MidMark IQmark ECG Service manual
Version 8.0.1
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Style B
OPERATION MANUAL
Part Number: 3-100-1021 Revision 8.0.1B
IQmark Digital ECG Operation Manual
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TABLE OF CONTENTS
A WORD OF THANKS ................................................................................................. III
PRECAUTIONS ............................................................................................................ V
I. GENERAL INFORMATION ............................................................................... 1
A. DESCRIPTION ............................................................................................................ 1
B. NECESSARY COMPUTER SKILLS...................................................................................... 2
C. CONFIGURATIONS ...................................................................................................... 2
Typical PC Configuration ....................................................................................... 2
Thin Client Configurations .................................................................................... 2
D. SYSTEM SPECIFICATIONS .............................................................................................. 5
II. SYSTEM INSTALLATION ................................................................................. 6
A. COMPUTER REQUIREMENTS ......................................................................................... 6
B. HARDWARE SETUP ..................................................................................................... 6
C. SOFTWARE INSTALLATION ............................................................................................ 7
Windows Taskbar ................................................................................................. 7
Screen Saver .......................................................................................................... 8
Installation Steps for IQmark Diagnostic Workstation .......................................... 8
D. CONNECTING THE IQMARK DIGITAL ECG MODULE .......................................................... 8
Serial-Type ECG module ........................................................................................ 8
USB-Type ECG module .......................................................................................... 8
E. CONFIGURING THE IQMARK DIGITAL ECG ...................................................................... 9
Configuring for Serial-Type ECG Module ............................................................ 10
Configuring for USB-Type ECG Module............................................................... 10
Thin Client Channel Setting ................................................................................. 10
Database Settings ............................................................................................... 11
List Management ................................................................................................ 11
ECG Settings ........................................................................................................ 13
III. OPERATION ................................................................................................. 19
A. INTRODUCTORY NOTES ............................................................................................. 19
B. PREPARATION ......................................................................................................... 19
Instructions for Performing ECG Acquisition ...................................................... 20
C. STARTING THE PROGRAM .......................................................................................... 21
D. OPENING SCREEN .................................................................................................... 21
STAT ECG ............................................................................................................. 22
E. TESTING A NEW PATIENT .......................................................................................... 23
Live ECG .............................................................................................................. 24
F. REVIEWING PATIENT REPORTS .................................................................................... 26
ECG Report Review ............................................................................................. 27
Editing Diagnostic Statements ........................................................................... 27
ECG Report (Details) Review ............................................................................... 28
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Serial Comparison ............................................................................................... 30
RR Variability Report Review .............................................................................. 31
APPENDIX ................................................................................................................ 33
A. OPERATIONS AT A GLANCE ........................................................................................ 33
B. TROUBLESHOOTING GUIDE ........................................................................................ 34
C. MAINTENANCE AND STORAGE OF THE ECG MODULE ..................................................... 38
Preventative Inspection ...................................................................................... 38
Cleaning .............................................................................................................. 38
Storage................................................................................................................ 38
D. MAINTENANCE AND STORAGE OF 10-LEAD RESTING ECG PATIENT CABLE .......................... 38
Instructions for Use ............................................................................................. 38
Cleaning .............................................................................................................. 39
Disinfection ......................................................................................................... 39
E. RADIO AND TELEVISION INTERFERENCE......................................................................... 40
F. EMC REQUIREMENTS FOR THE IQMARK DIGITAL ECG .................................................... 40
G. CUSTOMER SUPPORT ................................................................................................ 45
Warranty............................................................................................................. 45
Return Materials Authorization .......................................................................... 45
Shipping .............................................................................................................. 45
H. SAFETY AND INTERNATIONAL SYMBOLS ........................................................................ 46
I. GLOSSARY .............................................................................................................. 47
IV. IQMARK DIGITAL ECG SERVICE MANUAL ..................................................... 48
A. INTRODUCTION ........................................................................................................ 48
B. THEORY OF OPERATION ............................................................................................ 48
10-Leadwire Patient Cable.................................................................................. 49
ECG Buffer Amplifiers ......................................................................................... 49
Instrumentation Amplifiers ................................................................................. 49
Filters and Gain Amplifiers ................................................................................. 50
Analog to Digital Conversion .............................................................................. 50
Microcontroller ................................................................................................... 50
Isolated Serial Interfaces .................................................................................... 51
Lead-Off Detector ............................................................................................... 51
Pacemaker Detector ........................................................................................... 51
DC-DC Power Converter ...................................................................................... 51
C. SYSTEM MAINTENANCE AND OBTAINING SERVICE .......................................................... 52
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A Word of Thanks
Thank you for purchasing the IQmark Digital ECG. Midmark has used the latest
microelectronic and computer software technology to develop a compact, lowmaintenance and high-quality ECG system. Our goal is to enable healthcare
professionals to provide quality and efficient patient care. With that in mind, our
product is designed with intuitive layouts and features that will enable more physicians
to conduct office-based tests, which will result in more timely diagnoses and enhanced
patient outcomes.
We believe you will be pleased with the user-friendly operation of our product and with
your results. As your partner in healthcare, we look forward to working with you in the
coming years as we develop even more sophisticated diagnostic technology for the
cardiopulmonary field. Your thoughts, questions, and comments about our product are
welcomed.
Midmark Diagnostics Group.
800-624-8950, ext. 2
www.midmark.com
Caution: Federal Law restricts this device to sale by or on the order of a physician.
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IQmark Digital ECG Operation Manual
Physician’s Responsibility
The interpretations provided by the Midmark IQmark Digital ECG are for the exclusive
use of licensed physicians or personnel under their direct supervision. Not all ECG
abnormalities can be detected by computerized / automated ECG analysis algorithm.
The suggested interpretation, including numerical and graphical results, should be
examined with respect to the patient’s overall clinical condition.
It is the responsibility of the physician to ensure proper administration of the test,
making a diagnosis, obtaining expert opinions on the results, and instituting the correct
treatment.
Notice
The information in this manual is subject to change without notice.
Midmark Diagnostics Group shall not be liable for technical or editorial omissions made
herein, nor for incidental or consequential damages resulting from the furnishing,
performance, or use of this guide.
This document may contain proprietary information protected by copyright. No part of
this document may be photocopied or reproduced in any form without prior written
consent from Midmark Diagnostics Group.
IQmark and IQpath are registered trademarks of Midmark Diagnostics Group.
Windows is a registered trademark of Microsoft Corporation.
Pentium is a registered trademark of Intel Corporation.
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Precautions
Read the following precautions to ensure proper operation of this instrument.
1. Familiarize yourself thoroughly with the operations and procedures of the
instrument prior to use.
2. Installation and maintenance of the instrument:
Install and keep the instrument away from splashing water.
Do not install the instrument where humidity, ventilation, direct sunlight or
air containing dust, salt, sulfur, etc. might affect it.
Protect the instrument from shock and vibration while transporting it.
Do not install the instrument in a chemical storage area or where gas is
generated.
3. Preparation of the instrument prior to operation:
Verify proper instrument operation.
Check that all cable connections are safe and secured.
When in use with additional equipment, such as a computer, request the
assistance of personnel familiar with the additional equipment, if needed.
4. Observe the patient and instrument closely during use. If any abnormality is
observed, immediate proper action, such as stopping the operation of the
instrument, should be taken for the safety of the patient.
5. Keep the instrument clean to ensure trouble-free operation for the next use.
6. In case of a malfunction, call a Midmark Support Services at (800) 624-8950, ext. 2
and describe the problem precisely.
7. Inspect the instrument and accessories regularly.
8. Do not make any modifications to the instrument.
9. Environmental operating limits:
Operation:
59 to 95 °F (15 to 35 °C)
30 to 75% humidity (non-condensing)
760mm Hg +/- 20%.
Storage/Shipping (batteries removed):
4 to 120 °F (-15 to 50 °C)
30 to 95% humidity (non-condensing)
760mm Hg +/- 20%
DANGER: There is a possible explosion hazard if used in the presence of flammable
anesthetics.
10. The IQmark Diagnostic Workstation and ECG have been tested for proper function
with the Off-The-Shelf (OTS) Operating Systems (OS) specified in this manual. Do
not operate the IQmark Diagnostic Workstation and ECG with an operating system
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other than the OTS OS specified. Future releases of currently approved operating
systems should not be used until Midmark has had an opportunity to test the ECG
with them. Before updating your operating system, contact Midmark for the latest
OTS operating systems information.
CAUTION: Replace the patient cable with Midmark patient cables equipped with
built-in defibrillation protection. Contact Midmark for cable replacement.
CAUTION: Contact Midmark for any servicing questions.
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I. General Information
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A. Description
IQmark Digital ECG Operation Manual
Figure 1-0 The IQmark Digital ECG (serial-type - with On/Off switch)
Figure 1-1 The IQmark Digital ECG (USB-type - without On/Off switch)
NOTE: This manual is intended for IQmark Diagnostic Workstation users. If you are
using your IQmark Digital ECG through an EMR, please contact Midmark
Support Services for assistance with installation, setup and operation.
The IQmark Digital ECG is a portable device that converts a supported Microsoft
Windows-based personal computer (PC), be it desktop, laptop, notebook or pen-based,
to an electrocardiograph with interpretive capabilities. The device is electronically
isolated from the PC and connects to it directly through the USB port or serial port.
Together with IQmark Diagnostic Workstation, the IQmark Digital ECG makes it easy to
record 12-lead ECG, interpret them, archive the reports for future reference and share
them with your colleagues via networks or email. As simple to use as a traditional office
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ECG device, it features fully integrated PC technology and a host of advanced diagnostic
features.
NOTE: There are two types of IQmark Digital ECG acquisition modules: a serial
(COM) port type and a USB port type, both are designed for use with a
Microsoft-based computer. The serial-type ECG module requires batteries
and has a power switch, indicated by ; the USB-type ECG module does not
require batteries and does not have a power switch. This manual is written
for both types of modules.
B. Necessary Computer Skills
This manual assumes that you are already capable of using Windows-based applications,
that you have some understanding of how a PC works, and that you are familiar with the
basic operations of Microsoft Windows. If this is true, you will have no problem using
the product. However, in the event that you have any technical questions or problems,
please refer to Appendix B, Troubleshooting Guide for immediate assistance. Support
Services information is listed in Appendix G, Customer Support.
C. Configurations
Typical PC Configuration
The block diagram below illustrates the standard configuration of the IQmark Digital
ECG system. The primary components are a Windows-based PC, a printer, and the
IQmark Digital ECG acquisition module. A portable computer is recommended if mobility
is a consideration. Please refer to this diagram when setting up your IQmark Digital ECG
system.
Figure 1-2 Block Diagram for the IQmark Digital ECG system
Thin Client Configurations
If you have a thin client environment, you can install the software on the Terminal
Server and operate the IQmark Digital ECG through a thin client terminal.
IQmark Diagnostic Workstation supports two thin client configurations: IQpath Virtual
Channel Solution and COM port mapping. IQpath uses either USB or serial port versions
of the IQmark Digital ECG in high-latency, limited bandwidth network configurations
with Windows-based PC clients. For non-Windows thin client devices on low-latency
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high-speed networks, use the serial port versions of the IQmark Digital ECG and connect
to client devices via COM port mapping.
Setting up any application in a network environment typically requires special access
rights and knowledge of the network. Please have your system administrator install and
configure the IQmark Diagnostic Workstation to your office environment.
Thin Client Using the IQpath Virtual Channel Solution
IQpath provides the following advantages over COM port mapping:
Improved performance on high-latency, low-bandwidth, high-loss networks.
o Microsoft Terminal Services: Improvement is approximately 10-to-1 in
latency tolerance.
o Citrix ICA: Improvement is approximately 40-to-1 in latency tolerance.
No COM port mapping is required.
The USB version of the ECG module is compatible.
Improved device auto-configuration and diagnostics.
NOTE: IQpath has specific requirements for computer hardware, software and
network performance. System administrators should read Setup Manual:
IQpath Thin Client Virtual Channel Software before installing, configuring and
using this software in a thin client environment.
The following block diagram describes IQpath. In this thin client environment, the client
computers must be running Windows XP SP2 or Windows Vista:
To use IQpath, load IQmark Workstation on the terminal server and install one of the
following software components on each client PC that you intend to use for data
acquisition:
IQpath for Microsoft Terminal Services if you are using Microsoft Terminal
Services (Microsoft RDP).
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IQpath for Citrix ICA if you are using Citrix software on your clients and servers.
These software products are provided separately and may be obtained by contacting
Midmark at (800) MIDMARK (643-6275).
Once you have installed the software on the server and client computers, you must
configure the software for virtual channel operation as described in Section II-D
Connecting the IQmark Digital ECG Module and Section II-E Configuring the IQmark
Digital ECG.
Thin Client Using COM Port Mapping
COM port mapping refers to a configuration in which the ECG device connects to a serial
port of the client and the server is configured so that logical COM ports on the terminal
server are mapped to the physical COM ports of the client.
If you are using non-Windows-based thin client terminal devices on a low-latency, highspeed network you must use the serial port versions of the ECG device and configure
the thin client server for COM port mapping.
NOTE: In order to use the COM port mapping solution in a thin client environment,
the computer hardware and software as well as the network must meet
stringent performance requirements. System administrators must read the
document Setup Manual: Midmark Products over Thin Client Environments
before installing, configuring and using this software in a thin client
environment using COM port mapping.
The following block diagram illustrates the use of the ECG device in a thin client
environment using COM port mapping:
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IQmark Digital ECG Performance Specifications
Category
Specification
Intended Use
To provide 12-lead resting electrocardiograms, which permit the
detection of abnormalities in the transmission of the cardiac impulse
through the heart muscle; serves as an important aid in the diagnosis
of heart ailments.
Physical
Characteristics
2.8” (7.1 cm) x 5” (12.7 cm) x .88” (2.3 cm) (W x L x H)
0.56 lb. (USB-type ECG module without batteries)
0.66 lb. (serial-type ECG module with batteries)
Two 1.5V AA alkaline batteries (serial-type ECG module only)
25 hours of “ON” time (serial-type ECG module)
Anatomical Sites
Noninvasive device, 12-lead electrocardiogram
Safety Parameters
Patient electrically isolated from main current supply.
Patient leakage current not to exceed 10 uA.
Ground leakage current not to exceed 50 uA.
ECG Acquisition
12 leads, simultaneous.
Input impedance > 100 MegaOhm
Frequency response 0.05-150 Hz –3 dB
Sensitivity: 5, 10, 20 mm/mV +/- 10%
Dynamic range: +/- 10 mV
ADC resolution: 13 bits at 2.44 uV/bit
Acceptable electrode offset: +/- 300 mV per AAMI and EC-11
specifications.
A/D 500 samples/sec.
Patient Connection
10-lead patient cable with RFI filter, defibrillator protection and
patient isolation.
Monitor
Varies by computer system, minimum 800x600 resolution
ECG Analysis &
Measurement
Midmark 12-Lead Resting Electrocardiogram Analysis Program.
Printer
Windows-supported ink-jet or laser printer.
Paper
Plain 8.5” x 11” (Letter size) or 210 mm x 297 mm (A4 size)
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To use the ECG device in this configuration, install IQmark Diagnostic Workstation on the
terminal server and configure the server to map to the COM port on the client terminal.
System administrators should configure the terminal server for COM port mapping as
described in the document entitled Setup Manual: Midmark Products over Thin Client
Environments.
D. System Specifications
The following are the physical and performance specifications for the IQmark Digital
ECG:
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II. System Installation
NOTE: Please call Midmark Support Services before installing and seting up your
IQmark Digital ECG. Computers today are more complex than ever, coming
with wide variations of software and hardware options, making your
computer almost unique. Midmark wants to make sure that your ECG device
is installed and configured as quickly and easily as possible. Please call 1-800624-8950, ext. 2, and Support Services will make sure your system is up and
running in no time.
A. Computer Requirements
The IQmark Digital ECG system employs 32-bit Windows-based medical software. In
order to install and successfully use the ECG system, your computer must meet the
following minimum requirements:
Microsoft Windows-based PC with Windows 2000, XP or Vista
Hard disk with a capacity of at least 1 GB of free space
CD-ROM drive
Intel Pentium IV or compatible microprocessor with 2.0 GHz or faster CPU speed
VGA display accommodating 1024x768 or higher resolution with 16-bit color; for
ease of use, a touch-screen flat-panel 17” or larger display is recommended.
Minimum 1GB of RAM
Microsoft Windows-compatible mouse
Microsoft Windows-compatible keyboard
One high-speed serial port (115 KB per second) or an USB port
B. Hardware Setup
1. Remove the IQmark Digital ECG from its packaging and verify that you have the
following items:
IQmark Digital ECG data acquisition module
Operation manuals CD
Patient cable (10-lead)
10 universal clips
Package of electrodes
Four (4) AA alkaline batteries (for serial-type ECG module)
USB to serial port adapter (for serial-type ECG module)
NOTE: Please call your Midmark rep or Support Services to order an IQmark
Diagnostic Workstation Installation CD, if needed.
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Patient Cable Connection
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2. For the serial-type ECG module, slide out and remove the battery door
underneath the module and install 2 AA batteries. Be sure to follow the
battery positions indicated. Replace the battery compartment door.
For the USB-type ECG module, no batteries are required.
3. Attach the patient cable to the 15-pin connector on the ECG acquisition module.
Figure 2.0 IQmark Digital ECG Acquisition Module.
C. Software Installation
NOTE: The following software installation information refers to IQmark Workstation
only. If you are using your IQmark Digital ECG through an EMR, please
contact Midmark Support Services for assistance with installation and setup.
The medical diagnostic application, IQmark Digital ECG, uses IQmark Diagnostic
Workstation to manage patient records. When you install or upgrade the IQmark Digital
ECG, IQmark Workstation is automatically installed or upgraded accordingly (see IQmark
Diagnostic Workstation Operation Manual for further information).
You can also access other Midmark products, such as the IQmark Digital Holter, IQmark
Digital Spirometer, Digital Stress, Vital Signs Interface and Weight/Scale Interface from
IQmark Diagnostic Workstation. Call Midmark Sales Department for the latest
information on available Midmark products.
NOTE: If you already have IQmark Diagnostic Workstation installed on your
computer and you are now either upgrading or adding a new Midmark
product, please skip this section and refer to the IQmark Diagnostic
Workstation Operation Manual for installation information.
Before installing IQmark Diagnostic Workstation on your computer, it is important that
you understand and carry out the following tasks:
Windows Taskbar
IQmark Diagnostic Workstation is designed to run as a full-screen program. For best
results, the Windows Taskbar should not be displayed in order to provide maximum
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display area. Place the mouse pointer on the blank portion of the Taskbar on the bottom
of the screen, then right-click and select Properties. Check the Auto-hide the taskbar
box to hide the taskbar when it is not in use; to display the taskbar when it is hidden,
move your mouse cursor over the area where your taskbar is normally set, and it will
reappear.
Screen Saver
If a screen saver or any energy saving feature is enabled on the computer, make sure
that it does not activate and interfere with data acquisition during patient care. Refer to
your computer or software manual for these settings.
Installation Steps for IQmark Diagnostic Workstation
NOTE: Close all Windows programs before installing this software. Do not interrupt
the installation program while it is running. The installation should take less
than five minutes.
1. Insert the IQmark Diagnostic Workstation Installation CD into the CD-ROM or DVD-
ROM drive. The installation starts automatically. If the installation does not start
automatically, double-click My Computer on the desktop and double-click the CDROM icon to start.
2. Follow the instructions on the screen. For detailed installation, setup and detailed
operation instructions, please refer to the IQmark Diagnostic Workstation Operation
Manual.
D. Connecting the IQmark Digital ECG Module
Serial-Type ECG module
If you have a serial-type ECG module, attach the female end of the 9-pin communication
cable to any available serial port on the PC. If you are using a USB port with the serialtype ECG module, install the USB to serial port adapter before you connect the ECG
module to the Adapter. Secure the connections with the thumbscrews. Do not overtighten.
NOTE: Almost all USB to serial port adapters come with specific software drivers
that must be installed prior to use. Before connecting the ECG module to any
adapter, ensure that all software drivers have been installed according to the
manufacturer’s instructions.
USB-Type ECG module
If you received a USB-type ECG module, you can connect it to any available USB port on
the computer after IQmark Diagnostic Workstation is installed. As with other USB
devices, Windows will attempt to identify the ECG module the first time it connects to it.
This may take a few seconds.
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E. Configuring the IQmark Digital ECG
Through the IQmark Configuration program, you can customize IQmark Diagnostic
Workstation and the IQmark Digital ECG for your operation. If you are using the
database on your local and network computers, the configuration program also enables
you to set your default database.
The configuration program can be accessed from the desktop by double-clicking the
IQmark Configuration icon:
The IQmark Configuration Settings dialog box appears:
Complete the Institution Name and Institution Address boxes with information about
your medical practice. The IQmark Digital ECG will display your institution name on each
of the procedure screens and on printed reports. Enter a name that describes your
practice or operation to enable other medical personnel to identify your reports.
You may choose between Metric and English units of measurement, and between the
AC power source frequencies of 50 Hz or 60 Hz. The IQmark Digital ECG uses the latter
information to filter out background noise introduced by the power source through its
AC filter. In the United States, this frequency is 60 Hz. If you are using this product
outside of the United States, please consult with the local power utility company to
determine the appropriate frequency.
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Configuring for Serial-Type ECG Module
If you have a serial-type ECG module, you can select the serial port for the ECG module
in the configuration screen. Click Serial Port to open the following dialog box:
NOTE: The default serial communications port is COM 1.
Click Auto Detect to find the port that the ECG module is connected to; the ECG module
must be connected to an available serial port on the computer. Confirm that a fresh set
of batteries is installed in the ECG module and click Auto Detect for ECG COM ports. The
result appears on the screen. Some ECG modules may need to be turned on manually
for Auto Detect to work; press the switch to turn on the module.
Configuring for USB-Type ECG Module
If you received a USB-type ECG module and it is already connected to the computer, the
ECG COM Port setting will be disabled once it is detected.
Thin Client Channel Setting
The Thin Client Channel setting applies only if you are using IQmark Diagnostic
Workstation in a thin client environment. This setting is ignored when the software is
not running in a thin client environment. The drop-down list contains the following
selections:
COM port mapping (default)
Microsoft RDP
Citrix
Select COM port mapping if you are using IQmark Diagnostic Workstation in a thin client
environment and are not using IQpath. If you are using IQpath, select Microsoft RDP or
Citrix, depending on what your clients and servers are using. Please refer to the Setup
Manual: IQpath Thin Client Virtual Channel Software for more information.
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Database Settings
IQmark Diagnostic Workstation uses the local database by default. If using a network
database, you can set the default to be either the local or network by clicking Database
Settings on the IQmark Configuration screen.
Select a network database as the default by checking the Enable Network Database box
then clicking Network. Refer to the IQmark Diagnostic Workstation Operation Manual
for more details.
IQmark Diagnostic Workstation allows you to archive the ECG reports from the database
as individual files. It also allows you to send the ECG reports using your default email
program. The default format for this report is Compressed Archive Report (*.car). The
SCP-ECG (*.scp) format is more popular in the European countries.
If you have purchased a Midmark Holter product, you also have the choice to select a
different location to store your Holter ECG files.
List Management
List Management enables you to add or customize medications, history statements, race
categories, ECG/Holter indications and ECG diagnostic statements. You can also enter
the doctors and technicians using IQmark Diagnostic Workstation. Once these lists are
entered, you can later select them from the appropriate lists in the test without having
to retype them.
Click List Management in the Configuration screen and choose to configure the lists for
your local database or network database. If the network database is not setup, the
Network Database selection will be disabled as shown below.
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