Norav Medical 1200WR WIRELESS ECG RECORDING SYSTEM User Manual PCECG1200WR Revised UserMan

Norav Medical Ltd. WIRELESS ECG RECORDING SYSTEM PCECG1200WR Revised UserMan

Contents

USERS MANUAL 3

Measurements/ Interpretation NV-54/PCECG1200W 89QRS Display Figure 22: Measurements—QRS display The QRS screen displays the QRS in each of the leads and a strip lead of a default lead (defined in the setup of the application from which Measurements was accessed). The QRS displayed in each of the leads is marked by a red rectangle in the strip lead. To view a different QRS in all the leads, drag and drop the square by to a different QRS. The QRS markers can be moved to the left and right (between the previous and the next marker). Changes in marker positions are recalculated and displayed in the tabular screen and the Averages screen.
Instructions for Use and Technical Description Norav Medical Ltd. 90Toolbar of Averages/QRS Displays Figure 23: Toolbar of Averages/QRS Horizontal ScaleVertical Scale
Measurements/ Interpretation NV-54/PCECG1200W 91Caliper Display Figure 24: Measurements—Caliper Toolbar of Caliper Display Figure 25: Toolbar of Caliper Print AverageSave Table Reset measurementCaliper Grid Next QRS About Add/remove markerRight/down markerRemarksQRS Next stripPreviousQRS Filters Back Left/up markerWave type Marker time
Instructions for Use and Technical Description Norav Medical Ltd. 92The Caliper screen (above) is opened via the menu, the toolbar, or by double clicking a lead in the QRS or Averages screens. It displays one QRS with its values. The user can edit locations of wave markers, display different QRS in the same lead, or navigate through leads and display QRS in different leads. Changes in wave marker positions are recalculated and displayed in the tabular screen. Toolbar and Menus To do this Click this icon Or use this short-cut key Or select this menu Description Save Measurements Ctrl+S File > Save Saves measurements to test file on disk. Print ECG F6 File > Print ECG Off line printing. The ECG is printed in miniature format. Horizontal: 6.25 mm/sec, vertical: 2.5 mm/mV. Add/View Remarks Alt+V+R View > Remarks Lets you enter free text during or after the ECG recording. This is printed and saved together with ECG traces. Reset Measurements Alt+F+M File > Reset MeasurementsReset measurements to those calculated by the application. This option will eliminate all the modification performed manually in the measurements. To Open Measurements in Table Format View > View Format > Measurements table Displays the measurements in a table format. To Display QRS Averages View > View Format > Averages Displays the QRS averages on screen. To Display QRSs in All the Channels View > View Format > QRS Displays the QRSs in all the channels on screen . Display Caliper View > View Format > Caliper Displays the Caliper. Display the Next Leads Ctrl+0 View > View Format > Next strip Lets you scroll through all leads in the 3X1 display. Display/Hide the Grid View > Grid Optional display of 5mm raster.
Measurements/ Interpretation NV-54/PCECG1200W 93To do this Click this icon Or use this short-cut key Or select this menu Description To Display Information Help > About… Displays software version number. Quote this for any software inquiry. Also shows memory size and free disk space. The HASP ID number is the ID of existing software keys. This ID number is used for adding software options. Previous QRS View > View Format > Previous QRSMoves to previous QRS on the same channel. Next QRS View > View Format > Next QRS Moves to next QRS on the same channel. Set 50/60 Hz Filter ECG > Filters > 50/60 Hz ON/OFF for line interference filter. Set OPTIONS for 50 or 60 Hz prior to operation. Set EMG Filter ECG > Filters > EMG ON/OFF for muscle noise filter. Set Base Line Filter ECG > Filters > BaseLine ON/OFF for baseline filter on ECG data. Move Marker to Right/Bottom / ------------ Enabled in Caliper screen when a wave type and marker name are selected. Click to move the marker right or down (according to the marker selected). Disabled when no wave marker is selected or the Caliper screen is not displayed. Horizontal Resolution --------------- (Averages and QRS screens) Lets you choose between horizontal displays of 12.5, 25, 50, and 100 mm/sec. (Default: 25 mm/sec) Select QRS Wave Type ------------- In Caliper, lets you select the QRS wave type from the list to view its markers. After selecting the wave type, select a marker name to move it. Vertical Resolution ------------- (Averages and QRS screens) Lets you choose between vertical displays of 5, 10, 20, and 40 mm/mV. (Default: 10 mm/mV)
Instructions for Use and Technical Description Norav Medical Ltd. 94To do this Click this icon Or use this short-cut key Or select this menu Description Select Name of QRS Marker ------------- In Caliper, lets you select the name of a marker to edit it (move it up/down/left/right). Add/Remove ECG Wave Marker File > Add/Remove ECG Wave Marker (Caliper screen only) Opens a dialog box and lets you check/clear the wave markers to be displayed and calculated. Print Reports ------ File > Print Reports Lets you choose the report to be printed from the sub-menu: Single QRS/QT Report, Multiple QRS Report, or All Reports. Table 26: Measurements Toolbar and Menus
DATABASE APPLICATION NV-54/PCECG1200W 95CHAPTER 13: DATABASE APPLICATION (This option is available with the D1\D2 license) Database application is an optional package requiring a D1 or D2 permission license. Install Database from the PC-ECG1200 package. Keep and manage ECG studies in a catalog organized according to patient name or ID. In a network, users can share the database (save it in the server). Data acquisition for all applications can be initiated either in the application itself or from the database main screen. Figure 26: Database Main Screen Select group field values for query of displayed list of patients List of tests referring to selected patient (selected test highlighted) List of patients in database (or in selected group)
Instructions for Use and Technical Description Norav Medical Ltd. 96First Time Use When you first start Database application, you are prompted to confirm the location of the database. • Choose New if no database exists • Choose Open to work with an existing database Figure 27: Database Patient Query
DATABASE APPLICATION NV-54/PCECG1200W 97 Figure 28: Database Properties of Selected test Comparing Rest Tests Database application allows the user to compare rest tests on 1 or 12 channels. To Compare Rest Tests 1. Select two or more Rest tests from the Database interface 2. Click Compare
Instructions for Use and Technical Description Norav Medical Ltd. 98Database Setup Click Setup on the Toolbar to access the following parameters: Tab Description Default Workspace Select the default workspace. Choose Data Directory Input data directory (with browsing option). External Patient Data file Input the location of the external patient data file (with browsing option for PatientFile.INI file). Delete with Password Check this option to require a password for DELETE (default: unchecked). Table 27: Database Setup Options Toolbar and Menus To do this Click this icon Or use this short-cut key Or select this menu Description Main Toolbar Connect to Database Ctrl+W File > Database Connection Wizard Creates a new database or retrieve path for an existing one. Import tests to database Ctrl+I File > Import ECG Data FileAdds studies recorded and saved outside the database. To select all patient data files within a directory, press CTRL + A and verify that all files are checked. Define Workspace Preferences Ctrl+T View > Setup Defines the location of default workspace, patient identification, and a special file called External File. This file (Windows.INI format) allows the user to prepare a list of patients that can be read by PC-ECG 1200 applications. Note: This feature does not require the D3 software key. Edit Groups File > Groups Defines different patient groups, such as Private, HMO, Military, etc.
DATABASE APPLICATION NV-54/PCECG1200W 99To do this Click this icon Or use this short-cut key Or select this menu Description View Application Information Help > About Displays version number, communication and web information, and disk and RAM memory size. The HASP ID number is used for identification of the software key for adding software options. Patient Toolbar Find a Patient Patient > Find Allows the user to find a patient by entering a string in any or all of ID, Last Name, and First Name fields. Open Patient Detail Patient > Open Patient Allows the user to check for patient information before performing a study on a patient. Add New Patient to Database Patient > New Patient Inserts a new patient. You are prompted to enter partial or complete patient details. Enter ID, Last, and First Name at least. If patient details match an existing one you cannot add this patient to the list. The existing patient matching the details will be checked to allow the user to add a study. Delete a Patient Patient > Delete Patient Deletes an entry. If the entry is not empty of studies, you will be asked to confirm deletion. Perform a New Test Patient > New Test Starts the application and starts recording. Test Toolbar Open a Test Test > Open Test Allows the user to view a study. You must first select a study to activate OPEN.
Instructions for Use and Technical Description Norav Medical Ltd. 100To do this Click this icon Or use this short-cut key Or select this menu Description Compare Rest tests Test > Compare Select two or more Rest tests from the Database interface and click Compare. This option is only available when you check Setup > ECG Recording > Use ECG Database. Click Compare again to end Compare mode and display the Rest test. Copy a Test Test > Copy Test Copies a study. Move a Test Test > Move Test Moves a study and deletes it from the database. The default option is to leave the study’s properties in the database: upon completion of the operation. The study remains in the list with an X sign. You can choose to remove the entire study instead. Delete a Test Test > Delete Test Deletes a study from the database. The default option is to leave the study’s property in the database: upon completion of the operation, the study remains in the list with an X sign. You can choose to delete the entire study instead. Update Database File > Update Database Updates the database. Print Setup File > Print Setup Opens the Print Setup dialog box to set printing preferences. View Test Properties Test > Test Properties Displays study properties. Table 28: Database Toolbar and Menus
Interfacing with Information Systems NV-54/PCECG1200W 101APPENDIX A: INTERFACING WITH INFORMATION SYSTEMS There are several ways to exchange information between PC-ECG 1200 and Hospital Information System (HIS). These are described below: Demographic Data Information System Prepares Patient Demographic Data for PC-ECG 1200: This uses a text file called PatientFile.ini. The location is defined in Database setup. File Name: PatientFile.ini File Format: [PATIENTDATAXXX] ID= LastName= FirstName= BirthDay= BirthMonth= BirthYear= Sex= Weight= Height= Address= Phone1= Phone2= Fax= E-Mail= Medications= Other= [PatientDataXXX]—Section name. XXX—number from 000 to 200. At least one of the keys ID, LastName, or FirstName must be completed. If all these keys are empty, section of this patient will be ignored. The keys Height, Address, Phone1, Phone2, Fax, Email, Medications and Other appear only with Database.
Instructions for Use and Technical Description Norav Medical Ltd. 102Example: [PatientData001] ID=1234567890 LastName=Smith FirstName=Worker BirthDay=11 BirthMonth=6 BirthYear=1959 Sex=1 Weight=59 Height=170 Address=523 Main st. Tacoma Mexico Phone1=702-8765643 Phone2=702-8743031 Fax=702-8743032 E-Mail=nkir@sympo.ca Medications=none Other=none [PatientData003] ID=123456789 LastName=Smith FirstName=Worker3
Interfacing with Information Systems NV-54/PCECG1200W 103HL7 Format File PC-ECG Prepares HL7 Format File with Stress Test Results This file is created upon demand in the study review screen. The file of Stress test in Format HL7 includes: 1. Patient Information: Name: John Last Name: Smith Id Number: 12345678 Birth Date: 24/1/1955 Sex: M Weight: 80 kg 2. Hospital and Physician Information: Hospital Name: General Hospital Hospital Address: Megapolis Physician Name: Dr. Stern 3. Test Date and Time: Test Date: 18/09/1999 Test Time: 12:41:51 4. Test Results: Protocol: Bruce Target HR: 183 Max HR: 175 (95%) Max. SBP: 200 Max. DBP: 100 Max. METS: 8.8 Max. VO2: 30.9 ST = J+60
Instructions for Use and Technical Description Norav Medical Ltd. 1045. Results of Blood Pressure, HR, Double Product (HRXBP sys.), ST level (mm) and ST Slope (mV/sec) for the Most Important Stages of Stress Test: Rest: BP: 150/100, HR: 79, Product: 11850, ST Level (mm), Slope (mV/sec) (-1.2/0.7, 0.2/1.8, 1.9/-0.5, -2.0/0.4, -2.9/3.3, -1.1/2.6, -1.4/2.2, -1.6/1.8, -1.3/6.1, -1.8/2.5, -1.7/1.5) Max HR: Time: 7:05, BP: 200/100, HR: 175, Product: 35000, ST Level (mm), Slope (mV/sec) (-1.2/0.7, 0.2/1.5, 1.9/-0.5, -2.0/01, -2.9/3.3, -2.1/2.6, -1.4/2.2, -1.4/1.8, -1.7/6.1, -1.2/2.4, -1.7/1.5) Worst ST: Lead aVF:-1.2 mm, Time:4:15, BP:200/100, HR:137, Product: 27400, ST Level (mm), Slope (mV/sec) (-1.3/0.4, 0.2/1.5, 1.2/-0.5, -2.0/01, -2.5/3.3, -2.1/2.6, -1.7/2.2, -1.4/1.8, -1.3/2.1, -1.2/2.4, -1.7/1.5) Recovery: Time: 10:59, BP: 170/80, HR: 127, Product: 21590, ST Level (mm), Slope (mV/sec) (-1.3/0.4, 0.6/1.5, 1.3/-0.5, -2.0/01, -1.5/3.3, -2.1/2.6, -1.5/2.2, -1.4/1.9, -1.3/2.1, -1.2/2.3, -1.7/1.5) 6. Physician Remarks and Conclusions: Reason for Test: Chest pressure Reason for Ending Test: Fatigue Conclusions: Normal blood pressure
Interfacing with Information Systems NV-54/PCECG1200W 105GDT/BDT Type Communication PC-ECG and HIS (Hospital Information System) Maintain Bi-Directional GDT/BDT Type Communication 1. Import demographic data from HIS to PC-ECG a. In setup, select GDT/BDT. b. Check Import from GDT/BDT. c. Define the GDT/BDT directory (in which the HIS file will be ready). d. Define the first four characters of the “Token for PC-ECG” file. This file always contains the last patient data. 2. Export the GDT/BDT file from PC-ECG to HIS. a. In setup, select GDT/BDT. b. Check Save Test in GDT/BDT. c. Define the GDT/BDT directory (in which PC-ECG file will be ready). It can be the same as in 1. d. Define the first four characters of the “Token for Practice EDP” file. This file always contains the last patient data.
Instructions for Use and Technical Description Norav Medical Ltd. 106Saving the Stress Test as a RAW Data (“native binary”) Format File 1. Record a stress study 2. Under File menu, create a RAW Data File. A file with extension RDT is created, with the following structure: (low byte, high byte) x 12 Leads x n samples (1sec = 500 samples). Leads sentence - I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6. Byte Number Byte Type Lead Number Sample Number Second Number 1 Lb 2 Hb I 3 Lb 4 Hb II … … … 21 Lb 22 Hb V5 23 Lb 24 Hb V6 1 25 Lb 26 Hb I 27 Lb 28 Hb II … … … 45 Lb 46 Hb V5 47 Lb 48 Hb V6 2 1 … … … … … 1+(n-1)*24 Lb 2+(n-1)*24 Hb I 3+(n-1)*24 Lb 4+(n-1)*24 Hb II … … … 21+(n-1)*24 Lb 22+(n-1)*24 Hb V5 23+(n-1)*24 Lb n * 24 Hb V6 n n/500 Table 29: Stress Raw Data File Format
Interfacing with Information Systems NV-54/PCECG1200W 107Saving the Monitor Test as a Raw Data (“Native Binary”) Format File 1. Record a Monitor study. 2. Under File menu, create a RAW Data File. A file with extension RDT is created, with the following structure: Number Leads (low byte, high byte) + Sample Rate (low byte, high byte) + (low byte, high byte) x Number Leads x n samples (1sec = (sample rate)). Byte Number Byte Type Lead Number Sample Number Second Number 1 Lb 2 Hb 1 3 Lb 4 Hb 2 … … … 2N -1 Lb 2N Hb N 1 2N +1 Lb 2N +2 Hb 1 2N +3 Lb 2N +4 Hb 2 … … … 2N*2-1 Lb 2N*2 Hb N 2 1 … … … … … 1+(n-1)*2N Lb 2+(n-1)*2N Hb 1 3+(n-1)*2N Lb 4+(n-1)*2N Hb 2 … … … 2N*n-1 Lb 2N*n Hb N n n/ (sample rate) Table 30: Monitor Raw Data file format
Instructions for Use and Technical Description Norav Medical Ltd. 108APPENDIX B: TECHNICAL SPECIFICATIONS 1200W (Transmitter) ECG Patient Leads Detachable 10 lead wires conform to AAMI Lead Standards AHA or IEC Defibrillator Protection: Protected against 360 J discharge Patient Leakage current <10 µA Input Impedance >100 Mohm CMRR >100 db DC max. input +/- 300 mv Frequency Range (-3db) 0.05 –150 Hz Signal dynamic range 20 mV Battery 4 - AA alkaline or NIMH rechargeable Operation Time Up to 40 hours with 4 AA alkaline battery A2D A2D resolution 16 bit, 2‘ complement Full scale range +/- 10 mV LSB weight 0.3 µV Full scale + +10 mV (Digital value = 7FFF hex ) Midscal 0 mV (Digital value = 0000 hex ) Midscale – LSB -0.3 µV (Digital value = FFFF hex ) Full scale - -10 mV (Digital value = 8000 hex ) Sample Rate 500 Communication Frequency Range 2400-2483.5 Mhz Output Power 0.4mW, conform to FCC part 15.249 Mechanical Weight [g] 350 Size [mm] 160x100x45 Environmental Operating Temperature Range 0°C to 50°C Storage Temperature Range: -40°C to 70°C Relative Humidity 0-85% non-condensing Regulatory Safety Standards IEC60601-1; IEC60601-2-25; IEC60601-2-27; IEC60601-2-51; EN301 489-1; EN301 489-3; EN300 440 Device Classification Type CF, battery operated
Technical Specifications NV-54/PCECG1200W 109
Instructions for Use and Technical Description Norav Medical Ltd. 1101200WR (Receiver) Communication Frequency Range 2400-2483.5 Mhz Output Power 0.4mW, conform to FCC part 15.249 USB 2.0 compliant, Full Speed Device Control, Isochronous Transfer Types Power In 5v, 40mA Mechanical Weight[g] 50 Size [mm] 103x30x30 Environmental Operating Temperature Range 0°C to 50°C Storage Temperature Range: -40°C to 70°C Relative Humidity 0-85% non-condensing
Report Samples NV-54/PCECG1200W 111APPENDIX C: REPORT SAMPLES Figure 29: Rest Report
Instructions for Use and Technical Description Norav Medical Ltd. 112 Figure 30: Stress Applications - Comprehensive Report
Report Samples NV-54/PCECG1200W 113 Figure 31: ECG Monitoring Report
Instructions for Use and Technical Description Norav Medical Ltd. 114 Figure 32: Heart Rate Variability Report
Report Samples NV-54/PCECG1200W 115 Figure 33: Late Potential Report
Instructions for Use and Technical Description Norav Medical Ltd. 116APPENDIX D: TROUBLESHOOTING USB Driver is not Installed Properly on Windows XP During PC-ECG Installation Problem If you connect the device to the PC via the USB before installing PC-ECG 1200 (including the USB driver), the USB driver is not installed. The Windows operating system identifies new hardware and starts the hardware installation wizard. If you complete the wizard, the driver is not found and the hardware is defined in the Device Manager as “USB device” with an icon ‘?’ indicating that the driver is not correctly installed. If the USB cable is left connected while trying to install the driver from the PC-ECG1200 installation CD—a message regarding Win XP signature does not appear and the driver is not installed. Solution 1. Disconnect the USB cable. 2. Install the PCECG software from the CD-ROM. During installation a message should appear about the Windows XP signature. If the message does not appear during the installation of PC-ECG, then the driver is not installed. If working under Windows XP press “Continue anyway” on message regarding the digital signature. 3. Check if the driver is now installed correctly (there is no question mark icon next to the USB driver in the device manager and the LED on the USB adaptor is on). If the device is still not correctly installed, then complete the following steps: 4. uninstall the unidentified USB driver as follows: a. While still connected to the USB, right click My Computer. b. Select Properties from the pop-up menu. c. Click Device Manager on the Hardware tab. d. Double click the USB Device with the ? icon in the list of devices. e. Select Driver tab. f. Click Uninstall and then OK. 5. After the driver is deleted, disconnect the USB cable from the PC. 6. Install the PC-ECG software and continue to the next step. 7. Reconnect the USB cable to the computer connector. Windows XP identifies the new hardware automatically and the new hardware wizard opens. 8. Follow the instructions on screen. If working under Windows XP press “Continue anyway” on message regarding the digital signature. After the driver is installed make sure the green light is illuminated on the 1200 USB adaptor
Troubleshooting NV-54/PCECG1200W 117Recovering ECG Data after Unexpected Shutdown of the Stress Application Problem If the application terminates unexpectedly before the ECG test is completed and saved, it may be possible to recover the ECG data of the (exhausted [??]) patient. Solution Stress ECG application stores native ECG data in the temporary file. You can convert this data into Monitoring ECG application file format as follows: 1. Start the Stress ECG application. 2. Click Recovery File to Monitoring Format… in the File main menu. The Choose files for conversion… dialog box is displayed. 3. Select the Windows\Temp folder. 4. Select strXX.tmp last created temporary file and click Open. 5. Select the Monitoring ECG files folder. 6. Insert monitoring ECG file name according to patient ID or last name and click Save. 7. Close the Stress ECG application. 8. Open the Monitoring ECG files folder and double click on the last stored file. The monitoring ECG application opens. 9. Click the Patient main menu button and insert patient data. 10. Save the updated Monitoring ECG file. You can now inspect and print ECG strip from the Monitoring ECG application. Working in AutoSave Mode Without Saving Modifications If you perform modifications (adds/edit remarks, measurements, recalculations, etc…) while in AutoSave mode, but do not wish to save the modifications, do the following: 1. Click Setup. 2. Uncheck the Auto Save option and click OK. 3. Close the application (or the file) with the X button. A dialog box is displayed requesting acknowledgement for the save. 4. Click No. 5. Reopen the application and the file. 6. Check that the modifications were not saved. 7. It is now safe to re-enable the Auto Save mode (if required).
Instructions for Use and Technical Description Norav Medical Ltd. 118 A Thick Straight Line is Displayed For All Leads Problem A thick straight line appears on screen for all leads when the connection to the acquisition box fails. Solution When using USB connection, check that the led on the 1200USB adapter is illuminated. If the led on USB adapter is not illuminated, check connections to the USB port and to the adapter. If the led on the USB adapter is illuminated or if connected through RS232, check the connection to the acquisition box and make sure the box is switched on. Noisy ECG Signal on Leads Problem A noisy ECG signal on one or more of the leads may be caused due to poor connection of the appropriate electrodes or leads on the patient. Solution Check the connection of the appropriate leads on the patient Make sure the electrodes are applied OK on the patient.
Troubleshooting NV-54/PCECG1200W 119Missing data after a thick line Problem On the screen and in printouts of the ECG, appears for a few seconds a thick strait line and after that there is missing data for a period of time. The ECG traces resume after this random period of time. This problem may be caused due sleep mode or hibernation mode the PC entered while the ECG test was running. Solution Any settings related to the power management should be disabled: no standby, no stop HD, no hibernation, etc... on the laptop during the Stress test. To set the power management do the following: 1. right click on the desktop. 2. select PROPERTIES form the pop-up menu. 3. Select SCREENSAVER tab. 4. Press on POWER button in the Monitor Power frame. 5. Select Power Schemes as either PRESENTATION or HOME\OFFICE DESK. 6. Set NEVER to "Turn off Hard Disk", "System Standby" and "System Hibernates". 7. Press OK to apply this configuration.

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