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

Norav Medical Ltd. WIRELESS ECG RECORDING SYSTEM PCECG1200WR Revised UserMan

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USERS MANUAL 1

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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
Cau t io n
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 POTETIAL SIGAL AVERAGIG 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 1
CHAPTER 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:
Warnings call attention to possible hazards involving potential damage or injury to
persons.
W A RN ING
Cautions refer to practices necessary to protect against potential damage or loss to
equipment. Pay careful attention to instructions.
Cau t io n
Notes provide pertinent information to help obtain optimum performance from
the software or signify an important step or procedure that requires special
attention.
No te
NV-54/PCECG1200W
Instructions for Use and Technical Description
Abbreviations 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.
Norav Medical Ltd.
Overview
CHAPTER 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)
NV-54/PCECG1200W
Instructions for Use and Technical Description
Programs
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)
Records and measures ECG tests on patients under stress conditions using a predefined test protocol. The stress test includes 3 basic stages:
• Rest
Stress
• 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)
Norav Medical Ltd.
Overview
Indications 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.
NV-54/PCECG1200W
6
Instructions for Use and Technical Description
Contraindications for Use and Adverse Effects
The device has no contraindications or adverse events.
Norav Medical Ltd.
Software Installation
CHAPTER 3:
SOFTWARE
INSTALLATION
System Requirements and Prerequisites
Hardware
Stress application with real-time printout is resource intensive.
No te
To optimize performance, we recommend that you disable “Start Up” programs to
free system resources. For instructions, see Windows help.
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.
No te
PC Minimum Configuration
Application
CPU Speed
(MHz)
RAM Memory
(MB)
Disk Space (GB)
Number
of Free
RS232 or
USB Ports
Rest
100
32
Monitoring
Application
200
32
LP
450
128
HRV
450
128
Database
200
64
Stress
1000
128
20
Stress + R
trigger
1300
128
20
Stress + Blood
pressure
monitor
1500
128
20
Table 1: Minimum Computer Configuration
NV-54/PCECG1200W
Instructions for Use and Technical Description
Installing Printers
Application
Technology
RAM Memory
(MB)
Driver
Rest
LASER/INK
Vendor / MS
Monitoring Application
LASER/INK
Vendor / MS
LP
LASER/INK
Vendor / MS
HRV
LASER/INK
Vendor / MS
Database
LASER/INK
Vendor / MS
Stress
Fast LASER
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: ":\MP200\OEMPRINT.inf".
Installing or Updating The PC Software
Install the software before installing the hardware. If the device is connected to the
PC, disconnect the device before installing the software.
No te:
The software package works under Windows NT, 98, ME, 2000, and XP operating
systems.
Norav Medical Ltd.
Software Installation
To 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:
Icons are displayed only for those programs for which you have purchased the
license
No te:
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
NV-54/PCECG1200W
Instructions for Use and Technical Description
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:
Norav Medical Ltd.
Software Installation
To 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).
NV-54/PCECG1200W
11
Instructions for Use and Technical Description
12
To 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.
Norav Medical Ltd.
Hardware Installation 13
CHAPTER 4:
HARDWARE
INSTALLATION
Safety
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.
W A RN ING
•
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.
NV-54/PCECG1200W
Instructions for Use and Technical Description
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.
No te
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.
Install hardware only after software installation.
No te
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
Norav Medical Ltd.
Hardware Installation 15
Installing 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
NV-54/PCECG1200W
Instructions for Use and Technical Description
16
Figure 3: USB Cable
Norav Medical Ltd.
Hardware Installation 17
To Connect Via USB
Make sure the device is switched off Cautions refer to practices necessary to
protect against potential damage or loss to equipment.
Cau t io n
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.
NV-54/PCECG1200W
Instructions for Use and Technical Description
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
The device is not waterproof. Do not expose the device to water or any kind of
liquid. Maintain in a dry place.
Cau t io n
1.
Use alcohol pads to clean the device of moisture and hairs.
2.
Replace the pouch or wash it at 300C.
Norav Medical Ltd.
Hardware Installation 19
Calibration
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.
NV-54/PCECG1200W
Instructions for Use and Technical Description
20
Connecting 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.
Norav Medical Ltd.
Accessories Installation
CHAPTER 5:
21
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=
D/A1=
WAIT STATE=
-5
-5
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
D1-a
Treadmill
300H. switches 8,9
DOWN the rest UP
Out 1
pin no.
on D25
connector
Out 2
pin no.
on D25
connector
Speed
Grade
pin : 24
pin: 18
Analog control
Power
D1-a
Ergometer
300H. switches 8,9
DOWN the rest UP
pin : 24
Analog control
D1-s
Metabolic
Interface
D1-t
ECG Trigger
304H. switches 8,9,2
DOWN the rest UP
308H. switches 8,9,3
DOWN the rest UP
Heart Rate
Work Load
pin: 24
pin: 18
TTL OUT
pin: 24
Table 4: D/A Board 0 to+4 Volt
NV-54/PCECG1200W
Instructions for Use and Technical Description
22
Settings 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
D1-a
Treadmill
300H. switches 8,9
DOWN the rest UP
300H. switches 8,9
DOWN the rest UP
304H. switches 8,9,2
DOWN the rest UP
Analog control
D1-a
Ergometer
Analog control
D1-s
Metabolic
Interface
Out 2
pin no.
on D25
connector
Speed
Grade
Pin: 23
pin: 17
Power
pin: 23
Heart Rate
Work Load
pin: 23
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.
Norav Medical Ltd.
Accessories Installation
23
PCI 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.
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.
No te
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.
NV-54/PCECG1200W
Instructions for Use and Technical Description
24
Installation of the TANGO Automatic BP Unit
No te
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.
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
Norav Medical Ltd.
Accessories Installation
2.
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
NV-54/PCECG1200W
25
Patient preparation
CHAPTER 6:
27
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
NV-54/PCECG1200W
Resting ECG
CHAPTER 7:
Program
Timed
recording
RESTING ECG
Menu bar
Toolbar
Selected strip
display (strip
lead)
Blood pressure
systole/diastole
(user input)
Multiple lead
display
Figure 6: Resting ECG Main Screen
NV-54/PCECG1200W
Heart rate
(beats/min)
Horizontal
(mm/sec) and
vertical
(mm/mV) scale
29
Instructions for Use and Technical Description
30
Quick 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
Norav Medical Ltd.
Resting ECG
31
the 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)
New
Print
Open
Show patient
details
Set
preferences
View/modify
QRS values
Add
remarks
Start/stop
Select leads
to display
Select
Filters
Record 10
seconds
Figure 7: Resting ECG Toolbar
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.
No te
NV-54/PCECG1200W
Instructions for Use and Technical Description
32
Resting 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.
Default is cleared.
ECG Recording
Filter 50/60Hz
EMG Filter
Baseline Filter
When checked, the default status of 50/60Hz filter is ON (according to
the checked frequency 50 or 60).
Default is cleared.
When checked, the default status of the EMG filter is ON.
Default is cleared.
When checked, the default status of the Baseline filter is ON.
If Auto Save is ON, the file is stored by last name or by ID.
Save options
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.
Auto Print
If checked, stops recording automatically after 10 sec.
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.
If cleared (default), ECG recording is done from the PC-ECG unit.
Simulator ECG
Data Directory
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.
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.
Norav Medical Ltd.
Resting ECG
Tab
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
View
33
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.
If checked (default), does not limit the extreme high amplitude ECG
pulses from exceeding the borders.
Draw over lead
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.
If cleared (default), the base line of each lead is exactly in the middle of
the lead’s area.
Leads Base line
shift
If checked, a special shift is added to each lead to view its maximum. For
example: lead V6, being positive pulsed, gets negative shift.
If checked, leads are displayed framed and separated from each other.
Separate Leads
If cleared, leads are not separated.
Default is checked.
If checked, displays grid lines when the application is opened.
Draw Grid
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
Text Label
If checked, allows the user to use the regular Icons.
If cleared, allows the user to use the optional Icons
Adds text to the Icons.
Enables use by keyboard.
NV-54/PCECG1200W
Instructions for Use and Technical Description
34
Tab
Option
Description
Saves users’ data (hospital and physician). This data is printed on any
print out and sent as email.
Installation
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.)
Select the option button (COM port/USB), to choose the port the device
should be connected through.
Environment
Connection
If the COM port option is selected, select the serial input for the PCECG 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.
If set to On, prints 1mm and 5 mm squares on printouts.
Graph paper
Regular Grid is guaranteed to fit any printer.
Improved Grid shows a fine grid but may not work on some printers.
Paper Size
Large Remarks
Font
Picture Format
GDT/BDT Format
Sets paper size. either conventional printer or 4-inch thermal printer.
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.
AutoSave ECG
in Picture Format
Select 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.
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.
Norav Medical Ltd.
Resting ECG
Tab
Text File
35
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.
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
shortcut key
Or 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.
NV-54/PCECG1200W
Instructions for Use and Technical Description
36
To do this
Click
this
icon
Or use
this
shortcut key
Import Data
from SCP Format
Import
demographic
data from HIS to
PC-ECG
Description
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.
File >
GDT/BDT
Format
This file always contains the last patient data.
For details see
Import from
GDT/BDT,
page 105
File >
GDT/BDT
Format
Export the
GDT/BDT file
from PC-ECG to
HIS
Save a
recording
Or select this
menu
For details see
Save Test in
GDT/BDT
page 105
Ctrl+S
File > Save
This file always contains the last patient data.
Saves recording on disk (default file name: REST).
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).
Send results via
email
File > Send
Export to
MATLAB format
File > Export
to Matlab
Format
Ctrl+E
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.
Saves ECG results in MATLAB format.
(For details see Using the Matlab Feature within PCECG 1200, page 39).
Norav Medical Ltd.
Resting ECG
Click
this
icon
Or use
this
shortcut key
37
Or 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 Format
Saves 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.
File > Print
Prints the recordings currently shown on the screen.
Note that the 1-mV signal is always printed.
To do this
Print results
F6
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
Print patient
data
Add remarks
Help > About
—
View > Patient
Data
—
View >
Remarks\
Interpretation
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.
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.
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.
NV-54/PCECG1200W
Instructions for Use and Technical Description
38
To do this
Click
this
icon
Or use
this
shortcut key
Or select this
menu
Description
An optional feature that requires a software key (I1 or I2
license).
View and
modify QRS
values
—
View >
Measurements
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 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.*
Display
information from
different leads (5
options)
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.
Norav Medical Ltd.

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