode of gt 5mm da tee oc cee Pod me mm tate A Pee L em 10 4568 46686 3568 3668 2568 2668 1588 1888 566 4568 4888 3500 3668 2568 26686 1568 1888 568 3DMP User Manual Example ofa poor quality ECG tracing 1986 16686 11 1466 1356 1368 1258 1288 1156 1166 1858 1888 958 968 1466 1358 1368 1256 1288 1158 1168 1658 1668 958 968 3DMP User Manual Example of a marginal quality ECG tracing 1666 1888 12 3DMP User Manual How To Use the 3DMP System How To User management e Jogin as a user e add a user e delete a user Patient management e add a new patient e edit an existing patient e find a patient e delete a patient Patient test EKG data e testa patient e review patient test data e send patient test data to the server e find patient test data e delete patient test data Reports e download a report e view a downloaded report e delete a downloaded report e download a report using the Web App Handling problems and errors e test the network connection e test the EKG sampling hardware e test report displaying e send a bug report e enable remote administration 13 3DMP User Manual User management Jog in as a user To log in as a
9. er Manual O Table of Conte gt 5 SDMP Single Sample Patient 16552 Name Sample Paticnt Gender M SSN 111111111 Age 37 3DMP is a new non invasive device for the diagnosis of coronary artery disease CAD t mathematically analyzes clectrecardiogram EKG data from leads IH and V5 simultineously The results of the mathematical calculations are represented graphically as the power spectrum and its variations impulse response amplitude histogram phase angle shift coherence and cross corelition They represent various aspects of the electrical activity of the heart The dithase in 3OMP contains the graphs of 7 000 healthy people and 16 000 people with heart diseases The results of each tested individual are statistically matched with the database to derive accurate diagnostic conclusons Clinical studies have shown that 3DMP has a sensitivity of 90 and a specificity of 83 90 in detecting ischemia duc to CAD withowithout myocardial infarction MI However a positive finding of CAD or CAD with MI by this test does not guarentee that one has the disease Similarly a negative finding of CAD or CAD with MI by this test does not guarantee that one does not hawe the disease SDMP assumes that the person tested has normal or comected serum electrolyte chemistry and complete blood count CBC If these laboratory test results are either unknown or dated and if they are unknowingly abnormal at the time of this 3ODMP test the re
10. ive hydro gel ECG electrode fo lead V5 and four limb clamps to the extremities 9 Lead placements two finger breadth above the distal radial crease of the inner wrists two finger breadth above the medial maleoli of the inner ankles and one at the intersection of anterior axillary line and the fifth intercostal space V5 10 Lead placements for amputees are demonstrated in the following diagram a channel mode 7 Lead 3 channel moc 5 Lead 3 cha Le ELECTRODES TA ELECTRODES ee Channel 1 farsa 3 Red Brown Red 00 N modified v1 Red Black Brown ry Channel 3 Channel 3 ba Eq LEAD II nano mo White Black Orange Torso lead placements for amputees 11 Place the yoke of the ECG lead wires between the patient s legs to allow each wire to fan out to its destination in the Peacock Tail configuration to avoid crossing over of the lead wires 12 The lead wires should not touch any metal surface 13 Enter the patient s demographic data through the GUI according to the instructions in the manual 14 Instruct the patient to remain still and no talking for approximately 82 seconds during each ECG sampling period 3DMP User Manual 15 Repeat the tests a minimum of 3 or more times as the situation allows to generate good quality tracings and reproducible test results 16 Generate the automatic reports for review and printing according to the instructions in the manual 3DMP User Manual Reviewing ECG Data
11. loaded report Type Automatic Fri Jan 21 2005 The report can be viewed in Adobe Acrobat Reader by pressing the View button view a downloaded report 32 3DMP User Manual To view a downloaded report on the results of a test select Patient gt Patient List from the menu bar This will open the Patient List dialog TT Name Gender DOB DBID Created DE O RSS RS RR eee Patient Test Male MonMayl 30088 Fri Jan 21 2 Select the patient whose report you wish to view then press the View button This will open the Patient dialog Go to the Tests tab Select the test whose report you wish to view from the list and press the Report button This will open the Report List dialog which contains a list of all reports that have been downloaded for the test If no reports have been downloaded use the Download button to download the report 33 3DMP User Manual Press the View button This will open the report in Adobe Acrobat Reader able of Conte Patient Report 3DMP and Angiogram gt 3 3DMP Single Table of Contents IOMP Test SHEILA scrosressssese crase nro cenas onaa ara cas sara Auto Power Spectrum of Lead IL Transfer Function Impulse Response Function Amplitude Histogram V5 Amplitude Histogram IL EKG Trace for Lead V5 ES ros mansas wsunenescwssa ves 12 Of 16 EKG Trace for Lead IL sumen assesmoanosessasses aaen 13 of 16 jon eb of 16 PRI CH
12. mode At this point you should inform Premier Heart support personnel that the system is available for remote administration The Premier Heart technician will inform you when work has been completed on your machine at this time you can return to the System Administration Menu by pressing the Ctrl Alt and Backspace keys simultaneously The Close Remote Connection will now appear press ENTER to disconnect the system from the remote administration server This will return you to the System Administration menu select Exit to reboot the system 41
13. oh wu 16 of 16 delete a downloaded report To delete a downloaded report on the results of a test select Patient gt Patient List from the menu bar This will open the Patient List dialog 34 3DMP User Manual FR RR Patient Test Male Mon May1 30088 Fri Jan 21 2 Select the patient whose report you wish to delete then press the View button This will open the Patient dialog Go to the Tests tab Select the test whose report you wish to delete from the list and press the Report button This will open the Report List dialog which contains a list of all reports that have been downloaded for the test Select the report you wish to delete and press the Delete button A message box confirming the delete will appear press the OK button to delete the report download a report using the Web App 35 3DMP User Manual To download a report using the 3DMP Web Application go to http www premierheart com in your web browser Click on the Login link in the upper right hand corner of the page This will open the Login page Enter your username and password and press the Login button When you have logged in the Welcome page will appear Select the Patient List link from the menu bar on the left side of the page This will bring up the Patient List page Enter a portion of the patient name and press the Submit button to search for a specific patient or press the All Patients button to browse the list of all of your p
14. r inquiries please contact us at 516 883 3383 Use your fax machine to receive send general product information and fact sheets by dialing 516 883 5812 Support for old and discontinued versions In the event that a new version of the 3DMP software is released you will receive updated information via email Telephone support will be also provided for the set up of the latest software Service and Support Offices North America Premier Heart 14 Vanderventer Ave Port Washington NY 11050 U S A Tel 516 883 3383 Fax 516 883 5812 Manager Joseph T Shen MD jtshenmd premierheart com Technical Support support premierheart com Asia Pacific Rim Premier Heart Asia Ltd Room 1202 3 121F Chinachem Johnston Plaza 178 186 Chinachem Johnston Road Wan Chai Hong Kong 040 Tel 852 9771 5445 Fax 852 3006 4275 Contact Eric Chien eric chien O premierheart com 3DMP User Manual Overview 3DMP is a non invasive device for the diagnosis of coronary artery disease CAD It mathematically analyzes electrocardiogram EKG data from leads II and V5 simultaneously The results of the mathematical calculations are represented graphically as the power spectrum and its variations impulse response amplitude histogram phase angle shift coherence and cross correlation They represent various aspects of the electrical activity of the heart The complete 3DMP system consists of an application used to gather patient EK
15. sults may be skewed send a bug report To send a bug report select Help gt Send Error Report from the menu bar This will open the Send Error Report dialog box Enter a description of the problem and the the steps that led up to it then press OK to send the bug report 38 3DMP User Manual enable remote administration Important This operation could render the 3DMP system unusable Only perform this operation under the direction of Premier Heart support staff Reboot the system to get to the System Administration Menu Select the Remote Administration Mode option 39 3DMP User Manual 3dmp Administration Utility Admin Menu Select an administration task Ethernet LAN config Wireless LAN config Add DNS server Display IP address Display WLAN MAC address Display system statistics Set system date Set timezone Remote Administration Mode Update software Network troubleshooting menu Exit The Initiate remote Connection dialog will display prompting you to press ENTER Once this is done the system will connect to the Premier Heart remote administration server 40 3DMP User Manual L ry fi g mi Press ENTER to allow remote connections to the machine This will start a screensaver while remote technicians work on your machine To exit from the screen saver press Ctrl Alt Backspace K DK gt The system will then display a screensaver while it is in Remote Administration
16. to the local machine and close the dialog box 21 3DMP User Manual review patient test data To review a test for a patient select Patient gt Patient List from the menu bar This will open the Patient List dialog Nome Gender bon DBID created o O O O 1010 Patient Test_ Male MonMay1 30088 Fri Jan 21 2 22 3DMP User Manual Select the patient whose test you wish to review then press the View button This will open the Patient dialog Go to the Tests tab TES11164 Created O T Select the test you wish to review from the list and press the Edit button This will open the Test dialog for that test Go to the EKG Sample tab and click on the image of the EKG 23 3DMP User Manual This will open the EKG Image Display dialog which you can use to review the EKG trace data The X axis represents time in 10 ms intervals and ranges from 0 to 8192 that is 81920 ms or 81 92 seconds the Y axis represents voltage in millivolts send patient test data to the server To send a test for a patient to the database server select Patient gt Patient List from the menu bar This will open the Patient List dialog 24 3DMP User Manual FR RR Patient Test Male Mon May1 30088 Fri Jan 21 2 Select the patient whose test you wish to send then press the View button This will open the Patient dialog Go to the Tests tab Select the test you wish to send from the list and press the Edit b
17. up the Patient Dialog 28 3DMP User Manual festa ES o Ee EES JE O Mate 4 o 2 01 21 2005 Click on the Test tab In this screen click on the test that you wish to delete and press the Delete button A message box will open asking you to confirm that the test should be deleted Click OK to finish deleting the test 29 3DMP User Manual Reports download a report To download a report on the results of a test select Patient gt Patient List from the menu bar This will open the Patient List dialog a Saas ae Male MonMay1 30088 Fri Jan 212 Patient Test Select the patient whose report you wish to view then press the View button This will open the Patient dialog Go to the Tests tab 30 3DMP User Manual Select the test you wish to download a report for from the list and press the Report button This will open the Report List dialog which contains a list of all reports that have been downloaded for the test Type bate Press the New button This will open the Report Download dialog Select the Report Type usually Session Summary then press the Download button A message box will be displayed confirming that the report has been downloaded 31 3DMP User Manual If the report is not yet available a message box explaining this will be displayed Ea The Report Download dialog will close and the Report List dialog will be updated to included the newly down
18. user on startup of the 3dmp machine select your user name in the scrolldown bar of the Login dialog box and click the OK button Testuser M OK If the 3dmp machine is already running and you wish to switch users select Admin gt User gt Set Active User from the menu bar This will bring up the Switch User dialog box Premier Heart 7 OK Select your user name and click the OK button to log in add a user To add a new user to the system select Admin gt User gt New User from the menu bar This will bring up the User Profile dialog box 14 3DMP User Manual Enter in the new user s name in this dialog box The location field is always set to the name entered in the Location dialog box can not be changed by the user You may also input an email address and phone number for the user Once you have input the information click the OK button to finish creating the new user delete a user To delete a user select Admin gt User gt Delete Current User from the menu bar A message box will open asking you to confirm that the user should be deleted Click OK to finish deleting the user Once the user is deleted the Switch User dialog box will open and you may log in as another user 15 3DMP User Manual Patient management add a new patient To add a new patient select Patient gt New Patient from the menu bar This brings up the Patient dialog box EE Pr l 1 JE ee Mate o
19. utton This will open the Test dialog for that test Go to the EKG Sample tab and press the Send button Note that the EKG Tracing Quality field must be set to a value other than undescribed or the send will fail 25 3DMP User Manual A message box will appear confirming that the data has been sent to the server 26 3DMP User Manual find patient test data To find a test select Patient gt Find Test Data from the menu bar This brings up the Find dialog box Make sure the Test Filename button is selected then type in the name or partial name of the filename you are trying to find and press the Search button This will bring up the Search results dialog box 27 3DMP User Manual Patient ID Name Create Dat Test ID_ Filename Test Date Status Results a 1010 Patient TesFrijan212 1041 TES11821 Created O Results of search It contains all possible matches from the search and you can now select the test you are looking for by clicking on the test and pressing the Select button If you type nothing in the Find dialog box and press the Search button it will bring up a list of all tests delete patient test data To delete a test select Patient gt Patient List from the menu bar This will bring up the Patient List Dialog as ae aaa 1010 Patient Test Male Mon May1 30088 Fri Jan 21 2 Click on the patient whose test you wish to delete then click the View button This will bring
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