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 1

定䝬䪚䝰䝲䝲ȶȶȶ Instructions for Use and Technical Description 0473
ii Instructions for Use and Technical Description Norav Users Guide For Models: 1200W recorder; software versions: 5.0 and later Copyright © Norav, March 08. All rights reserved. Document Number: NV-54/PCECG1200W No part of this publication may be reproduced in any material form (including photocopying or storing it in any medium by electronic means whether or not transiently or incidentally to some other use of this publication) without the prior written permission of the copyright owner, or under the terms of a license issued by the copyright owner. The information contained in this document is subject to change without notice. Norav is neither responsible for nor liable to anyone in connection with this document. Contact Information: Norav Medical 2, Hamada St., P.O. Box 81, Yokneam, 20692, Israel Telephone: +972 (04) 9893001 Fax: +972 (04) 9893004 Email: sales@norav.com Standards Compliance The interference generated by the device was tested according to the EMC 89/336/EEC and found compliant with the standard. The software complies with Standards for Analysis of Ventricular Late Potentials Using High Resolution or Signal Averaged Electrocardiography, published in 1991 by the Task Force Committee of the European Society of Cardiology, the American Heart Association, and the American College of Cardiology. The PC-ECG conforms to MDD 93/42 EEC Annex II, EC11 and EN 60601-2. MDD authorized representative in Europe is: Daniele Marangoni Dr. Eng. , Marangoni Consultants Vicolo S. Franc. al Corso 4 Ang. Pontiere 11 37122 Verona Italy phone +39 045 8030516, fax +39 045 8036028 mobile +39 335 290679, Email marangon@easynet.it ! Caution US Federal Law restricts this device to sale by, or on the order of, a physician
iii The PC-ECG 1200W is tested and certified for the following standards: EN60601/1: International EN60601/2/25: International EN60601/2/27: International EN301 489-1; International EN301 489-3; International EN300 440; International Protection type and class: CF Defibrillation protection: Built in Disclaimer This system is intended as a decision support system for persons who have received appropriate medical training, and should not be used as a sole basis for making clinical decisions pertaining to patient diagnosis, care, or management. Any application of medical information from the program, other than the original design or intended use thereof, is not advised and considered a misuse of the software product. Norav Limited Warranty Norav products are warranted to be free from manufacturing and material defects for a period of one (1) year from the date of shipment from Norav or the dealer to the original purchaser. Excluded from this warranty are expendable supply items including, but not limited to, electrodes, lead wires, patient cables, and batteries. This warranty does not apply to any product that Norav determines has been modified or damaged by the customer. Except for the express warranties stated above, Norav disclaims all warranties including implied warranties of merchantability and fitness. The stated express warranties are in lieu of all obligations or liabilities on the part of Norav for damages, including but not limited to, special, indirect, or consequential, arising out of or in connection with the use or performance of Norav products. Any action for breach of warranty shall be commenced within one (1) year of said breach or be forever barred. Any repairs made to the product that are not covered by the warranty shall be billed to the customer. For service or technical support contact your local supplier or Norav Medical.
v Table of Contents CHAPTER 1: INTRODUCTION.......................................................................... 1 MANUAL ORGANIZATION...........................................................................................................1 DOCUMENT CONVENTIONS.......................................................................................................1 Notes and Cautions .....................................................................................................................1 Abbreviations and Acronyms .......................................................................................................2 Equipment Symbols .....................................................................................................................2 CHAPTER 2: OVERVIEW ....................................................................................3 PACKAGE CONTENTS..................................................................................................................3 PROGRAMS.....................................................................................................................................4 PC-ECG MODELS........................................................................................................................4 INDICATIONS FOR USE OF THE PC-ECG 1200........................................................................5 ECG Intended Use......................................................................................................................5 Stress Testing Intended Use ..........................................................................................................5 CONTRAINDICATIONS FOR USE AND ADVERSE EFFECTS......................................................6 CHAPTER 3: SOFTWARE INSTALLATION ..................................................... 7 SYSTEM REQUIREMENTS AND PREREQUISITES........................................................................7 Hardware ....................................................................................................................................7 INSTALLING OR UPDATING THE PC SOFTWARE.....................................................................8 To Install PC-ECG 1200 ..........................................................................................................9 To Uninstall PC-ECG 1200....................................................................................................10 To Free Disk Space and Ensure Smooth Operation ...................................................................10 BACKING UP AND RESTORING SETUPS AND PROTOCOLS....................................................10 To Save Stress Test Setup ..........................................................................................................11 To Load Stress Test Setup .........................................................................................................11 To Save Stress Protocols .............................................................................................................11 To Load Stress Protocols ............................................................................................................12 To Set Preferences.......................................................................................................................12 CHAPTER 4: HARDWARE INSTALLATION.................................................. 13 SAFETY.........................................................................................................................................13 CLASSIFICATION OF THE EQUIPMENT ........................................................ 14 INSTALLING MODEL 1200W.....................................................................................................15 To Connect Via USB................................................................................................................17 To Verify the Connections ..........................................................................................................18 To Perform Maintenance ............................................................................................................18 Calibration ................................................................................................................................19 CONNECTING AN EXERCISE DEVICE......................................................................................19 To Connect an RS232 Controlled Treadmill/Ergometer ............................................................19
vi Instructions for Use and Technical Description To Connect an Analog Controlled Treadmill/Ergometer............................................................ 19 Cabling ..................................................................................................................................... 19 To Determine Treadmill Cabling ............................................................................................... 19 CONNECTING A BLOOD PRESSURE STRESS MONITOR......................................................... 20 To Connect a Blood Pressure stress Monitor ............................................................................... 20 CHAPTER 5: ACCESSORIES INSTALLATION ...............................................21 D/A BOARD: MODEL: CIO-DAC02 FOR ISA BUS............................................................... 21 Jumpers Setting.......................................................................................................................... 21 Settings and Output of the D/A Board for 0-4 Volt Output .................................................... 21 Settings and Output of the D/A Board for -4 to +4 Volt Output ............................................ 22 To Continue Setup (After Installing the ISA Board/s).............................................................. 22 PCI BUS BOARD FUNCTIONING AS AN ECG TRIGGER....................................................... 23 To Set Up an ECG Trigger via PCI Bus Board ....................................................................... 23 To Complete Setup .................................................................................................................... 23 Cable for PCI board.................................................................................................................. 23 INSTALLATION OF THE TANGO AUTOMATIC BP UNIT..................................................... 24 To Verify that the Driver is Installed Correctly .......................................................................... 24 To Update the Driver ................................................................................................................ 24 Connecting TANGO Automatic BP Unit................................................................................ 24 To Set Up PC-ECG Software .................................................................................................. 25 To Set Up Tango Unit.............................................................................................................. 25 CHAPTER 6: PATIENT PREPARATION .........................................................27 CHAPTER 7: RESTING ECG .............................................................................29 QUICK START............................................................................................................................. 30 To Perform a New Test ............................................................................................................. 30 Operation with Function Keys.................................................................................................... 30 RESTING 12 LEAD ECG ........................................................................................................... 30 LEADS PLACEMENT................................................................................................................... 30 To Define the Lead System........................................................................................................ 31 TOOLBAR OVERVIEW................................................................................................................ 31 The Toolbar (Easy Toolbars Mode)........................................................................................... 31 RESTING ECG SETUP............................................................................................................... 32 TOOLBAR AND MENUS.............................................................................................................. 35 USING THE MATLAB FEATURE WITHIN PC-ECG 1200 ....................................................... 39 Example of ECG Display with MATLAB............................................................................. 40 CHAPTER 8: STRESS ECG .................................................................................41 To Customize the Display ......................................................................................................... 41 To Lock Screen Window Borders............................................................................................... 41 QUICK START............................................................................................................................. 42 To Perform a New Test ............................................................................................................. 42 To Print an ECG..................................................................................................................... 42 To Print a Report...................................................................................................................... 42
vii LEADS PLACEMENT....................................................................................................................43 To Define the Lead System.........................................................................................................43 OPERATION WITH FUNCTION KEYS........................................................................................43 TOOLBAR OVERVIEW................................................................................................................44 Main Toolbar (Easy Toolbars Mode).........................................................................................44 Stress Test Commands ...............................................................................................................44 Views and Filters Toolbar .........................................................................................................45 Average Viewer Toolbar ............................................................................................................45 Post Processing Options Toolbar .................................................................................................46 STRESS ECG SETUP....................................................................................................................47 TOOLBAR AND MENUS: MAIN..................................................................................................52 TOOLBAR AND MENUS: STRESS TEST COMMANDS...............................................................53 TOOLBAR AND MENUS: AVERAGE VIEWER...........................................................................54 TOOLBAR AND MENUS: POST PROCESSING............................................................................54 To Start the Stress Recording Program........................................................................................55 To Start a New Test..................................................................................................................55 Recovery Phase ...........................................................................................................................56 VIEWING RESULTS.....................................................................................................................56 To View Study Results ..............................................................................................................57 To Display the Review Screen Automatically ..............................................................................57 To Display the Review Screen Manually.....................................................................................57 To Save Study Results................................................................................................................57 METABOLIC STRESS ESTIMATION (METS).............................................................................58 TRANSFER FILE “TRNSF.TXT”..................................................................................................58 To Transfer a File......................................................................................................................58 ADDITIONAL FEATURES............................................................................................................59 To Define Max. HR.................................................................................................................59 To Define Worst ST..................................................................................................................59 RS232 CONTROLLED TREADMILL TYPES...............................................................................60 RS232 CONTROLLED BICYCLE ERGOMETERS.......................................................................61 CHAPTER 9: LATE POTENTIAL SIGNAL AVERAGING ............................. 63 QUICK START..............................................................................................................................64 To Start a New Test..................................................................................................................64 To Print.....................................................................................................................................64 OPERATION WITH FUNCTION KEYS........................................................................................65 LEADS...........................................................................................................................................65 LP SIGNAL AVERAGING SETUP................................................................................................66 TOOLBAR AND MENUS..............................................................................................................68 INTERPRETING RESULTS...........................................................................................................70 Numerical Results......................................................................................................................71 CHAPTER 10: MONITORING ............................................................................ 73 QUICK START..............................................................................................................................74 To Start a New Test..................................................................................................................74
viii Instructions for Use and Technical Description To Print .................................................................................................................................... 74 Print Study (print a selected time range and leads) ...................................................................... 74 MONITORING ECG SETUP....................................................................................................... 74 TOOLBAR AND MENUS.............................................................................................................. 77 CHAPTER 11: HEART RATE VARIABILITY (HRV) ........................................79 QUICK START............................................................................................................................. 80 To Start a New Test ................................................................................................................. 80 To Print an HRV Report......................................................................................................... 80 To Print an ECG..................................................................................................................... 81 HRV SETUP................................................................................................................................81 STARTING A STUDY................................................................................................................... 83 To Add or Subtract an Interval................................................................................................. 83 To Edit Interval Names............................................................................................................ 83 To Import or Save GDT/BDT Format.................................................................................... 83 RESULTS DISPLAY...................................................................................................................... 84 HRV INTERVAL MEASUREMENT............................................................................................. 84 CHAPTER 12: MEASUREMENTS/ INTERPRETATION................................85 QUICK START............................................................................................................................. 86 To Start Measurements.............................................................................................................. 86 To Print Reports ....................................................................................................................... 86 PERFORMING CHANGES IN CALCULATIONS.......................................................................... 86 To Move the QRS Marker........................................................................................................ 86 To Add or Remove a Wave Marker.......................................................................................... 86 To Move the Wave Marker ....................................................................................................... 87 FEATURES................................................................................................................................... 87 To View the Measurements on a QRS ...................................................................................... 87 To View the Measurements on a Channel.................................................................................. 87 To View the Measurements on All Channels for QT................................................................. 87 TABULAR SCREEN...................................................................................................................... 87 AVERAGES DISPLAY.................................................................................................................. 88 QRS DISPLAY............................................................................................................................. 89 TOOLBAR OF AVERAGES/QRS DISPLAYS.............................................................................. 90 CALIPER DISPLAY...................................................................................................................... 91 Toolbar of Caliper Display ........................................................................................................ 91 TOOLBAR AND MENUS.............................................................................................................. 92 CHAPTER 13: DATABASE APPLICATION........................................................95 First Time Use.......................................................................................................................... 96 COMPARING REST TESTS.......................................................................................................... 97 To Compare Rest Tests.............................................................................................................. 97 DATABASE SETUP...................................................................................................................... 98 TOOLBAR AND MENUS.............................................................................................................. 98 APPENDIX A: INTERFACING WITH INFORMATION SYSTEMS.............. 101
ix DEMOGRAPHIC DATA............................................................................................................. 101 HL7 FORMAT FILE.................................................................................................................. 103 GDT/BDT TYPE COMMUNICATION................................................................................... 105 SAVING THE STRESS TEST AS A RAW DATA (“NATIVE BINARY”) FORMAT FILE........... 106 SAVING THE MONITOR TEST AS A RAW DATA (“NATIVE BINARY”) FORMAT FILE..... 107 APPENDIX B: TECHNICAL SPECIFICATIONS.............................................108 1200W (TRANSMITTER).......................................................................................108 1200WR (RECEIVER).............................................................................................110 APPENDIX C: REPORT SAMPLES.................................................................... 111 APPENDIX D: TROUBLESHOOTING ..............................................................116 USB DRIVER IS NOT INSTALLED PROPERLY ON WINDOWS XP DURING PC-ECG INSTALLATION......................................................................................................................... 116 Problem................................................................................................................................... 116 Solution .................................................................................................................................. 116 RECOVERING ECG DATA AFTER UNEXPECTED SHUTDOWN OF THE STRESS APPLICATION........................................................................................................................... 117 Problem................................................................................................................................... 117 Solution .................................................................................................................................. 117 WORKING IN AUTOSAVE MODE WITHOUT SAVING MODIFICATIONS........................... 117 A THICK STRAIGHT LINE IS DISPLAYED FOR ALL LEADS................................................ 118 Problem................................................................................................................................... 118 Solution .................................................................................................................................. 118 NOISY ECG SIGNAL ON LEADS............................................................................................ 118 Problem................................................................................................................................... 118 Solution .................................................................................................................................. 118 MISSING DATA AFTER A THICK LINE.................................................................................... 119 Problem................................................................................................................................... 119 Solution .................................................................................................................................. 119
x Instructions for Use and Technical Description List of Figures FIGURE 1: SAVING STRESS SETUP....................................................................................11 FIGURE 2: PC-ECG 1200W.............................................................................................15 FIGURE 3: USB CABLE....................................................................................................16 FIGURE 4: 1200 WR RECEIVER.......................................................................................18 FIGURE 5: ELECTRODE PLACEMENT................................................................................27 FIGURE 6: RESTING ECG MAIN SCREEN.........................................................................29 FIGURE 7: RESTING ECG TOOLBAR................................................................................31 FIGURE 8: STRESS ECG RESULTS SCREEN......................................................................41 FIGURE 9: MAIN STRESS TOOLBAR.................................................................................44 FIGURE 10: STRESS TEST COMMANDS TOOLBAR.............................................................44 FIGURE 11: STRESS ECG VIEWS AND FILTERS TOOLBAR................................................45 FIGURE 12: STRESS ECG POST PROCESSING DISPLAY TOOLBAR....................................45 FIGURE 13: STRESS ECG PLAYBACK TOOLBAR..............................................................46 FIGURE 14: CHANGE TEST PROTOCOL.............................................................................55 FIGURE 15: PATIENT DATA ENTRY..................................................................................56 FIGURE 16: LATE POTETIAL SIGAL AVERAGIG SCREE.......................................63 FIGURE 17: LP SIGNAL AVERAGING REVIEW SCREEN.....................................................70 FIGURE 18: MONITORING SCREEN...................................................................................73 FIGURE 19: HRV RESULTS..............................................................................................84 FIGURE 20: MEASUREMENTS—TABULAR SCREEN..........................................................85 FIGURE 21: MEASUREMENTS—AVERAGES DISPLAY.......................................................88 FIGURE 22: MEASUREMENTS—QRS DISPLAY.................................................................89 FIGURE 23: TOOLBAR OF AVERAGES/QRS ......................................................................90 FIGURE 24: MEASUREMENTS—CALIPER.........................................................................91 FIGURE 25: TOOLBAR OF CALIPER...................................................................................91 FIGURE 26: DATABASE MAIN SCREEN.............................................................................95 FIGURE 27: DATABASE PATIENT QUERY.........................................................................96 FIGURE 28: DATABASE PROPERTIES OF SELECTED TEST..................................................97 FIGURE 29: REST REPORT..............................................................................................111 FIGURE 30: STRESS APPLICATIONS - COMPREHENSIVE REPORT....................................112 FIGURE 31: ECG MONITORING REPORT........................................................................113 FIGURE 32: HEART RATE VARIABILITY REPORT...........................................................114 FIGURE 33: LATE POTENTIAL REPORT...........................................................................115
xi List of Tables TABLE 1: MINIMUM COMPUTER CONFIGURATION............................................................ 7 TABLE 2: PRINTERS INSTALLATION REQUIREMENTS......................................................... 8 TABLE 3: PROGRAM ICONS............................................................................................... 9 TABLE 4: D/A BOARD 0 TO+4 VOLT............................................................................... 21 TABLE 5: D/A BOARD –4 TO +4 VOLT............................................................................ 22 TABLE 6: OPERATION WITH FUNCTION KEYS................................................................. 30 TABLE 7: RESTING ECG SETUP OPTIONS....................................................................... 35 TABLE 8: RECORDING RESTING ECG ............................................................................. 39 TABLE 9: STRESS FUNCTION KEYS................................................................................. 43 TABLE 10: STRESS ECG SETUP OPTIONS........................................................................ 51 TABLE 11: MAIN STRESS TOOLBAR AND MENUS............................................................ 52 TABLE 12: STRESS TEST COMMANDS............................................................................. 53 TABLE 13: AVERAGE VIEWER TOOLBAR........................................................................ 54 TABLE 14: POST PROCESSING TOOLBAR AND MENUS..................................................... 55 TABLE 15: TRANSFER FILE FORMAT............................................................................... 58 TABLE 16: CONTROLLED TREADMILLS........................................................................... 60 TABLE 17: CONTROLLED ERGOMETERS.......................................................................... 61 TABLE 18: LP SIGNAL AVERAGING FUNCTION KEYS..................................................... 65 TABLE 19: LP SIGNAL AVERAGING LEADS PLACEMENT................................................ 65 TABLE 20: LP SIGNAL AVERAGING SETUP..................................................................... 67 TABLE 21: LP SIGNAL AVERAGING TOOLBAR AND MENUS............................................ 69 TABLE 22: LP SIGNAL AVERAGING NUMERICAL RESULTS............................................. 71 TABLE 23: MONITORING SETUP OPTIONS....................................................................... 76 TABLE 24: MONITORING TOOLBAR AND MENUS............................................................ 78 TABLE 25: HRV SCREEN................................................................................................ 80 TABLE 26: MEASUREMENTS TOOLBAR AND MENUS....................................................... 94 TABLE 27: DATABASE SETUP OPTIONS........................................................................... 98 TABLE 28: DATABASE TOOLBAR AND MENUS.............................................................. 100 TABLE 29: STRESS RAW DATA FILE FORMAT............................................................... 106 TABLE 30: MONITOR RAW DATA FILE FORMAT............................................................ 107
Introduction NV-54/PCECG1200W 1CHAPTER 1: INTRODUCTION Manual Organization This manual explains in detail how to install and use the PC-ECG 1200. At the beginning of each application chapter, there is a Quick Start section, which is a brief explanation of how to carry out a study, including the keyboard short-cuts for the main functions. If you are familiar with ECG procedures, you can use this Quick Start section to get up and running quickly. The software must be installed before the hardware. See Software Installation, page 7 and Hardware Installation, page 13. Document Conventions Notes and Cautions Pay particular attention at specific points in a procedure when one of the following messages appears: WARNING Warnings call attention to possible hazards involving potential damage or injury to persons. ! Caution Cautions refer to practices necessary to protect against potential damage or loss to equipment. Pay careful attention to instructions. Note Notes provide pertinent information to help obtain optimum performance from the software or signify an important step or procedure that requires special attention.
Instructions for Use and Technical Description Norav Medical Ltd. 2Abbreviations and Acronyms Abbreviation Meaning BP Blood pressure ECG Electrocardiogram Database Database application HRV Heart Rate Variability ID Identification LP Late Potential LQTS Long QT Syndrome METS Metabolic Stress Estimation SN Serial Number USB Universal Serial Bus Equipment Symbols Symbol Description Defibrillated CF type equipment Class II equipment Complies with the Medical Device Directive of the European Union Attention, consult ACCOMPANYING DOCUMENTS Non-ionizing radiation.
Overview NV-54/PCECG1200W 3CHAPTER 2: OVERVIEW Package Contents The PC-ECG 1200W package contains the following elements: • Wireless Acquisition box PCECG1200W (page 15) • Patient leads • USB cable • 1200WR Receiver • Antenna • Software CD with the PC-ECG 1200 installation package, including: ◊ Rest ◊ Stress ◊ Monitor ◊ HRV ◊ LP ◊ Database • Software key (if optional software is included)
Instructions for Use and Technical Description Norav Medical Ltd. 4Programs Each program has a specific purpose. The following is a brief description of when to use each one: Rest Records and measures short ECG tests on patients in resting position (up to 10 seconds) Stress Records and measures ECG tests on patients under stress conditions using a pre-defined test protocol. The stress test includes 3 basic stages: • Rest • Stress • Recovery Each stage may be divided into more than one phase according to the testing protocol used. Monitor Works with an ECG device to record, monitor and save a prolonged ECG test in rest condition HRV Tests according to time how patient pulse and heart rate varies with load, medication, etc. LP Predicts tendency to ventricular tachycardia Database ECG Database Management System. Manages patients and ECG tests details. PC-ECG Models 1200 W Wireless ECG Recording test during stress and rest condition (attached to patient’s body)
Overview NV-54/PCECG1200W 5Indications for Use of the PC-ECG 1200 ECG Intended Use ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases: ◊ Patients with suspected cardiac abnormalities ◊ Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired. QT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacological therapy. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization. The PC ECG 1200 has been tested to measure Heart Rate Variability to within 1 millisecond tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician. The PC ECG 1200 has been tested to measure Late Potential to a tolerance of within 1 millisecond, and 1 microvolt. The clinical significance of Late Potential measures should be determined by a physician. Stress Testing Intended Use Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are determined by predefined protocols. The ECG signals are recorded for the resting, exercise, and recovery phase portions of the exercise protocol. The changes in ECG waveforms are compared to the resting ECG records. Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.
Instructions for Use and Technical Description Norav Medical Ltd. 6Contraindications for Use and Adverse Effects The device has no contraindications or adverse events.
Software Installation NV-54/PCECG1200W 7CHAPTER 3: SOFTWARE INSTALLATION System Requirements and Prerequisites Hardware Note Stress application with real-time printout is resource intensive. To optimize performance, we recommend that you disable “Start Up” programs to free system resources. For instructions, see Windows help. Note The PC should not be set up to work under saving power conditions. Do not enable PC sleep mode (standby), hibernate, or turning off the hard disk while running an ECG test. PC Minimum Configuration Application CPU Speed (MHz) RAM Memory (MB) Disk Space (GB) Number of Free RS232 or USB PortsRest 100 32 2 1 Monitoring Application 200 32 4 1 LP 450 128 2 1 HRV 450 128 2 1 Database 200 64 8 1 Stress 1000 128 20 2 Stress + R trigger 1300 128 20 2 Stress + Blood pressure monitor 1500 128 20 3 Table 1: Minimum Computer Configuration
Instructions for Use and Technical Description Norav Medical Ltd. 8Installing Printers Application Technology RAM Memory (MB) Driver Rest LASER/INK 2 Vendor / MS Monitoring Application LASER/INK 2 Vendor / MS LP LASER/INK 2 Vendor / MS HRV LASER/INK 2 Vendor / MS Database LASER/INK 2 Vendor / MS Stress Fast LASER 8 MS Table 2: Printers Installation Requirements Installing the Thermal Printer Use a 4 inch or 8 inch thermal printer. The thermal printer driver is installed separately from the PC-ECG 1200 program. A thermal printer can be supplied by Norav (MP200, 8 inch). This printer requires the purchase of a dongle with P1 license permission. The MP200 driver is available on the PC-ECG 1200 CD at the following path: "<CD>:\MP200\OEMPRINT.inf". Installing or Updating The PC Software Note: Install the software before installing the hardware. If the device is connected to the PC, disconnect the device before installing the software. The software package works under Windows NT, 98, ME, 2000, and XP operating systems.
Software Installation NV-54/PCECG1200W 9To Install PC-ECG 1200 1. Insert the CD in the drive. The installation program starts automatically. 2. Follow the instructions on-screen.0. After you have completed installation, a group icon called PC-ECG 1200 is added to the desktop. Double-click the group icon to display the following program icons: Note: Icons are displayed only for those programs for which you have purchased the license Icon Explanation Heart Rate Variability Late Potential Signal Averaging Monitoring Resting ECG Stress Test Database application Table 3: Program Icons Resting ECG is the basic software package. It does not require a software key. The following are optional and require software keys: ◊ Measurement and interpretation functions for Resting ECG
Instructions for Use and Technical Description Norav Medical Ltd. 10◊ ECG Database ◊ Heart Rate Variability ◊ Late Potential ◊ Monitoring ◊ Stress Test You can activate optional packages that have no key by selecting Simulator in Setup (see Simulator ECG, Page 32). If you have purchased the S2 remote viewing, install the Remote View program from the Remote View directory on the CD. This program enables a remote viewer for an ECG study. The image is displayed in JPEG format. To Uninstall PC-ECG 1200 New Version Replacing Old Version There is no need to remove the previous installation. The existing setup will remain for the new version. If the new software version does not operate properly, remove the old installation (see Old Version Replacing New Version, below) and then remove the old existing setup as follows: Start  Run Type regedit OK Choose HKEY_CURRENT_USER  Software NORAV MEDICAL Edit Delete Old Version Replacing New Version Uninstall the existing version as follows: My Computer  Control Panel  Add/Remove Programs  PC-ECG 1200  Add/Remove  OK To Free Disk Space and Ensure Smooth Operation Windows provides utilities to delete superfluous files, and to defragment the disk. Refer to Windows help for instructions on using Disk Cleanup and Defragment. Backing up and Restoring Setups and Protocols When you reinstall or upgrade PC-ECG 1200, the program overwrites your existing configurations and protocols. To save the configuration data for stress application, follow these procedures:
Software Installation NV-54/PCECG1200W 11To Save Stress Test Setup 1. Start Stress ECG. 2. Click View\Save Setup (see Figure 1). Figure 1: Saving Stress Setup 3. Name the file. 4. Provide a location in which to save the file and Click OK. To Load Stress Test Setup 1. Start Stress ECG. 2. Click View\Load Setup. 3. Click Browse and find the location in which the file is saved. 4. Select the file (with the name you gave it and the suffix ‘STF’) and click OK. To Save Stress Protocols 1. Create a new directory in C:\My Documents, with a name like PcBackup. 2. Copy file StWorked.mdb from the directory where PC-ECG is installed (normally C:\Program Files\PC-ECG). 3. Paste it into a backup directory (e.g., C:\My Documents\PcBackup).
Instructions for Use and Technical Description Norav Medical Ltd. 12To Load Stress Protocols 1. Copy the file StWorked.mdb from the directory where you saved it (e.g., C:\My Documents\PcBackup). 2. Paste it into the directory where PC-ECG is installed (normally C:\Program Files\PC-ECG). A window is displayed, asking you if you would like to replace the existing file. 3. Click Yes. To Set Preferences 1. After installing the PC-ECG 1200 package, and prior to operation, click Setup to tailor your preferences. 2. Begin with Environment, which configures the hardware. 3. Continue with the other tabs in any order.
Hardware Installation NV-54/PCECG1200W 13CHAPTER 4: HARDWARE INSTALLATION Safety WARNING The PC-ECG 1200W transmitter uses battery power supply. PCECG1200WR receiver uses Power supply via USB port. It is also sensitive to electrical interference. The PC-ECG 1200 controls exercise machines. To prevent possible injury, read this page carefully prior to installing the device. • A patient undergoing a test must be at a distance of at least:  1.5 meters from the computer, printer and other peripherals, • If such conditions cannot be fulfilled, the entire system needs to be connected to the A/C power supply through an Isolation transformer meeting the EN60601/1 standard. • Use only the recommended battery type as instructed in the technical specifications to operate the PCECG1200W (4 - AA alkaline or NIMH rechargeable). • Do not use batteries with expired dates. • Remove batteries form the PCECG1200W when it is not in use. • Any treadmill used with the PC-ECG 1200 must contain a manual control in order to allow the user to stop the operation of the treadmill in case of emergency. • In the event of apparent changes in the performance of the device, discontinue use immediately. Do not resume use until the device is approved by the manufacturer or by a representative of the manufacturer. • If audio is playing on the PC, the ECG shows interference. Do not run an audio CD on the PC while running an ECG test via the USB connection. • Defibrillation protection is built in for Model W. • Operate the unit only at clinics and hospitals. Do not use at home. • Operation only by trained medical staff.
Instructions for Use and Technical Description Norav Medical Ltd. 14 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference and (2) This device must accept any interference received, including interference that may cause undesired operation. Note The manufacturer is not responsible for any Radio or TV interference caused by unauthorized modifications to this equipment. Such modifications could void the user’s authority to operate the equipment. Note Install hardware only after software installation. CLASSIFICATION OF THE EQUIPMENT - According to the type of protection against electric shock: INTERNALLY POWERED EQUIPMENT - According to the degree of protection against electric shock: TYPE CF APPLIED PART - According to the degree of protection against ingress of water: ORDINARY EQUIPMENT - According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide: EQUIPMENT NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE. - According to the mode of operation: CONTINUOUS OPERATION
Hardware Installation NV-54/PCECG1200W 15Installing Model 1200W The PC-ECG 1200W kit contains the following items: ◊ Acquisition box (see Figure 2, below) ◊ Patient leads ◊ USB cable (see Figure 3, page 16) ◊ Antenna ◊ 1200 WR receiver (see Figure 4, page 18) ◊ Software CD of PC-ECG 1200 installation package. ◊ Software key (if optional software is included) Figure 2: PC-ECG 1200W 1234
Instructions for Use and Technical Description Norav Medical Ltd. 16 Figure 3: USB Cable 12
Hardware Installation NV-54/PCECG1200W 17To Connect Via USB ! Caution Make sure the device is switched off Cautions refer to practices necessary to protect against potential damage or loss to equipment. 1. Connect Antenna (Figure 4, Page 18, detail 4) to the connector on 1200WR Receiver (Figure 4, Page 18, detail 2). 2. Connect the A-type connector of the USB cable (Figure 3, Page 16, detail 1) to the PC. 3. Connect the B-type connector of the USB cable (Figure 3, Page 16, detail 2) to the input of the 1200WR Receiver (Figure 4, Page 18, detail 1). 4. A wizard for installing new hardware driver appears. Follow the instructions. If working under Windows XP press “Continue anyway” on message regarding the digital signature (each time it appears). After the driver is installed make sure the green light is illuminated on the 1200 WR Receiver (Figure 4, Page 18, detail 3) 5. Insert 4 - AA alkaline or NIMH rechargeable batteries into the battery compartment of the PCECG1200W unit. 6. Switch on the PC-ECG 1200W (Figure 2, Page 15, detail 2) and verify that the ON light is illuminated Figure 2, Page 15, detail 3). 7. Connect the 10 patient leads according to the lables to the 10 connectors of the PC-ECG 1200W (Figure 2, Page 15, detail 1). 8. If the optional software key is included, connect it to the parallel port of the computer. 9. If a printer is connected via the parallel port, plug the printer cable into the key. The optional BNC output (Figure 4, Page 18, detail 5) is a trigger control for connecting to an external device, such as an ergometer or the Tango unit.
Instructions for Use and Technical Description Norav Medical Ltd. 18 Figure 4: 1200 WR Receiver To Verify the Connections 1. Connect the PC-ECG 1200W to the patient. 2. Connect the electrode leads to the electrodes, starting with RL. 3. Verify that an ECG is acquired and displayed on the screen. To Perform Maintenance ! Caution The device is not waterproof. Do not expose the device to water or any kind of liquid. Maintain in a dry place. 1. Use alcohol pads to clean the device of moisture and hairs. 2. Replace the pouch or wash it at 300C. 351 24
Hardware Installation NV-54/PCECG1200W 19Calibration The device does not need any calibration. Connecting an Exercise Device You can connect a treadmill or ergometer to the computer independently of the PC-ECG 1200W. You can also operate the exercise device without using an ECG recorder by using the software with Simulator option selected. To Connect an RS232 Controlled Treadmill/Ergometer Connect the RS232 cable (as specified by the vendor) to COM 2 (if COM 2 is in use, then wait until the software has been installed and use the assigned COM port). To Connect an Analog Controlled Treadmill/Ergometer A digital/analog converter (D/A) board converts the digital signal from the computer into an analog signal that the treadmill or ergometer can read. 1. Insert the D/A board into the PC. 2. Connect the cable from the D/A board as specified in the D/A board table. Cabling The RS232 cable should contain at least 3 wires: TD, RD using pin 2 and 3 and GROUND using pin 5. Straight type means that pin 2 on the PC side connects to pin 2 on the exercise device side, pin 3 on the PC side connects to pin 3 on the exercise device side, and pin 5 on the PC side connects to pin 5 on the exercise device side. Crossed type means that pin 2 on the PC side connects to pin 3 on the exercise device side, pin 3 on the PC side connects to pin 2 on the exercise device side and pin 5 on the PC side connects to pin 5 on the exercise device side. To Determine Treadmill Cabling Check which pins are assigned for TD and RD on the exercise device connector. • If pin 2 is RD and pin 3 is TD, then the exercise device requires a crossed cable • If pin 2 is TD and pin 3 is RD, then the exercise device requires a straight cable.
Instructions for Use and Technical Description Norav Medical Ltd. 20Connecting a Blood Pressure Stress Monitor To Connect a Blood Pressure stress Monitor 1. Insert the D/A board into the PC and connect the cable from the D/A board to the BNC input on the monitor. 2. Connect the RS232 cable (as specified by the monitor vendor) to COM 4. If COM 4 is in use, wait until the software is installed and use the assigned COM.
Accessories Installation NV-54/PCECG1200W 21CHAPTER 5: ACCESSORIES INSTALLATION D/A Board: Model: CIO-DAC02 for ISA Bus The software uses a digital signal, but the exercise device (treadmill or ergometer) operates through an analog signal. To make communication possible, the D/A board converts the digital signal into an analog signal. Jumpers Setting D/A0= -5 D/A1= -5 WAIT STATE= Off Settings and Output of the D/A Board for 0-4 Volt Output Board P/N and Board target Board address and address switches Common pin no. on D25 connector Out 1 pin no. on D25 connector Out 2 pin no. on D25 connector D1-a Treadmill Analog control 300H. switches 8,9 DOWN the rest UP1 Speed pin : 24 Grade pin: 18 D1-a Ergometer Analog control 300H. switches 8,9 DOWN the rest UP1 Power pin : 24 D1-s Metabolic Interface 304H. switches 8,9,2 DOWN the rest UP1 Heart Rate pin: 24 Work Load pin: 18 D1-t ECG Trigger 308H. switches 8,9,3 DOWN the rest UP1 TTL OUT pin: 24 Table 4: D/A Board 0 to+4 Volt
Instructions for Use and Technical Description Norav Medical Ltd. 22Settings and Output of the D/A Board for -4 to +4 Volt Output Board P/N and Board target Board address and address switches Common pin no. on D25 connector Out 1 pin no. on D25 connector Out 2 pin no. on D25 connector D1-a Treadmill Analog control 300H. switches 8,9 DOWN the rest UP 1 Speed Pin: 23 Grade pin: 17 D1-a Ergometer Analog control 300H. switches 8,9 DOWN the rest UP 1 Power pin: 23 D1-s Metabolic Interface 304H. switches 8,9,2 DOWN the rest UP 1 Heart Rate pin: 23 Work Load pin: 17 Table 5: D/A Board –4 to +4 Volt To Continue Setup (After Installing the ISA Board/s) 1. In Stress ECG, click Setup > Environment. 2. Select the Advance tab. 3. Check the appropriate boxes for R-wave Trigger, USB Connection, and Cards.
Accessories Installation NV-54/PCECG1200W 23PCI Bus Board Functioning as an ECG Trigger The ECG trigger function can be provided either via the PCI bus board (see immediately below) or by connecting to the 1200 USB through the BNC output. The Stress application can control an analog/trigger signal. The analog/trigger control can be configured in the setup dialog for connection through either the PCI card or the 1200 USB adaptor. To Set Up an ECG Trigger via PCI Bus Board Install the board as instructed by the manufacturer. To Complete Setup 1. Click Stress Setup > Environment. 2. Click the Advance tab. 3. Check the appropriate boxes for R-wave Trigger, USB Connection, and Cards. Cable for PCI board Connector pin 21 on D37 connector—common Connector pin 37 on D37 connector—TTL The target side can be either BNC or PHONO. Note Install the PCI-DIO24 driver from the CD before connecting the Tango device. If the device was connected before the driver is installed, then cancel the Add New Hardware wizard, disconnect the Tango device, and install the software.
Instructions for Use and Technical Description Norav Medical Ltd. 24Installation of the TANGO Automatic BP Unit 1. Insert the PCI-DIO24 card driver CD in the CD driver. 2. Select Install InstaCall from the menu displayed. 3. Follow the instructions. To Verify that the Driver is Installed Correctly 1. Right click My Computer on the desktop and select Properties from the pop-up menu. 2. Select Hardware tab from the dialog box and click Device Manager. 3. Locate the icon next to “Das Computers PCI-DIO24”. If the icon has no accompanying marks, then it is correctly installed. If it is checked with “?” or “!”,update the driver, as explained below. To Update the Driver 1. Double click the icon and click Update Driver. 2. Select Install the software automatically and click Next. 3. Define the path for the driver as C:\Windows\inf\OEM XX.inf and follow the instructions on screen to complete the installation. Connecting TANGO Automatic BP Unit (Requires Option S1 or S2) The Tango unit connects to the PC by 2 cables: 1. RS232 modem cable both sides female D9 connectors. Pin 2 --------------------Pin 3 Pin 3 --------------------Pin 2 Pin 5 --------------------Pin 5 Note You must install the PCI-DIO24 driver from the CD before connecting the Tango device. If the device was connected before the driver was installed, then cancel the Add New Hardware wizard, disconnect the Tango device, and install the software.
Accessories Installation NV-54/PCECG1200W 252. R-R trigger cable connecting board D1-t (plugged in PC) by D37 (D25 on old boards) connector to the BNC socket of the Tango. To Set Up PC-ECG Software 1. In Environment, assign a COM port for Automatic Blood Pressure COM Port and check R-Wave Trigger. 2. In Protocols, check Measure BP by automatic device To Set Up Tango Unit The configuration of the Tango unit for communication should be SUNTECH (as device) and DKA (as technique). Define these as follows: TEST PARAMETERS, TECHNIQUE = DKA UTILITIES, DEVICE = SUNTECH
Patient preparation NV-54/PCECG1200W 27CHAPTER 6: PATIENT PREPARATION The ECG traces quality depends very much on the stability and conductivity of the electrodes during the test, especially during high stages when the patient movements can cause artifacts. Here are some basic rules to ensure good electrical contact: ◊ Shave hair at the electrode contact points ◊ Use a special shirt that attaches the electrodes and lead wires to the body ◊ Use high quality liquid gel electrodes ◊ Make sure that the lead wires do not swing Attach the leads as shown in Figure 5, below (RA=right arm, LA=left arm, RL=right leg, LL=left leg). Figure 5: Electrode Placement
Resting ECG NV-54/PCECG1200W 29CHAPTER 7: RESTING ECG Figure 6: Resting ECG Main Screen Program Menu bar Toolbar Blood pressure systole/diastole (user input) Heart rate (beats/min)Timed recording Selected strip display (strip lead) Multiple lead display Horizontal (mm/sec) and vertical (mm/mV) scale
Instructions for Use and Technical Description Norav Medical Ltd. 30Quick Start To Perform a New Test 1. Click F1 (or the New button on the tool bar). 2. Insert patient details in the dialog box. 3. Click OK. 4. Enter blood pressure. 5. Click F2 to stop data collection or F3 to start data collection (10 seconds). Operation with Function Keys F1 New Recording F2 Start/Stop F3 10 sec. recording F6 Print F11 Open Saved Study Table 6: Operation with Function Keys For an example of a printed report, see Appendix C:, page 111. Resting 12 Lead ECG This application uses the standard 10 contact cables. It contains four limbs (RA, LA, LL, and RL) and six chest (V1-V6) contacts. 12 derivations are recorded and displayed: • 3 Bipolar derivations: I, II, III • 3 Augmented derivations: aVR, aVL, aVF • 6 Unipolar derivations: V1-V6 • You can use a simpler cable with four contacts (only limbs). It produces six derivations only: three Bipolar and three Augmented Leads Placement You can place the leads on the patient in various ways. The usual method is to place the leads in the standard positions on the chest (V1-V6). To identify the placement of
Resting ECG NV-54/PCECG1200W 31the leads, the channels are renamed. Additional options for lead placement are V7-V9, and the Right chest Lead system. To Define the Lead System 1. Click Setup > Lead. 2. Select the lead system to use (Default: Standard). Toolbar Overview The Toolbar (Easy Toolbars Mode) Figure 7: Resting ECG Toolbar Note The icons shown on page 35 are from the full toolbar. You can use the view menu to show an abbreviated display with or without captions. New Print Show patient detailsView/modify QRS values Start/stop Select FiltersOpen Set preferencesAdd remarksSelect leads to display Record 10 seconds
Instructions for Use and Technical Description Norav Medical Ltd. 32Resting ECG Setup Click Setup on the Toolbar to access the following parameters: Tab Option Description Leads Lead Systems Define the lead system to be used and displayed according to the electrode placement on the patient. Choose between Standard, Cabrera, V7-V9, and V3R-V5R lead systems (default: standard system). Default 3 leads Define the 3 leads that will be displayed as default when using 3x1-view format. Default 6 leads Define the 6 leads that will be displayed as default when using 6x1 or 3x2-view format. Strip Lead 10 sec lead to appear in 4x3 and 6x2 formats. ECG Recording Filter 50/60Hz Default is cleared. When checked, the default status of 50/60Hz filter is ON (according to the checked frequency 50 or 60). EMG Filter Default is cleared. When checked, the default status of the EMG filter is ON. Baseline Filter Default is cleared. When checked, the default status of the Baseline filter is ON. Save options If Auto Save is ON, the file is stored by last name or by ID. If Auto Save is OFF, a dialog box is displayed asking the user to enter a file name. Auto stop after 10 sec If cleared (default), recording runs till stopped by the user. If checked, stops recording automatically after 10 sec. Auto Print Use this option for automatic printing of the test at the end of the Rest test. If more than one printer is defined in the network, select the appropriate one from the list. Simulator ECG If cleared (default), ECG recording is done from the PC-ECG unit. If checked, the ECG recording is done from the demo file included in the software package. In this case, the recording unit is not needed. Data Directory Allows the user to define a directory for saved ECG recordings (if ECG database is not used). Use a secondary hard disk, if one is available. Use ECG Database Select this option to connect to the default ECG database. When this option is selected (checked) the ECG tests are saved in the database.
Resting ECG NV-54/PCECG1200W 33Tab Option Description BACKUP Data directory for AutoSave mode When Auto Save option is selected, this allows the user to define a local path for a backup directory. The backup directory is useful when the data directory or database is not on the same computer. In such a case, ECG file save can fail due to failure in connection. Diagnosis Optional. Active only if the measurement option (I1) is installed. ST after J Defines the ST spot relative to the J point. Print Options Allows the user to determine if and when to have automatic results printed. Define if measurements and/or interpretations should be added to printouts. Options are Never, After Confirmation, or Always. View Draw over lead borders If checked (default), does not limit the extreme high amplitude ECG pulses from exceeding the borders. If cleared, chops the pulses at the borders. View calibration pulse 1 mV If cleared (default), the 1-mV pulse will appear only in printing. If checked, the 1-mV pulse will also appear on the screen. Leads Base line shift If cleared (default), the base line of each lead is exactly in the middle of the lead’s area. If checked, a special shift is added to each lead to view its maximum. For example: lead V6, being positive pulsed, gets negative shift. Separate Leads If checked, leads are displayed framed and separated from each other. If cleared, leads are not separated. Default is checked. Draw Grid If checked, displays grid lines when the application is opened. If cleared, the application is opened with no grid lines Default is checked. Horizontal Scale Sets the default value for the horizontal scale window on the screen (mm/sec). Vertical Scale Sets the default value for the vertical scale window on the screen (mm/mV). Rest ECG color selection Allows the user to choose colors for the Rest ECG application for background, traces, grid, and text. Restore Defaults When activated, restores the factory default colors: black for background, yellow for traces, green for grid, turquoise for text. Easy Toolbar Mode If checked, allows the user to use the regular Icons. If cleared, allows the user to use the optional Icons Text Label Adds text to the Icons. Enables use by keyboard.
Instructions for Use and Technical Description Norav Medical Ltd. 34Tab Option Description Installation Saves users’ data (hospital and physician). This data is printed on any print out and sent as email. Measurement Standard Define whether measurements will be calculated according to the metric or the USA standard. Default is metric. Magnetic Card Reader Select this option to use a magnetic card with bar-code to insert patient details. (Select the magnetic card type.) Environment Connection Select the option button (COM port/USB), to choose the port the device should be connected through. If the COM port option is selected, select the serial input for the PC-ECG unit from the COM port selection list. If the USB connection is selected, the COM PC-ECG selection list is disabled. (Default at installation is USB). Display Size Choose between 14/15-inch screen (default) and 17-inch screen. This setting is required in order to display the ECG and grid in the correct scale. Graph paper If set to On, prints 1mm and 5 mm squares on printouts. Regular Grid is guaranteed to fit any printer. Improved Grid shows a fine grid but may not work on some printers. Paper Size Sets paper size. either conventional printer or 4-inch thermal printer. Large Remarks Font Enables large font for user entered free text. Color Printout Select this option for colored printouts. Shadow/Frame For Area of Interest Allows the user to choose between shadow and frame to highlight the interest area. Picture Format AutoSave ECG in Picture FormatSelect this option to save the test automatically as a JPG image. Set File Name By Set the file names to include Patient Last Name or Patient ID. Check date and/or hour to include them in the file name. Picture Format Select the resolution of the picture (normal or high resolution). Picture Directory Set the directory for saved pictures. The default is C:\Program Files\PCECG\Data. GDT/BDT Format Automatic Setup automatic GDT/BDT format. Save test in GDT/BDT If checked, save test automatically to GDT/BDT format. Import from GDT/BDT If checked, imports tests automatically as GDT/BDT format.
Resting ECG NV-54/PCECG1200W 35Tab Option Description File Format Select the file format: GDT or BDT. Import Codepage 437 Check this option to import Code page 437. Export Codepage 437 Check this option to export Code page 437. Edit Labels Click this button to open a dialog box with an editable list of the field labels used in the GDT and BDT files. GDT/BDT Data Directory Define the directory path where the GDT/BDT files should be maintained. Token for PCECG Default is PEKG. Token for Practice EDP Default is EDV1. Text File Auto Save Test Data in Text file Select this option to save the test data in a text file automatically at the end of the rest test. Set Text file Name by Set the text file name according to Test File Name or according to the fields Patient ID and/or Patient Last Name. Text File Data Directory Set the directory path to maintain the text files with the ECG data. Default is C:\Program Files\PCECG\Data. Table 7: Resting ECG Setup Options Toolbar and Menus To do this Click this icon Or use this short-cut keyOr select this menu Description Start a new study F1 File > New Rest Test Starts a new 12 lead recording. The patient data can be entered prior to ECG recording, but this is not mandatory. The recording time is according to the setup for ECG Recording: either continuous or limited to 10 sec. To stop recording, click GO/STOP. Open an existing study F11 File > Open Shows recordings that are saved on disk.
Instructions for Use and Technical Description Norav Medical Ltd. 36To do this Click this icon Or use this short-cut keyOr select this menu Description Import Data from SCP Format File > Import from SCP Format (Select the required file(s) and path from the dialog box and click OK) SCP format is a European format for ECG files. The Rest application can identify these files, import them, and save them as Rest files, either to the database or to the defined folder for the Rest files. Import demographic data from HIS to PC-ECG File > GDT/BDT Format For details see Import from GDT/BDT, page 105 This file always contains the last patient data. Export the GDT/BDT file from PC-ECG to HIS File > GDT/BDT Format For details see Save Test in GDT/BDT page 105 This file always contains the last patient data. Save a recording Ctrl+S File > Save Saves recording on disk (default file name: REST). Send results via email File > Send Sends recording data via email. If the large icons are used the operation must be performed through the FILE menu Prerequisites: e-mail software package, modem, and internet provider (not included in the PC-ECG 1200 package). Once an ECG study is displayed on the screen of the transmitting side, click this icon to attach the ECG file and send an e-mail to a specified address. The receiver must have the PC-ECG 1200 software installed. A regular email is sent with the ECG as an attached file. The receiver can either double click the file to display the ECG on the screen, or save it in the PC-ECG 1200 studies default directory. Export to MATLAB format Ctrl+E File > Export to Matlab Format Saves ECG results in MATLAB format. (For details see Using the Matlab Feature within PC-ECG 1200, page 39).
Resting ECG NV-54/PCECG1200W 37To do this Click this icon Or use this short-cut keyOr select this menu Description Create a text file File > Create Text File Saves ECG data in text format. Save the test as an image File > Save ECG to Picture FormatSaves ECG test as a JPG image. Print a miniature printout of results File > Print Average Mini Card Prints results as a mini-card that can be carried in the pocket or wallet. Print results F6 File > Print Prints the recordings currently shown on the screen. Note that the 1-mV signal is always printed. Set preferences View > Setup Allows the user to set preferences for Leads, ECG Recording, Diagnosis, View, Installation, Environment, Picture Format, GDT/BDT Format, and Text File. For details see Table 7, page 35. Display program, hardware, and contact information Help > About Displays software version number (which should be quoted on any software inquiry) software key, and permissions; Norav contact information; memory size and free disk space; HASP ID number (ID of existing software keys). This ID number is used for adding software options. Print patient data — View > Patient Data Can be added to the recording. It will be printed together with ECG traces. If the recording is saved, then the PATIENT DATA will be saved together with the ECG traces. Use the Previous option if the same patient undergoes a second study. Add remarks — View > Remarks\ Interpretation Allows the user to enter free text during or after the ECG recording. This is printed and saved together with ECG traces. If the Interpretation option is installed, then Interpretation Statements is also displayed.
Instructions for Use and Technical Description Norav Medical Ltd. 38To do this Click this icon Or use this short-cut keyOr select this menu Description View and modify QRS values — View > Measurements An optional feature that requires a software key (I1 or I2 license). Displays a comprehensive table of measured values. You can alter the values either by editing them in the table or by using Caliper to change the horizontal and vertical markers. When Caliper is activated, a large QRS is shown with the standard markers. Open the Standard Markers window (upper right side) and select the QRS interval of interest for modification. The area changes to blue. Use the mouse to move the markers. (For details see Measurements/ Interpretation, page 85). Display/hide the grid — View > Grid Displays or hides the 5mm raster grid. Print outs are always with 1mm raster. Display information from different leads (5 options) Display 3x4 — View > Leads Format > 3x4 Windows Classical format. 12 lead ECG of 2.5sec ECG + 10sec trace.* Display 6x2 — View > Leads Format > 6x2 Windows 12 lead ECG of 5sec ECG + 10sec trace.* Display 12x1 — View > Leads Format > 12 Leads 12 lead ECG of 10sec ECG.* Display 6x1 — View > Leads Format > 6 Leads 6 lead ECG of 10sec ECG.* Display 3x1 — View > Leads Format > 3 Leads 3 lead ECG of 10sec ECG.* View/print averages — Produces a typical QRS for every lead from the raw ECG data. The averages can be printed either full size or minimized in a credit card size. To perform a miniature print, enter FILE and then PRINT MINIATURE.

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